Health Committee Report on the Kenya drugs authority bill no.54 of 2022 (1)

THENATIONALASSEMBLY THIRTEENTHPARLIAMENT-SECONDSESSION-202S

DIRECTORATEOFDEPARTMENTALCOMMITTEES DEPARTMENTALCOMMITTEEONHEALTH

REPORTON:

THEKENYADRUGSAUTHORITYBILL(NATIONALASSEMBLYBILLNO.54OF 2022)

CLERKSCHAMBERS DIRECTORATEOFDEPARTMENTALCOMMITTEES PARLIAMENTBUILDINGS NAIROBI

SEPTEMBER.202S

TABLEOFCONTENTS

| LISTOFANNEXURES 2 | |---------------------------------------------------------------------------------| | CHAIRPERSON'SFOREWORD 3 | | PART ONE. | | 1.0PREFACE | | 1.1ESTABLISHMENTANDMANDATEOFTHECOMMITTEE | | 1.2COMMITTEEMEMBERSHIP | | 1.3 COMMITTEESECRETARIAT | | PARTTWO | | 2.0OVERVIEWOFTHEKENYADRUGSAUTHORITYBILL,2022,NATIONAL ASSEMBLYBILLNO.54OF2022.. | | PARTTHREE ..10 | | 3.0CONSIDERATIONOFTHEBILLBYTHECOMMITTEE ...10 | | 3.1 LEGALPROVISIONONPUBLICPARTICIPATION. ..10 | | S.2PUBLICPARTICIPATION/STAKEHOLDERSCONSULTATIONINTHEREVIEWOF THEBILL ...11 | | S.2.1 SUBMISSIONS ON THEBILL .11 | | 4.0 COMMITTEEOBSERVATIONS. ..91 5.0COMMITTEERECOMMENDATIONS .92 |

LISTOFANNEXURES

Annexure1:

Minutes of Committee sittings

Annexure2:

Report adoption schedule

Annexure3:

Analysis of submissionsby stakeholders on the Bill

Annexure4:

Copy of the newspaper advertisement on public participation on the Bill

Annexure 5:

Letter inviting stakeholders to submit views on theBill

Annexure6:

Letters inviting stakeholders for a meetingwith the Committee on the Bill

Annexure7:

Submissions by stakeholders

CHAIRPERSON'SFOREWORD

Thisreport contains proceedingsof theDepartmental Committee on Health onits consideration of theKenya Drugs Authority Bill (National Assembly Bill No.54of2022)which was published on 6thOctober 2022.The Bill went through First Reading on gthNovember 2022and was thereafter committed to theDepartmental Committee on Health for consideration and reporting to the House pursuant to the provisions of Standing Order 127.

The Bill has ninety-seven (97) clauses.The Bill seeks to consolidate the regulation of health World Health Organization.Thiswill promote and guarantee the quality,safety and efficacy and effectiveness of health products and technologies in the country.The Bill also establishes the Kenya Drugs Authority that is responsible for the regulation,investigation,inspection and approvalof health products and technologies and relatedmatters.Following placement of advertisements in the print media on Monday,8th May,202S seeking public and stakeholder views on theBill pursuant to Article 118(1)(b)ofthe Constitution and Standing Order 127(s). the Committeereceived memoranda from thirty-two(S2)stakeholders.

TheCommittee alsoinvited stakeholdersvideletterREF:NA/DDC/DC-H/202s/o24dated 1oMay,202s to submit their memoranda to the Clerk of the National Assembly on theBill. TheCommitteevideletterREF:NA/DDC/DC-H/202s/0s9dated11hJuly,202Sandinvited the key stakeholders namely the Ministry of Health,the Office of the Attorney General,the Kenya Law Reform Commission,theLaw society of Kenya,thePharmaceutical Society ofKenya, the Pharmacy and Poisons Board,the Kenya Pharmaceutical Association, the Kenya Medical Association, theKenya Association ofPharmaceutical Industry and the National Quality Control Laboratory for a meeting to make their oral submissions before theCommitteein a meeting held onTuesday18thJuly2023at9:00amin Committeeroomgndfloor continental house and on10th August,202s Committee room 12 Parliament Buildings.House.The Committee also held a retreat with some of these key stakeholders on 18th August,202sin English point Marina in Mombasa.

The Committee isgrateful to the Offices of theSpeaker and the Clerkof the National Assembly for thelogistical and technical support accorded toit duringitssittings.The Committeefurther wishes to thank the sponsor of the Bill,Hon.Dr.Robert Pukose,MP and all stakeholders who submitted their comments on the Bill.Finally,Iwish to express my appreciation to the Honourable Members of the Committee and the Committee Secretariat who made useful contributions towards the consideration of the Bill and production of thisreport.

On behalf of the Departmental Committee onHealth and pursuant to provisions ofStanding Order 199(6),it is my pleasant privilege and honour to present to this House theReport of the Committee onits consideration of theKenyaDrugsAuthority Bill (National Assembly Bill No.54 of2o22).It is my pleasure to report that the Committee has considered the Kenya Drugs Authority Bill (N.A.Bill No.54of2022)and has the honour to report back to the National Assemblywith therecommendation that theBillbe approved with amendiments.

HON.(DR)ROBERTPUKOSE,M.P. CHAIRPERSON,DEPARTMENTALCOMMITTEEONHEALTH

1.0PREFACE

1.1ESTABLISHMENTANDMANDATEOFTHECOMMITTEE

• 1.TheDepartrmental Committee on Healthisestablishedpursuant to the provisions ofStanding Order 216oftheNationalAssemblyStanding Orders andinline withArticle124of the Constitution which provides for the establishment of the Committees by Parliament.The mandate and functions of the Committee include:
• a)To investigate,inquire into,andreport on allmatters relating to the mandate,management, activities,administration,operations and estimates ofthe assignedministries and departments;
• ba)onaquarterlybasismonitorandreportontheimplementationofthenationalbudgetinrespectof its mandate,
• 6 Tostudy theprogrammeandpolicy objectives ofministries and departments and theeffectiveness oftheimplementation;
• c)Tostudyandreviewall legislationreferredtoit;
• d To study,assess and analyse therelative success ofthe ministries and departments asmeasured by theresults obtainedas comparedwiththeir statedobjectives;
• f Vetandreport onallappointmentswheretheconstitution orany other lawrequires thenational Assembly toapprove,except those nderstanding Order 2O4(Committee onappointments)
• Toinvestigateandinquireinto allmattersrelating to theassignedministriesanddepartments as they may deemnecessary,andasmay bereferred to themby theHouse
• g To examine treaties,agreements and conventions;
• Toconsiderreports ofCommissions andIndependentOfices submitted to theHousepursuant to theprovisionsofArticle254oftheConstitution;and
• Tomakereports andrecommendationsto theHouseasoftenaspossible,includingrecommendation ofproposedlegislation;
• Toezamine anryquestions raised by Members ona matter uithinits mandate.
• 2.In accordance with the Second Schedule of the Standing Orders,the Committee is mandated to consider matters related to health,medical care and health insurance including universal healthcoverage.
• S.In executingits mandate,the Committee oversights the Ministry ofHealth withits twoState Departments namely theState Department for Medical Services and theStateDepartment for PublicHealth and Professional Standards.

PARTONE

1.2COMMITTEEMEMBERSHIP

• 4.TheDepartmental CommitteeonHealth wasconstituted by the House on 27th October 2022 andcomprisesofthefollowingMembers:

Chairperson Hon.(Dr.)Robert Pukose,MP Endebes Constituency UDA Party

Vice-Chairperson Hon.Ntwiga,Patrick Munene,MP Chuka/Igambang'ombe Constituency UDA Party

Hon.Owino Martin Peters,MP Ndhiwa Constituency ODMParty

Hon.Mathenge Duncan Maina,MP Nyeri Town Constituency UDA Party

Hon.Muge Cynthia Jepkosgei,MP Nandi (CWR) UDA Party

Hon.Lenguris Pauline,MP Samburu(CWR) UDAParty

Hon.Wanyonyi Martin Pepela,MP Webuye East Constituency Ford KenyaParty

Hon.Oron Joshua Odongo,MP Kisumu Central Constituency ODMParty

Hon.Kipngok Reuben Kiborek,MP Mogotio Constituency UDAParty

Hon.(Prof)Jaldesa GuyoWaqo,MP Moyale Constituency UPIAParty

Hon. (Dr.) Nyikal James Wambura, MP Seme Constituency ODMParty

Hon.Mukhwana Titus Khamala,MP Lurambi Constituency ANCParty

Hon.Kibagendi Antoney,MP Kitutu Chache South Constituency ODMParty

Hon.Julius Ole Sunkuli Lekakeny,MP Kilgoris Constituency KANU

Hon.Maingi Mary,MP Mwea Constituency UDA Party

1.3 COMMITTEESECRETARIAT

• 5.The Committeeis supported by the following secretariat:

Mr.Hassan Abdullahi Arale ClerkAssistantI/Head ofSecretariat

Ms.Gladys Jepkoech Kiprotich Clerk Assistant III

| Ms. Marlene Ayiro Principal Legal Counsel II | Ms.Abigael Muinde Research Officer III | |------------------------------------------------|---------------------------------------------------------| | Ms.Faith Chepkemoi Legal Counsel II | Mr.Hiram Kimuhu Fiscal AnalystIII | | Mr.Yakub Ahmed MediaRelationsOfficerII | Mr.Benson Kimanzi Serjeant-At-ArmsIII Mr.Salat Abdi Ali | | Ms.Rahab Chepkilim | Senior Serjeant-At-Arms | | AudioRecordingOfficerII | |

PARTTWO

2.0OVERVIEWOFTHEKENYADRUGSAUTHORITYBILL,2022,NATIONALASSEMBLY BILLNO.54OF2022

• 6.PARTI(Clause 1-3)of the Bill contains the preliminary provisions on the short title,interpretation and application of the Act.The Bill seeks to regulate health products and technologies including:
• (b)therapeutic cosmetics;
• (a)chemical substances;
• (c)herbal medicines and products;
• (e)medicines;and
• (d)medical devices including radiation-emitting devices;
• (f)scheduled substances.
• 7.PART II(Clause 4-21)of the Bill establishes the Kenya Drugs Authority in Clause 4with its headquarters in Nairobi. The Authority is to be managed by a Board,the Kenya Drugs Board established under clause 8of the Bill.ThePart alsoprovides for:
• b) the composition and qualifications for appointment as a member of the Kenya Drugs Board.The Kenya Drugs Board comprises of twelvemembers namely thePrincipal Secretaries in the Ministry ofHealth and Ministry of Finance,theDirector-General of Health,the Managing Director of KEBS,representatives of the Law Society of Kenya,Pharmaceutical Association, Council of County Governors,Kenya Association of Manufacturers and Consumer Federation of Kenya and a Chairperson appointed by thePresident.
• a)thepowers of the Kenya Drugs Authority in clause 1s.
• the functions of theKenya DrugsAuthority in clause 1q-the main fiunction of the Authority is the regulation,investigation,inspection and approval of healthproducts and technologies andrelated Bill and prescribe standards of quality for products to be manufactured in the country among others.
• d the appointment ofaDirector Generalin clause 6by thePublicService Commission with the approvalofParliament for a term of fouryears.TheDirector General shall be the ChiefExecutive Officer,Accounting Officer and Registrar of the Authority as well as the Secretary to the Board.
• e)t the power of the Cabinet Secretary,Ministry of Health under clause 21 to establish scientific advisory committees that will provide expert,independent advice to the Cabinet Secretary on complex scientific issues presented to the Kenya Drugs Authority.
• 8.PARTIII (Clause 22-36)of the Bill provides for the regulation of medicines.The Bill therefore:
• a)penalizes the sale of adulterated and substandard medicine and medicine which has not been registered by theKenya Drugs Authority;

• b)requires compliance with standards of manufacturing,labeling,packaging,sale or advertisement;
• penalizes the manufacture, sale,preparation and storage of medicine including herbal medicine contrary to theprescribed standards;
• P sets out thefactors tobemet to warrant theissuance ofaproduct licence;
• e)provides for the establishment and management of a medicinesregister;and
• f provides the procedure for theregistration of medicines.
• 9.PART V(Clause S7-46)of the Bill provides for the regulation of scheduled substances.Under this Part, the Kenya Drugs Authority is to prepare and submit thelists of scheduled substances to the Cabinet Secretary that shall only be sold by authorized sellers specially licensed to do so.The Bill therefore criminalizes the possession of scheduled substances by unlicensed persons.The Bill further makes provision for the licensing of the dealers of scheduled substances,labelling of containers that will be used to supply scheduled substances and the sale of such substances including through electronic or online means.
• 10.PART VI(Clause 47-48)of the Bill provides for the manufacture ofmedicinal substances upon the issuance of a manufacturing license,renewable annually,by the Kenya Drugs Authority and compliance with good manufacturingpractices.
• 11.PARTVII(Clause49-54)of theBill provides for theregulation oftherapeutic cosmetics.It prohibits the sale of therapeutic cosmetics that contains a substance that may cause injury to a user's health when there is adherence to the directions on the label as wellas the preparation of therapeutic cosmetics under unsanitary conditions. The Kenya Drugs Authority is also empowered to prohibit any ingredientin therapeutic cosmetics.
• 12.PART VIlI(Clause 55-59)of the Bill provides for the regulation ofmedical devices.The Bill penalizes the sale ofadulterated and substandard medical devices and medical devices which have not beenregisteredby theKenyaDrugsAuthority theBill furtherrequires compliancewithstandards of manufacturing,labeling.packaging,sale,or advertisement of medical devices.
• 13.PARTIX(Clause 60-61)oftheBillestablishes theNational Quality Control Laboratoryresponsible for:
• a)the examination and testing of drugs and anymaterial or substance from or with which and the manner in which drugs may be manufactured,processed or treated and ensuring the quality control of drugs and medicinal substances;
• b) performing chemical,biological,biochemical,physiological and pharmacological analysis and other pharmaceutical evaluation;
• C) conducting research and training:and
• d) testing the quality oflocally manufactured and imported medicines ormedicinal substances, medical devices or therapeutic cosmetics onbehalf of theKenya DrugsAuthority,with a view to determining whether such drugs or medicinal substances comply with the Act.

The National Quality Control Laboratory is to issue a certificate ofanalysis in the prescribed format for every analysis undertaken.

• 14.PART XII(Clause 62-70)of the Bill provides for the standards of advertisement and labelling of health products and technologies.All advertisements must be authorized by the Kenya Drugs HIV,leprosy,diabetes,pneumonia as well as drugs and appliances for procuring abortions.
• 15.PART XIII(Clause 71-87)of the Billprovides for the administration and enforcement of the Act The Bill makes provision for the general power of the Cabinet Secretary on the recommendation of the Kenya Drugs Authority to prohibit or control certain medicines or medical devices and torequest further information.The Bill further authorizes the Kenya Drugs Authority to:
• b) request for information;
• a) authorize the sale or supply of unregistered medicine ormedical device for a specified period;
• C inspect licences and books oflicensed sellers;
• inspect animals intended for slaughter;and
• e) )retain and dispose seized goods.
• 16.PART XIV (Clause 88-94)of the Bill provides for financial provisions.The Bill sets out the sources of funding for the Kenya Drugs Authority,the preparation of annual estimates,the preparation of annual report and specialreports,theinvestment of theKenya Drugs Authority'sfunds,accounts and audit.The source of funding of the Kenya Drugs Authority includes appropriations from the ConsolidatedFund,monies accruingin the courseofthe performance ofits functions andgifts,grants or donationsgiven to theKenyaDrugsAuthority.
• 17.PART XV (Clause 95-97)of the Bill provides for miscellaneous provisions.The Kenya Drugs prescribed forms under theAct,procedures ofclinical trialsand thelectronic saleofmedicines among others.The Bill also contains transition and savings provisions on what happens to the assets, liabilities,legal obligations and staffoftheNationalQuality Control Laboratory and thePublicHealth (Standards)Board beingrepealed.Under this Part,the Pharmacy and Poisons Board shall continue to exist for purposes of regulating the pharmacy profession until Parliament enacts a law for the regulation of the pharimacy practice.ThePart further provides that the Bill shall apply subject to the provisions of thePublicHealth Act.
• 18.SCHEDULES-theBill hasseven schedules:
• a)First Schedule-which contains provisions on the conduct of business and affairs of the Board in terms ofmeetings,quorum,voting,committees,disclosure ofinterest among others;
• b)Second Schedule-which provides the oath or affirmation of the Office of the Chairperson, Member and Director;
• c)Third Schedule-which contains provisions relating to appointment of members of the Board;

• d)Fourth Schedule-which provides for the establishment and membership of Scientific Advisory Committees such as the National Food Safety Committee,Human Medicines Committee, Veterinary Medicines Committee,Medical Devices Committee and National Quality Control Committee;
• e Fifth Schedule-whichprovides the specified publications on standards of medicines;
• f)Sixth Schedule- which sets out the purposes for which drugs may not be advertised; and
• g)Seventh Schedule- which sets out therepeals being made under the Bill.

PARTTHREE

S.OCONSIDERATIONOFTHEBILLBYTHECOMMITTEE

S.1LEGALPROVISIONONPUBLICPARTICIPATION

• 19.Article 118(1)(b)of the Constitution of Kenya provides as follows-

Parliament shallfacilitate publicparticipationandinvolvementinthelegislativeandother businessof ParliamentanditsCommittees.

• 20.Standing Order 127(s)provides that-

"TheDepartmentalCommitteetowhichaBilliscommitted shallfacilitatepublicparticipationon theBill throughanappropriatemechanism,including

• (a)inuiting submissionofmemoranda;
• (b)holdingpublic hearings
• (c)consultingrelevant stakeholdersina sector,and
• (d)comsultingezperts on techmicalsubjects

• 21.Standing Order127(sA)further provides that--

TheDepartmentalCommitteeshall takeintoaccount thevieusandrecomnendationsofthepublicuder paragraph(3)in its report to theHouse.

S.2PUBLICPARTICIPATION/STAKEHOLDERSCONSULTATIONINTHEREVIEW OF THEBILL

S.2.1 SUBMISSIONSONTHEBILL

• 22.Following the call for memoranda from thepublic through the placement ofadverts in the printmedia on14thFebruary 2028and theCommittee's engagements inmeetings held onTuesday18thJuly2023 at9:00 aminCommitteeroomdfloorcontinentalhouse,on1othAugust,202sCommitteeroom12 Parliament Buildings.House and at a retreat held on 18thAugust,202Sat English point Marina in Mombasa, the Committee received submissions through oralpresentations and writtenmemoranda from the following stakeholders:
• 1)TheMinistry of Health (MOH)
• (S TheNational Quality Control Lab(NQCL)vide memorandum dated 2gthMay2023; 4
• 2) ThePharmacy and Poisons Board (PPB)vide letter dated22ndMay202s;
• TheNational Gender andEquality Commission(NGEC)videletter dated22ndMay202s; 5)
• 6 The Kenya Law Reform Commission(KLRC)
• TheKenya Association of Manufacturers(KAM)videletter dated 1gth May 2023;
• 7} ThePharmaceutical Society ofKenya(PSK)videletter dated24tJuly202s;
• (6 AgnesKuvuna Maina,a qualified Pharmaceutical Technologistvidememorandum dated2gndMay 2029;
• 8) TheKenya Pharmaceutical Association (KPA)videletter dated22ndMay 2023;
• 10)MathewWamuiga Gaturuku,an enrolledPharmaceuticalTechnologist vide email dated 2gudMay 2028;
• 12)WilliamKomenvideemail of22May202s;
• 11)Kabui John vide email of22nd May 202s;
• 13)Vincent Gathukiavide email of22dMay202s;
• 15)Duncan Simwavideemailof24thMay202s;
• 14)Robert Ngetichvide email of22ndMay2028;
• 16)Bernard Kariukivide emailof24hMay202S;
• 18)Dr.John Ngethe and Dr.Naoni Ngethe;
• 17)BenjaminMunyaoNthumo vide emailof2qnd May202s;
• 19)Dr.Alex Ogero Okaru,PhD
• 21)DanielKiru Mwangi ofKimanjo SubcountyHospitalvide email of22ndMay 202s;
• 20)Winfred WambuiNdirangu;
• 22)Pest Control Products Board(PCPB)videletter dated25thApril202s
• 24)AgrochemicalsAssociation ofKenya(AAK)vide letter dated 27thFebruary 2023;
• 23)The Veterinary Medicines Directorate (VMD)in the Ministry of Agriculture and Livestock Developmentvidememorandum submitted on31stJuly202s;
• 25)TheKenya National Union of Pharmaceutical Technologists(KNUPT) dated 2qnd May 202s;
• 27)The LawSociety ofKenya(LSK)vidememorandum dated 1gthJuly 202s;
• 26)TheKenya Medical Association(KMA)vide letter dated 19thJuly202s;
• 28)The Kenya Association of Pharmaceutical Industry (KAPI)vide email of 19thJuly 2029;

• 29)TheKenya VeterinaryBoardvideletter dated s1s July202s;
• S1)The Office of theAttorney Generaland Department ofJustice(forwarded thememorandaby the Pest Control ProductsBoard and theMinistry ofAgriculture and LivestockDevelopment.

S.2.2THEMINISTRYOFHEALTH

Inits memoranda,the Ministry of Health proposed thefollowing amendments:

• 23.Amendment of the title of Part II by deleting the wordsThe Kenya Food and Drugs Authority'and replacingwith thewords,KenyaHealthProducts and Technologies Regulatory Authority' Justification:For consistency in the nomenclature used when referring to the Authority as the Ministry proposed therenamingoftheBillfrom theKenyaDrugsAuthorityBill to theKenya Health
• Products andTechnologiesRegulatory Authority Bill.
• 24.Deletion of the long title and substitution with thefollowing"Abillforan ActofParliament to establish acomprehenstve legalframeruorkforregulationofHealthProducts andTechnologies;to safeguardpublic health through developmentofaregulatory system toensure safety,quality,efficacy/efectivenessandperformance of health products;to establish theKenyaHealthProducts andTechnologies Authority". Justification:Tohighlight themain purpose ofthe Bill and to reflect thefull scope of the Bill which includes medical devices and in vitro diagnostics.International best practice recommends a centralized or nationalregulatoryauthority formedicines.
• 25.Insertion of the following new definition
• 26."Biologicalsmeans adiverse group ofmedicineswhichincludesvaccines,grouthfactors,immunemodulators monoclonalantibodies,aswellasproducts derivedfromhuman bloodandplasma. Justification:The term notincluded in theBill.
• 27.Deletion of the definition of"chemical substance"and substitution therefor with thefollowing new definition"chemical"or"chemical substance"means any substance or micture ofsubstances prepared sold orrepresentedforuse asa germicideantiseptic,disinfectant,pesticide;nsecticiderodenticide,vermicideor detergent,or any other substance or mizture ofsubstances which the Authority may,declare to bea chemical substance,

Justification: The proposed replacement of the Pharmacy and Poisons Act,Cap.244 with the Bill.

• 28.Deletion ofthe definition of"medical substance"with"medicinal substance "and substitution therefor with thefollowingnew definitionmedicinalsubstancemeans a substance,theoriginofuhich may behuman,animalvegetableorchemicalincludinghuman bloodand human bloodproducts,micro-organisms, uhole animalsparts oforgans,animal secretions,toxins,extracts,bloodproductsmiro-organisms,plats, parts ofplantsvegetable secretions,extractselements,naturally ocurring chemicalmaterials and chemical products obtained by chemicalchange or synthesis;
• 29.Deletion of the definition of"medical devices"and substitution therefor with the following new definition"Medical Devices"means any instrument,apparatus,implement,machine,appliance,mplant, reagentforinvitrouse,sofuare,materialorothersimilarorrelatedarticle,intendedbythemaufacturero beused,alone orincombinationforamedicalpurpose.
• so.Deletion of the definition of"manufacture"and substitution therefor with the following new definition-

"manufacturein relation to medicines,means the production ofmedicines or any part of the process.j producing medicines or bringing the products to their finalstate,including engagingin theprocessing, assembling,packaginglabelling,storagesterilizingtestingorreleasingforsupplyoftheproductsorofany dspossspqsdfodsoo product by diluting ormizingit uith someother substances usedasvehicleforadministration;

OR

"manufactureinrelation toa medical device,means to make,fabricate,produce or process themedica deviceandincludes:

(i)anyprocesscarriedoutinthe course ofsomakingfabricating,producingorprocessing themedicaldevice and/or(ii)thepackaging and labellingof the medicaldevice before it is supplied.

• S1.Deletion of the definition of"therapeutic cosmetic"and substitution therefor with thefollowing new definition"Therapeutic cosmeticmeans-prodaucts with the ability to trigger biologicalactions on thedermisa skinlevelbeneath the stratum corneum,and have theability to:Target andrepair skin issues, preventfuturedamagecontainingingredientsthatareusuallynotfoundinregularcosmetics orat higher strengths than could be sold safely over-the-counter.
• S2.Deletion of the definition of"drug"and substitution therefor with the followingnew definition "drugincludesany substance ormiztureof substances manufacturedsold orrepresentedforusein a)thediagnosis,treatment,mitigation orprevention ofadisease,disorder orabnormalplysicalstate,orits symptoms,in human beings or b)restoring,correctingor modifing organic functionsn human beings or animals,or c)disinfectionin premises in whichfoodis manfactured,prepared orkept;andincludes biologicals.
• ss.Deletion of the definition of"registeredpharmacist"and substitution therefor with the following new definition"Registered Pharmacistmeans a holder ofa degree in pharmacy froma universit recoguised by theAuthority andwhose name is enteredon theregister,
• S4.Insertion of the following new definition"Medicine"includes;(a)anymedicinemedicinalpreparation,medicinalsubstance,therapeutic substanceorvaccine,or (b)any substance or mizture ofsubstances including any medicine,medicinalpreparation or therapenutic substancepreparedsoldorrepresentedforuseinthediagnosis,treatment,mitigationorpreventionofadisease disorder orabnormalplysical state,or the symptomsthereofinhumans oranmals;orrestoring,correctingor modifyingfunctioningoforgansinhumansoranimals Justification: The need to define"medicine"owing to the adoption of the termhealth product and

technology"instead of the term"drug"

• 35.Insertion of thefollowingnew definition"scheduling"means inrelation toa substance,determining the schedule or schedules to the currentPoisons Standardinwhich the name ora descriptionofthesubstanceis to beincluded.

Justification: There is no clear definition for scheduling in the Bill

• S6.Insertion of the following new definition"Wholesale dealermeans a busimess wuhere health products are stored,dispensed,distributedorsoldin bulktopersoms other hanindvidualcomsumersorpatients

ORWholesaledealermeansapersonorcompary thatsellsoodsinlargequantities toretaildealersrather than selling smallerquantities darectly to consumers.

Justification:Theintroduction ofthisdefinition will bringout better clarity as towho awholesale dealer isunder theBill.

• S7.Insertion of the following new definition"cosmetic"means-(a)articles intended to berubbed,poured sprinkled,or sprayedon,introducedinto,or otherwise appliedto thehumanbody or any part thereoffon acompoment ofanrysucharticles;except that such term shallnotinclude soap; Justification:The definition provided contradicts the definition ofregular cosmetic
• s8.Insertion of the following new definition "herbsmeans herbal materials,herbalpreparations,finished herbalproductsthatcontainactiveingredientspartsofplantsorotherplantmaterialsorcombinations. Justification: To expand the scope of herbs regulated under the Bill to include herbal materials and herbal combinations.
• s9.Insertion of the followingnew definitions:

"Lotreleasemeans"theprocessoftheKenyaDrugAuthorityeualuation ofanindividual lot ofa licensed biologicalproductbeforegivingapprovalforitsrelease ontothemarket

"ot/sub-lotmeansa definedquantityofstartingmaterialpackagingmaterial orproductprocessedina singleprocessorseriesofprocessesso thatthequantityis erpectedtobehomogeneous.In continuousmanufacture thelotcorresponds toa definedfraction oftheproduction,characterizedby itsintendedhomogeneity

"Substandardmedicalproductsalso called"outofspecification", means"registeredmedical products that fail to meet either their quality standards or specifications,or both"

"Unregisteredmedicalproductsmeans"the products that have notundergone eoaluatiom and/or approval by theKenya NationalRegulatory Authority(Kenya DrugsAuthority)subject topermitted conditions under theKenya Drugs Authority Act and the rules therein.

identity,composition or source";

anduho holdsamnimumofadiplomainpharmacy"

"Active surveillancemeansprospective measures taken to detect adverse drugreactions and adverseevents andinuolvesactivefollore-up duringandaftertreatmentofpatientswhere theeventsmay be detected byasking the patient directly or screeningpatientrecords";

patients or other volunteers,in order to discover or verify the effects ofidentify any adverse reaction to ivestigationalproducts,tostudytheabsorption,distribution,metabolismandexcretionoftheproductswith the object ofascertaining their efficacy andsafety

"Adverse event"means"any untoward medicaloccurrence that may present during treatmentwith a pharmaceuticalproduct but uhich does notnecessarily have a causalrelationship with the treatment";

"Adverse drugreactionmeans"aresponse toa drug whichisno.ious andunintendedand wuhich occur aldosesnormally usedinhumansfortheproplylaris,diagnosisor therapy ofdisease,orfor themodification plysiologicalfunctionandischaracterizedbythe suspicionofacausalrelationship betrweenamedicalproduct

"register"meansto obtain marketingapproval fora medicaldevice from the Regulatory Authority ofa MemberState in order toplace the medicaldeviceonthemarketofthat MemberState

"Putting into servicemeans"thestage at whichamedical device has beenmadeauailable to thefinal user as beingready for use on themarket ofaMemberStatefor its ntendedpurpose",

"Refurbishedmedical devicemeansamedical device ofwhich the whole oranypart thereofhas been substantiallyrebuilthetherornotusingpartsfomomeormoreusedmedicaldevicesofthatsamekindsoas tocreateamedicaldeuicethatcanbeusedforthepurposeoriginallyintendedbytheproductoumeroftheoriginal medical device,andwhichmay havehad thefollorwingwork carriedout om it":

mplementationofaclinicalinvestigation".

"invitro diagnostic(IVD)medical devicemeans"any reagent,reagentproduct,calibrator,control materialkitinstrumenapparatusequmentorsytemwhethersedalomeorincombinatiowithanyoter reagentreagentproduct,calbrator,cotrolmaterialkit,instrumen,apparatusequpment orsystem,thats intended byitsproductoumer tobeusedinvitrofortheezaminatiomofanyspecimenincludingary bloodor tissuedonationderivedfrom thehumanbodysolelyorprincipallyforthepuposeofproidinginformation

"Health productsinclude"human and veterinary medicines,medicalproducts,medicinal substances, vaccines,diagnosticsmedicaldeuicesbloodproductstraditionalandaltrnativemedicine,therapeuticfeedsand nutritionalformulations,cosmetics andrelatedproducts".

"Health technologiesmeans"the applicatiomoforganizedknowledge andskillsn theformofmedicines, devices,vaccimes,procedures,andsystems developedtosolve ahealthproblemandmprove thequalityoflves

"Therapeuticproductmeansa drugormedicaldevice oranycombinationof drugsandmedicaldevices, but does not include a homeopathic medicinalproduct or an herbal medicinalproduct;

"MedicationTherapy Management"meansarangeof services provided by pharmacists towardsreview ofallmedicationsprescribedbyallprescribersprovidingcare tothepatient,andany over-the-counterandherbal products thepatient may be taking to identifyandaddressmedicationproblems.Problems may include medicationsnotbeingusedcorrectly,duplicationofmedicationsunmecessarymedications,andtheneedfo medication(s)for an untreated orinappropriately mamagedcondition2;

"Dietary supplement"also callednutritional supplementmeans aproduct takenbymouththatisadded to the diettohelp meet one'sdaily requirements ofessentialmutrients,usually contains ome or more dietary ingredient andinclude vitamns,mmerals,herbs,amznoacids,livemicrobialsandenzynes

with a particular medical device to enable or assist that device to be used in accordance with its intendedpurpose.

"Adverse event"means'eithera malfunctionora deteriorationin the characteristicsorperformanceofa injury to healthofpatients or other persons."

"personmeansanaturalpersomoralegalentity includingacorporation,apartmershiporassociation duly establishedpursuant to theprevailinglausandregulationsofMemberStates".

product owner,acts andmay beaddressedby authorities and bodies inaMember Stateinsteadoftheproduct owmerwithregard to thelatter'sobligationsunder thisAgreement,andrelevantlaus andregulatioms ofthe Member State

medicalpractitiomer'srittenprescriptionwhichgivesuderhisresponsibility,specificdesigncharacteristics andisintendedforthesoleuseofaparticularpatient.Forthepurposesofthisdefinition,adulyqualifiedmedical practitioneris definedasapersonohois dulyqualified by therelevant laus andregulationsof theMember Stateuhere the custommademedicaldeviceisused.Forpurposesofclarity,massproduceddevicesuhichneed tobeadaptedto meet the specificrequirementsofthemedicalpractitioner or any otherprofessiomaluser shallnot be considered to be custom-made medical devices.

"Deviceintended for clinicalinvestigation"meansany device intendedforuse byaduly qualified medicalpractitioner whenconducting clinicalinvestigations asreferred toinAnnex8(ClinicalInvestigation) inan adequate humanclinicalenvironment.For thepurposesofconductingofclinicalnvestigation,aduly qualifiedmedicalpractitioneris definedasapersonwho isdulyqualified by therelevant lausandregulations ofthe Member State uhere the clinicalinvestigationis carriedout,and by virtue ofhis professional qualifcationsisauthorisedtocarryoutsuchnvestigation

"Authorised distributor",inrelation to the placing on the market ofa medical device,means'any personwhohasbeenauthorised bytheproductowmer orauthorisedrepresentativetodistribute themedicaldevice inthatMemberState".

"FieldSafety CorrectiveAction(FSCA)"means"any action taken by a product ouner to reduce a risk ofdeathor serious deteriorationin the stateofhealthassociatedwith the useofamedicaldevice.Thismay include:

(i)thereturnofamedicaldevice to the productowmer oritsrepresentative(ii)device modificationwuhichmay include:(a)retrofit in accordance with theproduct orumersmodification or design change;b)permanentor temporary changes to the labelling orinstructions foruse;(c)softuareupgrades including those carriedout by remoteaccess,(d)modification to theclinicalmanagement ofpatients to addressariskofserious injury or death related specifically to the characteristics ofthedevice.(ii)device exchange;(io)device destruction;(v)advice given byproductoumerregarding the useofthedevice.

"Intendedpurpose"means"theusefor which themedicaldeviceisintended according to the specifications ofitsproductoumeras statedonany orallofthefollowing":

• thelabelofthemedicaldevice;
• (222) thepromotionalmaterialsinrelationto themedicaldevice.
• () theinstructiomsfor use ofthemedical device,

"Physical manufacturer",in relation to a medical device,means"ay person who performs the actiuit ofmanufacture'

"Placingon themarket"means"themakingauailable inreturnfor payment orfree of charge ofamedicai marketofaMemberState"

Product owner"inrelation to amedical device,meansany person who:(i)supplies themedical deuice underhisoumname,oruderany trademark,design,tradenameorotherameormarkowmedorcontrolled dsipofs(p refurbishingormodifying themedicaldevice,orforassiguingtoitapurposewhether those tasksareperformed by him or on his behalf.

"examinationmeans"Set ofoperations hauing the object of determining thevalue ofa property"

note:Examinationofananalyteinabiologicalsampleiscommonlyreferred toasa testassay oranalysis.

sqdqo device".

"Tvy medical device for self-testing:meansanyIVD medical device intended by theproduct oumerfor use by lay persons.

"Near patient testing":meansany testingperformed outsidealaboratory enuironment by ahealthcare as Point-of-Care(POC)"

by the product oumer to be used as IVDmedicaldevices

"self-testingmeans"testingperformed by lay persons"

bytheir product orumer fortheprimarycontainment ofspecimens derivedfrom thehuman body"

"Transmissible agentmeansanagent capableofbeing trausmitted toa person,asa commuicable infectious orcontagious disease".

"Anti-infectivesmeans"medicines thatwork to prevent or treat infections and include antibacterial, antivirals,antifungals and antiparasitic medications"

"Centre"means"theNationalPharmacovigilance Centre";

"Passive surveillance"means"thatno active measures are taken to lookfor adverseeffects other than the encouragementofhealthprofessionals and others to report safety concerns;

"pharmacovigilancemeansthe science andactivitiesrelating to the detectio,assessment,understanding andprevention ofadverse effects or any other possiblehealth product relatedproblem

"Premisesincludesany land,any buildingduelling-placeand any otherplacewhatsoeverincludesstand aloe commuityretailpharmacy,priuatehospitalpharmacy,publicmedicalfacilitypharmacy,uholesale

VesselmansTrucksans,busesminibusescars,railers,aircraf,railaycarriagesboats andt meansulichare used to convey healthproducts andtechnologies

"Goodclinicalpracticesinmanufacturingregulatestheprocessesandcomditions uderwhichclinicaland non-clinicalresearchis comducted and governs horw theseresearch facilities should bemaintained apparatus implement,machine,applianceimplant,invitroreagentandcalibrator,sofruare,materialorothersimilarr

• (i)intendedby theproduct oumer to be usedaloneorin combination,forhumanbeingsforoneormoreofthe specific purpose(s)of(a)diagnosis,prevention,monitoring,treatment or alleviation of disease(b)diagnosis monitoring,treatment,alleviationoforcompensationforannjury;(c)investigation,replacement,modificatiom, doo)fsoddsp)dooafooooddo (f)disinfectionofmedical devices;and(g)providinginformationfor medicalor diagnosticpurposes bymeans ofinvitro examimationofspecimens derivedfromthehuman body;

(i)which does not achieve its primaryintended action in or on thehuman body bypharmacological immunologicalormetabolic means,butuhich may be assistedinits intendedfunction by such means.

"GoodLaboratory practices"means"the generation ofhighqualityandreliable test data related to the safety ofindustrialchemical substancesand preparations".

Justification:To include the full scope ofhealth products and technologiesregulated under the Bill

40.Deletion of clause S(1)and substitution with the following clause-

ThisAct applies toregulation ofhealth products and technologiesincluding

• (a)Drugs
• (b)Chemical substances as definedby the Authority in the schedule;
• (c)Plasma derived medicinal products and acellular blood and bloodproducts;
• (e)Starting materialsused in the manfacture ofmedicinesmedicalproductsand biological products;
• (d)Biologicalproductsforuseinhumans,
• (f)Therapeutic cosmetics,
• (h)Herbal medicines and products;
• (g)Products containing scheduled substances andintendedforuseinhumans;
• (i)Medical devices;
• (k)Medicines;
• (i)In vitro diagnostics;
• l)Scheduled substances andallproducts containing scheduled substances;
• (m)Therapeuticfeedsand
• (n)Dietary supplements".

Justification:To include the full scopeof health products and technologies regulated under the Bill.

• 41.Deletion ofclause 4(1)and substitution with the following:There s established anAuthority to be know. as theKenya HealthProducts andTechnologies Regulatory Authority"

Justification: The Authority will regulatemore than drugs and the name should reflect the same

• 42.Deletion of clause 5 and substitution with the following"the headquarters oftheAuthority shall be in Nairobiorinsuch other placeas theboardof theAuthority may,by resolution,determine

Justification:The Board should have the Authority to determine the location of the Authority headquarters.

• 43.Deletion ofclause 6(1),(2),(S),(4),(5)and (6)and substitution with the following;
• 2i. Noperson shallqualify for appointment uuder this sectiomunless suchperson(a)HasaBachelors'degree in Pharmacy or itsequiualentfromaUniversityrecognizedinKenya;(b) Hold a mastersdegreein Pharmacy years(d) Isamember ofa professiomal body;(e) Meets therequirements ofchapter sitoftheconstitutiom on leadershipandntegrity.
• ThereshallbeaDirector-GeneralwhoshallbethechiefexecutiveofficeroftheAuthorityappointedbythe Boardanduhose termsofreference shall be deterninedby theBoardintheinstrumentofappointment o otherwise inwritingfromtimetotime.

222. TheDirector-Generalshallsubject to the directions oftheBoardand

• TheDirector General Shall beresponsiblefor the day-to-daymanagement oftheaffairsandstafofthe Authority.

Justification:Toalign with good corporate governance as provided under theMuongozo Code of GovernanceforState Corporationsand theState CorporationsAct Cap446.whichprovides that the Chief Executive Officer is appointed by the Board of Directors.To further clarify the role of the DirectorGeneral in the day-to-day management of the affairs and staff of the Authority and to ensure that the Director-General has therequisite qualifications togovern the organization.

• 44Deletion of clause 8(1) and (2)and substitution with the following;

(2)The Board shall comprise(a)a mon-ezecutive Chairperson appointed by thePresident and wuho shall;(i) bearegisteredpharmacistofgood standing;and(i)have at least ten yearsezperiencein the pharmaceutical sector,five ofuhich shall be atsenior management level(b)thePrincipalSecretary theMinistry for the time beingresponsiblefor healthoradesignatedrepresentative(c)thePrincipalSecretary the Ministryfor the time beingresponsibleforfinance ora designatedrepresentative;(d)Headof theDirectorate ofHealthProducts and Techologies;(e)arepresentativefromthe CoumcilofGovernorsnotbeingagovernor andwithknowledgeand Kerya;(g)arepresentativenominated by theKenyaPharmaceuticalAssociation;(h)arepresentativemomimated by the associationrepresentingBiomedical Engineers;(i)theDirector General ofthe Authority who shallbe the secretary"

"(I)The Authority shall bemanaged by aBoard ofDirectors;

Justification:The number ofboardmembers of theAuthority should be between seven andnine in compliance with'Mtuongozo CodeofGovernancefor State Corporatioms.Given that the Authority shall bemanaged by a Board of Directors,a definitivename for the Board is not required.Members of the further align with the State Corporations Act, Cap.446which does not provide for the position of a vice-chairperson elected by the Board.

• 45.Amendment of clause 12 by inserting the following new paragraphs immediately after paragraph(e)
• (ea)disposalofhealthproducts and technologies;
• (ec)conducting analytical tests ofhealth products and technologies.
• (eb)monitor themarketfor the presence ofumregisteredandillegalhealth products and technologies,

Justification:These are critical functions of the Authority.

• 46.Amendment of clause 12 of the Bill by deleting paragraph (f) and substituting the following new paragraph-

analysisofreports on adverse reactions andeventsincluding any other Health Product and Technology use relatedissuesand take appropriateregulatoryactions whenmecessary

Justification:In country safety monitoring of health products and technologies takes precedence. However,safety information from otherNational Regulatory Authorities may be considered through regulation and reliance mechanisms for decision making.

• 47.Amendment of clause 12 by deleting paragraph (g)and substituting therefor the following paragraph-

"(g)Ensure that clinicaltrialprotocols ofhealthproducts and technologies are being assessed according to the prescribedethicalandprofessionalcriteria and definedstandardsincluding mandatory bioequivalence studies"

Justification:Globalbest practicefor clinical trial oversight requiresentrenchment of clinical trials specifies the minimum legal requirements.These minimums are not captured in the Bill as currently proposed even though they are currently provided for in the Pharmacy and Poisons Act, Cap.244.

• 48.Amendment of clause 12 of the Bill by inserting a new paragraph immediately after clause (g)

(ga)approve theuse ofanry unregisteredmedicinal substance for purposes ofclinical trials and compassionate

Justification:To cater for emergency situations in public health

• 49.Amendment of clause 12 of the Bill by inserting a new paragraph immediately after clause(ga)"(gb) Practices and theprescribedrequurements".

Justification:The Bill does not provide for the conduct of Good Pharmacovigilance Practice Inspections,which are key towards ensuring that marketing authorization holders,local technical representatives,parallel importers,distributors and outsourced persons or companies meet the prescribed requirements thereby ensuring the safety of the health products and technologies.

• 50.Amendment of clause 12 by deleting paragraph (n)and substituting therefor the following paragraph-

(n)appontinspeclorsandorder inspection ofmanfacturingpremises,medical devices establishments, retail outlets and any other premises subject to this Act.

Justification:To clarify premises subject to the inspection by the Authority

51.Amendment of clause 12 by inserting a new paragraph after clause (o)

"(oa)Conduct NatiomalRegulatory Authority lotrelease(official authority batchrelease)ofspecifiedbiological to ensure thequality,safetyandefficacyofbiologicalproducts througharegulatoryeleasesystemincompliance withestablishedapproaches,policiesguidelines,proceduresandinlinewithWrldHealthOrganizationand internatiomally recognized guidelines"

Justification:The regulatoryfunction of the Authorityinvolves lotrelease which is a key component in vaccine production.

• 52.Amendment of Clause 12 by inserting the following new paragraphs after clause (q)-

"(qa)Ensure thatallhealth products and technologiesmamufacturedininportedinto orerportedfrom the country conform toprescribedstandardsofquality,safety andefficacy

"(qb)Enforce theprescribed standardsofquality,safety andefficacyofall healthproductsand technologies manfacturedmportedintoorerported out ofthecountry

"(gc)Grantorrevokelcensesandpermitsforthemanufacturemortation,eportatimdistributionandsale ofhealth products and technologies

(qd)Maintain aregister ofall authorized health products and technologies mamually or electronically

(qe)Regulate licituseofmarcoti,psychotropic substances andprecursorchemical substancesinaccordance uith either thesingle conventiomonNarcoticdrugsof1961,theconventiomonPsychotropic substances1971andthe UN conventionagainstillicit traffcofprecursor chemical substances 1988

pharmacies,including those in hospitals and clinics and other retailoutlets"

Justification:Control over theimport and export of health products and technologies import is a critical regulatory function of the Authority.

• 53.Amendment of clause 1s by deleting paragraph 1s(a)and substituting therefor the following paragraphs-

"(a)Collaborateuith.such other bodies ororganizatiomswithin oroutsideKenya as itmay consider desirable orappropriateand infiurtherance ofthepurposeforwhichtheAuthority is established;

"(aa)Adopt andimplementany such internationally recognizedgoodregulatory practices

"(ac)Issuesuspendwithdraw/revoke any licensecoplincecertificat

"(ab)Determine andimplementeffectiveandefficientreliance mechanism

"(ad)Levy,collect and utilize feesfor services rendered"

"(ae)Grant or withdraw licenses andpermits to manfacturers,uholesalers,retailers,inporters,exporters and distributors"

• "(af)Formulateguidelinesforregulating themanufactureimportanderport,distribution,sale andusef medicalproducts". Justification:To comply withWHOrequirements onregulatory functions as provided in the Global Benchmarking Tool.
• 54.Amendment of clause 21(1),(s)and(4) by deleting the words'Cabinet Secretaryand substituting therefor thewords,'theBoardoftheAuthority;
• 55.Amendment of clause 21(9)by deleting the words'Cabinet Secretaryand substituting therefor the words'theBoardoftheAuthority'andby deletingtheword'Parliament'and substitutingtherefor thewords'CabinetSecretary:

theBoard of theAuthority in effectively carrying out its mandate.

• 56.Amendment of PART IV by deleting the word"medicine"in the title of the part and replacing it with the words"health products and technologies".

regulated under the Bill.

• 57.Under Clause 22,amendment of paragraph (c) by inserting a new paragraph immediately after (c)

(ca)"falsified"

Justification:The term"falsified"is globally used and recommended by WHO

• 58.Amendment of clause 22(1)Xa)by deleting the word "medicine"and substituting thereof the words "healthproduct and technology

Justification:To harmonize terms and cover the whole scope ofregulated products

• 59.Amendment of clause 22 by inserting new clauses immediately after clause 22 (1)

22(1)"(A)Authorization of health products and technologies"

• (1)Aperson shallnotimport any healthproduct or technology unless:
• (a)Thehealth productor technologyhasbeenauthorized throughissuance ofanimportlicenseoray urittenauthorizationsby theauthority

theportsofentrybeforerelease

• (2)No batch/lot ofanyregisteredproduct shall bereleased by themanufacturerprior to thecompletionoftestsfor conformitywith standards applicable to suchproduct andofficialbatch/lotrelease by theAuthorityin casesof biologicaltherapeutics.
• (3)Eachapplicable test conducted by themanufacturer under subsection(2)shall bemade on each batch/lot after completionofallprocesses ofmanfacturewhichmayaffect compliancewiththe standardapplicable to theproduct.

(4)TheMamfacturerormarketingauthorization holderofanyregisteredbiologicaltherapeutic shallsubmit Lo SummaryProtocolforeachLotthatcontainsregistered tests,andresultsoftestsperformedandmay berequiredt subinitsamplesofproductfrom the specifiedLottotheAuthorityforofficialbatch/lotreleasein accordancewith prescribedregulations.

(5)Euery batch/lotofaregisteredbiological therapeuticimportedintoKenya or mamfacturedinKerya shall be Registrar shall approueitsreleaseinto the market andissuea certificateofofficialbatch/lotreleaseintheprescribed format.

Authoritiesofother countriesforaspecificbatchorlotsofbiologicaltherapeuticmanufacturedwithinthe territories ofthose NationalRegulatory Authorities to issuea certificate underthis section.

(7)Aperson uho contravenes thuis section commits an offence.

Justification:To cater for authorizations of health products and technologies into the country including the requirement for batch or lot release in line with WHO requirements.

• 60.Amendment of clause 22(s)by deleting the word"medicine"and substituting thereof with the word "healthproduct or technology"

Justification:Toharmonize terms and cover the whole scope ofregulated products.

• 61.Amendment of clause 22(s)(b) by deleting the words "pharmaceutical product"and substituting thereofwiththeword"healthproductortechnology"

Justification:Toharmonize terms and cover the whole scope ofregulatedproducts

• 62.Amendmentofclause 2s(1)(a),2s(1)(b)and 2s(1)(c)by deleting theword"medicine"and substituting thereofwith the word"health product or technology".

Justification:Toharmonize terms and cover the whole scope ofregulated products

• 63.Amendment of clause 2s(2Xa)by deleting the words"one"and substituting thereof with thewords "two"and amendment of clause 2s(2)b)by deleting the words"two"and substituting thereof with the words"five"

Justification: To make the fines prohibitive and punitive due to the serious risks to public health

• 64.Amendment of clause 24(1),(2)and (s)by deleting the word "medicine"wherever it appears in the paragraph and substituting therefor with the words"health product or technology"

Justification: To harmonize terms and cover the whole scope of regulated products.

• 65.Amend Clause 24(4)a)by deleting the words"onehundredthousand"and substituting thereof with the words"two million"and amend Clause 24(4)(b)by deleting the words"two hundred thousand

Justification:Tomake the fines prohibitive and punitive due to the serious risks to public health.

• 66.Deletion ofclause25.

Justification:Clause 25ismore of apractice-based offense rather than a product-based offense.

• 67.Amendment of clause 26 by deleting the word"medicine"and substituting therefor with the words "healthproductortechnology"
• 68.Amendment of clause 27(a)of the Bill by deleting the words"medicinal productsand replacing with thefollowingnewwords"healthproducts
• 69.Amendment of clause 27(b) and (c) by deleting the word "medicine"and substituting therefor with thewords"healthproductor technology".

Justification: To harmonize terminologies in the Bill.

• 70.Amendment of clause 28(1) and(2)by deleting the word "medicine"and substituting therefor with the words"healthproducts or technologies"

Justification:To harmonize terminologiesin the Bill.

• 71.Amendment of clause 28 of the Bill by deleting subclause(1)and substituting therefor the following new paragraphs-

"(1)Aperson who intends toimport,manufacture or sella healthproductor technology shallapply to the Authorityfor theregistrationofthehealthproduct or health technologyintheprescribedform. (1A)Anapplication madeunder subsection(1)shall

• (a)specify theparticulars ofthepersonwith appropriateknowledgeofallaspectsof thehealth productor health technologywho shallberesponsibleforall communication between the applicant andthe pououny
• (b)where theapplicantisnota citizen ofKenya or is a company incorporatedoutsideKenya,appointa localrepresentative who shallbea citizenofKenya,apersonwhoishaspermanent residence ora company incorporatedin Kenya.
• (1B)Theapplicationmade undersubsection(1) shallbeaccompanied by-
• (a)aproposed label for use on thehealth product;
• (b)acopy ofthemanufacturinglicence ofthehealthproduct,where applicable
• ooo the country where thehealthproduct is manufactured;
• (d)acopyofacertificateofanalysisfroma qualitycontrol laboratoryrecognized by theAuthority,where applicable;
• (e)acopyofthemarketingauthorization or certificateofregistrationof thehealthproductor technology from theregulatory authorityofthecoutry here thehealthproduct ortechnologyis sold
• f)theavailabledata on thequality,safety,effcacyandperformanceofthehealthproductor technology submittedinacommon technicaldossierformat
• (g)asampleofthe health product
• (h)proofofoumershipofthe sitefor themanufactureofthehealthproduct,ifapplicable;

• (i)where theapplicant isnot a citizenofKenya or isacompany incorporated outsideKenya,acopy ofth agreementappointing the localrepresentative;
• ()where the application relates toa health product or technologywhich isregisteredwitha foreig regulatory body-
• i)a copy ofthe certificate ofregistration;
• i)theprofessionalinformationrelating to thehealthproduct ortechologyand
• ii)theconditionsoftheregistrationofthehealthproduct or technology
• (k)proof that the applicant holds
• (i)avalidpracticinglicence issued inaccordance withsection9AofthePharmacy andPoisonsAct
• (ii)aualiduholesale dealerslicenceissuedinaccordancewith section39oftheAct;
• (ii)avalid licence to dealinhealthproducts issuedinaccordancewith theAct;or
• (iv)avalid manufacturing licence issuedin accordance with section 47ofthe Act;and
• (l)proof ofpayment oftheprescribed applicationfees.

(1C)Anapplicant shallnotiftheAuthorityofanyuariationto theagreementappointingthelocalrepresentative within seven daysofthe variation"

• 72.Amendment of clause 29(2)by deleting the wordsor Essential Veterinary Medicines List"

Justification:To delete aspects touching on veterinary medicines that are out of scope of the Bill

• 73.Amendment of clause 29(2)and 29(s)by deleting the word "medicine"wherever it appears in the paragraph and substituting thereforwith the words"health product or technology"
• 74.Amendment of the Bill by inserting the following new clause immediately after clause 29 (s) the following new paragraphs

(3A)TheAuthoritymay,whileconsidering the applicationmade under this section,approue the details as oosq followngparticulars-

• (a)themameunder which the health product or technology may be sold
• (b)the labellingofthe health product
• (c)the statement ofthe representations to bemade for the promotiomofthe healthproductregarding-
• (i)the claim to be madefor thehealth product
• (i)theroute ofadministering the health product
• (iz)the dosage ofthe health product

• (io)the storage conditions ofthehealthproduct;
• (v)thecontra-indications,thesideeffectsandprecautionsfanyofthehealthproduct;ad
• (vi)thepackage size ofthe health product
• (sB)Whenevaluating anapplicationmadeunder this section theAuthority may
• (b)(b)consider theevaluation report ofaninstitution that has eualuated the health product.
• 75.Amendment of clause 29(4)and 29(6)by deleting the word"medicine"wherever it appears in the paragraph and substituting therefor with the words"health product or technology
• 76.Amendment of clause 29(6) by inserting the following additionalwords immediately after the word "medicine"if it is satisfied of the safety,efficacy,quality,performance and economic value of the health product or technology."

Justification:Harmonization of terminologies.

Justification:To emphasize on the need to be satisfied about safety,efficacy,quality,performance and economicvalue of a health product or technology.

• 77.Amendment of subclause(7).(8),(9),(1o),(11)and (12)of clause 29 by deleting the word"medicine wherever it appears in the paragraph and substituting therefor with the words"health product or technology"

Justification:Harmonization of terminologies.

• 78.Deletion of clause 29(13).

Justification: Clause 29(1s) may not be ideal as the Registraris already required under the Bill to publish the health productsregistered in the Gazette and those whose registrations are cancelled.

• 79.Amendment by deleting clause 29(14(a)and substituting therefor the following new definition (a) Supplieslist'means the list of essential medicines,diagnostics andmedical supplies included in the latest editions of the official publications relating to guidelines for standard treatment which is compiled by the state department responsible for Health;
• 80.Amendment by deleting Clause 29(14(b).
• 81.Amendment of theBill by inserting the following newparagraph immediately after clause29

29A.Registrationduringemergency

• (1)TheAuthoritymay,where it considersitnecessary to protectpublicoranimalhealthorintheevent ofa threat to human oranimal lifeor health,theAuthorityissue aprovisionalcertificate ofregistrationforahealthproduct ortechnology.

• (2)Apersonwhointends to obtaintheprovisionalcertificateofregistratiomforahealthproductor technologyder sub section(1) shallapply to theAuthorityin the prescribed form.
• (3)Where the applicant is nota cilizenofKenya orisa companyincorporated outsideKenya,the applicant shal appontalocalrepresentatvewhoshallbeacitizenofKenyaapersonwhoishaspermanentresidence oracompa incorporated inKenya.
• (4)An application under subsection(2) shall be accompanied by
• (b)wheretheapplicantisnotacitzenofKeyaorisacomparyncorporatedoutsideKeya,acopyoftheagreement appointing thelocalrepresentative;
• (c)proofthat the applicant holdsavalidpracticing licenceissuedinaccordance withsection9AofthePharmac andPoisonsAct;
• (i)avalidwholesale dealer'slicence issued in accordancewith section 39of the Act
• ()avalid licence to dealinhealthproducts issuedinaccordancewith theAct,or
• (ii)avalid mafacturinglicence issuedinaccordance withsection47oftheAct
• (d)thefees specifiedin theSecondSchedule.
• (5)Whendetermininganapplicationumder subsection(1),theAuthority shallconsider thefactsestablishedfrom thevalidmarketing authorizationfor thehealthproduct or technology and thereporton theassessmentofthe healthproductor technologyobtainedfrom theauthority competent formedicinalproducts,ifavailable.
• (6)The person to whom thecertificateofregistrationisissuedunder subsectiom(1)shall beresponsiblefor the
• (i)a validwholesale dealer's licence issued in accordancewith section S9ofthe Act
• (ii)avalid licence to dealin health products issuedin accordance with theAct,or
• ()avalidmanufacturinglicence issuedin accordancewith section47oftheAct
• (8)Aprovisionalcertificateofregistrationisuedunder subsection(1)shallbevalidfortruoyearsfromthedate assue or until the declarationmade under section35ofthePublicHealthActisrevoked.
• (9)Ayvariation to the agreement appointing thelocalrepresentative to the applicationmadeuder subsection(2) shall benotifiedto theAuthoritywithin seven daysofthevariation.
• Justification:To cater for registration of health products and technologies during public emergency situations.
• 82.Amendment of the Bill by inserting the following new clause immediately after clause 29

29B.Authorizationofunregistered healthproductortechnology

• (1)TheAuthority may,i wuriting,authorizeaperson to import or distributefora specifiedperiod toa specifiedpersonornstitutionaspecifiedquantityofaparticularhealthproduct thatisnotregistered
• (3)Apersonwhointendstoobtaintheauthorizationunder subsection(1)forpurposesotherthanaclical trial,shallapply to theAuthority,in theprescribedform.
• (2)Ahealthproduct distributedpursuant toauthorizationgranted under subsection(1)may be used for suchpurposesandin such manner andduring such periodas the Authoritymayinwriting determine.
• (4)Where theapplicant isnota citizenofKerya orisa compayincorporatedoutsideKerya,the applicant shallappointalocalrepresentativewho shallbeacitizenofKenrya,apersonwhoishaspermanentresidence ora company incorporatedinKenya.
• (a)aproduct brochure containingrelevant chemicalpharmaceutical,pre-clinicalpharmacological and tozicologicaldataandwhereapplicablehumanoranimalpharmacologicalandclinicaldatawiththehealth productconcerned;
• (5)Theapplicationmadeunder subsection(3)shall be acompanied by
• (b)witessedinformedwrittenconsent document,whereapplicable
• (c)detailsofregistratinorpendingregistrationofthehealthproductwithanyotherregulatoryauthority ifavailable,
• (d)evidenceofcompliance ofthemamufacturer of the health productwithGoodManufacturingPractice standards as determined by theAuthority;
• fooyoood agreement appointing thelocalrepresentative,
• (e)reasons ulry aregistered health productcanot be used;
• (h)thefees specifiedintheSecondSchedule.
• (i)avalidwholesaledealer's licence issuedinaccordance with section 39oftheAct
• (6)The Authority shallgrantauthorizatiomunder subsection(1)ifthe applicant has
• (ii)avalid licence to dealinhealthproducts issuedinaccordancewiththe Act;or
• (iii)avalidmanfacturinglicence issuedin accordance with section47oftheAct

(7)WheretheAuthority issues anauthorizationunder this sectiontheperson to wuhom theauthorizationis issuedshallsubmit to theAuthority

(a)progressreports afterevery sitmonthsfrom the date when theauthorizationwas issued

• (b)any adverse event reportwhenever an adverse event occurs;and
• (c)aprogressreportwithin thirtydays after the completionor termination oftheuse ofthe healthproduct.
• (8)TheAuthoritymay,ifitisoftheopinionthat the safetyofanypatientoraimaliscompromisedor the scientificreasonsforadministering theuregistered health product have changed
• (b) )request additionalinformation;
• (a)impose any additional conditions
• (c)inspectthe sitewheretheuregisteredhealthproductismamufacturedstoredoradministeredor
• (9)TheAuthoritymay,bynoticeinuritingwithdrawtheauthorizationissueduder subsection(1)ifany ofpurposes or themanmer specifiedin subsection(2)is contravened.
• (d)withdraw theauthorization to treat thepatient oranimal
• (10)Ahealthproductauthorizedunder thisAct shall belabelledinaccordance with section 67oftheAct.
• (11)An applicant shallnotify theAuthorityofanyvariation tothe agreement appointingthe local representativewithin sevendaysofthe variation.

• (12)Therequzrenents in this section shall apply to applications for donations ofhealth products anc technologies.

Justification:To cater for authorization of health products and technologies during public emergencysituations.

• 8s.Amendment of clause so(1)and (3)s1(1)and s1(s)(c)by deleting the word "medicine"and substituting therefor with the words"health product or technology":
• 84.Amendment ofclause S2(1),s2(2),32(4)and s2(5)by deleting the words"medicine or medical device

Justification:To ensure harmonization of terminologies.

• 34(b) by deleting the word"medicine"and substituting therefor with the words health product or technology".

Justification:To ensure harmonization of terms while still providing for the specific category of

• 86.Amendment of clause S5(1),s5(2)and s5(s) by deleting the word"medicine"wherever it appears in the paragraph and substituting therefor with the wordshealth product""

Justification:To ensure the role of the pharmacist as a prescriber is provided and for costeffectiveness ofhealth products.

• 87.Amendment of clause S5(4)by deleting the paragraph and substituting thereof the followingnew paragraph-

(4)A pharmacist may substitute a prescribed health product for an interchangeable multi-source medicine in consultation with therelevant prescriber,

Justification:To ensure the role of the pharrmacist as a prescriber is provided and for costeffectiveness of health products.

• 88.Amendment of clause 35(1) by inserting the word "pharmacist"immediately before the word "medical".
• 89.Justification:To ensure the role of the pharmacist as a prescriber is provided and for costeffectiveness ofhealth products.
• s "alternative or complementary".

Justification:To cover a wider scope ofalternativemedicinesincludingherbal medicines

• 91.Amendment of the Bill by inserting new clause immediately after clause S6-

36AClinical trials

(1)Apharmaceuticalproduct shallnot beusedforclinical trialunless anapprovalisgranted bytheAuthorily uith theapprovaloftherelevant ethics body.

(2)Anypersonwhontends to commenceaclinicaltrialonapharmaceuticalproduct shallmakeanapplication prescribedformat and theprescribedfee.

(3)The study protocol submittedunder subsection(2)shall includeapost-trialaccess program to ensure access o Authority.

(4)The Authority shallprescribe guidelinesfor evaluation ofapplications made under subsection(2)to be iplementedfor acceleratedevaluations duringemergency situations,epidemics and outbreaks.

(6)TheAuthority shallcarryoutinspectionsoftheclinical trials soastoensurecomplianceoftheclinicaltrials wunith theprescribedrequirements.

(5)Apersongrantedanapprovalunder thissection shallputuparobustquality assurance system toensure that participants.

(7)Any protocolamendments applications shall besubmitted to the Authority for approval before implementation.

Justification:To ensure effectiveregulationof clinical trials by theAuthority

92.Deletion ofclause S7(2)andsubstitution with-

• (2)Theliststo bepreparedunder thisSection shallinclude
• (a)Scheduled substances thatwillbe availableforgeneralsalesin anyretailoutlet
• (b)Scheduledsubstances thatuillbeauailableontheprofessionaladviceofapharmacistwithout aprescriptio from anauthorised prescriber,and auailable omly in licensed pharmacies;
• (c)Scheduledsubstancesthatwillbeavailableonlyontheprescriptionofaauthorisedprescriberanddispensed bya pharmacist or licensed dispenser;

(d)Scheduled substances thatwillbeavailableonlyontheprescriptiomofanauthorisedprescriber,anddispensed byapharmacist or licenseddispenser,subjecttothe controlmeasures prescribedinaccordancewitheither the Single Convention onNarcoticDrugsof1961,the Convention onPsychotropicSubstances 1971,and theUN Convention against Illicit TrafficDrugandPsychotropicSubstances,1988;

• (e)Scheduledsubstances thatmaynot besold,ezceptin accordamcewithapermitfor thepurposesofeducatio analysis or research,orfor individual patient purposes.

Justification:To effectively cater for different levelsof control and to align to the African Union Model law of scheduling.

• shall review thelists whenever necessary in the interest of public health and safety.

Justification: One year is too short,and maybeimpractical if need arises.The proposed amendment allows the Authority to act in the interest of public health and safety.

• 94.Introduction of new provisions as follows:

37.Requirementsforscheduledsubstances

TheAuthority shallestablishauformsystemofaccesscomtrolfor productscomtaining scheduledsubstances hich shalltakeintoaccount--

• (a)restrictions on accessibility and availability to thepublic
• (b)interest ofpublic healthand safety
• (c)risks of poisoning from,misuseandabuse ofscheduled substances

The followingnew clauses are proposed.

Listofscheduledsubstances

• (1)TheAuthority shallprepare andsubmit to the Cabinet Secretary a list ofthe substances whichare to be treated as Scheduled Substances for the purposes of this Act
• (3)The lists to be prepared under this Sectiom shall include-
• (a)substancesuhich,subject to thisactarenot tobesoldexcept byauthorizedsellersofScheduledSubstances and by licensedwholesale dealers and dealers inminingagriculturalorhorticulturalaccessories;(b) substamces ohich,subject to this Act,are not to be soldexcept by persons specially licensed to do so,and(c) ary other substance declared to beaScheduledSubstance by the authority.
• (s)Uponreceipt ofthe list under sub-section(1),the Cabinet Secretarymay-
• (a)comfirm the list
• (b)amend the list by-
• altering anyreference toa substance;
• 司 omittingany substance,or
• ii) insertingany substance
• (c)vary the list.

Reviewofthelist

The schedulingofsubstances shall beundertaken at least every three years oruheneverecessaryinthe Interest ofpublichealthand safety.

Justification:The proposal introduces a transparent process of scheduling of substances in a manner that takes into consideration restrictions on accessibility and availability to the public including public health, safety and use.

• 95.Clause S8(1)should beredrafted as follows:

ThefollowingperonsmaybeinpossessionofScheduledSubstances

• (a)uholesale dealer licensed under this Act;
• (b)an authorized seller of ScheduledSubstances registered by the Authority

• (c)aperson licensed by the Authority to selScheduled Substances,thepersomalrepresentative ofa deceased person,or the liquidator,receiver or otherperson appointed to dealwiththepropertyofabankrupt orofa companywhichisbeinguoundupcompulsorilyorthemamageroftheestateofapersonfsoundmindin respect ofpoisons in possessionofScheduledSubstances
• (d)aperson,institutionordepartment,to whichaScheduledsubstancehas beenlaufullysoldunder thisAct
• (e)aperson forwhom the Scheduled Substance has been laufully supplied ordispensedby a healthcare professionalauthorizedunder thisAct;(f)thepersonalrepresentativeofadeceasedperson,ortheliquidator.

Justification:Tobring out the clarity of who may bein possession of scheduled substances and to prescribe limits as the current subclausedoes not prescribe any limits.

• 96.Redrafting of clause S9(4) and (5) as follows-

S9.(4)No licence shall beissuedorrenerwedunder this section umless thepersonapplyingforor holding suchlicence isaregisteredpharmacist oranenrolledpharmaceuticaltechnologistincontrolofthe distribution oftheScheduled substancesandis aresident inKenya.

• (5)Euerylicence issuedunder thissectionshallepire65daysfromthedateofissue.
• 97.Deletion of clause 40(s).

Justification:Issuance of licence is already provided for in clauseS9.

• 98.Redrafting of clause 40(5) as follows
• (5)Every licence issuedunder this section shallezpire365daysfrom
• the date ofissue.Justification Justification:The current clause is punitive for those who apply in the middle of theyear.
• 99.Redrafting clause 41(b) as follows-
• ydossgoopod()()()
• os to theprescribed schedule ofsubstances;

Justification:To capture both cadres in pharrmacy practice

• 100.Deletion of"veterinary surgeon and veterinary treatment" in clause 41 (1)(d).

101. Deletion ofclause 41(2)(b)and(c)

• 102.
• Deletion of the National or County government or their institutions in clause 41(1)(e). Justification:County governments referred in clause 41(1)(e) is not clear.
• 109.Redrafting clause 41(1)(f)as follows-

Alicencedhositaldispensaryor similarinstitutionorapersomorinstitution concernedwithscientific educationorresearchuhere suchhospitaldispensaryinstitution butitshallbeanoffenseto sellScheduled substances to anyoftheseunlessaregisteredpharmacistoran enrolledpharmaceutical technologistisin directcontroloftheScheduledSubstances at thepremisesfromwhich they are sold.

• 104.Amendment of clause 42(1)by deleting and substitution with the following paragraph:

(1)Anauthorizedseller shallenter arecordofsuchparticulars ofthe ScheduledSubstance before delivery oftheScheduledSubstance under this Act.Therecords hall bein sucha mannerand format asprescribea by theAuthorityandshallindicate-thedateofthesale,thename andaddressofthepurchaser,quantityf the Scheduled Substances sold,and the purpose for whichit is stated by the purchaser to be requzred.

Justification: The current clause is impractical and infringes on privacy among patients.The proposed amendment ensures the keeping of an accountable record of sold scheduled substances.

• 105.Deletion of clause 4s(1)and substitution with-

(1)Aqualifiedhealthcareprofessiomalmay supplyordispenseaScheduledSubstancewiththerapeuticvalue for thepurposeofmedical or dental treatment,as thecasemay beprovided by thisAct.

Justification:To restrict dispensing to authorized personnel.

• 106.Redraftingof43(1)(b)as follows-

-Theperson supplyingordispensinga scheduledsubstance shallmakearecordofthe scheduledsubstances suppliedwnthintuwenty-fourhoursinaPrescriptionBook.

theAuthority andshailindicate

(i)the date onuhich the ScheduledSubstance with therapeuticvalueuas supplied or dispensed

(ii)thengredients and the quantity supplied;

(ii)thename andaddressoftheperson to uhomtheScheduledSubstancewith therapeuticvaluewas supplied,

(in)thenameandaddressoftheperson by whom theprescriptionwasgiven.

Justification:The countryis moving towards digitization of processes.There are policies and guidelines available within the Ministry of Health.

107. Deletion of but shall not in respect of the supply be required to make an entry in the Scheduled Substances in the prescription book" in clause 4S(2)

Justification: To change the prescription book to a record as the first part is sufficient.

• 108.Deletion of43(1)(c). Justification:The content of 43 (1)(c)is covered in 43 (1)which has the expanded list of practitioners.
• 109.Redrafting clause44(3)as follows-

-Anypersonuho commits anoffenceunder thisSectionis uponcomviction,liabletoafinenoterceeding ten millio shillngs,ortomprisonmentforatermoterceedingthreeyears,orto both.

Justification:Theproposalmakes the fine more reasonable and commensurate to the offence.

• 110.Deletion of clause 45 and substitution therefor with the following new clause—

45"Automaticmachines-

45(1)An authorized seller may usean automaticmachine to dispense over-the-counter Scheduled Substances.

• (2)TheAuthority shalldevelopregulationson
• (a)classes ofsubstances permitted;
• (b)quantities of substances to be dispensed
• (c)records ofsubstances dispensed
• (d)locatiomofautomaticmachines;and
• (e)registration ofautomaticmachines.

Justification:Toprovide for the use of automaticmachines in dispensing selected scheduled substances in an effort to embrace technological advances.

• I11.Deletion of clause 46and substitution therefor with thefollowingnew clause

scheduledsubstances suchasthroughe-pharmacy,telemedicinemedicationtherapymanagementandonline pharmacy.

• (2)Theregulatioms in section46(1) shallincorporate procedures to ensure;
• (i)licensure ofe-pharmacies
• (ii)safety of the patient
• (1)Thisshallbepermittedas lomgas thesupplyofthemedicineconformswithallrequirementsfortheparticular medicineintermsofits scheduling statusandany otherrequirementsasmay bespecifiedinRegulatioms pertaining to thistype ofsupply.
• (2)In the case ofaPrescription-onlymedicine,therequiredprescriptionshall have been obtainedasaresult of atleastonephysicalinteractionbetrueen anauthorisedpractitionerandthepatientwithin sizmonths.

(4)Any personwhocontravenes theprovisionsofthis sectiomshall beguilty ofanoffence and shall beliable to afinemotexceedingonemillionshillingsor toimprisonmentforatermnotezceedingoneyear,orto both.

Justification:To make provision for the Authority to develop detailed,futuristic regulations regarding telemedicine,e-pharmacy,authenticity ofprescriptions,traceability,onlinedispensing,and related platforms with consumer safety in mind.Electronic sale ofmedicines is already a global phenomenon.Many online platforms already sell medicines to consumers.The fineprovided for in the bill is too lenient for the type of business and the consequences of contravening the provisions.

• 112.Redrafting clause 47(2)as follows-

o isrevoked or is suspended.

Justification:A license should be valid for S65 days from date of issue unless revoked or suspendedearlier as the case maybe.

113.Replacing.the word"medicinal substance"with"health product"in clause 47(s)

Justification:To harmonize the terms used in the Bill.

114.Insertion of the following new provision--

Qualified persons in manufacturing site.

TheAuthorityshallprescriberegulations settingoutconditionsforthequalificationsofpersomnelinuolve in the production processesofahealthproductin thisAct.Personnelqualifiedfor conductinglotrelease oj vaccines andpersonnelqualifiedforBatchrelease ofhealthproducts shall submit to theauthori qualificationsfor the same.

Justification:To provide for development of regulations.

115.Insertion of the following new penal provision-

AnypersonwhocommitsanoffenseumderthisSectionisuponconvictionliabletoafnenotexceedingKshs 100millionKenyaShillings,or to imprisommentfora termnotexceeding1Oyears,or to both.

Justification:Having substandard,falsified and falsely labelled health products released to the public has potential for severe adverse public health consequences.

116. Redrafting clause 48 as follows-

(1)Aperson uhois granted amanfacturing license under Section 47shall comply with the Good ManufacturingPractice,as prescribed by the Authority.

(2)The Authority shall have powers toenter andinspectthe manufacturingpremises to confirm compliance with prescribed Good ManufacturingPractices andissue a Certificate ofCompliancein theprescribed afpq.dfouododnof

Justification:To encourage continuous improverment of internal quality control systems and production processes of manufacturers in line with good manufacturingpractices byWHO.

117.Insertion of the following new clause 48(2)

Revocation andsuspensionofmanufacturinglicenses

(1)TheAuthoritymaybynoticeinwritnggiventotheholderofalicensereuoke thelicenseorsuspendth license for aperiodspecified in thenotice,asprescribed inRegulations,f

(a) at least oneofthe followingpersons:the holder,aperson(a manager)who makes,orparticipates in making,decisioms that affect theuhole,or a substantialpart,ofthe holder's affairs;ftheholder is a body

Has been convicted ofanoffense against this Act;

(ii)or breacheda conditionofamamufacturing license;

(i)orbeenconvictedofanoffenseivolvingfraudordishomesty

(ii)or beenamanager,oramajornterest holder,ofabody corporatef the conductresultingin that inrespect ofuhich subsection ),ii)oriiapplies it the conductresultingin the subsection applying occurred when theperson wasamanager ormajor interest holder ofthe body corporate,or

• (b) theholder requests inwriting that the licence berevokedor suspendedas the casemay beor

or

• (c) theholder ceases tocarry on the business ofmamufacturing theproducts to wohichthelicencerelates
• (d) theholder contravenesamanufacturing siteauthorisationinrelationto thelicence,or
• (#) theproducts are exemptasprescribed byregulations and theholderhas breachedaconditionofthe exemptioninrelation to thoseproducts;or
• (e) d they becomepayable;or
• (g) thelicence coversabiologicalthatisezemptbyregulationsandtheholderhasbreachedacondition ofthe ezemption inrelation to the biological,or
• (h) any other circumstances prescribedby theregulationsfor thepurposes ofthis section ezist.
• (3) Subsection(1)(a)doesnot limit subsection(1)(h).
• (2) Areference in subsection(1)(a)toaperson convictedofanoffence includesa reference toa person inrespectofwhomanorder has beenmaderelating to theoffenceunder anapplicablemationallare.
• (4) Amanfacturing licence grantedunder thisActshall be
• (6) alicence,grantedundera corresponding mationallawrelating tohealthproducts relatingto manufacturingof suchproducts.
• (a) alicence granted under thisPart;or
• (5) Where theAuthorityproposes torevokealicence orsuspendalicence otherwisethanat therequest oftheholderofthe licence,theAuthority shallunless theAuthoritycomsiders thatfailure toreookeor suspend thelicenceimmediatelyoould create animminent riskofdeath,serious illness or serious inury bynotice in uritinggivento theholder,inform the holderoftheactiomthat theAuthorityproposes to takeandofthe reasonsfor thatproposedaction
• (8) WherealicenceissuspendedtheAuthoritymaybynoticeinuritinggiventotheholderfthe licence,reuoke the suspension.
• (7) A licence may bereuokednotwithstanding that thelicence is suspended
• (6) Where theAuthority reookes or suspends a licence,the Authority shall cause particulars ofthe decision tobepublishedin the Gazette andupdated on theAuthority'swebsite as soon asis practicableafter the decision is made.

Justification:Toprovidetheconditions forwithdrawal of revocation of licence onrequest from a manufacturer.

• 118.Insertion ofthefollowingnewclause onwithdrawalofrevocationofmanufacturinglicence uponrequest andtransferofmanufacturinglicense. Justification:The Bill shouldprovidefor a mechanismfor thereview of decisionsmadeunder the Bill by theAuthority.
• 119.Restriction of clause 49 to cosmetics that contain scheduled substances by redrafting as follows49Therapeutic cosmetics containing Scheduled substances
• (I)A person shallnot sell any therapeuticcosmetics containing scheduledsubstances that-
• used-
• (i)according to the derections on thelabelofor accompanyng such therapeutic cosmetic;or

()for suchpurposes and bysuchnethodsofuse asarecustomary orusual thereoforcomsiderinclusiomoj aclauseonadulteratedcosmeticsandmisbrandedcosmetics asfollous

(1)Acosmeticshall be deemedto beadulterated-

• ()Ifit bears orcontainsanypoisonous or deleterious suzbstanceuhichmayrenderitinjurious to usersunde the comditionsofuseprescribedin thelabelling thereoforundersuch conditionsofuseasarecustomaryor requrementsprescribedunder subsection(i);Forpurposes ofthis subsection,the Authority in consultation with the Cabinet Secretary shallprescribe labellingrequirements applicable tocoal tarhair dyes.
• (ii)For the purposes ofthis subsection and subsection(e)the term"hair dyeshall notinclude eyelash dyes o7 eyebrow dyes.
• (b)Ifit consistsholeorinpartfayfilthry,putrid,ordecomposedsubstance
• (d)Ifitscontainer is composedinwholeorinpart,ofanypoisonous or deleterious substance whichmay render thecontentsingurious to health;
• (c)Ifit has beenprepared,packedor held uder insanitaryconditions wherebyit may have become contaminatedwnthfilth,oruherebyitmayhave beenrenderedinjurious tohealth;

(1)Acosmeticshall be deemed to bemisbranded-

• (f)Ifinpackage form unless it bears a labelcontaining-
• (e)Ifits labellingis false or misleadinginanyparticular.

(i)thename andplaceofbusinessofthemanufacturer,packer,ordistributorand

• (ii)anaccurate statement ofthe quantity ofthe contents in terms ofweight,measure,ornumericalcoumt:

Provided,thatunder clause(i)ofthis subsectinreasonable variations shall bepermittedandexemptions as to small packages shall be establishedbyregulations prescribedby the Cabinet Secretary.

• (a)Ifanyword,statement,orotherinformationrequiredby orunder authorityofthisPart toappearon thelabelor labellingismot prominentlyplaced thereonwnith suchconspicuousness(as comparedwith otherwordsstatements,designs,or devices,inthelabelling)andinsuch termsastorenderitlke tobereadandunderstood bytheordinaryindrvidualunder customary conditionsofpurchase amd use.
• (C) Ifit isacolouradditiveunlessitspackagingandlabellingareinconformity withsuchpackaging issued under this Act;This subsection shallnot apply topackages ofcolour additives which,with respect to their usefor cosmetics,are marketed andintendedfor use only in oronhair dyes.
• b)Ifitscontaineris somadeformedorflledastobemsleadng

Ifitspackagingorlabellingisinviolatiomofanapplicableregulationissuedpursuant thissection.

Justification:Not all cosmetics contain scheduled substances.The other cosmetics areregulated through KEBS.The issues listed will not apply under good manufacturing practice(GMP).

120. Inserting the following new clause immediately after clause 51-

Information thatisrequiredtobedisplayedinthepack

51A.(1)Aperson dealing ina therapeutic cosmetic shall indicate:

• (a)thecommonname oftheraperuticcosmetic
• (c)all the cosmeticingredients(exceptflavors andfragrances)must appear on theproduct labelintheorderof prominence;
• (b)the net weight;
• (d)thenameand address ofmanufacturer,
• f)a statement that the therapeutic cosmeticiscapable to cure ortreatanydiseaseormedicalconditiom.
• (e)awarning statement,and

Justification:For transparency with regards to the ingredients in the prescribed requirements.

• I21.Deletion and substitution thereforof clause51with followingnew clause-

"51Manufacturingofcosmetics

• (1)The CabinetSecretary shallfor theeffectiveimplementationofthis section,developregulations.(2)The regulationsmadeunder subsection(1)may
• a)requiremanufacturersofcosmetics toregisterwith theAuthority
• (b)imposerestrictionsrequrementsorotherconditionsomanufacturersofcosmetics,fsuchrestrictins

Justification:For transparencywith regards to theingredients in the prescribed requirements in line with good manufacturingpractice(GMP)and other guidelines.

• 122.Amendment of clause 52 by deleting the words "have a therapeutic effect or valueand substituting therefor the wordsto treat,diagnose orprevent disease,oraffect the structhure orfunctions ofthe body"

therapeutic cosmetic is used this already means the cosmetic has therapeutic effect.

• 123.Inclusion of a penalty for theoffence by redrafting clause 54(s)to-

Arypersonwhomanufactures,suppliesimportsorezportsacosmeticthatisadulteratedormisbranded commits an offense andupon conviction,shall be liabletoafineofnotless than Kshs 50o,ooo or to imprisonmentfora termofnotlessthanoneyear,or both.

• 124.Inclusion of the following clause-

Regulations making exemptions.

"TheCabinetSecretary shallpromulgateregulations exemptingfromany labellingrequirement ofthisPart cosmetics uhich are,in accordance withthepractice ofthe trade,to beprocessed,labelled,orrepackedi substantialquantities atestablishments other than thosewhereoriginallyprocessedorpackedonconditio that suchcosmetics arenot adulteratedormisbrandedunder theprowisions ofthisPartuponremovalfrom

Justification:To cover instances where such exceptions will be necessary based on the advice of the technical teams.

• 125.Insertion of the words"and in-vitro diagnostics medical devices registerimmediately after the words"human medical devices register"in clause 55.

Justification:Toprovide forin-vitro diagnostics

• 126.Amendment of clause 55(1)byremoving the words"human andveterimary'immediately after th words"humanmedicaldevicesregisterandveterinary medical devices toremain withmedicaldevices"
• 127.Inserting the following new subclauses immediately before clause 55(2)-

Justification:Toharmonize the terms used in the Bill.

Amedicaldevice to be placed on the market shall beregisteredwith the Authority.-No person shai manfactureimportorezportor distribute any medicaldeviceunlessheor sheis theholderofaregistratio certificate-TheAuthority mayezempt certainmedicaldevicesfrom therequirementfor registrationwher appropriate.-Fora medical device to be assessedthe authorityshallputinplacean appropriatesystemfo the conformity assessment ofmedicaldevices.-Medical devices shall meet the essentialprinciples set outi Schedule1(EssentialPrinciplesofSafety andPerformanceofMedicalDevices),asmay beapplicable,takin account oftheintendedpurpose ofthe medicaldevice concerned.-Therisk-basedclassification ofmedica devices inaccordance with theriskclassification rules set out inschedule 2,shall be used.-In the event of disputein the classificatiomofamedicaldevice,theAuthority shall decideon theproperclassificationofth medical device comcerned,whose decision shall befinal".

• 128.Inserting the following new subclauses immediately after clause 58(1)

Theauthoritywillreceivefromthenationalnuclearauthoritydocumentedevidenceofradiatimrequire toenable themedicaldevice toperform its therapeuticanddiagnosticfuctions and theintendedpurpose the device for issuance ofregistration certificates oftheMedicalDevice

• 129.Inserting the following new subclauses immediately after clause 59(1)-

"Aniporter/distributor/dealerwuill establishandimplement documentedproceduresfor themaintenanc ofimportationand/ordistributiomrecordsandmaintainanimportationand/ordistributionrecordofeacl medicaldevice to be submitted tothe Authority-Applicatiomsforregistration ofmedical device establishments shallbe submitted to theAuthorityintheprescribedformat andshallbeaccompanied by th prescribedfees-Anzmporter/distributor/dealerwillestablisha system ofnotficationoffield safet corrective action and shallnotify the Authority.

• 130.Insertion of the following new provisions as follows
• 1.IftheAuthority is satisfied that the applicantmeets theprescribedrequzrements,theRegistrar shallissue aregistrationcertificatefor themedicaldevices establishmentin theprescribedformat.
• 2.Amedicaldevices establishment registration certificate shallexpireon 3iDecember eachyear,unless itisrenerwedupon application by theApplicant in accordancewith the conditions set forthin the applicationform.

3. reinspectiom.

• a.theapplicant has madefalse or misleading statement(s)in the application;or
• Refusal to issue a medicaldevices establishment registration certificate.The Authority mayrefuse tc issue amedicaldevices establishmentregistrationcertificate if

• b.the authorityhasreasonablegrounds tobelieve thatissuing themedicaldevices establishmentregistration certificatewill constitute arisk tothehealth or safetyofpatientsusers orotherpersons;or
• theapplicanthasfailed tomeet theconditionsformedicaldevices establishmentregistrationasspecified insection(a)above.
• 5.Inany casewhere theAuthority does notrecommend theissuingofamedicaldevices establishment registration certificate,the Authority shall
• notif theapplicantinuritingofthereasons for notrecommending/refusing the registration ofthe establishment,and
• b. givetheapplicantanopportunitytorespondtotheAuthorityandprouiderelevant documentation/evidence insupport of theapplication.
• 6.Notification ofchangefor MedicalDevicesEstablishment.

Afer the issuance ofamedical devicesestablishmentregistration certificate,if there is a change to anyf theinformationsubmittedatthetimeofapplication,theholderoftheregistrationcertificate shall submitthe newinformation to theAuthority within10 wuorkingdays ofthe change.

Justification:It isa requirement to submit post-market alerting system requirements to the authority.An importer,distributor or dealer willestablish a system ofnotification of field safety corrective action and shall notify the Authority.

• 1S1.Inserting the following newPart immediately after Part IX

"PartIXA-TheNationalPharmacovigilanceSystem"

• (1)The Authority shall throughthe NationalPharmacovigilanceCentre manage thenational pharmacovigilanceandpostmarketingsurveillancesystentoreceive andmaintainallrelevantinformation about suspected adverse drugreactions andadverseevents tohealthproducts ortechnologieswhichhave been authorizedby theAuthority
• (2)TheAuthority shall conduct both passive and active surveillance ofhealthproducts and technologies.
• (3) The Authority shallcarryoutpharmacovigilanceaudits andinspectionsinorder toensurecomplianceuith GoodPharmacovigilancePractices and theprescribedrequzrements."
• (4)Allentitiesresponsibleforplacingahealthproduct or technologyin themarket shallestablishand maintain apharmacowigilance system for mamaging safety information ofhealth products and techuologies.The entities insubsection(4) shall submit safetyinformation to theAuthority asprescribed
• (5)The consumers,generalpublic,health care professionals shall report adverse reactions and events to the Authority as prescribed"

Justification:The Pharmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules,2022 describe these roles but it is important to anchor the regulatory role of pharmacovigilancein the Bill thatwould then serve asguidanceon development or review of existingregulations.

• 132.Deletion of clause 60and substitution therefor with the followingnew clause

60.(1)There is be establishedaNatiomalQuality Control Laboratory which shall beusedasa facilityfor-

• a)the examination and testing healthproducts and technologies including vaccines and biopharmaceuticai andany materialorsubstancefrom oruithwhichand themarnerinhichdrugsmay bemamufacturec processed ortreatedandensuring thequalitycontrolofdrugs andmedicinal substances,
• b)performing chemicalbiologicalbio-chemicalphysiologicaland pharmacologicalanabysis and othe pharmaceuticalevaluation
• testing,onbehalfoftheGouernmentoflocallymanfacturedandimportedhealthproductsandtechnologie intheKenyanmarket,prior tomarketing authorization,redistributionandpost distribution;
• providing technicalsupportto localmanufacturers andbuildingtheircapacityinmatters pertainingt quality controlofregulatedproductsthroughonsite andbmoff-site training and laboratoryassessments;
• g conductresearchand training andprovidehighqualityanalytics andexpertknouledgeinthearea ofhealtl products andactivepharmaceuticalingredients.
• conducting investigationsinto thequalityandsafety status ofregulatedproducts developingant scientificevidence andreports on the quality and safety status oftheregulatedproductsand
• h)to developandadministeradatabankonqualityassuranceonbehalfoftheAuthoritycollaboratewithothey laboratoriestoensurequalityinhealthproducts;

Justification:HPTs play an essentialrole in ensuring the health of the Kenyan population and the attainment ofUHC.At the same time,medicines are potential poisons that need to be safeguarded by qualified professional custodians in their wholelife cycle from development to formulation,quality assurance,distribution,administration to the patient and ultimately,their disposal.NQCLplays a pivotal role in assuring the safety and quality and HPTs in circulation in the Country.

For theNQCL to effectively deliver on itsmandate,its establishment ought to be anchoredin thelaw with clear articles defining its governance,structure and administration.These are lacking in the KDA bill,which in effect immobilizes its existence and effective discharge ofits mandate

• 133.That Clause 61(1)of the Bill be amended by deleting the words "Director-Generalappearing immediately before thewords"signed by theandinsert thewords Director NatiomalQuality Control Laboratory".

Justification:A Certificate ofAnalysis is a document that communicates theresults ofa scientific testdoneon aproduct/HPT.In compliancewithWHOgoodpracticesforpharmaceutical quality control laboratories,this certificate should beissued by a person who will ensure the test sample's authenticity and that it fulfils the prescribed standards set. Therefore, this role should be in the purviewofDirector of theLaboratory.

• 134.That Clause 61 is amended by inserting a new Clause 61A as follows-

61A.(1)TheAuthority shallappoint aDirectorofLaboratory Serviceswho shall bethechiefezecutiveoy the laboratory responsibleto theauthority for day-to-daymanagementofthe laboratory.(2)TheDirector Laboratory Services shall holdoffice on such terms and conditions ofservices asmay be specifiedin the instrumentofhisappointment."

1s5.Amendment of Clause 62byinserting the following clause-

62(1)(a)"Apersonwho without permissionfrom the Authority,manufactures,mportsdistributessupplies the smallestpresentation availablefor sale commits anoffence.

62(1)(b)This subsection doesnot apply to distributionoffreepromotional samples ofHPTs byauthorized pharmaceuticalrepresentatives ina standardwell-labelledpackagepermanently marked"not for sale"to qualifiedand licensed healthcare professionals.

62(2)(a)TheAuthority shall cause to bekept aregisterofallapplications for the advertisementofa healthproduct andtechnology includingrestrictedrepresentations;and

(c)For purposes ofthis act,theadvertisementofany health product and technology shall-(i)Have an advertisement code granted by theAuthority;(ii)notmakereference to an authorized practitiomer or association.(ii)take into accountpublic good and interest.(d) The Cabinet Secretary shall,make Regulationsonthetypesofadvertisementshichrequiresanapprovalandthemanmerinwuhichapplication. (e)Apersonuho contravenes theprovisioms ofclause 62commits anoffemse andis liabletofinenotexceeding ooso

(b)developuniform standardsfortheadvertisingofhealthproductsand technology

Justification: To make provision for the handling of promotional samples of HPTs.

136.Deletion of clause6s(2)and substitution with the following;

compositionandpurpose,areintendedanddesignedforuseuithouttheinterventionofamedicalpractitioner fordiagnosticpurposesorfortheprescriptionormomitoringoftreatmentwiththeadviceofthepharmacist ifnecessary.

(i)The prohibition containedin subsection(1)shall notapply to vaccination campaigns carried out and approvedby the Authority.

(i)Notuwithstanding subsection (1),the Authority in consultation with the Cabinet Secretary may ban advertisingto thegeneralpublicofhealthproductsand technologies.

• (ii)The directdistributionofhealthproductsand technologies tothepublic by theindustry forpromotiomal purposes,is prohibited.

Justification:For consistency in the document and clarity in implementation promotion of appropriate use of the medicines,to mitigate against antimicrobial resistance and to align to currentbestpractices.

The proposed clause providesa framework for exclusionofcertainpersons andprofessionals from prohibition ofadvertisement.

1S7.Deletion of 6s(s)

Justification:This provision is misplaced as it is already covered under Part V-Scheduled Substances.

138.Deletion of clause 65and substitution with the following:

65(a)"Aperson shall nottake part in the publication ofadvertisement referring toa healthproduct or technology or similar articlein terms uhichin theassessment ofthe Authorityisconsideredtobefalse on misleadingand to bearlittleornorelationto thepharmacologicalproperties andactionoftheingrediemnts or the component or correct use of thehealthproduct and technology

Justification:To give more clarity on the prohibition so that the Authority's decision is not merely based on opinionby assessment.

139.Deletion of clause 66 and substitution with the following:

• (1)Apersom commits anoffencef
• (i)publishes or broadcastsor
• (a)theperson:
• (i)causes tobepublishedorbroadcastednspecifiedmediaanadvertisement thatisrequired by the Regulations to beanapprovedadvertisement;and
• (2)Aperson commits an offence f
• (b)theadvertisement is notanapproved advertisement.
• (a)the persom:
• (i)causes to bepublishedor broadcast;anadvertisement in specified media,and
• (i)publishes or broadcasts;or
• (b)the advertisement isnotan approved advertisement in thatit differs,in anyrespect,from the advertisement that was approved.
• (a)thepersonprosecutedisapublisher or broadcaster whoreceived the advertisement towhich the business,or
• (3)It is a defence to a prosecution under subsection(2)f
• (2)Aperson commits an offence f
• ()publishes or broadcastsor
• (a)theperson:
• (ii) causes to be publishedor broadcastaparticular advertisement in specifiedmedia referred toin subsection(a),(c)or(d)ofthedefinition ofspecifiedmedia;and
• (b)the advertisement:
• (i)doesnot display its approvalnumber,or
• (tii)displays an approvalnmber thathas expired.
• (i)displays anumber purporting to be itsapproval number but thatisnot its approual umber;or
• (5)It is a defence to aprosecution under subsection(4)f theperson prosecuted
• (b) isa broadcasteruho received theaduertisement touhich theprosecutionrelatesfor broadcastingin visual broadcastmedia,in the ordinary course ofbusiness.
• (a)isapublisher wuhoreceivedtheadvertisement touhich theprosecutiomn relates forpublicationin specifedmedia referred toin subsection(a),(c)or(d)ofthe definitionof specified media;or
• (6)Aperson commitsanoffence f
• ()publishes or broadcastsor
• (a)theperson

• (ii)causes to bepublishedor broadcast,inspecifiedmedia,anapproved advertisement;and
• (b)theperson'saction isin contraventionofa comdition touhichtheapprovalofthe advertisementis subject.

(7)It isa defence toaprosecutiomunder subsection(6)if thepersonprosecutedis apublisheror broadcaster whoreceived the advertisement touhichtheprosecutionrelatesforpublication or broadcastingin specified media in the ordinary course ofbusiness.

(8)Apersonwho comtravenes any oftheprovisionsof sectionsho commits anoffenceunder subsection shall subject to this Act,beliable

• (a)in the case ofafirst comwictiom,toafinenot more thanfive hundred thousand Kenya shillings orto imprisonmentforatermnotexceedingoneyear,orboth;
• (b) in the caseofasubsequent convictiom,toa finenot more than onemillion Kenya shillings or o imprisonmentforatermnotexceedingtuoyearsortoboth.
• C

subsection2.

Justification:For consistency of theuse of the term"Health product technologyinstead ofarticle in the entire Bill.

• I41.Insertion ofthe followingnew clause-
• (1)Ifadrug(other thaninsulin,an antibioticdrug,an animal drug,oran unapproved drugexported has differentoradditiomal labellingrequirementsorconditions for useandsuchcountryrequires the drug tobelabelledinaccordancewiththoserequirements orusessuchdrugmay belabelledinaccordancewith suchrequirements andconditionsfor usein the country towhichsuch drugis beingexportedfit alsois labelledinaccordancewiththerequirements ofthisAct.(2)Ifpursuant to subsection(1),thelabellingofa ezporteddrugincludes conditionsforuse thathavenotbeenapprovedunder thisAct,the labellingmust state that suchcomditionsforusehave notbeenapproved under thisAct.(3)Anuapproved drugerportedunder regulations promulgatedforsuch under thisAct is exemptfrom this section

Justification:This is to ensure compliance with labelling requirements as approved during marketing authorization by making the fine deterrent.

• 142.Insertion of the following new clause-
• (1)The follorwinginformatiom shallappear on theouter packagingandom theimmediatepackagingof unauthorisedinvestigationalmedicinalproductsandwnauthorisedauziliary medicinalproducts
• (a) Information toidentifycontact persons orpersons involvedin the clinical trial
• (c) Information toidentifthemedicinalproduct;
• (6) Information toidentify the clinical trial;
• (d) Informationrelated to the useofthemedicinal product.

• (2)Theinformationunder subsection(1)shall-
• (a) ensure subject safety andreliability androbustness ofthedata generatedin the clinicaltrialhil takingaccountofthe designofthe clinicaltrialuhether theproducts areinvestigationalorauxiliary medicinalproduct,andwhether they are products with particular characteristicsand
• (b)be clearlylegible;and
• (3)TheCabinet Secretary shall promulgateregulations to givefurther effect to subsection(1)and(2);anc toprovide labellingrequirementsapplicableto-
• (a) authorisedinvestigationalmedicinalproducts andauthorisedauxiliarymedicinalproducts
• (b)radiopharmaceuticals usedas diagnostic investigational medicinalproducts or as diagnostic auziliar) medicinalproducts.
• and thereliabilityandrobustnessofdatageneratedinaclinicaltrialor to takeaccountoftechmicalprogress
• (5)The languageofthe information on the label shall beEnglish.The medicinal productmay be labelle in several languages.

Justification:The labelling requirements for all Health products Technology (HPTs) is not specified in this clause.

• 143.Amendment of clause S(a)by deleting the words"twohundred thousand"and substituting thereo theunth the words"one million"
• 144.Amendment of clause s(b)by deleting thewords "three hundred thousand"and substituting thereofthewiththewords"twomillion"
• 145.Deletion ofclause 68.
• Justification:Clause 68 isnot relevant as any valid exemptions may be considered.
• 146.Amendmentofclause(1)by deleting the words"homoeopathicmedicine,preparationormedical device and substitute with the words"health products and technologies

Justification:To expands the scope

• 147.Amendment by including the words "including a health product and technology fo emergency use"immediately after the word"technology"in clause72(1) Justification:IncludesHPTs foremergency use.

148. Amendment by deleting the entire clause 7s(1)and replacing with the following new paragraphforaperiodnotexceedingomemonth or'furithin thatperiodproceedings are commenced for anoffence proceedings".

Justification:Consistency in use of the termhealth product and technology"

149. Amendment by deleting theentire clause7s(2)andreplacingwith the followingnew paragraph"(2)Whereamagistrateis satisfied that any healthproduct and technologyisofaperishablenature or that byreasonofthefact that themarketfor the healthproduct and technologyisseasonal,orforanyotherreason, delayindisposingthehealthproductandtechologyuould undulyprejudicetheowner,themagistratemay authorize the sale or other disposalofthe healthproduct and technology".

Justification: Consistency in use of the term"health product and technology"

• 150.Amendment by deleting the entire clause 7s(s)and replacing with the following new paragraph3)where proceedings are takenfor anoffence under thisActor any rules thereuder the court by orbefore product and technology inrespect ofuhichsuchoffence wascommittedas thecourt shall seefit

Justification: Consistency in use of the term"health product and technology"

• 151.Amend by deleting the entire clause 7s(4)and replacing with the following new paragraph-"I this sectionreferences toa healthproduct and technology shall beconstruedasincluding theproceeds ofa saleeffectedinaccordance with theprovisions ofsubsection(2)

Justification: Consistency in use of the term"health product and technology"

152. Insertion of the following new clauses immediately after clause(74) 2. 15S. 74(a)InspectionandverificationofHealthProductsandTechnologiesatthePortsof Entry 3. (1)Apersonuhoimports healthproductsmedical devices or technology shall notify theKDAinspectors al thePorts ofEntry to conduct pre-clearanceinspectionand verification. 4. (2)Axy personwhoimports healthproducts,medical devices or technology andcauses it to bereleased to the market without the authorization shallbeguiltyofanoffence. 5. (s)Finesofconcealment,cross border smuggling,misdeclaratiom and diuersion ofHPTs to be Kshs. million.

Justification:To give power to the Authority's inspectors to enforce compliance with set or prescribed standards of quality,safety and efficacy of HPTs before release at the ports ofentry. To deal with the problem of concealment,misdeclaration,diversion and cross border smuggling of HPTs and other illicit trade practices which endangers public safety.

• 154.Deletion ofclause79.

Justification:The functionis outside theregulatorypurviewof theAuthority

• 155.Amendment of Clause s0(1)(a)by deleting the word "article"and replaced it with "Health productsandtechnologies"

Justification:For consistent use of HPTinstead of article throughout the whole document.

• 156.Amendrment of Clause so1(b)by including immediately after the word "vehicle"the words"or any other vessel usedas a means of transport

Justification:To include all other transport means including bicycles motorcycles etc

• 157.Amendment by deleting the entire clause. Justification:Interferes withindependence of theregulatory authority.
• 158.
• Amendment by deleting the entire clause.

Justification:Regulation is a function of National Government

• 159.Amendment by deleting the entire clause 83. Justification: Interferes with independence of the regulatory authority as recommended by the WHO.
• 160.Amendment of clause 85(1)and (2)by deleting the word "articleand replaced it with"Health productsand technologies".
• 161.Amendment of clause S6(1)(b) by deleting the words"seven hundred thousand"andreplacing with thewords"one million"

Justification:To harmonize terminologies in the Bill.

Justification:To enhance the fines.

162. .Replacinga NationalQualityControl Laboratory"with"aNationallyAccreditedQuality Control KENAS or any otherinternational accrediting body like WHO.

Justification:Thisis to accommodate other nationally accredited laboratorieslikeKEBS,MEDS, NQCL,Public Health Labs,KEMRI.

• 163.Amendrment of clause 87(c) by deleting the word"article"and replacing with"health products and technologies".

Justification:Harmonization of technologies

• 164.Deletion of'Funds'and substitution withFund'in clause S8(a) Justification:Nomenclature is 'Consolidated Fund' as outlined in the Public Finance Management Act,No.18 of2012
• 165.Deletion ofclause 9o(s)and substitution with the following new sub clauseThe anrual estimates shall beapproved by theBoardoftheAuthoritybefore the commencementofthe financialyear towhich theyrelate,and shall be submitted to the Cabinet Secretary for approval.The

Authoritymayatany timebeforetheendofeachfinancialyear,prepareandsubmitto theBoardforapproval Cabinet Secretary for consent.

Justification:Theintroduction of supplementary estimates within the organization will allow for effective execution of the Authority's mandate to adequately execute its regulatory function as need arises.

• 166.Deletion of clause 91(s)and (4)and substitution with the following new sub clause(S)

"The Authority shallkeep accounts andrecordsofits transactions andaffairsand shallensure that all momeysreceivedareproperlybrought to account,allpaymentsoutofitsfundsarecorrectlymadeandpropery authorizedandthatadequate controlismaintainedover itspropertyand liabilities theAuthoritymayincur under this Act"

(4)TheDirectorGeneralshallwithin threemonthsafter theendofeachfinancialyearsubmit to theKenya NationalAudit Office,followingBoard approval,theaccounts oftheAuthority inrespect to thatyear togetherwith

(a)astatement oftheincome andezpenditureoftheAuthorityduring thefinancialyear;and

(b)a statementoftheassets andliabilitiesoftheAuthorityon the last dayofthatfinancialyear

Justification:Clause 91(S)introduces the clause on accounting and provides direction on how theAuthority will run its affairsin accordance with existing laws andregulations. Introduction of'following Board approval'prescribes theprocessupon which the Authority will present its reports for Audit.

167. Deletion of clause9s(2) and substitution with the following new sub clause-"TheDirector General shallithin three monthsafter the endofeachfinancial year,submit to the Board and the CabinetSecretary the annual reportin respect of that year"

Justification:Introductionof the'Director General'prescribes the onus on the Authority's accountingofficer topreparetheannualreport.

• 168.Insertion of the following new paragraphs after paragraph (i) in clause 95(2)-

(ia)toregulateillicit useofnarcoticandpsychotropic substances;

(iib)toregulateparallelinportationofmedicines.

Justification:To give theAuthority power to make rules pertaining to illicit use of narcotic and

"(ba)onPharmacovigilance andPost market surveillance.

"(bb"OfficialRegulatoryLotReleaseofvaccines andother biologicalproducts importedandmanufactured in Kenrya.

bc) Good Practices(GXP) in the regulation ofmedical products

bdInspectionslicensureandcertficationofthemanufactureofmedicalproductsbyhealthfacilities

"beInpections,licensure andcertificationofmanufactureofmedicalproducts andotherregulatedproduct byfacilities not directlyregulatedby theKenya drugAuthoritymcluding steelindustries,sugarindustries

"bfInspectionandrecognitionofPharmaceuticalQualityControlLaboratories.

Justification:Inclusion ofa clause on makingregulations on pharmacovigilance andpost market surveillancewhich are criticalto the attainmentofWHOmaturityleveleThereis an existing subsidiary legislation,the Pharmacy and Poisons Board (Pharmacovigilance and Post Market Surveillance)Rules,2022.although the Pharmacy and Poisons Act,Cap 244 is silent on safety monitoring andpharmacovigilance.

• 170.Deletion of"former Board" and substitution with "former Boards"in clause 96(1)

Justification: To avoid ambiguity and contradiction of clause 96 (s)(a)

171. Deletion ofBoardof National Quality Control Laboratory established under CAP244 in clause 96(2).

Justification:This provision ispegged on determination of contentious issues in clause 61 on the governance structure of theNQCL.

• 172.Amendment of clause 96(s)by deleting thewords12months and substituting therefor the word 24months.

Justification:To give adequate time for stakeholder involvement on pharmacy practice regulation.

• 173.Amendment of clause 97(1) by adding the following words at the end of the subsection "with reference to 96(3)".

Justification:To ensure that Cap.244remainsin force for regulation of practice and there is no gapupon repeal of Cap.244with regard to regulation of HPTs as prescribed in the Seventh Schedule.

Consider addressing the specific consequential amendments to thePublic Health Act if any.

174. Reference of theBill to the Board under thePublicHealth Actis erroneous because repealing this Board introduces implementation challenges to thePublic HealthAct.The Board referred to here isunder the Food Chemicals and substances Act.

interpretation challenges.

175. Deletion ofparagraph(1)of theFourth Schedule

Justification:Food is outside thepurview of the Bill

176. Deletion of paragraph(2) of theFourth Schedule.

Justification.There is an established Scientific Advisory Committee,PERAC that conducts causality assessment,riskmanagement and scientific,expert advice on pharmacovigilancerelated issues forHPTs.The Committeeissues recommendations to the CEO,PPB based on scientific evidences.Besides human medicines,the Committee handles incidences following use ofmedical devices and transfusion reactions issues.Its scope is wider than that of human medicines only. This ensures the independence of the Authority to take regulatory actions,that may arise from suchrecommendations.

• 177.Deletion of the whole repeal of cap.254.

Justification:The provisionsof Cap254are majorly on food thatis outside the objectand scope of the Bill.Cap 254 is the mother Act for food in Kenya,other legislations and standards regulating food and implemented by other regulatory agencies are referenced to the Act Repealing it will create a huge gap in food control in the Country.The Act is currently under review to align with the constitution and tobein tandem with thechanging trends in food safety.

• 178.Deletion of clause 79 in the Memorandum ofobjects and reasons.

179. In general,the Ministry noted that there isneed for the Bill to comprehensively provide for local manufacturingas the government is keen on expanding local manufacturingincludingHPTs to ensure commodity security and to promote sustainability,accessibility and affordability.The Bill should thereforeprovide asfollows-

TheAuthority will develop standardsfor themanufacture ofhealthproductsfromtime to time. The cabinet secretaryin collaborationwith theAuthorityshallprescribe theminimum standards to be appliedinamanufacturingsitethathandleshealthproducts

• (2)Obligationsfor manufacturingincluding:-
• health products,
• (b)procedures forqualityassuranceandquality control to be employedin the manufacturingofhealth products;
• (c)the qualifications andexperiencerequiredofpersonsemployedinthe manufactureofhealthproducts;
• (e)othermattersrelevant to thequality,safetyandefficacyofhealthproducts
• (d)the manufacturing practices to beemployedin the manufacturingofhealthproducts;or
• f)may include codes ofgoodmamfacturingpractice.

Justification:

Toalign with the Trade-related AspectsofIntellectual PropertyRights (TRIPS)flexibility and the African Union strategy of local manufacturing agenda.The Kenya Pharmaceutical Sector production that envisagedambitious solutions to the core challenges to thepharmaceutical sector in Kenya.

3.2.STHEPHARMACYANDPOISONSBOARD(PPB)

In its memoranda,the PPBproposed the following amendments:

• 180.1 Deletion of the definition of the term "therapeutic cosmeticand substituting therefor the following definition"Therapeutic cosmeticmeans a cosmeticwhich offers an additional benefit to aperson over an ordinary cosmetic;contains a bioactive product formulated from an animal

ingredient that may have visible and measurable short- or long-term effects on a person;may include aproduct that may be absorbed through the skin or amucousmeimbrane.

Justification:The definition defines cosmeticsin general that aremeant toprovide thebody with appropriate aesthetics,texture,pH,color and smell.It is not specific to special cosmetics.

181. Amendment of the definition of the term "health products and technologies",article"and "package" by inserting the words"dietary supplement" immediately after the words"therapeutic cosmetic".

Justification:Food/dietary supplement is missing. It should be listed among theHPTs.

182. Deletion ofthedefinition of the term"medicinal substance"and substituting therefor the following definition—medicinal substancemeans a substance,the origin of which may behuman,animal, vegetable orchemical including human blood and human bloodproducts,micro-organisms,whole animals,parts of organs,animal secretions,toxins,extracts,blood products,micro-organisms, plants,parts of plants,vegetable secretions,extracts,elements,naturally occurring chemical materials and chemical products obtained by chemical change or synthesis; 183. Deletion of the definition of the term"medical deviceand substituting therefor the following reagent for in vitro use,software,materialor other similar or related article,intended by the manufacturer tobeused,alone orin combination,forhumanbeings,for oneormore of thespecific technologies and does not achieve itsprimary intended actionby pharmacological,immunological or metabolic means,in or on the human body,but which may be assisted in its intended function by such means. 184. Insertion of the following new definitions including "in-vitro diagnostics medical device", Inspector of Drugs,active surveillance, Clinical Trial,adverse event,adverse drug reaction, Centre,passive surveillance,pharmacovigilance,Premises,vessel,substandard, unregistered medicalproducts,falsified medicalproducts,and lot/sub-lot.

definitions.

• 185.Amendment of the definition of the term"herbal medicine or product"to include"herbs,herbal materials,herbal preparations,finished herbal products that contain active ingredients,parts of plants or other plant materials or combinations".

Justification:To expand the scope to include herbalmaterials and herbal combinations.

• 186.Amendment of clause 12 by inserting the following new paragraphs immediately after paragraph (e)—

"(ea)disposalofhealth products and technologies;"(eb)monitor themarket for thepresence ofunregisterea andillegalhealth products and technologies";"((ec)conducting analytical testsofhealth products and technologies".

Justification:These are critical functions of the Authority.

• 187.Amendment of clause 12of the Bill by deleting paragraph(f) and substituting the following new paragraph(f)ensure continuous momitoringofthesafetyofhealthproducts and technologies regulatea

under this Act by analysisofreports on adverse reactions and events,including any otherHealthProduct andTeclnologyuse relatedissues and take appropriate regulatory actions when necessary

Justification:In country safetymonitoring ofhealth products and technologies takes precedence. However,safety information from other National Regulatory Authorities may be considered throughregulation andreliancemechanismsfor decisionmaking.

• 188.Amendment of clause 12 by deleting paragraph(g)and substituting the following paragraph(g)

"Ensure that clinical trialprotocolsofhealthproducts and technologiesare being assessed according to the prescribedethicalandprofessionalcriteria anddefinedstandards including mandatory bioequivalence studies.The bestglobalbestpractice for clinical trialoversightrequires entrenchmentofclinical trials in requirements".

Justification:These minimums are not captured in the KDA bill as currently proposed.The detailsbelowasper the lastCAP244amendments provide theminimum requirements for clinical trialsoversight.

• '681 Amendment of clause 12of the Billbyinsertinga newparagraph immediately after clause(g)"(ga) approve theuse ofanyunregisteredmedicinalsubstanceforpurposes ofclinical trials and compassionate use".

Justification:This is to cater for emergency situations in public health

190. "(gb)carry outpharmacovigilance audits andinspections in order to ensure compliance with Good PharmacovigilancePractices and the prescribed requirements"

Justification:The Bill does not provide for conduct of Good Pharmacovigilance Practice Inspections,which arekey towards ensuring that marketing authorization holders,local technical representatives,parallelimporters,distributors and outsourced persons or companies meet the prescribed requirements towards ensuring safety of the health products and technologies they havereceivedmarketing authorization for.

• 191.Amendment of clause 12 by deleting paragraph (n)and substituting therefor the following paragraph(n)

appoint inspectors andorder inspectionofmanufacturingpremises,medical devices establishments, importingandexporting agentsuholesalers,distributors,pharmaciesincluding those inhospitals and clinics,retail outlets and any other premises subject to this Act"

Justification:To clarify premises subject to the inspections.

192. Amendment of clause 12 by inserting a new paragraph after clause (o),"(oa) Conduct National RegulatoryAuthority lotrelease(officialauthority batchrelease)ofspecifiedbiologicaltoensure the quality safety andefficacyofbiologicalproducts througharegulatoryrelease systemincompliancewith established approaches,policies,guidelines,proceduresandinlinewithWorldHealthOrganizatioanditernationally recognizedguidelines".

Justification:Theregulatory function involves lot releasewhich is a key component in vaccine production.

• 193.Amendment of Clause 12by inserting the following new paragraphs after clause(q)

(qa)Emsure thatall healthproducts and techmologies manufactured in,importedinto orexportedfrom the countryconform toprescribedstandards ofquality,safetyandefficacy

(qb)Enforce theprescribedstandardsofquality,safety andefficacyofall healthproducts and technologies manufacturedimportedintoorerportedoutofthecountry

(gc)Grantorrevoke licensesandpermitsfor themanufacture,importation,eportation,distributionan saleofhealthproductsand technologies

(qd)Maintainaregisterofallauthorizedhealthproductsand technologiesmamually orelectronically

(qe)Regulatelicituseofnarcotic,psychotropicsubstancesandprecursor chemicalsubstancesinaccordance witheitherthesingleconventiononNarcoticdrugsof1961,theconventiononPsychotropic substances1971 andtheUNconventionagainstillicit trafficofprecursorchemical substances1988

distributorspharmaciesncludingthoseinhospitalsandclnicsandotheretailoutlets.

Justification: Control over health product and technology import and export is a critical regulatory function.

• 194.Amendment of clause 1s by deleting paragraph 1s(a)and substituting therefor the following paragraphs(a)Collaborate with such other bodies or organizations within or outside Kenya asit may consider desirableorappropriateandinfurtherance of thepurposeforwhichtheAuthorityisestablished (aa)Adopt andimplement any such internatiomally recognixedgoodregulatorypractices(ab)Determine andimplement effective andefficientreliance mechanzsm.(ac)Issue,suspend,uithdraw/reuokeany license, compliance certificate(ad)Levy,collectandutilizefeesforservicesrendered;(ae)Grant orwithdrar licenses andpermitstomanfactrersuholesalersretailersmportersezportersanddistriutors(@f)Formulte guidelinesforegulatinghemamfactureportandexportdstributonaleandusefmedicalroduts

Global Benchmarking Tool Control over imports and exports is critical for any regulatory authority.

• 195.Amendment of clause 21(1),21(S)and 21(4)by deleting the words'Cabinet Secretaryand substitutingthereforthewords,'theBoardoftheAuthority'

196. Amendment of clause 21(9)by deleting thewords'CabinetSecretaryand substituting therefor the words'theBoardofthe Authority'and by deleting theword'Parliament'and substituting therefor the words'CabinetSecretary:

Justification:These are technical committees of the Authority tasked with guiding theBoard in effectively carrying out its mandate.

• 197.Deletion of clause 22(d)and substitution with (d)"falsified.

Justification:The terminology is globally used and recommended byWHO.

• person shall notimport any medicines or medicaldevices unless:Theimported medicine(s)or medica deuice(s)has been authorized throughissuance ofanimportpermit or any written authorizations by the

authority.Theimported health products andtechnologies beinspectedandverified by the authoritys znspectors at theports ofentry beforerelease".

Justification: To adopt the offences and charges in subclause (1) and to cater for importation of HPTs.

199. Insertion of anewclause immediately after clause24-

Clinical trials

24A(1) A pharmaceuticalproduct shall not be used for clinical trial unless an approvalis granted by theAuthority with the approval of therelevant ethics body.

(2)Any person who intends to commence a clinical trial on a pharmaceutical product shallmake an application to the Authority in the prescribed form and the application shall be accompanied by the study protocol in the prescribed format and the prescribed fee.

(s)The studyprotocol submitted under subsection(2) shall include a post-trial access program to ensure access of investigational medicinal substances by participants in a trial before grant of marketing authorization by the Authority.

(4)The Authority shall prescribe guidelines for evaluation of applicationsmade under subsection (2)to be implemented for accelerated evaluations during emergency situations,epidemics and outbreaks.

(5)A person granted an approval under section 24(1) shall put up a robust quality assurance the safety and well-being of study participants.

(6)The Authority shall carry out inspections of the clinical trials so as to ensure compliance of the clinical trials with the prescribed requirements.

(7)Any protocol amendments applications shall be submitted to theAuthority for approval before implementation.

Justification: This is for effective regulation by theAuthority on the clinical trial function.

200.Insertion of the followingnew clauseimmediately after clause26

Factors relevant to the determination of applicationforproductlicense

(1)Aperson who intends to import,manufacture or sell a health product or technology shall apply to theAuthority for the registration of the health product or health technologyin Form 1 set out in the First Schedule.

(2)An applicant subsection(1)shall

(b)where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya appoint a local representative who shall be a citizen ofKenya,a person who is has permanent residence or a company incorporated inKenya.

(a)specify theparticulars of the person with appropriate knowledge ofall aspects of the health product or health technology who shall be responsible for all communication between the applicant and the Authority in the declaration page of the application form;and

(3) The application made under sub rule (1) shall be accompanied by—

(a)aproposed label for use on the health product;

(b)a copy of the manufacturing licence of the health product,where applicable;

authority of the country where the health product is manufactured;

(e)a copy of themarketing authorization or certificate ofregistration of the health product or technology from theregulatory authority of thecountry where thehealth product or technology is sold;

(d)a copy ofa certificate of analysisfrom a quality controllaboratory recognizedby the Authority. where applicable;

(f)the available data on the quality,safety,efficacy andperformance of the health product or technology submitted ina common technical dossier format;

(h)proof of ownership of the site for the manufacture of the health product,if applicable;

(g)a sample of the health product;

(i)where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, a copy of the agreement appointing thelocal representative;

(i)where the application relates toahealth product or technology which isregistered with a foreign regulatorybody,

(i)a copy of the certificate ofregistration;

(ii) the conditions of theregistration of the health product or technology;

(ii)theprofessional information relating to the health product or technology;and

(k)proof that the applicant holds-

(i)a valid practicinglicence issued in accordance with section 9A of the Act;

(ii)avalid wholesale dealer'slicence issued in accordance with section27of the Act;

(ii)avalid licence to deal in poisons for mining or agricultural purposes issued in accordance with section 28of theAct;

(iv)avalid licence to sell Part IIpoisons issued in accordance with section S2 of the Act;or

(v)avalid manufacturing licence issued in accordancewith section S5A of the Act;and

()proof of payment of theapplication fees set outin theSecond Schedule

(4)An applicant shall notify theAuthorityof any variation to the agreement appointing thelocal representativewithin seven days of thevariation.

(1)The Authority shall consider the application made under rule 4, and, shall, ifit is satisfied of the safety,efficacy,quality,performance and economicvalue of the health product or technology, register thehealthproduct or technology and issue a certificate ofregistrationinForm2set out in theFirstSchedule

(2)The Authority may,while considering the application made under rule 4,approve the appropriate in respect of the following particulars;

(a)the name under which the health product or technology may be sold;

(b) the labelling of the health product;

(c)the statement of therepresentations to be made for the promotion of the health product regarding(i)the claim tobe madefor the health product;(i)theroute ofadministering thehealth product;(i) the dosage of the health product;(iv) the storage conditions of the health product;(v) the contra-indications,the side effects and precautions,if any of the health product;and (vi) the package size of the health product.

• (s)When evaluating an application made under rule 4,the Authority may:
• (a) subject a sample of the health product to an evaluation by an analyst;and
• (b)consider the evaluation report ofan institution that has evaluated the health product.

(4)The Authority shall issue a certificate of registration under subrule (1)if the applicant has (a)a valid practicing license issued in accordance with section 9A of the Act;(b)a valid wholesale dealer's license issued in accordance with section 27 of the Act;(c)a valid license to dealin poisons formining or agricultural purposes issued in accordance with section 28 of theAct;(d)a valid license to sell Part II poisons issued in accordance with section s2of the Act;or (e)a valid manufacturing license issuedIaccordance with section s5A of the Act.(5)If the Authority is not satisfied as to thequality,safety efficacy and performance,or economicvalue of thehealth product, it may,after providing an opportunity to the applicant to be heard,reject the application made under rule4 and inform the applicant the reasons for rejection in writing.

Register of healthproducts and technologies.

The Registrar shall maintain a register of health products and technologies registered in under their Rules in Form Sset out in the First Schedule.

• 201.Insertion of the following new clause immediately after clause 46

Dietary supplement

46A.(1)A dietary supplement shall not(a)contain controlled drugs;(b)have a stated or implied therapeuticpurpose.

(2)Where a dietary supplement contains folic acid,the maximum daily dose for the dietary

Justification:Details on contents of dietary supplements help theAuthority effectively regulate food supplements.

• 202.Insertion of the following new clause immediately after clause 51-

Information that is required to be displayed in the pack 5iA.(1)A person dealing in a therapeutic cosmetic shall indicate

• (iv)the common name oftherapeutic cosmetic;
• (vi)all the cosmeticingredients(except flavors and fragrances)must appear on the product labelin the order ofprominence;
• (v)the net weight;
• (vii)the name and address of manufacturer;

(viii)a warning statement;and

• medical condition.

Justification:For transparency withregards to theingredients in theprescribed requirements.

• 20s.Amendment ofclause 52 by deleting the words have a therapeutic effect or value"and substituting therefor the words"to treat, diagnose or prevent disease,or affect the structure or functions of the body".

Justification:Therapeutic may not necessarily ymean treatment.The fact that the term therapeutic cosmetic is used this already means the cosmetic has therapeutic effect.

• 204.Insertion of the wordsand in-vitro diagnostics medical devices registerimmediately after the words"human medical devices register" in clause 55.

Justification:To cater for in-vitro diagnostics.

• 205.Insertion of new terms:Falsified,falsely-labeled,counterfeited after clause 56(1)c)
• 206.Insertion of the following new subclauses immediately after clause 56(2)-

(3)"Apersonwho manufactures,sellssupplies,packages amedical device shallprovidefor theservice and maintenance ofthemedicaldevices at thetimeofinstallation andon operatiomalizationoftheuse ofthe medicaldevice".

(4)"Aperson who mamufactures,sellssupplies,packagesamedicaldevice shallremovefrom thehospital healthcenter oranyotherentitywhere theyhave supplied themedicaldeuiceafterthelifecycleofthemedical device is realized".

(5)Apersom uho mamufactures,sells,supplies,packages a medical device shall emsure requisite quality auditsofthemanufacturer tomeet therequiredquality managementsystems is conducted beforea medicai device is registered for sale inKenya".

Justification:Enables the Authority effectively regulate medical devices.

• 207.Insertion of the words"unregistered establishments for medical devices"immediately after the word

Justification:There is need to register establishments forMedical Devices.

• 208.Insertion of the following new clauses immediately after clause (74)

"74(A)InspectionandverificationofHealthProducts andTechnologiesat thePorts ofEntry

(1)Apersonwhoimports healthproductsmedicaldevices ortechnology shallnotify theKDAinspectors at thePortsofEntry to conductpre-clearanceinspectionandverification.

(3)Fines ofconcealment,cross border smuggling,misdeclaration and diversionofHPTs to beKshs. million."

(2)Anypersomwhoimports healthproductsmedicaldevicesor technologyadcausesittobereleasedtoth marketwithout theauthorization shallbeguilty ofanoffence.

Justification:Togive power to theAuthority'sinspectors to enforce compliance with set or prescribed standards of quality,safety and efficacy of HPTs before release at the ports of entry.To deal with the problem ofconcealment,misdeclaration,diversion and cross border smuggling ofHPTs and otherillicit trade practices which endangers public safety.

• 209.Under clause 91,insertion of the following new subclauses immediately after subclause(1)

"(1A)The Authority shall establish an audit committeewhich shallbea minimumofthree members excludingapersonwho shall beappointed to represent theNationalTreasury anda mazimumoffiue.(2) TheAcconuntingOfficershallensurethattheorganizationalstructureoftheinternalauditunitfacilitates

• (a)theentity toaccomplishitsinternalaudit respomsibilities;
• (c)appropriateaction to be takenoninternalauditrecommendations;and
• (b)theinternalauditorwithsufficient authority topromote independence and toensure broadauditcoverage adequate considerationofinternalauditreports,
• (dtheinternalauditor tobeindependentoftheprograms,operationsandactivitiesheorsheaudits to ensure theimpartialityandcredibilityofthe internalaudit work undertaken.

Justification:Alignment with the requirements of the PublicFinance Management Regulations, 2015(regulation 162and 174)and Mwongoxo Codeof Governance for State Corporations.

210. Deletion of the words"Kenya National Audit Office"and substituting therefor the words "Auditor-General"in clause 91(s).

Justification:This is a requirement under the Public Finance Management (National Government)Regulations,2015.

• 211.Deletion of paragraph (1)of theFourth Schedule.

Justification:Food is outside thepurview of the Bill.

• 212.Deletion ofparagraph(2)ofthe Fourth Schedule.

Justification:There is an established Scientific Advisory Committee,PERAC that conducts causality assessment,risk management and scientific,expert advice on pharmacovigilance related issues forHPTs.The Committee issues recommendations to the CEO,PPB based on scientific evidences.Besides human medicines,the Committee handles incidences following use ofmedical devices and transfusion reactions issues.Its scope is wider than that of human medicines only. This ensures the independence of the Authority to takeregulatory actions,that may arise from suchrecommendations.

3.2.4THENATIONALQUALITYCONTROLLABORATORY(NQCL)

In its memorandum,the NQCLproposed as follows:

• 21s.Deletion ofand substituting clause 60with thefollowingnew clause

60.(1)Thereis to be established theNationalQuality ControlLaboratory ofthe Authority which shall b used as afacility for--

• (a)Theexaminationandtestingofhealthproductsand technologiesincludingvaccinesand biopharmaceutical andany materialor substancefrom or withhichand themannerin which drugs may bemanufactured processedor treatedand ensuring thequality controlofdrugs andmedicinalsubstances;
• pharmaceuticalevaluation;
• (c)Testing,onbehalfofthe Governmentoflocallymanfacturedandimportedhealthproductsandtechologies itheKenyanmarketprior tomarketingauthorization,redistributionandpost-distribution
• (e)Providing technical support to localmanufacturers andbuilding their capacity in matters pertaining tc quality controlofregulatedproducts through on-site andoff-site trainingand laboratory assessments;
• (d)Field testingofregulatedproductsusing screening techniques suchasNear InfraredSpectroscopy,Raman Spectroscopy andHigh-performance thin-layer chromatograplry techniques;
• (f)Conductinginvestigationsinto the quality andsafety statusofregulatedproducts deuelopingana administeringa data bankom qualityassurance ofallhealthproductsand technologies andgenerating scientific evidence andreports on thequality andsafety statusoftheregisteredproductsand
• (g)Comductresearch and training and providehighqualityanalytics andexpertknowledgeinthe areaso medicinalproducts andactive pharmaceuticalingredients.

(2)TheNationalQuality ControlLaboratory shallbe theofficialgovernment agency for quality controlof drugs healthproducts and technologies.

Justification:NQCLplays a critical role in assuring the safety and quality of HPTs in the country.To effectively discharge its mandate,the NQCL's governance and structures should be set out in the Bill.

214. Deletion of the words"Director-General"appearing immediately before the words"signed by the"and inserting the words"Director Laboratory Services".

Justification:A certificate ofanalysis is a document that communicates theresults of a scientific test done on anHPT.In compliance with WHO best practice,the certificate should be issued by a person that will ensure the authenticity of the test samples.

215. Insertion of the followingnew clauses-

"6lADirector LaboratoryServices

(1)"TheDirectorofLaboratory Services shall bearegisteredpharmacist and shallpossessa Master'sdegree in sciencefrom a recogmixed umrversity"

(2)"TheDirector ofLaboratory Services who shall be ChiefExecutive oftheLaboratory responsible to th authorityfor day-to-day management ofthe laboratory"

(s)TheDirector Laboratory Seruices shall hold officeon such terms and conditions ofservice as may be specifiedin theinstrument ofhis appointment"

• 216.Insertion of the followingnew clauses

61BPowers of theDirectorLaboratoryServices

"TheDirector Laboratory Services shall havepouer:(a)to developandadministeradata bank omquality assurance on behalfofthe Authority(a)to advise andobtain advicefrom theAuthority inregardtoany other matter wnthinhispurview under this Act.

61CFunctionsoftheDirector

• (a)overseeand coordinatealloperations andadministrationoftheNationalQuality ControlLaboratory andprovide technicalguidance onquality control;

TheDirectorLaboratory Services shall

• standards;
• (c)co-ordinateandsupervisethe activities oftheNationalQuality ControlLaboratoryincluding staff;
• (d)collaborate with other laboratories,regulatory and law enforcement agencies,manufacturers of pharmaceuticalandother healthproducts toensure quality in drugs andhealthproducts;
• f)handleappealson testresults shall betheerpertwitness incourtonHPTquality matters
• (g)where the laboratory lacks capacity,the director shall subcontract laboratory testing services.

Justification:Health products need to be safeguarded by a reliable system and by qualified professional custodians from development to formulation,quality assurance,distribution, administration to the patient up to disposal.The NQCL should be provide with the necessary resources for its maintenance and sustainability.

• 217.Insertion of the following new paragraphs after paragraph (i) in clause 95 (2)

"(iia)to regulate illicit use ofnarcotic and psychotropic substances,

• (iib)toregulate parallelimportation ofmedicines"

Justification:Gives the Authority power to make rules pertaining to illicit use ofnarcotic and psychotropic substances and parallel importation of medicines.

218. Insertion of the following new paragraphs after paragraph (b)in clause 95(2)-"(ba)on Pharmacovigilance andPost market surveillance.

"(bb)OfficialRegulatoryLotRelease ofvaccines and other biologicalproducts imported andmanufactured in Kenya.

("bc")GoodPractices(GXP)intheregulationofmedical products.

(bd)Inspectionslicensureandcertificationofthemanfactureofmedicalproducts byhealthfacilities

(be)Inspections,licensure and certificationofmanufacture ofmedicalproducts and other regulated products by facilitiesnotdirectlyregulated bytheKenya drugAuthorityincluding steelindustriessugar imdustries

("bf)InspectionandrecognitionofPharmaceuticalQuality ControlLaboratories Justification: Inclusion of a clause on making regulations on pharmacovigilance andpostmarket surveillance. There is an existing subsidiary legislation, the Pharmacy and Poisons Board (Pharmacovigilance and Post Market Surveillance) Rules,2022.These are critical to the attainment ofWHOmaturity level2by thevigilance function.ThePharmacy and Poisons Act Cap 244 was silent on safety monitoring or pharmacovigilance. The regulations are withir statutory instrumentsfor the better carrying of regulatory functions by theAuthority.

• 219.In general, the Bill in its present form is vague on the identity ofprofessionals to handle and NQCL should be properly anchored in lawwith clearprovisions on its governance structure and administration so as to effectively dischargeits mandate

In its memorandum, the NGEC proposed as follows:

220. The deletion of the wordsPublic Service Commission througha transparentand competitive process, with theapproval ofParliamentand substitution with thewordstheBoardin clause 8.

Justification:It is the duty of the Board to hire and remove the CEO and senior management of an organizationunder the Mwongoxo Code of GovernanceforState Corporations.

• 221.Deletion of clause 8(2)(c)and (h)and insertion ofa new sub-clause as follows:TheBoard shall coopt other members as deemedfitfor theconduct ofits business."

Justification:ToreduceBoard membershipfrom 11 to9for compliancewith theMwongozo Codeof Governance for State Corporations.Representatives from the Pharmaceutical Association and the Director General may be co-opted as the Chairperson must have pharmaceutical qualifications and the PS, MOH is a member of the Board.

• 222.Insertion of the words"and fair representation of persons with disabilities"immediately after the words"gender"in clause 8(7).

Justification:Compliance with theMuongozo Code of Governance for State Corporations that allBoard appointrments should comply with theprincipleofinclusion in Article 27 and 2s2 of the Constitution.

223. Deletion of the words"with the approval ofParliamentand insert the words"notice in thegaxette

Justification:Thisis for compliance with the Muuongozo CodeofGovernanceforState Corporations

• 224.Deletion of clause 1o(e)as it is prejudicial to persons with mental and physical disabilities.

Justification:The Convention on the Rights of Persons withDisabilities and the Persons with Disabilities Act,No.14of 2o0s provides for reasonable accommodation,rehabilitation and habilitation of PWDs.

225. Deletion of paragraph 2(b)-(f)of clause 10 providing for a selection panel and for the nominees tc appearbefore Parliament and deletion of thewordsare determined by the Cabinet Secretary in charge of finance in consultation with a Committee of theNational Assembly designated by the

National Assembly for that purpose" and substitution with the words"are approved by the Salaries and Remuneration Commissionin paragraph(7)in the third schedule.

Justification:The Constitution specifies the offices thatneed theNational Assembly's approval. The Board nominees are non-executive and should be appointed by the Cabinet Secretary by noticein thegaxetteasprovidedin theMwongoxo CodeofGovernanceforState Corporations and the State Corporations Act,Cap.446.Determination of allowances and benefits is a mandate of the Salariesand Remuneration Commission under the Constitution.

226. In general,proposed thereview theState CorporationsAct toalignwith the Constitution and the Mwongozo CodeofGovernanceforStateCorporations

S.2.6THEKENYAASSOCIATION OFMANUFACTURERS(KAM)

In its memorandum,theKenya Association of manufacturers proposed:

• 227.

Justification:This gives the term a narrow interpretation which will leave out critical components such as medical devices and in vitro diagnostics.

228. Substitution of the word"therapeutic cosmetic"with"therapeutic product"in clause 2and wherever it appears in the Bill and the term"therapeutic product"defined to include any substance ormixture of substances manufactured,sold or represented that contain scheduled substances.

Justification:For clarity and compliancewith theEastAfricanStandard on cosmetics whichwill enhance free tradein theEastAfrican Community region.

229. The definition of therapeutic cosmetic is ambiguous as it does not distinguish between a therapeutic cosmetic and an ordinary cosmetic.It adopts the general definition of a cosmetic.An ordinary cosmetic is a substance deigned to be used on any external part of the body to change its odour or appearance,cleanse,protect or keep it in good condition e.g,perfume,make-up,nail polish while a therapeutic is used toprevent,diagnose or treat a disease or its symptoms or affect the structure or functions of the human body such as sunscreens and skin whitening lotions."

Justification:A therapeutic is used to prevent,diagnose or treat a disease or its symptoms or affect the structure or functions of the human body such as sunscreens and skinwhiteninglotions.

230. Deletion of the definition of a"therapeutic cosmetic"and substitution with a new definition that "Cosmetics with therapeuticeffectsmeansany cosmetic product thatcontains a scheduled substance.This includes steroidsandhydroquinonecontainng creams.

Justification:The current definition ofa therapeutic cosmeticis ambiguous as theBill does not differentiate between a therapeutic cosmetic and an ordinary cosmetic.In order to ensure that a cosmetic product is regulated by the relevant Authority,all ingredients that have any physiological activity will be added to the list of Scheduled Substances.

• 2S1.Substitution of the definition of"chemical substance"with a new definition tomean"any substance ormixture ofsubstancespreparedor soldwhichthe Authority may declare to be a chemical substance. Becauseincludinggermicidespesticidesinsecticides,rodenticides and vermicides in the definition f chemical substance createsa duplicationwith themandateofthePest ControlProducts Board established undersection5ofthePest ControlProducts Act"

Justification:The Board under the Bill regulates the manufacture,packaging,storage,display distribution,use or advertisement of any pest control product in the country.

• 232.Deletion of thewords"or detergentin the definition of the chemical substance.

Justification:To exclude detergents which are used forcleaninginanimate objects and would not fall under thepurview of the medicines'regulations.

• 2ss.Inclusion of thedefinition of the term"cosmeticsto meananry substance or preparation intended to be placedincontact uith thevarious erternalparts ofthehuman body(epidermis,hairsystem,nails,lips and externalgenitalorgans)orwiththeteethandthemucous membranesofthe oralcavitywithavieu eclusiuelyormainlytocleaningthem,perfuming them,changingtheirappearanceand/orcorrectingbod odours and/orprotectingthem orkeeping them ingoodcondition.

Justification:The definition is necessary in order to distinguish between a cosmetic product and a therapeutic cosmetic(cosmetics with therapeutic effects)

• 234.Deletion of the words"related products and technologiesand deletion of the reference to "chemical substances"and substitution of the term"therapeutic cosmetics"with "therapeutic products"in the definition of the term"health products and technologies".

Justification:The definition is too general and may be prone to abuse.

295. Substitution of the definition of the term"manufacture"with"all operations of purchase of materials and products,production,quality control,release,storage and distribution of pharmaceutical products and the related controls".

Justification: To adopt the globally accepted WHO definition which is more precise.

• 236.Add a new definition of the term"enrolled pharmaceutical technologist".

Justification:Most clauses only deal with registered pharmacists and yet there are several enrolled pharm-techs in the country.

• 237.Deletion ofreference to chemical substances and substitution of the term"therapeutic cosmetics with the term"therapeutic products"in clause S.

Justification:The current definition of a therapeutic cosmetic is ambiguous.

• 2s8.The pharmaceutical association referred to in clause 8(2)(h) should be specified

Justification:For clarity as there are many pharmaceutical associations in the country such as KPA,PSK and theFederation of KenyaPharmaceutical Manufacturers.

• 239.Under clause 28,introduction ofa medical device register.

Justification:To cure the exclusion ofmedical devices which fallswithin the mandate of the Authority.

• 240.Under clause 29,enhancement of the period provided from onemonth to sixty(60)days in clause 29(4)(b).

Justification: The appeal period provided is too short.

• 241.Deletion of clause 29(9).

Justification: Currently, the product registration validity has not been finalized for five years.

• 242.Inclusion of a provision to the effect that the details of the product owner or local representative be published in the gaxette in clause S2(2).

Justification:An applicant may be a local. representative and not the product owner and vice versa.

243. Insertion of thewords"or enrolled pharmaceutical technologist"immediately after the word pharmacist"in clause 39(4).

Justification:Retail premises managed by licensed pharm-techs arepart of the distribution chain

244. Insertion of the words"or pharmaceutical technologist"immediately after the word"pharmacist" in paragraph (b) and (f)of clause 41(1)

Justification:Pharmaceutical technologists routinely superintend licensed premises.Licensed or enrolled pharrmaceutical technologists keep and dispense scheduled substances.

245.Insertion of the word"human"immediately after the word"axy"in clause 47(1) Justification:To specify that the clause applies to human and not veterinary medicines.The Veterinary Medicines Directorate alreadyregulates the manufacture and handling ofveterinary medicines and other animal health products in the country.The Directorate should remain the sole regulator of veterinary medicines.

246. Deletion ofclause48.

Justification:The clause is unclear onwhichregulatory bodywill issue the good manufacturing practices certificate.

247. Redraftingofclause5O to clarify therole of theAuthorityin theBill and thatof theKenya Bureau ofStandards(KEBS)especiallyin theregulation of cosmetics.

Justification:Theremay be duplication ofroles in the cosmetic sector which will increase the cost ofcompliance and reduce the ease of doing business.Therapeutic and non-therapeutic

248. Redrafting of clause 51 as followsAny person who sells,prepares,preserves,packages,conveys,stores or displays for sale any therapeutic substances under goodmanufacturingpractices.

Justification:Forrecognition of Good Manufacturing practices'requirerments and ISO standards. Compliance with GMPmay bemade mandatory and needs to be stated by the manufacturer.

249. Provision bemade for a lighternotification process based on an online portalprior toplacing on the market ofcosmetic products instead of aregister.Justification:This is the current practice in theEuropean Union. 250. Deletion ofclause54.

Justification:TheBill does not set out theprocedure tobe used by theAuthorityin determining the probation of an ingredient in a cosmetic.KEBS has a standard listing ofall prohibited ingredients in cosmetics.The Authority engages in a consultative process involving the cosmetic sector in Kenya that will be used to determine how ingredients will be banned.

251.Insertion of thefollowingnewPart immediately afterPartIX

PARTIXA-TheNational PharmacovigilanceSystem

The Authority shall through the NationalPharmacovigilance Centre manage thenatioma pharmacovigilanceandpostmarketing surveillance system to receive andmaintainallrelevantinformatio aboutsuspectedadverse drugreactionsandadverseevents tohealthproductsor technologieswhichhave been authorized by theAuthority.The Authority shall conduct bothpassive andactive surueillanceofhealt. products and technologies.TheAuthority shall carry outpharmacovigilanceaudits andinspectionsin orde to ensure compliancewith GoodPharmacovigilancePracticesand theprescribedrequzrements.

Allentities responsibleforplacingahealthproduct or technologyin themarket shallestablishandmaintain apharmacovigilance system for managing safety information ofhealthproducts and technologies.The entities in subsection(4)shall submit safety information to theAuthorityas prescribed.The consumers generalpublic,health care professionals shall report adverse reactions and euents to the Authority as prescribed"

Justification:The Pharrmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules,2022describe theseroles but it is important to have them as the overarching statements in the Bill that would then serve as guidance on development or reviewof existing regulations.To anchor theregulatory role ofpharmacovigilancein the Bill thatwould then serve as guidance on development orreview ofexistingregulations.

252. Under clause 60,inclusion ofa provision that testingwill only be applicable to human medicines and medicinal products and allow other laboratories to do product analysis.

Justification:TheNQCL only tests human products and should notbegiven themandate to test

• 25s.KAM submitted that theAuthority's mandate overlapswith the mandate ofexisting bodies such asKEBSwhich will lead to duplication ofefforts.The Authorityhas taken the functions of the latter.There is no clear demarcation of the roles of the Authority and KEBS in terms ot standardization and quality control.KEBSpromotesstandardization inindustry and commerce pursuant to the StandardsAct,Cap.496 while the Authority will prescribe standards forHPTs pursuant to theBill.This may bring confusion even in dispute resolution as the decisions of the Standards Tribunal may contradict the Authority's decisions.Further,under the Bill,products regulated by theAuthority willnotberegulated by any other authority.Will this lead to dual regulation?Does one have to getregistered with KDA thengo toKEBS for testing or will the Authority do the testing?Does the Authority have the capacity to do testing?KAM also noted that the Bill facilitates the realization of the aim ofAfrican Union Model lawwhich is toincrease collaboration across countries and to provide a conduciveregulatory environment for HPTs.
• 254.TheFood,Drug and Chemical Substances Act, Cap.254 is being repealed without direction on how and who will regulate the medical examination of food handlers and licensing offood premises andmarkets.
• 255.The Bill isnot alignedwith the regulation and facilitation of trade as it is majorly concerned with safeandqualityHPTs.

• 256.Proposed theinclusion ofnew clauses as follows-
• onin-market control(setout themainelementsforin-market control,defineuhoisresponsiblefor the safetyoftheproductand how thesafetywill bemanaged)

222. provideforborderlineproductssuchasborderlinecosmeticsmedicineormedicaldeviceoracombinalion ofboth.

• require thatevery therapeuticproductplacedom theKenyan market should haveatechnicalProduct InformationFile(PIF).Thisprovision torequire that thecosmeticproduct benotifiedfreeofcharge andusinganelectronicportal.Thenotificationshouldgivegeneralinformationabout themainpurpose oftheproduct.Itshouldalsoprovidemutualrecognitionforproductsalreadynotifiedinotherregulatory jurisdictions suchas theEU becoming automaticallynotifiedinKenya.

Justification:In-market control allowsregulators to achieve a high level of consumer safety in a

• chain;
• C submittingcompanies torandomcontrols and inspections bylocal authorities.
• b) setting safety requirements and defining safety standards;
• 257.Inclusion ofaprovision on Product Information file(PIF)which is amandatory document that is in themarket and is availed to competent authorities during audit aspart of cosmetic compliance ThePIF should contain information on:
• 3.2.7THEKENYALAWREFORMCOMMISSION(KLRC)

258. The Commission emphasized that theBill needs to handle the transition from thePharmacy and Poisons Act,Cp. 244 effectively and provide for the transition mechanism in the regulation, training and licensing of professionalsin thepharmacy sector.

TheKLRCsubmittedasfollows:

259. TheCommissionfurther submitted that theBill is anexcellent contribution towards deliveringa progressive HPT regulatory law however the Bill presents numerous opportunities for improvementthat: 2. (a)Extensivestakeholderinvolvement should beundertakenin order to comprehensively address allaspects ofHPTregulation; 3. (c) Thenameof theBill shouldreflect thefunction oftheBill whichextendsbeyondestablishment ofan Authority to regulate drugs; 4. (e)The Bill to provide for regulation and monitoring of clinical trials,HPT manufacturing, product packaging,post marketing etc. 5. (d)To prevent errors ininterpretation,the Bill should use internationally accepted definitions; 6. Establishment and governance ofregulatory institutions under the Bill should align with the State CorporationsAct,cap.446.Their governance structures should further promote effective service deliveryand stewardship ofresources;

• (g)The Bill to provide for interaction of the regulatory institutions with county governments as may be necessary;
• (h)TheBill should not overlapwith otherlaws such as theFood,Drugs and Chemical Substances Act,Cap.254and theNuclear Regulatory Act,No.29of2019;and
• (i)A comprehensive plan should beprovided for theregulation ofpharmacists and pharmaceutica. technologists upon therepeal of the Pharmacy and Poisons Act, Cap. 244.

S.2.8THEPHARMACEUTICALSOCIETYOFKENYA(PSK)

In its memorandum,thePSK proposed the following amendments;

260. Deletion of the long title since the scope of the Act is wider than drugs and substitution of the name of the Authority from the Kenya Drugs Authority to the"theKenya Medicines and Health ProductsAuthority". 2. 261.Deletion of the phrase"Kenya Drugs"and substituting with the phrase"Kenya Medicines and Health components e.g.,medical devices and Invitro diagnostics. 262. The term"medicinesis appropriate as the term drugs means medicines and non-medicinal drugs such as heroin that are notregulated under the Bill. 4. 26S.The termhealth productsis used by WHO and covers medical devices,cosmetics,blood and blood components. 264. The title connotes that, the subject matter of the Bill relates to the establishment of the Authority whereas the content of the Bill relates to the regulation ofmedicines,therapeutic cosmetics, medical devices,scheduled substances,blood andblood products and tobacco products.

Justification:This contradicts the legislative drafting principles on drafting of a Bill title in relation to its subject matter.

• 265.Deletion and substitution of clause3(1) with the following new sub-clause "() This Act applies to regulationofHumanmedicines,medicalproductstechologiesVeterinarymedicinesmedicalproducts technologies,Medicaldevices includingradiation emitting products,Radiopharmaceuticals Complementay,alternative orherbal medicines,Cosmetics andBorderlineProducts Committee,Clinical trialScientificTechnicalAdvisory Committee,Nutraceuticals Dietary supplements,DigitalHeath and technologies,Comtrolled substancesChemicalsubstancesandBiologicalproductsforuseinhumansandthe starting materials usedin their manufacture".

266. Amendment of clause 4 by deleting the phrase "Kenya Drugs"appearing in sub clause (1) and substituting therefor the phrase"Kenya Medicines andHealth Products". 267. Deletion of sub-clause 6(1)and(2)

Justification:The provision contradicts thelegalframeworkfor recruitment of CEOs of State Corporations or Semi-Autonomous Government Agencies.TheDirector General is appointed by the Authority.The Director General is therefore not a State Officer and as such his or her recruitment doesnotrequirevettingbyParliament.

• 268.Deletion of the words"Kenya Drugs"and substitution with the phrase"Kenya Medicines and HealthProducts"inclause 8(1)

Justification:The name of the Board and its composition should reflect the proposed title of the Bill.

• 269.Deletion of paragraph(2)(b),2(c),2(d),2(e),2(h),2(i),2(k)in clause 8 Justification:Boardmembership should constituteprofessionalmix directlyrelated tomedicines andhealth products.Withregulation of medical devicesbeingakey function of theAuthority,one of the Board members should have expertise inbiomedical engineering.
• g70.Insertion ofthefollowingwords"and anex officio memberoftheBoardimmediately after the secretary appearing in clause 8(2)(1).
• 271.Deletion of clause 8(S)and substitution with following new sub clause(S) The Cabinet Secretary shall appoint the members of the Board under paragraph (2)(c),(d),(e).(h), (i) and (k);
• Insertion ofthe phrase"and economicvalue"after the word"efficacy"in paragraph (c)and insertion of the words"regulate clinicaltrials"before the words"ensure that clinical trials" in paragraph (g) of clause 12.
• 279.Deletion of paragraphs(f).(n),(p)ofclause 12.and substitution with the following new paragraphs )ensure continuousmonitoringofthe safetyofhealthproducts and technologies regulated under thisAct; (n)appointinspectors andorder inspectionofthepremisesmedicaldevices establishments,importingand exportingagentsuholesalers,distributors,harmaciesncludingthoseinospitalsandclncsretailoets andany otherpremises subject to this Act;(p)providemedicinesinformation andpromoterationaluseof medicinesand healthproducts";
• 274.Insertion of the following new paragraphs after paragraph (a)of clause 12-
• "(ab)regulate schedule medicines and health products";
• "((ac)carryout pharmacovigilanceofmedicines andhealth products";
• "(ad)carryout andpromote researchrelated to medicines and health products;(ae)ensure quality comtroland assurance in medicines and healthproducts
• "(af)regulate the disposal ofmedicinesand health products and technologies;
• "(ag)regulate complementary,alternative orherbalmedicines;
• "(ah)monitor the market for the presence ofunregistered and illegal health products and technologies;(ai) conductanalytical tests ofhealthproducts and technologies";
• "(aj)approve theuse ofany unregistered medicinal substance forpurposes ofclinical trials,compassiomate use and emergency use;

"(ak)carry outpharmacovigilance audits andinspections.in order to ensure compliancewith goo pharmacovnigilance practices and theprescribedrequirements2;

"(am)conductresearchonbiologicalstoensurequality,safetyandefficacyofbiologicalproducts through regulatoryreleasesystemincompliancewithestablishedapproachespoliciesguidelnesproceduresand linewithWoridHealthOrganizationandinternationally recognizedguidelines

"an)ensure thatallhealthproductsand technologiesmanufacturedinmportedinto orexportedfromth country conform to prescribedstandardsofquality,safety andefficacy;

"(ao)enforcetheprescribedstandardsofquality,safetyandefficacyofallhealthproductsandtechnologie manufacturedimportedintoorexported outofthecoutry;(ap)grantorrevoke licenses andpermitsforth manfacture,mortatimexportatiomdistributionandsaleofhealthproductsandtechnologies

"(aq)maintainaregisterofallauthorizedhealthproductsand technologies manually orelectronically

"(ar)inspectandlicensemanufacturingremisesmportingandexportingagentswholesalersdistributors pharmacies,including those in hospitals amd clinics andotherretailoutlets

(aq)maintaia register ofallauthorized health products and technologiesmanuallyorelectronically

"(ar)inspectandlicensemafacturingpremisesmportingandeportingagentsholesalersdistribuors pharmacies,includingthoseinhospitalsandclinicsandotherretailoutlets;TheAuthoritysfunctions shoul encompassthewholespectrumofmatterscoveredunderregulatoryregime dealingwithmedicinesandhealt products".

275.Deletion of clause13 and substitution with the followingnew clause18

"Thepowersofthe Authority shallbe to;

• (a)collaboratewith suchother bodies ororganizationswithinoroutsideKenya asitmay consider desirable o appropriatefor thefurtherance ofthepurposeoftheAct;
• (c)determine andimplementeffective andeffcientreliancemechanism;
• (b)adopt andinplement any suchinternatiomallyrecognizedgoodregulatory practices;
• (d)issue,suspend,withdraworrevoke anylicense,compliance certificate;
• grant oruithdraw licenses andpermits tomanfacturerswholesalers,retailers,importers,erporters and distributors;and
• (e) )leuy,collect andutiliefeesfor servicesrendered;
• (g)developguidelines onthemanufacture,mport andexport,distributiom,sale anduseofmedicalproducts. Justification:For compliance with WHOrequirements for regulatory functions in the Global
• 276.Deletion of clause 22(1)and substitution with the following
• (3)There shall be established such ScientificTechnical Committees oftheAuthority,appointed by theBoard for theeffectiveperformance ofthefunctionsoftheAuthority.Delete thewordadvisoryandsubstitutewith thewoord"technicalin sub-clause(2)and insert the folloungnew sub clauseimmediatelyafter sub clause (2)(2a)The Board shall in addition to the Committees establishedunder subsection(1),establish the followingCommittees-
• (a)Biologics Committee,

• (b)Pharmacovigilance Committee;
• (c)Complementary,Alternative orHerbal Medicines Committee,
• (a) Radiopharmaceuticais Committee,
• Cosmetics and Borderline Products Committee
• Clinical TrialScientificTechnicalAdvisory Committee
• (g)Health Technology Assessment Committee;
• (h)Nutraceuticals andDietary Supplements Committee,
• (i)Digital Health andTechnologies Committee
• )Veterinary Medicines andMedicalProducts Committee,and
• (k)MedicalDevices and Health Technologies Committee
• 277.Redrafting of clause S5(2)to read"Amedical or dental practitioner,nurse or other person registered umder therelevant statutesregulatinghealthprofessiomalsmay,inconsultatiomwitha licensedpharmacist, prevent the interchange ofa medicine as contemplated in subsection(1).

Justification; To enhance the safety of patients.

• 278.Deletion of clause S7(1) and(2) and substitution with the following new sub clauses

"(1)Apersonwhointendstomanufactrereparesuplyellditributeeortrmporthrbalmedice whichispresented to thepublic tohavetherapeuticeffectwhenconsumedappliedorinhaledshallobtaina licensefrom theBoard".

"(2)TheCabinetSecretary shall inconsultationwiththeAuthority,makeregulationsfor thebetter carrying into effect this section".

Justification:To ensure that thelevel of culpability is provided as the offence is a strict liability offence.It requires proof ofmens reaintent,wilful,reckless,negligent) is required

• 279.Deletion of clause S7(4)and substitute therefor the following new sub clause(4) The Authority shall atleast once every three years,review the lists under subsection(S),or whenever necessary in theinterest of public health and safety.

Justification: One year is too short and impractical. The Authority may act where need arises.

• 280.Deletion and substitution therefor clause 36(5)with the following new sub clause"(5)A licence issued uder this sectiom shall be valid for aperiod one year,reneruable anually

Justification: The provision is punitive for those who apply in the middle of the year.

• 281.Deletion and substitution of clause 45with the followingnewclause
• 45 Automatic machines
• (1)Anauthorized seller may use an automatic machine to dispense over-the-counter ScheduledSubstamces.
• (2)TheAuthority shalldevelopregulations on
• (a)classes of substances permitted;
• iquantities of substances to be dispensed;
• (b)records ofsubstances dispensed;
• (c)locatiomofautomaticmachines;and

• (d)registration ofautomaticmachines.

Justification:Automaticmachines to be included as part ofmedical devices/ technologies.To provide for the use of automatic machines in dispensing selected scheduled substances in an effort to embrace technological advances.

• 282.Deletion and substitution clause 46with the following new clause 46
• 46Electronic sale ofmedicines
• (1)TheAuthority shallfor theeffectiveimplementationofthis section,developregulations.
• (2)Theregulationsmade undersection(1)shallprovidefor-
• (b)safetyofthe patient
• (a)licensureofe-pharmacies;
• (c)verification of the identity and traceability ofthepatient;
• (e)integrity,legitmacyandauthenticityoftheprescriptionincludingauoidanceofmultipleuseofthesame prescription.
• (d)verificationofthe identity and traceabilityoftheprescriber,and
• (3)In thecaseofaprescription-omlymedicine,the prescription shallhave beenobtainedasaresultofatleast oneplrysicalinteractionbetueenanauthorizedpractitionerandthepatient.

(4)Aypersonuho contravenesthissectionshallbeguiltyfanoffence,andshallmconviction,beliabletoa noterceedingomemillionshilligs,ortoimprisonmentforatermnotexceedingomeyear,ortoboth.

Justification:Many online platforms already sell medicines to consumers.The Authority needs to develop appropriate regulations on telemedicine,e-pharmacy,authenticity of prescriptions, traceability,online dispensing,and related platforms with consumer safety in mind. To enhance the fine for sale of scheduled substance using electronic means.

• 28s.Deletion and substitution of clause 51 with followingnew clause-
• 51Manufacturingofcosmetics
• (1)The Cabinet Secretary shallfor theeffectiveimplementationofthis section,developregulations
• (2)Theregulatiomsmade under subsection(1),may
• (b)imposerestrictionsrequzrementsorotherconditionsonmanufacturersofcosmeticsfsuchrestrictions requzrements orconditions arenecessary toprotect public lealth.
• (a) requiremaufacturersofcosmetics toregisterwith theAuthority

Justification:For transparencywith regards to theingredients in the prescribed requirements in line with GMPand other guidelines.

• 284.Insertion of the following new subclauses immediately after subclause (2)-

"3)Arsowhomanufacturessellsupliespackagesamedicaldeviceshallovidefortheserviceand mainlenanceofthe medicaldevices at the timeofinstallation and onoperationalizationoftheuse ofthe medicaldevice.

• (4)Apersonuho manufactures,sels,supplies,packagesa medicaldevice shallremovefrom thehospital device isrealized.
• (5)Apersowhomanufacturessellssuppliesackagesamedicaldeviceshallensurerequisitequalityaudts ofthemanufacturer tomeet therequiredqualitymanagement systems is conducted beforeamedicaldevice s registered for saleinKenya.

s

• prescribed guidelines on good manufacturing practice"immediately after the word"Authority appearing in sub clause(2).

Justification:WHOpublishesgloballyrecognizedgoodmanufacturing standards that should set the benchmark forKenya.

286. Insertion of thewords"unregisteredestablishments formedicaldevicesimmediately after the word "under"appearing in clause 59 (1).

Justification:There is need to register establishments for Medical Devices.

• s
• (2)TheLaboratory established under sub section(1),shallbeabodycorporatewithperpetualsuccession and
• 288.Insertion of the following new sub clause immediately after sub clause (1) acommon seal,andshall inits corporatename
• (a)have power to sueand be sued;and
• (b)to acquire,holdand dispose ofmouable and immouableproperty.
• 289.Insertion of the following new clausesimmediatelyafter clause 60-

"60A Board of management"

• (1)The Laboratory shall bemanaged byaBoard consistingof
• (b)thePrincipalSecretary oftheMimistry for thetimebeing responsiblefor mattersrelating to health ortheir representative
• (a)anon-ezecutive chairperson appointed by thePresident,
• (c)thePrincipalSecretaryoftheMinistryfor thetime beingresponsibleformattersrelating toFinance ortheirrepresentative,
• (e)four other members nominatedandappointed by theCabinet Secretary,asfollous
• (d)Director-GeneralKenya Medicines andHealthProductsRegulatoryAuthorityorarepresentative nominatedinwriting
• three personwho arequalifiedPharmacists nominated byPharmaceutical Society ofKenya; and
• (ii)apharmaceutical technician nominated by theKenyaPharmaceuticalAssociation;and
• (2)ThechairpersonandmembersoftheBoardofManagement,exceptfor theex-officiomembers,shall serueforatermofthreeyears,renewableonce subjectto satisfactoryperformance.
• (f)thechieferecutiveofficer who shall bethesecretaryandexofficiomember ofthe laboratory.

• (s)For purposesqfthis section,the exofficiomembersincludethe members appointedder paragraph (1)(b)(c)(d).
• (5)The chairpersonand members oftheBoardofManagement,shall bepaid such allowances asmay be determinedbytheCabinetSecretaryinconsultationwith theSalariesandRemuneration Commission.
• (4)The BoardofManagement shall beresponsiblefor theperformance ofthefunctions oftheLaboratory setoutunder section 6OofthisAct.
• (6)TheBoard shallregulate the procedurefor the comduct ofits business and affairs.
• (7)The Cabinet secretary shallprescriberegulationsforeffectivemanagement oftheLaboratory.

60BChiefexecutiveofficer

• (2)Aperson qualifiesfor appointment as the chiefexecutive officer,ftheperson
• (1)There shallbeachiefezecutiveofficeroftheLaboratoryuho shallbecompetitivelyrecruitedandappointea by theBoardom such terms andconditions asmay bespecifiedintheinstrument ofappointment.
• (a)isa citizen ofKenya;
• (c)hasatleasttenyearspostqualficatins experienceinthereleuantfieldfiveofzhichshallbe atamanagement leveland
• (b)holdsa bachelor's degree inPharmacy,Quality Assurance orrelateddiscipline froma university recognized in Kenrya;
• (d)meets therequirementsofChapterSixoftheConstitution and theLeadership and Integrity Act.
• (s)The chiefexecutive officer shallholdoffice for a termofthree years and may subject to satisfactory performance,beeligibleforre-appointmentforasnglefurther andfinaltermofthreeyears.
• (4)The chiefezecutive officer shall
• 6) )secretaryandaccountingofficer oftheBoardand
• (a)be the accountingofficer oftheLaboratory;
• (c)umder the directionoftheBoard,beresponsible for
• (zz) the day-to-day management oftheaffairs oftheLaboratory
• theimplementationofthe decisionsoftheBoard;
• z2)
• (az) theperformance ofany otherfunctin thatmay be assigned by theBoard.

60CStaffoftheLaboratory

• (2)TheBoard shall,in therecruitment ofthe staffoftheLaboratoryunder subsection(1)ensure
• (1)TheBoardshallomsuchtermsandconditionsitmay determine,competitivelyrecruit suchmumberofstaf asit may considernecessary for the efficient dischargeofthefunctions oftheLaboratory under this Act.
• (a)that the appontment reflects ethnic andregiomal diversity ofthepeople ofKerya
• (c)thatnotmore than truo thirds ofits staffare of the samegender.
• (b) equalizationofopportunity for thepersonswithdisabilities,and

Justification:NQCL should be an independent Institution so as to complement the KDA's laboratory through provision of second opinions on products being tested.

Making NQCL independent will guarantee reliable results as best practice has noted that laboratories are an essential and fundamentalpart of all health systems and their goal to improve health and achievematurity level 3.

• 290.Insertion of the following new sub clauses immediately after clause 6s (3) and (4)

Sub section(1) shallnot apply to advertisements directed exclusively to

• (a)medicalpractitionerspsychologistsdentists,parmacistsoptometrists,chiropractorspysiotherapist nrses,midwives,dentallygienists,dentalprosthetistsor dentaltherapists,orpersonswho are
• (ii)purchasing officers in hospitals.
• under paragraph(4)(b)(i).

Justification:For inclusion of pharmaceutical technologists.

291. Introduction of consequentialamendments to thePharmacy and Poisons Act,Cap.244either as Clause 97(s)(c) in the Bill or as a separate amendment to accompany Bill as follows-

Amend section3ofthePharmacyandPoisonsAct by

• (d)sixother persons appointed by theCabinet Secretary,ofohom
• a)deletingparagraph(2)(d),(e)and(g)and substituting therefore thefollowing newparagraph
• (i)fourpersonsshallberegisteredpharmacistsoneeachwithezpertiseinsupplychaincommunity/hospital academia andmanufacturingsubsectorsofpharmacynominated by thePharmaceuticalSocietyofKenya
• b)Renumber paragraph (f) to be(e)
• (i)twopersons shallbeanenrolledpharmaceutical technologistwithexpertiseinacademiaandcommumily pharmacy nominated by theKenyaPharmaceuticalAssociation
• (e)the ChiefExecutiveOfficer,who shall beaner officio member
• (2)Thepersons appointed undersubsection(1)(d)shallbeappointedby theCabinetSecretary from amongmembers nominated by their relevantprofessionalassociationseachofuhich shallnominate tuo candidates ineachcategory takinginto considerationgender,ethnicityandregiomal balance.
• c)deleting sub clause(2)andsubstituting therefore thefolloruing new sub clause
• d)Deleting sub clause(3)and substituting therefore the following sub clause-
• (3)ApersonshallnotqualifyforappointmentasamemberoftheBoardundersubsection (1)(d)unless suchperson is theholderofa minimum ofadiplomain therelevantfieldfromanistitution recognizedinKenya and has at leastfiue years mamagerialezperience.

Justification:To alleviate thevacuum that may be created by the repeal of Cap.244

292. Deletion of the word"Advisory"appearing immediately below the Fourth Schedule and substitution with the word"Technical"; 2. 293.Deletion of paragraph1 of theFourth Schedule. 3. 294.Justification:Food is outside the scope of the Bill

S.2.9THEKENYAPHARMACEUTICALASSOCIATION(KPA)

In its memorandum,theKPA proposed the followingamendments;

• 295.The name of the Bill be changed as is not appropriate while the target of theBill is HPTs.

• 296.Adoption ofthedefinition of"enrolledpharmaceuticaltechnologistprovided in thePharmacy and Poisons Act,Cap.244without cross referencing.
• 297.Definition of the term "Roll tomean the Roll ofpharmaceutical technologists kept by the registrar.
• 298.Inclusion ofa definition of the term"pharmacy practitioner"

299. Redraftingof the definition of"pharmacy" 300. Redrafting of clause 6(4)a)as follows"holds a degree from a university recognized inKenya in either pharmacy or medicine or equivalent fields," such that the Authority will be managed by 301. Redrafting of clause 8(2)(h) as follows two persons nominated by the Kenya Pharmaceutical Association". 302. Redrafting of clause 8(2)(a)(i) as follows "be a registered pharmacist or enrolled pharmaceutical degree in a relevant medical field.This is for clarity and appropriate representation of pharmaceutical technologistsbased on expertise and numbers.

• 308.The manner of removal of the Chairperson is not clearly set out under clause 11.
• S04.Substitution of the word"brand"with the word"generic"in clause 35(s). Justification:An interchangeablemulti-source medicine should be dispensed using generic names for costeffective treatment outcomes.No brandgives superiority of the same molecule over the other. This gives pharmacy professionals room to use their expertise and knowledge

305. Deletion of clause S5(4)orredrafting as follows"Apharmacist/pharmaceutical technologistshall. (after consultation with the prescriber)substitute for a prescribed medicine an interchangeable multi-sourcemedicine-"

Justification:This may be used to deny thepublic access to other drugs for selfish promotion of brands through the influence of medical representatives.

• 306.Insertion of the words"/pharmaceutical technologist"wherever theword"pharmacist"appears in clause S5.

Justification:Toredress the exclusion of pharmaceutical technologists.

307. Deletion of clause S8(1)c)and substitution with"(c)a person for whom the Scheduled Substance has been lawfully supplied or dispensed by an authorized person under this Act or any other written law;"

Justification: To professionalize supply and dispensing.

• 308.Inclusion ofpharmacists/pharmaceutical technologists only in wholesale dealership in medicines and health technologies clause s9(1) and (4).

Justification:To enable thepublic access drugs timely from professional pharmacy practitioners

• 309.Redrafting ofclause 41(1)(b)and deletion of clause 41(2)(b)and (c)

Justification:To capture the two pharmacy cadres.To ensure that hospital facilities arelicensed and employ the two pharmaceutical cadres.

310. Definition of the termauthorized sellerused in clause 4s(2)as a registered pharmacist or an enrolledpharmacist technologist.

healthsecurity.

Substitution of clause 4S(1)with "(1)An authorized seller may supply or dispense a Scheduled Substancewith therapeuticvalue for the purpose ofmedical,dental orveterinary treatment,as the case may be,subject to the following provisionsOR"(1)A qualified medical practitioner,dentist therapeutic value for..."and addition ofthe wordsregistered pharmacist or enrolled pharmaceutical technologist"immediately before the words"Authorized Sellers"in clause 68(2)(d).

Justification:Forinclusion of pharmaceutical technologists.

311. Additionofthewords"registered pharmacist or enrolledpharmaceutical technologist immediately before the words "Authorized Sellers"in clause 6s(s)(b)(i).

Justification:For inclusion of pharmaceutical technologists.

312. Deletion of clause 79 and sO and substitution with a clause on regulatory officers for HPTs to include drug inspectors and facilityinspectors under enforcement.

enforcement ofregulation and standards.

313. Deletion ofthe clause 81and substitution with aclause onregulatory officersforHPTs toinclude drug inspectors and facility inspectors under enforcement.

Justification:Relates to food.Falls outside the ambit of the Bill.

• S14.Deletion of the words"or the Director ofVeterinary Services,inrelation to any matter appearing to affect the general interests of animal husbandry in Kenya,and the Director of Kenya,"in clause 81 and insertion of the word"human"immediately before the words"health productortechnology"

Justification:Matters of animal health and agriculture are regulated elsewhere. The Bill should only concern itself with human health products and technologies.

• S15.Deletion of clause 82,83,84,85,86 and 87 and substitution with clauses on regulatory officers for HPTs to include drug inspectors and facility inspectors under enforcement.

Justification:Relates to food.Falls outside the ambitof theBill.

• S16.Definition of the term"class"as used in clause 95(2)(q)

Justification:For clarity.

• S17.Definition the term"Boardasused in the Schedule

Justification:The Bill introduces a new term that conflicts with the Kenya Drugs Board establishedunderclause 8.

• 318.Deletion of the Third and Fourth Schedule.

Justification:The Schedules dealswith a strange Board and are beyond the scope of the Bill as they dealwithfood andestablishe strange Committeeswhosemembershipisunrelated toKDA.

TheSchedule

• 319.Under the Seventh Schedule,the Pharmacy and Poisons Act,Cap.244 should not berepealed

Justification:Repeal will have adverse impact on pharmacy practice

3.2.10AGNESKUVUNAMAINA,AQUALIFIEDPHARMACEUTICALTECHNOLOGIST

In her memorandum,Ms.Maina made the following submissions:Adoption of the definition of "enrolled pharmaceutical technologistprovided in the Pharmacy and Poisons Act,Cap.244.

• 320.Redrafting the definition of"pharmacy"as the Pharmacy and Poisons Act,Cap.244will be repealed.

Justification:To include pharmaceutical technologist who are currently excluded.

321. Deletion of Clause 8(2)h)and replace with:One person nominated by thePharmaceutical Society ofKenya and Oneperson nominated by theKenyaPharmaceutical Association.

Justification:The term"pharmaceutical association"is ambiguous as it is not defined. There are KPA of pharmacists and pharmaceutical technologists respectively.For inclusion of pharmaceutical technologists in the Kenya Drugs Board.Section S of the Pharmacy and Poisons Act currently recognizes the two cadres inpharmacy and theKenyaPharmaceutical Association (KPA)as theumbrellabody ofpharmaceutical technologists.

322. Inclusion of pharmaceutical technologists aspart of the classes ofpersons fallingunder defence for offences related to advertisements as to certain diseases in clause 6s(2)

Justification:Toredress theexclusion of pharmaceutical technologists.

323. Inclusion ofpharmaceutical technologists aspartofthe classesofpersons fallingunder defence for offences related to advertisements as to certain diseases in clause 66(sb)

Justification:Toredress the exclusion ofpharmaceutical technologists.

324. Insertion of the words",an enrolledpharmaceutical technologistimmediately after theword "pharmacistin clause 95(2)(bb).

Justification:For inclusion of pharmaceutical technologists.Training of pharmaceutical technologist is a continuous process.

325. She submitted that theBill does not recognize the two different cadres of pharmacy practitioners

current legislation,thePharmacy and Poisons Act,Cap.244.Pharmaceutical technologists have beenmarginalized,ignored and omitted by the Bill.They havebeenleft outin thekey definitions the Bill contrary to the principles of equality,fairness and fair labour practices.

3.2.11MATHEW\_WAMUIGAGATURUKU,ANENROLLEDPHARMACEUTICAL TECHNOLOGIST

Inhis memoranda,Mr. Gaturuku made the following submissions:

• It appears that the legislation for the regulation of the pharmacy practice in clause 96(s)(b) envisions two parallel Boardswhich does not amount toprudent use ofresources.

827. Theproposed amendments to thelaws governing thepharmacypractice do not fullyrecognize the noble roles played by pharmacy diploma holders who are the majority in both public and privatehealthcare practice 328. The Bill does not give the full description of enrolled pharmaceutical technologist and instead emphasizes the definition of pharmacists.

• 666 proposed Board even though this cadre forms the majority of pharmacy practitioners.
• If the Bill passes in its current state,then it will have negative repercussions on the health of the general public andultimately hampering the realization of universal health care.

3.2.12WILLIAMKOMEN

Inhis memoranda,Mr.Komen made the following submissions:

• 3S1. The Bill does not define the terms"enrolled pharmaceutical technologist" and "pharmaceutical technologist

Justification: The Bill makes reference to the Pharmacy and Poisons Act, Cap. 244 which will be repealed.

332. There isneed to specify the cadre thatwill be responsible for handling scheduled substances with therapeutic value.

Justification:Pharmaceutical technologists or pharmacists and veterinary officers to handle human medicines and veterinary medicines respectively so as to prevent quacks.

• The composition of theHuman Medicines Committeeinparagraph(2)(2)of theFourth Schedule leaves outpharmacyprofessionals byprovidingthat themembers of the Committee should have knowledge of human medicines.

Justification:This may lead to appointment of non-medicines experts and yet pharmacy professionals are known drug experts.

S.2.1SVINCENTGATHUKIAANDROBERTNGETICH

In their memoranda,Mr. Gathukia and Mr.Ngetich made the following submissions:

• 334.Insertion of the words."or pharmaceuticaltechnologist"immediately after the words "registered pharmacist"in paragraph(a)and (b)of the definition of the word "pharmacy"

Justification:For inclusion ofpharmaceutical technologist who are currently registered and regulated by thePPB.They constitute over 7o% of the workforce in the public and private health sector.

• The Pharmacy andPoisons Act has been changed frequently and such changes should not be done in a private members'bill.

336. The Bill should provide for the two cadres ofpharmacy (pharmacists and pharmaceutical technologists)as well as for the two cadres in veterinary (veterinary doctors and Para veterinary practitioners) Pharmaceutical technologists and Para veterinary practitioners should be represented in theKDA Board.

Justification:The Bill does not provide for the two cadres in the pharmacy and veterinary professions.Pharmaceutical technologists and Para veterinary practitioners are the majority and have been in existence longer than pharmacists andveterinary doctors.

337. Under theMemorandum ofObjects and Reasons,theBill should not beenacted as it will occasion unnecessary government expenditure and yet PPBhas been doing a good job

Justification:Available resources tobe channelled toPPB.

S.2.14DUNCANSIMWAANDBERNARDKARIUKI

• Ss8.In their memoranda,Mr. Simwa and Mr.Kariuki proposed the insertion of the words"or an paragraph (b) of the definition of the word "pharmacy".

Justification:For inclusion of pharmaceutical technologistwho are currently recognized by Pharmacy and Poisons Act,Cap.244 andregulated by the PPB.

3.2.15BENJAMINMUNYAONTHUMO

• 339.In his memoranda,Mr.Nthumo proposed theinsertion of the words"enrolledpharmaceutical definition of theword"pharmacy"

Justification:Pharmaceutical technologists are diploma holders are a majority cadre in the pharmacy profession.They also took over the profession of pharmacy from the colonial government.

3.2.16DR.JOHNNGETHEANDDR.NAONINGETHE

In their memoranda,Dr.John and Dr. Naoni submitted that they rejected the Bill the following reasons-

• (a)It allows persons who are not pharmacy professionals such as medical doctors,engineers to become members of theKDA Board.

• (b)It does not facilitate theresearch and developmentin health and genericsmanufacturingin Kenya and in Africa generally.It only benefits bigpharma'swhich will slow down the reduction in the prices of medicines.

3.2.17DR.ALEXOGERO OKARU,PHD

In his memoranda,Dr. Okaru made the following submissions:

340. The definition of"substandard medicines"is incomplete and should be redefined to mean pharmaceutical products that donot meet quality standards and specifications due to factors like incorrectingredients,poor manufacturing,contamination and deceptive packaging. 341. The Bill does not define substandard health technologies which are healthcare devices or technologies that do not meet established quality standards,posing risks to patient safety and efficacy.

Justification:The definitions should be provided as proposed to prevent misinterpretation and improperenforcementofthelaw.

• 8 The current definition of "therapeutic cosmetics"as including cleansing agents extends the scopeofregulation toincludehousehold soaps.

Justification:This may stifle growth in the cosmetics sector.

343. TheBill regulates chemical substances whichencompasses a broad category of substancesranging

Justification:The Bill lacks specific qualifications or criteria for inclusion of chemical substances,The lack of qualifications forregulation of chemical substances may lead to misinterpretation and improper enforcement of thelaw.

344. Designation of Nairobi as the headquarters of the Authority is unnecessary and restricts the flexibility of the KDA.

Justification:The Authority to have autonomy to have discretion in organizing itsfunctions and offices.

• 345.Requiring parliamentary approval of the Director General and inclusion of professional qualification from other fields disregards the necessary and specific expertise and qualifications requiredof theDirector General.

Justification:There is need to maintain the connection between the pharmacy profession and the regulation of medicines.

The Chairperson of theKDA should have aMasters'DegreeinPharmacy and thepharmaceutical association referred toin clause 8(2)(h) should be specified as the Pharmaceutical Society of Kenya.

• S46.Insertion of the word "Pharmaceutical"immediately before the word"manufacturers"in paragraph (i) of sub-clause (2)
• S47.Removal of the requirerment of parliamentary approval of the Board members in clause 8(3)
• 348.Removal of the requirement of the third gender principle in clause 8(7).

Justification:Itis unnecessary as equityprinciples in the public service alreadyencompass gende considerations.

• 349.Aperson seconded by the same government should be considered an employee of the same government and therefore should be ineligible.

350. Part IV addresses the profession of pharmacists and may conflict with the proposed Practitioners Bill. 351. Dispensing of controlled substances by dentists,medical practitioners and veterinary surgeons raises concerns about separation of duties and its impact on publichealth. 352. Designation of theDirector General as the signatory of the certificate of analysisissued byNQCL isnot aligned to international best practice such as the WHOguidance.

Justification:International best practice emphasizesindependence in laboratory operations.

353. Inits current form,the Bill poses significant risks to the regulation of medicines and medical devicesin the country and will hinder the country'sprogress towards the achievement ofWHO maturitylevels. 2. S54.The idea that the Bill will improve the ease of doing business neglects the primary objective of regulated products laws,which is public health.Further,the oversight role of pharmacists has been undermined through theremovalof medicines from thepurview of the pharmacy profession which will adversely affect public health and the subsequent handling of emerging challenges such as antimicrobialresistance.

3.2.I8WINFREDWAMBUINDIRANGU

In her memoranda,Ms. Ndirangu made the following submissions:

355. specification that authorized sellers are enrolled pharmaceutical technologists and registered pharmacists under clause 2of the Bill

Justification: To prevent abuse by placing scheduled substances under the control of the two cadres have elaborate training on drugs.

• 356.Placement of therapeutic cosmetics under the control of qualified medical practitioners. Justification:Kenyans arebuying therapeutic cosmetic products from unregulated outlets posing

great health hazards.

357. Redrafting of the definition of"pharmacy"to mean either,the profession of pharmacy as carried out by registeredpharmacists and/orpharmaceutical technologists;or the dulylicensed premises technologist." 2. S58.Insertion of the words"enrolled pharmaceuticaltechnologistimmediately after the words 3. 359.Insertion of the words"or an enrolledpharmaceutical technologistimmediatelyafter the words"registered pharmacistin paragraph (b) of the definition of the word"pharmacy"

• 360.Insertion of the words"or pharmaceuticaltechnologistimmediately after the words

361. Specification of the type of Masters'degreerequiredreferred toin clause6(4)and deletion of the requirement ofa degreeinmedicine.TheMasters'degreerequirement allows engineering courses is not mentioned in the Bill.

• 362.1 Inclusion of a requirement ofactive membership in the professional body referred to in clause 6 (4)(d).
• S69.Justification:Active membership sustains professional bodies.
• S64.Deletion and substitution paragraph (h)of sub-clause (2)in clause 8 with the following new paragraph "(h) one person nominated by Kenya Pharmaceutical Association"Pharmacists are represented in the Board by the Chairperson.

Justification:The KPA is the only pharmaceuticalassociation that is registered under the Societies Act.

• S65.Deletion of clause 8(2)d)

Justification:The practice oflawyers is different from what the Bill seeks to achieve.

• S66.Provision of minimum qualifications for appointment as inspectors under clause 12(n)

JustificationThe minimum qualification should be Diploma in Pharmacy.

• enrolled pharmaceutical technologists under clause 12(o).

Justification:Rational drug userequires the guidance of the right professional cadre.

• S68. Enrolled pharmaceutical technologists and registered pharmacists should be mandated to dispense scheduled substances with therapeuticvalue.

Justification:Allowing anymember or staff of a hospital or dispensary to supply or dispense scheduled substanceswill lead to mishandling of prescriptions causing many court cases.

369. Inclusion of enrolled pharmaceutical technologists under clause 6s(2)(d)as part of persons who will be covered by a defence. 2. 370.Inclusion of enrolled pharmaceutical technologists under clause 66(s)b)(i) and (ii) as part of persons who will be covered by a defence.

Justification: Training of pharmaceutical technologist is a continuous process.

371. Insertion of the words",an enrolled pharmaceutical technologist"immediately after the word "pharmacist"in clause 95(2)(bb).

Justification:For inclusion of pharmaceutical technologists.Training of pharmaceutical technologistisacontinuousprocess.

• 372.Provision of a timeframe within which parliament should enact thelaw on regulation of pharmacy practice in clause 96(s)(b)

Justification:The country needs the Pharmaceutical Technologists Council Bill for the regulation ofpharmaceutical technologists.

In his memoranda,Mr.Mwangi made the following submissions:

• s73.Definition of an enrolled pharmaceutical technologist according toArticle 26 of the Constitution.

Justification:A pharmtech is a trained health profession who is amember ofalicensed body and regulated to provide technical expertise in the pharmacy profession.The Health Workforce Forecast Kenya(2013)notes that the ratio of pharmtechs topopulation is 14.8 to 100,00o while pharmacists is 5.3to100,000.

• S74.Inclusion of a pharmaceutical technologist in the definition of the word "pharmacist
• Justification: The profession of pharmacy comprises of both pharrmacists and pharmaceutical technologist.

375.Inclusion of pharmaceutical technologists in the business ofretail pharmacy business Justification:Pharmaceutical technologistshave been engagedin the business ofretail pharmacy under thePharmacy and Poisons Act,Cap.244 in line with their scope of training

• 376.TheDirector General should be a pharmacy professional Justification:A pharmacy professionalunderstands the diversity ofmedicine andmedical devices

management from their knowledge and skills earned through their period of practice.

• 377.Increment of thenumber ofprofessions in theBoard from two tofive toinclude the diverse fields of pharmacy such as quality assurance,pharmacovigilance,research institutions,industry and TVETs.

Justification:TheFood and DrugAuthorities ofUSA and other middle-income countriesmanage pharmaceuticals and non-pharms by pharmacy specialty.

• 378.Incrementof the number of Pharmtechs in the Board from one to four drawn from TVETs community practice,hospital practice and association or regulator.

Justification:To enhance cohesiveness in pharmacy practice.Pharmtechs are over 1l,ooo.

• s79.Inclusion of pharmtechs in dispensing of multisource medicine.

Justification:Pharmtechs are healthcare professionals with expertise in pharmaceutical training They also work in therural areaswhich over 7o% of theKenyan population.

• S80.Inclusion ofPharmtechs in the provision oflicence under sub-clause(4).

Justification:Section 12 of the Health Act,No.21of2017 provides for inclusion ofhealth

• professionals in the delivery of expert services.

• 381.Provision ofonelicence for pharmacy professions in sub-clause(s)

Justification:The current clause will create ambiguity in the pharmaceutical practice.

382. Inclusion of the holders of higher national diploma in clinical pharmacy,renal pharmacy and pharmacy to provide wholesale business services in clause 41(1)(b).

Justification:According to the Kenya National Qualification Authority,higher diploma in pharmacy is equivalent to a degree. These Diploma holders have the capacity,knowledge and skills.

• 688 Insertion of the words",an enrolled pharmaceutical technologist"immediately after the word "pharmacist"in clause 95(2)(bb)

Justification:For inclusion of pharmaceutical technologists.Training of pharmaceutical technologist is acontinuous process.

3.2.20PESTCONTROLPRODUCTSBOARD(PCPB)

In its memoranda, the PCPB proposed as follows:

384. The deletion of the words "pesticides,insecticides,rodenticides and vermicides"in the definition of the"chemical substances.

Justification:The current definition brings about confusion,overlap of mandate and duplicity of roles as pesticides,insecticides,rodenticides and vermicides are already regulated by the PCPB under thePest Control ProductsAct, Cap.S46 and theVeterinary Medicines Directorate(VMD) under the Veterinary Surgeon and Veterinary Paraprofessionals Act,No. 29 of 2o11 for animal products.

385. The application and scope of the Bill in Clause S(2)includes chemical substances which takes away the mandate of PCPB and Veterinary Medicines Directorate to regulate pesticides,insecticides, rodenticides and vermicideswhich are treatedas chemical substancesin clause2of theBill. 2. 986 The functions of the Authority relate to theregulation of HPTs which are defined in clause 2 and S(2)as including chemical substances.

Justification:The clause takes away themandate ofPCPB andVeterinaryMedicinesDirectorate toregulate pesticides,insecticides,rodenticides and vermicides treated as chemical substances in clause 2of theBill.

• S87.The Bill does not disclose what constitutes Scheduled Substances.

Justification: This may lead to overlap of regulation with other regulatory agencies.

388. Establishment of theNational Food Safety Committee overlaps with themandate of theNational Food Safety Co-ordinatingAuthority.

Justification:AnewNational Food Safety Co-ordinationBillis currentlybeing developed

• 688 ThePSCPBappreciates theimportance oftheBillin addressingsomeweaknessesin theregulation ofdrugshowever theBill shouldnot dealwithpestcontrolproductswhich areregulated under thePest ControlProducts Act,Cap.S46a d should bealive to thefact thatregulation of chemical substances inKenya is domiciled in many agencies as provided for in various statutes.

3.2.21THEVETERINARY MEDICINESDIRECTORATE(VMD)IN THE MINISTRYOF AGRICULTUREANDLIVESTOCKDEVELOPMENT

In its memorandum,the VMD,whilst objecting to the Bill, submitted as follows:

390. Deletion of pesticide;insecticide,rodenticide;vermicide; or detergent in the definition of the word 'chemical substances".

Paraprofessionals Act,No.29 of2011.

• s91.Deletion of the words"orveterinary health benefits'in the definition of"herbal medicine or product"

Justification; These are regulated under the VeterinarySurgeon and Veterinary Paraprofessionals Act,No.29 of2011.

• s92.Deletion of the words"or animals"in the definition of"medical device","medicinal substance" and"medicine".

Justification:Animal medicines are regulated under the Veterinary Surgeon and Veterinary Paraprofessionals Act,No.29 of2011

• S93.Deletion of the veterinary surgeon"or"veterinary practitioner"

Justification: Already defined under the Veterinary Surgeon and Veterinary Paraprofessionals Act,No.29of2011.

• S94.Deletion of the definition of"veterinary medicine".

Justification:Animalmedicines are regulated under the Veterinary Surgeon and Veterinary Paraprofessionals Act,No.29 of2011.

• s95.Deletion of the word "anyappearing in paragraph(a) and (b) and delete the wordsor animals"

Justification:Veterinarymedicines areregulated under theVeterinary Surgeon and Veterinary Paraprofessionals Act,No.29 of 2011.

• 966 Insertion of the word "humanimmediately before the words"health products and technologies"in clause s(1)and paragraphs(a),(c).(d),(e),(f),(g).(l)of clause 12.

Justification:To differentiate from animal health products and technologies which areregulated under other Acts.

Deletion of the wordsor Essential Veterinary Medicines Listin clause 29(2)and deletion of clause 29(14)(b).

Justification:The Essential Veterinary MedicinesList is prepared under the Veterinary Surgeon and VeterinaryParaprofessionalsAct,No.29 of2011.

• 397.Deletion of the word"Every"and"any"and substitution with the word"A"in clause 29(7),clauses 34(a)47(1)and 47(s).56(1)and(2)clause 59(1)and deletion of the word "any"in clause 29(6).

Justification:To excludeveterinary medicines.

• s98.Deletion of the words"and dealers in mining,agricultural or horticultural accessories" in clause s7(2)(a)and deletion of clause 38(1)(c),clause 40,clause 41(1)(c).

Justification:To exclude mining,agricultural or horticultural accessories which are regulated under otherstatutes.

• '666 Deletion of the words"or veterinary surgeon"and"or veterinary treatment"in clause 41(1)(d). clause 48(1),6s(2))(c),6s(s)(b)(i)and deletion of the words"or veterinary surgeon"in clause 41(2)(a)and clause S8(1)(e).

Paraprofessionals Act,No.29 of2011.

• 400.Deletion ofthewords"andveterinary medical devicesregister,"and theword"all"appearing in clause 55(1).

Justification:Veterinary medical devices are regulated under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of2011.

• 401.Delete thewords"ortheBritish Veterinary Codexin clause 67(2)(b) Justification:Veterinary codex is relevant for veterinary medicineswhich are regulated under

theVSVPAct.

• 402.Deletion clause 79.

403. Justification:Animals and meat are regulated under the Animal diseases Act and Meat Control Act.

• 404.The memorandum of objects and reasons of the Bill is misleading. Justification:International best practice requires separation of regulation of human and

veterinary medicines.

• 405.Indicated thatit objects theBill for the followingreasons-
• a)Sessional PaperNo.2on theNationalLivestockPolicy,in paragraph S.4.8,separated the regulation ofveterinarymedicines from that ofhuman medicines andplaced it under the inordinate abuse and misuse of veterinary medicines in the country.
• b) TheVMDwas establishedvide theVeterinarySurgeons andVeterinaryParaprofessionals Act,2o11 to regulate veterinary medicines under veterinary domain in line with international best practice under the World Organization for Animal Health (WOAH) which Kenya is a signatory.These laws were enacted in compliance with requirements of Application of Sanitary and Phytosanitary Measures,particularly Article S,and the International Agreement for the Creation of World Organization for Animal Health, particularly ChapterS.4oftheTerrestrialAnimal Health Code.The Bill therefore deviates from the provisions ofand obligations under,these treaties,thereby also breaching the Constitution in Article 2(5)and Article 2(6)

• c)The veterinary medicine profession is satisfied with theregulation ofveterinarymedicines under the Veterinary Surgeons and Veterinary Paraprofessionals Act (Veterinary Medicines Directorate Regulations)2015.
• d) Veterinary medicines posepublic healthrisk through presence of their residuesin food of animal origin such as milk,if withdrawal periods are not observed.Livestock also play & major role in the zoonotic diseases cycle.
• The Bill is not addressing a felt need as there is in place adequate legislation,human resources and capacities to regulate matters drugs and pesticides.
• The Billis relating professionals from their central role in drugs matters and replacing them with a largely non-professional board.
• g The Bill is not implementing a known policy as no public policy precedes it.
• h) No publicparticipation was conducted during the development of theBill as envisaged by the Constitution ofKenya2010.
• i) The VMD is the recognized National Regulatory Authority (NRA) for veterinary medicinesunder theEastAfricanCommunityMutual RecognitionProcedure(EAC-MRP) established forjoint evaluations andinspections ofmanufacturingfacilities.

3.2.22AGROCHEMICALSASSOCIATIONOFKENYA(AAK)

In its memoranda,theAAKproposed as follows-

406. The deletion of the words pesticides,insecticides and rodenticides"in the definition of the "chemical substances.

Justification:The Pest Control Products Act,Cap.S46 regulates pesticides and other public health products such as insecticides and rodenticides.

• 407.Deletion of clause 8(2)(f)).

Justification:TheDirector ofVeterinary servicesshouldbeaBoard Member of theAuthority as he chairs the Veterinary Medicines Directorate Council (VMDC)domiciled in the State Department of Livestock. The Council regulates veterinary medicines under the Veterinary Surgeons and Veterinary Paraprofessionals (Veterinary Medicines Directorate)Regulations 2015.

408. Deletion ofeverything in the Bill that relates to veterinary medicine,veterinarians and animals.

Justification:There is no lacuna in the regulation ofveterinary medicine.Enactment of the Bili will present enforcerment challenges such as increased licensing costs arising from double regulation due to duplication with the existing veterinary medicines regulatory framework Veterinary products are best regulated under theState Department of Livestockrather than the Ministry ofHealth.TheWorld Organization forAnimalHealth(WOAH)vide ArticleS.4.11 ol theTerrestrialAnimalHealth Code-10/os/2022recommends theenactment ofa veterinarylaw for the regulation of the manufacture,importation,wholesale,retail and usage ofveterinary medicinal products anchored the Ministry that deals with animal diseases.Further,pharmacists under the Bill do not have capacity to regulate veterinary medicine practice and to handle pharmacovigilance,the practice of surveillance and monitoring of adverse events ofveterinary medicines on animals following administration.

S.2.2STHE KENYA NATIONALUNION OF PHARMACEUTICALTECHNOLOGISTS (KNUPT)

Inits memorandum,KNUPTsubmittedas follows:

409. Pharmaceutical technologists are left outin the key definition ofpharmacy practice which is discriminatory and the definition of"enrolled pharmaceutical technologist"cross references the Pharmacy and Poisons Act, cap.244.

Justification:ThePharmacy and PoisonsAct,Cap.244 to berepealed.

410. nominated by the Kenya Pharmaceutical Association"

Justification:For clarity on the institution to nominate the representative ofpharmaceutical technologists in the KDA Board.

411. The Bill does not provide the transitional provisions on howpractitioners practicing under the Pharmacy and Poisons Act, Cap. 242 will be regulated once the law is enacted. 412. The Bill includes one cadre(pharmacists)and discriminates against pharmaceutical technologists. The two cadres are notincluded at every level of the drug management cycle(from quantification, procurement,storage ofproducts and technologiesincluding their retailingandwholesaling)The Bill should furtherprovide for apharmaceutical technologist council.

Justification:The pharmaceutical technologist council to regulate more than 12,0o0 pharmaceutical technologists in the country.

3.2.24THEKENYAMEDICALASSOCIATION(KMA)

In its memoranda,theKMA proposed the following amendments:

• 41s.Insertion of the following new paragraph in clause 8(2)"(m) one person nominated by Kenya Medical Association".

Justification:The inclusion of KMA in theKenyaDrugs Board forrepresentation of prescribers ofdrugs who will also give feedback on the quality,efficacy and safety of drugs.

• 414.Inclusion of KMA in the composition of theNQCL Board.

Justification:Pathologists who are members ofKMA would be suitableleads inNQCL

• 415.ThePPB to be made thePharmacy Practice CouncilandKMA to bemember ofitsBoard.

Justification:Inclusion ofKMA forrepresentation of prescribers of drugs who will also give feedback on the quality,efficacy and safety of drugs.

• 416.Inclusion of prescribers in all the scientific advisory committees.

Justification:Inclusion of doctors whowill givefeedback on the quality,efficacy and safety of drugs.

S.2.25THELAWSOCIETYOFKENYA(LSK)

• 417.In its memoranda,the LSK proposed the following amendments:The deletion of the word "ifand substitute therefor the word"ofin sub-paragraph(ii)in the definition of the word"drug"

Justification:This is to correct a typographical error.

418. under this Act"in sub-clause(f).

Justification:This is to correct a typographical error.

• 419.Under clause 21,the number ofcommittee members for each advisory committee should be specified aswell as the expertise that thesemembersshould have andwhere they should be drawn from.
• 420.Under clause 29,a timeline within which an application for registration of a medicine is to be granted should be provided.

Justification: The provision may be misused.

Justification:For accountability purposes

3.2.26THEKENYAASSOCIATIONOFPHARMACEUTICALINDUSTRY(KAPI)

• 421.In its memoranda,KAPI proposed the following amendments:The definition ofborderline to be expanded.

Justification:The current definition(which provides that"borderline product"means a health product whose chemical characteristics and form may be categorized either asa medicine or a product such as a cosmetic depending on presence ofcertain substances and claim oftheir purpose)

• 422.The definition of a pharmacist to include both registered and licensed,notjust registered only

Justification: To require that a pharmacist is both licensed and registered.

423. The Chairperson and Director General of the Board to be a registered and licensed Pharmacist.

Justification: To require that a pharmacist is both licensed and registered.

424. It is impractical to disqualify a person who has been involved in the production,manufacture importation ordistributionfrombeinga BoardMember.Persons with over 10years'experience have been involved in production,manufacture,importation and distribution

Justification:One can be involved in these activities without conflict of interest arising in their capacity as aBoard Member provided that the declaration or statement ofconsent is provided.

425. Deletion of subsection 3,4,5,6and 8withregard to the grant of Market AuthorizationLicence on publication in the local dailies and limitpublication to the authority's website.The forty-eight hoursprovidedforrecallofmedicinebytheAuthority should be for communicationofintended recall to the Market AuthorizationLicence Holder and not the recall process itself. The twentyfour hours for issuance of notice should be expanded to a more feasible duration.The KDA to prescribe procedures and standards for recall of medicines and health products.

Justification:The Board should approve the application and stop it at that and may publish the same on itswebsite. Communications to be donein forty-eight hours while the actual operations ofrecall shouldbe asperguidelines developedby the authority.

426. DispensingofSchedule2drugs should not belimited toPharmacists only but also extended to Pharmaceutical Technologists.

Justification:Pharmacyretail outlets are also manned by pharmaceutical technologists.

427. InPARTVIIl,theBill shouldprovidethat theAuthority shall prescribeprocedure and standards forrecall of medicines and health products waste which shall bein accordance with the standards and procedures prescribed by the World Health Organization.,provide for the application for registration under this section shallbeprepared andsubmitted by aqualifiedbiomedicalengineer, aregisteredpharmacist and allprofessionalswith relevant medical training as maybeprescribed, whoiscertified by the Authority,in the prescribed form,as a qualified agent for medical devices registration.Marking of conformity should be omitted inits entiretyfrom theBill.

Justification:The Authority to prescribe the standards for Medical Devices,not the Cabinet Secretary.Application should not belimited to biomedical engineers and registered Pharmacists only.Other qualified andrelevant professionals to beincorporated. Conformity to set standards of medical devices is being regulated by Kenya Bureau of standards.

• 3.2.27THEMINISTRYOFAGRICULTUREANDLIVESTOCKDEVELOPMENT

428. TheBill should belimited to theregulation of human medicines and devices while theVMD is allowed to undertakeitsregulatory mandate overveterinary medicines.

The Ministry submitted as follows:

Justification:Veterinary medicines are regulated under a standardized law on veterinary medicinebasedonWOAH templates

• 429.TheBill should excludeveterinary medicines from the scope and long title and remove allissues concerning theregulation of animal medicines and other veterinary inputs in all clauses including the definition of drugs,herbal medicine or products,section 29 and 4S and theFourth Schedule on theVeterinaryMedicines Committee.

Justification:The memorandum ofobjects and reasons makes reference to the WHO providing international standards on human health.It does notmake reference to theWord Organization for Animal Health (WOAH)which provides standards on animalhealth and veterinary medicines. Distinct regulatory regimes for human andveterinary medicines isaligned to international good practice and standards and is backed by theLivestockPolicyand theVeterinary Policy approved by the Cabinet in 202o.Deviating from this wouldexposeKenyans toviolative drugresidues inanimals and animalproducts.It also makesKenya non-complaint with Terrestrialand AquaticAnimal Health Codes of WOAH enforced under the WTO Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures.

• 4S0.From 1957 until six years ago,allveterinary medicines were regulated by PPBunder Cap.244. which is being replicated by the Bill.At the time,Kenya could not access lucrative markets for animal and animal products because of a weak regulatory regime for veterinary medicines.

Justification:This was subsequently addressed with the establishment of theVMDwhichregulates the manufacture,importation,exportation,registration,distribution,prescription and dispensing of veterinary medicines and poisons.

• 431.The Bill should focus on human medicines utilized in hospital setups and allow the VMD to regulate veterinary medicines that are dispensed on farms and homesteads where only veterinary professionals have access and the necessary animal health training.

Justification:VMDandKDA as competent authoritieswill collaboratefor the safety ofKenyan TheFood and Feed Safety Control Coordination Bill,2022will also address the coordination of safety of food forhumans.

3.2.28THEKENYAVETERINARYBOARD

TheKenyaVeterinary Board submitted asfollows:

432. The Bill as currently drafted is notimplementable asKenya as a signatory to the World Trade Organization (WTO)must abide by the rules-based trade under the WTO including the Agreement on Application forSanitary andPhytosanitary Measures(SPSAgreement).Under this Agreement,Kenya may set its own laws and regulations,provided they are notin conflict with the provisions of this Agreement and they are based on the international guidelines and recommendations adopted by the Codex Alimentarius Commission(Codex).

Justification:Human medicines areregulated under the Pharmacy and Poisons Act, Cap.244 by thePPBasprovided in thenational Pharmaceutical Policyand guided byWHO standards.

• 433.For effective regulation,veterinary medicines regulation was separated from human medicines in 2016 as providedin theVeterinary Policy and LivestockPolicy.Thesemedicines areregulated by the Veterinary Medicines Directorate through theVeterinaryMedicines Regulations under the VeterinarySurgeons andVeterinary ParaprofessionalsActof2oll guided by global standardsset by theWorld Organization forAnimal Health(WOAH).
• 484.TheBill needs to review thePharmacy and Poisons Act,Cap.244 to strengthen it to provide for effectiveregulation of human medicines and devices in line with the standards set by WHO devoid of any regard to regulating medicines and veterinary medicinal products.

435. The Veterinary Surgeons and Veterinary Paraprofessionals Act,2o11 and the Veterinary Medicines Regulations,2015shouldbereviewedfor effectiveregulation ofveterinary medicines and devices in line with the standards setby theWorld Animal Health Organization. 436. Legislative proposals that pose hugerisks to critical sectors such as health and food security shouldbediscouraged

PARTIV

4.0COMMITTEEOBSERVATIONS

• 4S7.The Committee having considered theKenya Drugs Authority Bill,2o22,National Assembly Bill No.54of2022and submissions from stakeholders made the followingobservations:
• (a)The Bill expands the functions of the current Pharmacy and Poisons Board andreengineers the newregulatorbased oninternational best practiceinregulation of human health products and technologiesincluding therapeutic cosmetics.Thisreengineeringwill enable the country attain therecommended World Health Organization(WHO)maturitylevel 3;
• (b)The Bill strengthens the functions of the National Quality Control Laboratory which will improve the quality of tests,analyses and research for quality control.Thisin turn ensures

that thehealth products and technologies usedin the country meets internationalquality standards thereby guaranteeing patient safety. The Bill therefore fulfills the country's obligation in thewar against poor qualitymedicines in line with its commitment under the recently ratified African Union establishment of the African Medicines AgencyTreaty;

• (d)TheBill also encourages local manufacturingofhealthproducts and technologies as espoused in theKenya Universal Health Coverage Policy(2020-20so).TheBillis thereforeinline with the government's plan of promoting localmanufacturing especially in the pharmaceutical sector,a key contributor of Kenya's economy. The Bill will hasten the attainment of the government'svision for nationaleconomic transformation;and
• (c)The Bill strengthens the-regulation of medicines by providing a comprehensive regulatory framework which enables the country to comply with good manufacturing practices as envisioned under the African Union Model Law on Regulation of Medical products.This ensures that health products and technologies used in the country are safe and effective in line with section 66of theHealth Act,No.21of2017;
• (e)The Bill further improves the availability of health products and technologies and enhances access topriority health products and technologies.The Bill also improves the efficiency of operations,quality and pricing of medicines and vaccines which are key components and enablersfor the successful realization ofuniversal health coverage.

PARTV

5.0COMMITTEERECOMMENDATIONS

Upon considering the Kenya Drugs Authority Bill,2022,National Assembly Bill No.54of2022 and submissions from stakeholders,the Committee recommends the following amendments:

LongTitle

THAT theLong Title of the Bill beamended by deleting theLong Title and substituting therefor the followingnewLongTitle

"ANACTofParliament toestablish a comprehensivelegal frameworkforregulation of HealthProducts safety,quality,efficacy,effectiveness and performance of health products;to establish theKenya Health Products and Technologies Authority and for connected purposes".

Justification:This accords with international best practice and sets out the main purpose of the Bill which is to establish a centralizedregulatory authority forhealth products and technologies.

CLAUSE1

THAT Clause 1 of theBill be amended by

• (a)deleting the phrase "Kenya Drugs Authority Act,2022"and substituting therefor the phrase "Kenya Health Products and Technologies Regulatory Authority Act,2022";

Justification:This accords with international best practice and comprehensively covers the mandate of the proposed Authority.

• (b)deleting thewords"and commencement"in themarginalnote

Justification:Tolimit the marginal note to the content of clause1.

CLAUSE2

THAT Clause2of the Bill be amended by

• (a)inserting the words"dietary supplementimmediately after thewords"therapeutic cosmetic"in the definition of the term"article";

Justification:For inclusion of dietary supplements which arepart of health products and technologies.

• (b)deleting the phrase"Kenya Drugs Authority"and substituting therefor the phrase"Kenya Health Products and Technologies Regulatory Authority"in the definition of the word"Authority":

Justification:To ensure harmony with the title of the Bill asproposed for amendment.

• (c)deleting the words"pesticide;insecticide;rodenticide;vermicide; or detergent"in the definition of the word"chemical substances";

under the purview of the medicines'regulations.To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and Veterinary Para-Professionals Act, No.29of2011.

(d) in the definition of the word "drugs, by

• (q)pue(e)qdeeedu SureaddeuepomSunap()

(ii) deleting the word "if" and substituting therefor the word "of in sub-paragraph (ii). Justification: Veterinary medicines are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of 2011.

• (e)deleting the definition of"enrolled pharmaceutical technologist"and substituting therefor the following new definition-

"enrolled pharmaceutical technologist"means aperson enrolled as such by thebody for thetime being responsible for the enrolment ofpharmaceutical technologists;

• (f))deleting the definition of"pharmaceutical technologist"

Justification:The current definitions of terms "enrolled pharmaceuticaltechnologist"and pharmaceutical technologistmustbe enrolled.

• (g)inserting the words"dietary supplement" immediately after the words "therapeutic cosmetic" in the definition of the term"health products and technologies";

Justification:For inclusion of dietary supplements which are part of health products and technologies.

• (h)deleting the definition of the word "herbal medicine or product"and substituting therefor the followingnewdefinition-

"herbal medicine or product"means a plant derived material or preparations with claimed therapeutic or other human health benefits,which contain either raw or processed ingredients from one or more plants or material of inorganic or animal origin and includes herbs,herbal materials,herbal preparations, finished herbal products that contain active ingredients,parts of plants or other plant materials or combinations;

Justification:To expand the scope toinclude herbal materials and herbal combinations and to exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and VeterinaryPara-ProfessionalsAct,No.29ofe011.

• (i)deleting the definition of the term"medical device"and substituting therefor the following definition-—

use,software,material or other similar orrelated article,intended by themanufacturer to beused,alone or in combination,for human beings,for one or more of the specific medical purpose of

• (a) diagnosis,prevention,monitoring,treatment or alleviation of disease;
• (c) investigation,replacement,modification,or supportof the anatomy orofaphysiologicalprocess;
• (b) diagnosis,monitoring, treatment,alleviation of or compensation for an injury:
• (d) supporting or sustaininglife;
• ? disinfection of medical devices;
• (e) control ofconception;
• (g) providinginformation by means ofinvitro examination of specimens derived from the human body:
• aids for persons with disabilities;
• (h) disinfection substances;

• (i)devices incorporating animal and/or human tissues;
• (k)devices for in-vitro fertilization or assisted reproduction technologies

and does not achieveits primary intended action by pharmacological,immunological or metabolic means, in or on the human body,but which may be assisted in its intended function by such means.

Justification:To expand the scope to cover all aspects of theuse of medical devices inrelation tohuman health.

• (i)Deleting the definition of the term"medicinal substance" and substituting therefor the following definition—

"medicinal substance"means a substance, the origin of which may be human, animal,vegetable or chemical including human blood and human blood products,micro-organisms,whole animals,parts of organs,animal secretions,toxins,extracts,blood products,micro- organisms,plants,parts of plants, vegetable secretions,extracts,elements,naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

Justification:To expand the scope to cover all aspects of the use of medicinal substances in relation to human health.

• (k)deleting the words"or animals"wherever it appears in the definition of the term"medicine";

Justification:Veterinary medicines areregulated separate from humanmedicines under theVeterinary Surgeonsand VeterinaryPara-ProfessionalsAct,No.29of2011.

• the definition of the term"package";

Justification: For inclusion of dietary supplements which are part of health products and technologies.

• (m)deleting the definition of the word"pharmacy"and substituting therefor the following new definition-

"pharmacy"means either-

• (a) the profession of pharrmacy as carried out by registered pharmacists or enrolled pharmaceutical technologists;or
• (b)the duly licensed premises from which pharmacy services are provided by a registered pharmacistorenrolledpharmaceuticaltechnologist"

Justification:To providefor the two cadres in the pharmacy profession.

(n) deleting the definition of the term"registered midwife

Justification:The term is no longer used in the Bill in line with the proposed amendment ofclause 4S (1)(c).

• (o)deleting the words "or animals"in paragraph (c)in the definition of the term"substance recommended asa medicine";

Justification:Veterinary medicines areregulated separate from humanmedicinesunder theVeterinary Surgeons and Veterinary Para-Professionals Act, No. 29 of 2011.

• (p)deleting the definition of the term"therapeutic cosmetic"and substitute therefor the following definition-

"therapeutic cosmetic"means a cosmetic which—

• (a)offers an additional benefit to a person over an ordinary cosmetic;
• (b)contains a bioactive product formulated from an animal ingredient that may have visible andmeasurable short-or long-term effects on a person;

may include a product that may be absorbed through the skin or a mucous membrane.

Justification:Thecurrent definition defines cosmeticsin general that are meant toprovide thebody with appropriate aesthetics,texture,pH,color and smell.It is not specific to special cosmetics.

• (q)deleting the definition of the terms"veterinary surgeon"or"veterinary practitioner";
• (r)deleting the definition of"veterinary medicine";

Justification:Veterinarymedicines areregulated separate from human medicines under theVeterinary Surgeons andVeterinary Para-ProfessionalsAct,No.29of2011.

(s)Insert the followingnew definition-

Boardmeans the Board of the Authority established under section 8;

Justification:Toidentify theBoard asused in theBill

• (t)Inserting the following new definitionsin proper alphabetical sequence

adverse drug reaction"means a response to a drug which is noxious andunintended,and which occurs at doses normally used in humans for the prophylaxis,diagnosis or therapy of disease,or for the between a medical product and an occurrence;

pharmaceutical product but which does not necessarily have a causal relationship with the treatment;

"active surveillance"means prospective measures taken to detect adverse drug reactions and adverse

"biologicals"means a diverse group of medicines which includes vaccines,growth factors,immune modulators,monoclonal antibodies and includesproducts derived from human blood and plasma;

"Centre"means the National Pharmacovigilance Centre;

"clinical trialmeans any systematic study on pharmaceutical products in human subjects,whether in patients or other volunteers,in order to discover or verify the effects of,identify any adverse reaction to investigational products,to study the absorption,distribution,metabolism and excretion of theproducts with the object of ascertaining their efficacy and safety:

dietary supplement" means a product taken by mouth that is added to the diet to help meet daily requirements of essential nutrients,and may contain one or more dietary ingredient and includes vitamins, minerals, herbs;

identity,composition or source;

Field Safety Corrective Action"means any action taken by a product owner to reduce a risk of death or serious deteriorationin the state ofhealth associated with the use of a medical device,and includes-

• (a) the return ofa medical device to the product owner oritsrepresentative;
• (b) devicemodification including
• (i) retrofit in accordance with the product owner's modification or design change;
• (ii) software upgrades including those carried out by remote access;
• (i) permanent or temporary changes to thelabelling orinstructions for use;
• (iv) modification to the clinicalmanagement ofpatients to addressa risk of serious injury or death related specifically to the characteristics of the device;
• (vi) device destruction;and
• (v) device exchange:
• (vii) advicegiven byproduct owner regarding the use of the device.

"health products"includes human medicines,medical products,medicinal substances,vaccines, diagnostics,medical devices,blood products,traditional and alternative medicine,therapeutic feeds and nutritional formulations,cosmetics and related products;

devices,vaccines,procedures,and systems developed to solve a health problem and improve the quality oflives;

"in-vitro diagnostics medical device"means a medical device,whether used alone or in combination, intended by the manufacturer fortheinvitro examination of specimens derived from thehuman body solely orprincipally toprovide information for diagnostic,monitoring or compatibility purposes;

and who holds a minimum of a diploma in pharmacy;

lot or sub-lotmeans a defined quantity of startingmaterial,packagingmaterial or product,processed in a single process or series of processes so that the quantity is expected to be homogeneous;and in the case ofcontinuousmanufacture,thelot corresponds toa defined fraction of the production characterized byitsintendedhomogeneity;

"lot releasemeans the process of the evaluation of an individual lot of a licensed biological product by the Authority before giving approval for its release onto themarket;

"marketing authorizationmeans the certificate ofregistration issued by the competent health product product after evaluation for safety,efficacy and quality;

"passive surveillancemeans not taking active measures to look for adverse effects other than the encouragement of health professionals and others to report safety concerns;

parallel importation"means the importation intoKenya,by a licensed importer of health product other than the marketing authorization holder or his or her technical representative of the following health products which require marketing authorization in Kenya—

• (a)patented health products under section 58(2)of theIndustrial Property Act,2001;
• (c) )brandedgenerichealthproducts;
• (b)non-patented health products;or

(d)

parallel imported medicinal substance"means a medicinal substance imported into Kenya under this Act;

pharmacovigilance"means the science and activities relating to the detection,assessment,understanding and prevention of adverse effects or any other possible health product related problem;

"premises" includes any land, any building,dwelling-place and any other place whatsoever;includes stand-alone community retail pharmacy,private hospital pharmacy,public health facility pharmacy. wholesale pharmacy or distribution outlet,where health products and technologies are stored,handled or distributed;

"scheduling"means,in relation to a substance, the determination of the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included;

"substandard medical products"means registered medical products that fail to meet either their quality standards or specifications,or both;

"unregistered medical products"means the products that have notundergone evaluation and approval by the Authority subject topermitted conditions under the Act and therules therein;

"vessel"means trucks,vans,buses,minibuses,cars,trailers,aircraft,railway carriages,boats and oth means that are used to convey health products and technologies;

Justification:The new definitions are internally recognized by the World Health Organization and are critical for the execution ofregulatory functions of the Authority.

CLAUSE3

THAT Clause Sof theBill be amended by deleting sub-clause(1) and substituting therefor the following new sub-clause

• (1l)ThisAct applies toregulation of
• (a)human medicines,medicalproducts and technologies;
• (b)medical devices includingradiationemittingproducts;
• (c)radiopharmaceuticals;
• (d) complementary,alternative or herbal medicines;
• (e) cosmetics and borderline products;
• (f)in-vitro diagnostics medical devices;
• (g) therapeutic feeds;
• (h) clinical trials;
• (i)nutraceuticals and dietary supplements;
• (j)digital heath and technologies;
• (k)scheduled substances;
• (l)chemical substances;and

(m)biological products for use in humans and the starting materials used in their manufacture;

Justification:To comprehensively cover all aspects in the regulation of human health products and technologies.

CLAUSE4

THAT Clause4of the Bill be amended in sub-clause(1)by deleting the phrase"Kenya Drugs Authority and substituting therefor the phrase"Kenya Health Products and TechnologiesRegulatory Authority"

Justification:This accords with international best practice on the establishment ofa centralized regulatory authorityforhumanhealthproductsand technologies.

CLAUSE5

THAT Clause 5 of the Bill be amended by deleting thewords"but theAuthority may establish branches anywhere in Kenya and substituting therefor the words"or in such other place as the board of the Authority may,by resolution,determine".

Justification:Togive theBoard discretion in determining thelocation of the Authority's headquarters.

CLAUSE6

THAT Clause 6of the Bill be amended by

• (a)deleting sub-clause(1)and(2)and substituting therefor thefollowingnew sub-clauses-
• (1)There shall be aDirector-General who shall be the chief executive officer of theAuthority.

(2)TheDirector-General shall be appointed by theBoard,through a transparent and competitiveprocess, on such terms as may be specified in the instrument of appointment.

Justification:The Director General is not a State Officer and should therefore be appointed by the Authoritywithoutthe approval byParliament.

• (b) deleting the word "four"appearing in sub clause(S)and substitute therefor the word"three".

Justification:Appointments and term of service in State Corporations are normally capped at three(s) years which is renewable for one final term.

• (c)deleting sub-clause (4) and substituting the following new sub-clause

(4)Aperson shall be qualified for appointment as aDirector-General if such person-

• (a)holds a bachelor's degree in pharmacy from a university recognized in Kenya;
• (c)has atleast ten years'experience in pharmacy orits equivalent;
• (b)holds a mastersdegreein pharmacy,medicine or relevant field from a university recognized inKenya;
• (d)has served in a seniormanagement position for at least fiveyears;
• (e)is a member ofa professional body; and
• (f)meets the requirements of Chapter six of the Constitution.

Justification:TheDirector General should be a qualified pharmacist as theregulation ofhealth products and technologies requires specialized knowledge and technical expertise in the pharmaceutical field.

• (d)by deleting sub-clause(5).

Justification:The content included in the proposed sub-clause(1)

CLAUSE7

THAT Clause 7 of the Bill be amended in sub-clause (f) by deleting the words"Act. regulation under this and substituting therefor thewords"regulation under thisAct.".

Justification:To correct a minor error in drafting.

CLAUSE8

THAT Clause 8oftheBill be amended-

• (a)in sub clause(1) by deleting the words "Kenya Drugs"and substituting therefor the phrase"Kenya HealthProducts and Technologies Regulatory"

Justification:The name of the Board should reflect the amended Title of the Bill and name of the Authority.

(b)in sub clause(2)by—

• (i)deleting paragraph (d),(e).(f),(g),(h),(i),(j),(k),(l)and substituting therefor the following new paragraphs--
• (i)deleting the words"managerial"and substituting therefor the words"senior management" level in paragraph (a)(i);
• (d)oneperson nominated by thePharmaceutical Society ofKenya;
• (f)one person nominated by theKenya Medical Association;
• (g)a person,not being a Governor,with knowledge and experience in health products and technologiesnominated by the Councilof County Governors to represent the interests ofcounties;
• (h)a person,not being a public officer,representing consumer protection nominated by the ConsumerFederation ofKenya;and
• (i)the Director General of the Authority who shall be the secretary and an et officiomember oftheBoard.

Justification:The compositionof the Board should complywith theMwongozo Codeof Governancefor State Corporations in terms ofnumbers,skill mix and professional expertise which should include all relevant players involved in the matters of health products and technologies.

• (c)deleting sub clause(S) and substituting therefor the following new sub clause

(s)The Cabinet Secretary shall appoint the members of the Board under subsection(e),(f),(g)(h)and (i)

Justification:The members of the Board Members arenot State Officers and hence their appointment does not require approval by Parliament.

CLAUSE9

THAT Clause9of theBill be amended by deleting the entire clause.

Justification:Theprovision contradicts thelegalframework for appointment of the Chairperson,Board Members and CEOs of State Corporations or Semi-Autonomous Government Agencies.The Chairperson,Board Members and Director General of theAuthority are not State Officers and hence do not need to subscribe to an oath.

CLAUSE10

THAT Clause 10 of the Bill be amended in paragraph (c)by deleting the words section 12and substituting therefor the words"section 11".

Justification:To correct the wrongful cross reference.Clause makes provision forremoval from office of themembers of theBoard of theAuthority.

CLAUSE12

THAT Clause 12 of the Bill be amended by—

• (a)inserting the word "human"immediately before the words"health products and technologies"in subclause(a);
• (b)inserting the word "human"immediately before the words"health products and technologies"in subclause(c);
• (c)inserting the word"human"immediately before the words"health products and technologies"in subclause(d);
• (d)inserting the word "human"immediately before the words"health products and technologies"in subclause (e);

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and Veterinary Para-Professionals Act,No.29 of 2011.

• (e)inserting the following new subclauses immediately after subclause (e)

(ea)regulate the disposal of human health products and technologies;

(ec)conduct analytical tests of human health products and technologies;

(eb)monitor the market for thepresence ofunregistered andillegal health products and technologies;

Justification:To make provision for the functions of disposal,analytical testing and monitoring of the marketby the Authority.

• (f)deleting subclause(f)and substituting thefollowingnew subclause-

(f)ensure continuousmonitoringof thesafety of human healthproducts and technologiesregulated under thisAct through analysis ofreports on adverse reactions and events,including any other health product

Justification:Toexpressly align to theWHOrequirement on theestablishment ofa nationalvigilance system.

• (g)deleting subclause(g)and substituting therefor the following subclause
• (g)regulate clinical trials and ensure that clinical trial protocols of human health products and technologies are being assessed according to the prescribedethical and professional criteria and defined standards including mandatorybioequivalence studies;

Justification: To anchor the oversight of clinical trials in the law as recommended by the WHO.

• (h)inserting the following new subclauses immediately after subclause (g)

(ga)approve the use of any unregistered medicinal substance for purposes of clinical trials,emergency use and compassionate use;

(gb)carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements;

Justification:To provide for approval of health products and technologies during emergencies and to provide forpharmacovigilance whichcheck thesafety of healthproducts and technologies.

• (i)inserting the word"human"immediately before the words"health products and technologies"ir subclause(l);

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and VeterinaryPara-Professionals Act,No.29 of 201l.

• (i)deleting subclause(n) and substituting therefor thefollowing subclause

(n)appoint inspectors and order inspection ofmanufacturing premises,medical devices establishments, inporting and exporting agents,wholesalers,distributors,pharmacies,including thoseinhealthfacilities and clinics,retail outlets and any other premises and vessels subject to regulation under this Act;

Justification:To specify the premises subject to inspection by the Authority.

• (k)inserting a new subclause after subclause (o)

(oa)Conduct nationalregulatory authority lot release,official authority batch release of specified biologicals to ensure the quality,safety and efficacy of biologicalproducts through aregulatoryrelease systemin compliance with established approaches,policies,guidelines,procedures and inline with World Health Organization and internationally recognized guidelines;

(ob)carryout and promoteresearch related tomedicines and human health products;

Justification:To enable the conduct of research by theAuthority and the conduct of lot releases which are a key component in theregulation of theproduction ofvaccines.

• (l)inserting the following new subclauses after clause(q)

(qa)ensure that all human health products and technologies manufactured in,imported into or exported safety and efficacy;

(qb)enforce the prescribed standards of quality,safety and efficacy of all human health products and technologiesmanufactured,imported into or exported out of the country;

(qc)grantorrevokelicenses and permits forthemanufacture,importation,exportation,distribution and sale of human health products and technologies;

(qd)maintain a register of all authorized human health products and technologies manually o1 electronically;

(qe)regulate licit use of narcotic,psychotropic substances and precursor chemical substances in accordance witheither thesingle Convention onNarcotic drugs of1961,the Convention onPsychotropic substances 1971 and the United Nations Convention against Illicit Traffic of Precursor Chemical Substances1988;

(qf) inspect and license all manufacturing premises,importing and exporting agents,wholesalers, distributors,pharmacies,including those in hospitals and clinics and other retail outlets;

Justification:Toincludecritical functionsoftheAuthoritybased onbestpracticein regulation ofimport andexport ofhuman healthproducts and technologies thatwill enable the country attainWHOmaturity levels.

CLAUSE 1S

THAT Clause 1S of the Bill be amended by deleting subclause (a)and substituting therefor the following new subclauses-

(a)collaborate with such other bodies or organizations within or outside Kenya asit may consider desirable or appropriate for thefurtherance of thepurpose of theAct;

(ab)determine and implement effective and efficient reliance mechanism;

(aa) adopt and implement any such internationally recognized good regulatory practices;

(ac)issue,suspend,withdraw or revoke any license or compliance certificate;

(ae)grantorwithdrawlicenses andpermits tomanufacturers,wholesalers,retailers,importers,exporters and distributors;and

(ad)levy,collectand utilize fees for servicesrendered;

(af) develop guidelines on the manufacture,import and export,distribution, sale and use ofmedical products.

Justification:To comply with WHOrequirements for regulatory functions in the Global Benchmarking Toolespecially oncontrol overimportsandexports.

CLAUSE21

THAT Clause 21 oftheBill be amended——

• (a)by deleting subclause (1) and substituting therefor the following new subclause

There shall be established such scientific advisory committees of theAuthority,appointed by the Board for the effectiveperformance of thefunctions of the Authority.

• (b)by deleting the words "Cabinet Secretary"and substituting therefor the words"Board of the Authority"in subclause (s);
• (c)by deleting the words "Cabinet Secretary"and substituting therefor the words "Board of the Authority"in subclause(4);
• (d) in subclause (9) by—

• (i)deleting the words"Cabinet Secretary"and substituting therefor the words"Board of the Authority"; and
• (i)deleting thewordsand the Cabinet Secretary shall lay a copy ofeach report before Parliament"and substituting therefor the words"and the Board shall submit a copy of each report to the Cabinet Secretary".

Justification:The Committees ought to offer technical advice and report to the Board(its appointing authority)which then advices the Cabinet Secretary accordingly.

PartIV

THAT the title of Part IV of the Bill be amended by deleting the expression"PART IV-MEDICINES" and substituting therefor the expression "PARTIl—HEALTH PRODUCTS AND TECHNOLOGIES".

Justification:Toensure harmony with the title of theBill as proposed for amendment and to correct a minorerrorinnumbering of theparts of theBill.

CLAUSE22

THAT Clause22of theBill be amended

• (a) in subclause(1) by—
• (i)deleting the words"sell any medicine"and substituting therefor the words"sell, manufacture,supply,distribute or dispense any health product and technology"

Justification:To broaden the scope ofprohibited sale of health product and technologies to include manufacturing,dispensing,distribution and supply ofhealth product and technologies.

• (i) deleting paragraph (d) and substituting with the following new paragraph
• (d)falsified.

Justification:For alignment with international best practice.

• (b)in sub-clause(s)by-
• (i)deleting the words "or animal in paragraph (b);
• (ii)deleting the word "medicine"and substituting therefor the words "health product or technology";
• (ii)deleting the word"pharmaceutical product"and substituting therefor the words "health product or technology"paragraph (b);

• (c)in the marginal noteby deleting the word"medicines"and substituting therefor the words"health products and technologies".

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE2S

THAT Clause2SoftheBillbeamended-

• (a)by deleting the word"medicines"and substituting therefor the words "health products or technologies"in subclause(1)(a);
• (b)by deleting the word "medicine"and substituting therefor the words "health product or technology"in subclause(1)(b);and
• (c)by deleting the word "medicine"and substituting therefor the words "health product or technology"in subclause(1)(b).

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE24

THAT Clause24oftheBill beamended-

• (a)by deleting the word"medicine"wherever it appears and substituting therefor the words"health product or technology"in subclause(1)
• (b)by deleting the words"medicine"and"drug"and substituting therefor the wordshealth product or technology"in subclause(2);
• (c)by deleting the word "medicine"and"drug"wherever it appears and substituting therefor the words"health product or technology"in subclause(3);
• (d)in the marginal noteby deleting the word"medicines"and substituting therefor the words"health products and technologies";

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

• (e)by deleting the words"one hundred thousand shillings or to imprisonment for a term not exceeding three months"and substituting therefor the words "one million shillings or to imprisonment for a term not exceeding three years"in subclause(4)(a);
• (f)by deleting the words"two hundred thousand"and substituting therefor thewords"two million" in subclause(4)(b);and

Justification:To make the finesprohibitiveandpunitive due to therisk of the offences topublichealth.

CLAUSE25

THAT Clause 25 of the Bill be amended by deleting the entire clause.

Justification:The prohibition of sale of medicines ofa quality not demanded is a practice issue and falls outside the ambit of theBill.

CLAUSE26

THAT Clause 26of the Bill be amended by deleting the word"medicine"wherever it appears and

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE27

THAT Clause27oftheBill be amended-

• (a)by deleting the words"medicinal products" and substituting therefor the words "health products or technologies"in subclause(a);
• (b)by deleting the words"medicinal products"and substituting therefor the wordshealth products or technologies"in subclause(b);
• (c)by deleting the words "medicinal products" and "products" wherever it appears and substituting therefor the words "health products or technologies"in subclause (c);

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

(d)by inserting the followingnew clausesimmediately after clause27-

27A.Application forproduct license

• (1)A person who intends to import,manufacture or sell a health product or technology shall apply to the Authority for the registration of thehealth product or health technology in the prescribe form.
• (2)An applicant under subsection(1) shall
• health product or health technology who shall be responsible for all communication between the applicant and the Authority in the declaration page of the application form; and
• Kenya, appoint a local representative who shall be a citizen of Kenya,a person who is has permanent residence or a company incorporated in Kenya.
• (s) The application made under sub rule (1) shall be accompanied by-

• (a)a proposed label for use on the health product;
• (c)a copy of the good manufacturing practice certificate firom the Authority and the regulatory authority of the country where the health product is manufactured;
• (d) a copy of a certificate of analysis from a quality control laboratory recognized by the Authority, where applicable;
• (e)a copy of themarketing authorization or certificate ofregistration of the health product or technology from theregulatory authority ofthe country where thehealth product or technologyis sold;
• (f)the available data on the quality, safety,eficacy and performance of the health product or technology submitted in a common technical dossier format;
• (g)a sample of the health product;
• (h)proof ofownership ofthe sitefor themanufacture of thehealthproduct,ifapplicable;
• (i)where the applicant is not a citizen ofKenya or is a company incorporated outside
• (i)where the applicationrelates to a health product or technology which is registeredl with a foreign regulatory body,
• (i)a copy of the certificate of registration;
• (ii)the professional information relating to the health product or technology;and
• (ii)the conditions of theregistration of the health product or technology;

(k)proof that the applicant holds

• (i)a valid practicing licence issued by the body responsible for the profession of pharrmacy:
• (ii)a valid wholesale dealer's licence issued in accordance with this Act;
• (ii)avalid licence to sell poisons issued in accordance with this Act;or
• (iv)a valid manufacturing licence issued in accordance with this Act;and
• Authority.

• (4)An applicant shall notify theAuthority of any variation to the agreement appointing thelocal representative within seven days of the variation.

27B.Processing of application for registration of health product or technology

• (1)TheAuthority shall consider the applicationmadeunder section26A,and,shall,ifitis satisfiedofthe safety,efficacy,quality,performanceand economicvalue ofthehealthproductor technology,register the healthproduct or technology and issue a certificate ofregistration in theprescribed form.
• (2)TheAuthority may,while considering the application,approve the details as supplied by the applicant or approve it with such amendments as it may consider appropriate in respect of the following particulars-
• (a)the name under which the health product or technology may be sold;
• (b) the labelling of the health product;
• (c) the statement of the representations to be made for the promotion of the health product regarding——
• (i)the claim to be made for the health product;
• (i) the route of administering the health product;
• (ii)the dosage of the health product;
• (iv)the storage conditions of the health product;
• (v)the contra-indications,the side effects and precautions,
• (vi)if any of the health product;and
• (vii) the package size of the health product.
• (s)When evaluating an application,theAuthority may-
• (b)consider the evaluation report of an institution that has evaluated the health product.

(4)If the Authority isnot satisfied as to the quality,safety eficacy and performance,or economicvalue of the health product,it may,after providing an opportunity to the applicant to be heard,reject the application and inform the applicant the reasons for rejection in writing.

27C.Registration duringemergency

• (1)The Authority may,where it considers it necessary to protect public health orin the event of a threat tohuman life or health,the Authority,issue a provisional certificate of registration for a health product or technology.

• (2)A person who intends to obtain the provisionalcertificate ofregistration for a health product or technology under sub section (1) shall apply to the Authority, in prescribed form.
• (s)Wherethe applicant isnot a citizen ofKenya oris a company incorporated outsideKenya,the applicant shall appoint a local representative who shall be a citizen of Kenya,a person who is has permanent residence or a company incorporated in Kenya.
• (4)An application under subsection(2)shall be accompanied by-
• (b)where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya,a copy of the agreerment appointing the local representative;
• (a)such documents asmay be necessary to support the application;
• (c)proof that the applicant holds-
• pharmacy;
• (i)a valid wholesale dealer's licence issued in accordance with this Act;
• (ii)a valid licence to sell poisons issued in accordance with this Act;or
• (iv)a valid manufacturing licence issued in accordance with this Act;and
• (v)proof of payment of the application fees as prescribed by the Authority.
• (5)When determining an application under this section,theAuthority shall consider thefacts established from the valid marketing authorization for thehealth product or technology and the report on the products,ifavailable.
• (6)The person to whom the certificate ofregistration is issued under this section,shall be responsible for
• (7)Aprovisional certificate of registration issuedunder subsection(1) shall bevalid for twoyears firom the dateofissue or until the declaration madeunder section S5of thePublicHealth Actisrevoked.
• (8)Any variation to the agreement appointing thelocalrepresentative to the application made under subsection(2)shall be notified to the Authoritywithin seven days of the variation.

27D.Authorizationof unregistered health product or technology

• (1)TheAuthority may,n writing,authorize a person to import or distribute fora specified period to a
• such purposes and in suchmanner and during such period as the Authoritymay in writing determine.

• (S)A person who intends to obtain the authorization under subsection (1),for purposes other than a clinical trial, shall apply to the Authority,in the prescribed form.

(4)Where the applicantis not a citizen of Kenya oris a company incorporated outsideKenya,the applicant shall appoint a local representative who shall be a citizen of Kenya,a person who is has permanent residence or a company incorporated in Kenya.

(5)The application made under subsection(s) shall be accompanied by

• (a)aproduct brochure containing relevant chemical,pharmaceutical,pre-clinical pharmacological and toxicological data and where applicable,human pharmacological and clinical data with thehealth productconcerned;
• (b)witnessed informed written consent document,where applicable;
• (c)details of registration or pending registration of the health product with any other regulatory authority,if available;
• (d)evidence of compliance of the manufacturer of the health product with good manufacturing practice standards as determined by the Authority;
• (e)reasons why a registered health product cannot be used;
• (f)where the applicantis not a citizen of Kenya oris a company incorporated outside Kenya,
• (g)that the applicant holds-
• (i)a valid practicinglicence issued by the body responsible for the profession of pharmacy;
• (i) a valid wholesale dealer's licence issued in accordance with this Act;
• (ii)a valid licence to sell poisons issued in accordance with this Act; or
• (iv)a validmanufacturinglicenceissued in accordancewith thisAct;and
• (v)proof of payment of the application fees as prescribed by the Authority

(6)Where the Authority issues an authorization under subsection (1),the person to whom the authorizationisissued shall submit to theAuthority-

• (a)progress reports after every six months from the date when the authorization was issuedl;
• (b)any adverse event report,whenever an adverse event occurs; and
• (c)a progressreport within thirty days after the completion or termination of the use of the healthproduct.

(7)The Authoritymay,if the Authority is of the opinion that the safety ofany patient is compromised or the scientific reasons for administering the unregistered health product have changed

• (a)impose any additional conditions;
• (b)request additional information;
• (c)inspect the site where the unregistered health product is manufactured,stored or administered;or
• (d)withdraw the authorization to treat thepatient.

(8)The Authority may,by notice in writing withdraw the authorization issued under subsection(1)if the any of purposes or the manner specified in subsection(2)is contravened.

(9)A health product authorized under this rule shall be labelled in accordance with this Act.

(10)An applicant shallnotify the Authority ofany variation to the agreement appointing the local representative within seven days of thevariation.

(11)The requirements in this section shall apply to applications for donations of health products and technologies.

Justification:Toprovide for thehandling ofapplications of product licences by theAuthority.

CLAUSE28

THAT Clause28oftheBill beamended

• (a)by deleting the words"medicinesregister"and substituting therefor the wordshealth products and technologies registerin subclause(1);
• (b)by deleting thewords"medicines register"and substituting therefor the words"health products and technologies registerin subclause(2)
• words"health products and technologies register".

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE29

THAT Clause29 of theBill be amended-

• (a)by deleting the words"medicines or medical device"and"medicines"wherever it appears and substituting therefor the words"health product or technologyin subclause(1);
• (2);
• (c)by deleting the word"medicine"wherever it appears and substituting therefor the words"health product or technology"in subclause(3);

• (d)by deleting the word "medicine"wherever it appears and substituting therefor the words"health product or technology"in subclause(4);
• (i)deleting the word "medicine"wherever it appears and substituting therefor the words"health product or technology";
• (e)in subclause(6)by-
• (ii) deleting the word "any".
• (g)by deleting-the word "medicine"wherever it appears and substituting therefor thewords"health product or technology"in subclause(8);
• (f)by deleting the word "medicine"and substituting therefor the words health product or technology"in subclause(7);
• (h)by deleting the word"medicines"and substituting therefor the words"health products and technologies"in subclause(9);
• (i)by deleting the word "medicine"and substituting therefor the words "health product or technology"in subclause(11);
• (i)by deleting the word "medicine"and substituting therefor the words"health product or technology"in subclause(10);
• (k)by deleting the word "medicine"and substituting therefor the words "health product or technology"in subclause(12);
• (i)deleting paragraph (a) and substituting therefor the following new paragraph—
• (l)in subclause(14)by-

(a)'Kenya Essential Medicines List,Kenya Essential Diagnostics list and Kenya Essential Medical Supplieslist'means thelist ofessential medicines,diagnostics and medical supplies included in thelatest editions of the official publicationsrelatingtoguidelinesfor standard treatmentwhichis compiled by the state department responsible forHealth;

• (ii) deleting paragraph (b) of sub-clause(14).
• (m)in the marginal note by deleting the words "medicines and medical devices" and substituting therefor the words"health products and technologies";

Justification:To excludeveterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons andVeterinary Para-Professionals Act,No.29of2011 and to harmonize the terms used in theBill with the Title of the Bill asproposed for amendment.

• (n)inserting the following new clauses immediately after clause 29-

29A.Authorization ofhealth products and technologies

• (a)the imported health product or technology has been authorized through issuance ofan import permit or any written authorization by the Authority; and
• (b)theimported health products and technologies are inspected and verified by the inspectors of the Authority at the ports of entry before release.
• (2)No batch or lot of any registered product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such

product and official batch or lot release by the Authority in cases of biological therapeutics.

• (s)Each applicable test conducted by the manufacturer under subsection (2)shall be made oneachbatch orlotafter completion ofallprocesses ofmanufacturewhich may affectcompliancewith thestandard applicableto theproduct.
• (4)Themanufacturer or marketing authorization holder ofany registered biological therapeutic shall submit lot summaryprotocol for eachlot thatcontainsregistered tests and results of tests performed and,may be required to submit samples of product from the specified lot to the Authority for official batch orlotrelease in accordance with the prescribed regulations.
• (5)Every batch or lot of a registered biological therapeuticimported intoKenya or manufactured inKenya shall be evaluated and,onbeingsatisfied ofconformity with prescribed standards and payment of prescribed fees,the Registrar shall approve its release into themarket and issue a certificate of official batch or lotrelease in theprescribed format.
• (6)The Authority may recognize and accept official lot release certificates issued by other nationalregulatory authorities ofother countriesfor a specificbatch or lots ofbiologicaltherapeutic manufacturedwithin the territories of those national regulatory authorities to issue a certificate under this section.
• (7)Aperson who contravenes this section commits an offence and shall on conviction beliable
• (a)in the case ofa first offence,to a fine not exceeding one million shillings or toimprisonment for a termnot exceeding twoyears,or to both;or
• (b)in the case of a subsequent offence, to a fine not exceeding two million shillings or to imprisonment for a term not exceeding five years, or to both.

29B.Parallel importation of healthproducts and technologies

• (1)A person shall not parallelimport a health product or technology into Kenya unless
• (a)the person is incorporated as a limited liability company under the Companies Act;
• (b) the person has been granted a certificate of parallel importation;
• (c)the person is licensed to parallel import the health product or technology;
• (d)the health product or technology has a valid registration in Kenya under this Act;and
• (e)the health product or technology has a valid market authorization in the country of origin.
• (2)A person who wishes to undertake parallel importation shall apply, to the Board, for a certificate of parallel importation in the prescribed manner.
• (3)The Board shall establish and maintain a system that ensures that a registered parallel imported health product or technology can be traced through the sourcing,

manufacturing,packaging,storage, transport and delivery to the health facility, institution or private practice where the health product or technology is used

• (4)Aperson who-
• (a)is the holder of certificate of parallel importation or licensee and fails to comply with any requirement or obligation in this Act;
• (b)contravenes any prohibition prescribed by the Authority; or
• pursuant to this Act

commits an offence and is liable,upon conviction,to a fine not exceeding one million shillings or to imprisonment for a term not exceeding two years,or to both.

Justification:Toprovide for authorization ofhealthproducts and technologiesimportedinto thecountry including therequirementfor batch or lot release in line with WHOrequirements,and to make provision for parallel importation ofhealth products and technologies.

CLAUSE30

THAT Clause SO of theBill be amended

• (a)by deleting the word "medicine"and substituting therefor the wordshealth product or technology"in subclause(1);
• (b)by deleting the word"medicine"wherever it appears and substituting therefor the words"health product or technologyin subclause(s)b)

Justification: To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSES1

THAT Clause Sl of theBill be amended-

• (a)by deleting the word"medicine"and substituting therefor the words"health product or technology"in subclause(1);
• (b)by deleting the word "medicine"and substituting therefor the words health product o1 technology"in subclause (s)(c).

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE32

THAT Clause S2 of theBill be amended

• (a)by deleting the word"medicine ormedical device"wherever it appears and substituting therefor the words"health product or technologyin subclause(1);
• (b)by deleting the word"medicine ormedical device"whereverit appears and substituting therefor the words"health product or technologyin subclause(2);
• (c)by deleting the word"medicine or medical device"wherever it appears and substituting therefor the wordshealth product or technologyin subclause(4);
• (d)by deleting theword"medicine or medical device"wherever it appears and substituting therefor the words"health product or technologyin subclause(5);

Justification:To harmonize the terms used in the Bill with the Title ofthe Bill as proposed for amendment.

CLAUSESS

THAT Clause Ss of the Bill be amended by deleting the word "medicine or medical device"and substituting therefor the words"healthproduct or technology"in subclause(1);

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE34

THAT Clause S4of the Bill be amended by-

• (a)deleting the words"medicines"and "medicine"wherever it appears and substituting therefor the words"health product or technology";
• (c)in the marginal note by deleting the words"medicines"and substituting therefor the words"health products and technologies".

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and Veterinary Para-Professionals Act,No.29of2011 and to harmonize the terms used in theBillwith theTitle of theBill asproposed for amendment.

CLAUSE35

THAT Clause S5of the Bill be amended

• (a)in subclause(1)by-
• (i)inserting the word"or an enrolled pharmaceutical technologist"immediately after the word "pharmacist";
• (i)deleting the word"medicine"wherever it appears and substituting therefor the words"health product or technology";
• (b)in subclause(2)by-

• (i)inserting the word "or an enrolled pharmaceutical technologist"immediately after the word "pharmacist";
• (i) deleting the word "medicine"and substituting therefor the words "health product or technology";

(c)in subclause(s)by-

• (i)inserting the word "or an enrolled pharmaceutical technologist" immediately after the word "pharmacist";
• (i)deleting the word "medicine"and substituting therefor the words"health product or technology";

(d) in subclause (4) by-

• (i)inserting the word "or an enrolled pharmaceutical technologist"immediately after the word "pharmacist";
• (i)deleting the word "medicine"wherever it appears and substituting therefor the words"health product or technology";

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment andforinclusionof pharmaceutical technologistsin the dispensing ofinterchangeablemultisource medicine.

CLAUSE36

THAT ClauseS6of theBill be amended by

(a)deleting clause S6;

Justification:The provision is a practice related issues that is best handled through the proposed Pharmaceutical Practice Bill.

(b)inserting the following new clause immediately after clause S6

36A.Clinicaltrials

(1)A health product or technology shall not be used for clinical trial unless an approval is granted by the Authority with the approval of therelevant ethics body.

protocolin the prescribed format and the prescribed fee.

(3)The study protocol submitted under subsection(2) shall include apost-trial access program to ensure access of investigational medicinal substances by participants in a trial before grant ofmarketing authorization by theAuthority.

• (4)The Authority shall prescribe guidelines for evaluation of applications made under subsection(2) to beimplemented for accelerated evaluations during emergency situations,epidemics and outbreaks.
• (5)A person granted an approval under this section shall put up arobust quality assurance system to ensure that theclinical trial is carried out in a manner that ensures the integrity of data generated,the safety and well-being of study participants.
• (6)TheAuthority shall carry out inspection of the clinical trials and monitor compliance of the clinical trials with the prescribed requirements.
• (7)Amendments to clinical trials protocols shall be submitted to the Authority for approval before implementation.

Justification:Toprovide for effective regulation of clinical trialsby the Authority.

PartV

THAT the title of Part V of the Bill be amended by deleting the expression"PART Vand substituting therefor theexpression"PARTIV".

Justification:To correct a minor error in numbering of the parts of the Bill.

CLAUSES7

THAT Clause S7oftheBill be amended

• (a)by deleting the words"and dealers in mining, agricultural or horticultural accessories"in subclause(2)(a);

Justification: Scheduled substances used in mining, agriculture and horticulture are regulated under other laws.

• (b)by deleting subclause(4)and substituting therefor the following new subclause

(4)The Authority shall at least once every two years,review thelists under subsection (s),or whenever necessary in the interest of public health and safety.

Justification:To enhance theperiod ofreviewof thelists of scheduled substances from one year to two years and provide for review in public interest where need arises.

CLAUSE38

THAT Clause S8of theBill be amended in subclause(1) by-

• (a)deleting paragraph(c);and

Justification: Scheduled substances used in mining,agriculture and horticulture are regulated under otherlaws.

(b)deleting the words"or veterinary surgeon"in paragraph (e)

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29of2011.

CLAUSES9

THAT Clause S9 of theBill be amended—

• (a)inserting the words"or an enrolled pharmaceutical technologist"immediately after the word pharmacistin clause(4).

Justification:For inclusion of pharmaceutical technologists in wholesale dealership in medicines and health technologies.

• (b)deleting subclause(5) and substituting therefor the following new subclause

(5)A licence issued under this section shall be valid for a period of oneyear,renewable annually

Justification:Annual expiry of thelicence is too punitive especially for personswho apply in the middle of the year.

CLAUSE40

THAT Clause4O of the Bill be amended by deleting the entire clause.

Justification: Scheduled substances used in mining,agriculture and horticulture are regulated under otherlaws.

CLAUSE41

THAT Clause41of theBill be amended-

• (a)in subclause (1)by-—
• (i)inserting the words"or an enrolled pharmaceutical technologist"immediately after the word"pharmacist"in paragraph (b):

Justification:To givepharmaceutical technologists power to sell scheduled substances.

• (i) deleting paragraph (c);

Justification: Scheduled substances used in mining,agriculture and horticulture are regulated under otherlaws.

(iideleting paragraph (e);

Justification:TheNational or County government cannot buy scheduled substances on its own,it must do so through a person licensed to do so under the Bill.

(d)a qualified medicalpractitioner or dentistfor purposes ofmedical or dental treatrment respectively;

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of 2011.

(v)deletingparagraph(f) and substituting therefor the following new paragraph

(f)a licensed hospital,dispensary or similarinstitution ora person orinstitution concerned with scientific education or research where such hospital,dispensary,institution but it shall be an offence to sell Scheduled Substances to any of these unless a registered pharmacist or an enrolled pharmaceutical technologist is in direct control of the Scheduled Substances at theprermises from which they are sold;

Justification:To give pharmaceutical technologists power to sell scheduled substances and to ensure that hospital facilities are licensed and employ pharmaceutical cadres.

(b)in subclause(2)by-

• (i)deletingparagraph (b);
• (i) deleting paragraph (c);

Justification:The persons to whom a wholesaler dealer may sell scheduled substances to are set out in subclause (1).

(c)by deleting the subclause(s)

Justification:Scheduled substances used in mining,agriculture and horticulture are regulated under otherlaws.

CLAUSE42

THAT Clause 42 of the Bill be amended by deleting the words "three years"and substituting therefor the words"one year"in subclause(s)

Justification:Toreduce thepenalty ofimprisonment from threeyears to one year as the same isnot commensurate to the fine ofone hundred thousand shillingsinrelation to the offence ofnot making entries of sale of scheduled substancesin a scheduled substancesbook

CLAUSE4S

THAT Clause 4SoftheBill be amended-

• (1)A qualified healthcare professional may supply or dispense a Scheduled Substance with therapeutic value for the purpose of medical or dental treatment,as the case may be,subject to the following provisions-

Justification:Torestrict dispensing of scheduled substances to authorized persons and to exclude veterinary medicineswhich areregulated separate from human medicines under theVeterinary Surgeons and VeterinaryPara-ProfessionalsAct,No.29of2011.

• (b)by inserting the word"and immediately after the word"supplied"in subparagraph (ii)of clause 43(1)b)and deleting the word"and"immediately after the word"given"in subparagraph(i) of clause 48(1)(b);

Justification:To correct a minor drafting error.

• (c)by deleting paragraph(c)in subclause(1)

Justification:Registered midwives are included in the qualified healthcare professional provided in the amended subclause(1).

CLAUSE45

THAT Clause 45of theBill be amended by deleting the clause and substituting the following new clause-

45.Automaticmachines

• (1)An authorized seller may use an automatic machine to dispense over-the-counter Scheduled Substances.
• (2)The Authority shall developregulations on-
• (a)classes of substances permitted;
• (b)quantities of substances to be dispensed;
• (c)records of substances dispensed;
• (d)location of automatic machines;and
• (e)registration of automatic machines.

Justification:To provide for the use of automatic machines in dispensing selected scheduled substances in an effort to leverage on technology.

CLAUSE46

THAT Clause 46 of the Bill be amended by

• (a)deleting and substituting thefollowingnewclause-

46.Electronic sale of health products and technologies

scheduled substances including throughe-pharmacy,telemedicine,medication therapymanagement and online pharmacy.

(2)The regulations made under section (1) shall provide for

• (f) licensure of e-pharmacies;
• (g) safety of the patient;
• (h)verification of theidentity and traceability of the patient;
• (i)verification of theidentity and traceability of the prescriber; and
• (i)integrity,legitimacy and authenticity of the prescription including avoidance of multiple use of the same prescription.
• ($)The electronic supply and dispensing of scheduled substances shall be permitted provided that the supply ofthe healthproducts and technologies conforms with allrequirements for the particular health product or technology in terms ofits scheduling status and any other requirements as may be
• (4)In the case of a prescription-only medicine, the required prescription shall have been obtained as a result of at least one physical interaction between an authorised practitioner and the patient within six months.
• (5)Any person who contravenes this section shall be guilty of an offence,and shall on conviction,be liable to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding one year,or to both.

Justification:For properregulation of electronic sale of medicine which is already a global phenomenon as many online platforms are selling medicines to consumers and to enhance the fines in relation to the sale of scheduled substancesusingelectronic means to ensure that quality is guaranteed.

• (b)inserting the following new clause immediately after clause 46——

46A.Dietarysupplements

(1)A dietary supplement shall not-

• (a)contain scheduled substances;and
• (b)have a stated or implied therapeutic purpose.
• (2)Where a dietary supplement containsfolicacid,themaximum daily dose for the dietary supplement shall beasper theprescribedguidelinesby the Board of the Authority.

Justification:Toprovide for dietary supplementswhich will enhance theregulation offood supplements by theAuthority.

PartVI

THAT the title of Part VI of the Bill be amended by deleting the expression "PART VI MANUFACTURE OFMEDICINALSUBSTANCESand substitutingtherefor theexpression"PART IV-MANUFACTUREOFHEALTHPRODUCTS"

Justification:To correct a minor error in numbering of the parts of the Bill.

CLAUSE47

THAT Clause 47of the Bill be amended

• (a)in subclause (1)by—
• (i)deleting the word"medicinal substance"and substituting therefor the word "health product;
• (i) deleting the word "any"and substituting therefor the word "a";

Justification:To excludeveterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and Veterinary Para-ProfessionalsAct,No.29of2011 and toharmonize the terms used in theBill with the Title of the Bill asproposed for amendment.

• (b)deleting subclause(2)and substituting therefor the following new subclause

(2)A manufacturing licence issued under this section shall be valid for a period of one year,renewable Aenuue

Justification:Togive themanufacturinglicencevalidity for oneyear.

• (c)in subclause(s)by-
• (i)deleting the word"medicinal substance"and substituting therefor the word"health product;
• (i) deleting the word~any"and substituting therefor the word"a";
• (d)in subclause(1) by deleting the word"medicinal substance"and substituting therefor the word "healthproduct;

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and Veterinary Para-ProfessionalsAct,No.29of 2011 and to harmonize the terms used in the Billwith the Title ofthe Bill asproposed for amendment.

• (e)inserting the following new subclauses-
• (6)The Authority shall prescribe regulations setting out conditions for the qualifications of personnel involved in the production processes of a health product regulated under this Act.

• (7)Personnel qualified to conduct lotrelease ofvaccines and batchrelease ofhealth products shall submit their qualifications to the Authority.
• (8)Any person who commits an offence under this section is upon conviction,liable to a fine not exceeding ten million shillings,or toimprisonmentfora term not exceeding tenyears,or toboth

challenges.

CLAUSE48

THAT Clause48oftheBillbe amended-

• (a) by renumbering the clause as subclause (1) and inserting the following new subclauses—
• (2)The Authority shall have power to enter and inspect manufacturing premises to confirm compliance with prescribed good manufacturing practices and issue a certificate of compliance in the prescribed format upon payment of prescribed fes.
• (s)The Cabinet Secretary shall make regulations for the better carrying out of the provisions of this section.
• (4)Without prejudice to thegenerality of subsection(s),theAuthority may make regulations on
• (b)withdrawal of revocation ofmanufacturing licences upon request;and
• (a)revocation and suspension of manufacturing licences;
• (c)Transfer ofmanufacturing licences.

Justification:To give the Authority power enforce compliance with good manufacturing practices as recommended byWHOwhichwill in turn encourage continuousimprovementofinternalqualitycontrol

PartVII

THAT the title of Part VIIof the Bill be amended by deleting the expression "PART VII" and substituting therefor the expression"PART VI".

Justification:To correct a minor error in numberingof the parts of theBill.

CLAUSE51

THAT Clause51 of theBill be amended by inserting the followingnew clauses

51A.Information that isrequired to be displayed on the pack

(1)Aperson dealingin a therapeutic cosmetic shall indicate

• (a)thecommon name of therapeutic cosmetic;
• (b)thenetweight;

• (c)all the cosmetic ingredients in the order of prominence but notincluding flavors or fragrances;
• (d)the name and address of manufacturer;
• (e)a warning statement;and
• (f)a statement that the therapeutic cosmetic is capable of curing or treating any disease or medical condition.

51B.Manufacturing ofcosmetics

• (1)The Cabinet Secretary shall make regulations for the effectiveimplementation of this section.
• (2)The regulations made under subsection(1),may-
• (a)requiremanufacturers of cosmetics to register with the Authority;and
• (b)impose restrictions,requirements or other conditions on manufacturers of cosmetics,if such restrictions,requirerments or conditions are necessary toprotect public health.

Justification:To enhance transparency on theingredients used in therapeutic cosmetics in line with the Good ManufacturingPractices.

CLAUSE52

THAT Clause 52of the Bill be amended by deleting the words"have a therapeutic effect or value"and substituting therefor the wordsto treat,diagnose or prevent disease,or affect the structure orfunctions of the body"

Justification:Using the term"therapeutic cosmetic"already indicates that the cosmetichas therapeutic effecthence thereisno need to restate the same.

CLAUSE54

THAT Clause 54 of the Bill be amended by deleting subclause(S)and substituting therefor the following new subclause-

• (s)Any person who manufactures, sells, supplies,imports or exports a therapeutic cosmetic which contains a prohibited ingredient commits an offence and,upon conviction, shall be liable to a fine of not exceeding one million shillings,or to imprisonment for a term of not exceeding two years,or both".
• (4)The Authority shallmake regulations exempting from any labelling requirement of this Part, therapeutic cosmetics which are,in accordance with thepractice ofthe trade,tobeprocessed,labelled, or repacked in substantial quantities at establishments other than those where originallyprocessed or

packed,on condition that such cosmetics are not adulterated or misbranded under theprovisions of this Part upon removal from such processing,labelling orrepacking establishment.

Justification:To provide for a penalty for the offence ofmanufacturingor selling therapeutic cosmetics that contain prohibited ingredients and to allow for the making of regulations on use of prohibited ingredients in relation to therapeutic cosmetics.

PartVIII

THAT the title of Part VIII of the Bill be amended by deleting the expression "PART VIII"and substituting therefor the expression"PARTVII".

Justification:To correct a minor error in numbering of the parts of the Bill.

CLAUSE55

THAT Clause 55of theBill be amended by

• (a)in subclause(1)—
• the words"human medical devices register";

Justification:To makeprovision for in-vitro diagnostics

• (i) deleting the words "and a veterinary medical devices register" and deleting the word "all";

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and VeterinaryPara-ProfessionalsAct,No.29 of2011.

CLAUSE56

THAT Clause 56of theBill be amended by—

• (1).

Justification:Toincorporateinternationally accepted terminology.

(b) deleting the word "any"and substituting therefor the word "a"in subclause(1) and (2) Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of2011.

CLAUSE58

THAT Clause58of the Bill be amended by

• (a)inserting the wordsin accordance with the most recent World Health Organization's prescribed guidelines on good manufacturing practice"immediately after the word "Authorityin subclause(2);

Justification:This will enable the country to comply with WHO standards on manufacturing.

• (b)inserting the following new subclause

Nuclear Regulatory Act,documented evidence ofradiation required to enable the medical device to perform its therapeutic and diagnostic functions and the intended purpose of the device,forissuance ofa registration certificate for a medical device.

Justification:Toallow the Authority to consult andreceive advice from the Kenya Nuclear Regulatory Authority that exercises regulatory control over nuclear and radioactive materials and facilities under section 6(c)Xi)of the Nuclear Regulatory Act,No.29 of 2019.

• (c)inserting the following new subclause immediately after subclause(s)

(S)An importer,distributor or dealer shall establish and implement documented procedures for the maintenance ofimportation or distribution records and shallmaintain animportation or distribution record ofeach medlical device to be submitted to theAuthority.

Justification:Torequire importers,distributors or dealers to keeping of records of medical devices submitted to theAuthority.

CLAUSE59

THAT Clause 59 of the Bill be amended by-

• (d)inserting the wordsunregistered establishments for medical devices and" immediately after the word "under"in subclause (1);

Justification:To provide for the registration of establishments for medical devices by the Authority.

• (e)deleting the word"any"and substituting therefor the word"a"in in subclause(1);

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-ProfessionalsAct,No.29of2011.

• (f)inserting the following new clause immediately after clause 59

59A.Registration ofMedical devices establishment

• (1)Applications for registration ofa medical devices establishment shall be submitted to the Authorityin the prescribed format and shall be accompanied by theprescribed fees.

• (2)An importer,distributor or dealer will establisha system ofnotification of field safety corrective action and shall notify the Authority of such system.
• (3)If the Authority is satisfied that the application under subsection (1)meets the prescribed requirements, the Registrar shall issue a registration certificate for the medical devices establishmentin theprescribed format.
• (4)A medical devices establishment registration certificate under this section shall be valid for a period of one year,renewable annually upon application in accordance with the prescribed conditions.
• (5)Theregistration certificate for manufacturers shall bevalid for five years following a successful reinspection.
• (6)The Authoritymay refuse to issue a medical devices establishmentregistration certificatewhere-
• (a)an applicant has made a false ormisleading statement in the application;or
• (b)the Authority has reasonable grounds to believe that issuing the medical devices establishment registration certificate will constitute a risk to the health or safety of patients,users or other persons;or
• (c)an applicant has failed to meet the prescribed conditions for medical devices establishment registration.
• (7)Where theAuthority does notissue a medical devices establishment registration certificateunder subsection(7),the Authority shall
• (a)notify the applicant in writing of the reasons for refusing the registration of the establishment; and
• (b)give the applicant an opportunity to respond to the Authority and provide relevant documentation or evidence in support of the application.
• (8)After the issuance of a medical devices establishmentregistration certificate,if there is a change to any of the information submitted at the time of application,the holder of the registration certificate shall submit the new information to the Authority within ten working days of the change.

Justification: To make provision for the registration of establishments for medical devices.

• (g)inserting the following newPartimmediately after the new subclause(s)

PARTVIII-THENATIONALPHARMACOVIGILANCESYSTEM

60.Pharmacovigilance

• The Authority shall through the National Pharmacovigilance Centre manage the national pharmacovigilance and post marketing surveillance system to receive and maintain allrelevant information about suspected adverse drug reactions and adverse events to health products or technologieswhich have been authorized by the Authority.

TheAuthority shall conduct both passive and active surveillance of health products and technologies.

The Authority shall carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements.

All entities responsible for placing a health product or technology in themarket shall establish and maintain a pharmacovigilance system for managing safety information of health products and technologies

• The entities in subsection (4) shall submit safety information to the Authority in the prescribed manner.
• The consumers,general public and healthcare professionals shall report adversereactions and events to the Authority in the prescribed manner.

Justification: To anchor therole of the Authorityin the regulation of pharmacovigilance in the country.

PartXI

THAT the title ofPart XI of the Bill be amended by deleting the expression"PART XIand substituting therefor the expression"PARTIX"

Justification:To correct a minor error in numbering of theparts of the Bill.

CLAUSE60

THAT Clause 60of theBill beamendedby

• (a)deleting and substituting clause 60with the following new clause

(1)There is to be established theNational Quality Control Laboratory of the Authoritywhich shall be used as a facility for-

• (h)the examination and testing of health products and technologies including vaccines and biopharmaceuticals and anymaterial or substance from or with which and the manner in which drugsmay be manufactured,processed or treated and ensuring the quality control of drugs and medicinal substances;
• (i)performing chemical,biological,bio-chemical,physiological and pharmacological analysis and other pharmaceutical evaluation;
• ()) testing,on behalf of the Government, of locally manufactured and imported health products and technologies in the Kenyan market prior to marketing authorization, redistribution and post-distribution;
• (k)field testing ofregulated products using screening techniques;

• (l)providing technical support tolocal manufacturers and building their capacity in matters pertaining to quality control of regulated products through on site and off site training and laboratory assessments;
• (m)conducting investigations into the quality and safety status of regulated products developing and administering a databank on quality assuranceof all health products and technologies andgenerating scientific evidence andreports on thequality and safety status of theregisteredproducts;
• (n)conducting research and training and providing high quality analytics and expert knowledgein the areas ofmedicinal products and active pharmaceutical ingredients;and
• products and technologiesfor the Authority.
• shall be responsible to the Authority for the day to daymanagement of theNationalQuality Control Laboratory.
• (4)TheDirectorNational Quality Control Laboratory shall hold office on such terms and conditions of service asmay be specified in theinstrument of appointment by theBoard of theAuthority.
• (6)TheDirectorNational Quality Control Laboratory shall
• (5)The Director National Quality Control Laboratory shall be a registered pharmacist and shall possess a Master'sdegreein a science related field from a recognized university.
• (h)oversee and coordinate all operations and administration of theNational Quality Control Laboratory and provide technical guidance on quality control;
• (i)ensure timely quality control testing ofall samples in conformity with national and international standards;
• (i)co-ordinate and supervise the activities of the National Quality Control Laboratory including staff;
• (k)collaborate with other laboratories,regulatory and law enforcement agencies manufacturers ofpharmaceutical and other health products to ensure quality in health products and technologies;
• (l)handle appeals on test results;
• (m)where thelaboratory lacks capacity,subcontractlaboratory testing services;
• (n)advice the Authority on matters of testing and quality control over health products and technologies;and
• (o)perform any other duties assigned by the Authority from time to time.

Justification:The NQCL,headed by a Director appointed by the Authority,to become a regulatory laboratory of the Authority as recommended by theWHO so that the country can achieve MaturityLevel S.

CLAUSE61

THAT Clause 61 of the Bill be amended by deleting the expression"Director-Generaland substituting by the"in subclause(1).

Justification:For compliance with WHOguidelines whichrequires that a certificate of analysis should be issued by a person capable of ensuring the authenticity of the test samples.

Part XII

THAT the title of Part XIIof the Bill be amended by deleting the expression "PART XII" and substituting therefor theexpression"PARTX".

Justification:To correct a minor error in numbering of the parts of the Bill

CLAUSE62

THAT Clause 62of the Bill be amended by inserting the word "human immediately before the words "health product"in subclause(1)and (2)

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of 2011.

CLAUSE6S

THAT Clause 6sof theBill be amended-

• (a)in subclause (1) by deleting the words"a medicine,drug,appliance or article"wherever it appears and substituting therefor the words"health product or technology";

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

(b)in subclause(2)

• (i)by deleting the words", dentists and veterinary surgeons" and substituting therefor the words"and dentists"in paragraph(c);
• (ii)by inserting the word"or enrolled pharmaceutical technologists"immediately after the word "pharmacists" in paragraph (d);

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of 2011 and to include relation to offences as regards prohibition of advertiserments on diseases listed in the Sixth Schedule.

CLAUSE64

THAT Clause 64of the Bill be amended by deleting the words"a medicine,drug,appliance or article wherever it appears and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE65

THAT Clause 65of theBill beamended

• (a)in subclause(a)by-
• (i) deleting the word "extravagant,".
• (i)deleting the word "article"and substituting therefor the words"health product or technology".
• (b)in subclause (b)by deleting the word "article"and substituting therefor the words "health product or technology".

Justification:To ensure objectivity and to harmonize the terms used in the Bill with the Title of theBill asproposed for amendment and

CLAUSE66

THAT Clause 66oftheBill beamended-

• (a)in subclause (1)(a)and (b)by deleting the words"drug,appliance or article"wherever it appears and substituting therefor the words"health product or technology";

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

• (b) in subclause (s)by
• (i)renumbering clause(S)as clause(2)

Justification:To correct a typographical error.

• (i)by deleting the words",dentists and veterinary surgeons" and substituting therefor the words"and dentists" in paragraph (b)i);
• (ii)by inserting the words",enrolled pharmaceutical technologists"immediately after the word"pharmacists"in paragraph (b)(ii);
• (iv)by deleting the words"veterinary surgeons"and substituting therefor the words

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons and Veterinary Para-Professionals Act,No.29of2o11 and to include enrolledpharmaceutical technologists aspart of persons who are covered under the provided defence in relation to offences as regards prohibition of advertisements on abortion and false or misleading advertisements.

CLAUSE67

THAT Clause 67oftheBill be amended

• (a)in subclause(1),(2)and (s)by deleting the word"article"wherever it appears and substituting therefor the words"healthproductor technology";
• (b)in the marginal note by deleting the word "articles"and substituting therefor the words "health products and technologies";

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act, No. 29 of 2011.

• (d)by deleting the words"two hundred thousand"and substituting therefor the words"one million";
• (e)deleting the words"three hundred thousand"and substituting therefor the words "two million".

Justification:To make the fines payable commensurate to the offences relating to labelingof health products and technologiescontainingmedicine.

CLAUSE68

THAT Clause 68of theBill be amended by deleting the clause.

Justification:It is preferable to make provision for valid exemptions through regulations as opposed to providing defences to the offencesrelating tolabelingof medicines.

CLAUSE69

therefor the words"health product or technology"and "health products and technologies"respectively.

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment

Part XIII

THAT the title of Part XIII of the Bill be amended by deleting the expression"PART XIII" and substituting therefor the expression"PART XI".

Justification:To correct a minor error in numbering of theparts of theBill.

CLAUSE71

THAT Clause71oftheBill beamended by-

• (b)deleting the words"medicines or medical devices"and substituting therefor the words"health products and technologies"in the marginal note.
• (a)deleting the words"or homoeopathic medicine,preparation or medical device"and substituting therefor the words"health products and technologies"in subclause(1);and

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE72

THAT Clause72of theBill be amendedby-

• (a)inserting the words"including a health product and technology for emergency useimmediately after the word "technology"in subclause(1);

Justification:To make provision for supply of health products and technologies during emergency situations.

• (b)deleting the words"medicine or medical device product"and substituting therefor the words "health product or technology"in subclause(S);and
• (c)deleting the words"medicine or medical devices"and substituting therefor the words"health products and technologiesin the marginal note.

Justification:To harmonize the terms used in the Bill with the Title of the Bill asproposed for amendment.

CLAUSE7S

THAT Clause 7sof theBill be amended by

• (a)deleting the words"drug,article"wherever it appears and substituting therefor the words"health product or technologyin subclause(1);
• (c)deleting the words"drug or article"and substituting therefor the wordshealth product or technology"in subclause (s);
• (b)deleting the words"drug or article"wherever it appears and substituting therefor the words "health product or technologyin subclause(2);
• (d)deleting the words"drug or article"and substituting therefor the words"health product or technology"in subclause(4);and

• (e)deleting the word"goods"and substituting therefor thewords"health products and technologies in the marginal note.

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

CLAUSE75

THAT Clause 75 of the Bill be amended by deleting the wordsor veterinary surgeon" in subclause (2)

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons andVeterinary Para-Professionals Act,No.29 of2011.

CLAUSE78

THAT Clause 78 of the Bill be armended by inserting the wordsor enrolled pharmaceutical technologist in subclause(1)(b)

Justification:To providefor the application of penal sanctions onenrolledpharmaceutical technologists as regards body corporates.

CLAUSE79

THATClause79of theBill beamended by-

• (a)deleting clause 79:

Justification:The function of inspection of animals intended for slaughter is outside the regulatory purview oftheAuthority.

• (b) inserting the following new clause-

79.Inspection and verification of Health Products and Technologies at thePorts of Entry

(1)A person who imports a health product or technology shall notify the inspectors of the Authority at the Ports of Entry to conduct pre-clearance inspection and verification.

(2)Any person who imports a health product or technology and causes it to be released to the market without authorization under subsection (1) shall be guilty of an offence.

(S)Anyperson who commits an offence under this section is upon conviction,liable to a fine not exceeding one million shillings,or to imprisonment for a term not exceeding two years,or to both.

Justification:To enable the Authority to enforce compliance with the prescribed standards of quality safety and efficacy ofhealth products and technologiesbefore release at theports ofentry so as toprevent

CLAUSE80

THAT Clause8Oof theBill be amended by-

• (a)deleting the words"article"and"articles"whereverit appears and substituting therefor the words "health product or technology"andhealth products and technologies"respectively in subclause (1)pue(11)(o1)"(6)(s)()(9)(t)

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

• (b) inserting the words "or any other vessel immediately after the word "vehicle" in paragraph (b) of subclause(1).

Justification:To expand the scope to include all other means of conveying health products and technologies.

CLAUSE81

THAT Clause S1 of theBillbe amended by deleting the entire clause.

Justification:The clause infringes on the exercise of the functions of the Authority contrary to the recommendation of theWorld Health Organization.

CLAUSE82

THAT Clause82of theBill be amended by deleting the entire clause.

Justification:Regulation is a function of National Government under the Fourth Schedule to the Constitution.

CLAUSE8S

THAT Clausessof theBill beamended by deleting theentire clause.

Justification:The clause infringes on the exercise of the functions of the Authority contrary to the recommendation of theWorld Health Organization.

CLAUSE85

THAT Clause 85ofthe Billbe amended by deleting the word"article"and substituting therefor the words "health product or technology"in subclause(1) and (2).

Justification:To harmonize the terms used in the Bill with the Title of the Billas proposed for amendment

CLAUSE86

THAT Clause 86of the Bill be amended by deleting paragraph (b) of subclause (1) and substituting therefor thefollowingnew subclause

(b)in the case of a subsequent offence,to a fine not exceeding one million shillings,or to imprisonment for a terrm not exceeding twoyears,or to both

Justification:To make enhance thegeneral penalty for offences committed in relation to this Bill and to make the fines payable cormmensurate to theimprisonment terms.

CLAUSE87

THAT Clause 87 of the Bill be amended by deleting the word"article"wherever it appears and substituting therefor the words"health product or technology"in paragraph(c)in subclause(1)

Justification:To harmonize the terms used in the Bill with the Title of the Bill as proposed for amendment.

PartXIV

THAT the title of Part XIV of the Bill be amended by deleting the expression "PART XIV"and substituting therefor the expression"PARTXII"

Justification: To correct a minor error in numbering of the parts of the Bill.

CLAUSE88

THAT Clause 88of the Bill be amended by deleting the wordS"Consolidated Funds"and substituting therefor the words"Consolidated Fund"in paragraph (a).

Justification:For proper reference to the Consolidated Fund as designated under Article 206of the Constitution.

CLAUSE91

THAT Clause 91 of the Bill be amended by deleting the words "Kenya National Audit Office"and substituting therefor the words"Auditor-Generalin subclause(S)and (4).

Justification:For proper reference to the Auditor-Generalas designated under Article 229 of the Constitution and which is the successor of the Kenya National Audit Office.

PartXV

THAT the title of Part XVof the Bill be amended by deleting the expression "PART XV"and substituting therefor the expression"PARTXllI".

Justification:To correct a minor error in numbering of the parts of the Bill.

CLAUSE95

THAT Clause95of theBill be amended by

• (a) in subclause 2 by--
• (i) deleting the words"any drug"in paragraph(a)i);
• (i)deleting the word "drugs,in paragraph(a)(i);
• (ii)deleting the word"any"in paragraph(a)(ii) and paragraph(c);
• (v)deleting the word "product"and substituting therefor the word "products"in paragraph (d);
• (iv)deleting the word "any"and substituting therefor the word "a" in paragraph (b);
• (vi)deleting the words"any drugs"and substituting therefor the words"health products or technologies"in paragraph (h);
• (vi)deleting the word"articles"and substituting therefor the words"health products and technologies"in paragraph(m);
• (vii) product or technology"in paragraph(k);
• (ix)deleting the words"drugs,medical devices"and substituting therefor the words"health products and technologies"in paragraph(o);
• (xi)deleting paragraph (x) and substituting therefor the following new paragraph
• (x)deleting the word"medicines"and substituting therefor the words"health products and technologies"in paragraph(v);

(x)governing administration of clinical trials of health products and technologies;

• (xii)deleting the words"medicine,medical device"and substituting therefor the words "health product or technology"in paragraph(aa);
• (xiv)deleting paragraph(dd)and substituting therefor the following new paragraph
• (xii)deleting the words"medicines or medical devices" and substituting therefor the words"health products or technologies"in paragraph(bb);

(dd) the compounding of health products and technologies and the dispensing of health products and technologies

• (xvi)deleting the word"any"appearing in paragraph (a)
• (xv)deleting the words"dentist or veterinary surgeon"and substituting therefor the words"or dentist"in paragraph(aa);

Justification:To exclude veterinary medicines which are regulated separate from human medicines under theVeterinary Surgeons andVeterinaryPara-ProfessionalsAct,No.29of2011 and to harmonize the terms used in theBill with theTitleof the Bill as proposed for amendment.

• the word"pharmacist"in paragraph (bb); Justification:Forinclusion ofpharmaceutical technologistswho arecurrentlyinvolved in thedispensing

ofmedicines and medical devices pursuant to the Pharmacy and Poisons Act,Cap.244 and their scope of training.

(xvi)deleting paragraph (ii);

Justification:The general provision on the making of regulations is set out in subclause(1)

• (xix)inserting the following new paragraphs after paragraph (i)
• (i)on pharmacovigilance and post market surveillance;
• (kk) official regulatory lot release of vaccines and other biological products imported and manufactured in Kenya;
• (ll)good practices in the regulation of medical products;
• (mm) inspections,licensure and certification of themanufacture of medical products by health facilities;
• (nn)inspections,licensure and certification of manufacture of medical products and including steel industries, sugar industries;
• (pp) to regulate licit use of narcotic and psychotropic substances; and
• (qq) to regulate parallel importation of medicines;

Justification:To provide for the making of regulations on licit use of narcotic and psychotropic surveillance.

(b)in sub-clause(s),by renumbering subclause(2)as subclause (s). Justification:To correct the error in numberingin the clause.

CLAUSE96

THAT Clause 96of theBill be amended by

• (i)deleting the word "Board"and substituting therefor the word"Boards";
• (a)in subclause(1),by-
• (i) deleting paragraph (d) and substituting therefor the following new paragraph

(d)all members and staff of the former Boards shall be deemed tobemembers and staff of the Authority and subject to the provisions of any rules madeunder this Act,shall continue in office for the period for which they were appointed as members and staff of the former Boards.

• (b)in subclause (2),by deleting the subclause (2)and substituting therefor the following new paragraph-

(2)In this section,"the former Boards"means the Pharmacy and Poisons Board and the Board of Management of the National Quality Control Laboratory established under the Pharmacy and Poisons Act,Cap.244.

Justification:To provide for the transition of both the Pharmacy and Poisons Board and the Board of Managerment of the National Quality Control Laboratory.

• (c)in subclause(s),by deleting the word"twelve"and substituting therefor the words"twenty four"

Justification:To provide sufficient time which will facilitate the conduct ofextensive stakeholder

CLAUSE97

THAT Clause 97of the Bill be amended by inserting the words with reference to section 96(s) immediately after the words"that Schedule" in subclause(1)

SECONDSCHEDULE

THAT theSecondScheduleof theBill beamended by deleting the entireSchedule.

Justification:The Chairperson,Board Members and Director General of the Authority are not State Officers and hence do not need to subscribe toan oath.

THIRDSCHEDULE

THAT the Third Schedule of the Bill be amended by deleting theentire Schedule.

Justification:The matters of the tenure of office,allowances,protectionfrom liability and disclosure of interest by Board members are alreadyprovided for in themain Bill.The issue ofapproval of the Board members by the Parliarment has been proposed for deletion as the Authority's Board members are not State Officers.

FOURTHSCHEDULE

THAT theFourth Schedule ofthe Bill be amended by deleting the paragraph(1) to(5)and substituting therefor the followingnewparagraphs--

• 1.Biologics Committee.
• 2.Pharmacovigilance Committee.
• 3.Complementary,Alternative orHerbal Medicines Committee.
• 4.Radiopharmaceuticals Committee.

5. Cosmetics and Borderline Products Committee.

• 6.Clinical Trial Scientific Technical Advisory Committee.
• 7.Health Technology Assessment Committee.
• 8.Nutraceuticals and Dietary Supplements Committee.
• 9.Digital Health and Technologies Committee.
• 10.Medical Devices and Health Technologies Committee.

Justification:The scientific advisory committees amended to take into account all aspects of health products and technologies and to delete the Scientific Advisory Committees on food and veterinary medicine which are outside the scope of the Bill as amended.

FIFTHSCHEDULE

THAT the Fifth Schedule of the Bill be amended by deleting the words "The British Veterinary Codex.. (B.Vet.C)"

Justification:To exclude veterinary medicines which are regulated separate from human medicines under the Veterinary Surgeons and Veterinary Para-Professionals Act,No.29 of 2011.

SEVENTHSCHEDULE

THAT theSeventh Scheduleof theBill be amended by

• (a)deleting the word"Board"in the paragraph on Cap.244
• (b)deleting the phrase"(s.116)and substituting the phrase("s.97")

Justification:For proper cross referencing of thePharmacy andPoisons Act,Cap.244 and clause97 on repeals.

• (c)deleting the paragraph on Cap.254.

Justification:Fgpd is oytsigethepurview of the Bill.

2023

SIGN

.DATE.

HON.DR.ROBERTPUKOSE,MP CHAIRMAN,DEPARTMENTALCOMMITTEEONHEALTH.