07.11.2023 - Report of Health on Winnowing of KDA Bill

REPUBLICOF KENYA THENATIONALASSEMBLY THIRTEENTHPARLIAMENT-SECONDSESSION DEPARTMENTALCOMMITTEEONHEALTH

REPORTONTHE

WINNOWINGOFTHEPROPOSED AMENDMENTSTOTHEKENYADRUGS HON.DR.ROBERTPUKOSE,MP

Published by:DirectorateofDepartmental Committees Clerk's Chambers ParliamentBuildings NAIROBI

NOVEMBER,202S

TableofContents

| LISTOFANNEXURES | | |------------------------------------------------------------------------------------------------------------------------------|----| | CHAIRPERSON'SFOREWORD | | | CHAPTERONE | | | 1.2COMMITTEEMEMBERSHIP | | | 1.5 COMMITTEESECRETARIAT | | | CHAPTERTWO | | | 2.0OVERVIEWOFTHEKENYADRUGSAUTHORITYBILL,2022,NATIONAL ASSEMBLYBILLNO.54OF2022.. | | | CHAPTERTTHREE | | | S.OCONSIDERATIONANDWINNOWINGOFPROPOSEDAMENDMENTSTO THEKENYADRUGSAUTHORITYBILL(NATIONALASSEMBLYBILLNO.54OF 2022). | 9 | | S.1Referral oftheKenya DrugsAuthorityBill(National Assembly Bill No.54of2022).9 | | | S.OCOMMITTEECONSIDERATIONOFTHESUBMISSIONS | | | S.1 Submission by the Committee. | | | S.2Submissions by Hon.Anthony Oluoch,MP. | 56 | | 3.3 Submissions by the Hon.Irene Mayaka,MP | 59 | | 3.4Submission by theHon.Dr.Otiende Omollo,MP | 60 | | 3.5Submission by the Hon.Millie Odhiambo,MP | 60 | | 3.6 Submission by the Hon.Dr.James Nyikal,MP | 67 | | S.7 Submission by the Hon.Martin OwinoPeters,MP | | | S.8Submission by the Hon.Peter Kaluma,MP | 71 | | 3.OCOMMITTEEOBSERVATIONSONTHEWINNOWINGOFPROPOSED ASSEMBLYBILLNO.54OF2022). | 74 | | 4.0COMMITTEERECOMMENDATIONSONTHEWINNOWINGOFPROPOSED AMENDMENTSTOTHEKENYADRUGSAUTHORITYBILL(NATIONAL ASSEMBLYBILLNO.54OF2022) | 75 | | CHAPTERSIX | 76 | | SCHEDULEOFAMENDMENTS | 76 |

LISTOFANNEXURES

Annexure 1:Minutes of Committee sittings

Annexure 2:Report adoption schedule

Annexure S:Speakers Communication

Annexure 4:Letters invitingMembers tothe meeting tosubmit their proposed amendmentson theBill

Annexure 5:Submissionsby Members

CHAIRPERSON'SFOREWORD

This addendum report contains the Committee's proceedings on the consideration and winnowingofamendments from the Committee andindividual Members to theKenya Drugs AuthorityBill,2022(National Assembly Bill No.54of2022).

TheKenya Drugs Authority Bill,2022 (National Assembly Bill No.54 of2022) sponsored by Hon.(Dr.)Robert Pukose,MPwhich was published on 6t October 2022 and went throughFirst Readingon srdMay 2o2sand was thereafter committed to theDepartmental Committeeon Health for consideration and facilitation for public participation pursuant toArticle1i8of the Constitution and reporting to the House pursuant to theprovisions ofStanding Order 127(1).

Second Reading of the Billwasconcluded on 18th October2023 and theBillprogressed to the CommitteeofthewholeHouse.AftertheSecond ReadingoftheBill sevenHonourable Members proposed further amendments to theBill.

The Committee of thewhole house stage on theBill startedonTuesday25th October,202s and progressed up to clause 22.In resumption of the Committee of the whole house during the morning sitting ofWednesday26th October 202sbefore proceeding to the saidorder theHon. speaker stayed the consideration of the Bill and directed that the proposed amendments to the Billbesubjected toawinnowingprocess,pursuant to the provisions ofStanding Order1s1before the Committee onHealth forharimonizationbeforeconsideration at the Committee of thewhole house The outcome ofwinnowing would inform the Speaker on how best toguide the House before theBill isconsidered at the Committee ofwholeHouse.

Further,for clarity the speaker directed that,the Committee of the whole house had concluded consideration of clausesSto22and in the event contestations arisewithregard to those Clauses, the house will be at liberty to recommit the clauses in accordancewith standing Order 1s6A.

The Hon.Speaker directed that the proposed amendments be committed to the Committee on Health for harmonization before consideration at the Committee of theWhole House

During consideration oftheproposed amendments,the Committee held a totalof six(6)sittings during which it heard submissions from the following Honourable Members who proposed amendments

The Committee is thankful to the Office of theSpeaker and the Clerk oftheNational Assembly

On behalf of the Committee,and pursuant to Standing Order 127(4),it is my pleasant duty to table the Report on the winnowing process of theDepartmental Committee on Health on its Consideration of theKenya Drugs Authority Bill,2022(National Assembly Bill No.54of 2022)

HON.PATRICKNTWIGAMUNENE,MP VICE-CHAIRPERSON,DEPARTMENTALCOMMITTEEONHEALTH

1.0PREFACE

1.1ESTABLISHMENTANDMANDATEOFTHECOMMITTEE

• 1.TheDepartmental Committee onHealth is established pursuant to theprovisions ofStanding Order 216of the National Assembly Standing Orders andin line with Article 124 of the Constitution which provides for the establishment of the Committees by Parliament.The mandate and functionsofthe Committeeinclude:
• a)Toinvestigate,inquire nto,andreport on all matters relating to the mandate,management activities,administration,operations andestimates ofthe assignedministries and departments;
• baonaquarterlybasismonitorandreportontheimplementationofthenationalbudgetinrespectf its mandale,
• b)To study the programme andpolicy objectives ofministries anddepartmentsand theeffectiveness oftheimplementation;
• c)To study andreviewall legislationreferred toit;;
• Toinvestigateandinquire into allmatters relating to the assignedministriesanddepartments as they may deem necessary,and as may be referred to them by theHouse;
• To study,assess and analyse therelative success ofthe ministries and departments as measured by theresults obtained as comparedwith their statedobjectives,
• Vetandreportonallappointmentswhere theconstitution oranyotherlawrequires thenational Assembly to approve,except thosederstandingOrder2O4(Committeeonappointments)
• Tomakereports andrecommendations to theHouse asoflenaspossibleincludingrecommendation ofproposedlegislation;
• g Toezamine treaties,agreements and conventions,
• Toconsiderreports ofCommissionsandIndependentOffices submitted totheHousepursuantto theprovisions ofArticle254ofthe Constitution;and
• Toexamine any questions raised by Members on a matter within its mandate.
• 2.In accordancewith theSecond Schedule of the Standing Orders,the Committee is mandated toconsider matters related tohealth,medical care and health insurance including universal health coverage.
• 3.In executingitsmandate,the Committee oversights theMinistry ofHealth with itstwoState Departments namely the State Department for Medical Services and the State Department forPublicHealthand Professional Standards.

CHAPTERONE

1.2COMMITTEEMEMBERSHIP

• 4.The Departmental Committee onHealth was constituted by the House on 27th October 2022 and comprisesof thefollowingMembers:

Chairperson

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

Vice-Chairperson

Hon.Ntwiga,Patrick Munene,MP Chuka/Igambang'ombe Constituency

| Hon.Owino Martin Peters,MP | | |--------------------------------------------------------|----------------------------------------------------------------| | Ndhiwa Constituency | | | ODMParty | Hon.Maingi Mary,MP Mwea Constituency UDA Party | | Hon.Muge Cynthia Jepkosgei,MP | | | Nandi (CWR) | | | UDA Party | Hon.Mathenge Duncan Maina,MP Nyeri Town Constituency | | | UDA Party | | Hon.Wanyonyi Martin Pepela,MP Webuye East Constituency | | | Ford KenyaParty | Hon.Lenguris Pauline,MP Samburu(CWR) | | | UDA Party | | Hon.Kipngok Reuben Kiborek,MP Mogotio Constituency | | | UDA Party | Hon.Oron Joshua Odongo,MP Kisumu Central Constituency ODMParty | | Hon.(Dr.)Nyikal James Wambura,MP | | | Seme Constituency | | | ODMParty | Hon.(Prof.)Jaldesa GuyoWaqo,MP Moyale Constituency | | | UPIA Party | | Hon.Kibagendi Antoney,MP | | | Kitutu Chache South Constituency | | | ODMParty | Hon.Mukhwana Titus Khamala,MP | | | Lurambi Constituency | | Hon.Julius Ole Sunkuli Lekakeny,MP | ANCParty | | Kilgoris Constituency | | | KANU | |

UDA Party

1.3 COMMITTEESECRETARIAT

• 5.The Committeeis supported by the followingsecretariat:

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 OfficerIII | |----------------------------------------------------|------------------------------------------------------| | Ms.Faith Chepkemoi Legal Counsel II Mr.Yakub Ahmed | Mr.Hiram Kimuhu Fiscal Analyst III Mr.Benson Kimanzi | | AudioRecordingOfficerII | Mr.Salat Abdi Ali | | Ms.Rahab Chepkilim | | | Media Relations Officer II | Serjeant-At-Arms III | | | PrincipalSerjeant-At-Arms |

CHAPTERTWO

2.0OVERVIEW OFTHEKENYADRUGSAUTHORITY BILL,2022,NATIONAL ASSEMBLYBILLNO.54OF2022

• 6.PART I(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:
• (a) chemical substances;
• (b)therapeutic cosmetics;
• (c) herbal medicines and products;
• (d)medical devices including radiation-emitting devices;
• (e)medicines;and
• (f)scheduled substances.
• 7.PART II(Clause 4-21)of the Bill establishes the Kenya Drugs Authority in Clause4with its headquarters in Nairobi. The Authority is to be managed by a Board,the Kenya Drugs Board established under clause 8 of theBill.The Part also provides for:
• b the composition and qualifications for appointment as a member of the Kenya Drugs Board. The Kenya Drugs Board comprises of twelve members namely the Principal Secretaries in the Ministry of Health and Ministry of Finance,the Director-General of Health,the Managing Director ofKEBS,representatives of the Law Society of Kenya, Pharmaceutical Association,Council of County Governors,Kenya Association of Manufacturers and Consumer Federation ofKenya and a Chairperson appointed by the President.
• a) the powers oftheKenya DrugsAuthorityin clause 1s.
• the functions of the Kenya Drugs Authority in clause 12-the main function of the Authorityistheregulationinvestigation,inspection and approval ofhealthproducts and technologies and relatedmatters in public interest.TheAuthority will thereforemanage licences andregisters under theBill and prescribe standards ofquality for products to be manufactured in the country among others.
• the appointment of a Director General in clause 6by thePublic Service Commission with the approval ofParliament for a term of fouryears.The Director Generalshall be the Chief Executive Officer,Accounting Officer and Registrar of the Authority as well as the Secretary to theBoard.
• the power of the Cabinet Secretary,Ministry of Health under clause 21 to establish scientific advisory committees thatwill provideexpert,independent advice to theCabinet Secretary on complex scientific issues presented to theKenya Drugs Authority.
• 8.PART III (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;
• C】 penalizes the manufacture,sale,preparation and storage of medicine including herbal medicine contrary to the prescribed standards;
• dj sets out the factors to be met to warrant the issuance of a product licence;
• provides for the establishment and management ofa medicines register;and
• provides the procedure for theregistration of medicines.
• 9.PART V(Clause 37-16)of the Bill provides for the regulation of scheduled substances. Under this Part, the Kenya Drugs Authority is to prepare and submit the lists of scheduled substances to the Cabinet Secretary that shallonly be sold byauthorized sellers specially licensed to do so.The Bill therefore criminalizes thepossession of scheduled substances by unlicensed persons.The Bill further makes provision for the licensing ofthe 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 theBill provides for the manufacture of medicinal substances upon the issuance of a manufacturing license,renewable annually,by the Kenya Drugs Authority and compliance with good manufacturing practices.
• 11.PART VII (Clause 49-54)of the Bill provides for the regulation of therapeutic 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 thelabel aswell as thepreparation of therapeutic cosmetics under unsanitary conditions.The Kenya Drugs Authority is also empowered to prohibit any ingredient in therapeutic cosmetics.
• 12.PART VIII(Clause 55-59)of the Bill provides for theregulationofmedical devices.The Billpenalizes the sale of adulterated and substandard medical devices and medical devices which have not been registered by the Kenya Drugs Authority the Bill further requires compliance with standards ofmanufacturing.labeling.packaging,sale,or advertisement of medical devices,
• I3.PART IX (Clause 60-61)of the Bill establishes the National Quality Control Laboratory responsiblefor:
• a)the examination and testing of drugs and any material or substance from or with which and the manner in which drugs may bemanufactured,processed or treated and ensuring the quality control of drugs and medicinal substances;
• D performing chemical,biological,biochemical,physiological and pharmacological analysis and other pharmaceutical evaluation;
• conducting research and training,and
• testing gthe quality oflocally manufacturedandimported medicines or medicinal substances,medical devices or therapeutic cosmetics on behalf of the Kenya Drugs Authority,with a view to determining whether such drugs or medicinal substances comply with theAct.

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

• 14.PART XII (Clause 62-70)of the Bill provides for the standards ofadvertisement and labelling of healthproducts and technologies.All advertisements must be authorized by the Kenya Drugs Authority especially those relating to the diseases listed in the Sixth Schedule to the Bill including HIV, leprosy,diabetes, pneumonia as well as drugs and appliances for procuring abortions.
• 15.PART XIHI(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 to request further information.The Bill further authorizes the Kenya DrugsAuthority to:
• a) authorize the sale or supply of unregistered medicine or medical device for a specified period,
• b) request for information;
• c) imspect licences and books oflicensed sellers;
• d) inspect animalsintended for slaughter;and
• retain and dispose seized goods.
• 16.PART XIV(Clause S8-94)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 special reports, the investment of the Kenya Drugs Authority's funds,aecounts and audit.The source of funding of theKenya Drugs Authority includes appropriations from the Consolidated Fund,monies accruing in the course of the performance of its fiunctions and gifts,grants or donations given to the Kenya Drugs Authority.
• 17.PART XV (Clause 95-97)of the Bill provides for miscellaneous provisions.The Kenya Drugs Authority may make Regulations under the Bill on various matters including fees payable and prescribed forms under the Act,procedures of clinical trials and the electronic sale ofmedicines among others.The Bill also contains transition and savings provisions on what happens to the assets,liabilities,legal obligations and staffof the National Quality Control Laboratory and thePublic Health (Standards) Board being repealed. Under this Part, the Pharmacy and Poisons Board shall continue to exist for purposes ofregulating the pharmacy profession until Parliament enacts a law for the regulation of the pharmacy practice. The Part further provides that the Bill shall apply subject to the provisions of the Public Health Act.

18.SCHEDULES-theBill hasseven schedules:

• a)First Schedule-which contains provisions on the conduct of business and affairs of the Board n terms ofmeetings,quorum,voting.committees, disclosure of interest among others;
• b) Second Schedule-which provides the oath or affirmation of the Office of the Chairperson, MemberandDirector;
• Third Schedule-which contains provisions relating to appointment ofmembers of the Board;
• 小 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 QualityControl Committee;
• Fifth Schedule-which provides the specified publications on standards of medicines;
• f)Sixth Sehedule-which sets out the purposes for which drugs may not be advertised; and
• g)Seventh Schedule- which sets out the repeals being made under the Bill.

CHAPTERTTHREE

S.OCONSIDERATIONANDWINNOWINGOFPROPOSEDAMENDMENTSTOTHE 2022)

3.1 Referral of theKenya Drugs Authority Bill (National Assembly Bill No.54of 2022)

TheKenya Drugs Authority Bill (National Assembly Bill No.54) sponsored by Hon.(Dr.) Robert Pukose was read a First Time on sr May,2o2S and committed to the Departmental Committee on Health for facilitation of publicparticipation pursuant toArticle118of the Constitution and reporting to the House,pursuant to Standing Order 127(1).

TheSecond Reading of the Bill was doneon 4h,11th and concluded on 1gth October,2023.After the Second Reading of the Bill was concluded,the Committee and seven Honourable Members proposed further amendments to the Bill,namely:-

• 1.Hon.Peter Kaluma,MP;

2. Hon.Dr.OtiendeOmollo,MP; 3. Hon.Millie Odhiambo,MP;

• b. Hon.Irene Mayaka,MP;

5. Hon.Anthony Oluoch MP; 6. Hon.Dr.Jmaes Nyikal,MP

• 7.Hon.Martin Owino Peters,MP

Pursuant to the provisions of Standing Order 131, the Speaker directed that all the amendments received be referred to theDepartmental Committee on health and besubjected to thewinnowing process for harmonization.

S.OCOMMITTEECONSIDERATIONOFTHESUBMISSIONS

All the members with proposed amendments were invited by the Committee to prosecute the same before the Committee.The Committee thereafter considered and made observations and recommendations on each of theproposedamendments.

3.1 Submission by the Committce

The Hon.Dr.Robert Pukose,MP the chairperson of the Committee presented the Committee onHealth proposed amendments and appeared beforethe Committee ongudNovember,2ogs and made thefollowingsubmission:

LongTitle

THAT,the Bill be amended by deleting the LongTitle and substituting therefor the following newLongTitle

"AN ACTof Parliament to establish a comprehensive legal framework for the regulation of HealthProducts and Technologies;to safeguard public health through development of a regulatory system to ensure safety,quality,efficacy,effectiveness and performance of health products;to establish theKenya Health Products and Technologies Authority and forconnected purposes"

Justification:The amendment accords with international best practice and sets out the main purpose of the Bill which is to establish a centralizcdregulatory authority for health products and technologics.

Clause1

THAT,Clause 1 of the Bill be amended by

• (a)deleting the phrase"Kenya Drugs Authority Act,2o22"and substituting therefor the phrase "Kenya Health Products and Technologies Regulatory Authority Act, 2022";

Justification:The amendmcnt accordswith intcrnational best practice and comprehensively covers themandateoftheproposcdAuthority.

• (b) deleting the words and commencement in the marginal note.

Justification:Tolimit the marginalnote to the content of clause 1which only sets out the name of the Bill.The Clause does notmake any provision as regards the commenccment ofthe Bill.

Clause2

THAT Clause 2of theBill be amended

• (a)in the definition ofarticle"by-
• (i)inserting the words "dietary supplement"immediately afler the words "therapeutic cosmetic"appearing in paragraph (a); and
• (i)inserting the words "dietary supplement"immediatelyafter the words therapeutic cosmetic"appearing in paragraph (b);

Justification:For inclusion of dietary supplements which are part ofhealth produets and technologies.

• (b)in the definition of "Authorityby deleting the words "Kenya Drugs Authority"and substituting therefor the words,"Kenya Health Products and Technologies Regulatory Authority";

Justification:To ensure harmony with the title of theBill asproposed for amendment.

• (c)in the definition of"chemical substance" by deleting the words"or detergent";

Justification:To exclude detergents which are used for cleaning inanimate objects and doesnot fall under the purview of theregulation of health products and technologies.

• (d) in the definition of "drug" by deleting the word "if appearing in paragraph (b)(i) and substituting therefor the word"of";

Justification:To correct a minor typographical crror.

• (e)by deleting the definition of"enrolled pharmaceutical technologist";

Justification:The current definition cross referenccs the Pharmacy and Poisons Act,cap. 244which will be repcaled as provided under clausc 97. A new definition proposed.

• (f)in the definition of "health products and technologies"by inserting the words,dietary supplement"immediately after the words,"therapeutic cosmetics";

Justification:For inclusion of dietary supplements which are part of health products and technologies.

• (g)by deleting the definition ofherbal medicine or product";
• (h)by deleting the definition of"medical device";
• (i)by deleting the definition of"medicinal substance";

Justification:New definitions provided for these terms.These new definitions expand the scope to cover all aspects of the use ofmedical devices and medicinal substances in relation tohcalthand to includeherbalmaterialsandherbalcombinations.

• ()in the definition of "package"by inserting the words"dietary supplement" immediately after the words"therapeutic cosmetic;

Justification:For inclusion of dietary supplements which are part ofhealth products and technologies.

• (k)by deleting the definition of"pharmacy":

Justification:The current definition is inadequate.The term to be defined in the proposcd Pharmaceutical Practice Bill.

• (1)by deleting the definition ofpharmaceutical technologist";

Justification:The Pharmacy and Poisons Act,cap.24provides that a pharmaccutical technologist must be cnrolled in the roll cstablished under this Act.

(m)by deleting the definition of"registered midwife";

Justification:The term is no longcr uscd in the Bill in line with the proposed amendment ofclause 43 (1)(c).

• (n)in the definition of"scheduled substance by deleting the words"in the relevant schedule under this Act"and substituting therefor the words"in thelist published by the Cabinet Secretary under section 37of this Act";

Justification:There is no Schedule on scheduled substances.The Cabinet Secretary willpublish thelist of schcduled substances in the Gazctte.

• (o)by deleting the definition of"therapeutic cosmetic"; and

Justification:The current definition defines cosmctics in gencral that are mcant to provide the body with appropriate aesthetics, texture,pll,color and smell.It is not specific to special cosmeties.

• (p)by inserting the following new definitions in their proper alphabetic sequence

active surveillancemeans prospective measures taken to detect adverse drug reactions and adverse events and involves active follow-up during and after treatment of patients where the events may be detected by asking the patient directly or screening patient records;

adverse drug reactionmeans a response to a drug which is noxious and unintended,and which occurs at doses normally used in humans for the prophylaxis,diagnosis or therapy of disease,or for the modification of physiological function and is characterized by the suspicion of a causal relationship between a medical product and an occurrence;

"adverse eventmeans any untoward medical occurrence that may present during treatment with apharmaceuticalproduct but which does not necessarily have a causalrelationship with the treatment;

"biologicalsmeans a diverse group of medicines which includes vaccines,growth factors, immune modulators,monoclonal antibodies and includes products derived from human blood

"Boardmeans the Board of the Authority established under section 8;

"Centre"means the National Pharmacovigilance Centre establishedunder section 59B;

"clinical trialmeans any systematic study on pharmaceutical products in human subjects, whether in patients or other volumteers,in order to discover or verify the eflects of,identify any adverse reaction to investigational products, study the absorption,distribution,metabolism and excretion oftheproducts with the object of ascertaining their eflicacy 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 which usually contains one or more dietary ingredient and includes vitamins,minerals and herbs;

"enrolled pharmaceutical technologistmeans a person enrolled as such by the body for the time beingresponsible for the enrolment ofpharmaceutical technologists;"

falsified medical productmeans a product that is deliberately or fraudulently misrepresented in relation to its identity,composition or source;

Field Safety Corrective Actionmeans any action taken by a product owner to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device, and includes--

• (a) the return of a medical device to the product owner or its representative,
• (b) device modification which may include
• (i) retrofit in accordance with the product owner's modification or design change;
• (i) permanent or temporary changes to the labelling or instructionsfor use;
• (ii) software upgrades including those carried out by remote access;
• (iv) modification to the clinical management of patients to address a risk of serious injury or death related specifically to the characteristics of the device;
• (A) device exchange;

• (vi) device destruction; or
• (vii) advice given by product owner regarding the use of the device.

"health product"includes a medicine,medical product,medicinal substance,vaccine,diagnostic, medical device,blood or blood product,traditional and alternativemedicine,therapeutic feed and nutritional formulation,cosmetic and related products;

health technologymeans the application of organized knowledge and skills in the form of medicines, devices,vaccines,procedures,and systems developed to solve a health problem and improvethequality oflives;

"herbalmedicine or product"means a plant derived material or preparations with claimed therapeutic or other health benefits, which contain either raw or processed ingredientsfrom 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,

"in-vitro diagnostics medical device"means a medical device,whether used alone or in combination,intended by the manufacturer for thein vitro examination of specimens derived from the human body solely or principally toprovideinformation for diagnostic,monitoring or compatibility purposes;

Inspector of Drugs means a person who is competitively recruited by the Authority as a drug inspector and who holds a minimum of a diploma in pharmacy;

"lot"or "sub-lot"means a defined quantity of starting material, packaging material or product, processed in a single process or series of processes so that the quantity is expected to be homogeneous; and in the case of continuous manufacture, thelot corresponds to a defined fraction of the production characterized by its intended homogeneity;

"lot release"means the process of the evaluation of an individual lot of a licensed biological product by theAuthority before giving approval for its release onto the market;

"marketing authorization"means the certificate ofregistration issued by the competent health productregulatory authority in the country oforigin for the purpose ofmarketing or free distribution of a health product after evaluation for safety,efficacy and quality;

medical device"means any instrument, apparatus,implement,machine, appliance, implant, reagent forin vitro use,software,materialor other similar or related article,intended by the manufacturer to be used,alone or in combination,for human beings,for one or more ofthe specificmedical purpose of

• (a)diagnosis,prevention,monitoring,treatment or alleviation of disease,
• (b)diagnosis,monitoring,treatment,alleviation of or compensation for an injury:
• physiological process;
• (d) )supporting or sustaining life;
• (o) control ofconception;
• (f)disinfection ofmedical devices;

• (g)providing information by means of in vitro examination of specimens derived from thehuman body:
• (h))disinfection substances;
• (i)aids for persons with disabilities;
• (j)devices incorporating animal or human tissues;
• (k)devices for in-vitro fertilization or assisted reproduction technologies,and immunological or metabolic means,in or on the human body,but which may be assisted in its intended function by such means;

"medicinal substancemeans 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 ofplants,vegetable secretions,extracts,elements,naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

passive surveillance"means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns;

parallelimportationmeans importation into Kenya,by a licensed importer of a health product other than the marketing authorization holder or his or her technical representative,of the followinghealthproducts whichrequiremarketing authorization inKenya

• (a)patented health products under section 58(2)of the Industrial Property Act,200l;
• (b)non-patented health products;or
• (c)branded generic health products;

"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;

"premiseincludes any land,building,dwelling-place or any other place whatsoever;and 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;

schedulingmeans,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 product"means a registered medical product that fails to meet either its quality standards or specifications,or both;

"therapeutic cosmetic"means a cosmetic which

• (a)offers an additional benefit to a person over an ordinary cosmetic; or
• (b)contains a bioactive product formulated from an animal ingredient that may have visible and measurable short or long-term effects on a person, and may include a product that may be absorbed through the skin or a mucous membrane;

"unregistered medical product" means a product that has not undergone evaluation and approval by the Authority subject to permitted conditions under theAct and therules therein;

"vessel"means a truck,van,bus,minibus,car, trailer,aircraft,railway carriage,boat and othe means that are used for purposes of conveying health products and technologies;

Justification:The new definitions areinternationally recognized by the World Health Organization and are critical for the exccution ofregulatoryfunctions of theAuthority.

To further identify the Board asused in the Bill.

To provide new definitions for the words:cnrolled pharmaceutical technologist, therapeutic cosmetic,herbal medicinc,medical device and medicinal substances.

Clause 3

THAT,Clause Sof the Bill be amended by deleting sub-clause(1)and substituting therefor the followingnewsub-clause(1)

• "(I) This Act applies to the regulation of
• (a)medicines,medical products and technologies;
• (b)medical devices includingradiation emitting products;
• radiopharmaceuticals;
• d) complementary, alternative or herbal medicines;
• in-vitro diagnostics medical devices;
• (e) cosmetics and Borderline Products;
• (g)t therapeutic feeds;
• (i) nutraceuticals and dietary supplements;
• (h)clinical trials;
• G) digital health and technologies;
• (l)chemical substances; and
• (k)scheduled substances;
• (m)biological products for use in humans and the starting materials used in their manufacture."

Justification:To comprehensively cover all aspccts in the regulation of health products and technologies.

Clause4

THAT, Clause 4 of the Bill be amended in sub-clause (1) by deleting the words"Kenya Drugs Regulatory Authority".

Justification:This accords with international best practicc on the cstablishment of a centralizcd regulatory authority for hcalth products and technologies.

Clause5

THAT, Clause 5 of the Bill be amended by deleting the words,but the Authority may establish branches anywhere inKenya" and substituting therefor the words"or in such other place as the board of the Authority may,by resolution, determine

Justification:Togive the Board discretion in determining thelocation of the Authority's headquarters.

Clause 6

THAT, Clause 6 of the Bill be amended

• (a)by deleting sub-clause (1) and substituting therefor the following new sub-clause (1)

(1)There shall be a Director-General who shall be the chief executive oficer of the Authority.

Justification:For proper drafting of the clause.

• (b)by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)

(2)The Director-General shall be appointed by theBoard,through a transparent and competitive process,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 Authority without the approvalbyParliament.

• (c) in sub-clause (3) by deleting the word "four" and substituting therefor the word "three".

Justification:Appointments and term of servicein State Corporations arenormally capped at three(3)years which isrenewable for one final term.

• (d) by deleting sub-clause (4) and substituting the following new sub-clause (4)
• (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;
• (b)holds a masters' degree in pharmacy,medicine or any relevant field from a university recognized in Kenya;
• (d)has served in a senior management position for at least five years;
• (c)has at least ten years'experience in pharmacy or its equivalent;
• (e)is a member of a professional body;and
• meets the requirerments of Chapter six of the Constitution.;and

Justification:TheDircctor General should be a qualified pharmacist as the regulation of health products and technologies requires spccialized knowlcdge and technical expertise in the pharmaceutical field.

• (e)by deleting sub-clause (5).

Justification:The fact that the Dircctor-General shall bc the CEO of the Authority is provided in the sub-clause(1)as proposcd for amendment.

Clause7

THAT, Clause 7 of the Bill be amended in paragraph (f) by deleting the words Act. regulation under this"and substituting therefor the words"regulation under this Act."

Justification:To correct a typographical error.

Clause8

THAT,Clause 8 oftheBill be amended

• (a)in sub-clause(1) by deleting the words "Kenya Drugsand substituting therefor the words"Kenya Health Products and TechnologiesRegulatory';

Justification:Thename ofthe Board should reflect the amended Title of the Bill and name ofthe Authority asproposcd for amendment.

(b)by deleting sub-clause(2) and substituting therefor the following new sub-clause (2)

2)The Board shall comprise

• (a) a non-executive Chairperson appointed by the President and who shall
• (i)be a registered pharmacist of good standing with a degree in pharmacy; and
• (i)have at least ten years'experience in the pharmaceutical sector,five of which shall be at senior management level;
• (b) the Principal Secretary in the Ministry for the time being responsible for health or a representative designated in writing:
• (c) the Principal Secretary the Ministry for the time being responsible for finance or a representative designated in writing:
• (d) the Director-General for Health or a representative designated in writing;
• (c)one person nominated by the Pharmaceutical Society of Kenya;
• ()one person nominated by the Kenya Pharmaceutical Association;
• (g)one person nominated by theKenya Medical Association;
• (h)one person,not being a Governor,with knowledge and experience in health products and technologiesnominated by the Council of County Governors to represent the interests of counties;
• (i)one person,not being a public officer,representing consumer protection nominated by the ConsumerFederation of Kenya;and
• (j)the Director-General of the Authority who shall be the secretary and an ez officiomemberof theBoard.;and

Justification:The composition of theBoard should complywith theMwongozo Code of Governance for State Corporations in terms of numbers,skill mix and professional expertise which should include all relevant players involved in the matters ofhcalth products and technologies.

(c)by deleting sub-clause (s) and substituting therefor the following new sub-clause (S)—

"(s) The Cabinet Secretary shall appoint the members of the Board under subsection (e). (1).(g).(h) and (i) by notice in the Gazette"

Justification:The members of the Board Members are not State Officers and hence their appointment does notrequire approval by Parliament.It is sufficient that the Cabinet Secretary notifies the publicof the appointments in theKenya Gazette.

Clause9

THAT, the Bill be amended by deleting Clause 9.

Justification:The provision contradicts the legal framework for appointment of the Chairperson,Board Members and CEOs of State Corporations or Semi-Autonomous Government Agencies.The Chairperson,Board Members and Dircctor General of the Authority are not State Officers and hence do not nced to subscribe to an oath.

Clause10

THAT, Clause 10 of the Bill be amended in sub-clause (1)by deleting the words"section 12 appearing in paragraph(c) and substituting therefor the words"section 11"

Justification:To correct the crossreference as clause 11 makes provision for removal from officeof themembcrsof theBoard of theAuthority.

Clause 12

THAT, Clause 12oftheBill be amended by

(a)inserting the following paragraphs immediately after paragraph (e)

"(ea)regulate the disposal of health products and technologies;

(eb)monitor the market for the presence ofunregistered and illegal health products and technologies;

(ec) conduct analytical tests of health products and technologies";

Justification:To make provision for the functions of disposal,analytical testing and monitoringof the market by the Authority.

• (b)deleting paragraph (f) and substituting therefor the following new paragraph (f) including any other health product and technology use related issues and take appropriate

()ensure continuous monitoring of the safety of health products and technologies regulated under this Act through analysis ofreports on adverse reactions and events, regulatory actions when necessary";

Justification:To expressly align to the WHO requirement on the establishment of a nationalvigilance system.

• (c)deleting paragraph(g)and substituting therefor the following new paragraph (g)

(g)regulate clinical trials and ensure that clinical trial protocols of health products and technologies are being assessed according to the prescribed ethical and professional criteria and defined standards includingmandatory bioequivalence studies";

Justification:To anchor the ovcrsight of clinical trials in thc law as rccommended by the WHO.

• (d) inserting the following new paragraphs immediately after paragraph (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 theprescribedrequirements";

Justification:To provide for approval of health products and tcchnologics during cmergencies and to provide for pharmacovigilance which check the safety of health products and technologies.

• (e)deleting paragraph (n)and substituting therefor the following new paragraph (n) "(n) appoint inspectors and order inspection ofmanufacturing premises,medical devices establishments,importing and exporting agents,wholesalers, distributors,pharmacies, including those in health facilities and clinics,retail outlets and any other premises and vessels subject to regulation under this Act";
• (f)inserting the following new paragraphs after paragraph (o)

"(oa)conduct national regulatory authority lot release,official authoritybatch release of specified biologicals to ensure the quality, safety and efficacy of biological products through a regulatory release system in compliance with established approaches,policies,guidelines,procedures and in linewithWorld Health Organization and internationally recognizedguidelines;

(ob) carry out and promote research related to medicines and health products";

Justification:To cnable the conduct ofresearch by the Authority and the conduct of lot

(g)inserting the following paragraphs after paragraph (q)

(qa)ensure that all health products and technologies manufactured in,imported into or exportedfrom the countryincluding through parallel importation conform toprescribed standards of quality, safety and eflicacy;

(qb)enforce the prescribed standards of quality,safety and efficacy ofhealth products and technologies manufactured,imported into or exported out of the country;

(qc)grant orrevokelicenses and permits for themanufacture,importation,exportation, distribution and sale of health products and technologies;

(qd)maintain a register of all authorized health products and technologies manually or electronically:

(qe)regulate licit use of narcotic,psychotropic substances and precursor chemical substances in accordance with the Single Convention on Narcotic Drugs,1961,the Convention onPsychotropic substances,1971or theUnitedNations Convention against Illicit Traffic of Precursor Chemical Substances,1988;

(qf) inspect and license allmanufacturing premises,inmporting and exporting agents wholesalers,distributors,pharmacies including those in hospitals and clinics and other retailoutlets;"

Justification:To include critical functions of the Authority based on best practice in regulation of import and export of hcalth products and technologies that will enable the country attain WHO maturity level 3.

Clause1s

THAT, Clause 1S of the Bill be amended by

• (a)deleting paragraph (a)and substituting therefor the following new paragraph (a)

(a) collaborate with such other bodies or organizations within or outsideKenya as it may consider desirable or appropriate for the furtherance of the purpose of the Act;

• (b)inserting the following new paragraphs immediately after paragraph (a)

(aa)adopt and implement any such internationally recognized good regulatory practices; (ab) determine and implement effective and eflicient reliance mechanisms;

(ac)issue, suspend,withdraw or revoke any license or compliance certificate granted under this Act;

(ad) levy,collect and utilize fees for services rendered;

(ae)grant or withdraw licenses and permits to manufacturers,wholesalers,retailers, importers,exporters and distributors;(af) develop guidelines on the manufacture,import and export, distribution, sale and use of medical products".

Justification:Tocomplywith WHOrequirements forregulatory functionsin the Global BenchmarkingTool cspecially on control over imports and exports.

Clause21

THAT Clause21oftheBill be amended

(a)by deleting sub-clause (1) and substituting therefor the following new sub-clause(1)

"(1)The Board may establish such scientific advisory committees of the Authority,as may benecessary for the effective performance of the functions of the Authority"

• (b)in sub-clause (s) by deleting the words"Cabinet Secretary"and substituting therefor the words"Board of the Authority";
• (c)in sub-clause(4) by deleting the words"Cabinet Secretaryand substituting therefor the words"Board oftheAuthority";
• (d)by deleting sub-clause(9)and substituting therefor the following new sub-clause(9)

(9)An advisory committee shall submit, at least once every six months,a report to the Board of the Authority,with respect to its activities and the Board shall submit a copy of each report to the Cabinet Secretary".

Justification:The Scientific Advisory Committees ought to offer technicaladvice and report to the Board(itsappointing authority)which then advices the Cabinet Secretary accordingly.

PartIv

THAT,Part IV of the Bill be amended by deleting the title and substituting therefor the following new title

Justification:To cnsure harmonywith the title of the Bill asproposcd for amendment and to correct a minor crror in numberingof theparts of the Bill.

Clause22

THAT,Clause 22 of theBill be amended

• (a)in the marginal note by deleting the word "medicines"and substituting therefor the words "health productsand technologies";

Justification:To harmonize the terms used in the Bill with theTitle ofthe Bill asproposcd foramendmcnt.

• (b)in sub-clause (1) by
• (i)deleting the words"sell any medicine" appearing in the opening sentence and substituting therefor the words"sell,manufacture, supply,distribute or dispense any health product or technology";

Justification:Tobroaden thc scope ofprohibited sale ofhealth product and tcchnologies to include manufacturing,dispensing,distribution and supply of health product and technologies.

• (ii) deleting paragraph (d) and substituting therefore the following new paragraph
• (d)-
• "(d) is falsified,";

Justification:For alignment with international best practice as the proposed terminology is recognized by theWHO

(c)in sub-clause(s)by-

• i)deleting the word "medicine"appearing in the opening sentence and substituting therefor the wordshealth product or technology:; and
• substituting therefor the words,"health product or technology".

Justification:Toharmonize the terms uscd in the Bill with theTitle of theBill asproposed for amendment.

Clause23

THAT,Clause 2S of the Bill be amended in sub-clause(1) by-

• (a) deleting the word "medicines"appearing in paragraph (a) and substituting therefor the words,"health products or technologies";
• (b)deleting the word"medicine"appearing in paragraph (b)and substituting therefor the words,"health products or technologies";and
• (c)deleting the word "medicine"appearing in paragraph (c) and substituting therefor the words,"health products or technologies"

Justification:Toharmonize the terms used in the Bill with theTitle of the Bill asproposed for amendment.

Clause24

THAT,Clause24oftheBill be amended

• (a)in the marginal note by deleting theword medicines"and substituting therefor the words "health products and technologies";
• (b)in sub-clause (1) by deleting the word "medicinewherever it appears and substituting therefor the words"health product or technology";
• (c)by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)

(2)If a standard has not been prescribed for a health product or technology but a standard for the health product or technology iscontained in any of the publications specified in the Fifth Schedule,any person who manufactures,labels,packages,sells or advertises any other substance or article in such a manner that is likely to be mistaken for the health product or technology having met any of the standards contained in any of the publications specified in theFifth Schedule,commits an offence.;

• (d)in sub-clause(3)
• (i)by deleting the word "medicine" wherever it appears in the opening sentence and substituting therefor the words"health product or technology";and
• (i)by deleting the word "drug" appearing in paragraph (b) and substituting therefor the words"health product or technology";

Justification:To harmonize thc terms used in theBill with the Title of the Bill as proposed for amendment.

(e)in sub-clause(4)

• (i)by deleting the words"one hundred thousand shillings or to imprisonment for a therefor the wordsone million shillings or to imprisonment for a term not exceeding three years";and

• (i) by deleting the words"two hundred thousand appearing in paragraph (b) and substituting therefor the words"twomillion

Justification:Tomake the fines prohibitive andpunitive due to the risk of theoffences to publichealth.

Clausc 25

THAT,the Bill be amended by deleting Clause 25.

Justification:The prohibition of sale of medicines of a qualitynot demanded is a practice issue and falls outside the ambit of the Bill.

Clause26

THAT, Clause 26 of the Bill be amended by

• (a)deleting the word"medicine"appearing in the marginal note and substituting therefor the wordshealth product or technology;and
• (b)deleting the word "medicine"and substituting therefor the words"health product or technology".

Justification:To harmonize the terms used in theBill with theTitleof the Bill asproposed for amendment.

Clausc27

THAT,Clause 27 ofthe Bill be amended

• (a)by deleting the words"medicinal products" appearing in paragraph(a) and substituting therefor thewords"health products or technologies";
• therefor thewords"health products or technologies;and
• (c)by deleting paragraph (c)and substituting the following new paragraph (c)

(c)the quality of the health products or technologies of each such description,according to the specification and the method or proposed method ofmanufacture of the health products or technologies,and the provisions proposed for securing that the health products or technologies as sold or suppliedwill be of that quality; and"

Justification:To harmonize the terms used in theBill with theTitle of the Billas proposed foramendment.

New Clauses

THAT, the Bill be amended by inserting the following new clauses immediately after clause 27

Application 27A.(1)Apersonwho intends to import,manufacture or sell a health product forproduct or technology shall apply to theAuthority for the registration of the health licence. product or health technology in the prescribed form.

(2)An applicant under subsection(1) shall

• (a)specify the particulars of the person with appropriate knowledge ofall aspects of the health product or health technology who shall be responsiblefor all communication between the applicant and the Authority in the declaration page of the application form;and
• (b)where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya,appoint a localrepresentative who shall be a citizen of Kenya, a person who is or has permanent residence or a company incorporated inKenya.
• (s)The application made under subsection (1) shall be accompanied by-
• (a)a proposed label for use on the health product or technology;
• (b)a copy of the manufacturing licence of the health product or technology,where applicable;
• (c)a copy of the good manufacturing practice certificate from the Authority and the regulatory authority of the country where the health product or technology is manufactured;
• (d)a copy ofa certificate ofanalysis from a quality control laboratoryrecognizedby theAuthority,where applicable;
• (e)a copy of the marketing authorization or certificate of registration of the health product or technology from the regulatory authority of the country where the health product or technology is sold;
• (f)the available data on the quality,safety,efficacy and performance of the health product or technology submitted in a common technical dossier format;
• (g)a sample of the health product or technology;
• (h)proof of ownership of the site for the manufacture of the health product or technology,where applicable;
• (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;
• where the application relates to a health product or technology which is registered with a foreign regulatory body-
• (i)a copy of the certificate ofregistration;
• (ii)the professional information relating to the health product or technology;and
• (ii)the conditions of the registration 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 ofpharmacy;
• (i)avalid wholesale dealer'slicence issuedin accordance with this Act;

for registration of health product or technology-

Registration during emergency.

• (ija 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 applicationfees as prescribedby the Authority.
• (4)An applicant shall notify the Authority of any variation to the agreement appointing the local representative within seven daysof the variation.

Processing of27B.(1)The Authority shall consider the application made under section 27A and,shall,if it is satisfied of the safety,eflicacy,quality,performance and economic value of the health product or technology.register the health product or technology and issue a certificate of registration in the prescribed 1form.

(2)The Authority may,while considering the application,approve the may consider appropriate in respect of the following particulars

• (a) the name under which the health product or technology may be sold;
• (b)thelabelling of thehealthproduct or technology;
• (c)the statement of the representations to be made for the promotion ofthehealthproduct or technologyregarding
• (i)the claim to be made for the health product or technology;
• (ii)the dosageof the health product or technology;
• (i)the route of administering the health product or technology;
• (iv)the storage conditions of the health product or technology;
• (v)the contra-indications,the side effects and precautionsif any of the health product or technology;and
• (vi)the package size of the health product or technology.

(3)When evaluating an application, the Authority may

• (a)subject a sample of the health product or technology to an evaluation by an analyst;and
• (b)consider the evaluation report of the analyst that has evaluated the health product or technology.

(4)Where the Authority is not satisfied as to the quality,safety efficacy, performance or economic value of the health product or technology.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.(1) The Authority may,where it considers it necessary to protect public healthor in the event of a threat tolife or health,issue a provisional certificate ofregistration for a healthproduct or technology.

Authorization of unregistered health

(2)A person who intends to obtain the provisional certificate of registration for a health product or technology under subscction (1) shall apply to the Authority in the prescribed form.

incorporated outsideKenya,the applicant shall appoint a local representative who shall be a citizen of Kenya,a person who is or has permanent residence or a company incorporated in Kenya.

(4)An application under subsection (2) shall be accompanied by-

(a)such documents as may be necessary to support the

(b)where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya,acopy of the agreement appointing the local representative;

(c)proof that the applicant holds

• (i)avalid practicing licence issued by the body responsible for theprofession of pharmacy:
• (ii)a valid wholesale dealer's licence issued in accordance with this Act;
• (ii)avalid licence to sell health products or technologies issued in accordance with this Act; or
• (iv)a valid manufacturing licence issued in accordance with thisAct;and
• (v)proof of payment of the application fees as prescribed by the Authority.

(5)When determining an application under this section,the Authority shall consider the facts established from the valid marketing authorization for thehealth product or technology and thereporton the assessmentof thehealthproductor technologyobtained from theauthority competent for health products and technologies,if available.

(6)The person to whom the certificate of registration is issued under this section,shall be responsible for the labelling,packaging,advertising and pharmacovigilance system of the health product or technology.

(7)A provisional certificate of registration issued under subsection (1) shall be valid fortwoyears from the date ofissue oruntil thedeclarationmade under section S5of thePublic HealthAct is revoked.

(8)Anyvariation tothe agreement appointing the local representative to the application made under subsection(2) shall be notified to the Authority within seven days of the variation.

27D.(1) The Authority may,in writing.authorize a person to import or distribute for a specified period to a specifiedperson or institution a specified quantity of a particular health product or technology that is not registered.

product .1O technology.

(2)A health product or technology distributed pursuant to authorization granted under subsection (1) may be used for such purposes and in such

(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 applicant is not a citizen of Kenya or is a company incorporated outside Kenya,the applicant shall appoint a local representative who shall be a citizen of Kenya, a person who is or 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 toxicologicaldata and where applicable,human pharmacologicaland clinicaldata related to the health product or technology for which authority is sought;
• (b) written consent of the applicant,where applicable,
• () details ofregistration or pending registration of the health where applicable,
• (d)evidence of compliance by the manufacturer of the health standards as determined by the Authority;
• e) reasons why a registered health product or technology cannot be used;
• where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya,a copy of the agreement appointing the local representative;

(g)proof that the applicant holds-

• (i) a valid wholesale dealer's licence issued in accordance with this Act;
• (i)a valid practicing licence issued by the body responsible for the profession of pharmacy;
• (i)avalid licence to sell health products or technologies 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.

(6)Where the Authority issues an authorization under subsection (1), the person to whom the authorization is issued shall submit to theAuthority

• (a)progress reports after every six months from the date of issuance of the authorization;

• (b)any adverse event report,where an adverse event occurred; and
• (c)a progress report within thirty days after the completion or termination of the use of the healthproduct or technology.

(7)The Authority may,where it is of the opinion that the safety of any patient is compromised or where the scientific reasons for administering the unregistered healthproduct or technologyhave changed

• (a)impose any additional conditions;
• (b)request additional information;
• inspect the site where the unregistered health product or technology is manufactured, stored or administered;or
• (d)withdraw the authorization to treat the patient.

(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 or technology authorized under this section shall be labelled in accordance with this Act.

(10)An applicant shall notify the Authority ofany variation to the agreement appointing the local representative within seven days of the variation.

(11) The requirements in this section shall apply to applications for donations of health products and technologies

Justification:To provide new clauscs 27A,27B,27Cand 27D for the handling of applications ofproduct licences by the Authority.

Clause 28

THAT, Clause 28of the Bill be amended

• (a)in the marginal note by deleting the words"medicines register"and substituting therefor the wordshealthproducts and technologies register;
• (b)in sub-clause (1) by deleting the words"medicines register"and substituting therefor thc words"health products and technologies register;and
• (c)in sub-clause (2) by deleting the words"medicines registerand substituting therefor the wordshealth products and technologiesregister.

Justification:To harmonize the terms used in the Bill with theTitle of the Bill asproposcd for amendment.

Clause29

THAT, Clause 29 of the Bill be amended

• (a)in the marginal note by deleting the words"medicines and medical devices"and substituting therefor the wordshealth products and technologies";
• (b)by deleting sub-clause (1) and substituting therefor the following new sub-clause (1)

"(1)Every application for registration ofa health product or technology shall be submitted to the Registrar in the prescribed form and shall be accompanied by the prescribedparticulars and samples ofthe relevant healthproduct or technology and by the prescribed registration fee.

• (c)in sub-clause(s)
• (i)by deleting the word"medicine"appearing in paragraph (a) and substituting therefor the words"health product or technology;
• therefor the words"health product or technology;
• (ii)by deleting the word"medicine"appearing in paragraph (c)and substituting therefor thewords"health product or technology":
• (d) in sub-clause (4) by deleting the word "medicine" appearing in the opening sentence and substituting therefor the wordshealth product or technology";
• (e)by deleting sub-clause (6) and substituting therefor the following new sub-clause (6)

"(6)Where the Authority has approved the registration of any health product or technology ifitis satisfied ofthe safetyfficacy,qualitypeformanceand economicvalu ofthe healthproduct or technology,the Registrar shall register that health product or technology and shall enter in theregister such particulars inregard to the health product or technology as are required by thisAct to be so entered and shall issue to the applicant technology."

• (f)in sub-clause(7) by deleting the word"medicine"and substituting therefor the words "health product or technology";
• (g) in sub-clause (8) by deleting the word "medicine"wherever it appears and substituting therefor the words"health product or technology";
• (h)in sub-clause (9) by deleting the word "medicines"and substituting therefor the words "health products and technologies";
• (i)in sub-clause(1o)by deleting the word"medicineand substituting therefor the words "healthproduct or technology";
• (i)in sub-clause (11) by deleting the word medicineand substituting therefor the words "health product or technology";
• substituting therefor the words"health product or technology";

Justification:To harmonize the terms usedin thcBill with theTitle of theBill asproposed for amcndment.

• (l)in sub-clause(14) by deleting paragraph (a) and substituting therefor the following new paragraph (a)

"(a)Kenya Essential Medicines List,Kenya Essential Diagnostics list and Kenya Essential Medical Supplies list'means the list of essential medicines, diagnostics and medical supplies includedin the latest editions of the official publications relating toguidelines for standard treatment which is compiled by the statedepartment responsible for Health;

Justification:To broaden the scope ofHP'T's consideredunder the clause.

New Clauses

THAT, the Bill be amended by inserting the following new clauses immediately after clause 29-

Authorization of health products and technologies.

29A.(1)A person shall not import any health product or technology unless-

• (a)the imported health product or technology has been authorized throughissuanceof animport permit orawritten authorization by the Authority;and
• (b)the imported health product or technology is inspected and verified by an inspector of the Authority at the ports of entry prior to its release.

(2)No batch or lot of any registered product shall be released by the manufacturerprior to the completion of tests for conformity with standards applicable to such product and official batch or lot release by the Authority in cases ofbiological therapeutics

(s)Each applicable test conducted by the manufacturer under subsection (2)shall be made on each batch or lot after completion of all processes ofmanufacture and such test may affect compliance with the standard applicable to theproduet.

(4)The manufacturer or marketing authorization holder of any registered biological therapeutic shall submit lot summaryprotocol for cach lot that contains registered tests and results of tests performed and,such manufacturer or marketing authorization holder may berequired to submit samples ofproduct from the specifiedlottothe Authority for official batch orJotrelease in accordance with the prescribed regulations.

(5) Every batch or lot of a registered biological therapeutic imported into Kenya or manufactured in Kenya shall be evaluated and,on being satisfied of conformitywith prescribed standards and payment of prescribed fees,theDirector-General shall approve itsrelease into themarket and issue a certificate of official batch or lot release in the prescribed format.

(6)The Authority may recognize and accept oflicial lot release certificates issued by othernational regulatory authorities ofother countries for a specificbatch or lots of biological therapeuticmanufacturedwithin the territories of thosenational regulatory authorities,in issuance ofa certificate under this section.

Parallel importation of health products and technologies.

(7)A person who contravenes this section commits an offence and shall on convictionbeliable

• (a)in the case of a first offence, to a fine not exceeding one million shillings or toimprisonment for a termnot exceeding two years, ortoboth;or
• (b)in the case of a subsequent offence, to a fine not exceeding two million shillingsor to imprisonment for a termnot exceeding five years,or toboth.

Justification:To provide for authorization of health products and technologicsimported into the countryincluding the requiremcnt for batchor lot releaseinlinewith WHOrequirements.

29B.(1) A person shall not engage in the parallel importation of a health product or technology intoKenya unless-

• (a)the person is incorporated as a limited liability company under the Companies Act;
• (b)the person has been granted acertificate 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 oforigin.

(2)A person who wishes to undertake parallel importation of a health product or technology shall apply to the Board for a certificate ofparallel importation in the prescribed manner.

(3)The Board shall establish and maintain a system that ensures that aregisteredparallel imported health product or technology can be traced from its sourcing,manufacturing,packaging,storage.transport to its delivery to the health facility,institution or private practice where the health product or technology is intended to be used.

(4)Apersonwho

• (a)is the holder ofa certificate of parallel importation or licensee and fails to comply with any requirerment or obligation in this Act;
• (b)contravenes any prohibition prescribed by the Authority;or
• by the Board 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 excceding two years,or to both.

Justification:To make provision for parallel importation of hcalth products and technologies.

Clause S0

THAT,Clause 3O oftheBill be amended

• therefor the words"health product or technology;and
• (b)in sub-clause (s). by deleting the word "medicine"wherever it appears in paragraph (b) and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in theBill with theTitle of the Bill as proposed foramendment.

Clause 31

THAT,Clause 31 ofthe Bill be amended

• (a)in sub-clause (1) by deleting the word "medicine" and substituting therefor the words "health product or technology;and
• (b)in sub-clause (s).by deleting the word "medicineappearing in paragraph (c)and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in the Bill with theTitle oftheBill as proposed foramcndment.

Clausc S2

THAT, Clause S2 of the Bill be amended

(a)by deleting sub-clause(1) and substituting therefor the following new sub-clause(1)

"(1)The Authority shall cancel theregistration ofahealth product or technology if

• (a)a licensee has failed to comply with a condition subject to which a particular health product or technology has been registered;
• (b)a particular health product or technology does not comply with a prescribed requirement;or
• (c) it is not in the public interest to make a particular health product or technology available to the public."
• (b)in sub-clause (2)by deleting the wordsmedicine or medical devicewherever it appears and substituting therefor the wordshealth product or technology";
• (c)in sub-clause(4)-
• (i)by deleting the words medicine or medical device" appearing in the opening sentence and substituting therefor the wordshealth product or technology";and
• (i) by deleting the words "medicine or medical device" appearing in paragraph (b)and substituting therefor the words"health product or technology":and
• (d)by deleting the words"medicine or medical device"wherever it appears in sub-clause(5) and substituting therefor the words"health product or technology".

Justification:To harmonize the terms used inthe Bill with theTitle oftheBill asproposed foramendment.

Clause SS

THAT, Clause 53of the Bill be amended in sub-clause (1)by deleting the wordsmedicine or medical device"and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in the Bill with theTitle oftheBill asproposed foramendment.

Clause 34

THAT,Clause S4oftheBill beamended-

• (a)by deleting the words"medicines"and "medicine"wherever it appears and substituting therefor thewords"health product or technology":and
• (b)in the marginal note by deleting the words"medicines"and substituting therefor the words"health products and technologies".

Justification:To harmonize the terms used in the Bill with theTitle ofthe Bill asproposed foramendment.

Clausc 35

THAT, Clause 35of the Bill be amended

• (a)by deleting the word "medicine"wherever it appears and substituting therefor the words "health product or technology";

Justification:Toharmonize the terms used in the Bill with theTitle of the Bill asproposed for amcndmcnt.

• (b)in sub-clause (1) by inserting the words "or an cnrolled pharmaceutical technologist" immediately after the wordpharmacist";
• (c)in sub-clause(2) by inserting the words "or an enrolled pharmaceutical technologist immediately after the word"pharmacist";
• (d)in sub-clause(s) by inserting the words"or an enrolled pharmaceutical technologist immediately after the wordpharmacist;and
• (e)in sub-clause(4)by inserting the word or an enrolled pharmaceutical technologist immediately after the word"pharmacist".

Justification:For inclusion of pharmaccutical tcchnologists in the dispcnsing of intcrchangeable multi-source mcdicine.

Clause 36

THAT,theBill be amended by deleting Clause S6

Justification:The provision is a practicerelated issucs that is best handled through the proposed Pharmaceutical Practice Bill.

New Clause

THAT,theBill be amended byinserting thefollowing newclause immediately after clause S6

• Clinical trials. S6A.(1)A health product or technology shall not be used for clinical trial unless an approval is granted by the Authority with the approvalof the relevant ethics body.

(2)Aperson who intends to commence a clinical trialon ahealth product or technology 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.

(3)The study protocol submitted under subsection (2) shall include a post-trialaccess program to ensure access of investigational medicinal substances byparticipants in the trialbefore grant of marketing authorization by the Authority.

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

(5)A person granted an approval under this section shall put in place arobust quality assurance system to ensure that the clinical trial is carried out in a manner that ensures the integrity of data generated and the safety andwell-being of the participants of the study.

(6)TheAuthority shall carry out inspection of the clinical trials and monitor compliance of the clinical trials with the prescribedrequirements.

(7)Any amendments to clinical trials protocols shall be submitted to the Authority for approval beforeimplementation.

Justification:Toprovide for cffective regulation of clinical trials by the Authority.

Part V

THAT, the Bill be amended in the title to Part V by deleting the expression "PART V" and substituting therefor the expression"PART IV".

Justification:To correct aminor error innumbering of the parts of the Bill.

Clause 37

THAT,Clause 37of the Bill be amended

• (a)in sub-clause (2)by deleting the words"and dealers in mining.agricultural or horticultural accessories" appearing in paragraph (a);

Justification:Scheduled substances uscd in mining,agriculture and horticulture are regulatedunderotherlaws.

• (b)by inserting the following new sub-clause (s) immediately after sub-clause (2) (s)The Cabinet Secretary shall publish the list of scheduled substances prepared under subsection (1)in the Gaxette.

Justification:To provide for thepublication of the list of scheduled substances.

• (c)by renumbering sub-clause (S) as sub-clause(4);
• (d)by deleting sub-clause(4) and substituting therefor the following new sub-clauses

"(5)The Authority shall at least once every two years,review the lists under subsection (S),or whenever necessary in the interest of public health and safety.

(6)Any modification of the list of scheduled substances prepared under this section shall be subject to the procedure provided in subsection(1),(2)and (s)."

Justification:To cnhance the period of review of the lists of scheduled substances from oneyear to two years and providc for revicw in public interest where need arises.To cnsure that theprocedure setout in the clause in the preparation andpublication of the list ofscheduled substances is followed evenwhen thelists are modified.

Clause 38

THAT,Clause S8 of theBill be amended

(a)in sub-clause(1)by--

• (i)deleting the words "the Limitations prescribed by this sub-sectionand substituting therefor the words "the following limitations";

Justification:For proper drafting.The words "prcscribed by this sub-scction"are unnecessary.

(i) deleting paragraph (c)

Justification: Scheduled substances used in miningagriculture and horticulture are regulated under otherlaws.

(b)by deleting sub-clause(2)and substituting therefor the following new sub-clause(2)

(2) A person who is in possession of a scheduled substance otherwise than in accordance with theprovisions of thissection commits an offence and shall on conviction,beliable to a finenot exceeding twomillion shillings or to imprisonment for a termnot exceeding three years; or to both."

Justification:To enhance the penalty for the offence of possession of a scheduled substance contrary to the provisions of the Bill from Kshs.10o,00o to Kshs.2,0oo,0oo.

Clause S9

THAT,Clause S9 of the Bill be amended by deleting sub-clause(5)and substituting therefor the followingnew sub-clause(5)

(5) A license issued under this section shall be valid for a period of one year, renewable annually"

Justification:Annual cxpiry of the license is too punitive especially for persons who apply in themiddleof theyear.

Clause40

THAT,theBill be amended by deleting clause4O

Justification:Scheduled substances used in mining,agriculture and horticulture are regulatedunder otherlaws.

Clausc41

THAT,Clause 41of theBill be amended

(a)in sub-clause (1) by deleting paragraphs (c) and (e);

Justification:Scheduled substances used in mining,agriculture and horticulture are regulated under other laws.The National or County government cannot buy scheduled substances on its own,it must do so through a person licensed to do so under the Bill.

• (b)in sub-clause (2) by deleting paragraph (b) and (c); and

Justification:Thepersons to whom awholesaler dealer may sell scheduled substances to are set out in sub-clausc (1).

• (c)by deleting sub-clause(s).

Justification:Scheduled substances uscd in mining,agriculture and horticulture are rcgulatcd under other laws.

Clause42

THAT, Clause 42of the Bill be amended

Justification:To correct the cross reference as clause 41 makes reference to the written ccrtificate contemplated under clause 42.

• (b)in sub-clause (S)by deleting the words"three years" and substituting therefor the words "one year"

Justification:To reduce the penalty of imprisonment from thrce years to one year as the same is not commensurate to the fine ofone hundred thousand shillingsinrclation to the offence ofnot making cntries of sale of scheduled substances in a scheduled substances book.

Clause43

THAT, Clause 4S of the Bill be amended in sub-clause (1)

• (a)by deleting the opening sentence and substituting therefor the following new opening sentence-

(1)A qualified healthcare professional may supply or dispense a Scheduled Substance with therapeutic value for the purpose of medical, dental or veterinary treatment, as the case may be, subject to the following provisions

Justification:To rrestrict dispensing of scheduled substances to authorized persons.

(b)in paragraph (b)by-

• (i) inserting the word"and" immediately after the word"supplied" appearing in sub paragraph (ii); and
• (i) deleting the word "and" appearing in sub-paragraph (iv);

Justification:To correct a minor drafting crror.

(c)by deleting paragraph (c).

Justification:Registercd midwives are included in the qualificd healthcare professional provided in the amended sub-clause(1).

Clause45

THA'T, the Bill be amended by deleting Clause 45 and substituting therefor the following new clause 45

Automatic 45.(1)An authorized seller may use an automatic machine to dispense overmachines. the-counter scheduled substances.

• (2)The Authority shall develop regulations on the-
• (a) classes of substances permitted;
• (b)quantities of substances to be dispensed;
• (d)location of automatic machines; and
• (c)records of substances dispensed;
• (e)registration of automatic machines.

Justification:To provide for the use of automatic machines in dispensing selected scheduled substances in an effort toleverage on technology.

Clause 46

THAT,theBill be amended by deleting Clause 46 and substituting therefor the following new clause 46-

Electronic 46.(1) The Authority shall prescribe guidelines to provide for the electronic sale of healthsupply and dispensing of scheduled substances including through e-pharmacy, products and telemedicine,medication therapy management and online pharmacy. technologies.

(2)The regulations made under subsection(1)shall provide for

• (a)licensure ofe-pharmacies;

• (b) safety of patients;
• (c)verification of the identity and traceability of patients;
• (d)verification of the identity and traceability of prescribers; and
• (e)integrity.legitimacy and authenticity of prescriptions including avoidance of multiple use of the same prescription.

(s)The electronic supply and dispensing of scheduled substances shall be permitted provided that thesupply of such healthproducts and technologies conforms with all requirements for the particular health product or technology in terms of its scheduling status and any other requirements as may be specified in regulations in relation to such supply or dispensing

(4)In the case ofaprescription-only medicine,therequired prescription shall have been obtained as a result ofat least one physical interaction between an authorised practitioner and the patient within a period ofat least 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 proper regulation of clectronic sale of medicine which is already a global phenomenon asmany onlineplatforms are sellingmedicines to consumers and to enhance the fines in relation to the saleof scheduled substances using electroniemeans to cnsure that quality isguaranteed.

New Clause

THAT, the Bill be amended byinserting the following new clause immediately after clause 46

Dietary supplements.

46A.(1)A dietary supplement shall

• (a)not contain scheduled substances; and
• (b)have a stated or implied therapeutic purpose.

(2)Where a dietary supplement contains folic acid,the maximum daily dose for the dietary supplement shall be as per theguidelines prescribed by the Board of the Authority.

Justification:To provide for dietary supplements which will enhance the regulation of food supplements by the Authority.

Part Vi

THAT,the Bill be amended in the title of Part VI by deleting the expression "PART VIMANUFACTURE OF MEDICINALSUBSTANCES"and substituting therefor the expression "PARTIV-MANUFACTUREOFHEALTHPRODUCTS".

Justification:To correct a minor crror innumbering of the parts of the Bill.

Clause47

THAT,Clause 47of theBill be amended-

• (a)in sub-clause (1) by deleting the words medicinal substance" and substituting therefor the words"health product;

Justification:To harmonize the terms uscd in the Bill with theTitle ofthe Bill asproposed for amendment.

• (b) by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)

"(2) A manufacturing licence issued under this section shall be valid for a period of one year,renewable annually."

Justification:Togive themanufacturinglicencevalidity foroneyear.

• (c)in sub-clause (s) by deleting the words medicinal substance" and substituting therefor the words"health product;
• (d)in sub-clause(4)by deleting the wordsmedicinal substanceand substituting therefor the words"health product";

Justification:To harmonize the terms used in the Bill with theTitle oftheBill as proposed for amendment.

• (e)by inserting the following sub-clauses immediately after sub-clause (5)-

(6)The Authority shall prescribe regulations setting out conditions for the qualifications ofpersonnel involved in the productionprocesses of a health product regulated under this Act

(7)The personnel qualified to conduct lotrelease ofvaccines and batch release of health products shall submit their qualifications to theAuthority.

(8)Any person who commits an oflence under this section is on conviction,liable to a fine not exceeding ten million shillings,or to imprisonment for a term not excceding ten years, or to both."

Justification:Substandard,falsified and falsely labclled hcalth products occasion serious public health challenges.

Clause48

THAT,Clause 48of theBill be amended

• (a)by renumbering the provision as sub-clause(1);and
• (b)by inserting the following new sub-clauses immediately after sub-clause (1)

(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 fees.

(3)The Cabinet Secretary shall make regulations for the better carrying out of the provisions of this section.

(4)Without prejudice to the generality of subsection (s), the Authority shall make regulations on-

• (a)revocation and suspension of manufacturing licences;
• (b)withdrawal of revocation of manufacturing licences upon request;and
• (c)transfer ofmanufacturing licences."

Justification:Togive theAuthoritypower cnforce compliancewithgood manufacturing of internal quality control systems and produetion processes by manufacturers.

PARTVII

THAT, the Bill be amended in the title of Part VII by deleting the expression "PART VII and substitutingtherefor the expression"PARTVI".

Justification:To correct a minor error in numbering of the parts of the Bill.

Clause 51

THAT,theBill be amended by inserting the following new clauses immediately after clause 51

Information that is required to be displayed on the pack.

51A.A person dealingin a therapeutic cosmetic shall indicate

• (a)the common name of the therapeutic cosmetic;
• (b)the net weight;
• (c)all the cosmetic ingredients in the order of prominence but not including flavoursor fragrances;
• (d) the name and address of manufacturer of the therapeutic cosmetic;
• (e)a warning statement; and
• (f)a statement that the therapeutic cosmetic is capable of curing or treating any disease or medical condition.

Justification:To enhance transparency on the ingredients used in therapeutic cosmetics in line with the Good Manufacturing Practices

Manufacturing 51B.(1) The Cabinet Secretary shall make regulations for the efective of cosmetics. implementation of this section.

(2)The regulations made under subsection (1) may—

• (a)require manufacturers of cosmetics to register with the Authority;and

• (b)impose restrictions,requirements or other conditions on manufacturers of cosmetics,if such restrictions,requirements or conditions are necessary to protect 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 words "treat, diagnose or prevent disease, or affect the structure or functions of the body"

Justification:Using the term"therapeutic cosmetic"already indicates that the cosmetic has therapeutic effect hence there is no need to restate the same.

Clause54

THAT, Clause 54oftheBill be amended by

• (a) deleting sub-clause (s) and substituting therefor the following new sub-clause (s)

"(3)Any person who manufactures,sells,supplies,imports or exports a therapeutic cosmetic which contains a prohibited ingredient commits an offence and,on conviction, shall beliable to a fine not exceeding onemillion shillings,or to imprisonment for a term not exceeding two years, or to both.

Justification:To provide for a penalty for the offence of manufacturing or selling therapeutic cosmetics that contain prohibitedingredients.

• (b) inserting the following new sub-clause immediately after sub-clause (s)

"(4)The Authority shall make regulations exempting from any labelling requireinent of this Part,therapeutic cosmetics which are,in accordance with the practice of the trade tobe processed,labelled,or repacked in substantial quantities at establishments other than those where originally processed or packed,on condition that such cosmetics are not adulterated or misbranded under the provisions of thisPart upon removal from such processing,labelling or repacking establishment."

Justification:To allow for themaking ofregulations on use of prohibited ingrcdicnts in relation to thcrapcutic cosmetics.

PARTVIII

THAT, the Bill be amended in the title of Part VIII by deleting the expression PART VIII and substituting therefor the expression"PAR'TVII"

Justification:To correct a minor crror in numberingof the parts of the Bill.

Clause 55

THAT, Clause 55 of the Bill be amended in sub-clause (1) by inserting the words,in-vitro diagnostics medical devices register"immediately after the wordshuman medical devices register".

Justification:To make provision for in-vitro diagnostics.

Clause 56

THAT, Clause 56of the Bill be amended in sub-clause (1) by inserting the words "falsified, falsely-labelled or counterfeited"immediately after the word "substandard"appearing in paragraph (c).

Justification:To incorporate internationally accepted terminology.

Clause 58

THAT,Clause 58 of theBill be amended-

• (a)in sub-clause(2) by inserting the words"in accordance with the most recent World Health theword"Authority";

Justification: :This will enable the country to comply with WHO standardson manufacturing.

• (b)by inserting the following new sub-clauses immediately after sub-clause (2)

(3)The Authority shall receive from the Kenya Nuclear RegulatoryAuthority established under the Nuclear RegulatoryAct,documented evidence of radiation required to enable a medical device perform its therapeutic and diagnostic functions and the intendedpurpose of the device,for issuance of a registration certificate for a medical device.

(4)An importer,distributor or dealer shall establish and implement documented procedures for themaintenance of importation or distribution records and shall maintain an importation or distribution record ofeachmedicaldevice tobe submitted to the Authority."

Justification:To allow the Authority to consult and reccive advice from theKenyaNuclear Regulatory Authority that exercises regulatory control ovcr nuclear and radioactive materials and facilitiesunder section 6(c)(i)of the Nuclear Regulatory Act,No.29of2019. Torequire importers,distributors or dealers tokceprecords ofmcdical devices submitted to the Authority.

Clause 59

THAT, Clause 59 of the Bill be amended in sub-clause (1) by inserting the words unregistered establishments for medical devices and"immediately after the word"under".

Justification:To provide for thercgistrationof cstablishments formedical devices by the Authority.

New Clause

THAT, the Bill be amended by inserting the following new clause immediately after clause 59

Registration of59A.(1)An application forregistration of amedical devices establishment medical devices shall be submitted to the Authority in the prescribed format and shall be establishment. accompanied by the prescribed fees.

(2)An importer,distributor or dealer will establish a system of notification of field safety corrective action and shall notify the Authority ofsuch system.

(3)Where the Authority is satisfied that the application under subsection (1)meets the prescribed requirements,the Director-General shall issue a registration certificate for the medical devices establishment in the prescribed 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)The registration certificate for manufacturers shall be valid for five years following a successful reinspection.

(6)The Authority may refuse to issue a medical devices establishment registration certificate where

• (a)an applicant has made a false or misleading statement in the application;
• (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 ofpatients,users or other persons;or
• ((c)an applicant has failed to meet the prescribed conditions for medical devices establishment registration.

(7)Where the Authority does not issue a medical devices establishment registration certificate under subsection (6)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 providerelevant documentation or evidence in support of the application.

(8)After the issuance of a medical devices establishment registration certificate,where there is a change to any of the information submitted at thetime of application,the holder of theregistrationcertificate shall submit thenewinformation to theAuthoritywithin ten workingdays ofthe change.

Justification:To make provision for the registration of establishments for medical devices.

NEWPART

THAT,the Bill be amended by inserting the following new Part immediately after the new clause59A-

PARTVII-THENATIONALPHARMACOVIGILANCESYSTEM

Pharmacovigilance.59B.(1) The Authority shall establish a National Pharmacovigilance Centre which shall set up and manage thenationalpharmacovigilance and post marketing surveillance system.

(2)The Centre established under subsection(1) shall receive and maintain all relevant information about suspected adverse drugreactions and adverse events to health products or technologieswlhich havebeen authorized by theAuthority.

(s)The Authority shall conduct both passive surveillance and active surveillance of health products and technologies.

(4)The Authority shall carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements.

(5)All entities responsible for placing a health product or technology in the market shall establish andmaintaina pharmacovigilance system for managing safety information of health products and technologies.

(6)The entities referred to in subsection(5) shall submit safety information to the Authority in the prescribed manner.

()The consumers,general public and health care professionals shall report adversereactions and adverse events to the Authority in the prescribed manner.

Justification:To anchor the role of the Authority in the regulation of pharmacovigilance in the country.

PARTXI

'THAT, the Bill be amended in the title of Part XI by deleting the expression "PART XI and substituting therefor the expression"PARTIX".

Justification:To correct aminor error innumbering of the parts of the Bill.

Clause 60

THAT theBill be amended by deleting Clause 6O and substituting therefor the followingnew clause60

Establishment ofthe National Quality Control Laboratory.

60.(1) There is established the National Quality Control Laboratory of the Authority which shall be used as a facility for

• (a)the examination and testing of health products and technologies includingvaccines and biopharmaceuticals and any material 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 andmedicinal substances;
• (b)performing chemical,biological,bio-chemical,physiological and pharmacological analysis and other pharmaceutical evaluation;
• (c)testing.on behalf of the Government, of locally manufactured and imported healthproducts and technologiesin the Kenyan market prior to marketing authorization,redistribution and post-distribution;
• d) field testing ofregulated products using screening techniques;
• (e) providing technical support to local manufacturers and building regulated products through on site and off site training and laboratory assessments;
• conducting investigations into the quality and safety status of regulatedproducts developing and administering a data bank on quality assurance of all health products and technologies and generating scientific evidence and reports on the quality and safety status of theregisteredproducts;
• (g)conducting research and training and providing high quality analytics and expert knowledge in the areas of medicinal products and active pharmaceutical ingredients; and
• (h)developing and administering a data bank on quality assurance on behalfoftheAuthority.

(2)The National Quality Control Laboratory shall be the quality control laboratory of healthproducts and technologies for the Authority.

(S)The Board of the Authority shall appoint a Director,National Quality Control Laboratorywho shall beresponsible to theAuthority for the day to daymanagement of the National Quality Control Laboratory.

(4)The Director National Quality Control Laboratory shall hold office on such terms and conditions of service as may be specified in the instrument of appointment by theBoard of the Authority.

(5)The Director National Quality Control Laboratory shall be a registered pharmacist and shall possess a Master's degree in a science related field from a recognized university.

(6)The Director of the National Quality Control Laboratory shall

• (a)oversee and coordinate all operations and administration of the National Quality Control Laboratory and provide technical guidance on quality control;

• (b)ensure timely quality control testing ofall samples in conformity with national and international standards;
• (c)co-ordinate and supervise the activities of the National Quality Control Laboratory including staff;
• (d)collaborate with other laboratories,regulatory and law enforcement agencies,manufacturers of pharmaceutical and other health products toensure quality inhealth products andtechnologies;
• (e)handle appeals on test results;
• (f)where the laboratory lacks capacity,subcontract laboratory testingservices;
• (g)advice the Authority on matters of testing and quality control over health products and technologies;and
• (h)perform any other duties assigned by the Authority from time to time.

(7)The funds to be used for the management of theLaboratory shall consistof all moneysreceived or recoveredunder thisPart and a portion of the moneys appropriated byParliament to the Authority.

(8) Subject to subsection (7),monies generated by the Laboratory in the course of the performance of its functionsunder this section shall be solely expended on the Laboratory.

Justification:The NQCL,hcaded bya Director appointed by the Authority,to bccome a regulatorylaboratory of theAuthority asrccommended bytheWHOso thatthecountry can achieve Maturity Level s.To ringfence monics for the Laboratory such that monics generated by theLaboratory shall be solely expendedon theLaboratory and the Authority ought to give a portion of the monies appropriated to it byParliament to theLaboratory.

Clause 61

THAT,Clause 61 of the Bill be amended in sub-clause (1)by deleting the words "DirectorGeneraland substituting therefor the words "Director of the National Quality Control Laboratory".

Justification:For compliance with WHO guidelines which requires that a certificate of analysis should be issued by a person capableofensuring the authenticity of the test samples.

PARTXII

THAT, the Bill be amended in the title of Part XII by deleting the expression PART XII and substituting therefor the expression"PARTX"

Justification:To corrcct a minor crror in numbering of the parts of the Bill.

Clause 63

TIIAT,Clause 6S of the Bill be amended-

• (a)in sub-clause(1) by deleting the words"medicine, drug,appliance or article"wherever they appear and substituting therefor the words "health product or technology";and

Justification:To harmonize the terms used in the Bill with theTitle of theBill asproposed for amendment.

• (b)in sub-clause (2)by inserting the words "or enrolled pharmaceutical technologists

Justification:To include enrolled pharmaceutical technologists as part of personswho are covered under the provided defence in rclation to offences as regards prohibition of advertiscments on diseascslisted in the Sixth Schedule.

Clause 64

THAT,Clause 64 of the Bill be amended by deleting the wordsa 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 theTitle of the Bill as proposed for amendment.

Clause65

THAT,Clause G5 ofthe Bill be amended

• q(e)qdeeedu()
• (i)deleting the words"or similar article;and
• (ii) deleting the word"extravagant,"

Justification:To ensure objcctivity.

• (b)in paragraph(b) by deleting the word"an article"and substituting therefor the words"health product or technology".

Justification:Toharmonize the terms used intheBill with theTitle oftheBill asproposed foramendment.

Clause 66

THAT,Clause 66of theBill be amended

• (a)in sub-clause(1)
• (i)by deleting the words "drug. appliance or article"wherever they appear in paragraph (a)and substituting therefor the words"health product or technology;and

• (i)by deleting the words "drug.appliance or article"appearing in paragraph (b)and substituting therefor the words"health product or technology";

Justification:To harmonize the terms usedin theBill with theTitle ofthe Bill asproposed for amendment.

(b)in sub-clause(s) by-

• (i)renumbering the provision as clause (2) and
• (ii)by inserting the words",enrolled pharmaceutical technologistsinmediately afiter the word "pharmacistsappearing in paragraph (ii)

Justification:To include cnrolled pharmaceutical technologistsas part 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.

Clause 67

THAT Clause 67oftheBill beamended

• (a)by deleting the word"articles"appearing in the marginal note and substituting therefor the words"health products and technologies";
• (b)by deleting sub-clause (1) and substituting the following new sub-clause (1)

(1) Subject to this Act, a person shall not sell by retail a health product or technology consisting ofor comprising a substance recommended as a medicine unless there is written soas to be clearly legible on the health product or technology or on a label affixed thereto, orifthehealth product or technology is sold or supplied inmore than one container,on the inner container or onalabel affixed thereto

• (a)the appropriate designation of the substance so recommended or of each of the active constituents,or ofeach of the ingredients from whichit has been compounded;and
• (b)in a case where the appropriate designation of each of the active constituents or ingredients is written,the appropriate quantitative particulars of the constituents oringredients;provided that this subsection shall not apply to a health product or technology made up and supplied for the use of a particular person,being an article prescribed by reference to the needs of that person.
• (c) in sub-clause (2) by deleting the word "article"wherever it appears in the definition of appropriate quantitative particulars"and substituting therefor the wordshealth product or technology";

Justification:Toharmonize the tcrms used in the Bill with theTitle oftheBill as proposed for amendment.

(d) in sub-clause(s)by

• (i)deleting the word an article"appearing in sub-clause (S) and substituting therefor the words"a healthproduct or technology";

Justification:To harmonize the terms uscd in theBill with theTitle of theBill as proposed for amendmcnt.

• (i)deleting the words two hundred thousandappearing in paragraph (a) and substituting therefor the words"one million";
• (ii) deleting the words "three hundred thousand"appearing in paragraph (b)and substituting therefor the wordstwo million

Justification:To make the fines payable commensurate to the offencesrelating tolabeling ofhealth products and technologies containingmcdicine.

Clause68

THAT, the Bill be amended by deleting Clause 68.

Justification:It is preferable to make provision for valid excmptions through regulations asopposcd to providingdefences for offences relating to labeling ofmedicines.

Clause 69

TIAT, Clause G9 of the Bill be amended by

• (a)deleting the word article"and substituting therefor the words"health product or technology";and
• (b)deleting the word articles"and substituting therefor the words"health products and technologies".

Justification:To harmonize the terms used in theBill with theTitle of theBill asproposed foramendment.

PARTXIII

THAT, the Bill be amended in the title to Part XIII by deleting the expression"PART XIIl" and substituting therefor the expression"PART XI".

Justification:To correct a minor crror in numberingof the parts of the Bill.

Clause71

THAT,Clause71 of theBill be amended

• (a)in the marginal note by deleting the words medicines or medical devicesand substituting therefor the wordshealth products and technologies;and
• (b)in sub-clause (1) by deleting the words or homoeopathic medicine,preparation or medical deviceand substituting therefor the words"health products and technologies".

Justification:Toharmonize the terms used in theBill with theTitle of theBill asproposed foramendment.

Clause79

THAT,Clause 72 of the Bill be amended

• (a)in the marginal note by deleting the words"medicine or medical devices"and substituting therefor the words"health products and technologies";

Justification:To harmonize the tcrms used in theBill with theTitle of the Bill as proposed foramendment.

• (b)in sub-clause (1) by inserting the words including a health product and technology for

Justification:Tomake provision for supply of health products and technologies during cmergency situations.

• (c)in sub-clause (s)by deleting the words medicine or medical device product"and substituting therefor the words"health product or technology".

Justification:Toharmonize the terms usedin theBill with theTitle of the Bill asproposcd foramendment.

Clause 73

THAT, Clause 7S of the Bill be amended

• (a)in the marginal note by deleting the wordgoods"and substituting therefor the words "health products and technologies".
• (b)in sub-clause (1)by deleting the words "drug.article"wherever they appear and substituting therefor the words"health product or technology;
• substituting therefor the words"health product or technology";
• (d)in sub-clause (s)by deleting the words"drug or article"and substituting therefor the words"health product or technology;and
• (e)in sub-clause (4) by deleting the words"drug or article"and substituting therefor the words"healthproduct or technology"

Justification:To harmonize the terms usedin theBill with theTitle of theBill as proposed foramendment.

Clause78

THAT, Clause 78 of the Bill be amended in sub-clause (1) by inserting the words or enrolled pharmaceutical technologist" immediately after the wordsregistered pharmacist"appearing in paragraph (b).

Justification:To provide for the application ofpenal sanctions to enrolled pharmaceutical technologists as regards body corporates.

Clause79

THAT, the Bill be amended by deleting Clause 79 and substituting the following new clause 79

Inspection and 79.(1)Aperson who imports a health product or technology shall notify the verification ofinspectors oftheAuthority 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.

health products and technologies at theportsof entry.

(3)Any person who commits an ofence under this section is upon conviction,liable to a fine not excceding one million shillings,or to imprisonment for a term not exceeding two years,or to both.

Justification:Clause 79 be deleted as the function ofinspection of animals intended for slaughter is outside the regulatorypurview of the Authority.

Thenew clause on inspection andverification of hcalth products and technologies at the ports of entry cnables theAuthority tocnforce compliance with the prescribed standards ofquality,safety and cfficacy ofhealth products and technologies before relecase at the ports ofcntry so as to prevent concealment,misdeclaration,diversion and cross border smuggling ofhealth products and technologies.

Clause 80

THAT,Clause SO of the Bill be amended

• therefor the words "health product or technology"and "health products and technologies"respectively in sub-clause(6),(7),(8),(9),(10),(11)and (12).

Justification:Toharmonize the terms uscd in theBill withtheTitle of theBill as proposcd for amendment.

(b)in sub-clause(1) by

• (i)deleting the word"article"wherever it appears and substituting therefor the words "health product or technology";and

Justification:To harmonize the terms used in the Bill with theTitle oftheBill asproposed foramcndment.

• appearing in paragraph (b).

Justification:To expand the scopc to include all othermcans of conveying hcalth products and technologics.

Clause 81

THAT,the Bill be amended by deleting Clause 81.

Justification:The clause infringes on the exercise of the functions of the Authority contrary to therecommendation of theWorld Health Organization.

Clausc 82

THAT,the Bill be aimended by deleting Clause 82

Justification:Regulation is a function of National Government under the Fourth Schedule tothe Constitution.

Clause 8s

THAT, the Bill be amended by deleting Clause Ss.

Justification: Thc clause infringes on the exercise of the functions of the Authority contrary to therecommcndation oftheWorld Health Organization.

Clause 85

THAT, Clause 85 of the Bill be amended by deleting the word articlewherever it appears and and substituting therefor the words"health product or technology".

Justification:To harmonize the terms uscd in theBill with theTitle of the Bill as proposed foramendment.

Clause 86

THA'T, Clause 86 of the Bill be amended in sub-clause (1) by deleting paragraph (b)and substituting therefor thefollowing newparagraph (b)

"(b) in the case of a subsequent offence, to a fine not excecding one million shillings,or to inprisonment for a term not exceeding two years, or to both".

Justification:To makc cnhance the general penalty for offences committed in relation to this Bill and to makethe finespayable commensurate to the imprisonment terms.

Clause 87

THAT, Clause 87 of the Bill be amended in sub-clause(1) by deleting the word articlewherever it appears and substituting therefor the words"health product or technologyin paragraph (c)

Justification:Toharmonize the terms used in the Billwith theTitle of the Bill asproposed foramendment.

PARTXIV

THAT, the Bill be amended in the title of Part XIV by deleting the expression "PART XIV and substituting therefor the expression"PARTXII".

Justification:To correct a minor error innumbering oftheparts of the Bill.

Clauses8

THAT, Clause 88of the Bill be amended by deleting paragraph(a) and substituting therefor the following new paragraph (a)

"(a) such monies as may be appropriated by the National Assembly for the purposes of the Authority".

Justification:For proper drafting and consistcncyin the wording used in the StatuteBook.

Clause91

THAT, Clause 91 of the Bill be amended by-deleting the wordsKenya National Audit Office" wherever they appear and substituting therefor the words "Auditor-General".

Justification:For proper reference to the Auditor-General as designated underArticle 229 ofthe Constitution andwhich is the successor of theKcnya National Audit Office.

PARTXV

THAT, the Bill be amended in the title of Part XV by deleting the expression PART XV"and substituting therefor theexpression"PAR'TXIlI"

Justification:To correct a minor crror in numbering of the parts of the Bill.

Clausc95

THAT, Clause 95 of the Bill be amended

• (a)in sub-clause g by-
• (i) deleting thewords"any drug" in paragraph (a)(i);
• (i)deleting the word "drugs,in paragraph (a)(i);
• (ii) deleting the word "product"and substituting therefor the word "products"in paragraph(d);
• (iv)deleting the word"drugs"wherever it appears and substituting therefor the words"health products or technologies"inparagraph (h);
• (v)deleting the word"article"and substituting therefor the words "health product or technology"in paragraph (k);
• (vi)deleting the word"articles"and substituting therefor the words"health products and technologies"in paragraph (m);
• (vi) deleting the words"drugs,medical devicesand substituting therefor the
• (vii) deleting the word "medicines"and substituting therefor the words"health

(ix)deleting paragraph (x)and substituting therefor the following new paragraph (x)

• "(x)governing administration of clinical trials of health products and technologies;
• (x)deleting the words "medicine,medical device"and substituting therefor the wordshealth product or technologyin paragraph (aa);
• (xi)deleting the words"medicines or medical devices"and substituting therefor the words"health products or technologies"in paragraph (bb):
• (xii) deleting paragraph (dd)and substituting therefor the following new paragraph (dd)

(dd) the compounding of health products and technologies and the dispensing ofhealth products and technologies

Justification:To harmonize the terms used in the Bill with theTitle ofthe Bill asproposcd for amendment.

• (xili) inserting the words ",an enrolled pharmaceutical technologist immediately after the word "pharmacist" in paragraph (bb);

Justification:For inclusion of pharmaceutical technologistswho are currently involved in the dispensing ofmcdicines and medical devices pursuant to thePharmacy and Poisons Act, Cap.244 and thcir scope of training

• (xiv) deleting paragraph (i);

Justification:'The general provision on the making of regulations is set out in sub-clause (1).

• (xv) inserting the following new paragraphs immediately after paragraph (ii)

"(i)on pharmacovigilance and post market surveillance;

(kk)officialregulatory lot release ofvaccines and other biological products imported and manufactured inKenya;

(ll)pricing of health products and technologies;

(mm)good practices in the regulation ofmedical products;

(nn)inspections,licensure and certification of the manufacture ofmedical products by health facilities;

(oo)inspections,licensure and certification ofmanufacture of medical products and otherregulated products by facilitiesnot directlyregulated by the Authority including steel industries, sugar industries;

(pp)inspection and recognition of pharmaceutical quality control laboratories;

(qq)to regulate licit use of narcotic and psychotropic substances; and

(rr} to regulate parallel importation of medicines;

(b)by renumbering sub-clause (2) as sub-clause(s)

Justification:To provide for the making ofregulations on licit use of narcotic and psychotropic substanccs,parallel importation of medicines, safety monitoring, pharmacovigilance andpostmarket surveillance.

Clause 96

THAT,Clause 96 ofthe Bill be amended

• (a)in sub-clause(1)by-
• ()deleting the word "Board"and substituting therefor the word"Boards";
• (ii) deleting paragraph (d) and substituting therefor the following new paragraph (d)-

(d)all members and staffof the former Boards shall be deemed tobemembers and staff of the Authority,and subject to the provisions of any rules made under this Act, shall continue in oflice for the period for which they were appointed as members and staff of the former Boards.

• (b)by deleting the sub-clause (2)and substituting therefor the following new sub-clause (2)

"(2)In this section,"the former Boardsmeans 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:Toprovide for the transition ofboth thePharmacy and Poisons Board and theBoard ofManagemcntof thcNational Quality Control Laboratory.

• (c)in sub-clause(s) by deleting the word "twelve"appearing in the opening sentence and substituting therefor the words"twenty-four"

Justification:To provide sufficicnt time which will facilitate the conduct ofextensive stakcholder participation on the regulation of pharmacy practice rcgulation.

Clause97

THAT, Clause 97 of the Bill be amended by inserting the wordswith reference to section 96 (3) immediately after the words "that Schedule" in sub-clause (1).

Justification:To prevcnta lacuna in respect ofthe regulation of the pharmaccutical practice.

Second Schedule

THAT, the Bill be amended by deleting the Second Schedule.

Justification:The Chairpcrson,Board Members and Director General of the Authority arc not State Officers and hence do notneed to subscribe to an oath.

Third Schedule

THAT,the Bill be amended by deleting the Third Schedule Justification:The matters of the tenure of office,allowances,protection fromliability and disclosure of interest by Board members are already provided for in the main Bill.The issue of approval of theBoard members by theParliament hasbcen proposed for deletion as the Authority's Board members arc not State Officers.

Fourth Schedule

THAT, the Fourth Schedule of the Bill be amended by deleting paragraph (1),(2),(S).(4) and (5) and substitutingtherefor the followingnew paragraphs

1. Biologics Committee. 2. Pharmacovigilance Committee. 3. Complementary,Alternative or Herbal Medicines Committee

• k. Radiopharmaceuticals Committee.

5. Cosmetics and Borderline Products Committee 6. Clinical Trial ScientificTechnical Advisory Committee. 7. Health Technology Assessment Committee. 8. Nutraceuticals and Dietary Supplements Committee. 9. 9.Digital Health and Technologies Committee 10. 10.Medical Devices and Health Technologies Committee. 11. 11.Veterinary Medicines Committee.

Justification:The scientifie advisory committces amended to take into account all aspccts ofhealth products and technologies and to delete the Scientific Advisory Committces on food which is outside the scope of the Bill as amended.

Seventh Schedule

THAT,the Seventh Schedule of the Bill be amended by

• (a)deleting the word Boardin the paragraph on Cap.244
• (b) deleting the phrase"(s. 116) and substituting the phrase(s.97")

Justification:For proper cross referencing of the Pharmacy and Poisons Act,Cap.24 and clause 97 on repeals.

• (c)deleting the paragraph on Cap.254.

Justification: Food is outside the purview of the Bill.

3.2Submissions by Hon.Anthony Oluoch,MP

The Hon.Anthony Oluoch,MP appeared before the Committee on on S1 October,2021,and made the following submission:-

The Hon.Anthony Oluoch,MP presented the following amendments to the Committee;

LongTitle

THIAT,the Bill be amended by deleting the LongTitle and substituting therefor the following new LongTitle

"ANACTofParliament toestablish theKenya Health Products and Technologies Authority to ensure safety.quality and efficacy or performance of drugs,poisons,therapeutic and biological products,therapeutic cosmetics,herbal medicines and products,chemical substances,medical devices,veterinary products and other health technologies;toprovide for the harmonization and administration of the laws relating to the regulation of,drugs,poisons,therapeutic products, therapeutic cosmetics,chemical products,veterinary products and medical devices and the control and safe handling of poisons;to safeguard the security of the supply chains for, therapeutic products,cosmetics and veterinary products; to provide for measures to optimize the use of therapeutic products in health care in Kenya and for connected purposes.

Clausc2

THA'T,the Clauseof theBill be amended

• (a)in the definition of the term"advertisement"by deleting the wordsherbal medicines and products";
• (b) in the definition of the termarticle"by
• (i)deleting the words"herbal medicine"appearing in paragraph (a);and
• (c)in the definition ofauthorized seller ofscheduled substancesby inserting the wordsand enrolled as a pharmaceutical technologist or registered as a pharmacist" immediately after the word"Act";
• (d)in the definition of the term "health products and technologies by deleting the words "herbalmedicines and products";
• (e)by deleting the definition of the termherbal medicine or productand substituting therefor the following new definition-

"herbal medicine or product"means a plant derived material or preparations with claimed therapeutic or other health benefits,which contain either raw or processed ingredients fromone ormoreplantsormaterial ofinorganicor animal originand includes herbsherbalmaterials,herbal preparations,finished herbal products that contain activeingredients,parts of plants or other plant materials orcombinations andexcludes herbs,herbal materials,herbal preparations,finished herbal products sold ordispensedon a small scaleby traditional healthpractitioners;

• (f)in the definition of the term"medicineby inserting the words"other than herbal medicines or products"immediately after the words"or mixture of substances"
• (g)in the definition of"pharmacy"by inserting the words "licensed and"immediately after the wordscarried out by"appearing in paragraph (a);
• (h)deleting the definition of"chemical substance"and substituting therefor the following new definition--

"chemical substancemeans any substance or mixture of substances prepared, sold or represented for use as a germicide, antiseptic,disinfectant,pesticide,insecticide rodenticide,vermicide,detergent or any other substance or mixture ofsubstances which the Authority may,declare tobe a chemical substance;

• (i)deleting the definition of"therapeutie cosmetic"and substituting therefor the following new definition-

therapeutic cosmeticmeans a product with the ability to trigger biological actions on the dermis, to target and repair skin issues, to prevent fiuture damage and contains ingredients that are usually not found in regular cosmetics or at higher strengths than could be sold safely over the counter;"

Clause 3

THAT,Clause S of the Bill be amended

• (a)in sub-clause (1) by deleting paragraph (c); and
• (b)by inserting the following new sub-clause immediately after sub-clause(2) (s)This Act shall not apply to the regulation of herbal medicines or products.

Clause 6

THAT, Clause 6 of the Bill be amended in sub-clause (4) by deleting the word ten in appearing in paragraph (c) and substituting therefor the word "fifteen"

Clause 8

THAT, Clause 8 of the Bill be amended in sub-clause (7) by inserting the words",fair representation of persons with disabilities"immediately after the words"regional balance."

Clause 12

THAT, Clause 12 of the Bill be amended in paragraph (o) by deleting the words "and herbal drugs;"

Clause23

THAT, Clause 23 of the Bill be amended in sub-clause (2)by

• (a)deleting the wordsone million"appearing in paragraph (a) and substituting therefor the words"twomillion";and
• (b)deleting the wordstwo million"appearing in paragraph (b) and substituting therefor the words"five million".

Clause29

THAT, Clause 29 of the Bill be amended by deleting sub-clause (9).

Clause S5

THAT,Clause S5 of the Bill be amended in sub-clause(2) by inserting the word "registered immediately after the words"may prohibit a".

Clause 36

THAT, the Bill be amended by deleting Clause S6.

Clause S9

THAT,Clause S9 of the Bill be amended in sub-clause(4)by inserting the words"or pharmaceutical technologists"immediately after the words"a Registered Pharmacist"

Clause41

THAT,Clause 41 of the Bill be amended in sub-clause (1)by inserting the words"or pharmaceutical 1technologists"immediately after thewords a pharmacist"appearing in paragraph (b)".

Clause42

THAT,Clause 42 of the Bill be amended by

• (a)deleting sub-clause (1) and substituting therefor the following new sub-clause (1)

"(1) An authorized seller shall enter a record of such particulars of the scheduled substance before delivery of the scheduled substance under this Act."

• (b) inserting the following new sub-clause (2) immediately after the new sub-clause (1)—

"(2)A record under subsection(1) shall be in the format prescribed by the Authority and shall indicate-

• (a)the date ofthe sale,
• (b)the name and address of the purchaser;
• (c)the quantity of the scheduled substances sold; and
• (d) the purpose for which it is stated by the purchaser to be required."
• (c)renumbering sub-clause(2)as sub-clause(3);and
• (d)renumbering sub-clause(3)as sub-clause (4).

Clause 51

THAT,the Bill be amended in clause 51 by inserting the words"and,on conviction, shall be liable to afine not exceeding one million shillings,or to imprisonment for a term not excceding twoyears,or to both" immediately after the word"offence"

Clause 54

THAT, the Bill be amended by deleting clause 54.

Clausc 69-

THA'T, Clause 63 of the Bill be amended by deleting sub-clause (3)

3.s Submissions by the Hon.Irene Mayaka,MP

The Hon.Irene Mayaka,MP,appeared before the Committee on S1t October,2023andmade her submission of theproposed amendments as follows:-

Under ClauseS7

That clause S7 of the Bill be amended-

• (a)By inserting the following new sub-clause immediately after sub-clause(2)-(s) The Cabinet Secretary shall publish the list prepared under subsection(1)in the Gazette.

(4)the list published under subsection (S) shall include narcotic substances,prescription only medications,over the Counter medicines,hazardous and prohibited substances.

(b)Byrenumbering sub-clause(5):and

(c)By renumbering sub-clause (4) as sub-clause(6);

3.4Submission by the Hon.Dr.Otiende Omollo,MP

The Hon.Dr.Otiende Omollo,MP presented his proposed amendments through visual meeting on 1 November,202S and made the following submission:-

Under Clause2

That,the Clause 2of the Bill be amended by deleting the definition of pharmacy"and substituting therefor the following newdefinition-

pharmacy has the meaning assigned to it under the Pharmacy and poisons Act

Clause 8

That, Clause s be amended in sub-clause(2) by deleting paragraph j) and substituting therefor thefollowingnewparagraph-

one person,not being a governor,who is a registered pharmacist of good standing,nominated by the Council of Governors

Clause S9

That, clause S9 of the Bill be amended in the marginal note by deleting the wordsWholesale Dealers Licence"and substituting therefor the word "Local Technical Representative Licence

TheHonorablemember also said clause25and s5needs toberelooked

3.5 Submission by the Hon.Millie Odhiambo,MP

TheHon,Millie Odhiambo,MP presented his proposed amendments throughvisual mceting on 1aNovember,2023andmade the following submission:-

The Hon.Millie Odhiambo,MPwas invited to the winnowing process ofthe Kenya Drug AuthorityBill,2022throughaletterref.NA/DDC/DC-H/202s/(099)dated7thOctober,2023 for a meeting on S1st October and1November,202Sand attended themeeting through Visual on1s November and presented the followingproposed amendments to the Committeewhich she sent through email earlier as follows for consideration since shehad travelled out of the Country;

PARTI-PRELIMINARY:Add the definition of"alternativemedicine""alternative medicine" means alternative medicine as defined under the Health Act.

Definition of"drug"

• (a)Add the words "herbal medicine"afier the words "any medicine"and before the words medicinal preparation,medicinal substance,therapeutic substance prepared,sold or represented for usein-"
• (b)Add the word "herbal medicineafter the words "any medicine"and before the words "medicinalpreparation"

(b)(i) delete the word ifappearing after the words restoring,correcting or modifying functioning"and after the words "organs in humans or animals"and replace with the word of".

Definition of "falsified medicines"Put a semi colon () after the words.. of active or other ingredients"and beforethe words"or falsely labelled medicine"

Definition of health products and technologies Delete and replace with"hcalth products" means chemical substances,therapeutic cosmetics,herbal medicines,medicines, scheduled substances and related products and substances.

"health technologies"means medical devices including radiation-emitting devices and related products.

Definition of herbal mcdicine or products Delete and replace with"herbal mcdicinemeans the use ofplawts to treat disease andenhance general health and wellbeing.

"herbal product"means a plant derived material or preparations with claimed therapeutic or other human or veterinary health benefits,which contain either raw or processed ingredients from one or more plants,or material of inorganic or animal origin;

Definition of"insanitary condition"Add the words"herbal medicine"after the words"asmight contaminate a drug or a therapeutic cosmeticand before the words"with dirt or filth"

Definition of "LabelAdd the words herbal medicine"after the words accompanying any drug"and before the words"therapeutic cosmetic"

NB:There appears to be something missing in this definition and I cannot tell what it is.The original drafter can assist.

Definition of"manufacture"

Delete the word"product orappearing after the words"mcans any process carried out in the course ofmakingand add the wordsor product"after the words"medicinal substance"and add the word"extracting"after the words"and includes"and before the words"packaging.blending. mixing

Definition of "medicinal substance"Add the words "herbal medicine"after the words "medicine"and before the word"product"

Definition of"registered midwife"Delete the wordsby law to practice the profession of midwife in Kenya"a and replace with the wordsto practice as such under the Nurses and Midwives'Act"

Definition of"registered pharmacist"

Delete the words "by the body for the time being responsible for registration of pharmacists"and replace with the words "under the Pharmacy and Poisons Act:

Definition of"substandard mcdicine"

Add the words"under this Act or any other written law"after the wordsmeans medicines which do not meet defined standards and specificationsand before the words and includes products that have been contaminated

Definitionof"therapeuticcosmetic"

in cleaning,improving"and before the words"skin,hair,eyes or teeth

Clause 6(4)(a):Delete the word "engineering"appearing after the word "in either pharmacy. medicine,and before the wordsorequivalent fields";

Clause 7 (a)and (b)-Delete sub clause (a) and (b)and then replace with the following:

(a) Is a State officer

Renumber the subsections consequently.

(e)delete subsection"e"and replace with the wordsis a public officer

(f)delete the words Aet",regulation under thisappearing at the end of the sentence and replace with "regulations under this Act"

Clause 8(s)-Delete(e)appearing between"h"and "i"

(a)Clause 8 (6) Delete sub clauses (a) and (b) and replace with (a) Is a State officer

Clause 8(7)

Add the word "youth representation" after the words "regard shall be had of the need for"and before the word"regional"and add the word"and ethnicafter the word"regional"and before the words"balance and the realization"

Clause 10 (1) (f) Delete the wordspermission of the and replace with"notifying the"

Clause 12(o)-Add the words"chemicals,medicineafter the words"promote rational use of

Clause 12(A)-Delete the word"ensure"and replace with the word "set"

Clause 12(b)-Delete the word "thatappearing after the wordensure" and before the words 'compliance with existing legislation"and replace with the words"that there isand further delete thewords"isbeingpromoted and controlled"

Clause 12 (g)-Delete the word "being"after the word "products and technologies areand before the words "assesscd accordingly

Clause 1s (f)-Delete the wordsco-opt in such committeesand replace with the words"hire as consultants

Clause 17 (2)-Add the words "youth inclusion after the words"The principles ofand after the words"ethnic,regional and gender

Clause 21(1)-Delete the words"Cabinet Secretary"appearing after the word "The"and before the word "may establish scientific"and further delete the word "Cabinet Secretary"appearing before the word"under this Act"and replace with the word "Authority"

Clause 21(3)-Delete the word "Cabinet Secretary"and replace with"Board"

Clause 21 (4)-Delete the word "Cabinet Secretary"and replace with the"Board"

to its activities"and replace with the word"Board";further delete the wordsand the Cabinet Secretary shall lay a copy of each report before Parliament.

New Sub-Clause 21 (1o)-The Board shall prepare and submit annually a report ofits activities including that of any subcommittees to the Cabinet Secretary and the Cabinet Secretary shall submit the said report to parliament.

Clause 22(s)-Delete entire clause

Clause 24 (s)-Add sub clause(c)as follows:(c)is herbal medicine Clause 24(4)(A)-Delete the words"one hundred"and replace with "five hundred"

Clause 24 (b)-Delete the wordstwo hundred thousand" and replace with"one million shillings and further delete the words "five years"and replace with "three years"

Clause 27-Add anew Clause27(1)as follows:

27 (1) "The Authority may issue product licences as provided under this Act

Renumber current 27 to27 (g)

Clause 28 (1) -Add the words "and herbal medicines" before the word "register and after the word "There is established a medicines"

Clause 28(2)-Add the words "herbal medicine"after the words"content of the medicines"and before the word "register"

Clause 29(1) -Add anew Clause 29(1)as follows then renumber the subsequent subsections

29(1) Any pharmacist may apply for the registration of a medicine,herbal medicine or medical device asprovided for under this Act.

Clause 29 (1) -Add the word "herbal medicine in sub clause 29 (1) in the Bill after the words "Every application for the registration of a medicineand before the words"or medical device"

Clause 29(s)(a)-Add the words"or herbal medicine"after the word"the medicineand before

Clause 29 (s) (b)-Add the wordsor herbal medicine" afler the word "the medicine" and before

Clause 29(3)(c)-Add the words"or herbal medicineafter the word"that medicine"and before the word "is in the public domain"

Clause 29 (4)-Add the words"herbal medicine"after the words"ofa medicine" and before the words "it shall cause the applicant"

Clause 29 (+)(b)-Add the words"comment"after the words"with the applicant's"and after the words"on the Authority's reasons for not being so satisfied

Clause 29 (6)-Add the words"herbal medicine"after the word "medicine"and before the words "the registrar shall register"; and further after the word "medicine"and before the words"as are required by this Act";and further after the words"in the prescribed form in respect of that medicine"

Clause 29 (7)- Add the words "and herbal medicine" after the words "Every medicine" and before the words "shall be registered"

Clause 29(8)-Add the wordsand herbal medicine"after the wordsallocate to every medicine" and before the wordsregistered under this Act;and further after the words"name of such medicine"and before the wordsand which shall be stated in the certificate";and further after the words"issued in respect of that such medicine"

Clause 29(9)-Add the words"and herbal medicine"after the words"registration of medicine and before the words"already registered; and further add the words"under this Act or any other written law" after the words"already registered"and before the words"shall be valid for a period of Clause 29(12)Add the wordsand herbal medicine" after the words"in respect ofa medicine" and before the words"referred to in subsection(4)

New Sub clause 29 (12)(A), (B) And (C) Provide for a new sub clause 29 (12)and renumber the current 29 (12) to 29 (1s) and others consequently. Provide for the sub clause 29 (12) as follows:

• (a)"The Authority may reject any application if the applicant fails to meet the standards as required by thisAct or any other written law"
• (b)A person dissatisfied with the decision of the Registrar may appeal to the Board within the period specified under subsection 14
• (c)Where a person is dissatisfied with the decision of the Board,the applicant may appeal to the High Court within thirty days of the decision being communicated to him or her.

Clause 1s-\_Add the words of appeal after the words "expiry of the appropriate period;and further delete the words"referred to in sixty days

Clause so (1)

Add the words"or herbal medicine"after the words"on application by the holder"and before the wordsa certificate of registration;and further after the words register with respect to that medicine"

Clause so(3)(B)

Add the words "or herbal medicine"after the words "in respect of the medicine"and before the words"after receiving the existing certificate of registration";and further after the words "register with respect to that medicine";and further after the words"in respect ofthat medicine" and before the words"for cancellation"

A New Sub clause so(s)-Provide a new sub clause So(S)and renumber the current (S)as(4) and provide for the new ($) as follows: (s)The applicant shall provide reasons for the proposed amendments

Clause S2 (1)Add the words "herbal medicine"after the words "registration of a medicine" and before the wordsor medical device"

Clause s2(1)(a) Add the words"herbal medicineafter the words"to which particular medicine" and beforethe words"or medicaldevice

Clause S2 (1) (b)Add the words "herbal medicine" after the words "particular medicine"and before the words"or medical device

Clause S2 (1)(c)\_Add the words "herbal medicine"after the words "particular medicineand before the wordsormedical device

Clause S2(2)Add the words"herbal medicine"after the words"any medicine"and before the wordsor medical device;and further after the wordsin respect of that medicine"and before the words"or medical device"

Clause S(4)Add the words"herbal medicine" after the wordsregistration of that medicine" and before the words"or medical device Clause S2(4)(b)Add the words "herbal medicine"after the words"that the registration of the medicine"and before the words"or medical device"

Clause S2(5)Add the words"herbal medicine"after the words "in respect of a medicine"and before the wordsor medical device;and further after the words"of the registration of that medicine"and before the words"or medical device".

Clause ss(1)And (2)

• (1)Add the words"herbal medicine"after the words "registration of a medicine"and before the words"ormedicaldevice"
• (2) Add the words "herbal medicine" after the words "registration of a medicine"

New Sub clause 3s(s) Provide for a new sub clause S and renumber current sub clause (3) to (4).Provide for the new sub clause(S)as follows:

• (s)In the case of cancellation of registration ofa herbal medicine the Registrar shall in such case specify-
• (a)The name under which the herbal medicine is registered
• (b)The active components of the herbal medicine
• (c)The name of the applicant
• (d)The name of the person who has propriety rights over the herbal medicine
• (e)The registration number allocated to the herbal medicine;
• (f)The conditions if any, subject to which that medicine is registered

Clause S5 (1) Delete the word "shall" appearing after the words "A pharmacist" and before the words"dispense and interchangeable"and replace with the word"may

New Clause S5 (4)(d) Add a new sub-clause(4)(d) as follows:

S4 (4) (d) unless the purchaser or patient is first informed of the same and agrees to the change.

Clause S6(1).Delete the words"on a commercial scale

Clause S8(2)Delete"one hundred thousand"appearing after the wordsa fine not exceeding and before the words "shillings or to inmprisonment"

Clause 4o (4) Delete the wordswhose decision thereon shall be finalappearing at the end of the sentence.

Clause 4o(7) Delete the words"two hundred thousandappearing after the words"to a fine not exceeding"and replace with "one million"; and delete the words"two years" appearing after the words"imprisonment for a term not exceeding"and replace with"three years".

Clause 41(1)(d)\_Add the words "enrolled pharimaceutical technologist and registered pharmacist"after theword"practitioner"

Clause 42 (2)(A)

Delete the wordsprovided that where a person represents that he urgently requires a Schedule Substances for the purpose of his trade, business or profession and satisfies the seller that by reason of some emergency he is unable before delivery to furnish the order in writing,the seller may forthwith deliver the Scheduled Substances to the purchaser who will within twenty-four hours of the sale furnish the seller with the written order Clause 42(s)Delete the wordsone hundred thousand"appearing after the words"to a fine not exceedingand before the words"shillings or to imprisonment" and replace with"one million Clause 4s(3)Delete the words"one hundred thousand"appearing after the words"not exceedingand after the words"shillings or to imprisonment and replace with"one million".

Clause 44(s) Delete the words one hundred thousand"appearing after the words"not exceeding"and after the words"shillings or to imprisonment and replace with"one million"

Clause 45Delete the words"five hundred thousand" appearing after the words"not exceeding and after the words"shillings or to imprisonment and replace with "one million".

Clause 46 (1) Delete the word "Thisappcaring at the beginning of the sentence and replace with the words"The electronie supply of mcdicine

Clause 59 (s)Add the word "who" between the words "A person"and the words"sells or supplies'

Clause 60(1) (c)Add the words"medicinal herbs"after the words"manufactured and imported medicine"and after the words"or medicinal substances"

Clause 6s(1)Add thewordsmedical herbs"after the words"referring to a medicineand before the words"drug,appliance or article";and further before the words"to imply that the medicine and before the words"drug. appliance or article".

Clause 67 (s)(a) Delete the words"two hundred thousand"appearing after the words "a fine not exceedingand before the wordsshillings or to an imprisonment" and replace with the words "one million".

Clause 67 (s)(b)\_Delete the words"three hundred thousand"appearing after the words "a fine ofat least" and before the words"shillings or to an imprisonment and replace with the words "twomillion".

Clause 68 (1) Add the words"or herbal medicine"after the words"recommmended a medicine and before the words"to prove".

Clause 71\_Add the words "herbalmedicineafter the words "homoeopathic medicine preparation" and before the words"or medical device"

Clause 72 (s)\_Add the words herbal medicineafter the words"quantity of a particular medicine"and after the words"or medical device

Clausc 79DeleteClause79

Clause 86\_Delete the words "seven hundred thousand"appearing after the words"a fine not exceeding"and before the words"shillings or to imprisonment and replace with"one million"

Clause ss (v)Add the words"herbal medicine at the end of the sentence.

Clause 88 (aa) Add the words "herbal medicine" after the words"a specified medicine" and before the words"medical device"

Clause ss (bb)Add the words "herbal medicineafter the words"dispense medicine"and before the words"medical device"

Clause 88(dd) Add the wordsherbal medicine"after the wordscompounding of medicine"and before the words"medical device Fourth Schcdule Section(1)(1)replace Cabinet Secretarywith"the Board"

Section (4) (2)(1) Add the words "herbal medicine" after the words"human medicinal products" and before the words"giving advice

TITLE-ChangetheTitle to theKENYADRUGANDHEALTHTECHNOLOGIESBILL

3.6Submission bythe Hon.Dr.James Nyikal,MP

The Hon.Dr. James Nyikal, MP appeared before the Committee and presented his proposed amendments in a meeting held on gndNovember,202S as follows:-

Clause2

THAT,Clause 2of theBill be amended by inserting the following new definitions in the proper alphabetic sequence

No.21 of"Director-General for Healthhas the meaning assigned toit under the Health Act;

"wholesaler dealer"means a person who is licensed to carry out a business where health products and technologies are stored,distributed or sold in bulk to persons other than individual consumers and includes registration, importation, warehousing.good distribution practices and pharmacovigilance,"

Justification:To distinguish theDirector-General for Health with theDirector-Generalofthe Authority and for consistencywith the amendment proposed below to clause S1 of theBill.To define a wholesaler dealer as the term is used in theBill under clause S9 of the Bill

Clause 12

THAT, Clause 12 of the Bill be amended by deleting paragraph (t).

Justification:The provision relates to an administrative function as regards human resource management and development and need not be in the Bill.

Clause21

THAT,Clause 21 of theBill be amended

• (a)by deleting sub-clause(4);and
• (b)in sub-clause (9) by deleting the words"Cabinet Secretary,with respect to its activities and the Cabinet Secretary shall lay a copy ofeach report before Parliamentand substituting therefor the following words"Board of the Authority which shall submit a copy of the report to the Cabinet Secretary who shall transmit the report to Parliament".

Justification:Sub-clause (4) provides for the co-option ofmembers into the scientific advisory committees.This is unnecessary as the appointing authority needs to appoint the relevant skills to the Committee in the first instance.

Amendment of sub-clause(9)to require that the scientific advisory committees shall submit its report to theBoardof theAuthority which shall submit the same to the CabinetSecretary who must transmit it to Parliament.The Committee report hadnot provided for the transmittal of thereports of the scientific advisory committees toParliament.

Clause22

THAT, Clause 22 of the Bill be amended in sub-clause (3) by deleting the words sub-section (1)and substituting therefor the wordsIhe provisions of subsection(1)(a)"

Justification: Sub-clause (S)should not only apply where a medicine is not registered by the Authority andnot ininstances where a medicines is adulterated, substandard or fails to comply with the specifications inlaw.

Clause29

THA'T, Clause 29 of the Bill be amended by deleting sub-clause(4)and substituting therefor the followingnew sub-clause(4)

"(4)Where the Authority finds that an application for registration ofa medicine or medical device does not satisfy the requirements provided in subsection (S),it shall notify the applicant in writing of the reasonswhy that medicine or medical device should not be registered and invite the applicant to make comments on its finding within a period ofone month from the date of the notification."

Justification:For proper drafting of the sub-clause(4)as the provision is currently not clear.

Clause S1

THAT,theBill be amended by deleting clause S1.

Justification: To remove the aspect of transfer of certificate of registration of health products and technologies.

Clause35

THAT,Clause S5of theBill be amended

• (a)in sub-clause(1) by inserting the words"upon consultation and concurrence with the person who prescribed the medicine,immediately after the word"shall";
• (b)by deleting sub-clause(2):
• (c)by renumbering sub-clause(S) as sub-clause (2); and
• (d)by deleting sub-clause(4)

Justification:To require that a prescriber ofa medicine is consulted before medicine is substitution with a generic medicine.With the amendment to sub-clause (1), sub-clause (2) and (4)are unnecessary as the factors will be discussed by the Prescriber and the Pharrmacist at the point of consultation.

Clause 38

THAT,Clause 38of the Bill be amended by deleting sub-clause(2) and substituting therefor the followingnew sub-clause(2)

"(2) A person who is in possession of a scheduled substance otherwise than in accordance with the provisions of this section commits an offence and shall on conviction,be liable to a fine not exceeding one million shillings or to imprisonment for a term not exceeding three years;or to both."

Justification:To enhance the penalty for the offence of possession of a scheduled substance contrary to the provisions of the Bill firom Kshs.1oo,oo0 to Kshs.1,o0ooo0.

Clause 39

THAT,Clause S9 of the Bill be amended in sub-clause (4) by inserting the word "and immediately after the words"distribution of theScheduled Substances".

Justification:To insert a missing word which will make the sub-clausemuch clearer.

Clause42

TIAT, Clause 42 of the Bill be amended in sub-clause(s)by deleting the words one hundred thousand shillings or to imprisonment for a term not exceeding threeyearsand substituting therefor the words"five hundred thousand shillings or to imprisonment for a term not exceeding one year".

Justification:To enhance the fine for the offence of failure to record the sale or suplly of scheduled substances in a Schedules Substances Book as is required in clause 42 from Kshs. 100,000 to Kshs.5oo,0oo.To reduce the jail term from three years to one year as 5 years is too punitive.

Clause44

THAT,Clause 44of the Bill be amended in sub-clause(s)by deleting the wordstwo hundred thousand"and substitutingtherefor the words"five hundred thousand"

Justification:To enhance the penalty for the offence of failure to label a container of scheduled substances in the manner set out in clause 44 from Kshs.200,000 toKshs.500,000

Clause79

THAT,the Bill be amended by deleting Clause 79

Justification:The regulation of meat is outside the ambit of theregulation of theAuthority.

Clausc81

THAT, Clause S1 of the Bill be amended by deleting the wordsDirector of Medical Services" and substituting therefor the words"Director-General for Health".

Justification:The Health Act,No.21 of2o17 makes provision for the officeof theDirectorGeneral forHealthwhichreplaced the office of theDirector of Medical Services.

s

THAT,Clause S3 of the Bill be amended by deleting the words "Cabinet Secretary"wherever they appear and substituting therefor the words"the Authority"

Justification:The function ofregulation of HPTs is a preserve of the Authority and thepower provided in clause 8s is utilized administratively in the performance of this function.The Cabinet

Clause 90

THA'T, Clause 90 of the Bill be amended in sub-clause (2) by deleting the words"think fit" appearing in paragraph (f) and substituting therefor the words "deem appropriate" Justification:For proper drafting

Clausc 92

THA'T,Clause 92 of the Bill be amended in sub-clause (2) by inserting the words with the approval of the Cabinet Secretary"immediately after the word"determine"

Justification: For checks and balances in the investment of the funds of the Authority which will ensure prudent use of the funds by the Authority.

FourthSchedule

THAT,theFourth Schedule oftheBill be amended

• (a)in paragraph(1)by deleting the word "Coordination"appearing in sub-paragraph (4);

Justification: Amendment of paragraph (1) is necessary for consistency with sub-paragraph (1) whichestablishes theNational Food Safety Committee.

• (b) in paragraph (2) by inserting the following new sub-paragraphs immediately after subparagraph 2(e)-

(f)a registered medical practitioner nominated by theKenya Medical Association; (g)theDirector-General for Health or a representative designated in writing;

Justification:For inclusion of KMA in the Human Medicines Committee as prescribers of medicines are crucial in ensuring patient safety.

For inclusion of the Director-General for Health in view of his technical expertise on matters of health generally.

• (c)in paragraph (4) by deleting the words,"in consultation with the Cabinet Secretary

Justification:The words"in consultation with the Cabinet Secretary responsible for health,are superfluous as it is alreadyindicated that the Chairperson of theMedical Devices Committee will be appointed by the Cabinet Secretary.

S.7 Submission by the Hon.Martin Owino Petcrs,MP

The Hon.Martin Owino PetersMP appeared the Committee presented his proposed amendments to the Committee in a meeting held on gud November,202S as follows:-

That Clause 72of the Bill be amended in sub clause(1) by deleting the word"personappearing immediately after the words"The Authority may authorize aand substituting therefor the words"registered pharmacist"

3.8 Submission by the Hon.Peter Kaluma,MP

TheHon.Peter Kaluma,MPwas invited to the winnowing process of the Kenya DrugAuthority Bill,2022 through aletter ref.NA/DDC/DC-H/2023/(099)dated27th October,202s for a meeting on S1 October and 1 November,202s but sent the following written proposed amendments to the Committee for consideration since hehad travelled out of the Country:

Generalviews:

• 1.We exclude anything to do with the practice ofveterinary medicine from the Bill as this is dealt with under a law whose repeal has not been proposed here;

2. The manufacture of drugs be left to graduate Pharmacists;

• Sale and dispensing of drugs once prescribed by a qualified medical practitioner or Dentist be allowednotonly topharnacistsbut also to holders ofdiploma in pharmaceutical technology,pharmaey or equivalent qualifications;
• Proposed repeal of some sections of the Narcotic Drugs and Psychotropic Substances Act be avoided. The Aet is dealing with a different category of drugs the possession, use or consumption ofwhich ispunished differently

5. Measures be taken to ensure good provisionsof thelaws proposed to be repealed are incorporated into Bill.These include Part II of the Pharmacy and Poisons Act.

• This is serious law.while it secks to repeal two existing laws,the Memorandum states that it's purposed to comply with some WHOrequirements.It would be good to involve the Ministry of Health and key stakeholders in the harmonization process.This would secure that the government position is presented,understood and carried forth into the proposed law and therequirements ofWHO specified andmet.

7. Amendments proposed by the Committee infringe S.O 1s3 as they derogate from the substratum of the various clauses of the Bill they seek to alter.It would be better the wholeBill bewithdrawnanda new Bill bepresented by the Government.

Specific Amendment Proposals:

Clause2

Veterinary medicine-delete

"enrolled pharmaceutical technologist"-refers to definition in lawbeing repealed.Pick definition the Roll ofpharmaceutical technologists

"herbal medicine or product" - insert full stop (-) after "plants" in*second last line and delete all words following.

Insert:

``` "traditional medicines or products"means a plant or animal derived material or preparations with claimed therapeutic or other human benefits,which contain either raw or processed ingredients from one or more plants or animals,or material of inorganic origin." Clause s(2)-delete. Clause 6(S) substitute "four"with"three" Clause 6(4)(a)-insert full stop after"engineering" and delete the words following"or equivalent fields" Clause 6(+)(d) insert "established for regulation of pharmacy.medicine or engineering profession." Delete clause 6(6) - it conflicts with the lawful mandate of the Board in Clause 8(1). Delete Clause 6(8) Delete Clause 6(9) Delete Clause 7 (a) and (b) Delete"is"in 7(d) and substitute "has been" S2)(a)(i) insert,medical practitioner or medical engineer"after the word "pharmacist" Amend s(2)(a)(i) by inserting medical or medical engineering" after"pharmaceutical Delete 8(2)(f)s(2))-delete"County"before"Governor" Delete 8(s) Delete s(6)(a)and (b) Substitute"is"with"has been" in clause 8(6)(e) Clause 8(7) delete all words after "Board"and insert ",regard shall be had to the need for ethnic andregional balance and theneed to ensure that persons of same biological sexshall not comprise more than two thirds of the membersofthe Board." Delete Clause 9 Delete 10(2). Clause 12 (f) substitute"events"with"eflects" 13(a) substitute"association"with"collaboration 13(c)-delete"any"and substitute"lawfal". Delete Clause 21 and theFourth schedule.Fstablishment of Committees already provided for inn Clause 13(e).The Clause contradicts Clause 12(i) and (j)which vest the duty to advise CS in the Authority and Clause 34. Insert new22(4) subsection(1) shall not apply to traditional medicines or products" Clause S1 -insert full stop afterperson" and delete all words following. Delete clause 32(5) Clause S8(1)(b) insert semi colon () after"substances"and delete the words following thereafter. Clause Is(c) delete"for mining, agricultural or horticultural purposes" 13(e)*deleteby a qualified medical practitioner,dentistor veterinary surgeon orby a hospital, or dispensary or similarinstitution" S9(4) amend by inserting"is a qualified pharmacist,medical practitioner or medical engineering practitioner or holder of diploma in pharmacy.pharmaceutical technology Clause 41(1)(b) insert "or pharmaceutical technologist or dispensing chemist"after"pharmacist" Clause 41 (1)(d) delete"or veterinary"" Clause 41(1)(f) -insert full stop (.) inmediately after the word "bchalfand delete all words appearing thereafter as they arerepetitions of carlier provisions. Clause 41(2)(a)-delete"or veterinary surgeon" Clause 4S (1)- delete veterinary surgeon" Clause 46(1) substitute"This"with "Electronic sale of medicines" ```

DeleteClause79

Clause 81 -Deleteor the Director ofVeterinary Services,inrelation to any matter appearing to aflect the general interests of agriculture in Kenya,"

Clause 95 (aa) delete "or veterinary surgeon "Subject the regulations to approval by Parliament. SecondSchedule-Delete

FourthSchedule-Delete.

Seventh Schedule-Delete Narcotic Drugs and Psychotropic Substances Aet and its provisions.

NB: Ensure all good provisions of the Acts proposed to be repealed are carried into the new law byway ofsubstitutive provisions.These include sections 6,7,8,9 ofPPA.

CHAPTERFOUR

S.OCOMMITTEEOBSERVATIONSONTHEWINNOWINGOFPROPOSED AMENDMENTS TO THE KENYA DRUGS AUTHORITY BILL(NATIONAL ASSEMBLYBILLNO.54OF2022)

Having considered the all the proposcd amendments as proposed to theKenya Drugs Authority Bill,2022,by the Committee and individual Honourable Members submissions the Committee made the following observations on each of the proposed amendment:-

• 1.There is need to retain the regulation of herbal medicines in the Bill,and to this cffect,the Committee proposes the amendment of the definition ofhealth productsto include herbal medicine.Further,there is need to exclude traditional and alternative medicine from the ambit of theBill. The Committeenotes that there will beneed to come up withlegislation to give effect to the provisions of the Health at,No.21 of2017,which mandates Parliament to establish aregulatory body toregulate the practice oftraditionalmedicine and alternative medicine.
• 2.The Committee notes that the Registrar was not defined in the Bill,and to this end,there is need to introduce the definition of the term "Registrarto mean the Director-General of the Authority.
• 3.There isneed to ensure a smooth transition from the Pharmacy and Poisons Board to the Health Products andTechnologies Regulatory Authority.The Committee notes that during the transition period,the staffof thePharmacy and Poisons Board dealingwith theregulation of health products and technologieswould have tomove to the Authorityimmediately upon the enactment of the Bill,while the Pharmacy and Poisons Boardwill continue to exist for a period of two years to regulate the pharmacy practice.The Committee further notes that within thetwo-year transitionperiod,Parliamentwill have to enact alegislative framework for theregulation ofthe pharmacy profession.

CHAPTERFIVE

4.OCOMMITTEERECOMMENDATIONSONTHEWINNOWINGOFPROPOSED AMENDMENTS TOTHE KENYA DRUGS AUTHORITYBILL(NATIONAL ASSEMBLYBILLNO.54OF2022)

Having considered all the proposed amendments as proposed by the Committee and the honourable members,the Committee agreed upon the following harmonized version of amendments.The Committee therefore,recommends that,the house adopts the report of the winnowing process of the proposed amendments to the Kenya Drugs Authority Bill,(National AssemblyBill,No.54of2022).

2112023

SIGNED.

DATE

HON.PATRICKNTWIGAMUNENE,MP

VICE-CHAIRPERSON,DEPARTMENTALCOMMITTEEONHEALTH

Long'Title

THAT, the Bill be amended by deleting the Long Title and substituting therefor the following new Long Title

"ANACTofParliament to establish acomprehensive legal frameworkfor theregulation of Health Products and Technologies;to safeguard public health through development of a regulatory system to ensure safety,quality,efficacy,effectiveness and performance of health products; to establish theKenya Health Products andTechnologies Authority and for connected purposes".

Justification:The amendment accords with international best practice and sets out the main purpose of theBill which is to establish a centralized regulatory authority for health products and tcchnologics.

CLAUSE1

THAT,Clause 1 of the Bill be amended by

• (c)deleting the phrase "Kenya Drugs Authority Act,2o22and substituting therefor the phraseKenya Health Products and TechnologiesRegulatory Authority Act,2022";

Justification:\_The amendment accords with international best practice and comprehensively covers the mandate of the proposed Authority.

• (d)deleting the words"andcommencement"in the marginal note

Justification:Tolimit the marginal note to the content of clause I which only scts out the name of the Bill.The Clause does not make any provision as regards the commencemcnt of the Bill.

CLAUSE2

THAT Clause oftheBill be amended

(q)in the definition of"article"by

• (ii)inserting the words "dietary supplement"immediately afterthe words
• (iv)inserting the words "dietarysupplementinmediately afterthewords "therapeutic cosmetic" appearing in paragraph (b);

Justification:For inclusion of dietary supplements which are part of health products and technologies.

• (r)in the definition of"Authority"by deleting the words "Kenya Drugs Authority"and substituting therefor the words,"Kenya Health Products and Technologies Regulatory Authority";

Justification:To cnsure harmony with the title of theBill asproposcd for amendment.

CHAPTERSIX

SCHEDULEOFAMENDMENTS

• (s)in the definition of"chemical substance"by deleting the words"or detergent";

Justification:To exclude detergents which are used for cleaning inanimate objects and doesnot fall under the purview of the regulation of hcalth products and technologies.

• (t)in the definition of "drugby deleting the word"ifappearing in paragraph (b)(i)and substitutingtherefor the word"of";

Justification:To correct a minor typographical error.

(u) by deleting the definition of"enrolled pharmaceutical technologist";

Justification:The current definition cross references the Pharmacy and Poisons Act,cap. 244which will be repcaled asprovided under clause 97.Anew definition proposed.

• (v)in the definition of "health products and technologies" by inserting the words,"dietary supplement"immediately after the words,"therapeutic cosmetics";

Justification:For inclusion of dietary supplements which are part of hcalth products and technologies.

(w)by deleting the definition of"herbal medicine or product";

• (x)by deleting the definition of"medical device";
• (y)by deleting the definition of"medicinal substance";

Justification:New dcfinitions provided for these terms.These new definitions cxpand the scope to cover all aspects ofthe use of medical devices and medicinal substances in relation to healthand to includeherbal materialsand herbal combinations.

• (z) in the definition of "package" by inserting the words "dietary supplement" immediately after the words"therapeutic cosmetic";

Justification:For inclusion of dietary supplements which are part of health products and technologies.

(aa)by deleting the definition of"pharmacy":

Justification:The current definition is inadequate.The term to be defined in the proposed Pharmaceutical Practice Bill.

• (bb) by deleting the definition of"pharmaceutical technologist";

Justification:Thc Pharmacy and Poisons Act,cap.244 provides that a pharmaceutical technologistmust be cnrolled in the roll cstablished under this Act

(cc)by deleting the definition of"registered midwife";

Justification:The term is no longer used in the Bill in line with the proposed amendment ofclause 43(1)(c).

• (dd) in the definition of"scheduled substance"by deleting the words"in the relevant schedule under this Act and substituting therefor the words "in the list published by the Cabinet Secretary under section 37 of this Act";

Justification:There is no Schedule on scheduled substances.The Cabinet Secretary will publish the list of scheduled substancesin the Gazette.

(ee)by deleting the definition of"therapeutic cosmetic;and

Justification:The current definition defines cosmetics in gencral that are meant to provide the body with appropriate acsthetics, texture,pll,color and smell. It is not specifie to special cosmetics.

(ff)by inserting the followingnew definitions in theirproper alphabeticsequence

"active surveillancemeans prospective measures taken to detect adverse drug reactions and adverse events and involves active follow-up during and after treatment of patients where the events may be detected by asking the patient directly or screening patient records;

adverse drug reaction"means a response to a drug which is noxious and unintended,and which occurs at doses normally used in humans for theprophylaxis,diagnosis or therapy of disease,or for the modification of physiological function and is characterized by the suspicion of a causal relationship between a medical product and an occurrence;

"adverse event"means any untoward medical occurrence that may present during treatment with apharmaceutical product but which does not necessarily have a causal relationship with the treatment;

"biologicals"means a diverse group of medicines which includes vaccines,growth factors, immune modulators,monoclonal antibodies and includes products derived from human blood eusendpue

"Boardmeans the Board of the Authority established under section 8;

"Centre"means the National Pharmacovigilance Centre established under section 59B;

whether inpatients or other volunteers,in order to discover or verify the eflects of,identify any adverse reaction to investigational products,study the absorption,distribution,metabolism and excretion of the products with the object of ascertaining their eflicacy and safety;

requirements of essential nutrients,and which usually contains one or more dietary ingredient and includes vitamins,minerals and herbs;

"enrolled pharmaceutical technologist"means a person enrolled as such by the body for the time beingresponsiblefor the enrolment ofpharmaceutical technologists;

"falsified medical productmeans a product that is deliberately or fraudulently misrepresented in relation to itsidentity,composition or source;

"Field Safety Corrective Action means any action taken by a product owner to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device, and includes-

• (c) thereturnofamedicaldevicetothe product owner orits representative;
• (d) device modification which may include
• (vii) retrofit in accordance with the product owner's modification or design change;
• (ix) permanent or temporary changes to the labelling or instructions for use;
• (x) software upgrades including those carried out by remote access;
• (xi) modification to the clinical management of patients to address a risk of serious injury or deathrelated specifically to the characteristics of the device;
• (xii) device destruction; or
• (xii) device exchange;
• (xiv) advice given by product owner regarding the use of the device.

"health product includes a medicine,medical product,medicinal substance,vaccine,diagnostic medical device,blood or blood product,traditional and alternativemedicine,therapeutic feed and nutritional formulation, cosmetic and related products;

"health technology"means the application of organized knowledge and skills in the form of medicines,devices,vaccines,procedures,and systems developed to solve a health problem and improvethe quality of lives;

"herbal medicine or productmeans a plant derived material or preparations with claimed therapeutic or other healthbenefits,which contain citherraw orprocessed ingredientsfrom one ormore plants or material of inorganic or animal origin and includes herbs,herbalmaterials, other plant materials or combinations;

in-vitro diagnostics medical devicemeans a medical device,whether used alone or in combination,intended by the manufacturer for the invitro examination ofspecimens derived from the human body solely or principally toprovide information for diagnostic,monitoring or compatibility purposes;

"Inspector of Drugsmeans a person who is competitively recruited by the Authority as a drug inspector andwhoholds a minimum of a diplomain pharmacy:

"lot"or "sub-lot"means a defined quantity of starting material, packaging material or product, processed in a single process or series of processes so that the quantity is expected to be homogeneous;and in the case of continuous manufacture,thelot corresponds to a defined fraction of the production characterized by its intended homogeneity;

"lot release"means the process of the evaluation of an individual lot of a licensed biological product by the Authority before giving approval for its release onto the market;

"marketing authorization"means the certificate ofregistration issued by the competent health product regulatory authority in the country oforigin for the purpose ofmarketing or free distribution of a health product after evaluation for safety,efficacy and quality;

"medical devicemeans any instrument,apparatus,implement,machine,appliance,implant, reagent for in vitro use,software,material or other similar orrelated article,intended by the manufacturer to be used,alone or in combination,for human beings,for one or more of the specific medical purpose of

• (l)diagnosis,prevention,monitoring,treatment or alleviation ofdisease;
• injury:
• (n)investigation,replacement,modification or support of the anatomy or of a physiological process;
• (o) supporting or sustaining life;
• (d) control of conception;
• (b) disinfection of medical devices;
• () providing information by means ofinvitro examination of specimens derived from the humanbody;
• (s)disinfection substances;
• aidsforpersonswith disabilities;
• (u)devices incorporating animal or human tissues;
• (v)devices for in-vitro fertilization or assistedreproduction technologies,and does not achieve its primary intended action by pharmacological, immunological or metabolicmeans,in or on the human body,but which may be assisted in its intended function by such means;

medicinal substance means a substance, the origin of which may be human, animal,vegetable orchemical 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;

passive surveillancemeans that no active measures are taken to look for adverse eflects other than the encouragement of health professionals and others to report safety concerns;

"parallel importationmeans importation into Kenya,by a licensed importer of a health product other than the marketing authorization holder or his or her technical representative,of the followinghealth products which require marketing authorization inKenya

• (d)patented health products under section 58(2)of the Industrial Property Act,2001;
• non-patented health products;or
• brandedgenerichealthproducts;

parallel imported medicinal substancemeans a medicinal substance imported into Kenya under thisAct;

pharmacovigilancemeans the science and activities relating to the detection,assessment, understanding and prevention of adverse eflects or any other possible health product related problem;

"premiseincludes any land,building, dwelling-place or any other place whatsoever; and 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;

"schedulingmeans,inrelation 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 product"means a registered medical product that fails to meet either its quality standards or specifications,or both;

"therapeutic cosmetic means a cosmetic which-

• (c)ofers an additional benefit to a person over an ordinary cosmetic; or
• (d)contains a bioactive product formulated from an animal ingredient that may have visible and measurable short or long-term effects on a person,and may include a product that may be absorbed through the skin or a mucous membrane;

"unregistered medical product" means a product that has not undergone evaluation and approval by theAuthority subject to permitted conditions under the Act and therules therein;

"vesselmeans a truck,van,busminibuscar,railer,aircraf,railway carriage,boat and oth means that are used for purposes of conveying health products and technologies;

Justification:The new definitions are internationallyrecognized by the World Health Organization and are critical for the execution of regulatoryfunctions of theAuthority.

To further identify the Board as used in the Bill.

To provide new definitions for the words: cnrolled pharmaceutical technologist, therapeutic cosmetic,herbal medicine,mcdical device and medicinal substances.

CLAUSES

THA'T, Clause S of the Bill be amended by deleting sub-clause (1) and substituting therefor the followingnew sub-clause(1)

(l)This Act applies to the regulation of

• (n)medicines,medical products and technologies;
• (o)medical devices including radiation emittingproducts;
• (p) radiopharmaceuticals;
• (r) cosmetics and Borderline Products;
• (q)complementary,alternative or herbal medicines;
• (s) in-vitro diagnostics medical devices;
• therapeutic feeds;
• (u)clinical trials;
• V nutraceuticals and dietary supplements;

• (w)digital health and technologies;
• (x)scheduled substances;
• (y)chemical substances; and
• (z)biological products for use in humans and the starting materials used in their manufacture.

Justification:To comprchensively cover all aspects in the regulation of health products and technologies.

CLAUSE4

THAT,Clause 4 of the Bill be amended in sub-clause (1) by deleting the words"Kenya Drugs Authorityand substituting therefor the words Kenya Health Products and Technologies Regulatory Authority".

Justification:This accords with intcrnational best practice on the cstablishment ofa centralizedregulatory authority for healthproductsand technologies.

CLAUSE5

THA'T, Clause 5 of the Bill be amended by deleting the words,but the Authority may establish branches anywhere in Kenya and substituting therefor the wordsor in such other place as the board of the Authority may, by resolution, determine".

Justification:Togive theBoard discretion in determining the location of theAuthority's headquarters.

CLAUSE6

THAT,Clause 6 of theBill be amended

• (1)by deleting sub-clause(1) and substituting therefor the following new sub-clause(1)
• "(1)There shall be a Director-General who shall be the chief executive officer of the Authority."

Justification:For proper drafting ofthe clause.

• (g)by deleting sub-clause(2)and substituting therefor the following new sub-clause (2)

"(2)The Director-General shall be appointed by the Board, through a transparent and competitive process,on such terms as may be specified in the instrument of appointment."

Justification:The Director General is not a State Officer and should therefore bc appointed by theAuthoritywithout the approval byParliament.

• (h) in sub-clause (s) by deleting the word "fourand substituting therefor the word"three".

Justification:Appointments and term of servicein State Corporations are normally capped at three(s)years which is renewable for one final term.

• (i)by deleting sub-clause (4) and substituting the following new sub-clause (4)

"(4) A person shall be qualified for appointment as a Director-General if such person

• (g)holds a bachelor's degree in pharmacy from a university recognized in Kenya;
• (h)holds a masters' degree in pharmacy,medicine or any relevant field from a university recognized in Kenya;
• has at least ten years'experience in pharmacy or its equivalent;
• (j)has served in a senior management position for at least five years;
• (k) is a member of a professional body;and
• 1 meets the requirements of Chapter six of the Constitution."; and

Justification:TheDirector General should be a qualified pharmacist as theregulation of healthproductsand technologiesrequires specialized knowledge and technical expertise in the pharmaceutical field.

• Gj)by deleting sub-clause (5).

Justification:The fact that the Dircctor-General shall be the CEO ofthe Authority is provided in the sub-clause(l) as proposed for amendment.

CLAUSE7

THAT, Clause 7 of the Bill be amended in paragraph (f) by deleting the words Act.regulation under this"and substituting therefor the words"regulation under this Act.".

Justification:To corrcct a typographical crror.

CLAUSE8

THAT,Clause 8 of theBill be amended

• (d)in sub-clause (1)by deleting the words "Kenya Drugsand substituting therefor the wordsKenya Health Products and Technologies Regulatory';

Justification:Thename of theBoard should reflect the amendedTitle of theBill and name of theAuthority asproposcd foramendment.

• (e)by deleting sub-clause (2)and substituting therefor the following new sub-clause(2) "(2)The Board shall comprise-

(k)a non-executive Chairperson appointed by the President and who shall-

• (i) be a registered pharmacist of good standing with a degree in pharmacy; and
• (iv)have at least ten years'experience in the pharmaceutical sector,five of which shall be at senior management level;
• (l)the Principal Secretary in the Ministry for the time being responsible for health or a representative designated in writing:
• finance or a representative designated in writing;
• (n) theDirector-General for Health or a representative designated in writing;

• (o) one person nominated by the Pharmaceutical Society of Kenya;
• (p) one person nominated by the Kenya Pharmaceutical Association;
• (q) one person nominated by the Kenya Medical Association;
• (r)one person,not being a Governor,with knowledge and experience in health productsand technologiesnominated by the Council of County Governors to represent the interests of counties;
• (s)one person, not being a public oficer, representing consumer protection nominated by the Consumer Federation of Kenya; and
• (t)the Director-General of the Authority who shall be the secretary and an er oficio member of theBoard.;and

Justification:The composition of the Board should complywith the Mwongozo Code of Governance for State Corporations in terms ofnumbers,skill mix and professional expertise which should include all relevant players involved in the matters ofhealth products and technologies.

• (f)by deleting sub-clause (s) and substituting therefor the following new sub-clause (s) "(s)The Cabinet Secretary shall appoint the members of the Board under subsection (e). (f).(g).(h) and (i) by notice in the Gaxelte."

Justification:The members of the Board Members are not State Officcrs and hence their appointment does not require approvalby Parliament.It is sufficient that the Cabinct Secretary notifies the public of the appointments in the Kenya Gazettc.

CLAUSE9

THAT,the Bill be amended by deleting Clause 9.

Justification:The provision contradicts the legal framework for appointment of the Chairperson,Board Members and CEOs of State Corporations or Semi-Autonomous Governmcnt Agcncies.The Chairperson,Board Members and Dircctor General of the Authority are not State Officers and hence do not need to subscribe to anoath.

CLAUSE10

THAT, Clause 10 of the Bill be amended in sub-clause(1) by deleting the words "section 12 appearing in paragraph (c)and substituting therefor the words"section 11"

Justification:To correct the crossreference as clause 11 makesprovision forremoval from office of the members oftheBoard of the Authority.

CLAUSE12

THAT, Clause 12of the Bill be amended by

(h)inserting the following paragraphs immediately after paragraph (e)

(ea)regulate the disposal of health products and technologies;

(eb) monitor the market for the presence of unregistered and illegal health products and technologies;

(ec)conduct analytical tests of health products and technologies";

Justification:To make provision for the functions of disposal,analytical testing and monitoring of themarketby the Authority.

• (i)deleting paragraph (f) and substituting therefor the following new paragraph (f)

"(f)ensure continuous monitoring of the safety of health products and technologies regulated under this Act through analysis of reports on adverse reactions and events, including any other health product and technology use related issues and take appropriate regulatory actions when necessary";

Justification:To expressly align to the WHO requirement on the cstablishment of a nationalvigilance system.

• (j)deletingparagraph(g)and substituting therefor the following new paragraph(g) (g)regulate clinical trials and ensure that clinical trial protocols of health products and technologies are being assessed according to the prescribed ethical and professional criteria and defined standards includingmandatory bioequivalence studies;

Justification:To anchor the oversight of clinical trials in the law as recommended by the WHO.

• (k)inserting the following newparagraphs immediately after paragraph (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 withgood pharmacovigilancepractices and the prescribed requirements"

Justification:To provide for approval of hcalth products and technologics during emergcncies and to provide for pharmacovigilance which check thc safety of health products and technologies

• (n) appoint inspectors and order inspection of manufacturing premises,medical devices establishments,importing and exporting agents,wholesalers, distributors,pharrmacies including those in health facilities 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.

(oa)conduct national regulatory authority lot release, official authority batch release of specified biologicals to ensure the quality,safety and efficacy of biological products through a regulatory release system in compliance with established approaches,policies, guidelines,procedures and in linewithWorld Health Organization and internationally recognized guidelines;

(ob)carry out and promote research related to medicines and health products";

Justification:To cnable thc conduct ofresearch by thc Authority and the conduct of lot releaseswhich are a key component in the regulation of the production ofvaccines.

(n) inserting the following paragraphs after paragraph (q)

(qa)ensure that all health produets and technologiesmanufactured in,imported into or exported from the country including through parallel importation conform to prescribed standards of quality, safety and efficacy;

(qb)enforce the prescribed standards of quality,safety and eflicacy of health products and technologiesmanufactured,inported into or exported out of the country;

(qc)grant or revoke licenses and permits for the manufacture,importation,exportation, distribution and sale of health products and technologies;

electronically;

(qe)regulate licit use of narcotic,psychotropic substances and precursor chemical substances in accordance with the Single Convention on Narcotic Drugs,196l,the Convention on Psychotropic substances,1971 or the United Nations Convention against Illicit Traffic of Precursor Chemical Substances,1988;

(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:To include critical functions of the Authority based on best practice in regulation of import and export of health products and technologies that will cnable thc country attainWIIO maturitylevel s.

CLAUSE1S

THAT, Clause 1S of the Bill be amended by

(c) deleting paragraph (a) and substituting therefor the following new paragraph (a)

"(a)collaborate with such otherbodies or organizations within or outsideKenya as it may consider desirable or appropriate for the furtherance of the purpose of theAct;"

(d) inserting the following new paragraphs immediately after paragraph (a)

(aa)adopt and implement any such internationally recognized good regulatory practices; (ab)determine and implement effective and efficient reliance mechanisms;

(ac)issue,suspend,withdraw or revoke any license or compliance certificate granted under thisAct;

(ad) levy,collect and utilize fees for servicesrendered;

(ae)grant or withdraw licenscs and permits to manufacturers,wholesalers,retailers, importers, exporters and distributors; (af) develop guidelines on the manufacture,import and export, distribution, sale and use of medical products

Justification:To complywith WHOrequirements forregulatory functions in the Global BenchmarkingTool especially on control over imports and exports.

CLAUSE21

THAT Clause21 of theBill be amended

• (e)by deleting sub-clause (1) and substituting therefor the following new sub-clause(1)

"(1)The Board may establish such scientific advisory committees of the Authority,as may be necessary for the effective performance of the functions of the Authority"

• (f)in sub-clause (S)by deleting the words"Cabinet Secretary"and substituting therefor the words"Board of the Authority";
• (g)in sub-clause(4)by deleting the words "Cabinet Secretary" and substituting therefor the words"Board of the Authority";
• (h)by deleting sub-clause (9) and substituting therefor the following new sub-clause (9) (9)An advisory committee shall submit,at least once every six months,a report to the Board of the Authority,with respect to its activities and the Board shall submit a copy of each report to the Cabinet Secretary".

Justification:The Scientific Advisory Committces ought to offer technical advice and report to the Board (its appointing authority)which then advices the Cabinet Sccretary accordingly.

PARTIV

THAT,Part IV of the Bill be amended by deleting the title and substituting therefor the followingnew title-

"PARTIII-HEALTHPRODUCTSANDTECHNOLOGIES"

Justification:To cnsure harmonywith thetitle of theBill asproposed for amendment and to correct a minor error innumbering of theparts of the Bill.

CLAUSE22

THAT,Clause22of theBill be amended-

• (d)in the marginal noteby deleting the wordmedicines"and substituting therefor the words "health products and technologies";

Justification:To harmonize the terms used in the Bill with theTitleof theBill as proposed foramendment.

• (e) in sub-clause (1) by
• (ii)deleting the words"sellany medicine" appearing in the opening sentence and substituting therefor the words"sell,manufacture,supply,distribute or dispense any health product or technology";

Justification:Tobroaden the scope ofprohibited sale ofhealth product and technologies to include manufacturing,dispensing,distribution and supply of health product and technologies.

(iv)deleting paragraph(d) and substituting therefore thefollowing new paragraph (d)

• "(d)is falsified,;

Justification:For alignment with international best practice as the proposed terminology is recognized by theWHO.

(f)in sub-clause(s)by-

(ii)deleting the word "medicine"appearing in the opening sentence and substituting therefor the words"health product or technology:and

• (iv)deleting the words "pharrmaceutical product" appearing in paragraph (b) and substituting therefor the words,"health product or technology"

Justification:To harmonize the terms usedin the Bill with theTitle of the Bill asproposcd foramendmcnt.

CLAUSE2S

THAT, Clause 23 of the Bill be amended in sub-clause (1) by

• (d)deleting the word "medicines"appearing in paragraph (a) and substituting therefor the words,"health products or technologies";
• (e)deleting the word"medicine"appearing in paragraph (b) and substituting therefor the words,"health products or technologies";and
• 1 deleting the word"medicine"appearing in paragraph(c)and substituting therefor the words,"health products or technologies"

Justification:To harmonize the terms used in the Bill with theTitle of the Bill as proposed for amendment.

CLAUSE24

THAT,Clause24of theBill be amended

• (f)in the marginal note by deleting the word medicines" and substituting therefor the words "health products and technologies";
• (g)in sub-clause (1) by deleting the word "medicine"wherever it appears and substituting therefor the words"health product or technology;
• (h)by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)

"(2)If a standard has not been prescribed for a health product or technology but a standard for the health product or technology is containedin any of the publications specified in the Fifth Schedule,any person who manufactures,labels,packages,sells or advertises any other substance or article in such a manner that is likely to be mistaken for the health product or technology having met any of the standards contained in any of the publications specified in the Fifth Schedule,commits an offence.;

• (i)in sub-clause(s)
• (i)by deleting the word "medicine"wherever it appears in the opening sentence and substituting therefor the words"health product or technology:and
• (iv)by deleting the word "drug"appearing in paragraph (b)and substituting therefor the words"health product or technology";

Justification:Toharmonize the terms used in the Bill with theTitle oftheBill as proposcd for amendment.

• (i)in sub-clause(4)
• (i)by deleting the wordsone hundred thousand shillings or to imprisonment for a therefor the words"onemillion shillings or to imprisonment for a term not exceeding three years';and
• (iv)by deleting the words "two hundred thousand" appearing in paragraph (b) and substituting therefor the words"two million"

Justification:To make the fines prohibitive and punitive due to therisk of the offences to publichcalth.

CLAUSE25

THAT,the Bill be amended by deleting Clause 25.

Justification:The prohibition of sale of medicines ofa quality not demanded is a practice issue and falls outside the ambit of the Bill.

CLAUSE26

THAT, Clause 26 of the Bill be amended by

• (c)deleting the word"medicine" appearing in the marginal note and substituting therefor the wordshealth product or technology;and
• (d)deleting theword"medicine"and substituting therefor the words"health product or technology".

Justification:To harmonize the terms usedin theBill with theTitle of theBill asproposed foramendment,

CLAUSE27

THAT,Clause 27 of the Bill be amended

• (d)by deleting the words "medicinal products" appearing in paragraph (a) and substituting therefor the words"healthproducts or technologies";
• (e)by deleting the words "medicinal products"appearing in paragraph (b)and substituting therefor the words"health products or technologies;and
• (f)by deleting paragraph (c) and substituting the following new paragraph(c)

(c) the quality of the health products or technologies of each such description, according to the specification and themethod or proposed method ofmanufacture ofthe health products or technologies,and the provisions proposed for securing that the health products or technologies as sold or supplied will beof that quality;and

Justification:To harmonize the terms uscd in the Bill with theTitle oftheBill as proposed for amendment.

NEWCLAUSES

THAT, theBill be amended by inserting the following new clauses immediately after clause 27

27A.(1)A person who intends to import,manufacture or sell a health product productor technology shall apply to theAuthority for the registration of the health product or hcalth technology in the prescribed form.

• (5)An applicant under subsection(1) shall
• (c)specify the particulars ofthe person with appropriate knowledgeofallaspects of the health productor health technology who shall be responsible for all communication between the applicant and the Authority in the declaration page of the application form;and
• (d)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 of Kenya, a person who is or has permanent residence or a company incorporated in Kenya.
• (6)'The application made under subsection(1) shall be accompanied by-
• l)a proposed label for use on the health product or technology:
• (m)a copy of the manufacturing licence of the hcalth product or technology,where applicable;
• (n)a copy of the good manufacturing practice certificate from the Authority and the regulatory authority of the country where the health product or technology is manufactured;
• (o)a copy of a certificate of analysis from a quality control laboratory recognized bythe Authority,where applicable;
• (p)a copy ofthe marketing authorization or certificate of registration of the health product or technology from the regulatory authority of the country where the health product or technology is sold;
• (q)the available data on the quality,safety,eflicacy and performance ofthe health product or technology submitted ina common technical dossier format;
• (r)a sample of the health product or technology;
• (s)proof ofownership of the site for themanufacture of the health product or technology,where applicable;

Application for licence, application for registration of health product or technology.

• (t)where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya,a copy of the agreement appointing the local representative;
• (u)where the application relates to a health product or technology which is registered with a foreignregulatory body-
• (iv)a copy of the certificate of registration;
• (v)the professional information relating to the health product or technology; and
• (vi)the conditions ofthe registration ofthe health product or technology:

(v)proofthat the applicant holds

• (vi)a valid practicing licence issued by the body responsible for the profession of pharmacy;
• (vi)a validwholesale dealer's licence issued in accordance with this Act;
• (viii)a valid licence to sellpoisons issued in accordance with this Act;or
• (ix)a valid manufacturing licence issued in accordance with this Act;and
• (x)proofofpayment ofthe application fees as prescribed by the Authority.
• agreement appointing thelocal representative within seven daysof the variation.

Processing of27B.(1)The Authority shall consider the application made under section 27A and,shall,if it is satisfied of the safety,eflicacy,quality,performance and economic value of the health product or technology,register the health product or technology and issue a certificate of registration in the prescribed form.

(2)The Authority may,while considering the application,approve the details as supplied by the applicant or approve it with such amendments as it may consider appropriate inrespect of the followingparticulars

• (d)the name under which the health product or technology may be sold;
• (e)thelabelling of the health product or technology;
• (f)the statement of the representations to bemade for thepromotion ofthehealth product or technology regarding
• (vii)the claim to be made for the health product or technology:
• (vi)the route of administering the health product or technology,

Registration during emergency.

(ix)the dosage of the health product or technology:

• (x)the storage conditions of the health product or technology:
• (xi)the contra-indications,the side effects and precautions,f any of the health product or technology: and
• (xi) the package size of the health product or technology.

(s)When evaluating an application,the Authority may

• (c)subject a sample of the health product or technology to an evaluation by an analyst; and
• (d) consider the evaluation report of the analyst that has evaluated the healthproduct or technology.

(4)Where theAuthority is not satisfied as to the quality.safety efficacy, performance or economic value of the health product or technology,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.(1) The Authority may,where it considers it necessary to protect public health or in the event of a threat tolife or health,issue a provisional certificate of registration for a health product or technology.

(2)A person who intends to obtain the provisionalcertificate of registration for a health product or technology under subsection(1) shall apply to theAuthority in the prescribed form.

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

(4) An application under subsection (2) shall be accompanied by—

(a)such documents as may be necessary to support the application;

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

(c)proof that the applicant holds

• (via valid practicing licence issued by the body responsible for the profession of pharimacy;
• (vii) a valid wholesale dealer's licence issuedin accordance with this Act;
• (vii) avalid licence to sell health products or technologies issued in accordance with this Act;or
• (ix)a valid manufacturing licence issued in accordance with this Act;and
• (x)proof of payment of the application fees as prescribed by theAuthority.

Authorization of health product Or technology.

(5)When determining an application under this section, the Authority shall consider the facts established from the valid marketing authorization for the health product or technology and thereport on the assessment of the health product or technology obtained from the authority competent for health products and technologies,if available.

(6)The person to whom the certificate of registration is issued under this section,shall be responsible for the labelling.packaging.advertising and pharmacovigilance system of the health product or technology.

(7)A provisional certificate of registration issued under subsection(1) shall be valid for twoyears from the dateof issue or until the declaration made under section S5 of thePublic Health Act is revoked.

(8)Any variation to the agreement appointingthelocal representative to the application made under subsection(2) shall be notified to the Authority within seven days of the variation.

27D.(1)The Authority may,in writing.authorize a person to import or distribute for a specified period to a specified person or institution a specified quantity of a particular health product or technology that is not registered.

(2)A health product or technology distributed pursuant to authorization granted under subsection (1)may be used for such purposes and in such

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

(5)The application made under subsection (s) shall be accompanied by

• (h)aproduct brochure relevant chemical, pharmaceutical, pre-clinical pharmacological pue toxicological data and where applicable,human pharmacologicaland clinicaldata related to the health product or technology for which authority is sought;
• 1 written consent of the applicant,where applicable;
• details ofregistration or pending registration of the health product or technology with any otherregulatory authority, where applicable;
• (k)evidence of compliance by the manufacturer of the health product or technology with goodmanufacturing practice standards as determined by the Authority;
• (l)reasons why a registered health product or technology cannot be used;

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

(n)proof that the applicant holds-

• (vi)a valid practicing licence issued by the body responsible for the profession ofpharmacy;
• (vii) a valid wholesale dealer's licence issued in accordance with this Act;
• (vii) avalidlicence tosell health products or technologies issued in accordance with this Act; or
• (ix)a valid manufacturinglicence issued in accordance with this Act;and
• (x)proof of payment of the application fees as prescribed by the Authority.

(6)Where the Authority issues an authorization under subsection (1),the person towhom the authorization is issued shall submit to theAuthority-

• (d)progress reports after every six months from the date of issuance of the authorization;
• (e)any adverse event report, where an adverse event occurred; and
• f)a progress report within thirty days after the completion or termination of the use of thehealthproduct ortechnology.

(7)The Authority may,where it is of the opinion that the safety of any patient is compromised or where the scientific reasons for administering the unregistered health product or technology have changed

• (e)impose any additional conditions;
• (f)request additional information;
• (g)inspect the site where the unregistered health product or technology ismanufactured, stored or administered; or
• (h)withdraw the authorization to treat the patient.

(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 or technology authorized under this section shall be labelled in accordance with this Act.

(10)An applicant shall notify theAuthority ofany variation to the agreement

(11) The requirements in this section shall apply to applications for donations ofhealth products and technologies.

Justification:To provide new clauscs 27A,27B,27C and 27D for the handling of applications of product licences by theAuthority.

CLAUSE28

THAT, Clause 28of the Bill be amended

• (d)in the marginal note by deleting the words"medicines register" and substituting therefor the words"health products and technologies register"
• (e)in sub-clause (1) by deleting the wordsmedicines register"and substituting therefor the wordshealth products and technologies register";and
• (f)in sub-clause (2) by deleting the words "medicines registerand substituting therefor the words"health products and technologies register"

Justification:Toharmonizc the terms used in the Bill with theTitle of theBill as proposed for amendment.

CLAUSE29

THAT,Clause 29 of the Bill be amended

• (m)in the marginalnote by deleting the words "medicines and medical devicesand substituting therefor the words"health products and technologies";
• (n)by deleting sub-clause(1) and substituting therefor the following new sub-clause(1) "(1)Every application for registration of a health product or technology shall be submitted to the Registrar in the prescribed form and shall be accompanied by the prescribed particulars and samples of the relevant health product or technology and by theprescribedregistration fee."
• (o)in sub-clause(3)
• (iv)by deleting the word "medicine"appearing in paragraph (a) and substituting therefor the words"healthproduct or technology;
• (v)by deleting the word "medicineappearing in paragraph(b) and substituting therefor the words"health product or technology";
• (vi)by deleting the word"medicine"appearing in paragraph (c)and substituting therefor the words"health product or technology":
• (p) in sub-clause(4) by deleting the word medicine"appearing in the opening sentence and substituting therefor the words"health product or technology";
• (q)by deleting sub-clause (6) and substituting therefor the following new sub-clause (6)

"(6)Where the Authority has approved the registration of any health product or technologyifitissatisfiedofthe safety,flicacy,quality.erformance andeconomicvalue of the healthproduct or technology,the Registrar shall register that health product or technology and shall enterin theregister such particulars inregard to thehealth product or technology as are required by this Act to be so entered and shall issue to the applicant a certificate of registration in the prescribed form in respect ofthat health product or technology.

• (r)in sub-clause (7)by deleting the word "medicine"and substituting therefor the words "healthproduct or technology;
• (s)in sub-clause (8) by deleting the word "medicine"wherever it appears and substituting therefor the words"health productor technology":

• (t)in sub-clause (9) by deleting the word "medicines"and substituting therefor the words "health products and technologies";
• (u)in sub-clause(1o)by deleting the wordmedicine"and substituting therefor the words "health product or technology";
• (v)in sub-clause(11) by deleting the word "medicine"and substituting therefor the words "healthproduct or technology";
• (w)in sub-clause(12) by deleting the wordmedicine appearing in the opening sentence and substituting therefor the wordshealth product or technology;

Justification:To harmonize the terms used in theBill with theTitle of theBill asproposed for amendmcnt.

• (x)in sub-clause(14)by deleting paragraph (a) and substituting therefor the following new paragraph (a)

"(a)Kenya Essential Medicines List,Kenya Essential Diagnostics list and Kenya Essential Medical Supplies list'means the list of essential medicines, diagnostics and medical supplies included in thelatest editions of the official publications relating to guidelines for standard treatment which is compiled by the state department responsible for Health;

Justification:Tobroaden the scope of HPTs considered under the clause.

NEWCLAUSES

THAT, the Bill be amended by inserting the following new clauses immediately after clause 29-

Authorization of health products and technologies.

29A.(1)A person shall not import any health product or technology unless

• (c)the imported health product or technology has been authorized throughissuance ofan importpermit or a written authorization by the Authority;and
• (d)the imported health product or technology is inspected and verified by an inspector of the Authority at the ports of entry prior to its release.

(2)No batch or lot of any registered product shall be released by the manufacturer prior tothecompletion of tests for conformity withstandards applicable to such product andofficial batch or lot release by the Authority in cases of biological therapeutics

• (s)Each applicable test conducted by themanufacturer under subsection (2)shall be made on each batch or lot after completion ofall

Parallel importation of health products and technologies.

processes of manufacture and such test may affect compliance with the standard applicable to theproduct.

(4)The manufacturer or marketing authorization holder of any registeredbiological therapeutic shall submit lot summary protocol for each lot that contains registered tests and results of tests performed and,such manufacturer ormarketing authorization holder may berequired to submit samples ofproduct from the specifiedlot to the Authority for official batch or lot release in accordance with the prescribed regulations.

(5)Every batch or lot of a registered biological therapeutic imported into Kenya or manufactured in Kenya shall be evaluated and,on being satisfied of conformitywithprescribed standards and payment ofprescribed fees,theDirector-General shall approve its release into themarket and issue a certificate of official batch or lot release in the prescribed format.

(6)The Authority may recognize and accept official lot release certificatesissued by othernational regulatory authorities ofother countries for a specific batch or lots of biological therapeutic manufacturedwithin the territories of those national regulatory authorities,in issuance ofa certificate under this section.

(7)A person who contravenes this section commits an offence and shall on conviction beliable

• (c)in the case of a first offence, to a fine not exceeding one million shillings or to imprisonment for a term not exceeding twoyears ortoboth;or
• (d)in the case of a subsequent offence, to a fine not exceeding two million shillings or toimprisonment for a termnot exceedingfive years,or to both.

Justification:To provide for authorization of hcalth products and technologies imported into the country includingthe requirement for batch orlotrelease inline withWHO requirements.

product or technology intoKenya unless

• (f)the person is incorporated as a limited liability company under the Companies Act;
• (g)the person has been granted a certificate of parallel importation;
• (h)the person is licensed to parallel import the health product or technology:

• (i)the health product or technology has a valid registration in Kenya under this Act;and
• (i)the health product or technology has avalid market authorization in the country of origin.

(2)A person who wishes to undertake parallel importation of a health product or technology shall apply to the Board for a certificate ofparallel importation in theprescribed manner

(3)The Board shall establish and maintain a system that ensures that a registered parallel imported health productor technology can be traced from its sourcing,manufacturing,packaging.storage,transport to its delivery to the health facility,institution or private practice where the health product or technology is intended to be used.

(4)Aperson who

• (d)is the holder of a certificate ofparallel importation or licensee and fails to comply with any requirement or obligation in this Act;
• (e)contravenes any prohibition prescribed by the Authority; or
• fails to complywith anyrequireiment imposed on thatperson by the Board pursuant to thisAct,

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:To make provision for parallel importation of health products and technologies.

CLAUSESO

THAT,ClauseSO oftheBill be amended

• (c) in sub-clause (1) by deleting the word "medicine"wherever it appears and substituting therefor the words"health product or technology;and
• (d)in sub-clause(s),by deleting the word "medicine"wherever it appears in paragraph (b) and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in theBill with the Title of the Bill as proposed for amendmcnt.

CLAUSE31

THAT,Clause S1 of the Bill be amended

• (c)in sub-clause(1) by deleting the wordmedicine"and substituting therefor the words "healthproduct or technology;and
• (d) in sub-clause (s)by deleting the word "medicine"appearing in paragraph (c)and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in theBill with theTitle of the Bill asproposed foramendment.

CLAUSE32

TIIAT,Clause S2ofthe Bill be amended

(e)by deleting sub-clause (1) and substituting therefor the following new sub-clause(1)

• (1)The Authority shall cancel theregistration of a health product or technology if
• (d)a licensee has failed to comply with a condition subject to which a particular health product or technology has beenregistered;
• (e) a particular health product or technology does not comply with a prescribed requirement; or
• (f)it is not in the public interest to make a particular health product or technology available to the public."
• (f)in sub-clause(2)by deleting the words "medicine or medical device"wherever it appears and substituting therefor the words"health product or technology";
• (g)in sub-clause(4)
• (ii)by deleting the words"medicine ormedical device" appearing in the opening sentence and substituting therefor the words"health product or technology":and
• (iv)by deleting the words "medicine or medical device" appearing in paragraph (b) and substituting therefor the wordshealth product or technology:and
• (h) by deleting the words "medicine or medical devicewherever it appears in sub-clause(5) and substituting therefor thewords"health product or technology"

Justification:Toharmonize the terms used in theBill with theTitle of theBill as proposed for amendment.

CLAUSE33

THA'T,Clause S3 of the Bill be amended in sub-clause (1) by deleting the wordsmedicine or medical device"and substituting therefor the words"health product or technology"

Justification:Toharmonize the terms used in the Billwith theTitle of theBill asproposed for amendment.

CLAUSE34

THAT,Clause S4oftheBill be amended

• (c)by deleting the words"medicines" and "medicine"wherever it appears and substituting therefor the words"health product or technology;and
• (d)in the marginal note by deleting the words"medicines"and substituting therefor the words"health products and technologies".

Justification:To harmonize the terms usedin theBill with theTitle oftheBill asproposcd foramendment.

CLAUSE35

THAT, Clause S5 of the Bill be amended

• f)by deleting the wordmedicine"wherever it appears and substituting therefor the words "health product or technology":

Justification:To harmonize the terms usedin the Bill with the Title of the Bill as proposed for amendment.

• (g)in sub-clause (1)by inserting the words"or an enrolled pharmaceutical technologist immediately after the word"pharmacist";
• (h) in sub-clause(2)by inserting the words"or an enrolled pharmaceutical technologist immediately after the word"pharmacist";
• in sub-clause(s)by inserting the wordsor an enrolled pharmaceutical technologist immediately after the word"pharmacist;and
• in sub-clause (4) by inserting the word "or an enrolled pharmaceutical technologist immediately after the word"pharmacist".

Justification:For inclusion of pharmaceutical technologists in the dispensing of interchangeable multi-source medicine.

CLAUSES6

THAT,theBill be amended by deleting Clause 36

Justification:The provision is a practice related issues that is best handled through the proposed Pharmaceutical Practice Bill.

NEWCLAUSE

THAT,theBill be amended by inserting the following new clauseimmediately after clause S6

Climical trials.

S6A.(1)A health product or technology shall not be used for clinical trial relevant ethics body.

(2)A person who intends to commence a clinical trial on a health product or technology shall make 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.

(3)The study protocol subrmitted under subsection (2) shall include a post-trial access program to ensure access of investigationalmedicinal substances by participants in the trial before grant of marketing authorization by theAuthority.

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

(5)Aperson granted an approval under this section shall put inplace a robust quality assurance system to ensure that the clinical trial is carried out in a manner that ensures the integrity of data generated and the safety and well-being of the participants of the study

(6)The Authority shall carry out inspection of the clinical trials and monitor compliance of the clinical trials with theprescribed requirements.

(7) Any amendments to clinical trials protocols shall be submitted to the Authority for approval before implementation.

Justification:To provide for cffective regulation of clinical trials by the Authority.

PARTV

substituting therefor the expression"PART IV"

Justification:To correct a minor crror in numbering of the parts of the Bill.

CLAUSES7

THAT,Clause S7of the Bill be amended

• (e)in sub-clause (2)by deleting the words and dealers in mining,agricultural or horticultural accessories"appearing in paragraph (a);

Justification: Scheduled substances used in mining,agriculture and horticulture are regulated under other laws.

• (t)by inserting the following new sub-clause (s) immediately after sub-clause(2) "(s) The Cabinet Secretary shall publish the list of scheduled substanees prepared under

subsection (1) in the Gaxette.

Justification:To provide for the publication of the list of scheduled substances.

• (g)by renumbering sub-clause(S) as sub-clause(4);
• (h)by deleting sub-clause (4) and substituting therefor the following new sub-clauses
• "(5)The Authority shall at least once every two years,review the lists under subsection (3),or whenever necessary in the interest of public health and safety.

(6)Any modification of the list of scheduled substances prepared under this section shall be subject to the procedure provided in subsection (1),(2) and (s)."

Justification:To enhance thepcriod ofreview of the lists of scheduled substances from one year to two years and provide for review in public interest where nccd arises.To cnsure that theproccdure set out in the clause inthe preparation and publication of the list ofscheduled substances isfollowed evenwhen thelists aremodified.

CLAUSESS

THAT,ClauseS8oftheBill beamended

(c)in sub-clause(1)by

(ii)deleting the words "the Limitations prescribed by this sub-sectionand substituting therefor the words"the following limitations";

Justification:For proper drafting.The words "prescribed by this sub-section"are unnecessary.

(iv)deletingparagraph (c)

Justification: Scheduled substances used in mining.agriculture and horticulture are regulated under other laws.

(d)by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)

(2)A person who is in possession of a scheduled substance otherwise than in accordance with the provisions of this section commits an offence and shall on conviction,beliable to a fine not exceeding two million shillingsor to imprisonment for a term not exceeding three years; or to both."

Justification:To enhance the penalty for the offence of possession of a schcduled substance contrary to the provisions of the Bill from Kshs.100,000 to Kshs,2,00o,000.

CLAUSE39

THAT, Clause S9 of the Bill be amended by deleting sub-clause(5)and substituting therefor the following new sub-clause(5)

(5)A licence issued under this section shall be valid for a period ofone year,renewable annually

Justification:Annual expiry of the licence is too punitivc cspecially for persons who apply in the middle of the year.

CLAUSE40

THAT,the Bill be amended by deleting clause 40

Justification:Scheduled substances uscd in mining,agriculture and horticulture are regulated under other laws.

CLAUSE41

THIAT,Clause41of theBill be amended

(d) in sub-clause (1) by deleting paragraphs (c) and (e);

Justification:Scheduled substances used in mining,agriculture and horticulture are regulated under other laws.The National or County government cannot buy scheduled substances on its own,it must do so through a person licensed to do so under the Bill.

• (e) in sub-clause (2) by deleting paragraph (b) and (c): and

Justification:The persons to whom awholesaler dealermay sell scheduled substanccs to are sct out in sub-clause (1).

• (1)by deleting sub-clause (s)

Justification:Scheduled substances used in mining,agriculture and horticulture are rcgulatedunder otherlaws.

CLAUSE42

THAT,Clause 42of the Bill be amended

• (c)in sub-clause (1) by deleting the words paragraph (b) of Section 53(2)appearing in paragraph (a)and substituting therefor the wordssection 41(2)(b);and

Justification:To corrcct the cross refercnce as clause 41 makes reference to the written certificate contemplated under clause42.

• (d)in sub-clause (s) by deleting the words"three years"and substituting therefor the words "one year"

Justification:Toreduce the penalty ofimprisonment from threeyears to one year as the same isnot commensurateto the fine ofone hundred thousand shillingsinrclation to the offence ofnot making cntries of sale of scheduled substances in a scheduled substances book.

CLAUSE4S

THAT, Clause 4S of the Bill be amended in sub-clause (1)

• (d)by deleting the opening sentence and substituting therefor the following new opening sentence

(1) A qualified healthcare professional may supply or dispense a Scheduled Substance with therapeutic value for the purpose ofmedical,dental or veterinary treatment,as the case may be, subject to the following provisions

Justification:To restrict dispensing of scheduled substances to authorized persons.

• (e)in paragraph (b) by
• (ii) inserting the word and immediately after the word"supplied"appearing in subparagraph (i);and
• (iv) deleting the word "and" appearing in sub-paragraph (iv);

Justification:To correct a minor drafting crror.

• (f)by deleting paragraph (c).

Justification:Registered midwives are included in the qualificd healthcare professional provided in the amended sub-clause (1).

CLAUSE45

THAT,the Bill be amended by deleting Clause 45 and substituting therefor the following new clause45

Automatic 45.(1)An authorized seller may use an automatic machine to dispense overmachines. the-counter scheduled substances.

• (2)The Authority shall develop regulations on the-
• (f)classes of substances permitted;
• (g)quantities of substances to be dispensed;
• (h)records of substances dispensed;
• (i) location of automatic machines;and
• (j)registration of automatic machines.

Justification:To provide for the use of automatic machines in dispensing selected schcduled substances in an effort to leverage on technology.

CLAUSE46

THAT,the Bill be amended by deleting Clause 46 and substituting therefor the following new clause46

46.(1)The Authority shall prescribe guidelines toprovide for the electronic supply and dispensing of scheduled substances including through e-pharmacy, products andtelemedicine,medication therapy management and online pharmacy

• (2)The regulations made under subsection (1) shall provide for-
• ()licensure of e-pharmacies;
• (g) safety of patients;
• (h)verification of the identity and traceability of patients;
• verification of the identity and traceability of prescribersand
• avoidance of multiple use of the same prescription.

(s)The electronic supply and dispensing of scheduled substances shall bepermitted provided that the supplyof such health products and technologies conforms with all requirements for the particular health product or technology in terms of its scheduling status and any other requirements as may be

(4)In the case of a prescription-onlymedicine,therequiredprescription shall havebeen obtained as a result ofat least one physical interaction between an authorised practitioner and the patient within a period ofat least six months.

Electronic saleofhealth technologies.

(5)Any person who contravenes this section shall be guilty of an offence,and shall on conviction,beliable to a fine not exceeding one million shillings,or to imprisonment for a term not excceding one year,or to both.

Justification:For proper regulation of electronic sale of medicine which is alreadya global phenomenon as many online platforms are sclling medicines to consumcrs and to cnhance the fines inrelation to the sale of schcduled substances using clcctronic means to cnsure that quality is guaranteed.

NEWCLAUSE

THAT, theBill be amended by inserting the following new clause immediately after clause 46

Dietary 46A. (1) A dietary supplement shall— supplements.

• (c)not contain scheduled substances;and
• (d)have a stated or implied therapeutic purpose.

(2)Where a dietary supplement contains folic acid, the maximum daily dose for the dietary supplement shall be as per the guidelines prescribed by the Board of the Authority.

Justification:To provide for dietary supplements which will cnhance the regulation of food supplementsby theAuthority.

PARTVI

THAT,the Bill be amended in the title of Part VI by deleting the expression"PART VI MANUFACTURE OFMEDICINALSUBSTANCESandsubstitutingtherefor theexpression "PARTIV-MANUFACTUREOFHEALTHPRODUCTS"

Justification:To correct a minor crror in numbering of the parts of the Bill.

CLAUSE47

THAT,Clause 47 of the Bill be amended

• ()in sub-clause(1)by deleting the words"medicinal substanceand substituting therefor the words"health product";

Justification:To harmonize the terms used in the Bill with theTitle of the Bill as proposed for amcndment.

(g)by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)

(2)A manufacturing licence issued under this section shall be valid for a period of one year,renewable annually."

Justification:To give the manufacturinglicense validity for one year.

• (h)in sub-clause (3) by deleting the wordsmedicinal substance" and substituting therefor the words"health product;
• (i)in sub-clause (4) by deleting the words"medicinal substance" and substituting therefor the words"health product";

Justification:To harmonize the terms used in theBill with theTitle of theBillas proposed foramendment.

• (i)by inserting the following sub-clauses immediately after sub-clause (5)
• (6)The Authority shall prescribe regulations setting out conditions for thequalifications of personnel involved in the production processes of a health product regulated under this Act.
• (7)The personnel qualified to conduct lot release ofvaccines andbatchrelease of health products shall submit their qualifications to theAuthority.
• (8)Any person who commits an offence under this section is on conviction,liable to a fine not exceeding ten million shillings,or to imprisonment for a term not exceeding ten years, or to both."

Justification:Substandard,falsified and falscly labelled health products occasion serious public health challengcs.

CLAUSE48

• THAT, Clause 4S of the Bill be amended
• (c)by renumbering the provision as sub-clause (1); and
• (d)by inserting the following new sub-clauses immediately after sub-clause (1)
• "(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 fees.
• (3)The Cabinet Secretary shall make regulations for the better carrying out of the provisions of this section.
• (4)Without prejudice to the generality of subsection (s), the Authority shall make regulations on-
• (d)revocation and suspension of manufacturing licences;
• (e)withdrawal of revocation of manufacturing licences upon request;and
• (f))transfer of manufacturing licences.

Justification: Togive the Authority power to cnforce compliance with good manufacturing practices as recommended by WlIO which will in turn cncourage continuousimprovcmentofinternalquality control systems andproductionproccsscsby manufacturers.

PARTVII

THAT,the Bill be amended in the title of Part VII by deleting the expression"PART VII and substituting therefor the expression"PART VI".

Justification:To correct a minor error in numbering of the parts of the Bill.

CLAUSE51

THAT, the Bill be amended by inserting the following new clauses immediately after clause 51

Information 51A.A person dealing in a therapeutic cosmetic shall indicate

that is required to be displayed on the pack.

• (g)the common name of the therapeutic cosmetic;
• (h)thenet weight;
• (i)all the cosmetic ingredients in the order of prominence but not includingflavours or fragrances;
• the name and address of manufacturer of the therapeutic cosmetic;
• (k)a warning statement, and
• (l)a staterment that the therapeutic cosmeticis capable of curing or treating any disease or medical condition.

Justification:To enhance transparency on the ingredients used in therapeutic cosmctics in line with the Good Manufacturing Practices

Manufacturing 51B.(1)The Cabinet Secretary shall make regulations for the effective ofcosmetics. implementation of this section.

(3)The regulations made under subsection (1) may

• (a)require manufacturers of cosmetics to register with the Authority;and
• (b)impose restrictions,requirements or other conditions on manufacturers of cosmetics,if such restrictions,requirements or conditions are necessary to protect public health.

Justification:To enhance transparency on theingredients used in therapeutic cosmetics inline with the Good ManufacturingPractices

CLAUSE52

THAT, Clause 52 of the Bill be amended by deleting the words have a therapeutic effect or value and substituting therefor the words treat, diagnose or prevent disease,or aflect the structure or functions of the body".

Justification:Using the term"therapeutic cosmetic"already indicates that the cosmetic has therapeutic cffect hence there is no necd to restate the same.

CLAUSE54

THAT,Clause 54ofthe Bill be amended by

(c)deleting sub-clause (S) and substituting therefor the following new sub-clause (s)—

(s)Any person who manufactures,sells,supplies,imports or exports a therapeutic cosmetic which contains a prohibited ingredient commits an offence and,on conviction, shall be liable to a fine not exceeding one million shillings,or to imprisonment for a term not exceeding two years, or to both.

Justification:To provide for a penalty for the offence of manufacturing or selling therapeutic cosmetics that contain prohibited ingredients.

• (d) inserting the following new sub-clause immediately after sub-clause (3)

(4)The Authority shallmakeregulations exempting from any labellingrequirement of this Part,therapeutic cosmetics which are,in accordance with the practice of the trade to be processed,labelled,or repacked in substantial quantities at establishments other than those where originally processed or packed,on condition that such cosmetics are not adulterated or misbrandedunder the provisions of this Part upon removal from such processing.labelling or repacking establishment.

Justification:To allow for the making of regulations on use ofprohibited ingredients in relation to therapeutic cosmetics.

PARTVIII

THAT, the Bill be amended in the title ofPart VIII by deleting the expressionPARTVIII and substituting therefor the expressionPARTVIl"

Justification:To correct a minor error in numbering of the parts of the Bill.

CLAUSE55

THAT, Clause 55 of the Bill be amended in sub-clause 1) by inserting the words ", in-vitro diagnostics medical devices registerimmediately after the words "human medical devices register".

Justification:To make provision for in-vitro diagnostics.

CLAUSE56

THAT, Clause 56 of the Bill be amended in sub-clause (1) by inserting the words"falsified, falsely-labelled or counterfeited"immediately after the word "substandard"appearing in paragraph (c).

Justification:To incorporate intcrnationally accepted terminology.

CLAUSE58

THAT,Clause58oftheBill be amended

• (c)in sub-clause (2) by inserting the words"in accordance with the most recent World Health Organization's prescribed guidelines on good manufacturing practiceimmediately after the word"Authority";

Justification: This will cnable the country to comply with WHO standards on manufacturing.

• (d) by inserting the following new sub-clauses immediately after sub-clause (2)

"(3)TheAuthority shall receive from theKenya Nuclear Regulatory Authority established under the Nuclear Regulatory Act,documented evidence ofradiation required to enable a medical deviceperform its therapeutie and diagnostic functions and the intendedpurpose ofthe device, for issuance of a registration certificate for a medical device.

(4)An importer,distributor or dealer shall establish and implement documented procedures for themaintenance of importation or distribution records and shall maintain animportation or distribution recordofeach medicaldevice tobe submitted to the Authority."

Justification:To allow the Authority to consult andrecciveadvice from theKenyaNuclear Rcgulatory Authority that cxerciscs regulatory control ovcr nuclcar andradioactive materials and facilitics under scction 6(c)(i)of the NuclcarRegulatory Act,No.29 of 2019. Torequire importers,distributors or dealers tokeep records ofmedical devices submitted to the Authority.

CLAUSE59

THA'T, Clause 59 of the Bill be amended in sub-clause(1) by inserting the wordsunregistered establishments for medical devices andimmediately after the wordunder".

Justification:Toprovide for theregistration of cstablishments for mcdical devices by the Authority.

NEWCLAUSE

THA'T, theBill be amended by inserting the following new clause immediately after clause 59

Registration of 59A.(1)An application for registration ofa medical devicesestablishment medical devices shall be submitted to the Authority in the prescribed format and shall be establishment. accompanied by the prescribed fees.

(2)An importer,distributor or dealer will establish a system of notification of field safety corrective action and shall notify the Authority of such system.

(3)Where the Authority is satisfied that the application under subsection (1)meets the prescribed requirements, the Director-General shall issue a registration certificate for themedical devices establishment in the prescribed 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 theprescribed conditions.

(5)The registration certificate for manufacturers shall be valid for fiveyears following a successful reinspection

(6)The Authority may refuse to issue a medical devices establishment registration certificate where

• (d)an applicant hasmade a false or misleading statement in the application;
• (e)theAuthority 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
• (1)an applicant has failed to meet the prescribed conditions for medical devices establishment registration.

(7)Where the Authority does not issue a medical devices establishment registration certificate under subsection (6),the Authority shall---

• (c)notify the applicant in writing of the reasons for refusing the registration of the establishment; and
• (d)give the applicant an opportunity to respondto the Authority and provide relevant documentation or evidence in support of the application,

(8)After the issuance ofamedical devices establishment registration certificate,where 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.

NEWPART

THAT,the Bill be anended by inserting the following new Part immediately after the new clause 59A-

PARTVIII-THENATIONALPHARMACOVIGILANCESYSTEM

Pharmacovigilance.59B.(1) The Authority shall establish a National Pharmacovigilance Centre which shall setup and manage the nationalpharmacovigilance and post marketing surveillance system.

(2)The Centre established under subsection (1) shall receive and maintain all relevant information about suspected adverse drug reactions and adverse events to health products or technologies which have been authorized by the Authority.

(s)The Authority shall conduct both passive surveillance and active surveillance of health products and technologies

(4)The Authority shall carry out pharmacovigilance audits and inspectionsin order to ensure compliancewith goodpharmacovigilance practices and the prescribedrequirements.

(5)All entities responsible for placing a health product or technology in the market shall establish andmaintain a pharmacovigilance system for managing safety information of health products and technologies.

(6)The entities referred to in subsection (5) shall submit safety information to the Authority in the prescribed manner.

(7)The consumers, general public and health care professionals shall report adverse reactions and adverse events to the Authority in the prescribed manner.

Justification:To anchor therole of the Authority in the regulation ofpharmacovigilance in the country.

PARTXI

THAT, the Bill be amended in the title ofPart XI by deleting the expression "PART XI and substituting therefor the expression"PARTIX".

Justification:To correct a minor error in numberingof the parts of the Bill.

CLAUSE60

THAT the Bill be amended by deleting Clause 6O and substituting therefor the following new clause 60-

60.(1)There is established the National Quality Control Laboratory of the 1Authority which shall be used as a facility for-

• (i)the examination and testing of health products and technologies includingvaccines and biopharmaceuticals and any material 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;
• G) performing chemical,biological,bio-chemical,physiological and pharmacological analysis and other pharmaceutical evaluation;
• (k)testing,on behalf of the Government,oflocally manufactured and imported health products and technologies in the Kenyan market prior to marketing authorization,redistribution and post-distribution;
• (l)field testing ofregulatedproducts using screening techniques;
• (m)providing technical support to local manufacturers and building their capacity in matters pertaining to quality control of regulated products through on site andofl site training and laboratory assessments;
• (n)conducting investigations into the quality and safety status of regulated products developing and administering a data bank on quality assurance ofall health products and technologies and generating scientific evidence and reports on the quality and safety status of the registered products;
• (o)conducting research and training and providing high quality analytics and expert knowledge in the areas ofmedicinal products and active pharmaceutical ingredients;and
• on behalf of the Authority.

(2)The National Quality Control Laboratory shall be the quality control laboratory of health products and technologies for the Authority.

Establishment ofthe National Quality Control Laboratory.

(3)The Board of the Authority shall appoint a Director,National Quality Control Laboratorywho shall beresponsible to theAuthority for the day to day management of the National Quality Control Laboratory.

(4)The Director NationalQuality Control Laboratory shall hold office on such terms and conditions of service as may be specified in the instrument of appointment by theBoard of theAuthority.

(5)The Director National Quality Control Laboratory shall be a registered pharmacist and shall possess a Master's degree in a science related field from a recognized university.

(6)The Director of theNational Quality Control Laboratory shall

• (i)oversee and coordinate all operations and administration of the National Quality Control Laboratory and provide technical guidance on quality control;
• 们 ensure timely quality control testing of all samples in conformity with national and international standards,
• (k)co-ordinate and supervise the activities of the National Quality Control Laboratory including staff;
• collaborate with other laboratories,regulatory and law enforcement agencies,manufacturers of pharmaceutical and other health products to ensure quality in health products and technologies;
• (m)handle appeals on test results;
• (n)where the laboratory lacks capacity,subcontract laboratory testing services;
• (o)advice the Authority on matters of testing and quality control over healthproducts and technologies;and
• (p)perform any other duties assigned by the Authority from time to time,

(7)The funds to be used for the management of the Laboratory shall consistof all moneysreceived or recovered under thisPart and a portion of themoneys appropriated by Parliament to the Authority.

(8)Subject to subsection (7),monies generated by the Laboratory in the course of the performance ofits functions under this section shall be solely expended on the Laboratory.

Justification:The NQCL,headed by a Director appointed by the Authority, to bccome a regulatory laboratory of the Authority as rccommended by the WHOso that thc country can achieve Maturity Level s.To ringfence monics for the Laboratory such that monies generated by the Laboratory shall be solely expendedon the Laboratory and the Authority ought to give a portion of the monies appropriated to it by Parliament to the Laboratory.

CLAUSE61

THAT, Clause 61 of the Bill be amended in sub-clause (1) by deleting the words "DirectorGeneraland substituting therefor the words Director of the National Quality Control Laboratory".

Justification:Forcompliance with WHOguidelines which requires that a certificate of analysis should be issued by a person capable ofensuring the authenticity of the test samples.

PARTXII

THAT, the Bill be amended in the title of Part XII by deleting the expression PART XII and substituting therefor the expression"PART X"

Justification:To correct a minor crror in numberingof the parts of theBill.

CLAUSE6S

THAT,Clause 6S of the Bill be amended

• (c)in sub-clause (1) by deleting the words medicine, drug, appliance or articlewherever they appear and substituting therefor the words health product or technology";and

Justification:To harmonize the terms uscd in theBill with theTitle of theBill as proposcd foramendment.

• (d)in sub-clause (2)by inserting the words "or enrolled pharmaceutical technologists"

Justification:To include cnrolledpharmaccutical technologists aspart ofpersonswho are covered under thc provided defence in relation to offences as regards prohibition of advertisements on diseases listed in the Sixth Schedule.

CLAUSE64

THAT, Clause 64of the Bill be amended by deleting the wordsa medicine, drug,appliance or article"wherever it appears and substituting therefor the words"health product or technology

Justification:To harimonize the terms used in the Bill with thcTitle of thc Bill asproposed for-amendment.

CLAUSE65

THAT,Clause 65of the Bill be amended

• (c)in paragraph (a)by-
• (ii)deleting the words"or similar article;and
• (iv)deleting the word"extravagant,

Justification:To ensure objectivity.

• (d) in paragraph(b)by deleting the word"an article"and substituting therefor the words "health product or technology"-

Justification:To harmonize the terms used in the Billwith theTitle of the Bill as proposed for amendment.

CLAUSE66

THAT, Clause 66 of the Bill be amended

• (c)in sub-clause (1)
• (ii)by deleting the words"drug,appliance or article"wherever they appear in paragraph (a)and substituting therefor the words"health product or technology";and
• (iv)by deleting the words"drug,appliance or articleappearing in paragraph (b)and substituting therefor the wordshealth product or technology";

Justification:Toharmonize the termsuscd in the Bill with theTitle of theBill asproposed for amendment.

• (d) in sub-clause(3) by
• (ii)renumbering the provision as clause(2):and
• (iv)by inserting the words",enrolled pharmaceutical technologists"immediately after

Justification:To include enrolled pharmaccutical technologists aspart of personswho are covered under the provided defence in relation to offences as regards prohibition of advertisementson abortion and false ormisleading advertisements,

CLAUSE67

THAT Clause 67ofthe Bill be amended

• (e)by deleting the word articles" appearing in the marginal note and substituting therefor the words"health products and technologies";
• (f)by deleting sub-clause (1) and substituting the following new sub-clause (1)

"(1) Subject to this Act,a person shall not sell by retail a health product or technology consisting ofor comprising a substance recommended as a medicine unless there is written so as to be clearly legible on the health product or technology or on a label affixed thereto, orif the health product or technology is sold or supplied inmore than one container,on the inner container or on a labelaffixed thereto

• (c)the appropriate designation of the substance so recommended or ofeach of the active constituents,or ofeach of theingredients fromwhichit has been compounded;and
• (d)in a case where the appropriate designation ofeach of the active constituents or ingredients is written,the appropriate quantitative particulars of the constituents or ingredientsprovided that this subsection shall not apply to a healthproduct or technologymade up and supplied for the use of a particular person,being an article preseribed by reference to the needs of that person."
• (g)in sub-clause (2)by deleting the word "article"wherever it appears in the definition of appropriate quantitativeparticularsand substituting therefor the words"health product or technology":

Justification:To harmonize the terms uscdin theBill with theTitleof theBill asproposcd foramendment.

• (h)in sub-clause(S)by (iv)deleting the word "an article" appearing in sub-clause (S) and substituting therefor the words"a health product or technology";

Justification:To harmonize the terms used in the Bill with theTitle of the Billas proposed foramendment.

• (v) deleting the words"two hundred thousand"appearing in paragraph (a)and substituting therefor the words"onemillion";
• (vi)deleting the words "three hundred thousand"appearing in paragraph (b)and substituting therefor the words"two million".

Justification:To make the finespayablecommensurate to the offencesrelating tolabcling ofhealthproducts and technologies containingmedicine.

CLAUSE 68

THAT,the Bill be amended by deleting Clause 68

Justification:It ispreferable to make provision for valid exemptions through regulations as opposcd to providing defences for offences rclating to labeling of mcdicines.

CLAUSE69

THAT, Clause 69 of the Bill be amended by

• (c)deleting the word "article"and substituting therefor the words"health product or technology":and
• (d)deleting the word"articles"and substituting therefor the words"health products and technologies".

Justification:Toharmonize the terms usedin theBill with theTitleoftheBill as proposed foramcndment.

PAR'TXIII

THAT, the Bill be amended in the title to Part XIII by deleting the expression "PART XIII and substituting therefor the expression"PART XI".

Justification:To correct a minor error innumberingof the parts of the Bill.

CLAUSE71

THAT,Clause 71 of theBill be amended

• (c)in the marginal note by deleting the words "medicines or medical devices"and substituting therefor the words"health products and technologies;and
• (d)in sub-clause (1)by deleting the words"or homoeopathic medicine,preparation or medical device"and substituting therefor the words"health products and technologies"

Justification:To harmonize the terms used in theBill with theTitle of the Billas proposed foramendment.

CLAUSE72

THAT,Clause72of the Bill be amended

• (d)in the marginal note by deleting the words "medicine or medical devices"and substituting therefor the words"health products and technologies";

Justification:To harmonizc the terms used in theBill with theTitle oftheBill as proposed for amendmcnt.

• (e)in sub-clause(1)by inserting the words"including a health product and technology for

Justification:To make provision for supply of hcalth products and technologies during emergcncy situations.

• (f)in sub-clause (s)by deleting the words"medicine or medical device product"and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in theBill with theTitle of the Billasproposed foramendmcnt.

CLAUSE7S

THAT,Clause 7S of the Bill be amended

• (f)in the marginal note by deleting the word"goods"and substituting therefor the words "health products and technologies".

• (g)in sub-clause (1) by deleting the words "drug.article"wherever they appear and suhstituting therefor the words"health product or technology";
• (h)in sub-clause(2)by deleting the words"drug or article"wherever they appear and substitutingtherefor the words"health product or technology";
• (i)in sub-clause (s) by deleting the words"drug or article" and substituting therefor the words"health product or technology;and
• ()in sub-clause (4)by deleting the words"drug or article"and substituting therefor the words"health product or technology".

Justification:Toharmonize the terms used in the Bill with the Title of the Bill as proposcd for amendment.

CLAUSE78

THAT, Clause 78 of the Bill be amended in sub-clause(1)by inserting the words or enrolled pharmaceutical technologist"immediately after the words"registered pharmacist"appearing in paragraph (b).

Justification:To provide for the application of penal sanctions to cnrolled pharmaceutical technologists as regards body corporates.

CLAUSE79

THAT,the Bill be amended by deleting Clause 79 and substituting the following new clause 79

• Inspection and 79.(1)A person who imports a health product or technology shall notify thc verification of inspectors ofthe Authority at the ports ofentry to conduct pre-clearance inspection and verification.
• (2)Any person who imports a health product or technology and causes it tobereleased to themarket without authorization under subsection(1)shall beguilty of anoffence.

health technologies at

products and entry.

• (s)Any person who comnits 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 twoyears,or to both.

Justification:Clause 79 be deleted as the function of inspcction of animals intended for slaughter is outside the regulatory purview of the Authority.

The new clause oninspection andverification of health products and technologies at the portsofcntry cnables thcAuthority to cnforce compliancewith the prescribed standards ofquality,safety and cfficacy of health products and technologies before release at the ports of entry so as to prevent conccalmcnt, misdcclaration,diversion and cross border smugglingofhealthproducts andtechnologics.

CLAUSE 80

THAT,Clause SO of theBill be amended

• (c)by deleting the words"article" and "articles"wherever they appear and substituting therefor the words"health product or technology"and "health products and technologies"respectively in sub-clause(6),(7),(8),(9),(10),(11)and (12).

Justification:Toharmonize the terms used in theBill with theTitleoftheBill asproposed foramendmcnt.

• (d) in sub-clause (1) by (ii)deleting the word"article"wherever it appears and substituting therefor the wordshealthproduct or technology;and

Justification:To harmonize thc terms uscd in the Bill with theTitle of theBill as proposed for amendmcnt.

• (iv)inserting the words "or any other vessel" immediately after the word "vehicle appearing in paragraph (b)

Justification:To expand the scope toinclude all othermeans of conveying health products and technologics.

CLAUSE81

THAT, the Bill be amended by deleting Clause 81.

Justification:The clause infringes on the excrcise of the functions of the Authority contrary to therecommendation of theWorld Health Organization.

CLAUSE82

THIAT,the Bill be amended by deleting Clause S2.

Justification:Regulation is a function of National Govcrnment under theFourth Schedule to the Constitution.

CLAUSE8S

THAT, the Bill be amended by deleting Clause Ss.

Justification:The clause infringes on the cxercise of the functions of the Authority contrary to therecommendation of theWorld Health Organization.

CLAUSE85

THAT, Clause 85 of the Bill be amended by deleting the word article"wherever it appears and and substituting therefor the words"health product or technology"

Justification:To harmonize the terms used in the Bill with theTitle of theBill asproposed foramendment.

CLAUSE86

THAT, Clause 86 of the Bill be amended in sub-clause (1)by deleting paragraph (b)and substitutingtherefor the followingnew paragraph (b)

"(b) in the case of a subsequent offence, to a fine not exceeding one million shillings,or to imprisonment for a term not exceeding two years, or to both".

Justification:To enhance the general penalty for offences committed in relation to this Bill and tomakethe finespayable commensurate to the imprisonmcnt terms.

CLAUSE87

THA'T, Clause S7 oftheBill be amended in sub-clause(1)by deleting the wordarticle"wherever it appears and substituting therefor the wordshealth product or technologyin paragraph (c)

Justification:Toharmonize the terms used in the Billwith theTitle oftheBill asproposed foramendment.

PARTXIV

THAT, the Bil be amended in the title of Part XIV 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.

CLAUSES8

THAT, Clause S8 of the Bill be amended by deleting paragraph(a and substituting therefor the following new paragraph(a)

"(a) such monies as may be appropriated by the National Assembly for the purposes of the Authority".

Justification: For proper drafting and consistency in the wording used in the Statute Book.

CLAUSE91

THAT,Clause 91 of the Bill be amended bydeleting the wordsKenya National Audit Office wherever they appear and substituting therefor the words"Auditor-General"

Justification:Forproper refercnce to thc Auditor-Gcneral as designatedunder Article229 ofthe Constitution and which is the succcssor of the Kenya National Audit Office.

PARTXV

THA'T, the Bill be amended in the title of Part XV by deleting the expression"PART XVand substituting therefor the expression"PART XIII".

Justification: To correct a minor crror in numbering of the parts of the Bill.

CLAUSE95

THAT,Clause 95oftheBill be amended-

• (c)in sub-clause2 by-
• (xvii) deleting the words"any drug"in paragraph (a)(ii);
• (xvi) deleting the word"drugs,"in paragraph(a)(i);
• (xvii) deleting the word"product"and substituting therefor the word"products" in paragraph (d);
• (xix) deleting the word "drugs"wherever it appears and substituting therefor the words"health products or technologies"in paragraph(h);
• (xx) deleting the word "article"and substituting therefor the words "health product or technology" in paragraph (k);
• (xxi) deleting the word"articles"and substituting therefor the words "health products and technologies"in paragraph(m);
• (xxii) deleting the words"drugs,medical devices"and substituting therefor the words"health products and technologies" in paragraph (o);
• (xxini) deleting the word"medicines"and substituting therefor the words"health products and technologies"in paragraph (v);
• (xxiv) deleting paragraph (x)and substituting therefor the following new paragraph (x)
• (x)governing administration of clinical trials of health products and technologies;
• (xxv) deleting the words"medicine,medical device"and substituting therefor
• (xxvi) deleting the words"medicines or medical devices"and substituting therefor the words"health products or technologiesin paragraph (bb);
• (xxvi)deleting paragraph (dd)and substituting therefor the following new paragraph (dd)

"(dd) the compounding of health products and technologies and the dispensing of health products and technologies

Justification:To harmonize the terms used in theBill with the Title of the Bill as proposed foramendment.

• (xxviii) inserting the words ,an enrolled pharmaceutical technologist immediately after the word "pharmacist in paragraph (bb);

Justification:For inclusion of pharmaccutical technologists who are currently involved in the dispensing ofmedicines and medical devices pursuant to the Pharmacy and Poisons Act, Cap.244 and thcir scope of training.

(xxix) deleting paragraph (ii);

Justification:The general provision on the making ofregulations is set out in sub-clause (1).

(xxx) inserting the following new paragraphs immediately after paragraph (i)

(i) on pharmacovigilance andpost market surveillance;

(kk)oflicial regulatory lot release ofvaccines and other biological products imported and manufactured in Kenya;

(llpricing of health products and technologies;

(mm)good practices in theregulation ofmedical products;

(nn)inspections,licensure and certification of the manufacture of medical products by health facilities;

(oo)inspections,licensure and certification ofmanufacture ofmedical products including steel industries,sugar industries;

(pp) inspection and recognition of pharmaceutical quality control laboratories;

(qq)to regulate licit use of narcotic and psychotropic substances; and

(rr)to regulate parallel importation of medicines;

• (d)by renumbering sub-clause(2)as sub-clause(S).

Justification:To provide for the making of regulations on licit use ofnarcotic and psychotropic substances,parallel importation of medicines,safety monitoring, pharmacovigilance and post market surveillance.

CLAUSE96

THAT,Clause 96of the Bill be amended

``` (d) in sub-clause(i) by (ii)deleting the word "Boardand substituting therefor the word "Boards"; (iv)deleting paragraph (d) and substituting therefor the followingnew paragraph (d) ```

"(d)all members and staff of the former Boards shall be deemed to be members and staff of the Authority,and subject to the provisions ofany rules made under this Act,shall continue in office for the period for which they were appointed as nembers and staff of the former Boards."

• (e)by deleting the sub-clause(2)and substituting therefor the following new sub-clause (2)

(2)In this section,"the former Boards"means the Pharmacy and Poisons Board and the Board of Management of theNational 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 theBoard of Managcmcnt of the National Quality Control Laboratory.

• (f)in sub-clause (s) by deleting the word "twelve"appearing in the opening sentence and substituting therefor the words"twenty-four".

Justification:To provide sufficient time which will facilitate the conduct ofextensive

CLAUSE97

THAT,Clause 97of the Bill be amended by inserting the wordswith reference to section 96 (s) immediately after the words"that Schedule" in sub-clause(1)

Justification:To prevent a lacuna in respcct of the regulation of the pharmaccutical practicc.

SECONDSCHEDULE

THAT,the Bill be amended by deleting the Second Sehedule

Justification:The Chairperson,Board Members and Director General of theAuthority are not State Officers and hence do not necd to subscribe to an oath.

THRDSCHEDULE

THAT,the Bill be amended by deleting the Third Schedule

Justification:The matters of the tenure ofoffice,allowances,protcction from liability and disclosure of interest by Board members are already providcd for in the main Bill.Thc issueof approval ofthe Boardmembers by theParliament has beenproposcd for deletion as the Authority's Board membcrs are not State Officers.

FOURTHSCHEDULE

THAT, the Fourth Schedule of the Bill be amended by deleting paragraph (1),(2),(s),(4) and (5) and substituting therefor the followingnewparagraphs

• 12.Biologics Committee.
• 13.Pharmacovigilance Committee.
• 14.Complementary,Alternative or Herbal Medicines Committee
• 15.Radiopharmaceuticals Committee.
• 16.Cosmetics and Borderline Products Committee.

17. Clinical Trial Scientifie Technical Advisory Committee.

• 18.Health Technology Assessment Committee.
• 19.Nutraceuticals and Dietary Supplements Committee.
• 20.Digital Health and Technologies Committee.
• 21.Medical Devices and Health Technologies Committee
• 22.Veterinary Medicines Committee.

Justification:The scientifie advisory committees amended to take into account all aspects ofhealth products and technologics and to deletc the Scientific Advisory Committees on foodwhich isoutside the scope oftheBillas amended.

SEVENTHSCHEDULE

THAT,the Seventh Schedule of the Bill be amended by

Justification:For proper cross referencingof thePharmacy and PoisonsAct,Cap.244 and clause97onrepeals.

• (f)deleting the paragraph on Cap.254.

Justification:Food is outside thepurview oftheBill.