Health Laws (Amendment) Act, 2019 (No. 5 of 2019)

SPECIAL ISSUE Kenya Gazette Supplement No. 69 (Acts No. 5) REPUBLIC OF KENYA KENYA GAZETTE SUPPLEMENT ACTS, 2019 NAIROBI, 17th May, 2019 CONTENT Act— PAGE The Health Laws (Amendment) Act, 2019 407 hAL et40611 REpoRtING RECEIVED U JUN 2019 agX 104id!titliY4 SAIROBI, KENYA 2-1 1031 FAX: 211260A PRINTED AND PUBLISHED BY THE GOVERNMENT PRINTER, NAIROBI 407 THE HEALTH LAWS (AMENDMENT) ACT, 2019 No. 5 of 2019 Date of Assent: 13th May, 2019 Date of Commencement: 17th May, 2019 AN ACT of Parliament to make amendments to health related laws ENACTED by the Parliament of Kenya, as follows — 1. This Act may be cited as the Health Laws Short title. (Amendment) Act, 2019 and shall come into force upon publication. 2. The several laws specified in the first column of the Amendment of Schedule are amended in the provisions specified in the written laws. second column thereof, in the manner respectively specified in the third column. 3. (1) In this section, "Board" includes any Council Transition. proposed to be reconstituted under this Act. (2) At the commencement of this Act, any person who, immediately before the commencement of this Act was a member or staff of any of the Boards proposed to be reconstituted under this Act shall be deemed to be a member or staff of the reconstituted Board for the unexpired period of his or her term of service. (3) At the commencement of this Act, all the funds, assets and other property, both movable and immovable, which immediately before such date were vested in any of the Boards shall by virtue of this sub-section, vest in the new Board under this Act. (4) At the commencement of this Act, all rights, powers and liabilities, whether arising under any written law or otherwise which immediately before such date were before such date were vested in, imposed on or enforceable against any Board shall, by virtue of this sub-section, be deemed to be vested in, imposed on or enforceable against the respective new Board. (5) Any reference in any written law or in any document or instrument to any of the Boards shall on and after the appointed day, be construed to be a reference to the respective new Board. 408 No. 5 Health Laws (Amendment) 2019 SCHEDULE Amendment Delete the definition of the term "enrolled pharmaceutical technologist" and substitute therefor the following new definition— "enrolled pharmaceutical technologist" means a holder of a diploma in pharmacy from a training institution recognised by the Board and whose name appears on the Roll; Delete the definition of the term "Inspector of Drugs" and substitute therefor the following new definition— "inspector of drugs" means a person who is competitively recruited by the Board as a pharmaceutical inspector and who holds a minimum of a diploma in pharmacy; Delete the definition of the term "pharmaceutical inspector"; Delete the definition of the term "registered pharmacist" and substitute therefor the following new definition— "registered pharmacist" means a holder of a degree in pharmacy from a university recognised by the Board and whose name is entered on the register; Insert the following definitions in proper alphabetical sequence— "clinical trial" means any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, identify any adverse reaction to investigational products, to study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety; "Good Manufacturing Practice", also referred to as "GMP", "cGMP" or "current Good Manufacturing Practice" is the part of Written law Provision The Pharmacy s.2 and Poisons Act, (Cap 244) 409 2019 Health Laws (Amendment) No. 5 No. 21 of 2017. quality management which ensures that products are consistently produced and controlled according to their intended use as required by the marketing authorization, clinical trial authorization or product specification; "health facility" has the meaning assigned to it in the Health Act; "health product" includes human and veterinary medicines, medical products, medicinal substances, vaccines, diagnostics, medical devices, blood products, traditional and alternative medicine, therapeutic feeds and nutritional formulations, cosmetics and related products; "health technology" means the application of organized knowledge and skills in the form of devices, medicine, vaccines, procedures and systems developed to solve a health problem and improve the quality of life; "investigational medicinal substance" means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled, formulated or packaged, in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form; "medical device" means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article — (a) intended by the manufacturer to be used, alone or in combination, for humans or animals for — (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; 410 No. 5 Health Laws (Amendment) 2019 (i) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (ii) investigation, replacement, modification or support of the anatomy or of a physiological process; (iii) supporting or sustaining life; (iv) control of conception; (v) disinfection of medical devices; or (vi) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and (b) which does not achieve its primary intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means; "pharmacovigilance" means the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions, and includes the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem; "post market surveillance" means the practice of monitoring the safety and quality of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance; "practising license" means a license issued under section 9A; and "specialist pharmacist" means a registered pharmacist who has completed an approved 411 2019 Health Laws (Amendment) No. 5 postgraduate training programme in a particular field of pharmaceutical sciences, and who has gained sufficient experience and demonstrated to the Board's satisfaction, adequate knowledge and skill in his or her chosen field. s.3 Delete and substitute therefor the following new section— Establishment of (1) There is established a Board which the Pharmacy and Poisons Board. shall consist of— (a) a chairperson who shall be appointed by the President and who shall— (i) be a registered pharmacist of good standing with a degree in pharmacy; and (ii) have at least ten years' experience in the pharmaceutical sector; (b) the Director of pharmaceutical services; (c) the Principal Secretary in the ministry for the time being responsible for matters relating to finance or his or her representative; (d) two persons representing the pharmacy training institutions, of which one shall be a pharmacist and one shall be a pharmaceutical technologist; (e) three other persons appointed by the Cabinet Secretary, of whom— (i) one person shall be a pharmacist representing institutions of higher learning; (ii) one person shall be a pharmaceutical technologist representing mid-level colleges; and (iii) one person shall be an enrolled pharmaceutical technologist with expertise in community 412 No. 5 Health Laws (Amendment) 2019 New Section Powers of the Board. pharmacy nominated by the Kenya Pharmaceutical Association; (f) the Chief Executive Officer, who shall be an ex officio member; and (g) one medical practitioner nominated by the Kenya Medical Association and appointed by the Cabinet Secretary. (2) The persons appointed under subsection (1)(f) shall be appointed by the Cabinet Secretary from among members nominated by their relevant professional associations, each of which shall nominate two candidates in each category taking into consideration gender, ethnicity and regional balance. (3) A person shall not qualify for appointment as a member of the Board under subsection (1)(e) and (1) unless such person is the holder of a minimum of a diploma in the relevant field from an institution recognized in Kenya and has at least five years managerial experience. Insert the following new section immediately after section 3 3. The Board may— (a) formulate guidelines for regulating the manufacture, import and export, distribution, sale and use of medical products; (b) grant or withdraw authorization for conducting clinical trials of medical products; (c) grant or withdraw marketing authorization for medical products subject to appropriate conditions and revise such conditions for marketing authorization as necessary; (d) recall medical products from the market; 413 2019 Health Laws (Amendment) No. 5 (e) grant or withdraw licenses to manufacturers, wholesalers, retailers, importers, exporters and distributors; (f) investigate conduct related to the manufacture, import, export storage, distribution, sale and use of medical products; (g) levy, collect and utilize fees for services rendered; (h) prescribe the standards appropriate for new medical products; new uses, dosages, and formulations of existing medical products; and such other categories as may be appropriate; (i) constitute technical and expert advisory committees; (j) institute administrative, civil and criminal proceedings; (k) exercise such other powers as necessary for the performance of its functions. New section. Insert the following new sections immediately after section 3— Functions of the 3B. (1) The Board shall be responsible Board. for the regulation of health products, technologies and the profession of pharmacy. (2) The Board shall perform the following functions in relation to regulation of health products and technologies— (a) advise the national and county governments in all matters relating to the safety, packaging and distribution of medicines; (b) ensure that all medicinal products manufactured in, imported into or exported from the country conform to prescribed standards of quality safety and efficacy; 414 No. 5 Health Laws (Amendment) 2019 (c) ensure that the personnel, premises and practices employed in the manufacture, storage, marketing, distribution and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements; (d) enforce the prescribed standards of quality, safety and efficacy of all medicinal substances manufactured, imported into or exported out of the country; (e) grant or revoke licenses for the manufacture, importation, exportation, distribution and sale of medicinal substances; (f) maintain a register of all authorized medicinal substances; (g) publish, at least once in every three months, lists of authorized or registered medicinal substances and of products with marketing authorizations; (h) regulate licit use of narcotic, psychotropic substances and precursor chemical substances in accordance with either the Single Convention on Narcotic Drugs of 1961, the Convention on Psychotropic Substances 1971, and the UN Convention against Illicit Traffic Drug and Psychotropic Substances, 1988; (i) consider applications for approval and alterations of dossiers intended for use in marketing authorization of medicinal substances; (j) inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies, including those in hospitals and clinics, and other retail outlets; (k) prescribe a system for sampling, analysis and other testing procedures of finished medicinal products released into the market to ensure compliance with the labeled specifications; 415 2019 Health Laws (Amendment) No. 5 (1) conduct post-market surveillance of safety and quality of medical products; (m) monitor the market for the presence of illegal or counterfeit medicinal substances; (n) regulate the promotion, advertising and marketing of medicinal substances in accordance with approved product information; (o) approve the use of any unregistered medicinal substance for purposes of clinical trials and compassionate use; (p) approve and regulate clinical trials on medicinal substances; (q) disseminate information on medical products to health professionals and to the public in order to promote their rational use; (r) collaborate with other national, regional and international institutions on medicinal substances regulation; (s) advise the Cabinet Secretary on matters relating to control, authorization and registration of medicinal substances; and (t) perform any other function relating to regulation of medicinal substances. (3) The Board shall perform the following functions in relation to regulation of the profession of pharmacy— (a) promote the practice of pharmacy that complies with universally accepted norms and values; (b) prescribe the minimum requirements and consider and approve the qualifications of persons wishing to be registered as pharmacists under this Act; 416 No. 5 Health Laws (Amendment) 2019 No. 42 of 2012 (c) prescribe the minimum requirements and consider and approve the qualifications of persons wishing to be enrolled as pharmaceutical technologists under this Act; (d) maintain a register of all persons registered or enrolled under this Act; (e) prescribe and conduct examinations for purposes of recognition, registration or enrolment under this Act; (f) establish or prescribe the different categories of pharmacy business and the scope of practice of persons registered or enrolled in terms of this Act, or the services or acts which shall for purposes of this Act be deemed to be services or acts specially pertaining to pharmacists or pharmaceutical technologists, and the conditions under which those services may be provided or the acts which may be performed; (g) approve institutions to be established or accredited under the Universities Act, 2012 training pharmacists, and mid level institutions training pharmaceutical technologists; (h) license the practice of pharmacists and pharmaceutical technologists under this Act; (i) approve and license the premises for the practice by pharmacists and pharmaceutical technologists under this Act; (j) regulate the professional conduct of pharmacists and pharmaceutical technologists and take such disciplinary measures as may be appropriate to maintain proper professional standards and ethics; (k) establish, approve and accredit continuing professional educational 417 2019 Health Laws (Amendment) No. 5 programs for pharmacists and pharmaceutical technologists; (1) establish and maintain a professional code of conduct for pharmacists and pharmaceutical technologists; and (m)perform any other function relating to regulation of the profession of pharmacy. s.4(5) Delete the word "registrar" and substitute therefor the words "Chief Executive Officer". s.5 Delete the expression "Chief Pharmacist" appearing in subsection (1) and substitute therefor the expression "Chief Executive Officer". Insert the following subsections after subsection (2)— (3) The Registrar shall be responsible to the Board for the day to day management of its affairs. (4) The Board shall through a transparent and competitive recruitment process appoint the Registrar who shall— (a) be a Kenyan citizen; (b) hold at least a pharmacy degree and is registered to practice pharmacy in Kenya; (c) belong to the professional body of registered pharmacists; (d) have at least fifteen years of pharmacy practice experience; (e) have served in a senior management position for a period of at least ten years; and (f) meet the requirements of Chapter Six of the Constitution. (5) The Registrar shall hold office for a term of four years, but shall be eligible for reappointment once subject to good performance 418 No. 5 Health Laws (Amendment) 2019 s.6(1) Insert the words "and specialist pharmacists" immediately after the word "pharmacists". s. 8(2) Delete subsection (2) and substitute therefor the following new subsection— "(2) Any person who satisfies the Board that he holds a diploma in pharmacy from any college recognised by the Board in Kenya shall, subject to this Act, be entitled to have his or her name entered in the register. New sections. Insert the following new sections immediately after section 9— Practising license. 9A. (1) The Registrar shall issue, in accordance with rules made under this Act, a practising license authorizing registered pharmacists or enrolled pharmaceutical technologists to practice as registered pharmacists or enrolled pharmaceutical technologists. (2) Every practising license shall expire at the end of the practising year in which it was issued. (3) The practising year shall be from 1st January to 31st December. (4) Any registered pharmacist or enrolled pharmaceutical technologist who practices without a valid practising license in line with subsection (1) commits an act of professional misconduct. Application for 9B. A person wishing to be issued with a practising license. practising license under section 9A shall make an application to the Registrar in the prescribed form and such application shall be accompanied by the prescribed fee. Issue of practising 9C. (1) Where an application for a license. practising license is made by a person in accordance with section 9B, the Registrar shall issue a practising license if satisfied that the person— (a) is registered under section 6 of this Act; 419 2019 Health Laws (Amendment) No. 5 (b) has undertaken continuous professional development in the preceding year as prescribed by the Board; and (c) meets such other requirements as may be prescribed. (2) For the purposes of this Act, a person shall be deemed to engage in the practice of pharmacy if the person— (a) engages in, conducts or carries on the dispensing, manufacture, compounding of any drugs or medicines, or offers any form of pharmaceutical care or pharmaceutical services within Kenya; or (b) advertises or represents himself or herself by a title, sign, display, declaration, or other item to be a pharmacist or pharmaceutical technologist. (3) For purposes of this Act, it shall be a requirement for every practising registered pharmacist and enrolled pharmaceutical technologist, practising in their private capacity, government, faith based institutions, non-governmental organizations, training institutions, research organizations or any other institution, to have a valid practising license. Refusal to issue or 9D. The Board may deny or refuse to issue renew a license. or renew a license under this Act if it determines after due process, that the applicant has failed to comply with the requirements of this Act or its rules. Renewal, 9E. (1) A registered pharmacist or enrolled cancellation and pharmaceutical technologist issued with a suspension of license under this Act may apply for renewal license. of the license in the prescribed form at least thirty days before the date of expiry thereof. (2) A registered pharmacist or an enrolled pharmaceutical technologist who fails to renew a license within the prescribed period shall, when applying for a renewal, be required to 420 No. 5 Health Laws (Amendment) 2019 Continuous professional development. pay such late application fee as shall be prescribed. 9F. For purposes of maintaining a level of competence in his or her ongoing practice, every registered pharmacist and enrolled pharmaceutical technologist shall undertake appropriate Continuous Professional Development as prescribed by the Board. New section. Insert the following new section immediately after section 12— 12A. (1) The Board shall establish an Enquiries and Disciplinary Committee which shall enquire into any matter arising under section 12 of this Act. (2) Where on the recommendations of the Enquiries and Disciplinary Committee the Board is satisfied that a pharmacist or pharmaceutical technologist is in breach of any of the terms or conditions of practice prescribed by the Board, the Board may— (a) issue the pharmacist or pharmaceutical technologist with a letter of admonishment; (b) impose a fine as may be prescribed in regulations; (c) suspend the registration or enrolment of the pharmacist or pharmaceutical technologist for a specified period not exceeding five years; or (d) remove the name of the pharmacist or pharmaceutical technologist from the Register as may be appropriate. (3) The Board may order a pharmacist or pharmaceutical technologist to reimburse costs and expenses incurred in connection with a disciplinary hearing and such costs shall be a civil debt recoverable summarily by the Board. s.20 Insert the following subsection immediately after subsection (1A)— Enquiries and Disciplinary Committee. 421 2019 Health Laws (Amendment) No. 5 (1B) No person shall operate the business of a pharmacist or pharmaceutical technologist without the presence of a registered pharmacist or enrolled pharmaceutical technologist in the premises where such business is being carried out. (2) Delete the words "twenty thousand shillings" and substitute therefor the words "one million shillings". s.23 Insert the following subsection immediately after subsection (1)— (1A) No person shall carry on the business of a pharmaceutical technologist except in premises registered in accordance with this section. (6) shillings" appearing in subsection (6) and Delete the words "thirty thousand substitute therefor the words "one million shillings". Insert the following section immediately New section. after section 23— Power to close 23A. (1) Any premises having been premises. deleted from the register of premises by the Board or any premises which in the Board's opinion have become unsuitable for the carrying on of the business of a pharmacist or pharmaceutical technologist shall be closed. (2) The Board shall give the person in charge of the premises at least fourteen days' notice of the intended closure under subsection (1) and the reasons thereof in writing. (3) If at the expiry of the period under subsection (2), the Board is not satisfied that the improvements required have been made, an authorized officer shall order closure of the premises New section. Inserting the following new section after subsection 25— Clinical trials. 25A. (1) A pharmaceutical product shall not be used for clinical trial unless an approval 422 No. 5 Health Laws (Amendment) 2019 is granted by the Board with the approval of the relevant ethics body. (2) Any person who intends to commence a clinical trial on a pharmaceutical product shall make an application to the Board 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-trial access program to ensure access of investigational medicinal substances by participants in a trial before grant of marketing authorization by the Board. (4) The Board shall prescribe guidelines for evaluation of applications made under subsection (2) to be implemented for accelerated evaluations during emergency situations, epidemics and outbreaks. (5) A person granted an approval under section 25A (1) shall put up a robust quality assurance system to ensure that the clinical trial is carried out so as to ensure the integrity of data generated, the safety and well-being of study participants. (6) The Board shall carry out inspections of the clinical trials so as to ensure compliance of the clinical trials with the prescribed requirements. s.27 Insert the following subsection after subsection (6)— (7) It shall be an offence to deal as a wholesale dealer in poisons without a licence granted by the Board under subsection (1). s. 40 (4) Delete subsection (4). s.44 (1) Insert the following new paragraphs immediately after paragraph (mm)— (mma) the standards and practice of pharmacy; 423 2019 Health Laws (Amendment) No. 5 (mmb) pharmacy education and training; (mmc) continuing professional development for all practising pharmacists and pharmaceutical technologists; (mmd) criteria for issuance of pharmaceutical representatives permits; (mme) pharmacovigilance, post market surveillance and Good Manufacturing Practice; and s.46 Insert the following subsection immediately after subsection (4)— (5) The Board may retain or confiscate a medicinal substance that it has reasons to believe is a counterfeit or is illegally imported and the substance, if found to be counterfeit or illegally imported shall be disposed at the expense of the owner or importer of such substance. New section. Insert the following new section immediately after section 50 Offences. 50A. (1) A person who engages in the manufacture, importation, exportation, compounding, storage, promotion or distribution of medicinal substances— (a) that is unfit for use in humans or in animals; (b) that is adulterated; (c) that has upon it any natural or added deleterious substances which renders it injurious to human or animal health; (d) that has been manufactured, prepared, preserved, packaged or stored for sale under insanitary and or unfavourable conditions; (e) that has been labeled, packaged or promoted in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding its source, character, value, quality, composition, potency, merit or safety; or (f) any counterfeit starting materials, commits an offence under this Act. 424 No. 5 Health Laws (Amendment) 2019 The Medical s.2 Delete the definition of "Board" and Practitioners substitute therefor with the following new and Dentists definition— Act, (Cap "Council" means the Kenya Medical 253). Practitioners and Dentists Council established under section 3; Delete the definition of "register" and substitute therefor with the following new definition— "register" means the register of medical practitioners, dental practitioners and health institutions for public and private practice which the Council is required by section 5 to keep; Insert the following new definitions in proper alphabetical sequence— "assessment" means the determination of the suitability for registration under the Act by means of oral or written examination or both"; "Cabinet Secretary" means the Cabinet Secretary for the time being responsible for matters relating to health; "community oral health" means the provision of curative, preventive and promotive oral health care"; "community oral health officer", means a person who has undergone the prescribed course of training in an approved institution, and holds a diploma, higher diploma or degree in community oral health; "general practice" means the practice of general medicine or dentistry other than specialist practice as defined in the Act; "health facility" has the meaning assigned No. 21 of to it in the Health Act; 2017. "health institution" means a facility that is operated or designed to provide in-patient or out-patient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health 425 2019 Health Laws (Amendment) No. 5 service for public and private use by medical and dental practitioners; "intern" means a person holding a medical or dental degree or its equivalent recognized by the Council or a person who has passed the internship qualifying examination, who is undergoing a prescribed period of internship in a recognized institution; "internship" means a prescribed period of employment during which a medical or dental graduate works under supervision to fulfill registration requirements; "internship qualifying examination" means a written or oral examination or both which determines the suitability of foreign trained graduates who holds a degree recognized by the Board to undergo internship"; "licence" means an annual practising licence issued under section 12 of this Act; "pre-registration examination" means a written or oral examination or both which determines the suitability for registration under section 6(3) of the Act" "professional misconduct" means a serious digression from established or recognized standards or rules of the profession, that includes a breach of such codes of ethics or conduct as may be prescribed for the profession from time to time; "specialist" means a medical practitioner or dentist who has completed an approved post graduate training programme in a particular field of medicine or dentistry, and who has thereafter gained sufficient experience and demonstrated to the Council's satisfaction adequate knowledge and skill, in his chosen field; "specialist practice" means the practice of medicine or dentistry in a specialized field; s.3 Delete and substitute therefor with the following new section— 426 No. 5 Health Laws (Amendment) 2019 Establishment of the Council. New section. Composition of the Council. 3. (1) There is established a Council to be known as the Kenya Medical Practitioners and Dentists Council. (2) The Council shall be a body corporate with perpetual succession and a common seal and capable, in its corporate name, of— (a) suing and being sued; (b) taking, purchasing or otherwise acquiring, holding, charging and disposing of movable and immovable property; and (c) doing or performing all such other things or acts necessary for the proper performance of its functions under this Act as may lawfully be done or performed by a body corporate. Insert the following new section immediately after section 3 3A. (1) The Council shall consist of— (a) a chairperson who shall be appointed by the President and who shall— (i) be a specialist medical or dental practitioner of good standing ; and (ii) have at least ten years' experience, five of which shall be in a managerial position; (b) the Director General for Health or a designated representative; (c) four persons appointed by the Cabinet Secretary, nominated as follows— (i) one person who shall be a representative of universities in Kenya which have the power to grant a qualification which is registerable under this Act; (ii) one person who shall be a representative of the Kenya Medical Association; 427 2019 Health Laws (Amendment) No. 5 (iii) one person who shall be a representative of Kenya Dental Association; and (iv) one person who shall be a representative of oral health practitioners; (d) three persons appointed by the Cabinet Secretary, as follows— (i) one person who shall be nominated by Kenya National Commission on Human Rights; (ii) one person who shall be a representative of the private sector in health; and (iii) one person with knowledge and expertise in finance or audit; and (e) the Chief Executive Officer who shall be the Registrar and an ex officio member and also the secretary to the Council. (2) A person appointed as a member of the Council under this Act, other than the ex officio member, shall serve for a term of three years and shall be eligible for reappointment for a further and final term of three years. (3) The chairperson shall preside at all meetings of the Council and, in the absence for any reason of the chairperson, the other members of the Council who are present at that meeting shall choose one of the members to act as the chairperson at the meeting. (4) A member of the Council may— (a) at any time resign from office by giving thirty days' notice in writing to the chairperson; (b) be removed from office if the member— (i) has been absent from three consecutive meetings of the Council without permission of the chairperson; 428 No. 5 Health Laws (Amendment) 2019 is convicted of an offence involving dishonesty or fraud; is convicted of a criminal offence and sentenced to imprisonment for a term exceeding six months or more; or is incapacitated by prolonged physical or mental illness or is deemed otherwise unfit to discharge his or her duties as a member of the Council. members of the Council shall quorum at any meeting. powers of the Council shall not be any vacancy in the membership (5) Six constitute a (6) The affected by thereof (7) The Council shall meet at least once in every three months. (8) The chairperson, may, with prior approval of the Council, appoint suitable persons to assist in carrying out particular decisions of the Council or particular duties or investigations for the Council. (9) Subject to the provisions of this Act, the Council may regulate its own procedure. (10) Pursuant to nominations in paragraphs (1)(c) and (d), each organization shall present two nominees one of whom shall be appointed by the Cabinet Secretary taking into account ethnic diversity, gender, disability, skills mix and regional balance. s.4 Delete and substitute therefor the following new section— Functions of the Council. 4. (1) The functions of the Council shall be to— (a) establish and maintain uniform norms and standards on the learning of medicine and dentistry in Kenya; (b) approve and register medical and dental schools for training of medical and dental practitioners; 429 2019 Health Laws (Amendment) No. 5 (c) prescribe the minimum educational entry requirements for persons wishing to be trained as medical and dental practitioners; (d) maintain a record of medical and dental students; (e) conduct internship qualifying examinations, preregistration examinations, and peer reviews as deemed appropriate by the Council; (f) inspect and accredit new and existing institutions for medical and dental internship training in Kenya; (g) license eligible medical and dental interns; (h) determine and set a framework for professional practice of medical and dental practitioners; (i) register eligible medical and dental practitioners; (j) regulate the conduct of registered medical and dental practitioners and take such disciplinary measures for any form of professional misconduct; (k) register and license health institutions; (1) carry out inspection of health institutions; (m)regulate health institutions and take disciplinary action for any form of misconduct by a health institution; (n) accredit continuous professional development providers; (o) issue certificate of status to medical and dental practitioners and health institutions; and (p) do all such other things necessary for the attainment of all or any part of its functions. 430 No. 5 Health Laws (Amendment) 2019 New. Insert the following new sections immediately after section 4— Committees of the 4A. (1) The Council shall constitute the Council. following committees— (a) training, assessment, registration and human resources committee; (b) disciplinary and ethics committee whose mandate shall include— (i) conducting inquiries into complaints submitted to it; (ii) regulating professional conduct; (iii) ensuring fitness to practice and operate; (iv) promoting mediation and arbitration between parties; and (v) at its own liberty, recording and adopting mediation agreements or compromise between parties, on the terms agreed; (c) inspections, licensing, finance and general purposes committee; and (d) audit and risk committee. (2) The Council may from time to time appoint such other ad hoc committees as it may deem necessary for the effective carrying out of its functions under this Act. (3) Any committee appointed by the Council under subsection (1) or (2) shall consist of such persons as the Council deems necessary. (4) The Corporation Secretary shall be •the secretary of all committees appointed under this Act. 4B. The Council shall have all powers necessary for the proper performance of its functions under this Act and in particular, but without prejudice to the generality of the foregoing, shall have power to— Powers of the Council. 431 2019 Health Laws (Amendment) No. 5 No. 18 of 2012 Chief Executive Officer. (a) control, supervise and administer the assets of the Council in such manner and for such purpose as best promotes the purpose for which the Council is established; (b) determine the provisions to be made for capital and recurrent expenditure and for the reserves of the Council; (c) receive any grants, gifts, donations or endowments and make legitimate disbursements therefrom; (d) enter into an association with other bodies or organizations within or outside Kenya as the Council may consider desirable or appropriate and in furtherance of the purpose for which the Council is established; (e) open a bank account or banking accounts for the funds of the Council; and (f) invest any of the funds of the Council not immediately required for its purposes in accordance with the Public Finance Management Act and other relevant laws. 4C. (1) There shall be a Chief Executive Officer of the Council who shall be appointed by the Council through a competitive process and whose terms and condition of service shall be determined by the Council in an instrument of appointment or otherwise in writing from time to time. (2) A person shall be qualified to be appointed as the Chief Executive Officer if the person— (a) possesses a masters' degree or its equivalent from a university recognised in Kenya; (b) has at least ten years professional and administrative experience in matters related to health; and 432 No. 5 Health Laws (Amendment) 2019 Staff of the Council. (3) (c) meets the requirements of Chapter Six of the Constitution. (3) The Chief Executive Officer shall be responsible for the daily management of the staff and affairs of the Council (4) The Chief Executive Officer shall serve for a term of four years and shall be eligible, subject to satisfactory performance, to reappointment for a single further term of four years. 4D. The Council may employ such professional, technical and other staff for the proper and efficient discharge of its functions on such terms and conditions as the Council may determine. Delete the words "of Medical Practitioners and Dentists". Delete the words "Director of Medical Services" and substitute therefor the words "Chief Executive Officer". Delete and substitute therefor the following subsection— (3) The Registrar shall annually maintain— (a) a register for interns; (b) a register of medical and dental practitioners; (c) a register of community oral health officers; (d) a register of general practitioners; (e) a register of specialist practitioners; (f) a register of foreign medical and dental practitioners; (g) a register of approved medical and dental schools; (h) a register of approved internship training centres; 7 433 2019 Health Laws (Amendment) No. 5 s.6 Registration of medical practitioners and dentists. (i) a register of health institutions; and (j) such other registers as may from time to time be required by the Council. Delete and substitute therefor the following new section 6. (1) A person who— (a) is a citizen of Kenya; (b) is a holder of a degree or other qualification obtained from a University in Kenya or the East African Community which is recognized by the Council as making him eligible for registration; (c) presents proof of completion of internship; and (d) satisfies the Council that he is a person of good moral standing, may apply to the Council for full registration as a medical or dental practitioner under this Act. (2) A person who— (a) is a citizen of Kenya; (b) is a holder of a degree or other qualification obtained from a University outside Kenya or outside the East African Community which is recognized by the Council as making him eligible for registration; (c) has passed the internship qualifying examinations; (d) presents proof of completion of internship; and (e) satisfies the Council that he is a person of good moral standing, may apply to the Council for full registration as a medical or dental practitioner under this Act. (3) A person who— (a) is a citizen of Kenya; 434 No. 5 Health Laws (Amendment) 2019 (b) is a holder of a degree or other qualification obtained from a University outside Kenya or outside the East African Community which is recognized by the Council as making him eligible for registration; (c) presents proof of completion of internship in the country in which he trained; (d) has passed pre-registration examination; and (e) satisfies the Council that he is a person of good moral standing, may apply to the Council for full registration as a medical or dental practitioner under this Act. (4) A person who— (a) is a citizen of the East African Community; (b) is a holder of a degree or other qualification recognized by the Council as making him eligible for registration; (c) presents proof of registration in their country of origin; and (d) satisfies the Council that he is a person of good moral standing, may apply to the Council for reciprocal registration as a medical or dental practitioner under this Act. (5) A person who— (a) is not citizen of Kenya or of a partner state of the East African Community; (b) is a holder of a degree or other qualification recognized by the Council as making him eligible for registration; (c) presents proof of registration from the country of origin or any other jurisdiction; (d) satisfies the Council that, he has acquired sufficient knowledge of, and experience in, the practice of medicine or dentistry as the case may be; 435 2019 Health Laws (Amendment) No. 5 (e) satisfies the Council that he is a person of good moral standing; and (f) has passed an examination prescribed by the Council, may apply to the Council for temporary registration as a foreign medical or dental practitioner under this Act as is prescribed in regulations. (6) An application made under subsections (1), (2), (3), (4) or (5) shall be in the prescribed form and shall be accompanied by the prescribed fee. (7) The Council shall consider every application made under this section and shall register the applicant if satisfied that the applicant is— (a) duly qualified in terms of this section; and (b) a fit and proper person to be so registered. s.7 Delete the words "the Registrar" and substitute therefor the words "the Council". Insert the words "of registration" immediately after the word "certificate". (2). Delete the words "the Registrar" and substitute therefor the words "the Council". Insert the words "and health institutions" immediately after the words "dental practitioners". Delete the word "Board" and substitute therefor the word "Council". s.11 Registration of higher qualifications for medical practitioners or dentists. Delete and substitute therefor with the following new section 11. A person registered under this Act who has obtained a higher degree or qualification than the qualification in respect of which he has been registered may apply to the Council to have that higher degree or qualification 436 No. 5 Health Laws (Amendment) 2019 inserted in the register in addition to the qualification previously registered, on the payment of a prescribed fee. Insert the following new section immediately after section 11A 11B. (1) The Council may recognize a medical or dental practitioner as a specialist in any of the fields under the Act or the rules thereunder. (2) A medical or dental practitioner shall be recognized as a specialist if the medical or dental practitioner— (a) is a holder of a post graduate qualification equivalent to masters' degree in medicine or dental surgery awarded after a period of training recognized by the Council; and (b) has at least two years' experience after obtaining the post graduate qualification under the supervision of a recognized specialist. (3) The Council may recognize a medical or dental practitioner as a sub-specialist in any of the fields under the Act or the rules thereunder. (4) A medical or dental practitioner shall be recognized as a sub-specialist if the medical or dental practitioner— (a) possesses a basic specialist qualification in his or her discipline; (b) has at least six months training; and (c) has at least one year experience under the supervision of a recognized sub specialist. s.12 Delete and substitute therefor the following section— Specialist 12. (1) The Council shall issue in licences. accordance with this section and rules made under this Act, general, specialist and any New section. Recognition of specialists. 437 2019 Health Laws (Amendment) No. 5 other practising licences as the Council shall determine from time to time authorizing medical practitioners and dentists named therein to practice medicine or dentistry. (2) An application for a practising licence under subsection (1) shall be made to the Council in the prescribed form and accompanied by the prescribed fee. (3) All medical practitioners and dentists shall be required to satisfy the Council's requirement for continuing professional development before the renewal of annual practising licences. (4) A practising licence shall bear the date of day on which it is issued and shall have effect from that day: Provided that a practising licence issued during the first month of any practising year shall have effect, for all purposes, from the beginning of that month. (5) The practising year for a practising licence shall be from the first of January to the thirty-first of December: Provided that the Council, in consultation with the Cabinet Secretary, may, by order in the Gazette, alter the practising year and the order may make such transitional provisions regarding incidental matters as may be expedient. (6) A practising license shall expire at the end of the practising year in which it was issued: s.13 Internship and temporary licences. Provided that, where the name of a medical or dental practitioner is removed or struck off the register, the practising license, if any, shall expire forthwith. Delete and substitute therefor the following section 13. (1) A medical and dental graduate who intends to undertake internship training shall 438 No. 5 Health Laws (Amendment) 2019 s.14 Renewal of practising licences. apply to the Council in the prescribed form and upon payment of the prescribed fee for an internship licence. (2) If the Council is satisfied that the graduate meets the set requirements, it shall issue the graduate an internship licence with or without conditions on the licence. (3) The Council shall grant temporary licences to eligible foreign medical and dental students to perform specific work or works in specific institutions in Kenya. (4) An internship licence issued under subsection (2) shall be for a period not exceeding twelve months within a practising year. (5) A temporary licence issued under subsection (3) shall be for a period not exceeding twelve months within a practising year and may be renewed. Delete and substitute therefor the following section 14. (1) A medical practitioner or dentist, issued with a practising licence may apply for the renewal of the licence in the prescribed form at least thirty days before the expiry thereof (2) A medical practitioner or dentist who fails to apply for renewal of their practising licence within the period specified under subsection (1), shall, when applying for renewal, be required to pay such late application fee as shall be prescribed by the Council. (3) The Council may refuse to renew, or suspend, withdraw or cancel any practising licence, if satisfied that the medical practitioner or dentist is guilty of professional misconduct or is in breach of any provisions of this Act or any regulations made thereunder, within a period of twelve months immediately 439 2019 Health Laws (Amendment) No. 5 preceding the date of the application for renewal. (4) A person who is aggrieved by the decision of the Council in the exercise of its powers under subsection (3) may appeal to the High Court. s.15 Delete and substitute therefor the following section— Registration of 15. (1) A person or organization may apply health institutions 0 .. t the Council for the registration of a health institution in the prescribed form which shall be accompanied by the prescribed fee. (2) Where the applicant satisfies the Council that the institution meets the requirements for registration, the Council shall register the facility as an approved health institution. (3) The Council shall issue to every approved health institution registered under this Act, a certificate of registration in the prescribed form. (4) The Council shall issue in accordance with this section and rules made under this Act, a licence authorizing the use of any premises as a health institution. (5) An application for a licence under subsection (4) shall be made to the Council in the prescribed form and accompanied by the prescribed fees and shall be made on or before the thirtieth of October of each practising year. (6) A licence issued under this section shall bear the date of day on which it is issued and shall have effect from that date: Provided that a licence issued during the first month of any practising year shall have effect for all purposes from the beginning of that month. (7) A licence issued under this section shall be displayed in a conspicuous place at the health institution to which the licence relates. 440 No.5 Health Laws (Amendment) 2019 (8) A licence issued under this section shall specify the nature of services that may be provided by the health institution. (9) The Council may decline to renew, cancel, withdraw or revoke any licence issued under this section, if it is satisfied that the health institution is being operated in a manner that contravenes any provisions of the Act or any regulations made under this Act. (10) A health institution registered under this Act shall be inspected by the Council. (11) No premise shall be used by any person as a health institution unless it is registered and licenced for such use by the Council. New section. Insert the following new section immediately after section 15— Professional 15A. Every practitioner shall in each year indemnity. take a professional indemnity cover and every health institution shall in each year insure the health institution against professional liability of its staff. s.19 Delete. s.20 Delete and substitute therefor the following section 20. (1) Any person who is dissatisfied with any professional service offered, or alleges a breach of standards by a registered or licensed person under this Act, may lodge a complaint in the prescribed manner to the Council. (2) The Council may, or through a committee appointed for that purpose, inquire into any complaint of professional misconduct, malpractice or any breach of standards. (3) Upon an inquiry held by the Council to determine the complaint made under subsection (2), the person whose conduct is being inquired into shall be afforded an opportunity of being heard, either in person or through a representative. Disciplinary proceedings. 441 2019 Health Laws (Amendment) No. 5 (4) For purposes of proceedings at any inquiry held under this section, the Council may administer oaths, enforce the attendance of witnesses and production of books and documents. (5) The Council shall regulate its own procedure in disciplinary proceedings. (6) Where after an inquiry, the Council determines that a person is guilty, the Council may— (a) issue a caution or reprimand in writing; (b) direct a medical practitioner or dentist to undergo remedial training for a period not exceeding twelve months; (c) direct the medical practitioner or dentist be placed on probation for a period not exceeding six months; (d) suspend, withdraw or cancel the practising licence of a medical practitioner or dentist for a period not exceeding twelve months; (e) suspend, withdraw or cancel the licence of a health institution or a section of the health institution for a period not exceeding twelve months; (f) permanently remove the name of a medical practitioner or dentist from the registers under section 5(3); or (g) in addition to the penalties stipulated in paragraphs (a), (b), (c), (d), (e) or (f), impose a fine which the Council deems appropriate in the circumstance. (7) A person or health institution whose licence has been withdrawn or cancelled under subsection (6), shall forthwith surrender the license to the Council. (8) A person or health institution whose name has been removed from the register under subsection (6)(f) shall forthwith surrender the registration certificate to the Council. 442 No. 5 Health Laws (Amendment) 2019 (9) A person aggrieved by a decision of the Council made under subsection (6) may, within thirty days from the date of the decision of the Council, appeal to the High Court. (10) Notwithstanding the provisions of section 3A (5), the Council shall not remove the name of a person from the register under subsection (6) unless at least seven members of the Council are present in the inquiry. s.22 Delete and substitute therefor the following section 22. (1) A person who is not registered or licensed, including a person aiding or assisting therein, under this Act, and makes or produces or causes to be made or produced any false or fraudulent presentation or declaration either orally or in writing, commits an offence and shall be liable, on conviction, to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years or to both. (2) Any person who falsely takes or uses any name, title or addition implying a qualification to practice medicine or dentistry or who not being registered or licensed under this Act, practices or professes to practice or publishes his name as practising medicine or dentistry, commits an offence and shall be liable on conviction to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years or to both. (3) Any person who uses the title "doctor" unless he is registered or licensed under this Act as a medical practitioner or dentist or has acquired doctoral qualifications or has obtained such qualifications which entitles him to use that title, commits an offence and shall be liable on conviction to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years or to both. Penalty for unregistered and unlicensed person practising. 443 2019 Health Laws (Amendment) No. 5 (4) Any person who, while in charge of a health institution, employs or engages the services of another person as a medical practitioner or dentist who is not registered and licenced under this Act, commits an offence and shall be liable on conviction to a fine not exceeding ten million shillings or imprisonment for a term not exceeding five years or to both. (5) A person who uses premises as a health institution which premises is not licensed as a health institution commits an offence and shall be liable on conviction to a fine not exceeding ten million shillings or imprisonment for a term not exceeding five years or to both. s.23 Delete the opening sentence and substitute therefor the following new opening sentence— "The Cabinet Secretary may, after consultation with the Council, make rules generally for the better carrying out of the provisions of this Act, and any such rules may, without prejudice to the generality of the foregoing—" Insert the following new paragraphs immediately after paragraph (d)— (e) provide for indemnity for clients against loss or damage arising from claims in respect of any liability incurred by a practitioner or a health institution or the employee of a practitioner or health institution; (f) provide for the training, registration, licensing and regulation of community oral health officers; and (g) provide for the process and criteria for registration and licensing of foreign doctors. s.24 Delete. 444 No. 5 Health Laws (fimcnirin ) 2019 yew section, Insert the following, new section immediately after section 25 26. (1) All property, assets, rights, liabilities, obligations, agreements and other arrangements existing at the commencement of this Act and vested in, acquired, incurred or entered into by or on behalf of the Medical Practitioners and Dentists Board, shall be deemed to have vested in or to have been acquired, incurred or entered into by or on behalf of the Council to the same extent as they were enforceable by or against Kenya Medical Practitioners and Dentists Council. (2) A person who is an employee of the Medical Practitioners and Dentists Board, shall be deemed to be an employee of the Kenya Medical Practitioners and Dentists Council on the terms and conditions existing, until the expiry of the contract. (3) Any legal proceedings pending in any court or tribunal by or against the Medical Practitioners and Dentists Board, in respect of any matter shall continue by or against the Council. (4) The members of the Medical Practitioners and Dentists Board, who were appointed, nominated or elected as Board members under section 4, shall continue to hold and act as Council members, until the end of their term. The Nurses Act, s. t Insert the words "and Mid i yes (Cap 257). immediately after the word "Nurses". s2. Delete the word "Minister" in the definition of the words "approved institution" and substitute therefor the expression Cabinet Secretary"; Delete the word "Minister" wherever it appears in the definition of the words "local supervising authority" and substitute therefor the expression "Cabinet Secretary". Savings and transition. 445 2019 Health Laws (Amendment) No. 5 Insert the words "or midwifery" immediately after the word "nursing" in the definition of-the word "licence"; Insert the following new definitions in proper alphabetical sequence— "Cabinet Secretary" means the person for the time being responsible for matters relating to health; "enrolled community health nurse" means a person who has undergone training in an approved nursing programme in an approved institution and has been enrolled and licensed by the Council; "member" means a member of the Council; "midwife" means a person who has successfully completed midwifery education programme based on the essential competences for basic midwifery practice according to global standards of midwifery education and is recognized and licensed in the country of origin; "nurse" means a person who is authorized by licensure to practice as an enrolled or registered nurse; "post basic" means acquiring a second qualification after initial entry into the profession through a basic nursing course; "private practice" means the engagement as a registered or enrolled nurse or midwife in the provision of nursing care in the private sector in an independent capacity; "specialist" means a person registered under this Act as a nurse practitioner, an advanced practice nurse, nurse or registered midwife who has acquired the expert knowledge base, complex decision-making skills and clinical competencies for expanded practice and who has a master's degree or above from a recognized university in any of the following disciplines— 446 No. 5 Health Laws (Amendment) 2019 (a) midwifery; (b) medical surgical nursing; (c) paediatrics nursing; (d) oncology and palliative care nursing; (e) forensic nursing; (f) community health nursing; (g) nursing education; (h) nursing management and leadership; (i) mental health nursing; (j) nursing informatics; (k) critical care nursing; (1) gerontology nursing; (m)nephrology nursing; and (n) such other specialization that the Council may from time to time deem necessary; and "year" means financial year; s.4. Delete and substitute therefor the following new section— Membership of the 4. (1) The Council shall consist of the Council. following persons appointed by the Cabinet Secretary— (a) a chairperson who shall— (i) be a holder of a diploma or Bachelor's degree in nursing from a university or college recognized in Kenya; and (ii) have at least ten years' experience in leadership and management; (b) the Director of Nursing Services or a representative appointed in writing by the Director of Nursing Services; (c) one person nominated by the National Nurses Association of Kenya; 447 2019 Health Laws (Amendment) No. 5 (d) one person nominated by other professional associations of Kenya representing nurses and midwives; (e) one representative of midwives involved in clinical practice; (f) one representative of accredited mid level institutions involved in the training of nurses and midwives in Kenya; (g) one representative of accredited universities involved in training of nurses and midwives in Kenya; (h) one person nominated by the Cabinet Secretary to represent the public; (i) the Chief Executive Officer who shall be the Registrar and shall be appointed in accordance to section 11 of this Act and shall be an ex officio member of the Council; and (j) the Director General of Health or a representative appointed in writing by the Director General of Health. (2) Appointments under subsection (1)(h) shall take into consideration gender and regional balance and the mix of skills and competencies required for the achievement of the organization's long-term goals, and shall be published in the Kenya gazette. (3) A member appointed under paragraph (1)(b) shall be an ex officio member of the Council. (4) A member of the Council including the chairperson shall be a Kenyan citizen of good professional standing and meet the requirements of Chapter Six of the Constitution. (5) A member of the Council appointed under this Act shall be a holder of a relevant diploma or degree obtained from a 448 No. 5 Health Laws (Amendment) 2019 university or institution recognized by the Council. (6) A member of the Council except the ex officio members shall hold office for a term of three years and may be eligible for reappointment for one further term. (7) There shall be a Corporation Secretary who shall be appointed by the Council through a competitive process. (8) Pursuant to nominations in paragraphs (c), (d), (e), (f) and (g) of subsection (1), each organization shall present two nominees one of whom shall be appointed by the Cabinet Secretary taking into account ethnic diversity, gender disability, skills mix and regional balance. New section. Insert the following section immediately after section 4— Corporation Secretary. 4A. There shall be a Corporation Secretary to the Council who shall be appointed by the Council, on such terms and conditions of service as the Council may determine. s.5(1). Delete the expression "section 25(1)" in paragraph (b) and substitute therefor with the expression "section 18B". Insert the following new paragraph immediately after paragraph (b)— (c) he has contravened the provisions of Chapter 6 of the Constitution or convicted of a criminal offence punishable by a fine or imprisonment for more than six months. Delete the word "Minister" wherever it appears in and substitute therefor the expression "Cabinet Secretary". s.6. Delete. s.7(1). Delete the word "chairman" and substitute therefor the word "chairperson". (3) 449 2019 Health Laws (Amendment) No. 5 Delete and substitute therefor the (2) following new subsection— "(2) The chairperson may at any time convene a special meeting of the Council and shall do so within fifteen days of a written requisition of the meeting signed by at least five members." Insert the following new subsection immediately after subsection (2)— (3) Council meetings shall be presided over by the chairperson or in the chairperson's absence any other member elected by the Council at the meeting for that purpose. s.8(1). Delete and substitute therefor the following new subsection— (1) The quorum of the Council meetings shall be five members, but no meeting shall be held or continued, notwithstanding that there is quorum, unless the Registrar or a person deputizing the Registrar is present. (2) Delete the word "chairman" in subsection (2) and substitute therefor the word "chairperson". s.9(1) Delete the word "Minister" wherever it appears and substitute therefor the expression "Cabinet Secretary". Delete the words "nursing commodities" appearing in paragraph (i). Delete paragraph (k) and substitute therefor the following new paragraph— (k) to advise the Cabinet Secretary on any matter falling within the scope of this Act. s.10(1). Delete subsection (1) and substitute therefor the following subsection— (1) The Council may, for the effective discharge of its functions under this Act, establish the following committees— 450 No. 5 Health Laws (Amendment) 2019 (a) registration, education and examination; (b) discipline, standards and ethics; (c) finance, strategy and development; and (d) risk and audit. Delete the word "chairman" wherever it appears and substitute therefor the word (6) "chairperson". (7) Delete. s.11(1) Delete subsection (1) and substitute therefor the following subsection— (1) The Council shall, with the approval of the Cabinet Secretary, competitively appoint a Registrar who shall— (a) be a registered nurse or midwife; (b) be the Chief Executive Officer to the Council; (c) perform such duties as may be prescribed by this Act or directed by the Council; and (d) be an ex officio member of the Council. (2) Delete subsection (2) and substitute therefor the following subsection— (2) The Council may appoint such other officers as the work of the Council may require, and those officers shall perform such duties as the Council may direct. (4) Delete the word "may" appearing in subsection (4) and substitute therefor the word "shall". (5) Delete subsection (5) and substitute therefor the following new subsection— "(5) The officers appointed under this section shall be paid such remuneration and allowances as the Council may, on 451 2019 Health Laws (Amendment) No. 5 the advice of the Salaries and Remuneration Commission, determine." New Subsection Insert the following new subsection immediately after subsection (5)— "(6) The Chief Executive Officer shall serve for a term of four years and shall be eligible for reappointment for one further term of four years, subject to satisfactory performance." s.12. Delete and substitute therefor the following new section Registers to be kept. keep a register of nurses and midwives in 12. (1) The Registrar shall compile and the prescribed form. (2) Every person eligible to be registered as a nurse or midwife may apply in the prescribed form to the Registrar for registration and every such application shall be accompanied by the prescribed fee. (3) Subject to payment of a retention fee, there shall be entered and maintained in the appropriate register the name and address of every person entitled to be registered under this Act together with his or her professional qualifications and such other particulars as may be prescribed by the Council. (4) Every person registered under this Act who has obtained a higher degree or qualification other than the qualification in respect of which he has been registered, shall be entitled to have that higher degree or additional qualification inserted in the register in substitution for or in addition to the qualification previously registered, upon paying the prescribed fee. s.14(1). Delete the word "Minister" and substitute therefor the expression "Cabinet Secretary". s.16(1). Delete the word "Minister" wherever it appears and substitute therefor the expression "Cabinet Secretary". 452 No. 5 Health Laws (Amendment) 2019 s.17. Delete and substitute therefor the following new section— Private practice 17. (1) A person may engage in private practice as a nurse or a midwife if that person— (a) is a citizen of Kenya or a foreign national; (b) is registered and licensed to practice in Kenya; (c) is a holder of a valid practising license issued under this Act; (d) is of professional good standing, as may be prescribed by the Council; (e) has paid the fee as prescribed by the Council; (f) meets such other requirements as may be prescribed by the Council; and (g) is a holder of such other nursing or midwifery qualification as may be prescribed. (2) A person is not qualified to operate a clinic in community nursing or midwifery services as a private practitioner unless such person has at least three years post qualification experience in community nursing or midwifery and is in active practice in Kenya. (3) Despite the provisions of sub sections (1) and (2), a person is not qualified to operate a nursing home, maternity home or a nursing and maternity home as a private practitioner unless such person has been in active practice for at least five years in Kenya. (4) If a license is due for renewal and the licensee has not made an application within the thirty days from the date of expiry, the licensee shall not engage in private practice until a renewal license is issued. 453 2019 Health Laws (Amendment) No. 5 (5) An application to engage in private practice or for renewal shall be made to the Council in the prescribed form, accompanied with the prescribed fee. (6) A person who has made an application to engage in private practice shall be issued with such license by the Council upon satisfying such requirements for issuance with a licence under this Act. (7) A practising certificate shall be valid from the date on which it is issued and shall expire on the thirtieth day of December of every year unless its holder ceases to be a registered person under this Act. (8) A person who contravenes the provisions of this section commits an offence and is liable upon conviction, to a fine not exceeding one million shillings or to imprisonment for a term not exceeding one year, or to both. s.19(2). Delete the word "Minister" and substitute therefor the expression "Cabinet Secretary". s.26. Delete the word "Minister" and substitute therefor the expression "Cabinet Secretary". s.27. Delete the word "Minister" and substitute therefor the expression "Cabinet Secretary". Insert the following new sections immediately after section 27 27A. The financial year of the Council shall be the period of twelve months commencing on the first of July and ending on the thirtieth of June of the subsequent year. 27B. (1) The Council shall keep proper books and records of account of income, expenditure, assets and liabilities of the Council. New sections. Financial year. Accounts and Audit. 454 No. 5 Health Laws (Amendment) 2019 The Kenya s.2. Medical Training College Act, (Cap. 261). (2) Within a period of three months after the end of each financial year, the Council shall submit to the Auditor-General accounts of the Council in respect of that year together with a— (a) statement of the income and expenditure of the Council during that year; and (b) statement of the assets and liabilities of the Council on the last day of that financial year. (3) The annual accounts of the Council shall be prepared, audited and reported upon, in accordance with the provisions of Articles 226 and 229 of the Constitution and the law relating to public audit. Delete the expression "Board of management" appearing in the definition of the word "statutes" and substitute therefor the expression "Board of Directors". Delete the definitions of "Academic Board", "Board of Management", "Principal" and "Deputy Principal". Insert the following new definitions in proper alphabetical sequence— "Academic Council" means the Academic Council of the College established under section 11; "Board of Directors" means the Board of Directors of the College established under section 9; "Cabinet Secretary" means the Cabinet Secretary for the time being responsible for matters relating to health; "Chief Executive Officer" means the Chief Executive Officer appointed under section 8; and "Deputy Director" means a Deputy Director of the College appointed under section 8. 455 2019 Health Laws (Amendment) No. 5 s.3(1)(b) s.4(1) Delete and substitute therefor the following paragraph— (b) such other institutions as the Cabinet Secretary may, from time to time in consultation with the Board of Directors, by notice in the Gazette, declare to be a campus of the College. Delete and substitute therefor the following new subsection— (1) The Common seal of the College shall be kept in the custody of the Corporation Secretary and shall not be used except by the order of the Board of Directors. Delete and substitute therefor the (2) following new subsection— "(2) The common seal of the College shall be kept in the custody of the Corporation Secretary and shall be authenticated by the signature of the Chief Executive Officer." Delete the expression "Board of Management" and substitute therefor the expression "Board of Directors". Delete the expression "Academic Board" and substitute therefor the expression "Academic Council". Delete the expression "constituent training centres" appearing in paragraph (h) and substitute therefor the expression "campuses". Delete the expression "Board of Management" and substitute therefor the expression "Board of Directors". Delete the expression "Principal" and substitute therefor the expression "Chief Executive Officer". Delete the expression "Deputy Principal" and substitute therefor the expression "Deputy Directors". (3) s.5(1) (b) (h) (2) s.7(a) (b) 456 No. 5 Health Laws (Amendment) 2019 (c) (1) (2) (3) Delete the words "constituent training centre" and substitute therefor the word "campus". Delete the expression "Board of Management" and substitute therefor the expression "Board of Directors". Delete the word "Board" and substitute therefor the word "Council". Delete. Delete the expression "Board of Management" and substitute therefor the expression "Board of Directors". Delete the marginal note and substitute therefor the following new marginal note— The Chief Executive Officer and Deputy Directors. Delete and substitute therefor the following new subsection— (1) There shall be a Chief Executive Officer who shall be the secretary to the Board of the College who shall be appointed by the Board of Directors, and who shall have the following minimum qualifications— (a) hold a masters' degree in the relevant field from a university recognized in Kenya; (b) have at least ten years' knowledge and experience in the relevant field; (c) meet the requirements of Chapter Six of the Constitution; and (d) have served in a position of senior management for a period of at least five years. Delete the expression "Principal" and substitute therefor the expression "Chief Executive Officer". Delete the expression "Board of Management" appearing in paragraph (c) 457 2019 Health Laws (Amendment) No. 5 and substitute therefor the expression "Board of Directors". Delete and substitute therefor the following subsection (3) The Board of Directors shall appoint Deputy Directors in the following areas to assist the Chief Executive Officer— (a) academic; (b) finance, planning and administration; (c) research and innovation; and (d) business development, resource mobilization and consultancy. (4) Delete and substitute therefor the following subsection— "(4) The Chief Executive Officer shall hold office for a term of four years and shall be eligible for reappointment for one further term of four years subject to satisfactory performance of duties." (5) Delete and substitute therefor the following subsection— "(5) There shall be a Corporation Secretary to the Board who shall be appointed by the Board, on such terms and conditions of service as the Board may determine." s.9 Delete the marginal note and substitute therefor the following new marginal note The Board of Directors. (1) Delete and substitute therefor the following paragraph — (1) The Board shall comprise the following— (a) a chairperson appointed by the President who shall— (i) have a minimum of a bachelors' degree in a relevant 458 No. 5 Health Laws (Amendment) 2019 field from a university recognised in Kenya; and (ii) have at least ten years' experience in leadership and management; (b) the Chief Executive Officer who shall be an ex-officio member; (c) the Principal Secretary in the Ministry for the time being responsible for health or their designated representative; (d) the Principal Secretary in the Ministry for the time being responsible for national treasury or their designated representative (e) the Director General of Health or their designated representative; (0 three independent members appointed by the Cabinet Secretary taking into consideration gender balance, regional balance and skills mix; and (g) one person with knowledge and expertise in finance or audit appointed by the Cabinet Secretary. Insert the following new subsections immediately after subsection (1)— (1A) The chairperson shall preside over all meetings of the Board of Directors and in his or her absence the members present shall choose one of the members to act as the chairperson. New (1B) A person appointed to act as Subsections chairperson shall have all the powers and privileges of the chairperson in respect of the meeting at which he or she presides. (1C) The Board of Directors shall meet at least once every three months. 459 2019 Health Laws (Amendment) No. 5 (1D) Each member of the Board of Directors shall have a deliberative vote and the chairperson for the time being at any meeting of the Board shall, in addition to the deliberative vote have a casting vote. (1E) Two thirds of the members of the Board of Directors, including the chairperson, shall constitute a quorum at any meeting of the Board, and all acts, matters or things authorized or required to be done by the Board of Directors, may be decided at any meeting at which a quorum is present. (1F) The powers of the Board of Directors shall not be affected by any vacancy in membership thereof. (1G) The Chief Executive Officer shall be a member without voting rights. (1H) The Board of Directors may constitute committees to perform the following functions— (a) audit; (b) governance; (c) risk; (d) compliance; (e) finance; (f) human resource; (g) strategy; and (h) technical matters. Delete the expression "Board of management" and substitute therefor the expression "Board of Directors 9f . Insert the words "for one further term" immediately after the word "re appointment". Delete and substitute therefor the following new subsection— "(3) The office of a member of the Board of Directors shall become vacant— 460 No. 5 Health Laws (Amendment) 2019 (a) if, not being an ex officio member— (1) he resigns from office by writing to the appointing authority; (ii) he is convicted of an offence and sentenced to imprisonment for a term exceeding six months without the option of a fine; (iii) he is absent, without permission of the Board of Directors, from three consecutive meetings; (b) if the Board of Directors is satisfied that such member is, by reason of physical or mental infirmity, unable to exercise the functions of his office; (c) upon death; (d) upon adjudication of bankruptcy by a court of competent jurisdiction; (e upon conviction of an offence related to fraud; or (f) upon the conviction for offence under this Act." Delete the expression "Principal" and substitute therefor the expression "Chief Executive Officer". Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". Delete and substitute therefor the following subsection— (5) Notwithstanding the provisions of this section, the procedure and conduct of affairs of the Board of Directors shall be regulated by the statutes. (2) (3) (4) (5) 461 2019 Health Laws (Amendment) No.5 Delete the marginal note and substitute therefor the following marginal note— Functions of the Board of Directors. Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". Delete and substitute therefor the (2) following subsection— (2) Notwithstanding subsection (1), the Board of Directors shall have power (a) to administer the property and funds of the College in a manner and for purposes which shall promote the best interests of the College; but the Board of Directors shall not charge or dispose of immovable property of the College except in accordance with the procedures laid down by the State Corporations Advisory Committee established under the Cap. 446. (b) to receive, on behalf of the College State Corporations Act; or a campus, gifts, donations, grants or other moneys and to make disbursements therefrom to the campuses or other bodies or persons; (c) in consultation with the Cabinet Secretary, to determine the scales of fees payable by or in respect of students at the College and to prescribe the conditions under which fees may be remitted in whole or in part; (d) to provide for the welfare of the staff and students of the College; ) to enter into association with universities, other colleges and other institutions of learning whether within Kenya or otherwise, as the Board of Directors may deem necessary and appropriate; s.10 (1 ) 462 No. 5 Health Laws (Amendment) 2019 s.11 The Academic Council. (f) to make, after consultation with the Academic Council, regulations governing the conduct and discipline of students of the College; and (g) to make investments on behalf of the College. Delete and substitute therefor the following section 11. (1) There shall be an Academic Council of the College which shall consist of— (a) the Chief Executive Officer, who shall be the chairperson of the Academic Council; (b) four Deputy Directors; (c) one head of the faculties of the College appointed by the Board; (d) one head of each campus appointed by the Board; (e) two members of the academic staff of the College, not being members of the Academic Council under any other provisions of this subsection, elected by the College Staff Association; and (f) two student members elected by the student body of the College, except that the student members shall not be entitled to attend deliberations of the Academic Council on matters which are considered by the Chief Executive Officer to be confidential and which relate to examinations, the general discipline of students and other related matters. (2) The Academic Council shall have the following powers— (a) to satisfy itself regarding the content and academic standard of any course of study in respect of any diploma, 463 2019 Health Laws (Amendment) No. 5 certificate or other award of the College, and to report its findings to the Board of Directors; (b) to propose regulations to be made by the Board of Directors regarding the standard of proficiency to be gained in each examination for a diploma, certificate or other award; (c) to decide which persons have attained such standard of proficiency or are otherwise fit to be granted the diploma, certificate or other award; (d) to initiate proposals relating to the conduct of the College generally, and to discuss any matter relating to the College, including the establishment of faculties or training programmes, and make representations thereon to the Board of Directors; (e) to make regulations governing such other matters as are within its powers in accordance with the provisions of this Act or the statutes; (f) selection and admission of students; and (g) to establish technical committees to enable the Academic Council to carry out the necessary functions. (3) Notwithstanding any other provisions of this Act, the Board of Directors shall not initiate any action in respect of any of the matters mentioned in subsection (2) (a), (b) or (c), except upon receipt of a report or proposal of the Academic Council thereunder and except in consultation with the Academic Council." (4) Subsection (2) shall be construed to incorporate the provisions of all other written laws that govern training, registration, enrolment and licensing of health professionals. 464 11(,ilib l ait's (Amendment) 2019 ,,.12(2) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". Delete the words "Academic Board" and substitute therefor the words "Academic Council". s.13(1) Delete the expression "Principal, the Deputy Principals" and substitute therefor the expression "Chief Executive Officer, the Deputy Directors". (2) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". Delete the expression "Board of management" wherever it appears and substitute therefor the expression "Board of Directors". Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". Delete the expression "Principal" and (5)(a) substitute therefor the expression "Chief Executive Officer". Delete the expression "Board of management" and substitute therefor the expression -Board of Directors". Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". 4/ l)elete and substitute therefor the following subsection— ( 1) In the event of the incapacity, the 'unctions of the Chief Executive Officer Tall, during the incapacity, be performed by he Deputy Director appointed for that purpose by the Board of Directors. Delete and substitute therefor the l'ollowing subsection— (3) (4) (6) 465 2019 Health Laws (Amendment) No. 5 "(2) In the event of the simultaneous incapacity of the Chief Executive Officer and the Deputy Directors, the Cabinet Secrctary, after consultation with the Board of Directors, shall appoint a member of the Academic Council to perform the functions of the Chief Executive Officer during such incapacity. Delete the expression "Principal" (3) wherever it appears and substitute therefor the expression "Chief Executive Officer". s.16(1) Delete the expression "Board of management" and substitute therefor the (2) expression "Board of Directors". Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". s.17(1) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". (2)(f Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". (3) Delete the expression "Board of Management" wherever it appears and substitute therefor the expression "Board of Directors". Delete the expression "M in i ster" wherever it appears and substitute therefor the expression "Cabinet Secretary". (4) Delete and substitute therefor the following subsections— (4) No expenditure shall be incurred for the purposes of the College except in accordance with the annual estimates approved under subsection (3) or in pursuance of an authorization of the Board of Directors given with the prior approval of the Cabinet Secretary. 466 No. 5 Health Laws (Amendment) 2019 (5) Where justifiable reasons exist, the College may seek authorization of the Board of Directors given with the prior approval of the Cabinet Secretary for reallocation of funds. (6) The sources of funds for the College shall be— (a) the Exchequer; (b) fees charged by the College; (c) the income from resource mobilization; and (d) any other source that the Board of Directors may authorize. s.18(1) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". (2) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". Delete the expression "(Corporations)". Delete the expression "Board of management" wherever it appears and substitute therefor the expression "Board of Directors". Delete the words "boarding charges" appearing in paragraph (e) and substitute therefor the words "user charges". Delete. (2) (3) Delete. (4) Delete. s.20(1) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". (2) Delete and substitute therefor the following new subsection— 467 2019 Health Laws (Amendment) No. 5 "(2) Any person who, except with the written consent of the Board of Directors, uses the words "Kenya Medical Training College" in furtherance of, or as, or in connection with, any advertisement for any trade, business, calling or profession commits an offence and shall be liable on conviction to a fine not exceeding five hundred thousand shillings or to imprisonment for a term not exceeding two years or to both." s.21 Delete the expression "Minister" and substitute therefor the expression "Cabinet Secretary". Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". s.22(8) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". (9) Delete the expression "Board of management" and substitute therefor the expression "Board of Directors". SCHEDULE Delete the expression "constituent training centres" and substitute therefor the expression "campuses" appearing in heading to the Schedule. Delete the expression "Medical training centres" and substitute therefor the expression "campuses" appearing in paragraph 1. Insert a new paragraph immediately after paragraph 3 4. The College campuses shall be gazetted annually. The Nutritionists s.2 Delete the definitions of the terms and Dieticians "dietician" and "nutritionist". Act (No. 18 of Insert the following definitions in proper 2007 alphabetical sequence— II, dolt I on, i liitrnilnie,it) 2010 "article" includes-- (a) ally food, nutrient or food supplements and any labelling or advertising materials in respect thereof; and (b) anything used for the preparation, preservation, packing or storing of any food, nutrient or food supplements; "diet" means food or nutrient concentrates consumed by an individual or population for the purpose of nourishment and can either be formal diets, non-formal diets or informal diets; "dietetic technologist" means a person who has undergone professional training at diploma level with a bias in dietetics, registered and licensed under this Act; "dietician" means a person who has undergone professional training at degree level, with bias in clinical dietetics and food service diet therapy registered and licensed under this Act; "indexing" means a process of keeping records of an individual student pursuing a course in nutrition or dietetics for purposes of monitoring and subsequent professional examination, registered and licensed under this Act; "internship" means undergoing supervised one-year competency practice in a specialized area of nutrition or dietetics: "label" includes any legend, work or mark attached to, included in, belonging to or accompanying any food or food supplements; "nutrients" means compounds contained in food which nourish the body such as amino acids, simple sugars, fatty acids. vitamins and minerals; 469 2019 Health Laws (Amendment) No. 5 "nutrition technician" means a person who has undergone professional training at certificate level, registered and licensed under this Act; "nutrition technologist" means a person who has undergone professional training at diploma level, registered and licensed under this Act; and "nutritionist" means a person who has undergone professional training at degree level, with a bias in clinical, food science, community and public health competencies in nutrition registered and licensed under this Act. s.3 Delete and substitute therefor the following section Restriction on the use of titles. Act, no person shall practise under the 3. (1) Subject to the provisions of this name, title or style containing the words or phrases "Nutritionist", or "Dietician", "Nutrition technologist" "Technologist" "Nutrition or Dietetics technicians" unless that person holds a relevant degree, diploma or certificate from a recognized university or college, and is registered and licensed under this Act. "(2) Notwithstanding any other provisions of this Act, a person registered and licensed under this Act shall engage in private practice only if he holds a diploma or a degree and has completed one-year internship or has a minimum of three years' experience in nutrition and dietetics." s.5(2) Delete and substitute therefor the following subsection— (2) The Council shall consist of— (a) a chairperson who shall be appointed by the Cabinet Secretary and who shall— (i) be a holder of a bachelors' degree in nutrition or dietetics; and 470 No. 5 Health Laws (Amendment) 2019 (ii) have at least ten years of professional experience after the first degree of which two years shall be at leadership and managerial level; (b) one qualified nutritionist or dietician professional with a minimum of a diploma in good standing from private practice who shall be appointed by the Cabinet Secretary; (c) the Director of Nutrition and Dietetics Services in the Ministry responsible for health or their designated representative; (d) one representative of the Consumers Federation of Kenya, who shall be a holder of at least a bachelors' degree; (e) one representative of faculties teaching nutrition and dietetics at public universities who shall be competitively sourced and who shall be a holder of at least a masters' degree; (f) one representative from public and private middle level colleges, offering courses in nutrition or dietetics; (g) the Director General for health or their designated representative; (h) one member with technical knowledge and competencies in finance who shall be appointed by the Cabinet Secretary; and (i) the Chief Executive Officer as an ex officio member. (4) Delete and substitute therefor the following new sub section— (4) All appointments under this section shall be notified in the Gazette by the Cabinet Secretary for the time 471 2019 Health Laws (Amendment) No. 5 being responsible for matters relating to health. New subsections. Insert the following subsections immediately after subsection (4)— "(5) Pursuant to nominations in paragraphs (d), (e) and (f) of subsection (2), each organization shall present two nominations one of whom will be appointed by the Cabinet Secretary taking into account ethnic diversity, gender disability, skills mix and regional balance. (6) The appointments under subsection (2) shall consider gender, regional and ethnic balance. (7) The Council shall establish a maximum of four committees to deal with matters of training, registration, finance and human resource, audit and risk policies management for proper administration of the Act, but may establish such other ad hoc committees as may be necessary to carry out the functions of the Council. (8) The Council shall regulate its own procedures in accordance with the First Schedule." s.6 Insert the following paragraph immediately after paragraph (i)— (j) working jointly with other bodies, participate actively on reviews of food, food supplements and fortifiers with nutrient claims. s.7 Delete and substitute therefor the following section 7. Subject to this Act, the Institute may either generally or in a particular case, delegate to any committee of the Council or to any member, officer, employee, agent of the Institute or technical working group, the exercise of any of the powers of the Institute under this Act. Delegation of powers of the Institute. 472 No. 5 Health Laws (Amendment) 2019 s.8 Delete and substitute therefor the following section— Remuneration of 8. The Institute shall pay such Council members. remuneration, fees, and other allowances to members of the Council as may be determined from time to time by the Council in consultation with the Salaries and Remuneration Commission. s.9 Delete and substitute therefor the following section— The Chief 9. (1) There shall be a Chief Executive Executive Officer. Officer of the Institute who shall be competitively recruited by the Council and whose terms and conditions of service shall be determined by Public Service Commission. (2) A person shall be qualified to be appointed as the Chief Executive Officer if the person— (a) possesses a Master of Science degree or its equivalent from a university recognised in Kenya; (b) has at least ten years professional and administrative experience in matters related to health; and (c) meets the requirements of Chapter Six of the Constitution. (3) The Chief Executive Officer shall hold office for a term of four years renewable once based on performance. (4) The Chief Executive Officer shall, subject to the direction of the Council, be responsible for the management of the day to day affairs of the Institute. New section. Insert the following section immediately after section 9— Corporation Secretary. 9A. (1) The Council shall competitively appoint a Corporation Secretary on part time or full time basis to facilitate the functions of the Council. 473 2019 Health Laws (Amendment) No. 5 (2) The Corporation Secretary shall be the secretary to the Council but not a member of the Council. (3) The Corporation Secretary shall discharge his duties as stipulated in the State Corporation guidelines. (4) The Corporation Secretary shall coordinate with the office of the Chief Executive Officer to facilitate the activities of the Council. (5) The Corporation Secretary shall be a person of high integrity who meets the requirements of Chapter Six of the Constitution. s.12 Delete the word "Board" wherever it appears and substitute therefor the word "Committee". s.13 Delete and substitute therefor the following new section— Functions of the Accreditation Committee. 13. The Accreditation Committee shall generally, in the conduct of examinations— (a) provide proper training of persons to be registered and licensed; (b) prepare syllabuses of instruction and training courses for persons seeking registration under the Act; (c) prepare and conduct examinations for persons seeking registration under the Act; (d) charge the appropriate examination fees in consultation with the Council of the Institute; (e) prepare regulations to be made by the Institute regarding the standard of proficiency to be gained in each examination for a diploma, degree or other award; 474 No. 5 Health Laws (Amendment) 2019 No. 21 of 2017. (f) develop regulations for internship programmes for students of nutrition and dietetics during pre-service training; (g) set up quality assurance units to generally carry out broad perspectives of quality management systems; (h) develop standards for training institutions for purposes of accreditation and licensing; (i) engage inspectors for various functions of the Committee who shall serve on such terms and conditions as the Council may determine from time to time; (j) participate actively in the committees of food and drugs authority within the Health Act; (k) review the authenticity and appropriateness of documents to be presented for purposes of examination, internship, registration and licensing; (1) spearhead systems audits and certification of processes of the Institute; (m) register and license persons qualified to be registered under this Act; (n) prepare a list of professionals to be deregistered by the Institute in accordance with this Act; (o) keep a register of all registered members; (p) keep a register of all licensed and retained professionals; and (q) carry out the indexing of students enrolled in various institutions and monitor their progression. 475 2019 Health Laws (Amendment) No. 5 s.14 Delete. s.15 Delete. s.16(c) Delete and substitute therefor the following subsection— (c) has passed the professional examination set by the Accreditation Committee of the Council. s.17(1) Delete the expression "Registrar" and substitute therefor the expression "Chief Executive Officer". s.19(1) Delete the expression "Registrar" and substitute therefor the expression "Chief Executive Officer" wherever it appears. (2) Delete the expression "Registrar" and substitute therefor the expression "Chief Executive Officer". (3) Delete the expression "Registrar" and substitute therefor the expression "Chief Executive Officer". (5) Delete the expression "Registrar" and substitute therefor the expression "Chief Executive Officer". s.21(1) Insert the words "within thirty days of notification of the decision" immediately after the word "Court". s.25(1) Insert the words "of the Institute" immediately after the words "Disciplinary Committee". (2) Delete paragraph (c) and substitute therefor the following new paragraph— (c) one member of the Accreditation Committee; Delete the word "Board' appearing in paragraph (e) and substitute therefor the word "Committee" Insert the following new subsections immediately after subsection (2)— 476 No. 5 Health Laws (Amendment) 2019 (2A) The quorum for the meetings of the Disciplinary Committee shall be four which shall include at least the chairperson or vice-chairperson. (2B) The members of the Disciplinary Committee shall be paid such allowances as may from time to time be determined by the Council in consultation with the Salaries and Remuneration Commission. (3) Delete the words "chief executive officer" and substitute therefor the words "Corporation Secretary". Insert the following subsection immediately after subsection (5)— (6) The Disciplinary Committee shall develop its Standard Operating Procedures which shall be adopted by the Committee for proper discharge of duties. s.27(a) Insert the words "or under any other written law" immediately after the word (c) "Act". Delete. New Section Insert the following new section immediately after section 27 Establishment of General Fund. the Institute to be known as the General 27A. (1) There is established a Fund of Fund. (2) The Fund shall vest in the Institute and shall be administered by the Council through the Chief Executive Officer. (3) The Fund shall consist of— (a) all monies received as subventions, grants or donations to the Fund; (b) monies earned or arising from any investment of the Fund; (c) foreign aid and assistance from bilateral and multilateral agencies; and 477 2019 Health Laws (Amendment) No. 5 (d) all other sums which may, in any manner become lawfully payable to, received by or vested in the Institute relating to any matter incidental to its duties and functions under this Act. s.30 Delete and substitute therefor the following section— Annual estimates. 30. (1) The annual estimates of the Institute shall provide for— (a) the payment of salaries, allowances and other charges in respect of the members of the Council, the Chief Executive Officer, the Corporation Secretary and the staff of the Institute; (b) the payment of pensions, gratuities and other charges in respect of the members of the Council, the Chief Executive Officer, the Corporation Secretary and the staff of the Institute; (c) the proper maintenance of the premises of the Institute; (d) the maintenance, repair and replacement of the equipment and other property of the Institute; and (e) the creation of such reserve funds to meet future or contingent liabilities in respect of retirement benefits, insurance or replacement of buildings or equipment, or in respect of such other matter as the Institute may deem appropriate. (2) The annual estimates shall be approved by the Institute before the commencement of the financial year to which they relate: Provided that the amounts in estimates shall not be increased before the prior consent of the Institute. 478 No. 5 Health Laws (Amendment) 2019 (3) The Institute shall keep all proper books and records of accounts of the income, expenditure, assets and liabilities of the Institute. (4) Within a period of four months after the end of every financial year, the Council shall submit to the members of the Institute at an Annual General Meeting or Special General Meeting convened for that purpose the audited accounts of the Institute together with— (a) a statement of the income and expenditure of the Institute for that year; and (b) a statement of the assets and liabilities of the Institute as at the last day of that year. (5) The annual accounts of the Council shall be prepared, audited and reported upon in accordance with the provisions of Articles 226 and 229 of the Constitution and the law relating to public audit. s.31 Delete. s.38 Insert the following paragraph after paragraph (g)— (h) any other matter that may be necessary for the proper administration of the Act. s.39 Delete. First Schedule. Delete and substitute therefor the following new Schedule— FIRST SCHEDULE [Section 5(8).] MEETINGS OF THE INSTITUTE 1. (1) The Annual General Meeting of the Institute shall be convened by the 479 2019 Health Laws (Amendment) No. 5 Council within the first quarter of every financial year by giving every professional of the Institute in good standing a written notice— (a) stating the place where and the day and hour when the meeting is to be held; and (b) indicating the business which is proposed to be transacted at the meeting. (2) A notice of a meeting shall be given, not less than fourteen days before the date on which it is to be held, to each member of the Institute by posting the notice to the address of the member last known to the Institute, or by handing the notice to the member in person. (3) The validity of any proceedings of the Institute shall not be affected by any failure to comply with the requirement of subparagraph (2) of this paragraph unless it is proved that the failure so to comply in relation to any member was a deliberate failure. 2. (1) The chairperson shall preside at all meetings of the Institute at which he or she is present. (2) At a meeting of the Institute at which the chairperson is not present, the members shall choose one of the Council members to preside over the meeting. 3. (1) Subject to this paragraph, the quorum at a meeting of the Institute shall be one-third of the members. (2) No business shall be transacted at a meeting of the Institute unless the business is indicated in the notice of the meeting as business which it is proposed to transact. (3) The minutes of the proceedings at meetings of the Institute shall be kept in such a manner as the chairperson or in his or 480 No. 5 Health Laws (Amendment) 2019 her absence the person presiding at a particular meeting, directs. (4) The person presiding at a meeting of the Institute may adjourn the meeting from time to time and from place to place, with the consent of the members. 4. (1) Any question arising at a meeting shall be determined by the majority of the members of the Institute voting on the question. (2) The voting on any question shall be by a show of hands unless, before the declaration of the result of the voting by the hands, a ballot is demanded— (a) by the person presiding at the meeting; or (b) by at least two thirds of the members present, in which event the question shall be determined by a ballot taken in such manner as the person presiding at the meeting directs. (3) The person presiding at a meeting of the Institute shall have a deliberative vote, and, in the event of an equality of votes, shall have a casting vote. (4) A declaration by the person presiding at a meeting of the Institute that a resolution has or has not been carried and an entry to that effect in the minutes of the meetings shall be evidence of that fact. 5. (1) At least four months before expiry of the term of the Council, an Annual General Meeting or Special General Meeting shall be convened by the Council for professionals to nominate three qualified members for possible appointment of one of them as the chairperson of the Council as follows— (a) three persons shall be competitively nominated by professionals through an election and the names forwarded 481 2019 Health Laws (Amendment) No. 5 to the Cabinet Secretary for appointment; (b) other positions of the Council shall be filled as guided by section 5 and regulations; (c) such positions shall be confirmed and minutes taken during the Annual General Meeting; (d) for purposes of continuity, half of the members of the Council shall remain in office for one more term. 6. (1) A person who holds the office of Chairperson may resign from the office by writing a letter addressed to the Council. (2) On the advice of the Council, the members of the Institute may appoint a person to act as chairperson during a special general meeting convened for that purpose— (a) during a vacancy in the office of Chairperson; or (b) during any period when the Chairperson is for any reason unable to exercise and perform the functions of his or her office. (3) The appointment of a person to act as Chairperson ceases to have effect if— (a) made during a vacancy in the office of chairperson, when the vacancy ends by the election of a Chairperson; (b) the person appointed resigns from the office in writing to the Council; or (c) the Council revokes the appointment under subparagraph (2) of paragraph 2. Second Delete. Schedule. 482 No. 5 Health Laws (Amendment) 2019 The Kenya s. 4 Medical Supplies Authority Act, 2013 (No. 20 of 2013). s.5(1)(a) Insert the following new subsections immediately after subsection (2)— "(3) A national or county public health facility shall, in the procurement and distribution of drugs and medical supplies, obtain all such drugs and medical supplies from the Authority subject to— (a) the drug being duly registered by the Board; and (b) the drugs and medical supplies meet the standards of quality and are efficacious as authorized by the Board. (4) A person responsible for the procurement and distribution of drugs and medical supplies in a national or county public health facility and who contravenes provisions of this section, commits an offence and is liable on conviction to a fine not exceeding two million shillings or to imprisonment for a term not exceeding five years, or to both." Delete and substitute therefor the following new paragraph— (a) a chairperson appointed by the President and who shall— (i) have at least a university degree in a relevant discipline; (ii) have at least fifteen years' experience in matters relating to healthcare, business management or public administration; and (iii) satisfy the requirements of Chapter Six of the Constitution. Delete. Delete. Delete and substitute therefor the following new paragraph— 483 2019 Health Laws (Amendment) No. 5 New paragraph. (2). (3). New subsection. "(e) three persons recruited and appointed by the Cabinet Secretary, one of whom shall at least hold a degree in pharmacy and two shall be from among persons who— (i) have at least a university degree in a relevant discipline; (ii) have at least ten years' experience in management or in the health sector; and (iii) satisfy the requirements of Chapter Six of the Constitution." Insert the following new paragraph immediately after paragraph 5(1)(e)— (ea) one person recruited by the Council of Governors and appointed by the Cabinet Secretary from among persons who— (i) have at least a university degree in a relevant discipline; (ii) have at least ten years' experience in management or in the health sector; and (iii) satisfy the requirements of Chapter Six of the Constitution." Delete. Delete Insert the following new subsection immediately after subsection (6)— "(7) The persons referred to in subsection (1) (e) shall be appointed by the Cabinet Secretary, taking into account regional, gender and skills balance." s.8(2)(a). Delete and substitute therefor with the following new paragraph— 484 No. 5 Health Laws (Amendment) 2019 (a) holds a minimum first degree in Pharmacy, Medicine, Business Management, Finance, Supply Chain Management or any other related field from a recognized University. (4). Insert the words "upon satisfactory performance" immediately after the word "years". New Section. Insert the following new section immediately after section 9— Corporation Secretary. 9A. (1) There shall be Corporation Secretary of the Authority who shall be competitively recruited by the Board and whose terms and conditions of service shall be determined by the Board upon the advice of the Salaries and Remuneration Commission, in the instrument of appointment or otherwise in writing from time to time. (2) The Corporation Secretary shall have the following responsibilities— (a) provide guidance to the Board on their duties and responsibilities and on matters of governance; (b) assist the Board in carrying out its work; (c) be the custodian of the seal of the organization and account to the Board for its use; (d) maintain and update the register of conflicts of interest; (e) ensure that Board members are aware of all relevant laws affecting the organization; and (0 facilitate effective communication between the organization and the shareholders. s.13 (2). Delete and substitute therefor the following subsection— 485 2019 Health Laws (Amendment) No. 5 The Counsellors s. 4(1) and Psychologists Act, 2014, (No. 14 of 2014). "(2) The affixing of the common seal of the Authority shall be authenticated by the signature of the Chief Executive Officer and the Corporation Secretary and any document not required by law to be made under seal and all decisions of the Board may be authenticated by the signature of the Chief Executive Officer or the signature of the Corporation Secretary upon delegation by the Chief Executive Officer." Delete and substitute therefor the following new subsection— (1) The Board shall be composed of— (a) a chairperson appointed by the Cabinet Secretary who shall have— (i) a minimum of a bachelors' degree in a relevant field; and (ii) at least fifteen years' experience in counselling or psychology; (b) the Director General of Health or their designated representative; (c) the Principal Secretary in the ministry for the time being responsible for matters relating to finance; (d) two persons, who shall be counsellors or psychologists, representing training institutions appointed by the Cabinet Secretary, of whom— (i) one shall represent middle level colleges; and (ii) one shall represent institutions of higher learning; (e) two persons, one representing counsellors and the other representing psychologists, 486 No. 5 Health Laws (Amendment) 2019 nominated by registered counsellors and psychologists; (f) one person from minorities and marginalized groups who shall be a counsellor or a psychologist and shall be nominated by the Cabinet Secretary; and (g) the Registrar, who shall be an ex officio member and the secretary to the Board. Delete the word "five" appearing in paragraph (a) and substitute therefor the word "fifteen". Delete and substitute therefor the following subsection— (6) The Cabinet Secretary shall, in appointing the members of the Board under subsection (1), consider gender and regional balance, and the mix of skills and competencies required for the achievement of the organization's long-term goals. Insert the following new subsections immediately after subsection (6)— "(7) Pursuant to nominations in paragraphs (d) and (e) of subsection (1), each organization shall present two nominations one of whom shall be appointed by the Cabinet Secretary. (8) The members of the Board appointed under paragraphs (d), (e) and (f) of subsection (1) shall hold office for a term of three years and shall be eligible for reappointment in accordance with the procedure set out for one further term." s.6 Insert the words "and standards" immediately after the word "programs" appearing in paragraph (j). Insert the following new paragraph immediately after paragraph (j); (ja) issue guidelines in consultation with the Cabinet Secretary to govern (5) (6) New subsections. 487 2019 Health Laws (Amendment) No. 5 matters related to the practice of counsellors and psychologists; s. 9(3) Delete and substitute therefor the following new subsection— (3) The Registrar shall serve— (a) according to terms and conditions determined by the Board; and (b) for a term of four years renewable once subject to satisfactory performance. s.15 Delete. s.16 Delete. s.17 Delete. s.18 Delete. s.19 Delete. s.20 Delete. s.21 Delete. s.22 Delete. s.23(a) Delete the expression "at least a bachelor's" and substituting therefor the words "a diploma"; (b) Delete the expression "at least a bachelor's" and substituting therefor the words "a diploma". s.28(1) Delete and substitute therefor the following subsection— (1) A person shall not practice as a counsellor or psychologist unless such a person has— (a) been registered under this Act; (b) complied with the prescribed requirements for continuing education and supervision; and (c) been issued witl{a valid practising licence by the Board in accordance 488 No. 5 Health Laws (Amendment) 2019 with Regulations made under this Act. First Schedule, Delete the word "seven" and substitute paragraph therefor the word "five". 3(5). Second Delete and substitute therefor the Schedule. following Schedule SECOND SCHEDULE (s.12(5)) COMMITTEES OF THE BOARD 1. The Board shall establish the following committees for the effective discharge of its functions— (a) Examination and Registration Committee; (b) Continuing Education Committee; (c) Disciplinary Committee; and (d) Finance and Administration Committee. 2. Despite paragraph 1, the Board may establish such other ad hoc committees as may be necessary for the effective carrying out of the functions of the Board. Third Delete. Schedule. Fourth Delete. Schedule. Physiotherapists s.2 Insert the following new definition in Act, 2014 (No. proper alphabetical sequence 20 of 2014). "physiotherapy" also referred to as "physical therapy" means the application of physiotherapy knowledge, skill and judgment by a physiotherapist to obtain, regain or maintain optimal health and functional performance and includes but is not limited to— (a) the assessment of neuro musculoskeletal and cardio respiratory, neural and vascular 489 2019 Health Laws (Amendment) No. 5 systems and establishment of physiotherapy diagnosis; (b) the development, progression, implementation and evaluation of physiotherapeutic interventions; (c) the education of patients, care providers on matters of health promotion, wellness, disease prevention and rehabilitation givers, students and other health services; (d) the manual therapy treatment techniques including soft tissue manipulation, proprioceptive neuro muscular facilitation, manual lymphedema drainage and muscle relaxation techniques; (e) the spinal and peripheral joints mobilization and manual manipulation; (f) work-place and modifications, prescription, fabrication, modification and application of braces, splints, taping, mobility aids or seating equipment; (g) sports and physical activity pre participation screening and assessment, sports injury prevention, treatment and rehabilitation, hydrotherapy, electrotherapy and use of mechanical, radiant or thermal energy; (h) the ergonomic evaluation, modification, education, assessment and categorization of disability and counseling; (i) tracheal suctioning; (j) the administration of physiotherapy related medication as prescribed by a physician; and 490 No. 5 Health Laws (Amendment) 2019 (k) performing such other aspects of physiotherapy as may be prescribed in regulations. s.4(2)(e) Delete and substitute therefor the following new subsection— (e) in collaboration with the Council for University Education and Technical and Vocational Educational and Training Authority, approve and accredit institutions offering physiotherapy training leading to registration under this Act; s.6(1)(b) Delete and substitute therefor the following paragraph— (b) a person from the Ministry responsible for health with expertise in health appointed by the Cabinet Secretary; s. 6(1)(d) Delete and substitute therefor the following new paragraph— "(d) one person with disability nominated by the National Council for Persons With Disabilities;" New Insert the following new subsections subsections. immediately after subsection 6(2)— "(3) Pursuant to section 6 (1) (e), the Kenya Society of Physiotherapists shall present two nominees from each of the categories given in (i), (ii), (iii) and (iv), one of whom will be appointed by the Cabinet Secretary taking into account diversity, gender, skills mix and regional balance. (4) The members of the Council appointed under subsections (1) (a) and (e) shall hold office for a term of three years and shall be eligible for reappointment for one further term." s. 10(2) Delete and substitute therefor the following new subsection— (2) A person shall not be appointed under this section unless such person— 491 2019 Health Laws (Amendment) No. 5 (a) holds a degree in physiotherapy from a university recognized in Kenya and is a Kenyan citizen; (b) is registered as a physiotherapist under this Act; and (c) has at least ten years' post qualification working experience. s.19(1) Delete and substitute therefor the following new subsection— (1) The Council shall approve and recognize all training institutions that offer courses in physiotherapy. Insert the following new subsection immediately after subsection (1)— (1A) No person, being in charge of a training institution in Kenya, shall— (a) admit persons for training with a view to qualifying for registration under this Act; (b) conduct a course of training or administer the examination prescribed for the purposes of registration under this Act; or (c) issue any document or statement implying that the holder thereof has undergone a course of training or passed the examinations prescribed by the Council for purposes of registration, unless such institution is established under the Kenya Medical Training College Act, established or Cap. 261. accredited under the Universities Act or the Technical and Vocational No. 42 of 2012. Education and Training Act, and is No. 29 of 2013. approved and recognized by the Council for that purpose in accordance with this Act. s. 22(3)(a) Insert the words "and in the official Council website" immediately after the words "publish in the Gazette". 492 No. 5 Health Laws (Amendment) 2019 The Health Records and Information Managers Act, 2016 (No. 15 of 2016) s.2 Delete the words "health records and information management or science" appearing in the definition of the term "health records and information diploma" and substitute therefor the words "health records and information Technology"; Delete the definition of the term "Manager" and substitute therefor the following definition— "Manager" means an officer trained in health records and information and charged with the responsibility of managing health records and information for health services which includes— (i) consulting in clinical coding; (ii) coding for insurance firms; (iii) capacity building in disease classifications and health information management; (iv) appraisal of medical documentations and audits; (v) medical data analytics and research; (vi) use of e-health applications; (vii) development of strategic documents and policies in health records and information management services; (viii) advice on medical legal issues; (ix) advice on retrieval and disposal of medical records; (x) management of bed bureaus; or s.6(1)(a) (xi) consultancy in administrative statistics and big data analytics. Delete the words "and to safeguard the interests of all managers". 493 • 2019 Health Laws (Amendment) No. 5 Delete paragraph (d) and substitute therefor the following new paragraph— (d) in consultation with institutions offering training on health records and information technology, prescribe syllabuses of instruction; Delete paragraph (e) and substitute therefor the following new paragraph— (e) recommend to the Cabinet Secretary the institutions to train in health records and information technology; Delete paragraph (f) and substitute therefor the following new paragraph— (f) with the approval of the Cabinet Secretary, make provision for proficiency examination for persons seeking registration or enrolment under this Act. s.7(1)(a) Delete and substitute therefor the following paragraph— (a) a chairperson appointed by the Cabinet Secretary from among persons nominated from the public sector with knowledge and expertise in health and who shall have — (i) a minimum of a bachelors' degree in a relevant field; and (ii) ten years' relevant experience; (1)(b) Insert the words "Director or" immediately after the word "the". (1)(c) Delete and substitute therefor the following paragraph— (c) two representatives, one from middle level training colleges and one from universities offering training in health records and information technology; 494 No. 5 Health Laws (Amendment) 2019 (1)(d) Delete and substitute therefor the following new paragraph— (d) three registered managers, who shall be competitively and transparently nominated and appointed by the Cabinet Secretary as representatives of— (i) the private sector; (ii) faith-based organisations; and (iii) the Association; (1)(e) Delete and substitute therefor the following paragraph— (e) one person with expertise in financial management or accounting and who shall be a bona-fide member of a professional body regulating the accountancy profession who is in compliance with the requirements thereof, appointed by the Cabinet Secretary; (1)(g) Delete. s. 7(2) Delete and substitute therefor the following new subsection— (2) The Registrar shall be the Chief Executive Officer and the Secretary to the Board. (3) Delete and substitute therefor the following subsection— (3) The Board shall appoint an audit committee and up to three (3) other committees that shall deal with matters of finance, risk, standards and education, registration and licensing, human resource, discipline and ethics for the effective performance of its functions, but may establish such other ad hoc committees as may be necessary for the carrying out of the functions of the Board. 2019 495 Health Laws (Amendment) No. 5 New Insert the following new subsection subsection. immediately after subsection (3)— (4) The appointments to the Board shall take into consideration gender and regional balance and the mix of skills and competencies required for the achievement of the Board's long-term goals. New Insert the following new subsection subsection. immediately after subsection (4)— (5) Pursuant to subsections (1) (c), (d) and (e), the organizations shall present two nominations from each of the categories, one of whom shall be appointed by the Cabinet Secretary taking into account gender balance, regional balance and skills mix. s. 9 Delete subsection (1). s.15(1)(a) Delete the word "diploma" and substitute therefor the word "certificate". s.19(1) Delete and substitute therefor the following subsection— (1) A person, being in charge of a training institution in Kenya, shall not— (a) admit persons for training for the purpose of qualifying for registration under this Act; (b) conduct a course of training or administer the examination prescribed for the purposes of registration under this Act; or (c) issue any document or statement implying that the holder thereof has undergone a course of training or passed the examinations prescribed by the Board for purposes of registration, unless the training is to be conducted by the Kenya Medical Training College or an institution approved by the Board or is 496 No. 5 Health Laws (Amendment) 2019 established or accredited under the Universities Act or the Technical and Vocational Education and Training Act. Insert the following new definition in proper alphabetical sequence— "Kenya Clinical Officers Association" means the Kenya Clinical Officers Association registered by the Registrar of Societies. Delete and substitute therefor the following new subsection— (1) The Council shall consist of the following persons— (a) a chairperson appointed by the President and who shall have— (i) a relevant bachelors' degree from a recognised university; (ii) at least ten years' relevant experience; (iii) be registered as a clinical officer under this Act; (b) the Director General for health or his or her designated representative; (c) the Chief Clinical Officer; (d) one clinical officer elected by members of faculty of Clinical Medicine from Kenya Medical Training College; (e) one clinical officer representing the Kenya Clinical Officers Association who shall be nominated by the Association and appointed by the Cabinet Secretary; No. 42 of 2012. No. 29 of 2013. Clinical Officers s.2. (Training, Registration and Licensing) Act, 2017, (No. 20 of 2017). s.4(1) 497 2019 Health Laws (Amendment) No. 5 (f) one clinical officer representing universities training clinical officers, elected by the teaching staff from among their number; (g) the Registrar who shall be an ex officio member and secretary to the Council; (h) two clinical officers, one in public practice and the other in private practice from each gender nominated by the Cabinet Secretary; (i) one person with knowledge and expertise in finance or audit appointed by the Cabinet Secretary; and (j) one person representing the public nominated by consumer organisations and appointed by the Cabinet Secretary. Insert the following new subsection immediately after subsection (6)— (7) A member of the Council other than an ex officio member may— (a) by notice in writing addressed to the Cabinet Secretary, resign from office; (b) be removed from office by the Cabinet Secretary , if the member— (i) is absent from three consecutive meetings of the full Council without permission of the chairperson; (ii) is convicted of a criminal offence and sentenced to imprisonment for a term exceeding six months; or (iii) is incapacitated by physical or mental illness that leads to 498 No. 5 Health Laws (Amendment) 2019 inability to perform the functions of the office. s.15(1) Insert the following new subsections immediately after subsection (1)— (1A) A person shall be qualified for appointment as Registrar if that person— (a) holds a bachelors' degree from a university recognized in Kenya; (b) has at least fifteen years' experience; and (c) is registered as a clinical officer under this Act. (1B) The Registrar shall serve for a term of four years and shall be eligible for re-appointment for a further and final term of four years. Insert the words "and in the official (6)(a) Council website" immediately after the word "Gazette" Part IV Delete the heading under Part IV and substitute therefor the following new heading— PART IV— PROVISIONS RELATING TO LICENSING AND PRACTICE s.20 Insert the following new subsections immediately after subsection (4)— (5) The Council shall register and license medical centres and medical clinics for private practice by clinical officers. (6) No premises shall be used for the purpose of private practice unless such premises is inspected, registered and licensed by the Council. (7) The initial inspection for licensing shall be conducted by a joint inspection team or any relevant authorized body for the purposes of this Act. 499 2019 Health Laws (Amendment) No. 5 (8) The Council shall have power to enter any practice premises at all times, for the purposes of this Act. (9) A clinical officer licensed under this Act may, with respect to patients— (a) examine; (b) diagnose; (c) order laboratory and imaging investigations; (d) prescribe treatment; and (e) perform procedures, as per their scope of training. New section. Insert the following new section immediately after section 23 Professional indemnity. year take a professional indemnity cover and 23A. Every clinical officer shall in each every health institution shall in each year insure the health institution against professional liability of its staff. s.34 Delete.