health law draft 1

7/31/2019 Health Law Draft 1

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13TH MARCH 2012

Note: The footnotes in this draft are intended only to assist in discussion; and are notpart of the Law.

LAWS OF KENYA

THE HEALTH LAW

CONTENTS OUTLINE

Part 1 Short Title, Definitions and Objects

Part 2 Rights and Duties

Part 3 The National Health System

Part 4 The Health Council

Part 5 The Health Services Authority

Part 6 The National Health Inspectorate Service

Part 7 Public Health Facilities

Part 8 Definition and governance of Health Professionals

Part 9 Control of Medicines and medical products

Part 10 Procurement, supply of medicines, vaccines, medical devices, appliances and

materials

Part 11 Promotion and Advancement of Public and Environmental Health

Part 12 Mental Health

Part 13 Traditional and Complementary Medicines

Part 14 Human Blood, Blood Products, Tissues and Gametes

Part 15 Control of dangerous drugs, narcotics and psychotropic substances

Part 16 Health Financing and Health Insurance

Part 17 Role of Private Sector

Part 18 Promotion and conduct of Health Research

Part 19 E- Health

Part 20 Inter- departmental collaboration

Part 21 Transitional & Miscellaneous provisions


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DEFINITIONS1

1. Definitions relating to licensing and accreditation

Licensesare permits used to individuals institutions or premises and valid for a specifiedperiod. A licence may cover a broad area of operation or a narrow field of specialization

within that area.

Licensing: a. Licensing of individuals

The issue of a licence conferring on an individual the right to exercise aspecified profession or carry on a specified trade, business or activity regulated by law,

subject to the conditions of the licenceb. Licensing of institutions

The issue of a licence conferring on an institution the right to perform a

specified role in society or carry on a specified trade, business or activity regulated by law,subject to the conditions of the licence

c. Licensing of premises

The issue of a licence confirming the suitability of particular premises for theperformance of a particular profession or a specified trade, business or activity regulated by

law, subject to the conditions of the licence.

Accreditation of institutions:An official certification that an institution is in the possession of the

necessary competence, staffing and facilities to perform a specialized activity regulated bylaw, falling within the scope and validity of the licence that it currently holds , subject to

such conditions as may be attached to the accreditation.

- - - - - - -

2. General definitions

Note: Many of the definitions below are already taken from other laws and official documents;

where they have been modified for the present purpose an x is added:PP = Position Paper ; WH=WHO ; KB=KEMSA Bill 2010

PH = Public Health Act 1986 NG = Nigerian National Health Bill, 2008

Abortion (PPx): Termination of a pregnancy before the offspring is viable as anindependent life outside the womb. This can occur spontaneously or be induced bytherapeutic action. A therapeutic abortion is performed where it is considered that

continuation of the pregnancy would constitute a threat to the life or health of the motheror where the offspring is seriously abnormal or incorrectly sited.

Adult (PH): A person of eighteen years of age or over.

1These will be inserted in the document proper under PART 1 once complete and agreed upon


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Blood product (NGx): Any product derived or produced from blood, including plasma,

sera, circulating progenitor cells, bone marrow progenitor cells and umbilical cordprogenitor cells.

Child (PH): A person under eighteen years of age

Counties (KB): Geographical areas for Devolved Government as provided by the

Constitution.

Disease (TTx): Any physical or mental condition that causes pain, dysfunction, distress,social problems and/or death to the person afflicted and/or similar problems for those in

contact with the person.

Emergency (TTx): Any event/crisis that exceeds the communitys or an individuals ability

to respond.

eHealth: The combined use of electronic communication and information technology in the

health sector

Gazette (KB): The Kenya Gazette.

Health (WHO): A state of complete physical, mental and social well-being and not merelythe absence of disease or infirmity.

Health care professionals (TT): The workforce that delivers the defined health care

services. The workforce includes all those whose prime responsibility is the provision ofhealth care services, irrespective of their organizational base (public, or non-public).

Health Care Services (TT): The prevention, management or alleviation of disease,illness, injury, and other physical and mental impairments in individuals, delivered by healthcare professionals through the health care systems routine health services, or its emergency

health services.

Health Care workers: Employees of the health care services, including both health care

professionals (as defined above) and those who do not themselves contribute directly to theprovision of care (e.g. those involved in catering, administration or maintenance activities)

Health facility (NG): The whole or part of a public or private institution, building or

place, whether for profit or not, that is operated or designed to provide inpatient oroutpatient treatment, diagnostic or therapeutic

interventions, nursing, rehabilitative, palliative, convalescent, preventative or other healthservice.

Health research (SA): Research which seeks to contribute to the extension of knowledge

in any health related field, such as that concerned with:

- the biological, clinical, psychological or social processes in human beingsimproved methods for the provision of health services

- human pathology


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- the causes of disease- the effects of the environment on the human body;

- the development or new application of pharmaceuticals, medicines and otherpreventative, therapeutic or curative agents

- the development of new applications of health technology.

Health System (TTx): The mechanism to deliver quality health care services to allpeople, whenever and wherever they are needed.

Human Resources for Health (TTx): The totality of individuals engaged primarily in theimprovement ofthe health of populations. The public health workforce includes those primarily involved in

protecting andpromoting the health of whole or specific populations, as distinct from activities directed to

the care of

individuals.

KEMSA (KB): Kenya Medical Supplies Agency.

Non-State Actors (TTx): Individuals or institutions whose primary concerns are in theprovision of Health Services, but which are not attached to of the State. They include service

providers (for profit or not-for-profit), Health Care Civil organizations, and FBOs (Faithbased organizations),. NGOs (Non-Governmental Organizations) and their related

management systems.

Public Health Services (TT): The health care services concerned with the science andart of preventing disease, prolonging life and promoting health through organized efforts and

informed choices of society, organizations, public and private, communities and individualsand are concerned with threats to the

overall health of a community.

Referral (TTx): The process by which a given level of health service that has inadequatecapacity to manage a given health condition or event affecting an individual, seeks the

assistance of a higher level of health care to assume responsibility for the case.

Traditional medicines (KBx): Products derived from plant, animals or mineral sources,prepared and recommended according to traditional teaching rather than scientific medicine

and offered for use in humans as drugs

Telemedicine: The delivery of health care services and sharing of medical knowledge overdistance using telecommunications. It includes consultative, diagnostic, and treatment

services.


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LAWS OF KENYA

THE HEALTH LAW

AN ACT of Parliament to give effect to Article 43 of the Constitution; toprovide for the maintenance and advancement of health and the provision of

health services of the highest attainable standard; to provide for the powers,functions, and responsibilities of the Health Council, the Health Services

Authority, the National Health Inspectorate Service and the Council forHealth Professionals and for other connected purposes

ENACTED by the Parliament of Kenya as follows

PART 1

Short Title

(1) This Act may be cited as The Health Act, 20122Objects of Act

(2) The objects of this Act are to enable the realization of the rights to health asprovided for in the Constitution of Kenya and to provide uniformity in respect of

health services across the nation by:

(a) Establishing a national health system which-

(i) encompasses State and Non State providers of health services at the Nationaland County Levels; and

(ii) provides in a progressive and equitable manner the highest attainable standard ofhealth services

(b) setting out the rights and duties of the various actors within the National Health

System; and

(c) protecting, respecting, promoting and fulfilling the rights of:

(i) All persons living in Kenya to the progressive realization of their right to thehighest attainable standard of health, including reproductive health care and

the right to emergency medical treatment;(ii) the people of Kenya to an environment that is not harmful to their health(iii) children to basic nutrition and health care services contemplated in Articles

43(1) (c) and 53( l)(c) of the Constitution; and

iv) vulnerable groups as defined in Article 21 of the Constitution in all mattersregarding health.

2It is assumed that the Law will be passed in the coming calendar year.


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Responsibility for Health

(3) It is a fundamental duty of the State to observe, respect, protect, promote and fulfillthe right to the highest attainable standard of health including reproductive health

care and emergency medical treatment by:

a) developing policies, laws and other measures necessary to protect,promote, improve and maintain the health and well-being of every person;

b) promoting the prioritization of health issues and investment in the healthsector plans of the Republic;

c) ensuring the realization of the health related rights and interests ofvulnerable groups within society, including women, older members of

society, persons with disabilities, children, youth, members of minority ormarginalized communities and members of particular ethnic, religious or

cultural communities;d) ensuring the provision of a health service package at all levels of the healthcare system, which shall include services addressing promotion, prevention,

treatment and rehabilitation of health, as well as physical and financialaccess to health care as defined in consultation with the Health Council; and

e) ensuring equitable investment in health service delivery.

PART 2

Rights and Duties

Right to the highest attainable standard of health

(4) (1) Every person has the right to the highest attainable standard of health which shallinclude progressive physical and financial access to promotive, preventive, curative

and rehabilitative services.

(2) Every person shall have the right to be treated with dignity, respect and have

their privacy respected in accordance with the Constitution and this Act.

Right to reproductive health

(5) (1) everyone has a right to reproductive health care which includes:

a) the right of men and women to be informed about, and to have access reproductivehealth services including to safe, effective, affordable and acceptable family planning

services, except elective abortions;


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b) the right of access to appropriate health-care services that will enable parents to gosafely through pregnancy, childbirth, and the post-partum period, and provide

parents with the best chance of having a healthy infant;

c) access to treatment by a trained health professional for conditions occurring duringpregnancy including abnormal pregnancy conditions, such as ectopic, abdominal and

molar pregnancy, or any medical condition exacerbated by the pregnancy to such an

extent that the life or health of the mother is threatened. All such cases shall be

regarded as comprising notifiable conditions.

(2). For the purposes of Sec 5 (1) (c), the term a trained health professional is

considered to refer to a health professional with formal medical training at the

proficiency level of a Medical Officer (doctor), a nurse midwife, or a clinical officer

who has been educated and trained to proficiency in the skills needed to manage

uncomplicated abortion and post-abortion care and in the identification, management

and referral of abortion-related complications in women, and who has a valid licence

from the recognized regulatory authorities to carry out that procedure.

(3) Any procedure carried out under Sec 5 (1) (a) or, 5 (1) (c) shall be performed in a

legally recognized health facility with an enabling environment consisting of the

minimum human resources, infrastructure, commodities and supplies for the facility

as defined in the norms and standards developed under this Act.

Right to emergency medical treatment

(6) (1) Every person has the right to emergency medical treatment.(2) No person shall be denied emergency treatment by the health service provider of

first contact

(3)Emergency medical treatment shall include:-a. pre-hospital care

b stabilizing the health status of the individual; and/orc. arranging for transfer:

i. once the emergency nature of the condition has been stabilized orii. in the event that the heath provider of first call does not have the

facilities to stabilize the health status of the individual or individuals

(4)(1)Any person who contravenes this section is guilty of an offence and is liable uponconviction to a fine not exceeding Kenya Shillings 1,000,000 or imprisonment for 12

months or both.

(2) Notwithstanding 4(1), an institution administratively responsible for a personguilty of an offence under this section is liable that person s conviction, to a fine not

exceeding Kenya shillings 3,000,000 and any other penalty provided for in the law.


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Right to be informed

(7) (1) Every health care provider must inform a user or guardian of-

a) the users health status except in circumstances where there is substantial evidencethat the disclosure of the users health status would be contrary to the best interests

of the user;b) the range of promotive, preventative and diagnostic procedures and treatment

options generally available to the user;

c) the benefits, risks, costs and consequences generally associated with each option; andd) the users right to refuse health services and explain the implications, risks, and legal

consequences of such refusal.

(2) The health care provider concerned must, where possible, inform the user as

contemplated in subsection (1) in a language that the user understands and in a mannerwhich takes into account the users level of literacy.

(3) Where the user exercises the right to refuse a health service, the health provider may athis discretion require the user to confirm such refusal in a formal manner. 3

Consent of user

(8)(1) No health service may be provided to a user without the users informed consent

unless-

(a) the user is unable to give informed consent and such consent is given by a person -

(i) mandated by the user in writing to grant consent on his or her behalf; or(ii) authorised to give such consent in terms of any law or court order;

(b) the user is unable to give informed consent and no person is mandated or authorised to

give such consent, but the consent is given by the next of kin

(c) the provision of a health service without informed consent is authorised by an applicablelaw or court order; or

(d) the patient is being treated in an emergency situation

(e) failure to treat the user, or a group of people which includes the user, will result in a

serious risk to public health; or

(f) any delay in the provision of the health service to the user might result in his or her deathor irreversible damage to his or her health and the user has not expressly, by implication orby conduct refused that service.

3Regulations shall specify the manner in which such refusal should be recorded, e.g. employing a form signed

by the user or authorized person as contemplated in sections 7 and 8. Compare with section 12(f) below and the

relevant footnote.


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(2) A health care provider must take all reasonable steps to obtain the user s informedconsent.

(3) For the purposes of this section informed consent means consent for the provision of

a specified health service given by a person with legal capacity to do so and who has beeninformed as provided for in section 7 of this Act.

Duty to disseminate information

(9) (1) The National government, County Governments and every organ having a role orresponsibility within the National Health System, shall ensure that appropriate, adequateand comprehensive information is disseminated on the health functions for which they

are responsible being cognizant of the provisions of Article 35 (1)(b) of theConstitution, which must include-

(a) the types, availability and cost if any of health services;

(b) the organization of health services;(c) operating schedules and timetables of visits;

(d) procedures for access to the health services;(e) other aspects of health services which may be of use to the public;

(f) procedures for laying complaints; and(g) the rights and duties of users and health care providers under this Act and as

provided for in the applicable service charters.(h) managementof environmental risk factors to safeguarding public health.

(2) Disclosure of information contemplated under this section shall be released subject to

Sec 7 with the appropriate modifications.

Confidentiality

(10) (1) All information concerning a user, including information relating to his or her health

status, treatment or stay in a health facility is confidential.4

(2) Subject to the Constitution and this Act no person may disclose any informationcontemplated in subsection 1 unless:

(a) the user consents to such disclosure in writing in the prescribed form;5(b) a court order or any applicable law requires such disclosure; or

(c) non-disclosure of the information represents a serious threat to public health.

(3) Proposed disclosure of any information under 2 (c) shall be subject to review by the

Health Council

4An important exception to this section relates to the fact that a person suffering from an infection with Human

Immunodeficiency Virus (HIV) or a Sexually Transmitted Infection is considered to be under a duty to make this

known to his or her partner. See Art. 35 sect (1) of the Constitution and HIV and AIDS Prevention and Control

Act of 2006 Part VI HIV Transmission Sect. 24. If the infected individual refuses to inform his or her partner

accordingly, the partner will apparently have the right to access the information held by the health service on thematter. An appropriate modification of the present draft should be considered to allow for this situation.5

The nature of the required form will be laid down in regulation under this Act


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Rights and Duties of health care personnel

(11) (1) The Rights and duties of Health care personnel will include:

a) not being unfairly discriminated against on account of their health status.b) the right to a safe working environment that minimizes the risk of disease

transmission and injury or damage to the health care personnel or to their clients,

families or propertyc) the right to refuse to treat a user who is physically or verbally abusive or who

sexually harasses him or her except in an emergency situation where no alternativesource of appropriate care is directly available.

d) the right to apply for and accept a salaried post in the public service or the privatesector.

e) the right to challenge a decision of his or her immediate superior by way of appeal tothe next higher level of authority.

(2) As participants in the National Health System all health workers, whether in the public orprivate sector, shall have the duty:

a. To provide health care, conscientiously and to the best of their knowledge withintheir scope of practice and ability, to every person entrusted to their care or

seeking their support

b. To provide emergency medical treatmentc. To inform a user of the Health System, in a manner commensurate with his or

her understanding, of:

- his or her health status, except where this would be contrary to the bestinterests of the user; in such cases the requisite information should beavailable to the next of kin.

- the range of available diagnostic procedures and treatment options andthe availability and costs thereof.

- the benefits, risks, costs and consequences which may be associated witheach option- the users right to refuse any treatment or procedure

(3). Notwithstanding the provisions of Sec 11 (1) (a), but subject to any applicableprovision of law, the head of the health establishment concerned may, in accordance

with any applicable guidelines, impose conditions on the service that may be providedby a health care provider because of his or her health status.

Duties of users6

(12) A user of the Health System of Kenya has the duty, insofar as it is within his or hercapabilities, to:

a. adhere to the rules of a health establishment when receiving treatment or using thehealth services provided by the establishment

6No specific section on rights of users is required since user rights are well defined in Sections 4 to 10.


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b. to adhere to the medical advice and treatment provided by the establishmentc. to supply the health care provider with accurate information pertaining to his or her

health status

d. cooperate with the health care providere. treat health care providers and health workers with dignity and respectf. if so requested, sign a discharge certificate or release of liability if he or she refuses

to accept or implement recommended treatment.7

Complaints

(13) (1) any person has a right to file a complaint about the manner in which he or she was

treated at a health establishment and have the complaint investigated.(2) The relevant National and County Governments must establish and publish the

procedure for the laying of complaints within public and private health care

providers in those areas of the national health system for which they areresponsible.

(3) The procedures for laying complaints must-

(a) be displayed by all health establishments in a manner that is visible for any personentering the establishment and the procedure must be communicated to users on a

regular basis;(b) All complaints shall be passed to the head of the relevant establishment;

(4) Every Health establishment shall make monthly returns to the Health ServicesAuthority and the National Health Inspectorate Service of complaints filed and the

actions taken in that regard within a period of three weeks from the time thecomplaint was instituted and in every month thereafter until the complaint has been

resolved.(5) Notwithstanding provisions of 13(4), every complainant under section 13(1) has a

right to be informed of action taken within a period of three weeks in writing from

the time the complaint was registered.

PART 3

THE NATIONAL HEALTH SYSTEM

Community of Interests

(14) The National Health System of Kenya shall as a community of interests work in a spirit

of co-operation and shared responsibility in achieving the objectives of this Act.

The National Health System

7See also section 7 (1) (3) above. It seems doubtful whether in every instance a refusal to accept treatment needs

to be confirmed in writing; however, where the treatment seems medically necessary or even life-saving the

health provider will be well advised to require that a patient who refuses treatment confirm this in writing. .


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(15) (1) The National Health System shall include, though not exclusively, the NationalGovernments Ministry responsible for Health, the County Executive Department

responsible for Health, all health workers both in the State and non-State sectors,traditional and alternative health care providers, and all institutions whether public or

private, that are involved in ensuring the promotion, prevention and treatment ofillness or rehabilitation of health.

(2)The National Health System shall seek to realize progressively for all persons living

in Kenya the objectives set out in Section 2(c) of this Act.

(3) Notwithstanding the description in section 15 (1), The National Health Systemshall be divided into a National Government Health system and County Health

system.

Duties of the National Government Ministry responsible for Health

(16) (1) The National Government Ministry responsible for Health shall progressively:

a. ensure the development and regular updating of a national health policy and legalframework following the letter and spirit of the Constitution, issue guidelines for itsapplication and promote its implementation at all levels.

b. develop and maintain a firm managerial structure at the national level based ondirectorates headed by a Director-General of Health.

c. ensure the implementation of rights to health specified in the Bill of Rights, and moreparticularly the right of all to the highest attainable standard of health including

reproductive health care and the right to emergency treatment.

d. ensure, in consultation and collaboration with other arms of government and otherstakeholders, that there is stewardship in setting policy guidelines and standards forhuman food consumption, dietetic services that include basic child nutrition, nutrition

security and safety in terms of adequacy levels, acceptable quality and control ofmicronutrient deficiency diseases and or conditions and mitigation of the effects of

hunger on the health of the population.

e. offer technical support at all levels of the National Health System, with emphasis onplanning, investment, development and monitoring and evaluation of health servicesstandards and delivery.

f. develop and implement measures to promote equitable access to health services tothe entire population, with special emphasis on eliminating the disparity in realisation

of the objects of this Act for marginalized areas and disadvantaged populations.

g. promote and apply norms and standards for the development of human resourcesfor health including affirmative action measures for health workers working inmarginalized areas.

h. provide for medical audit of deaths with a special emphasis on maternal and neonataldeaths as a tool for the further development of obstetric and neonatal care.

i. develop, in co-operation with other sectors, standards of training and institutionsproviding education to meet the needs of service delivery.

j. set guidelines for the designation of National and County referral hospitals


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k. monitor the functioning of the National Health System at all levels, having regard toboth efficiency and standards of performance.

l. To give policy direction and standards on registration, licensing and accreditation ofindividuals and health institutions by respective regulatory authorities in the health

sector.m. coordinate health and medical services during disasters and emergencies

n. Ensure adequate mobilization of resources to meet the health needs of thepopulation and ensure their efficient application throughout the health sector

o. promote the development of state and non-state health institutions to ensure theirefficient and harmonious development and in the common interest facilitate

establishment of the national social health insurance to achieve universal coverage ofthe population in addition to providing guidelines on fees chargeable for the provision

of health servicesq. continues the development and expansion countrywide of a National Health

Management Information System.r. promote all forms of research that can advance the interests of public health

s. work to integrate considerations of health, well-being and equity during the

development, implementation and evaluation of Government policies and services inall fields.

t. collaborates in the common interest with the health authorities of other countriesand with regional and international bodies in the field of health.

u. establishes an emergency medical treatment fund for emergencies to provide forunforeseen situations calling for supplementary finance.

v. spearhead collaborations with the private sector in public-private partnerships toenhance private sector investment in health

(2) The Cabinet Secretary responsible for Health shall in addition and after due

consultation with the Health Council established under Section 19 of this Act. makeregulations on any matter where these are necessary or expedient in order:

a. to implement any provision of this Act; and orb. to implement within Kenya measures agreed upon within the framework ofany treaty, international convention or regional intergovernmental agreementto which Kenya is a party.

(3) For the purposes of 16 (1) (b) the Directorates shall be formed on the

recommendation of the Health Council established under this Act.

County Health System

(17) There shall be with respect to every County, a County Executive Departmentresponsible for Health, which shall be established in consultation with the Health

Services Authority and the County Public Service Board, and shall in all matters beanswerable to the Governor and the County Assembly subject to the provisions ofthe Constitution and of any applicable written law.


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Duties of a County Health Department

(18) (1) The County Executive Department responsible for Health shall, in furtherance ifthe functions assigned to it under Schedule 4 of the Constitution be responsible for:

a. implementing the national health policy and standards (Kenya Health LegalFramework)

b. service delivery, including the maintenance, financing and further development ofthose health services and institutions that have been devolved to it

c. coordination of health activities in order to ensure complementary inputs, avoidduplication and provide for cross-referral, where necessary to and from

institutions in other counties.

d. facilitating accreditation of health facilities and providers according to standardsset nationally by the Ministry responsible for health and relevant regulatorybodies.

e. designation of county referral hospitals according to criteria established by theMinistry responsible for Health.

f. developing and implementing, with the Health Services authority, in consultationwith the Salaries and Remuneration Commission, such incentives as may prove

necessary to ensure the staffing of the public health service in marginal areas.

g. procuring health supplies, subject to the provisions of Section 24 of this proposedAct.

h. maintaining standards of environmental health and sanitation as laid down in law;i. providing access and practical support to inspection and to monitoring

undertaken within the county by the National Health Inspectorate Service orother authorized bodies.

j. developing supplementary sources of income for the provision of services, insofaras these are compatible with the public interest

k. making due provision to compensate facilities for debts arising through failure tosecure payment for billsl. reporting, according to standards established by law, on activities, development

and the state of finance within the County Health Services.

m. making known to the public at all times the facilities through which generalized orspecialized services are available to them.

n. developing and promoting public participation in the planning and management oflocal health facilities so as to promote broad ownership.

o. ensuring and coordinating the participation of communities in the governance ofhealth services at the county level so as to promote a broad sense of ownership;


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(19) (1)The National Health System shall work in a manner that respects the distinct

levels of government, while respecting the principles of cooperation andcoordination as outlined in this Act and in legislation regulating the relationships and

functions of the two levels of government.

PART 4

THE HEALTH COUNCIL

Establishment

(20) There is hereby established a Health Council, independent of political, commercial orindustrial interests, the purpose of which shall be to promote and advance the health

of all citizens and inhabitants of Kenya.

Composition

(21) (1) The Health Council shall consist8 of:a. A Chairman, experienced in health service practice, to be appointed, for a period

of three years and a maximum of two terms by the Cabinet Secretary responsiblefor health through a process of competitive recruitment and subject to theprovisions of Article 232 and Chapter 6 of the Constitution of Kenya;

b. Five nominees of the county health governments, serving in rotation.9c. Five nominees of the health professions serving in rotationd. A nominee of the Health Services Authoritye. An expert in environmental healthf. three nominees of the consumer or patient interestg. A nominee of the private health sectorh. An expert in health law and regulationi. A representative of the field of traditional and complementary medicine.

(2) The Council may in addition co-opt not more than three external experts at anyone time to assist in the examination of specialized issues.

(3) A persons nominated under section 20 (g) and 20 (i), shall be a health professional as

defined in this Act.

8It should be realized that a Council of this type, based on experience with similar bodies in some other

countries (South Africa, Nigeria, The Netherlands), does not represent a large and costly bureaucracy. Much ofits work is done by small ad hoc study groups of experts working voluntarily, the reports of these groups being

critically reviewed by the Council as a whole. It may be wise to add a ruling that the Council will ordinarily meetin specialized groups and not in plenary. See also 18.4 below.

9It will be necessary to institute a mechanism for ensuring that the county members are reasonably

representative of the counties as a whole since the latter differ on size, economic resources, population, degree ofurbanization etc. ; a form of rotation will need to be devised and adopted in law or regulation to ensure that the

five members sitting in the Council at any time reflect these variations.


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Functions of the Council

(21) The Council shall have functions that shall include:-

a. Advising the National and County Governments through the Cabinet Secretary, andthe County Executive Member responsible for Health on the formulation and

implementation of necessary policies and measures and on the content of bothParliamentary Bills and draft international agreements of relevance to the field of

health

b. Consulting with the Cabinet Secretary in the development of regulations mandatedunder any written law.

c. Making recommendations to the Cabinet Secretary responsible for Health on any

issue regarding health research as provided for under Section 15 of this Act.

d. Advise the County Health Government on matters of principle relating to the

provision of health care.

e. Advise the Cabinet Secretary responsible for Health on any general or particularissue of Health Policy on which such advice is requested, having regard to the public

interest.

(23) Notwithstanding any of the above functions, the Council on its own motion and inthe public interest may identify matters on which it considers necessary to provideadvice or information to the Cabinet Secretary or County Executive Member

responsible for Health.

(24) Where necessary the Health Council shall advise on arbitration in disputes involvinginstitutions within the Health Sector in line with Article 189 (3) and (4) of theConstitution.

(25) In performance of its functions under this part, the Council may perform orcommission any form of study or investigation, the Council shall seek the agreement

of the Cabinet Secretary responsible for Health to the performance of such anactivity and request the Cabinet Secretary to advance the necessary funding for this

purpose.

Secretariat

(26) The Council shall establish a professional Secretariat charged with supporting theCouncil in the exercise of its functions under this Act, which Secretariat shallproduce a quarterly report for publication.


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Procedure and financing

(27) The work of the Council shall be undertaken primarily by specialized workinggroups, established and reporting back to the Council as a whole.

(28) Budgeting and procedures shall be in accordance with the rules governing theoperation of State Corporations.

(29) The National Government Ministry responsible for Health shall approve appropriateprocedures and provide a sufficient budget for the proper operation of the HealthCouncil, for the reimbursement of its members and external experts and shallprovide necessary facilities for its function.

(30) The quorum of the Council sitting as a whole shall be fifty per cent plus one of themembers five of whom shall be nominees of the health professions.

(31) There shall be at least one quarterly meeting between the Council and nationalgovernment ministry and the County executive department responsible for health.

PART 5

THE HEALTH SERVICES AUTHORITY10

(32) There is hereby established a Health Services Authority which shall be a body

corporate with perpetual succession and a common seal and shall in its corporatename, be capable of

(a)suing and being sued;(b)acquiring, holding, charging and disposing of movable and immovableproperty; and

(c)doing or performing all such other things or acts for the proper dischargeof its functions under this Act.

(33) The headquarters of the Authority shall be at a place it may determine, and theAuthority may establish branches at any place in Kenya.

(34) Working in consultation with the National Government Ministry, the County

Executive Department responsible for Health, and the Health Council, the Authorityshall be responsible for:

10In early drafts of the Constitution, Health Services Commission was proposed to deal with staffing

development in the Health Sector. Although the proposal was not approved, the extensive devolution in this

sector, with its numerous professions, specialisms and institutions, means that some form of guidance and

support is needed, especially if less experienced and more peripheral counties are during the initial years to

succeed in establishing successful health services. The Health Services Authority, proposed here, is intended tomeet this need, assisting the counties but in no sense impairing their autonomy.


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(a)Conducting continuous Human resource analysis, mapping, rationalization, andprojected training needs relating to Human Resources for Health

(b)Advising and making recommendations to the Public Service Commission and theCounty Public Service Boards on the recruitment and retention of competent

staff in the health sector

(c) Advising and making recommendations to the Salaries and RemunerationCommission in the exercise of its functions under Article 230 (4) and (5) as they

relate to the Health Sector professionals and other employees at all levels.

(d) Advising National and County Governments and health institutions bothgenerally and individually in the development and implementation of:

i. human resource manuals;ii. Staffing norms and standards;

iii. Codes of regulations for health workers;iv. Recruitment, deployment and re-deployment policies and guidelines;v. Schemes of service for health workers;

vi. Performance management;vii. Disciplinary measures and appeals;

viii. Remuneration packages;ix. human resource development;x. professional standards and ethics in consultation with professional bodies;

xi. compliance with the provisions of Chapter 6 of the Constitution of Kenya;and

xii. Standard operating manuals in consultation with professional bodies.(35) In responding to the Authoritys exercise of its functions under Sec 32 (b) and (c) and

further to Article 10 and Article 73 of the Constitution of Kenya, the Public Service

Commission, the County Public Service Board and the Salaries and Remuneration

Commission shall produce a memorandum setting out:

(a)an evaluation of the advice and recommendations made by the Authority; and(b)a summary of any significant deviation from the advice and recommendations,

with an explanation for each such deviation.


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PART 6

ESTABLISHMENT OF A NATIONAL HEALTH INSPECTORATE11

(36) The National Ministry responsible for Health shall establish the National HealthInspectorateService, charged in the public interest with examining and promoting thestandard of performance in all the services and professions engaged in the health

sector, both public and private.

Functions of the National Health Inspectorate Service

(37) The Inspectorate shall be responsible for:

a) Inspection of professional service delivery by health professionals, workers andinstitutions both private and public, including homes for the elderly and

institutions for persons with special needs;

b) Enhancing compliance of standards and technical requirements for institutions andhealth professionals;

c) Advising on formulation of standards and guidelines on delivery of quality healthcare including environmental health and sanitation;

d) Supporting the developing of benchmarks for service delivery in collaborationwith national, regional and international similar bodies;

e) Collaboration with other regulatory bodies to enhance compliance of standardsand enhance technical requirements;

f) Establishing a standards and quality assurance mechanisms within public andprivate health institutions;

g) Issuing Inspections, licensing, certification, quality assurance certification; andh)

Monitoring and evaluation of health management system to safeguard quality ofhealth care.

(38) Notwithstanding the above functions, the Inspectorate subject to the provisions in this

Act on National Public Health Institutions shall be responsible for makingrecommendations to the Health Council for designation of Public Health Institutions as

National Referral Institutions

(39) The Health Services Authority in consultation with the Public Service Commission andwhere necessary the County Public Service Board shall ensure:

11Many modern Health Services prove to be supported and complemented by an efficient and Inspectorates,

examining and maintaining standards of performance in the professions, trades and industries concerned withhealth issues. There is also some internationalization of inspection (notably as regards pharmaceutical factories).

While historically the emphasis has often been on detection of shortcomings and imposition of sanctions, a

modern inspectorate at least equally concerned with support, encouragement and raising of standards. In Kenya

inspection functions only to a limited extent, e.g. in the sanitary field (under the Public Health Act) ,in partialcontrol of the retail drug trade and under the Radiation Protection Act.. Evidence from the field points to the

need for a strong and autonomous Inspectorate enjoying the respect and support of all parties.


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a. The competitive selection and appointment of a the Director of Health InspectorateServices who shall direct the affairs of the Inspectorate;

b. The competitive selection and appointment of quality assurance officers inenvironmental health, three representatives from clinical and rehabilitative services,

mental health and substance abuse, policy and planning, medical supplies; and

c. Establishment of County health Inspectorate Services(40) The Health Council in consultation with the Inspectorate shall propose procedures for

the operation of the Inspectorate for the approval of the Cabinet Secretary.

Powers of the Inspectorate

(41) The Inspectorate shall have all powers generally necessary for the execution of itsfunctions under this Act, and without prejudice to the generality of the foregoing;

the Inspectorate shall have the power

(a) to investigate complaints against health professionals by members of the publicor on its own motion, and for that purpose, to gather, by such lawful means asit may deem appropriate, any information it considers relevant, including

requisition of reports, records, documents or any information from anysource, irrespective of whether that source is located within or outside Kenya

and irrespective of whether any other person or body, other than a court oflaw, has already instituted or completed a similar investigation or similar

proceedings;

(b)to enter upon any establishment or premises, on the strength of a warrant,for any purpose which is material to the fulfilment of its mandate or anyother written law subject to, in the event of the premises being a private home

or dwelling;

(c) to seize and remove any object or thing from any premises which may berelated to the matter under investigation, in respect of which a receipt shall begiven to the owner or person apparently in control of the object or thing;

(d)to interview and take statements under oath or affirmation from any person,group or members of organizations or institutions and, at its discretion, toconduct such interviews, in private;

(e)subject to adequate provision being made to meet its expenses for thepurpose, summon any person to meet with its staff, or to attend any of its

sessions or hearings, and to compel the attendance of any person who fails torespond to its summons;

(f) to administer oaths or affirmations before taking evidence or statements;(g) to summon any serving or retired Health Professional to appear before it to

produce any document, thing or information that may be considered relevantto the function of the Authority


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(h)to take over on-going internal investigations into professional misconduct orfailure to comply with any law if such investigations are inordinately delayed or

manifestly unreasonable;

(i) where appropriate, to provide relevant information to enable a victim ofprofessional misconduct, to institute and conduct civil proceedings for

compensation in respect of injuries, damages and loss of income;

(j) request the Attorney-General and or the Director of Public Prosecutions toprovide advice on any recommendation made by the Inspectorate to

prosecute any person or body;

(k)request any person or institution to within a specified, reasonable time provideit with information on issues relating to, measures taken in response to anyrecommendation made to it by the Inspectorate; and

(l) exercise any other power provided for in this Act or any other applicablelegislation or necessary for the effective performance of its functions.

(42) The Inspectorate may make rules relating to the initiation, hearing and disposalof complaints.

(43) The Inspectorate may in the exercise of its powers under this Act, request and

receive such assistance from the Police or any other governmental, international

body or person as may solely in its own opinion be necessary in the

enforcement of its powers.

(44) The Inspectorate may in exceptional circumstances regarding matters of national

importance submit a report simultaneously to the National Ministry responsible

for Health if such a matter requires urgent consideration in the public interest.

(45) The Inspectorate may in the exercise of its powers under this Act take actionsnot limited to:

a. Issuing a reprimand;b. recommending to the relevant authority having oversight over the

person or institution suspension of their licenses or activities and orappropriate disciplinary action; and or

c. recommending prosecution against the person or institution in question.(46) In the exercise of the powers under this Act, the Inspectorate shall apply the quality

and performance standards as published in regulations or any other written law,including those required under any relevant licence or statute and those consideredinherent to the provision of health care or the observance of professional ethics.

(47) Notwithstanding the actions set out in section 44, where faults or deficiencies in

performance are identified or opportunities are detected for the improvement orcorrection of performance, the Inspectorate shall in writing report explain the

relevant findings to the person or institution concerned, including making appropriateproposals to the party in question on the means by which such gaps of standards and


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quality as have been identified may be remedied or performance enhanced to thesatisfaction of the Inspectorate and where necessary shall set specific requirements

regarding measures to be taken.

(48) Where gaps of standards and quality of performance or breaches of standards areidentified as constituting a more than incidental problem, involving a range of

institutions the Inspectorate shall bring this fact to the attention of the relevant

regulatory authority and Cabinet Secretary and propose such legislative, regulatory

or other measures as may be considered necessary to provide correction.

(49) The activities of the Inspectorate shall in principle be regarded as confidentialprovided that nothing in this section shall prevent the Inspectorate from developing

annual reports incidental reports on the Inspectorates activities to the CabinetSecretary.

(50) No data bearing on the inspection of named individuals or institutions shall be madeknown by the Inspectorate to any party except:a. where a recommendation regarding imposition of sanctions on a particular

institution is to be made to the regulatory authority concerned

b. where it is proposed that criminal charges be brought against a particularindividual or institution.

International collaboration

(51) In appropriate cases the Inspectorate will through the Cabinet Secretary collaboratewith relevant institutions in other countries, notably for purposes of training or for

mutual investigation of cross-border activities that may further the objects of this

Act.

Appeal

(52) Appeal against any actions taken or penalties imposed by the Inspectorate on aHealth Professional shall lie with their respective regulatory body with a right of

appeal to the Health Professionals Council, and in relation to an Institution shall liewith the national Health Institutions Authority, with a right of appeal to the Health

Council.

PART 7

PUBLIC HEALTH FACILITIES

(53) The National and County Governments shall ensure the establishment and equitabledistribution throughout the country of such publicly owned institutions, includinghospitals, Health Centres, clinics and laboratories, as are deemed necessary for the

promotion, prevention, treatment and rehabilitation of health.


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(54) Notwithstanding the provisions of section 52, nothing shall prevent the National andCounty governments when unable to provide the services envisaged under this

section from cooperating and collaborating with Non-State health service providersin the provision of health services, which services will be appropriately

reimbursement from the public funds.

Devolution

(55) Notwithstanding but subject to Part 4 Section 15 of the Sixth Schedule of theConstitution of Kenya, the management, operation and further development of suchinstitutions shall, be devolved progressively to the County Government, in

accordance with prescribed procedures but subject to:

a. the eligibility of a given county to assume the responsibility involved, as assessedaccording to the procedure laid down in the Transition to DevolvedGovernment Bill, which shall be reassessed annually;

b. maintenance of access to any such devolved institution by appropriatelyauthorized bodies; and

c. the retention of authority for certain services at the National level as set out insection 56.

Retention of National Authority

(56) Notwithstanding but subject to the assignation of health functions and servicesbetween the national and county level of government as set out in Schedule 4 of theConstitution in the public health interest National Government shall manage and be

responsible for National Public Health Institutions which shall include:-

a. Any public health institution classified as a national referral facility under thisAct;b. Any institution or service engaged in such specialized health activities as can

only be provided effectively and efficiently at the national level

c. Any institution or service dependent for its function on expertise that is ashared resource as classified from time to time in regulations under this Act.

d. Laboratories and other institutions designated as serving a national ratherthan a regional purpose

e. Assessment, licensing and control of commercial and industrial activities withrespect to medicines and vaccines

f. Procurement for the public health facilities of medical materials and deviceshaving a unit value in excess of a level to be set by regulations under this Act

or any other written law.g. Supply to both national and county institutions of items procured under

clause (d) above.

(57) There is hereby established the National Public Health Facilities Service which shallbe an autonomous body, to be established under this Act, charged with

management, planning, resource mobilization and resource allocation for those


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Public Health Facilities and services listed under section 55 a, b, c, d, in consultationwith the National and County Governments.

(58) Procedures and financial provisions for the National Public Facilities Service shall bethe subject of a regulation to be promulgated by the Cabinet Secretary responsiblefor Health after consultation with the Health Council.

PART 8

GOVERNANCE OF THE HEALTH PROFESSIONS12

Council of the Health Professions

(59) (1) There is hereby established the Council of Health Professions charged in thepublic interest with ensuring the adequate training, examination and licensing of allpersons seeking to exercise a professional function in the health sector.

(2) Notwithstanding section 59(1), the nothing done by the health professions

Council shall take way the mandates or operations of statutory regulatory bodies ofprofessions recognised under this Act.

(60) The Council shall advise and assist the Cabinet Secretary responsible for Health, theHealth Council and the respective regulatory bodies in the National Health System indefining professional standards, forms of examination and licensing procedures, in

addition to advice the Health Services Authority on means of promoting adequaterecruitment and retention in the health professions.

Recognised Professionals

(61) (1) The professions in question shall include:- physicians and surgeons, including specialists and physicians dealing with

radiation sources

- dentists, including specialists- pharmacists, including recognized specialities- nurses, including specialists and midwives- clinical officers- community oral health officers- community health workers- physiotherapists- nutritionists

12At the present time some 16 health professions are considered to exist in Kenya. Some of these are governed

by specific statutes, some are the subject of Bills to create similar systems of governance, others are as yetunregulated. One notes certain concerns in this field, especially where one profession has some influence on the

governance of another. The present proposal suggests how a uniform system could be introduced, reducing

costs but introducing uniformity and maintaining all the rights and procedures currently in existence.


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a. promoting and regulating inter-professional liaison between regulatorybodies recognised under this Act;

b. proposing, for the approval of the regulatory bodies recognised under thisAct, standards and procedures applicable in the training, examination,licensing and post-graduation training of members of the health profession

concerned;c. ensuring the execution of respective mandates and functions of regulatory

bodies recognised under this Act,

d. overseeing the conduct of examinations of knowledge and competence bythe relevant health professions regulatory bodies;

e. Facilitating the registration of health professionals seeking to practice inKenya who are licensed in foreign countries; and

f. Receiving and determining appeals from any person with respect to adecision made by any regulatory body recognised under this Act.

Complaints

(66) Individuals or agencies are entitled to submit in writing to the Council complaintsalleging professional misconduct, gross negligence or other defects of performance

by a licensed health professional.

(67) Pursuant to complaints brought under section 67, the Council shall consider theissues that arose in the complaint to establish whether they merit furtherinvestigation.

(68) Where the Council is satisfied that a complaint other that a complaint brought bythe Health Inspectorate Service, merits additional investigation, it shall make a formal

directions for further investigation to be conducted by the relevant regulatory bodyand take such further action as may be considered appropriate.

Appeals

(69) Any appeal against decisions taken by the Council with respect to the licensing ofindividual health professionals and relating to the refusal, restriction or withdrawal ofa licence to practice shall be made to the Health Council.

(70) Parliament shall enact legislation to give full effect to provisions under this part.


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PART 9

REGULATION OF MEDICINES AND MEDICAL PRODUCTS15

(71) The manufacture, sale, importation, export, distribution or promotion of medicines,vaccines, devices or other products intended for promotion, prevention, treatment

rehabilitation, and alleviation of human disorders or for the modification of

physiological function shall be subject to standards and procedures to be established

by the National Government under appropriate legislation.

(72) The classes of products governed by such legislation shall extend to therapeuticfeeds and nutritional formulations.

(73) Legislation under Section 71 shall provide for the granting of marketing approval onlyby a technically competent body and only after appropriate assessment has

established that such a product meets generally recognized standards; approval may

be made subject to conditions, notably with respect to the conduct and content of

promotion and advertising.

Procedures.

(74) (1) A person, firm or institution may engage in one or more of the activities specifiedin sections 71whether by way of trade or otherwise, only if in the possession of a

licence granted after due assessment by the technically competent body specified in

that sub-section.

(2) Any person, firm or institution in the possession of such a licence shall be subject

to periodic or incidental inspection by the National Health Inspectorate createdunder this Act.

Standards

(75) A medicine, vaccine or other product as specified in sub-section 6.1. shall be eligiblefor licensing only if, after due assessment, it is found to possess the effect claimed

for it or which may reasonably be attributed to it, is sufficiently safe under the

normal conditions of use, and is made and packaged according to satisfactory

standards.

Transitional measures

(76) Pending the passage of the legislation referred to under section 71 existing legalprovisions for the approval of medicines and allied products will continue in force.

15This topic is covered only briefly in the general Health Law. There is specific legislation in the sector, but it is

widely considered that reform is needed in the form of a modern Medicines Act compatible with W.H.O.

recommendations and with the present draft Law.


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PART 10

PROCUREMENT AND SUPPLY OF MEDICINES AND VACCINES AND OF

MEDICAL DEVICES, APPLIANCES AND MATERIALS16

Medicines and vaccines

(77) (1) The procurement for the public health services of medicines and vaccines shall beundertaken primarily by a public agency to be established by legislation.(2)The classes of products governed by such legislation shall extend to therapeutic

feeds and nutritional formulations.(3)The agency in question shall be the point of first call for procurement at the

county level.

(4)Notwithstanding sub section (3), counties shall have the right to procure theseitems incidentally from other sources where the public agency is unable to supply

them in good time or at a competitive price.(5)National referral hospitals shall have a right to purchase medicines and vaccines

from other accredited sources.(6)National Legislation shall provide for the procurement, distribution and

management of essential medicines at all levels of the national health system.

Devices, appliances and materials

(78) (1) The procurement for the public health services of devices, appliances andmaterials shall similarly be undertaken primarily by the public agency established

under Section 77 (1), subject to right of facilities to procure from any source items oflow monetary value; the latter shall be subject to guidelines to be issued by the

Ministry responsible for Health.

(2)Pending the passage of specific legislation in this field, existing legal provisionsgoverning the procurement of medical goods will continue in force.

PART 11

PROMOTION AND ADVANCEMENT OF PUBLIC AND ENVIRONEMNTALHEALTH

(79) The National and County Governments, acting primarily through the agency of theMinistry and the County Executive department responsible for health respectively,and in collaboration and consultation with the Institutions and agencies created underthis Act and other arms of government, shall devise and implement measures to

promote health and to counter influences having an adverse influence upon it. Suchmeasures shall include:

16As in the case of Section 23,this matter is referred to only in principle in the general Health Act.Separate

legislation is planned, and comments on the current draft for a Bill have been submitted to KEMSA since it is

essential that it be compatible with the present draft for a general Health Law.


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a. Measures to reduce the burden imposed by communicable diseases, especially among

marginalized and indigent populationsb. The institution of measures to promote physical activityc. The promotion of supply of foodstuffs of sufficient quality in adequate quantities and

the promotion of nutritional knowledge at all population levels

d. The promotion of regular physical activity and the provision of facilities to this ende. Steps to counter the excessive use of alcoholic products and the adulteration of such

products.f. Measures to reduce the use of tobacco and other addictive substances and to

counter exposure of children and others to tobacco smoke.g. General health education of the publich. A comprehensive programme to advance reproductive health,17 including:

i. effective family planning servicesii. implementation of means to reduce unsafe sexual practicesiii. sexual health in adolescence and youthiv. pre-natal, post-natal and maternal carev. elimination of female genital mutilationvi. maternal nutrition and micro nutrient supplementation

Environmental and Public Health

(80) (1) National and County Governments shall ensure that measures for managingenvironmental risk factors to curtail occurrence and distribution of diseases are putin place and implemented. In particular measures shall target:

a) Reduction of disease burden arising from poor environmental hygiene, sanitation,occupational exposure and environmental pollution.

b) Reduction of morbidity and mortality of waterborne, and vector transmitteddiseases, and mitigate the health effects of climate change.

c) Reduction of morbidity, mortality, prolonged hospital stays, long-term disabilities,antibiotic resistance that emanate from health care acquired infections.

d) Strengthening of national and county capacity to address/forestall transmission ofdiseases of international concern.

e) Building community capacity in providing solutions to public health challenges.Legislation

(81) Pursuant to meeting the objects set out in section (80), Parliament shall enactlegislation that shall provide for measures that include:

a) Ensuring and promoting the provision of Quarantine and Port, boarders and frontiershealth Services;

b) Ensuring that food and water available for human consumption are hygienic and safec) Ensuring houses, institutions, hospitals and other public places maintain environment

to the highest level of sanitation attainable to prevent, reduce or eliminate

environmental health risks.

17See also Governmental duties as defined in Section 3 of this draft


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d) Developing risk-based, sustainable, integrated occupational health practices, watersafety systems,appropriate housing, and vector and vermin control.

e) Strengthening infection prevention and control systems including health care wastemanagement in all health facilities

f) Involving of all stakeholders especially in delineating their responsibilities and gainingtheir action and commitment.

g) Mobilizing resources including human resources for action.h) Public education and participation.i) Promoting the public health and the prevention, limitation or suppression of

infectious, communicable or preventable diseases within Kenya,j) Ensuring provision of environmental health and sanitation mechanisms to prevent and

guard against the introduction of infectious disease into Kenya from outside,

k) Issuing guidelines to counties in regard to matters affecting the public health fromthe environment and sanitation,

l) Promoting or carrying out researches and investigations in connection with theprevention of environmental, water and sanitation related diseases,

m)Addressing all issues pertaining to environmental hygiene and sanitation,PART 12

MENTAL HEALTH18

(82) (1) Appropriate policies shall be developed by the Health Council and proposed forformal adoption:

a. to protect the rights of any individual suffering from any mental disorder ordeficiency

b.

to ensure the custody of such persons and the management of their estates asnecessary

c. to establish, manage and control mental hospitals having sufficient capacity to serveall parts of the country.

d. to advance the implementation of other measures introduced by specific legislation

in the field of Mental Health

(2) Parliament shall enact legislation to give full effect to this section.

18Like various other topics in the later sections of this draft, Mental Health is and must be the subject of specific

legislation, and it is therefore mentioned ony briefly the present draft of a general Health Law.


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PART 13

TRADITIONAL AND COMPLEMENTARY MEDICINES

Investigation and Documentation

(83) (1) The Ministry responsible for Health shall establish and put in place measures toidentify and document:

a. the extent to which traditional medicine is practiced in Kenyab. the areas of Kenya in which contacts with traditional practitioners comprise a

particularly significant proportion of all health consultations

c. the conditions for which populations are most prone to seek traditional medicalsupport

d. the medical conditions in which such support is conceived to be particularlybeneficial

e. the practical considerations, financial or otherwise, which are most likely to leadto such consultation

f. the characteristics of those members of the population most prone to seek theassistance of traditional practitioners

g. the extent to which cross referral between orthodox and traditionalpractitioners is experienced

h. evidence as to the beneficial and adverse consequences of traditional orcomplementary methods of treatment

(2) The Cabinet Secretary responsible for Health shall, in consultation with the Health

Council, on the basis of information generated under measures set out in sub section (1),and shall make legislative or regulatory proposals accordingly.

(3)Parliament shall enact legislation to regulate the practice and assimilation of traditional

and complementary medicine within the National Health System.

PART 14

HUMAN BLOOD, BLOOD PRODUCTS, TISSUES AND GAMETES19

Kenya National Blood Service

(84) There is hereby established the Kenya National Blood Transfusion Service, whichservice shall establish County blood transfusion services governed by regulations

made under this Act.

19Like various other topics in the later sections of this draft, Blood and its derivatives are the subject of specific

legislation, and they are therefore mentioned only briefly the present draft of a general Health Law.


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Transfer of blood or tissue

(85) (1) The Kenya Blood Transfusion Service may grant a competent, non-profitorganisation the licence to provide blood transfusion services anywhere in theterritory of the Republic.

(2) The holder of the licence granted in terms of subsection (1)-

(a) must comply with prescribed norms and standards and must provide theprescribed blood transfusion and related services(b) may establish regional units, for the delivery of blood transfusion services,(c) has the sole right to provide a blood transfusion service in the Republic.

(d) prescribed blood transfusion and related services;Which must function under the control of the licence holder; and

(3) Any person other than the holder of the licence granted in terms of subsection(1) that provides a blood transfusion service in the Republic is guilty of an offence and

liable on conviction to a fine or to imprisonment for a period not exceeding fiveyears or to both a fine and such imprisonment.

(86) No person shall remove, blood, a blood product or tissue from the body of a livingperson without the consent procedure set out in section 8 of this Act and in theprescribed manner and conditions only for valid medical or dental purposes.

Manipulation

(87) (1) No person shall without the prior written approval of the Cabinet Secretarysubject to the recommendations of the Health Council:-

(a) manipulate any genetic material, including genetic material of human gametes,zygotes or embryos; or

(b) engage in any activity, including nuclear transfer or embryo splitting, for the

purpose of the reproductive cloning of a human being.

(2) No person shall import or export human zygotes or embryos without the priorwritten approval of the Cabinet Secretary on the recommendation of Health

Council.

(88) (1) A person may use tissue removed or blood or a blood product withdrawn froma living person only for such medical or dental purposes as may be prescribed.

(2) (a) subject to paragraph (b)The following tissue, blood or blood products may not

be removed or withdrawn from a living person for any purpose stated in subsection(1):

(i) tissue, blood or a blood product from a person who cannot give consent; or(ii) tissue which is not replaceable by natural processes from a person younger than

18 years.


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(iii)Tissue, blood, a blood product or a gamete from a person who is mentally ill inaccordance with the Mental Health Act

(iv) a gamete from a person younger than 18 years; or(v) placenta, embryonic or foetal tissue, stem cells and umbilical cord, excluding

umbilical chord progenitor cells

(b) The Cabinet Secretary subject to recommendations of the Health Council mayauthorize the removal or withdrawal of tissue, blood, a blood product or gametes

contemplated in paragraph (a) and may impose any condition which may be necessaryin respect of such removal or withdrawal.

(3) Any person who contravenes a provision of this section or who fails to comply

therewith is guilty of an offence and is liable on conviction to imprisonment for aminimum of five years with no option of fine

(89) (1) A person may not-(a) manipulate any genetic material, including genetic material of human(b) engage in any activity, including nuclear transfer or embryo splitting, gametes,

zygotes or embryos: orfor the purpose of the reproductive cloning of a human being.

(2)The Cabinet Secretary may, under such conditions as may be prescribed, permit

therapeutic cloning utilizing adult or umbilical cord stem cells.

(3) No person may import or export human zygotes or embryos without the priorwritten approval of the Cabinet Secretary.

(4) The Minister may permit research on stem cells and zygotes which are not more

than 14 days old on a written applicant and if-(a) the applicant undertakes to document the research for record purposes: and

(b) prior consent is obtained from the donor of such stem cells or zygotes.

(5) Any person who contravenes a provision of this section or who fails to complytherewith is guilty of an offence and is liable on conviction to a fine or to

imprisonment for a period not exceeding five years or to both a fine and suchimprisonment.

(6)For the Purposes of this Act-

(a) reproductive cloning of a human being means the manipulation of genetic

material in order to achieve the reproduction of a human being and includes nucleartransfer or embryo splitting for such purpose; and

(b) therapeutic cloning means the manipulation of genetic material from adult,

zygotic or embryonic cells in order to alter, for therapeutic purposes, the function of

cells or tissues.


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Transplantation

(90) (1) No person shall remove tissue from a living person for transplantation inanother living person or carry out the transplantation of such tissue except:-

(a) in a hospital authorised for that purpose; and

(b) on the written authority of:-(i) the medical practitioner in charge of clinical services in that hospital or any other

medical practitioner authorised by him or her; or(ii) in the case where there is no medical practitioner in charge of the clinical servicesat that hospital a medical practitioner authorised thereto by the person in charge ofthe hospital.

(2) The medical practitioner stated in subsection (1) (b) shall not be the leadparticipant in a transplant for which he has granted authorization under that

subsection.

Donations of blood and tissue

(91) (1) It is an offence for a person:-(a) who has donated tissue, blood or a blood product to receive any form of financialor other reward for such donation, except for the reimbursement of reasonable

costs incurred by him or her to provide such donation; and(b) to sell or trade in tissue, blood or blood products, except as provided for in this

Act.(2) Any person found guilty of an offence under subsection (1) is liable on conviction

to a fine of Kes 100,000 (one hundred thousand) or to imprisonment for a periodnot exceeding one year or to both fine and imprisonment.

(3) Nothing in this section prevents a registered health care provider from receivingremuneration for any professional service rendered by him or her.

Allocation and use of human organs

(92) (1) Human organs obtained from deceased persons for the purpose oftransplantation or treatment, or medical or dental training or research, shall only beused in the prescribed manner.

(2) Human organs obtained under subsection (1) shall be allocated in accordancewith the prescribed procedures.

(3) An organ may not be transplanted into a person who is not a Kenyan citizen or apermanent resident of the Republic without the Cabinet Secretarys authorization in

writing.

(4) The Cabinet Secretary must prescribe-

(a) criteria for the approval of organ transplant facilities; and(b) procedural measures to be applied for such approval.(5) (a) A person who contravenes a provision of this section or fails to comply

therewith or who charges a fee for a human organ is guilty of an offence.(b) Any person convicted of an offence in terms of paragraph (a) is liable on

conviction to a fine or to imprisonment for a period not exceeding five years or toboth a fine and such imprisonment.


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(93) (1) (a) A person who is competent to make a will may-

(i) in the will;

(ii) in a document signed by him or her and at least two competent witnesses; or(iii) in an oral statement made in the presence of at least two competent witnesses,

donate his or her body or any specified tissue thereof to be used after his or herdeath, or give consent to the post mortem examination of his or her body, for any

purpose provided for in this Act.(b) A person who makes a donation as contemplated in paragraph (a) must nominatean institution or a person contemplated under this Act.(c ) If no donee is nominated in terms of paragraph (b), the donation is null and void.

(d) Paragraph (b) does not apply in respect of anorgan donated for the purposescontemplated in section 91(1 ) and the donee of such organ must be determined in

terms of section 91(2).

(2) In the absence of a donation under subsection (l) (a) or of a contrary direction

given by a person whilst alive, the spouse, partner, major child, parent, guardian,

major brother or major sister of that person, in the specific order mentioned, may,

after that persons death, donate the body or any specific tissue of that person to an

institution or a person contemplated in section 63.

(3) (a) The Cabinet Secretary may, after the death of a person and if none of the

persons contemplated in subsection (2) can be located, donate any specific tissue of

that person to an institution or a person contemplated in section 63.

(b)The Cabinet Secretary may only donate the specific tissue if all the prescribed

steps have been taken to locate the persons contemplated in subsection (2).

Purposes of donation of body, tissue, blood or blood products of deceased

persons

(94) (1) A donation in terms of section 93 may only be made for-(a) the purposes of the training of students in health sciences;(b) the purposes of health research;

(c) the purposes of the advancement of health sciences;(d) Therapeutic purposes, including the use of tissue in any living person; or

(e) the production of a therapeutic, diagnostic or prophylactic substance.

(2) This Act does not apply to the preparation of the body of a deceased person forthe purposes of embalming it, whether or not such preparation involves the-

(a) making of incisions in the body for the withdrawal of blood and thereplacement thereof by a preservative; or

(b) restoration of any disfigurement or mutilation of the body before its burial.


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Revocation of donation

(95) A donor may, prior to the transplantation of the relevant organ into the donee,revoke a donation in the same way in which it was made or, in the case of a donation

by way of a will or other document, also by the intentional destruction of that will ordocument.

Post mortem examination of bodies

(96) (1) Subject to subsection (2), a post mortem examination of the body of a deceasedperson may be conducted if-

(a) the person when alive gave consent thereto

(b) the spouse, partner, major child, parent, guardian, major brother or major sister

of the deceased, in the specific order mentioned, gave consent thereto; or(c) such an examination is necessary for determining the cause of death.

(2) A post mortem examination may not take place unless-

(a) The medical practitioner in charge of clinical services in the hospital orauthorized institution or of the mortuary in question, or any other medical

practitioner authorised by such practitioner, or(b)in the case where there is no medical practitioner in charge of clinical services, a

medical practitioner authorised by the person in charge of such hospital orauthorised institution, may, has authorized the post mortem examination in writing

and in the prescribed manner.

Removal of tissue at post-mortem examinations and obtaining of tissue by

institutions and persons

(97) (1) (a) The Cabinet Secretary may, on the written application of an institution orperson requiring tissue for a purpose contemplated under this Act authorize that

institution or person, in writing, to obtain such tissue from a medical practitioner ora person or an institution contemplated under this Act.

Regulations relating to tissue, cells, organs, blood, blood products and gametes

(98) (1) The Minister may make regulations regardinga) the post mortem examination of bodies of deceased persons;b) the preservation, use and disposal of bodies, including unclaimed bodies;c) the removal of donated tissue or cells from persons, tissue or cells obtained from

post mortem examinations and the procurement, processing, storage, supply and

allocation of tissue or human cells by institutions and persons;d) tissue transplants;e) the production, packaging, sealing, labeling, storage and supplying of therapeutic,

diagnostic and prophylactic substances from tissue;

f) the supply of tissue, organs, oocytes, human stem cells and other human cells,


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PART 16

HEALTH FINANCING21

(101) Government shall ensure progressive financial access to health by taking measuresthat include:

a. Performing studies of financing models for health care;b. defining, in collaboration with the Ministry responsible for Finance, public

financing of health care, including annual allocations towards reimbursing private

health care providers responding to emergencies as contemplated under section6 of this Act;

c. establishing in collaboration with the Ministries responsible for Finance, Planningand any other for the time being responsible programmes to secure health care

by vulnerable groups and indigents;

d. determining, during each financial period and in consultation with individualCounty authorities, the extent to which and the manner in which fees can be

levied for services provided by the public health system without significantlyimpeding the access of particular population groups to the system in the areas

concerned;

e. examining means of optimizing usage of private health services as a result ofrelieving the burden carried by the publicly financed system; and

f. defining the role that traditional and alternative healers may responsibly play inthe economical provision of various forms of health care.

PART 17

ROLE OF THE PRIVATE SECTOR

(102) Having regard to the manner in which public and private services and facilities canand should complement each other in the provision of comprehensive and accessiblehealth care to the population, the Cabinet Secretary responsible for health shall

pursue approaches conducive to the development of private services and theirattunement to the needs of the population.

(103) Private undertakings shall be permitted to operate hospitals, clinics, laboratories andother institutions in the h

health law draft 1

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