Health Act

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A Senior Management
Course for Health Managers in
Kenya
2nd EDITION
July 2014
MODULE 1: Understanding
foundations of the health
system in Kenya
Unit 1.1: Strategic Direction and regulatory
frameworks for the health system in Kenya
Purpose
•Provide the participant with an
understanding of the strategic direction
and regulatory framework of Kenya’s
health system. It describes the
administrative structures of the health
system and organization of health
services in Kenya and also explores the
concepts of health sector reform and
regulation of the health system.
3
Objectives
By the end of this unit, the participant should be able
to:
•Describe the health policy development process.
•Describe the evolution of health policy in Kenya.
•Outline various ways through which health care
system is regulated
•Outline key health sector reforms in Kenya
4
Overview
This unit will cover the following topics:
•National health policy framework: process and
evolution.
•Regulation of health services and professionals:
national and international laws, declarations and
regulations related to health.
•Health sector reforms: components and
characteristics.
5
Overview (Cont’d)
6
Session 1.1
Health Policies and Policy Making
Process in Kenya
What is a Policy?
A policy is defined as a specific statement of
principles or guiding actions that imply clear
commitment by the government or
institutions as basis for consistent decision
making and resource allocation to determine
present and future.
8
What is a Health Policy?
•Embraces courses of action that affect sets of
institutions, organisations, services and funding
arrangements of the health care system.
•It goes beyond health services, however, and
includes intended actions or unintended actions by
public, private (including households) or voluntary
organisations that have impact on health.
(Walt 1994)
9
Policy Process: Model Policy Cycle
Problem definition/
Agenda setting
Policy formulation
Policy legitimation
Policy change
Policy evaluation
Policy
implementation
10
Problem Definition
This is based on one’s own perspective.
•What is a current problem?
•Why is it a problem?
•Who’s involved?
11
Agenda Setting
Systemic vs. government agenda:
•Systemic: public is aware of and may be
discussing;
•Government: considered to be those issues
and problems that policymakers are
addressing at a certain time.
What issues would you consider to be on the
government agenda currently?
12
Policy Formulation
•Debate over alternative policy choices.
•Importance of policy analysis.
•Actors provide their preferred positions.
Who’s involved:
—bureaucracy
—legislature/staff;
—interest groups.
13
Policy Legitimation
•Appropriateness of government action.
•Important for garnering support.
•Deals with two major issues:
— Substance of the policy;
— Process of adopting the policy.
14
Policy Implementation
•Where actual intervention is seen.
•Activities that put programmes into effect:
—money spent;
—laws passed;
—regulations formulated.
•Done mostly by executive branch through
regulations.
15
Policy Evaluation and Change
•Expected to feed information back into the
policy process.
•Different types of impacts:
– direct vs. indirect;
– short-term vs. long-term.
•This step is often disregarded in the process.
16
Policy Instruments
•Regulation.
•Government management.
•Taxing and spending.
•Market mechanisms.
•Education and information.
17
Contributions of Health Care Workers to Public
Policies
•Bring expertise in, and knowledge of, a range of
health-related topics and issues;
•Help interpret people’s and communities’ needs;
•Conduct health research that contributes evidence
to policy development through health care
knowledge and experience;
•Interpret and use the results of research to influence
policy;
•Communicate policies to communities.
18
Activity 1.3.6.1: Brainstorming (20 minutes)
Participants brainstorm on the process of health policy
making in Kenya.
Participants discuss for 20 minutes .
Copy to TLA unit 1.3.4
19
Policy Outline
Policy Parts
Policy Chapters
PART 1:
BACKGROUND
Chapter 1: Context
PART 2: POLICY
DIRECTIONS
PART 3: POLICY
IMPLEMENTATION
ANNEX
Chapter 2: Situation analysis
Chapter 3: Policy framework
Chapter 4: Policy goal, principles and objectives
Chapter 5: Policy orientations
Chapter 6: Implementation framework
Chapter 7: Monitoring and evaluation framework
Chapter 8: Conclusion
Glossary of terms
20
Framework for Defining Policy Directions in Kenya
Health Workforce
Service Delivery
Systems
Health Infrastructure
Halt, and reverse rising burden of
NCD’s
Reduce the burden of violence and
injuries
Provide essential medical services
Minimise exposure to health risk
factors
Physical and Financial Access
Health Information
POLICY GOAL
Eliminate communicable diseases
Quality and safe services
Health Products &
Technologies
Multi - sectoral
Health Leadership
Social accountability
Participation
People - centered
Equity
Health Financing
POLICY OBJECTIVES
(& strategies)
Efficiency
POLICY ORIENTATIONS
(& principles)
Better
Health,
In a
responsive
manner
Strengthen collaboration with
health related sectors
21
Relationships of the Different Policy Directions
Orientation 5:
H/Infrastructure
Obj. 2:
Non Communicable
conditions
Policy
Goal:
Better
Healt
h
22
Session 1.1.2
Regulatory framework for Kenya’s
health system
Regulation of Health Services
Health services are regulated by health laws
and commitments on improving health that
countries make at international, regional and
national forums.
24
Health Laws
•Health law refers to a statute, ordinance or code
that prescribes sanitary standards and regulations
for the purpose of promoting and preserving the
community's health. (Black's Law Dictionary, 8th
ed., 2004).
•Health law covers a wide range of legal concerns
for the entire health field.
25
Origins of Health Laws
•The health laws originate from:
-
International agreements or declarations which
each state party domesticates and prepares
legislation.
-
Constitution of a particular country.
• Many of the health laws are standard and aim at
promoting good health.
26
Role of Health Laws
•Assist countries in the development of
regulatory frameworks to promote good health.
•Form the legal frames for technical corporation
in promoting good health.
•Regulation of registration of medical products.
27
Role of Health Laws
•Assist countries in the development of
regulatory frameworks to promote good health.
•Form the legal frames for technical corporation
in promoting good health.
•Regulation of registration of medical products.
28
Comprehensive Health Legal
Framework
SPECIFIC LAWS
GENERAL HEALTH LAW
Health Financing
Legal provisions on:
HEALTH RELATED LAWS
•Assist countries in the development of
•
•
•
•
•
•
Economy and employment
Security and justice
Education and early life
Agriculture and food
Nutrition
Infrastructure, planning
and transport
Environments and
sustainability
Housing
Land and culture
Population
• Overall purpose of health
regulatory frameworks
tolegislation
promote good health.
Health Leadership
Health Products
• Scope of health legislation
• Health services
•Form the legal
frames
for technical •corporation
• Health
risk factor services
Health Information
Health Workforce
Service Delivery
• Harmonising with content of
in existing
promoting
good health.••
health related laws.
•
Health Infrastructure
•Regulation of registration of medical products.
REGULATIONS
Source: Government of Kenya, KHSSP, 2012 - 2017
29
The Constitution of Kenya, 2010
•The Constitution of Kenya 2010 has provisions that have an
impact on health in Kenya
•Two critical chapters, the Bill of Rights and the Devolved
Government, introduce new ways of addressing health
problems and have direct implications for the Health
Sector’s focus, priorities and functioning.
•The Bill of Rights provides guidance to the Health Sector on
the definition and policy implications of the content of the
right to the highest attainable standard of health. It uses
the standards and principles of International Human rights
instruments in defining the content of this right.
30
The Constitution of Kenya, 2010
(Cont’d)
•The Chapter on Devolution provides guidance on how a
the health sector will be organised for health services
delivery.
•To effectively implement devolution as envisaged in the
Constitution of Kenya 2010, the health sector will need
guidance on the following:
₋Organisation and management of county health
services;
₋Criteria for transfer of health related functions to
county governments;
₋County health facilities, assets and liabilities;
31
The Constitution of Kenya, 2010
(Cont’d)
₋Management of shared responsibilities between
national and county governments;
₋Procurement of health commodities at the county;
₋Planning, budgeting and monitoring and evaluation
at national and county levels;
₋Merger of ministries and other health related
functions;
₋Health Sector stakeholder partnership
arrangements.
32
Constitution Implementation: Ongoing Legislations
Legislation
Status
Kenya Health Bill 2012
Approved by cabinet. Submitted to CIC and
AG- returned to Ministries of Health for
amendments
KEMSA Bill 2012
Approved by cabinet. Submitted to CIC and
AG
NHIF Amendment Act 2012
Approved by cabinet. Submitted to CIC and
AG
Mental Health Bill 2012
Awaiting discussion by Sub-Cabinet
Committee on Social Sector
Establishment of National Referral Approved by cabinet, awaiting
Health Facilities in Kenya 2012
operationalisation by the MOH, MOF and
AG office
Food and Drugs Administration
Bill 2012
First draft shared with health stakeholders
33
Progress so Far in Implementation of the Constitution
•Health Sector Position Paper on constitution implications
in Health (2011) developed;
•Health Policies: Approved by Cabinet
—Kenya Health Policy: Sessional Paper No.6 of 2012
—Universal health care coverage in Kenya: Sessional
paper No.7 of 2012
—Pharmaceutical policy: Sessional paper No.4 of 2012
•Kenya Health Sector Strategic Plan 2013–17 (draft)
developed (awaiting county consultations)
34
The Proposed Health Act, 2012
An Act of Parliament to consolidate the laws relating to
health to provide for:
• regulation of health care services and health care
service providers;
• establishment of national regulatory institutions to
coordinate the inter relationship between the
national and county health institutions;
• establishment of a coordinating agency of
professionals within the health sector; and
• attainment of the basic right to health and for
connected and incidental purposes.
35
The objectives of the Proposed Health Act, 2012
The objects of this Act are:
• to enable the realisation of the rights to health as
provided for in the Constitution of Kenya, 2010;
• to provide uniformity in respect of health services
across the nation.
36
The objectives of the Proposed Health Act (Cont’d)
The Act aims to achieve the following objectives:
(a) Establish a national health system which
encompasses public and private providers of
health services at the national and county levels
and facilitate, in a progressive and equitable
manner, to ensure the highest attainable standard
of health services;
(b) To set out the rights and duties of the various
organs within the national health system;
37
Objectives of the proposed Health Act (Cont’d)
(c) To protect, respect, promote and fulfill the rights
of all persons living in Kenya to the progressive
realisation of their right to the highest attainable
standard of health, including reproductive health care
and the right to emergency medical treatment;
(d) To guarantee the people of Kenya an environment
that is not harmful to their health;
38
38
Objectives of the proposed Health Act (Cont’d)
(e) To protect, respect, promote and fulfill the rights of
children to basic nutrition and health care services
contemplated in Articles 43(1) (c) and 53( l)(c) of the
Constitution of Kenya 2010; and
(f) To protect, respect, promote and fulfill the rights of
vulnerable groups in all matters regarding health as
defined in Article 21 of the Constitution of Kenya,
2010.
39
Components of the Health Act
1. Definitions
2. Rights and duties
3. Roles and functions of the two-tier government
4. Establishment & functions of the Kenya Health
Services Authority
5. Human resource planning and capacity building
6. Inspectorate agencies
40
Components of the Health Act (Cont’d)
7. Public health facilities and private public
partnerships
8. Definition and governance of health professionals
9. Control of medicines and medical products
10.Procurement, supply of medicines, vaccines,
medical devices, appliances and materials
11. Promotion and advancement of public and
environmental health
12. Mental health
41
Components of the Health Act (Cont’d)
13. Traditional and complementary medicine
14. Human blood, blood products, tissues and gametes
15. Control of dangerous drugs, narcotics and psychotropic
substances
16. Health financing and health insurance
17. The role of private sector
18. Promotion and conduct of health research
19. E- health
20. Inter- departmental collaboration
21. Transitional and miscellaneous provisions
42
Health Act: Rights and Duties
Every person has the right to:
•Standard of health;
•Reproductive health;
•Emergency treatment;
•Health information;
•Informed consent;
•Information dissemination;
•Confidentiality;
•Health care provider;
•Duties of users;
•Complaints.
43
Health Act: Right to Standard of Health
Right to:
a) the highest attainable standard of health
which shall include progressive physical and
financial access to promotive, preventive,
curative and rehabilitative services;
b) be treated with dignity, respect and have
their privacy respected in accordance with
the Constitution and this Act.
44
Health Act: Right to Reproductive Health
Right of:
(a) men and women to be informed about, and to
have access to reproductive health services,
including safe, effective, affordable and acceptable
family planning services, except elective abortions;
(b) access to appropriate health-care services that will
enable parents to go safely through pregnancy,
childbirth, and the post-partum period, and
provide parents with the best chance of having a
healthy infant;
45
Health Act: Right to Reproductive Health (Cont’d)
(c) Access to treatment by a trained health
professional for conditions occurring during
pregnancy 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.
46
Health Act: Right to Emergency Treatment
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 prehospital care; or stabilising the health status of the
individual; or arranging for transfer in cases where
the health provider of first call does not have
facilities or capability to stabilise the health status of
the patient (s).
47
Health Act: Right to Emergency Treatment (Cont’d)
4) Any medical officer who fails to provide emergency
medical treatment while having ability to do so
commits an offence and is liable, upon conviction,
to a fine not exceeding Kenya Shillings One Million
or imprisonment for 12 months or both.
5) Any medical institution that fails to provide
emergency medical treatment while having ability
to do so commits an offence and is liable, upon
conviction, to a fine not exceeding Kenya Shillings
Three Million without prejudice to any other
punishment prescribed by law.
48
Health Act: Right to Health Information
1) Every health care provider must inform a user or,
where the user is a minor or incapacitated, the
guardian:
a) of the user’s health status except in circumstances
where there is substantial evidence that the
disclosure of the user’s health status would be
contrary to the best interests of the user;
b) of the range of promotive, preventative and
diagnostic procedures and treatment options
generally available to the user;
c) of the benefits, risks, costs and consequences
generally associated with each option;
49
Health Act: Right to Health Information (Cont’d)
d) of the user’s right to refuse recommended medical
options 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 takes
into account the user’s level of literacy.
3) Where the user exercises the right to refuse a treatment
option, the health provider may at his discretion require
the user to confirm such refusal in a formal manner.
50
Health Act: Right to Informed Consent
1.No health service may be provided to a patient
without the patient’s informed consent unless:
a) the patient is unable to give informed consent and
such consent is given by a person mandated by the
patient in writing to grant consent or authorised to
give such consent in terms of any law or court
order;
b) the patient 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;
51
Health Act: Right to Informed Consent
(Cont’d)
d) the provision of a health service without informed
consent is authorised by an applicable law or court
order; or
e) the patient is being treated in an emergency
situation, or
f) failure to treat the user, or a group of people
which includes the user, will result in a serious risk
to public health; or
52
Health Act: Right to Informed Consent
(Cont’d)
g) any delay in the provision of the health service to
the patient might result in his or her death or
irreversible damage to his or her health and the
patient has not expressly, or by implication or by
conduct refused that service.
2. A health care provider shall take all reasonable steps to
obtain informed consent.
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 been informed as provided for in section
8 of this Act.
53
Health Act: Right to Information Dissemination
The national government, county governments and
every organ having a role or responsibility within the
National Health System, shall ensure that appropriate,
adequate and comprehensive information is
disseminated on the health functions for which they
are responsible being cognisant of the provisions of
Article 35 (1) (b) of the Constitution, which must
include:
a) the types, availability and cost, if any, of health
services;
54
Health Act: Right to Information Dissemination (Cont’d)
b) the organisation of health services
c) operating schedules and timetables of visits;
d) procedures for access to the health services;
e) procedures for laying complaints;
f) the rights and duties of users and health care
providers under this Act and as provided for in the
applicable service charters;
g) management of environmental risk factors to
safeguard public health.
55
Health Act: Right to Confidentiality
(1) All information concerning a user, including
information relating to his or her health status,
treatment or stay in a health facility is confidential.
(2) Subject to the Constitution and this Act, no
person may disclose any information contemplated in
subsection 1 unless:
(a) the user consents to such disclosure in
writing in the prescribed form; or
56
Health Act: Right to Confidentiality (Cont’d)
(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
subsection 2 (c) shall be subject to consent of the
Kenya Health Services Authority which must be
obtained in writing before disclosure.
57
Health Act: Rights and Duties of Health Care Personnel
(1) The Rights and duties of Health care personnel
shall include:
a) not to be unfairly discriminated against on
account of their health status;
b) the right to a safe working environment that
minimises the risk of disease transmission and
injury or damage to the health care personnel or
to their clients, families or property;
58
Health Act: Rights and Duties of Health Care Personnel
(Cont’d)
c) 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 alternative health care
personnel is available;
d) the right to apply for and accept a salaried post
in the public service or the private sector;
e) the right to challenge a decision of his or her
immediate superior by way of appeal to the next
higher level of authority.
59
Health Act: Rights and Duties of Health Care Personnel
(Cont’d)
(4) Every Health establishment shall make monthly
returns to the Kenya Health Services Authority of
complaints filed by users against it or any of its
employees or agents and the actions taken in that
regard.(yet to be put in place)
(5) Notwithstanding provisions of subsection 14(4)
above, every complainant under section 14(1) has a
right to be informed, in writing and within a period of
three weeks from the date the complaint was lodged,
of the action taken or decision made regarding the
complaint.
60
Health Act: Rights and Duties of Health Care Personnel
(Cont’d)
(6) Where a health institution fails to resolve a
complaint to the satisfaction of the complainant, the
Authority may recommend to the relevant regulatory
authority disciplinary action and may present the
complaint before regulatory authority.
61
Health Act: Duties of Users
A user of the Health System of Kenya has the duty,
insofar as it is within his or her capabilities:
• to adhere to the rules of a health establishment
when receiving treatment or using the health
services provided by the establishment;
• to adhere to the medical advice and treatment
provided by the establishment;
• to supply the health care provider with accurate
information pertaining to his or her health status;
62
Health Act: Duties of Users (Cont’d)
• to cooperate with the health care provider;
• to treat health care providers and health workers
with dignity and respect;
• if so requested, to sign a discharge certificate or
release of liability if he or she refuses o accept or
implement recommended treatment.
63
Health Act: Right to Complaints
(1) Any person has a right to file a complaint about the
manner in which he or she was treated at a health
institution and have the complaint investigated by the
appropriate regulatory body.
(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 HS for which
they are responsible.
64
Health Act: Right to Complaints (Cont’d)
(3) The procedures for laying complaints must:
(a) be displayed by all health establishments in a
manner that is visible;
(b) All complaints shall be handled by the head of
the relevant establishment.
65
The Health Act: The Kenya Health Services Authority
There is hereby established the Kenya Health Services
Authority, which shall be a body corporate with
perpetual succession and a common seal with power
to sue and be sued in its own name and to acquire and
alienate property.
1) The Authority shall have all the powers necessary
or expedient for the performance of its functions.
2) The powers of the Authority shall be vested in the
Advisory Board.
66
The Health Act: The Kenya Health Services Authority
(Cont’d)
3) The business and affairs of the Board shall be
conducted in accordance with the First Schedule.
4) Except as provided in the First Schedule, the
Board may regulate its own procedure.
5) Eight members of the Board shall constitute a
quorum for the transaction of any business of the
Board.
67
Session 1.1.3
Health Sector Reforms
Definition
Health sector reform has been defined as a
sustained process of fundamental change in
national policy and institutional arrangements
led by government and designed to improve the
functioning and performance of the health sector
and ultimately the health status of the
population (WHO/SHS/96.1)
69
Characteristics
•Health Sector Reforms involve changing the entire
system, that is:
— preventive, curative, promotive and
rehabilitative services;
— the public and private sub-sectors; and
— primary, secondary and tertiary care.
•Health sector reform is a problem-solving as well as
a learning process.
70
Characteristics (Cont’d)
•It is a deliberate and planned undertaking intended
to bring about lasting change.
•It is a process which should go beyond redefinition
of policy objectives and discussion on the ideological
orientation of the health care system to structural
changes of existing organizational and management
structures as well as financing systems.
•It is also a political process, therefore, consensus of
all stakeholders is very crucial.
71
Key Elements
•Changes in the organisation and management of
health services.
•Management of resources: funds, commodities, HR
and infrastructure .
•Health financing.
•Legislation review and advocacy.
•Re-organisation of health services.
72
72
Expected Outcomes
Health Sector Reforms should lead to health system
strengthening characterised by:
–improved equity in health systems;
–improved management of health resources;
–improved performance of health systems.
Ultimately, leading to:
– improved overall health status of the
population;
–greater satisfaction of consumers and
providers of health care.
73
Health Sector Reform Agenda in Kenya
Priority health sector reforms are in line with the
sector policies (KHPF 1994-2010) and NHSSP II
strategic objectives of:
1. Increasing equitable access to health services;
2. Improving service quality and responsiveness;
3. Improving efficiency and effectiveness;
4. Fostering partnership;
5. Improving financing of the health sector.
74
1. Kenya Health Reform Outputs for Increasing Equitable
Access to Health Services
• The development and implementation of the Kenya
Essential Package for Health (KEPH) and the Community
Strategy.
•Addressing financial barriers to equitable access to
health services through:
— application of a budget allocation criteria that is
based on KEPH, general poverty indicators and
regional population disparities;
— Repeal of the 10/20 policy, free maternity Services
in public facilities services, free malaria treatment,
and under-five for tier 2/L2-3 HF, HSSF.
75
2. Kenya Health Reform Outputs for Improving Service
Quality and Responsiveness
•Development of Norms and Standards for KEPH
and integrated supervision to ensure compliance
with the norms and standards.
•Institutionalisation of the Health charters and
complaint handling structures and processes.
•Institutionalisation of the client satisfaction
surveys.
76
3. Kenya Health Reform Outputs for Improving Efficiency and
Effectiveness in Health Services Delivery
•Introduction and institutionalisation of results-oriented
performance management involving central, provincial
and district managers.
•Development and implementation of a uniform
performance-based health management information
system (HMIS) with authoritative source of information for
all M&E indicators.
•Implementation of the new KEMSA institutional and
procurement process.
•The restructuring of MOH to ensure improved efficiency
and effectiveness in delivery of public health and
sanitation services.
77
4. Kenya Health Reform Outputs for Fostering
Partnerships
•Institutionalisation of the concept of Sector Wide
Approach (SWAp).
•In line with the agreed key principles, the following
outputs have been achieved:
– Joint annual planning and budgeting with
associated Planning Summit;
– Joint annual reviews (JAR) with associated
Review Summit;
78
Kenya Health Reform Outputs for Fostering
Partnerships (Cont’d)
– The Code of Conduct for the health sector
partnership.
The development of JFA that will facilitate the
harmonisation of financing among partners and the
use of common management arrangements at an
advanced stage.
79
5. Kenya Health Reform Outputs for Improving
Financing of the Health Sector
•The improvement of the insurance benefit package
for the National Health Insurance Fund (NHIF).
•The creation of the National Health Social
Insurance Fund.
•Efficiency and costing studies to inform the
development of the Health Financing Policy which
will inform the next health financing reforms.
80
Outputs for Hospital Reforms
•Substantive restructuring of hospital management
structure with emphasis on:
— establishing efficient and effective management
support departments; and
— capacity building for health managers on leadership
and management of health systems.
•Rationalisation of distribution of the different levels of
hospitals in the country.
•Introduction and institutionalisation of e-health especially
the telemedicine.
•Rationalisation of the referral system and services.
81
Activity 1.3.7.1: Group Work (40 minutes)
Participants work in groups to undertake the
assignment with respect to their county or facility.
a) Describe one successful health sector reform in
your facility/county and outline 3 key factors for the
success;
b) Describe one example of a health sector reform
factor that has not worked well and outline 3 key
reasons for the slow pace and/or failure of the
reform.
Groups present in plenary (20 minutes)
(Copy to unit 1.3.4)
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