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) 82