The Regulatory dimension as an Essential Public Health Function

1. II Workshop on Medicines Regulation in the Caribbean The Regulatory dimensionas anEssential Public Health Function Dr. Gabriel Vivas Health Systems and Services Advisor PAHO/WHO Barbados and ECC Pan American Health Organization

2. Regional trends of health systems performance Governance on the health systems Health systems Steering role Regulation dimension EPHF M&E OVERVIEW Health Systems Steering role Governance Regulation Pan American Health Organization

3. Regional Trends thatInfluence Health Systems Performance • Separation of health system functions • Decentralization of public health services, of health regulation, and of health care provision • Increase in the proportion of public sector financing from intermediate and local State entities • Emergence of new public and private actors • Creation of national health funds that are separate, often autonomous, from the Ministries of Health. • Increase of private health insurances and private prepayment mechanisms • Growing participation of private providers and NGOs • New relations between the State and civil society

4. Due to the growing complexity of health systems, new relationships between the State, the public sector, financing and insurance institutions, and the private sector have emerged Public Vs. Private

5. Dynamic equilibrum to guarantee the right to health under principles of solidarity, social cohesion... Society – state –market relationship SOCIETY STATE MARKET Pan American Health Organization

6. Governance on the Health Systems Institutions and actors (MoH, SSI, Committees, etc) • Governance in • Health Systems • Quality and regulation • complying • Good practices culture • Relationship between actors • Public and private • participation • Institutional Governance • Managerial structure • Legal status • Autonomy (decision making) • Reporting mechanisms • Internal and external audits • Principles • Accountability • Transparency • Consistency • Efectivity • Sustaintability Governance/Stewardship on the Health systems Governance Assurance/Financing Governance hospitals/ Health network Desirable to have good governance and good practices WHO, EURO (2007)

7. Governance - Integrated Delivery Services

8. SERVICES PROVISION GOVERNANCE and LEADERSHIP INFORMATION HUMAN RESOURCES FINANCING MEDICINES AND TECHNOLOGY HEALTH SYSTEMS BUILDING BLOCKS

9. Welcome to the Health System ENTRANCE

10. Functions and Objectives of a Health System Access – Quality - Efficiency Maintain and improve health Values Needs Resources Stewardship Financing Protection from financial and social risks Provision Patient Satisfaction Participation - Equity

11. Dimensions CONDUCT/ LEAD REGULATION Financing Orientation STEERING ROLE Guarantee of Insuance Essential Public Health Functions Harmonization of Service provision

12. Shared responsibilities Financing orientation Guarantee insurance Harmonize Service Provision Sanitary Authority Conduction Exclusive responsibilities Regulation Essential public health functions

13. Regulatory dimension What is regulation? Why is the regulatory dimension important? What are the determinants of regulation? What makes the regulatory dimension effective?

14. Regulation • In terms of the `steering role`: • Manifestation of the State’s responsibility to order and systematize a reality according to a series of trends prevailing at a given time. • Requires building consensus between different State levels, among them and all sectors of society.

15. Why the regulatory dimension is important • Creates the legal framework needed to protect and promote the health of the population as well as to guarantee its enforcement

16. Why the regulatory dimension is important (2) • Is necessary to guarantee the state’s role as organizer of the relations between production and distribution of health resources, goods, services, and opportunities according to principles of solidarity and equity

17. Why the regulatory dimension is important (3) • Fulfills the states principal mechanism to mediate relationships between actors with power asymmetries (public/private) • It establishes the foundation for the articulation of the other dimensions of the steering role

18. State the regulatory mandates primarily emerge from the constitutional norms that create rights and duties for individuals and institutions International context States’ commitments and ratification of international agreements (common markets, integration blocs) Determinants of the regulatory function

19. Effectiveness of the regulatory function • The existence of a solid regulatory framework establishing the functions and competences of the NHA • Ensure the regulatory leadership of the NHA • Strong political will to perform the regulatory function with an adequate infrastructure • Clear policies and shared principles (equity, quality, universality). • Institutional capacity in terms of the conduction and articulation of actors and sectors

20. Effectiveness of the regulatory function (2) • Strategic intelligence to foresee current and future trends and orientations that will require new regulations • Periodic monitoring, evaluation and upgrading the regulatory framework • Good capacity to coordinate and articulate with decentralized entities/agencies to which the regulatory functions are being transferred • Strong capacity to enforce the regulation

21. Regulation of the health services and the private participation • Unique characteristic of the provision of health care as a public and private good, reinforces de need and importance of strong regulation • Essential element to guide the private practice • Public protection: market failures, inefficency of sevices, diminish high health care costs • Economic focus: monopoly control, vertical integrations of insurers and health providers, reduce transactional costs of insurance companies

22. Essential public health functions Indispensable set of actions, under the primary responsibility of the state, that are fundamental for achieving the goal of public health which is to improve, promote, protect, and restore the health of the population through collective action

23. Essential public health functions (1) • Monitoring, evaluation and analysis of health status • 2. Public health surveillance, research, and control of risks and threats to PH • 3. Health promotion • 4. Social participation in health • 5. Development of policies and institutional capacity for PH planning and management • 6. Strengthening of institutional capability forregulation and enforcement in PH

24. Essential public health functions (2) • Evaluation and promotion of equitable access to necessary health services • Human resources development and training in PH • Quality assurance in personal and population-based health services • Research in Public Health • Reduction of the impact of emergencies and disasters on health

25. EPHF #6 Includes: • The institutional capacity to develop the regulatory framework necessary to monitor and protect the population’s health • The capacity to create new laws and regulations directed towards improving population health and promoting the development of healthy environments • The protection of citizens in their relationship with the health system • The execution of these activities to ensure compliance with the standards in a timely, correct, congruent, and complete manner

26. M&E - Regulation Indicators • Period review, evaluation, and modification of the regulatory framework • Enforcement of health standards • Knowledge, skills, and mechanisms to review, enhance, and enforce the regulatory framework • Technical advisory and support for sub-national public health agencies to elaborate and enforce laws and regulations

28. http://www.lachealthsys.org/