Pan AmericanHealthOrganizationThe Regulatory dimension

as an

Essential Public Health Function

II Workshop on Medicines Regulation in the CaribbeanDr. Gabriel VivasHealth Systems and Services AdvisorPAHO/WHO Barbados and ECC

Pan AmericanHealthOrganization

OVERVIEW

Regional trends of health systems performanceGovernance on the health systemsHealth systemsSteering roleRegulation dimensionEPHF M&E

Pan AmericanHealthOrganizationSteering roleGovernanceRegulationHealth Systems

Pan AmericanHealthOrganization

Regional Trends thatInfluence Health Systems PerformanceSeparation of health system functionsDecentralization of public health services, of health regulation, and of health care provisionIncrease in the proportion of public sector financing from intermediate and local State entitiesEmergence of new public and private actorsCreation of national health funds that are separate, often autonomous, from the Ministries of Health.Increase of private health insurances and private prepayment mechanismsGrowing participation of private providers and NGOsNew relations between the State and civil society

Public Vs. PrivateDue to the growing complexity of health systems, new relationships between the State, the public sector, financingand insurance institutions, and the private sector have emerged

Pan AmericanHealthOrganizationSTATEMARKETSOCIETYDynamic equilibrum to guarantee the right to health under principles of solidarity, social cohesion...Society state market relationship

Pan AmericanHealthOrganization

Governance on the Health SystemsGovernance/Stewardship on the Health systemsGovernance Assurance/FinancingGovernancehospitals/Health networkGovernance in Health SystemsQuality and regulation complyingGood practices cultureRelationship between actorsPublic and private participation

Institutional GovernanceManagerial structureLegal statusAutonomy (decision making)Reporting mechanismsInternal and external auditsPrinciples

AccountabilityTransparencyConsistencyEfectivitySustaintability

WHO, EURO (2007)Institutions and actors (MoH, SSI, Committees, etc)

Desirable to have good governance and good practices

Governance - Integrated Delivery Services

HEALTH SYSTEMS BUILDING BLOCKS

Welcome to the Health System

ENTRANCE

Functions and Objectives of a Health SystemValues

Needs

ResourcesStewardshipFinancingProvisionMaintain and improve healthAccess Quality - EfficiencyProtection from financial and social risksPatientSatisfactionParticipation - Equity

REGULATIONHarmonization ofService provisionFinancingOrientationGuarantee ofInsuanceCONDUCT/LEADSTEERING ROLEEssential Public HealthFunctions Dimensions

Sanitary AuthorityFinancingorientation GuaranteeinsuranceRegulationHarmonize Service ProvisionConductionEssential publichealth functionsShared responsibilitiesExclusive responsibilities

Regulatory dimension

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

Regulation

In terms of the `steering role`:

Manifestation of the States 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.

Creates the legal framework needed to protect and promote the health of the population as well as to guarantee its enforcement

Why the regulatory dimension is important

Is necessary to guarantee the states role as organizer of the relations between production and distribution of health resources, goods, services, and opportunities according to principles of solidarity and equity

Why the regulatory dimension is important (2)

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

Why the regulatory dimension is important (3)

State

the regulatory mandates primarily emerge from the constitutional norms that create rights and duties for individuals and institutionsInternational context

States commitments and ratification of international agreements (common markets, integration blocs)

Determinants of the regulatory function

The existence of a solid regulatory framework establishing the functions and competences of the NHAEnsure the regulatory leadership of the NHAStrong 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

Effectiveness of the regulatory function

Strategic intelligence to foresee current and future trends and orientations that will require new regulationsPeriodic 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

Effectiveness of the regulatory function (2)

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

Essential public health functionsIndispensable 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

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 for regulation and enforcement in PH

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

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

M&E - Regulation IndicatorsPeriod review, evaluation, and modification of the regulatory frameworkEnforcement of health standardsKnowledge, skills, and mechanisms to review, enhance, and enforce the regulatory frameworkTechnical advisory and support for sub-national public health agencies to elaborate and enforce laws and regulations

http://www.lachealthsys.org/

*****1. Conduct/Lead includes the capacity to guide the sector and mobilize actors in support of the National HealthPolicy.2. Orientation of Financing includes the competencies to guarantee, monitor and steer the complementarity ofresources from different sources in order to ensure equitable access to health services.3. Guarantee of Insurance, which targets its efforts at guaranteeing access to a health service package for theentire population, or specifi c plans for special population groups.3. Harmonization of Service Provision is the ability to coordinate various providers and users groups in order toextend health care coverage equitably and effi ciently.4. The execution of the Essential Public Health Functions (EPHFs) which is a non-delegable competency of theHealth Authority.5.Regulation encompasses the design and enforcement of the health regulatory framework that protects andpromotes health.*A continuacin tenemos los resultados de la medicin del desempeo de las FESP en las 24 regiones del Per.A continuacin tenemos los resultados de la medicin del desempeo de las FESP en las 24 regiones del Per.A continuacin tenemos los resultados de la medicin del desempeo de las FESP en las 24 regiones del Per.