1. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health THE ROLE OF ANVISA IN REGULATING AND PROMOTING SOCIAL WELFARE IN HEALTH Cássio Nascimento Marques Specialist in Health Regulation and Surveillance INTERNATIONAL SEMINAR – ANTI-HIV VACCINE RESEARCH: ETHICAL AND REGULATORY ISSUES Brasília/DF, Brazil, 04-05 October 2006

2. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health CONCEPTUAL ASPECTS è ANVISA: Special government agency linked to the Ministry of Health through a Management Contract è Regulatory agencies as inspecting organizations (“police power”) è Promotion and protection of the population’s health (collectivity interests)

3. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health REGULATION ACTIVITY è Regulation: administrative activity of an intervening State è Disciplining, inspecting, controlling è Establishing rules è Target: public or private organizations

4. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health POLITICAL ASPECTS è Social welfare: Focus on social- democracy and the modern State concept è “...every individual would have the right, from birth, to a set of goods and services which should be supplied directly via the State or indirectly, through its power of regulation over civil society. (...)” (Brazilian Ministry of External Relations)

5. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health HISTORY BACKGROUND è Health Reform: Federal Constitution and specific Statutory Laws è Administrative Reform – the regulatory State è Health surveillance-related Laws in force in Brazil: Law 6,360/1976 and Decree 79,094/1977 è Health Surveillance in construction – specific Regulations: RDC´s and others

6. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health FEDERAL CONSTITUTION OF 1988 è Article 196 – Health is a right of all and a duty of the State and shall be guaranteed by means of social and economic policies aimed at reducing the risk of illness and other hazards and at the universal and equal access to actions and services for its promotion, protection and recovery.

7. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health FEDERAL CONSTITUTION OF 1988 è Article 197 – Health actions and services are of public importance, and it is incumbent upon the Government to provide, in accordance with the law, for their regulation, supervision and control, and they shall be carried out directly or by third parties and also by individuals or private legal entities.

8. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health FEDERAL CONSTITUTION OF 1988 è è Article 200 – It is incumbent upon the unified health system, in addition to other duties, as set forth by the law: è è I - to supervise and control proceedings, products and substances of interest to health and to participate in the production of drugs, equipments, immunobiological products, blood products and other inputs; è è II - to carry out actions of health and epidemiologic vigilance as well as those relating to the health of workers;

9. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health LAW 8,080/1990 (HEALTH ORGANIC LAW) è Art. 4 The Unified Health System (SUS) is the set of health actions and services, rendered by federal, state and municipal public organisms and institutions, of direct and indirect Administration and the foundations maintained by the Government è Paragraph 1. The federal, state and municipal public institutions of quality control, research and production of raw materials, drugs, including blood and blood derivatives, and health equipment.

10. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health LAW 8,080/1990 (HEALTH ORGANIC LAW) è Art. 6 The field of action of the Unified Health System (SUS) also includes I – the execution of actions a) of health surveillance; d) of whole therapeutic assistance; VII – the control and supervision of services, products and substances of health interest;

11. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health LAW 8,080/1990 (HEALTH ORGANIC LAW) è Art. 6º, § 1º Health surveillance is understood as a set of actions capable of eliminate, diminish or prevent risks to health and intervene in health problems from the environment, the production and circulation of goods e the health service rendering, including:: è I – controlling consumer goods that, direct or indirectly, are related to health, including all phases and processes, from production to consumption; and è II – controlling the rendering of services that are direct or indirectly related to health.

12. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health BRAZILIAN HEALTH SURVEILLANCE NATIONAL SYSTEM – SNVS ANVISA CONASS CONASEMS State, Federal District and Municipal Health Surveillance Centers LACENS INCQS/FIOCRUZ State, Federal District and Municipal Health Councils

13. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA IN THE SUS CONTEXT è Law 9,782/1999: “Art. 1 The National System of Health Surveillance shall be responsible for the range of activities (...) carried out by the direct and indirect public administrative institutions of the Union, of the States, of the Federal District and of the Municipalities, all of which pursue activities concerned with the setting of standards and rules, together with inspection and enforcement in the area of health surveillance. (...)”

14. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA IN SUS CONTEXT LAW 9,782/1999 è Art. 6 The institutional purpose of the agency is to promote the protection of the population’s health by exercising control over the health aspects of the production and marketing of products and services subject to health surveillance. The latter embraces premises, processes, inputs and the technologies related to the same. In addition, the Agency shall exercise health and hygiene control over ports, airports and the country’s borders.

15. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA - INSTITUTIONAL MISSION Mission – “To protect and promote health, ensuring the hygiene and safety of products and services and taking part in developing access to it."

16. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA - INSTITUTIONAL VALUES è Knowledge as a springboard for action è Transparency è Cooperation è Accountability

17. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA - INSTITUTIONAL VISION "To be an agent for transformation of the decentralized sanitary surveillance system, within a network, holding a distinct position, legitimized by the population, as regulator and promoter of social well-being.”

18. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health

19. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health Extrainstitutional Interfaces ANVISAANVISA ProfessionalOrganizationsProfessionalOrganizations Entities/AssociationsEntities/Associations WHO, PAHO UN, OAS UN, OAS WHO, PAHO UN, OAS UN, OAS CSOCSO RegulatoryAgenciesRegulatoryAgencies OfficialLaboratoriesOfficialLaboratories ScientificCommunityScientificCommunity RegulatedSectorRegulatedSector CivilSocietyCivilSociety

20. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health Anvisa – Field of Activity è Food è Cosmetics è Drugs è Health Products è Sanitizing Products è Toxicology è Tobacco derivatives è Health Services è Food è Cosmetics è Drugs è Health Products è Sanitizing Products è Toxicology è Tobacco derivatives è Health Services è Blood è Laboratories è Economic assessment of products è Ports, airports and borders è Foreign Relations è Blood è Laboratories è Economic assessment of products è Ports, airports and borders è Foreign Relations

21. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ECONOMIC MARKET è è 44,500 pharmacies è è 22,809 registered food companies è è 4,566 drug companies è è 3,186 cosmetics companies è è 2,556 health product companies è è 2,602 sanitizing product companies è è 12,000 laboratories of clinical analysis è è 11,012 radiodiagnosis companies è è 5,328 hospitals è è 2,581 hemotherapy service units (718 of them are public) è è 583 hemodialysis service units è è 256 nuclear medicine units è è 149 radiotherapy units è è 27 accredited Bioequivalence Centers è è 155 airports, 46 ports è è 111 borders

22. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health Drug. Legal Definition It is a pharmaceutical product with prophylactic, curative, palliative or diagnosis purposes. Legal Definition It is a crucial instrument for actions of health promotion, protection and recovery, involving the different levels of assistance, accomplished in public and private health sectors.

23. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health MARKET MONITORING Inspection and Control Pharmacosurveillance Notification Pharmacies Sentinel Hospitals MARKET REGULATION Drug Registration Drug Registration Price Monitoring Price Monitoring Clinical Research and Trials Clinical Research and Trials Medicine product area Anvisa’s activities

24. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health DRUG HEALTH SURVEILLANCE AUTHORIZATION FOR COMPANIESREGISTRATION HEALTH REGULATIONS MONITORING AND CONTROL OF PRODUCTS IN THE MARKET INSPECTION OF INSTALLATIONS INFORMATIONKNOWLEDGECAPACITY-BUILDING

25. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health HEALTH SURVEILLANCE SURVEILLANCE PRODUCTION PHARMACEUTICAL ASSISTANCE ASSISTANCE INTERLOCUTIONDIALOGUEINTERLOCUTIONDIALOGUE Safety, Efficacy, Quality Promotion of Rational Use Acess of the Population to Essential Drugs

26. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health NATIONAL POLICY ON DRUGS DIRECTIVE ASSURANCE OF SECURITY, EFFICACY AND QUALITY OF DRUGS National Health Surveillance System Assessment Compliance with health regulations Inspection/Control GMP – Inspection routes REBLAS – to restructure for certification

27. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health LAW 6,360/1976 – ASSURANCE OF DRUG QUALITY è Art 75 - The Ministry of Health shall enact norms and improve mechanisms meant to ensure consumers the quality of medicines, bearing in mind the identity, activity, purity, efficacy and innocuity of products, and encompassing quality specifications and production inspection.

28. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health REGISTRATION OF DRUGS è VACCINES: responsibility of UPBIH è They follow the same recommendations for the other biological products è Legal bases: RDC 315/2005 and Law 6360/76

29. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health VACCINES IN THE CONTEXT OF HEALTH SURVEILLANCE Good Manufacturing Practices Production Quality Control Efficacy Immunogenicity Safety Reactogenicity/Adverse Effects Public Health Costs Health Economy vs. Impact on Public Health

30. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health CLINICAL TRIALS è Essential to prove efficacy and safety by means of research with consumers è First step for registration è Approval in research è Importation for research è Pre-clinical studies è Clinical studies for registration purposes è Phases I, II, III and IV

31. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ETHICS IN CLINICAL RESEARCH AND QUALITY OF CLINICAL TRIALS è Declaration of Helsinki/Nuremberg Code è Resolution 196/CNS and RDC 219/2004 è “Good Clinical Practice” è Governmental Policies that foster Learning/Research and national competitiveness in the market è Greater and better participation of the Official Industry in clinical research and drug production, including vaccines

32. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA - PROGRESS Emphasis on guidance related to the WHO recommendations and international parameters Review and updating of health framework Implementation of public consultation Increase in company inspection Interaction with the regulated sector

33. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health ANVISA – GOALS AND CHALLENGES To have a differentiated, population-legitimated role as an agency of regulation and promotion of social welfare in the scope of health surveillance

34. National Agency of Health Surveillance www.anvisa.gov.br Ministry of Health THANK YOU! Cássio Nascimento Marques Specialist in Health Regulation and Surveillance Agência Nacional de Vigilância Sanitária SEPN 515, Bl. B - Edifício Ômega Brasília/DF - CEP: 70.770-502 Tel: 55 (61) 3448-1000 E-mail: cassio.marques@anvisa.gov.br cassio.marques@anvisa.gov.br