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THE ROLE OF ANVISA IN REGULATING AND PROMOTING SOCIAL WELFARE IN HEALTH

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

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THE ROLE OF ANVISA IN REGULATING AND PROMOTING SOCIAL WELFARE IN HEALTH

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

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

  3. Regulation: administrative activity of an intervening State Disciplining, inspecting, controlling Establishing rules Target: public or private organizations REGULATION ACTIVITY

  4. Social welfare: Focus on social-democracy and the modern State concept “...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) POLITICAL ASPECTS

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

  6. 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. FEDERAL CONSTITUTION OF 1988

  7. 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. FEDERAL CONSTITUTION OF 1988

  8. FEDERAL CONSTITUTION OF 1988 • Article 200 – It is incumbent upon the unified health system, in addition to other duties, as set forth by the law: • 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; • II - to carry out actions of health and epidemiologic vigilance as well as those relating to the health of workers;

  9. 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 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. LAW 8,080/1990 (HEALTH ORGANIC LAW)

  10. 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; LAW 8,080/1990 (HEALTH ORGANIC LAW)

  11. 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:: I – controlling consumer goods that, direct or indirectly, are related to health, including all phases and processes, from production to consumption; and II – controlling the rendering of services that are direct or indirectly related to health. LAW 8,080/1990 (HEALTH ORGANIC LAW)

  12. 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. 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. (...)” ANVISA IN THE SUS CONTEXT

  14. 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.   ANVISA IN SUS CONTEXT LAW 9,782/1999

  15. MISSIONMission – “To protect and promote health, ensuring the hygiene and safety of products and services and taking part in developing access to it." ANVISA - INSTITUTIONAL

  16. VALUES Knowledge as a springboard for action Transparency Cooperation Accountability ANVISA - INSTITUTIONAL

  17. 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.” ANVISA - INSTITUTIONAL

  18. Extrainstitutional Interfaces Regulated Sector Professional Organizations A N V I S A Scientific Community Entities/ Associations Official Laboratories WHO, PAHO UN, OAS Regulatory Agencies Civil Society CSO

  19. Anvisa – Field of Activity • Food • Cosmetics • Drugs • Health Products • Sanitizing Products • Toxicology • Tobacco derivatives • Health Services • Blood • Laboratories • Economic assessment of products • Ports, airports and borders • Foreign Relations

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

  21. Drug 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.

  22. Medicine product areaAnvisa’s activities MARKET MONITORING • Inspection and Control • Pharmacosurveillance • Notification Pharmacies • Sentinel Hospitals • MARKET REGULATION • Drug Registration • Price Monitoring • Clinical Research and Trials

  23. DRUG HEALTH SURVEILLANCE AUTHORIZATION FOR COMPANIES REGISTRATION INFORMATION KNOWLEDGE CAPACITY-BUILDING INSPECTION OF INSTALLATIONS HEALTH REGULATIONS MONITORING AND CONTROL OF PRODUCTS IN THE MARKET

  24. DRUG POLICY PHARMACEUTICAL ASSISTANCE PRODUCTION HEALTH SURVEILLANCE INTERLOCUTION DIALOGUE Safety, Efficacy, Quality Promotion of Rational Use Acess of the Population to Essential Drugs

  25. 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

  26. 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. LAW 6,360/1976 – ASSURANCE OF DRUG QUALITY

  27. VACCINES: responsibility of UPBIH They follow the same recommendations for the other biological products Legal bases: RDC 315/2005 and Law 6360/76 REGISTRATION OF DRUGS

  28. Good Manufacturing Practices Production Quality Control Efficacy Immunogenicity Safety Reactogenicity/Adverse Effects Public Health Costs Health Economy vs. Impact on Public Health VACCINES IN THE CONTEXT OF HEALTH SURVEILLANCE

  29. Essential to prove efficacy and safety by means of research with consumers First step for registration Approval in research Importation for research Pre-clinical studies Clinical studies for registration purposes Phases I, II, III and IV CLINICAL TRIALS

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

  31. 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

  32. 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

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

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