National Agency of Health Surveillance Ministry of Health THE ROLE OF ANVISA IN REGULATING AND PROMOTING SOCIAL WELFARE IN HEALTH Cássio

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

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

Cássio Nascimento MarquesCássio Nascimento MarquesSpecialist in Health Regulation and Specialist in Health Regulation and

SurveillanceSurveillance

INTERNATIONAL SEMINAR – ANTI-HIV VACCINE INTERNATIONAL SEMINAR – ANTI-HIV VACCINE RESEARCH: ETHICAL AND REGULATORY ISSUESRESEARCH: ETHICAL AND REGULATORY ISSUES

Brasília/DF, Brazil, 04-05 October 2006Brasília/DF, Brazil, 04-05 October 2006


CONCEPTUAL ASPECTS

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)


REGULATION ACTIVITY

Regulation: administrative activity of an intervening State

Disciplining, inspecting, controlling Establishing rules Target: public or private

organizations


POLITICAL ASPECTS

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)


HISTORY BACKGROUND

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


FEDERAL CONSTITUTION OF 1988

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

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 1988FEDERAL 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;


LAW 8,080/1990 (HEALTH ORGANIC LAW)

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.



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;



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.


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


ANVISA IN THE SUS CONTEXT 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 SUS CONTEXT ANVISA IN SUS CONTEXT LAW 9,782/1999LAW 9,782/1999

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 - INSTITUTIONALANVISA - INSTITUTIONAL

MISSIONMission – “To protect and promote

health, ensuring the hygiene and safety of products and services and taking

part in developing access to it."



VALUES Knowledge as a springboard for

action Transparency Cooperation Accountability



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.”



Extrainstitutional Interfaces

AANNVVIISSAA

AANNVVIISSAA

ProfessionalProfessionalOrganizationsOrganizationsProfessionalProfessional

OrganizationsOrganizations

Entities/Entities/AssociationsAssociations

Entities/Entities/AssociationsAssociations

WHO, PAHOWHO, PAHO UN, OASUN, OAS

WHO, PAHOWHO, PAHO UN, OASUN, OAS

CSOCSOCSOCSORegulatoryRegulatoryAgenciesAgencies

RegulatoryRegulatoryAgenciesAgencies

OfficialOfficialLaboratoriesLaboratories

OfficialOfficialLaboratoriesLaboratories

ScientificScientificCommunityCommunityScientificScientific

CommunityCommunity

RegulatedRegulatedSectorSector

RegulatedRegulatedSectorSector

CivilCivilSocietySocietyCivilCivil

SocietySociety


Anvisa – Field of ActivityAnvisa – Field of Activity FoodFood CosmeticsCosmetics DrugsDrugs Health ProductsHealth Products Sanitizing ProductsSanitizing Products ToxicologyToxicology Tobacco derivativesTobacco derivatives Health ServicesHealth Services

FoodFood CosmeticsCosmetics DrugsDrugs Health ProductsHealth Products Sanitizing ProductsSanitizing Products ToxicologyToxicology Tobacco derivativesTobacco derivatives Health ServicesHealth Services

BloodBlood LaboratoriesLaboratories Economic Economic

assessment of assessment of productsproducts

Ports, airports and Ports, airports and bordersborders

Foreign RelationsForeign Relations

BloodBlood LaboratoriesLaboratories Economic Economic

assessment of assessment of productsproducts

Ports, airports and Ports, airports and bordersborders

Foreign RelationsForeign Relations


ECONOMIC MARKETECONOMIC MARKET

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

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


DrugIt is a pharmaceutical product with prophylactic, curative, palliative or diagnosis purposes .. Legal DefinitionLegal Definition

It is a crucial instrument for actions of health It is a crucial instrument for actions of health promotion, protection and recovery, promotion, protection and recovery,

involving the different levels of assistance, involving the different levels of assistance, accomplished in public and private health accomplished in public and private health

sectors.sectors.


MARKET MARKET MONITORINGMONITORING

Inspection and Control Pharmacosurveillance Notification Pharmacies Sentinel Hospitals

MARKET REGULATIONMARKET REGULATION

Drug Registration Drug Registration

Price MonitoringPrice Monitoring

Clinical Research and TrialsClinical Research and Trials

Medicine product areaAnvisa’s activities


DRUG HEALTH SURVEILLANCE

AUTHORIZATION FOR COMPANIES

REGISTRATIONREGISTRATION

HEALTHREGULATIONS

MONITORING AND CONTROL OF PRODUCTS IN THE

MARKET

INSPECTION OF

INSTALLATIONS

INFORMATIONINFORMATIONKNOWLEDGEKNOWLEDGE

CAPACITY-BUILDINGCAPACITY-BUILDING


HEALTHHEALTH SURVEILLANCESURVEILLANCE

PRODUCTIONPRODUCTIONPHARMACEUTICALPHARMACEUTICAL

ASSISTANCEASSISTANCE

INTERLOCUTIONINTERLOCUTIONDIALOGUEDIALOGUE

INTERLOCUTIONINTERLOCUTIONDIALOGUEDIALOGUE

Safety, Efficacy, Quality Promotion of Rational Use

Acess of the Population to Essential Drugs


NATIONAL POLICY ON DRUGS NATIONAL POLICY ON DRUGS DIRECTIVEDIRECTIVE

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


LAW 6,360/1976 – ASSURANCE OF DRUG QUALITY

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.


REGISTRATION OF DRUGS

VACCINES: responsibility of UPBIH They follow the same

recommendations for the other biological products

Legal bases: RDC 315/2005 and Law 6360/76


VACCINES IN THE CONTEXT OF VACCINES IN THE CONTEXT OF HEALTH SURVEILLANCEHEALTH SURVEILLANCE

• Good Manufacturing PracticesProductionQuality Control

• Efficacy Immunogenicity

• SafetyReactogenicity/Adverse Effects

• Public Health Costs Health Economy vs. Impact on Public Health


CLINICAL TRIALS

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


ETHICS IN CLINICAL RESEARCH AND ETHICS IN CLINICAL RESEARCH AND QUALITY OF CLINICAL TRIALSQUALITY OF CLINICAL TRIALS

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


ANVISA - PROGRESSANVISA - 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


ANVISA – GOALS AND ANVISA – GOALS AND CHALLENGESCHALLENGES

To have a differentiated, population-legitimated role as an agency of regulation and

promotion of social welfare in the scope of health surveillance


THANK YOU!THANK YOU! Cássio Nascimento Marques Cássio Nascimento Marques

Specialist in Health Regulation and SurveillanceSpecialist in Health Regulation and SurveillanceAgência Nacional de Vigilância SanitáriaAgência Nacional de Vigilância Sanitária

SEPN 515, Bl. B - Edifício ÔmegaSEPN 515, Bl. B - Edifício ÔmegaBrasília/DF - CEP: 70.770-502 Brasília/DF - CEP: 70.770-502

Tel: 55 (61) 3448-1000Tel: 55 (61) 3448-1000E-mail: E-mail: [email protected]

Documents

National Agency of Health Surveillance Ministry of Health THE ROLE OF ANVISA IN REGULATING AND PROMOTING SOCIAL WELFARE IN HEALTH Cássio