(2002; 166 pages)
Harmonization in the Americas
Dr Grandville G. de Oliveira, Brazil
The Brazilian Sanitary Surveillance Agency (now called ANVISA) is the national regulatory agency in Brazil. It has financial and administrative independence despite being politically subordinate to the Ministry of Health. There are five directors, appointed for three years, who are responsible for developing plans for the Government. ANVISA has responsibilities in various specific areas, including products (e.g. biologicals, drugs, devices and cosmetics), medical and health services, price monitoring and the borders. It also deals with international affairs and financial and administrative matters. The administration of the health system has three levels: (1) federal, (2) state and (3) municipal/county. The mission is to protect and to promote health, by ensuring the safety of products and services.
The vision of ANVISA is “To be the agent of transformation of the decentralized sanitary surveillance system within a network, holding a distinct position, legitimized by the population, as regulator and promoter of social welfare.” Acting at the national level, ANVISA has as main activities the decentralization of surveillance, interaction with society, and the development of relationships with the regulated sector. The concept of essential drugs was developed in 1971. ANVISA is also responsible for national regulation and international harmonization. Harmonization has been achieved through the Pan American Network for Drug Regulatory Harmonization (PANDRHA) and MERCOSUR, the Southern Common Market.
The participants in PANDRHA are the regulatory authorities from each member state and representatives from industry, academia, professional groups, consumers, regional economic integration groups, global drug harmonization initiatives, and other interested groups. The initiative to support the processes of regulatory harmonization covers the whole of the Americas, with the coordination of the Pan American Health Organization. It deals with issues related to bioequivalence, good manufacturing practices, good clinical practice, counterfeit drugs and the pharmacopoeia. New issues to be taken up include medicinal plants, pharmacovigilance, drug registration and drug classification. Three conferences have already taken place.
MERSOCUR comprises Argentina, Brazil, Paraguay and Uruguay, and is a political and economic grouping. MERCOSUR seeks to harmonize efforts in health, to improve health protection and to eliminate nontariff barriers to increased flow of goods at national, regional and international levels. Some results are:
• regulation is harmonized among members, and the national legislation of each member state must reflect the agreements and be enacted simultaneously;
• the technical skills of human resources are improved through control and inspection;
• joint inspection programmes are carried out on manufacturing companies;
• sanitary surveillance systems have been improved in all member states;
• there is a common drug policy.