Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Close this folderAccess to drugs and vaccines II
View the documentTwenty-five years of essential medicines: progress and agenda for regulators
View the documentEssential drugs list: South African experience
View the documentThe role of government and essential drugs - Indonesian experience
View the documentThailand’s experience in access to medicines
View the documentCurrent vaccine shortages in the United States of America
View the documentExpanding access to essential medicines and vaccines: lessons learnt in Brazil
View the documentRecommendations
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover

Expanding access to essential medicines and vaccines: lessons learnt in Brazil

Dr Jorge Bermudez, Brazil

In order to expand access to drugs, Brazil has taken the following actions since formulation of the Patent Law in 1996:

• establishment of the National Drug Policy in 1998;
• review of the national essential drugs list in 1999;
• development of a basic pharmacy programme from 1997 to 1999;
• decentralization of basic pharmaceutical care in 1999;
• establishment of the new health surveillance system and regulatory agency in 1999;
• enactment of the Generics Act in 1999;
• establishment of a parametric formula for readjustment of prices of drugs in 2000; and
• exemption from federal and state taxes for drugs for continuous use in 2001.

The Brazilian HIV/AIDS programme is a broad-based programme with a comprehensive infrastructure for patient care which includes hospitals, specialized care services, day hospitals and home care. The Government is responsible for the procurement of 13 drugs used to treat HIV/AIDS. A computerized system has been developed for the control of drug logistics for the care of AIDS patients.

The prices of antiretroviral drugs have been reduced by 78% through domestic production, and by 70% through negotiation based on differential prices. The prices of imported antiretroviral drugs have also been reduced by 25%. As a result, it is estimated that 234 000 AIDS-related hospital admissions were avoided between 1997 and 2000. AIDS-related mortality has been reduced by approximately 50% and the incidence of the major opportunistic conditions associated with severe immunodeficiency in patients with HIV/AIDS decreased by 60-80%. In the future, we plan to make cooperation agreements with other countries.

The market for generic drugs is expanding and more companies are interested in manufacturing generic drugs in Brazil.

The Brazilian national immunization programme was created in 1973. The overall coverage increased from 40% in 1978 to 94.7% in 1999. 75% of the vaccines are locally manufactured (there is a development programme sponsored by the Ministry of Health) or supplied under international cooperation and technological agreements.

Our experience leads to several recommendations for expanding access to drugs:

• give importance to formulating, implementing and monitoring health sector policies;

• use regulation as a framework for political commitment of governments;

• potentiate alliances with developing countries;

• adopt a public health approach to trade issues;

• hold discussions with ICH and emerging countries on standards for manufacture of raw materials; and

• reaffirm government commitment and undertake necessary actions to ensure equitable access.


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