WHO Meeting of Interested Parties Scaling-up access to medicines within the Brazilian National Health System WHO Meeting of Interested Parties Geneva, 3 to 7 November 2003 (Presentation by Jorge Bermudez, MD, PhD, Director, National School of Public Health, Brazilian Ministry of Health)

The main principles of the Brazilian National Health System (SUS 15 years) Universal care Strongly based on Alma Ata Declaration, 1978 and guided by WHO guidelines Health as a citizenship right and State duty (1988 Constitution) Principles of universality, integrality, equity, decentralization and social control Adequated legal framework (Constitution, Law 8,080 and 8,142, Operational Norms 1991, 1993, 1996, 2001, 2003)

Relevance of the Brazilian National Health System (SUS 15 years) 90% of population is covered 28,6% of population exclusively use the SUS 63,650 out-patient units 5,794 hospital units, with 441,045 beds 1 million millions (1,000,000,000) of basic health care procedures yearly 251 million laboratory exams yearly 21,000 Family Health teams attending more than 73 million people in 90% of the Brazilian cities (in expansion 2003)

Ministry of Health guidelines for 2003 Expansion of access to health services and actions, including pharmaceutical care, ensuring quality Intensification of endemic diseases control and strengthening of health surveillance actions Formulation and implementation of a Human Resources policy Strengthening of the democratic management in the system

Ministry of Health guidelines (scaling-up of access to medicines) Setting NDP and the revision of the Essential Medicines List, following WHO guidelines Decentralization of Basic Pharmaceutical Care The new Regulatory Agency in 1999 (ANVISA) The Generics Law in 1999 regulating Bio-availability and Bio-equivalence with interchangeability of medicines A comprehensive system: central and decentralized procurement of medicines ensuring universal access IPR, Innovation and access to medicines in Brazil (actions related to universal access to ARV and the patent Law) Economic Regulation of the pharmaceutical sector (Medicines Chamber: Ministries of Health, Justice, Financing and the Civil House): monitoring OTC, price regulation.

Cathegories of medicines provision (Estimated values [R$]) Strategic programmes (Tuberculosis, leprosy, HIV/AIDS [ARV], endemic diseases, diabetes, blood factors, hypertension 997.179.443 Medicines for Basic Pharmaceutical Care, corresponding to R$ 2,00/inhabitant/year, with half funded by the Federal Government and the other half shared by the State and Municipal managements, coordinated previously within each State 332.798.754 High cost medicines with sharing of the Federal Government and States (Chronic renal disease, hepatitis, Gaucher Syndrome, others), all with STG 489.533.000 Hospital care, estimated (MAT/MED) 1.182.500.000 TOTAL ANNUAL 3.002.017.237 Source: Fernando Cárdenas (Apresentação no Seminário Internacional “Os desafios para uma assistência farmacêutica integral”, Brasilia, 1 de Outubro 2002)

State manufacturing facilities in Brazil (data from the Ministry of Health, 2003)

Participants in the National Conference (Brasilia, 15 to 18 September 2003) Segment Requests Present Absent % of Presents Health service delivery/Private provider 292 209 83 71,58% Health Professional 301 234 67 77,74% User (Consumer) 606 472 134 77,89% TOTAL 1199 915 284 76,31%

Brazilian insertion in ongoing global initiatives with PAHO and WHO PAHO, WB and IDB Shared Agenda Pharmaceutical Clearinghouse for the Americas PAHO Public Health Virtual Campus Medecins Sans Frontiers, OXFAM and WHO Drugs for Neglected Diseases project and initiative Health Action International, Rockefeller Foundation and WHO Pricing Methodology Manual MDG task forces and access to medicines Development of joint PAHO and WHO International Seminaries for Latin American and African participants

National School of Public Health as a PAHO/ WHO Collaborating Centre (core activities) Access to medicines (methodology, indicators, evaluation and assessment in the Americas) Rational Use of Medicines (RUM), including translation of WHO documents for Portuguese-speaking countries TRIPS Agreement and access to medicines monitoring network, assessing the Region of the Americas Access to care for PLWHA network (joint project with UNAIDS and the French MAE)