Propriedade Intelectual e Aids no Brasil Dr. Paulo Roberto Teixeira Secretaria de Estado da Saúde de São Paulo VIII Congresso Brasileiro de Saúde coletiva XI Congresso Mundial de Saúde Pública Rio de Janeiro, Agosto de 2006

Lei de Patentes no Brasil (incorpora medicamentos) Licença Compulsória Artigo 68: Uso abusivo; Prática abusiva de poder econômico; Não exploração do objeto da patente em território nacional Artigo 71: Emergência Nacional ou Interesse Público

Tratamento anti-retroviral no Brasil 1989: AZT - São Paulo 1991: AZT/DDI/Doenças oportunistas - Brasil 1995: Inibidores de Protease - São Paulo 1996/1997: Terapia combinada - Brasil (Lei Sarney)

Número de pacientes em terapia ARV Brasil, 1997 – 2005 Projeção 180000 160000 140000 120000 100000 80000 60000 170.000 40000 20000 jan/97 abr/97 jul/97 out/97 jan/98 abr/98 jul/98 out/98 jan/99 abr/99 jul/99 out/99 jan/00 abr/00 jul/00 out/00 jan/01 abr/01 jul/01 out/01 jan/02 abr/02 jul/02 out/02 jan/03 abr/03 jul/03 out/03 jan/04 abr/04 jul/04 out/04 jan/05 abr/05 jul/05 out/05 * Dados preliminares

Anti-retrovirais distribuídos pelo Sistema Único de Saúde. Brasil, 2005 ITRN e ITRNt IP ZIDOVUDINE (1993)* ESTAVUDINE (1997)* DIDANOSINE (1998)* LAMIVUDINE (1999)* ABACAVIR (2001) DIDANOSINE EC (2005) TENOFOVIR (2003) RITONAVIR (1996)* SAQUINAVIR (1996)* INDINAVIR (1997)* NELFINAVIR (1998) AMPRENAVIR (2001) LOPINAVIR/r (2002) ATAZANAVIR (2004) About 17 different ARVs are currently distributed through the public health system, including new drugs such as atazanavir, tenofovir and enfuvirtide. Of these 17 drugs, 8 have national production. The sharp drop in AIDS mortality mentioned before and the very low level of primary resistance, which, according to a 2003 survey, stands at 8,3%, represent very sucessful results of our national policy. Nevertheless, a National Network of Viral Load and CD4+ Laboratories, with 81 and 71 labs respectively, provides adequate patient monitoring. Genotyping tests are also carried out, through the National Genotyping Network, which counts with 14 laboratories and 180 accredited physicians. ITRNN Inibidor de Fusão NEVIRAPINE (2001)* EFAVIRENZ (1999) ENFUVIRTIDE (2005) *Produção Nacional

Redução de Preços - Nelfinavir Fonte: PN DST/Aids

Redução de Preços - Efavirenz

Ação internacional do Brasil 2000: Durban - Cooperação Técnica 2001: ARV como Direito Humano - ONU 2001: Resolução da Assembléia da OMS 2001: UNGASS – Acesso ao Tratamento ARV 2001: Reunião Ministerial da OMC - Doha

Declaração de Doha “Nós Concordamos que o Acordo de TRIPS não deve impedir os países membros de tomar as medidas necessárias para proteger a Saúde Pública.” (dezembro de 2001)

Redução de Preços – Lopinavir - r Fonte: PN DST/Aids

Custo Médio anual da Terapia anti-retroviral por paciente (US$) Custo Médio anual da Terapia anti-retroviral por paciente (US$). Brasil, 2005 7000 6240 6000 5486 5000 4603 4000 3464 3000 Thousands (US$) 2500 2210 2000 The average cost with antiretrovirals per patient/year decreased substantially from 1997 through 2001, in spite of the increase in the number of patients needing more expensive and complex treatments. It has been possible by a three-fold strategy: firstly, investments made by the Ministry of Health to set up national producers, such as public laboratories; secondly, the gains obtained from large scale procurement; and thirdly, price negotiations with pharmaceutical companies holders of patent rights. This strategy, however, has shown signs of exhaustion. (APERTAR QUALQUER TECLA) From 2002 to 2004, the average cost per patient/year decreased only marginally, as the prices of patented second-line stopped falling substantially, and the number of people using them increased significantly. In 2005, for the first time since 2001, the average cost per patient per year will actually rise, and is expected to go back to its pre-2001 level. 1500 1359 1336 1000 1997 1998 1999 2000 2001 2002 2003 2004 2005* Ano Fonte: PN DST/Aids, MS

Estimativa de Gastos com Medicamentos ARV para 2005, por Origem da Produção. Brasil, 2005 106.88 309.59 Lopinavir/r 34.5% Tenofovir 12.2% 31.60 Importados Produção Nacional 84.07 78,6% Efavirenz 17.8% 55.09 21,4% Outros importados : 37.5% When breaking down the expected expenditures in ARV procurement for 2005, an astonishing conclusion rises: 62.5% of the 310 million dollars budgeted for ARV branded acquired, in 2005, will be spent with the procurement of only three drugs: efavirenz, lopinavir and tenofovir. This proportion, already high, is expected to increase even further in the future. I would like to take this opportunity to clarify one point: Brazil does not impose any kind of duty or tax on the importation of antiretrovirals. Any allegation to the contrary as those made by certain American think tanks are absolutely false. 116.02 * Considerando 180.000 pacientes Fonte: PN DST/Aids, MS

Total de Gastos (em US$ milhão) com ARV e número médio de pacientes em tratamento – Brasil, 1997 – 2005* 450 200 395 400 180 336 160 350 305 303 140 300 120 250 224 232 Número de pacientes (milhares) Gastos em US$ milhão 203 100 179 181 200 80 150 60 TThis graph illustrates the new trend . From 1999 to 2002, substantial reductions in ARV expenditures were achieved year after year. Since 2002, however, this trend changed, and will be reversed in 2005, with expenditures raising to their highest level ever. As the number of patients increase, and new, expensive drugs are added to our national treatment guidelines (for example: Enfuvirtida and Tenofovir), there is every reason to believe that the situation could become economically unsustainable in short time, due to possibility of introduction new molecules and new ARV classes. 100 40 50 20 1997 1998 1999 2000 2001 2002 2003 2004 2005* Gasto (US$ milhão) Número médio de pacientes (milhares) Fonte: PN DST/AIDS|/SVS/MS * Dados sujeitos a revisão e modificação