Challenges in ensuring access to HIV medicines and IP rights: country experiences (Brazil)
Dr Jorge Bermudez,
Vice President of Health Production and Inovation
(VPPIS – FIOCRUZ)
UNITAID – 3rd Consultative Forum
Geneva, October 2011

In 1988
National Constitution – “Health is a right of all and a State duty”
In 1996
Law 9.313, 13 November 1996 - Guarantees free access to antiretroviral therapy.
National industries currently manufacture eight antiretroviral drugs and Brazil is in a strong position to negotiate prices with patent holders.
In 1999
Law 9.782, 26 January 1999 - Creates the National Regulatory Agency ANVISA, which decides the sanitary surveillance policies and regulation.
The State, with the full power of the Constitution to support it (1988), became the repository of a wide range of sanitary surveillance responsibilities, looking after the rights of the consumer and assuming responsibility for providing better health conditions for the population.
In 1999
Law 9.787, 10 Februrary 1999 - Alters Law nº 6.360, of 23 September 1976, concerning sanitary surveillance, establishes the generic drug policy, decides upon the use of generic names in pharmaceutical products, among other procedures.
Generics Drugs – The introduction of generic drugs on the brazilian market changes all the pharmaceutical market share and the pharmaceutical industries approaches.

In 2000
Faced with Merck’s refusal to reduce the price of an antiretroviral, the Brazilian government raised the possibility of issuing a compulsory license to manufacture the product.
In 2004
- Brazil and Cuba have undertaken joint projects in biotechnology. Among the most important are the production of recombinant erythropoietin and interferon as well as development and supply to Africa (at WHO’s request) of a meningitis vaccine.
,
In 2007
- The first compulsory license was effectively issued for the antiretroviral drug efavirenz , used by 75.000 patients.
In 2009
- Declaration by Brazil and India at WTO criticizing the European Union’s policy restricting the entrance of generic drugs and the FTA, following Schiphol confiscation of products in transit.

• There are 2792 generic medications registered in Brazil
(90% domestic manufacturing).
• The volume of generics has been growing from 223 million units distributed in 2007 to 330 million in 2010.
• Generics are 25% of all medications sold in Brazil, and there is more potential market. The share of generics is
50% in the United States and 45% in Europe.

• According to the Intellectual Property Rights Law amendment - “The prior consent for a patent to a pharmaceutical product is dependent on the previous evaluation of the Brazilian Health Regulatory Agency -
ANVISA (Agência Nacional de Vigilância Sanitária).”
• This new legal mechanism, known as Anuência Prévia (Prior
Consent), divides the examination of patent applications for pharmaceutical products and processes between two federal agencies in Brazil; the main one being the National Institute of Intellectual Property (INPI) and the second being
ANVISA.

• The law permits ANVISA, the federal agency devoted to the protection of public health, to consider the public interest when deciding whether to allow the grant of patents approved for patentability by INPI (Patent Office).
• Predictably, the law has instigated debate within Brazil and throughout the world as to the procedure's legality and policy, including the so-called 4 th requisite. What would be
Prior Consent's proper place within Brazil and under the international regime of intellectual property law, which is mainly defined by the WTO TRIPS Agreement is currently under debate.

• The Brazilian government, March 2006, publicly threatened to issue CL on four anti-retroviral medications -- Merck's Efavirenz, Abbott Laboratories'
Lopinavir and Ritonavir, and Gilead's Tenofovir - if the companies did not agree to allow Brazil to produce generic equivalents or buy those patented drugs at discounted prices.
• Eventually, Brazil reached an agreement with Abbott to lower the cost of
Lopinavir and Ritonavir, (Kaletra R) from $1.17 to 63 cents a pill, while still protecting the drug's patent.
• Under the terms of that agreement, Brazilian manufacturers can not produce a generic version of the drug for their domestic market.
• Brazil, according to writers, is now the world's tenth-largest economy, in part because of "this illegal seizure" of technology and information. All procedures are strictly legal and complying with international agreements.

• On the federal level, Brazil has taken steps toward strengthening IP protection. In December 2004, the federal government passed Law No. 10,973, which
"introduces provisions on incentives for innovation and scientific and technology research in the production environment”, adding that this law encourages publicprivate R&D partnerships and enables public subsidies to private technology commercialization initiatives. "With this law, the legislature and executive [branch] have confronted head on the overriding obstacles to technology innovation and commercialization in Brazil."

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895.070.562,07
Atazanavir 200mg
Atazanavir 300mg
Darunavir 300mg
Didanosina EC 250mg
Didanosina EC 400mg
Didanosina (4g)
Efavirenz Cápsula 200mg
Efavirenz 600mg
Medicine
Efavirenz
Enfuvirtida (T-20) 90mg/ml
Estavudina 30mg
Estavudina
Etravirina 100mg
Fosamprenavir 700mg
Fosamprenavir 95ml
Indinavir 400mg
Demand (units)
2010
4.800.000
10.200.000
12.960.000
1.200.000
1.376.250
9.000
330.030
54.000.000
24.500
21.750
3.852.000
20.000
403.200
1.800.000
1.480
Supplier
LAWRENCE
LAWRENCE
JANSSEN
LAWRENCE
LAWRENCE
LAFEPE
UNICEF
FIOCRUZ
LAFEPE
UNICEF
MERCK
ROCHE
FIOCRUZ
CRISTÁLIA
JANSSEN
GLAXO
GLAXO
4.950.000
Expenditure (R$)
LAFEPE
LAFEPE
LIFAL
LIFAL see next slide...
19.958.400,00
76.683.600,00
103.161.600,00
2.058.840,00
3.095.901,90
555.570,00
119.052,00
36.450.000,00
12.150.000,00
7.386.981,00
747.201,00
54.403.779,19
885.960,00
1.167.018,00
4.209.408,00
6.913.800,00
304.732,00
1.488.960,00
372.240,00
2.233.440,00
558.360,00

Medicine
Lamivudina 150mg
Lamivudina
Lamivudina
Lopinavir+Ritonavir 200mg + 50mg
Lopinavir+Ritonavir 100mg + 25mg
Lopinavir+Ritonavir 80mg/ml + 20mg/ml
Nevirapina 200mg
Raltegravir 400mg
Ritonavir 100mg
Ritonavir
Saquinavir 200mg
Tenofovir 300mg
Tipranavir 250mg
Tipranavir 100mg/mL
Zidovudina 100mg
Zidovudina 10mg/ml
Zidovudina 50mg/5ml
Zidovudina+Lamivudina 300mg + 150mg
Zidovudina+Lamivudina 300mg + 150mg
Demand (units)
2010
Supplier
63.000.000
91.000
106.080.000
660.000
25.000
16.451.160
5.100.000
20.400.000
530
1.015.200
30.000.000
136.080
1.676
6.200.000
18.000
129.000
133.750.080
FIOCRUZ
FURP
IQUEGO
IQUEGO
ABBOTT
ABBOTT
ABBOTT
FIOCRUZ
FUNED
FUNED
MERCK
ABBOTT
ABBOTT
CRISTÁLIA
GILEAD
BOEHRINGER
BOEHRINGER
FIOCRUZ
CRISTÁLIA
LAFEPE
FIOCRUZ
FURP
FUNED
IQUEGO
LAFEPE
479.005.936
72,66%
Expenditure (R$)
17.325.000,00
11.781.000,00
5.544.000,00
1.885.520,00
137.655.772,80
571.071,60
1.946.375,00
4.811.400,00
4.811.400,00
1.202.850,00
86.134.104,00
11.453.000,00
282.389,30
1.705.536,00
120.750.000,00
1.166.205,60
623.472,00
1.612.000,00
88.369,20
917.190,00
59.812.500,00
29.301.294,00
28.105.044,00
10.766.250,00
19.140.000,00
895.070.562,07
650.315.422,39

“O Brasil defende o acesso aos medicamentos como parte do direito humano. Sabemos que é elemento estratégico para a inclusão social, a busca da equidade e o fortalecimento dos sistemas públicos de saúde.
(...)
O Brasil respeita seus compromissos em matéria de propriedade intelectual, mas estamos convencidos de que as flexibilidades previstas no Acordo TRIPS da OMC, na Declaração de Doha sobre
TRIPS e Saúde Pública, e na Estratégia Global sobre Saúde Pública são indispensáveis para políticas que garantam o direito à saúde”.
Presidente Dilma Rousseff 19 Set-2011