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 ForumGeneva, October 2011

National experiences – Brazilian background

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.

Relevant Landmarks

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.

Generic Medicines in Brazil

• 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.

ANVISA Prior Consent

• 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.

ANVISA Prior Consent

• 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 4th 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.

“Breaking Patents?”

• 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, (KaletraR) 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.

Innovation Incentives and IP Protection

• 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 public-private 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."

MPP - License agreement signed

July 12th 2011- The first license agreement signed

between the Medicines Patent Pool Foundation and a private pharmaceutical company (Gilead Sciences)

- Brazil formally complained on:

.non-exclusivity

.non-discrimination

.transparency

Federal Government expenditure with ARV

R$ 895.070.562,07

see next slide...

Medicine Demand (units) 2010 Supplier Expenditure (R$)

Atazanavir 200mg 4.800.000 LAWRENCE 19.958.400,00

Atazanavir 300mg 10.200.000 LAWRENCE 76.683.600,00

Darunavir 300mg 12.960.000 JANSSEN 103.161.600,00

Didanosina EC 250mg 1.200.000 LAWRENCE 2.058.840,00

Didanosina EC 400mg 1.376.250 LAWRENCE 3.095.901,90

Didanosina (4g) 9.000 LAFEPE 555.570,00

Efavirenz Cápsula 200mg 330.030 UNICEF 119.052,00

Efavirenz 600mg 54.000.000 FIOCRUZ 36.450.000,00

LAFEPE 12.150.000,00

UNICEF 7.386.981,00

Efavirenz 24.500 MERCK 747.201,00

Enfuvirtida (T-20) 90mg/ml 21.750 ROCHE 54.403.779,19

Estavudina 30mg 3.852.000 FIOCRUZ 885.960,00

Estavudina 20.000 CRISTÁLIA 1.167.018,00

Etravirina 100mg 403.200 JANSSEN 4.209.408,00

Fosamprenavir 700mg 1.800.000 GLAXO 6.913.800,00

Fosamprenavir 95ml 1.480 GLAXO 304.732,00

Indinavir 400mg 4.950.000 LAFEPE 1.488.960,00

LAFEPE 372.240,00

LIFAL 2.233.440,00

LIFAL 558.360,00

Lamivudina 150mg 63.000.000 FIOCRUZ 17.325.000,00

FURP 11.781.000,00

Lamivudina IQUEGO 5.544.000,00

Lamivudina 91.000 IQUEGO 1.885.520,00

Lopinavir+Ritonavir 200mg + 50mg 106.080.000 ABBOTT 137.655.772,80

Lopinavir+Ritonavir 100mg + 25mg 660.000 ABBOTT 571.071,60

Lopinavir+Ritonavir 80mg/ml + 20mg/ml 25.000 ABBOTT 1.946.375,00

Nevirapina 200mg 16.451.160 FIOCRUZ 4.811.400,00

  FUNED 4.811.400,00

  FUNED 1.202.850,00

Raltegravir 400mg 5.100.000 MERCK 86.134.104,00

Ritonavir 100mg 20.400.000 ABBOTT 11.453.000,00

Ritonavir 530 ABBOTT 282.389,30

Saquinavir 200mg 1.015.200 CRISTÁLIA 1.705.536,00

Tenofovir 300mg 30.000.000 GILEAD 120.750.000,00

Tipranavir 250mg 136.080 BOEHRINGER 1.166.205,60

Tipranavir 100mg/mL 1.676 BOEHRINGER 623.472,00

Zidovudina 100mg 6.200.000 FIOCRUZ 1.612.000,00

Zidovudina 10mg/ml 18.000 CRISTÁLIA 88.369,20

Zidovudina 50mg/5ml 129.000 LAFEPE 917.190,00

Zidovudina+Lamivudina 300mg + 150mg 133.750.080 FIOCRUZ 59.812.500,00

FURP 29.301.294,00

FUNED 28.105.044,00

Zidovudina+Lamivudina 300mg + 150mg   IQUEGO 10.766.250,00

LAFEPE 19.140.000,00

479.005.936 895.070.562,07 72,66% 650.315.422,39

Medicine Demand (units) 2010 Supplier Expenditure (R$)

“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