Transcript jorge bermudez 1 Geneva_challenges (UTD CF)

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
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 $1.17 to 63 cents a pill, while still
protecting the drug's patent.
• Under the terms of that agreement, Brazilian manufacturers can not
produce a generic version of the drug for their domestic market.
• Brazil, according to writers, is now the world's tenth-largest economy, in
part because of "this illegal seizure" of technology and information. All
procedures are strictly legal and complying with international agreements.
Innovation Incentives and IP Protection
• On the federal level, Brazil has taken steps toward
strengthening IP protection. In December 2004, the
federal government passed Law No. 10,973, which
"introduces provisions on incentives for innovation and
scientific and technology research in the production
environment”, adding that this law encourages publicprivate R&D partnerships and enables public subsidies to
private technology commercialization initiatives. "With this
law, the legislature and executive [branch] have
confronted head on the overriding obstacles to technology
innovation and commercialization in Brazil."
MPP - License agreement signed
July 12th 2011
- The first license agreement signed
between the Medicines Patent Pool
Foundation and a private pharmaceutical
company (Gilead Sciences)
- Brazil formally complained on:
.non-exclusivity
.non-discrimination
.transparency
Federal Government expenditure with ARV
R$ 895.070.562,07
Medicine
Demand (units)
2010
Supplier
Expenditure (R$)
Atazanavir 200mg
4.800.000
LAWRENCE
19.958.400,00
Atazanavir 300mg
10.200.000
LAWRENCE
76.683.600,00
Darunavir 300mg
12.960.000
JANSSEN
Didanosina EC 250mg
1.200.000
LAWRENCE
2.058.840,00
Didanosina EC 400mg
1.376.250
LAWRENCE
3.095.901,90
Didanosina (4g)
Efavirenz Cápsula 200mg
Efavirenz 600mg
103.161.600,00
9.000
LAFEPE
555.570,00
330.030
UNICEF
119.052,00
54.000.000
FIOCRUZ
36.450.000,00
LAFEPE
12.150.000,00
UNICEF
7.386.981,00
Efavirenz
24.500
MERCK
747.201,00
Enfuvirtida (T-20) 90mg/ml
21.750
ROCHE
54.403.779,19
Estavudina 30mg
Estavudina
Etravirina 100mg
Fosamprenavir 700mg
Fosamprenavir 95ml
Indinavir 400mg
3.852.000
FIOCRUZ
885.960,00
20.000
CRISTÁLIA
1.167.018,00
403.200
JANSSEN
4.209.408,00
1.800.000
GLAXO
6.913.800,00
1.480
GLAXO
304.732,00
4.950.000
LAFEPE
1.488.960,00
LAFEPE
372.240,00
LIFAL
2.233.440,00
LIFAL
558.360,00
see next slide...
Medicine
Demand (units)
2010
Supplier
Expenditure (R$)
FIOCRUZ
17.325.000,00
FURP
11.781.000,00
IQUEGO
5.544.000,00
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
25.000
ABBOTT
1.946.375,00
16.451.160
FIOCRUZ
4.811.400,00
FUNED
4.811.400,00
FUNED
1.202.850,00
5.100.000
MERCK
86.134.104,00
20.400.000
ABBOTT
11.453.000,00
530
ABBOTT
282.389,30
Saquinavir 200mg
1.015.200
CRISTÁLIA
1.705.536,00
Tenofovir 300mg
30.000.000
GILEAD
Tipranavir 250mg
136.080
BOEHRINGER
1.676
BOEHRINGER
Lamivudina 150mg
63.000.000
Lamivudina
Lamivudina
Lopinavir+Ritonavir 80mg/ml + 20mg/ml
Nevirapina 200mg
Raltegravir 400mg
Ritonavir 100mg
Ritonavir
Tipranavir 100mg/mL
120.750.000,00
1.166.205,60
623.472,00
6.200.000
FIOCRUZ
1.612.000,00
Zidovudina 10mg/ml
18.000
CRISTÁLIA
88.369,20
Zidovudina 50mg/5ml
129.000
LAFEPE
Zidovudina 100mg
Zidovudina+Lamivudina 300mg + 150mg
133.750.080
Zidovudina+Lamivudina 300mg + 150mg
917.190,00
FIOCRUZ
59.812.500,00
FURP
29.301.294,00
FUNED
28.105.044,00
IQUEGO
10.766.250,00
LAFEPE
19.140.000,00
479.005.936
72,66%
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