brazilian context
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TRIPS flexibilities and examples which resulted in reduced medicine prices: Model legislation and compulsory licensing in Brazil Juliana V. Borges Vallini. Brazilian Context. Health system with universal access to the population; - PowerPoint PPT PresentationTRANSCRIPT
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TRIPS flexibilities and examples which resulted in reduced medicine prices:
Model legislation and compulsory licensing in Brazil
Juliana V. Borges Vallini
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Brazilian Context
Health system with universal access to the population;
Constitutional concept of "health" as global welfare - citizen's right and duty of the state - Structured Programs (HIV / AIDS, hepatitis ,...)
HIV/Aids Free and universal access law - 1996 –
centralized procurement – MoH (only buyer)
- budget 2008 = US$ 640 million December 2008 - 190.000 people on ART
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Brazilian Context
● Fundamental human right ● Incorporation into domestic law: the
obligation to grant patents for medicines – TRIPS
● Obligation of countries to accept the granting of patents for pharmaceutical products and its processes.
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Health Sector Participation
National level:- involvement of the health sector in the
analysis of the applications of pharmaceutical products and processes - the prior consent of ANVISA;
- Active participation in the Interministerial Group of Intellectual Property - GIPI
- Health sector at international meetings.
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Brazilian Law (9.279/96) – Previous Consent
Art. 229-C. The granting of patents for pharmaceutical products and processes depend on the prior consent
of the National Agency for Sanitary Surveillance - ANVISA.
Maximum 120 days to analyze. 4% not granted It’s not a linkage. Some cases:
- Valcyte: no novelty; Ritonavir: no novelty; Taxotere: process to product
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Possible consequences for public health of a frivolous patent
● Restriction of access to medicines. ● Improper payment of royalties. ● Abuse of the exclusive exploration of the subject of
the patent.● Undue protection for inventions that do not have the
patentability criteria. What about patentability criteria? Second use and new
formulations?
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Access and prices.
● Many prices in other countries are still lower than Brazil negotiates.
● IP as an element of prices definition.
● Necessary use of the flexibilities.
● The important role of Judiciary .
● Competition law.
● Subsidies to consideration: as in the Tenofovir case.
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*2007 – dados preliminares
Proportion - Expenditure with ARV, 2007
*
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Source of data: PN-STD/AIDS and Far-Manguinhos; includes a yearly depreciation rate of 10% for EFV and LPV/r in 2006-2009 and 5% in 2010
Expenditure estimated as result of local production (Far-Manguinhos)
Expenditure estimated using 2005 prices paid by MOHfor branded products
60.78 64.69 67.72 70.01 74.86
147.47
172.48
198.89
222.39
242.40
0.00
50.00
100.00
150.00
200.00
250.00
300.00
2006 2007 2008 2009 2010
FONTE: MS/SVS/PN-DST/AIDS
Saving: US$ 86,69
Saving: US$ 107,79
Saving:US$ 131,17Saving: US$ 152,38
Saving: US$ 167,54
Total potential savings (2006-2010): US$ 645,560,000
Exp
end
itu
res
(In
US
$ m
illio
n)
EFV, LPV/r e TDFEstimated savings with local production
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Compulsory License in Brazil (L. 9.279)
● Abusive exercise of patent rights (art. 68);● Abuse of economic power (art. 68);● Non-exploitation of the subject matter or the
patent in the territory of Brazil (art. 68, § 1, I);● Commercialization that does not meet the
market needs (art. 68, § 1, II);● dependency of one patent on another (Article
70);● Public interest or national emergency (art. 71) -
Decree No. 3.201
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Efavirenz
Most used imported ARV – 75,000 patients Long negotiation process – price stable since2003 - US$ 1,59/tb
– Thailand – 1,2% prevalence 17,000 patients – US$ 0,67/tb
Annual cost - from US$ 580.00 to US$166.36 Estimated “savings” until 2012 - US$ 237 millionsIn 2007 – from US$ 42 millions to US$ 12 millions National production in 2009
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Why an Compulsory License?
Patent pipeline; Public interest and feasibility of STD and
AIDS; Prior negotiation with the patent holder.
Saving $ 30 million / year; A clear example of the relationship between
patent - Price - access.
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Efavirenz Case
Portaria 886, April 24th 2007 - Public Interest Decree No. 6108 of 4 May 2007 - granted
compulsory license for public interest, patents relating to Efavirenz, for public non-commercial use;
Duration and the possibility of extension.; Patent holder - remuneration; Patent holder must provide the necessary and
sufficient information for the reproduction of the object;
Exploitation of the licensed patent: directly by the Government or by third parties (contracted)
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Compulsory license
The case of the compulsory license of Efavirenz in
Brazil
http://www.aids.gov.br/data/Pages/LUMISE77B47C8ITEMIDF
1F682AB8B064551A91E90EF1DA9C3EBESIE.htm
http://www.aids.gov.br/portalaids_services/data/Pages/LUMIS
E77B47C8ITEMIDE6C4A510A6EC4CA7A9F48F517BBDB01
CESIE.htm
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Other challenges for price negotiation 2009TDF = US$ 42 millions = 14,7% budget imported ARV
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Tenofovir
1st line ARV – increase fastly - 33,000 patients
Patent deposited in Brazil in1995OppositionMoH declared it of public interest in April 2008Brazilian Patent Office does not grant the patent (2009)HIV/Aids and hepatitis B.
– Brazil – US$ 3.25/tb = US$ 1,186/yr– Thailand – US$ 1,24/tb = US$ 454/yr
CIPLA – prequalified – US$ 0,43/tb = US$ 157/yr
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Technological Network on HIV/AIDS
Argentina, Brazil, China, Cuba, Nigeria, Russia, Thailand, Ukraine.
Production of anti-retroviral medicines and other medicines for treatment and prevention of opportunistic infections, aiming at the universal access, price reduction and the effective and rational use of generic medicines.
IP elements.
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Challenges for all of us
Expand access to fair prices – review of present criteria (differential price policies?)
Use of the flexibilities provided by the declaration of the Doha on TRIPS and Public Health – support from partners and WHO.
WHA 2008 – Global Strategy on Innovation, Public Health and Intellectual Property – put it into practice...
The need for cooperation and exchange of information among the developing countries.
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Mind the Gap!
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