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Compulsory License and Access to Medicines: Economics Savings of Efavirenz in Brazil. Francisco Viegas Neves da Silva ¹ ; Ronaldo Hallal² and André Guimarães ² International Cooperation Unit ¹ Care and Quality of Life Unit ² Department of STD, AIDS and VH Secretariat for Health Surveillance
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Compulsory License and Access to Medicines: Economics Savings of Efavirenz in Brazil
Francisco Viegas Neves da Silva¹;
Ronaldo Hallal² and André Guimarães²
International Cooperation Unit¹
Care and Quality of Life Unit²
Department of STD, AIDS and VH
Secretariat for Health Surveillance
Ministry of Health
XIX – International AIDS Conference (Washington - July/2012)
1988’s Constitution – “Health is a citizens right and a duty of the State”
Universal Access to ARV Law issued in 1996
Strong participation of Civil Society in the National HIV response
Industrial Property Law 1996
Patented in Brazil in 1996. (PP1100250-6 and PI9608839-7). Main patent expires in August/2012. (pipeline)
75 thousand patients on EFV in 2007.
In 2007, after more than 8 price negotiation meetings the patent owner initially offered a price of US$1.59 per pill at the end offered a price reduction of 30% (US$1.11 per pill).
At the same time the patent owner was supplying EFV to Thailand at the cost of US$ 0.65 per pill.
Brazil considered this unacceptable.
Presidential Decree nº 6.108 (04/may/2007)
–”compulsory license, on the ground of public interest, of Efavirenz’s patents, for public non-commercial use”
- Duration: 5 years, allowing extension for equal period
- Royaltiy fee for the patent owner (1,5% on the cost of the finished product)
- Patent owner obligated to transfer knowledge and information necessary to reproduce the patented medicine
Renewal of CL by the Decree nº. 7723 (04/may/2012)
Compulsory License legal framework
(Source: World Trade Organization)What is a compulsory license?
Effects of the Compulsory License
1999 = US$2,544 (inclusion)
2007 = US$259 (after CL)
2012 = US$107 (international suppliers)
EFV 600mg annual cost per patient
2003 = US$772 (inclusion)
2007 = US$158.78 (after CL)
2009 = US$279 (national production)
2011 = US$294
Total savings from 2007-2011 with the Compulsory License was around US$ 103,600,000. (includes savings of EFV 200mg)
With the Compulsory License Brazil has saved 58,47% buying from generic suppliers.
Intellectual property is a significant element of price negotiation;
It is necessary the full use and implementation of TRIPS flexibilities such as Compulsory Licenses to increase access to medicines.
Brazil has shown that increasing access is more important than economics.
Challenges and conclusion
Thank you very much!