Access to Generic Medicines The Use of Compulsory Licensing Gaëlle Krikorian IRIS, Interdisciplinary Research Institute on Social Issues UMR 8156 CNRS – Inserm – EHESS – Université Paris 13 XXVII International AIDS Conference Mexico, 4 August 2008

Event: The decision of the Minister of Health Between the end of 2006 and the beginning of 2008, the Minister of Public Health of Thailand issued 7 compulsory licenses. first-line HIV drug efavirenz (29 November 2006), known as Stocrin® of Merck Sharp and Dohme (MSD) second-line HIV drug lopinavir/ritonavir (24 January 2007), commercially known as Kaletra® of Abbott treatment for heart disease clopidogrel (25 January 2007), commercially known as Plavix® of Sanofi-Aventis - Cancer drugs (breast and lung) (4 January 2008), docetaxel (Taxotere®) of Sanofi Aventis, erlotinib (Tarceva®) of Roche, and letrozole (Femara®) and Imatinib (Glivec®) of Novartis

Context of the use of CLs in Thailand • The AIDS epidemic (1 million persons, 500 000 have died, 20 000 new infection / year) • The high price of the drugs: the daily cost of the medicine was about 2 - 10 times the daily wage. • The Universal Health Coverage: introduced in 2002, National Health Security Act. ARVs not included until 2003, prices too high to be covered by the system. Other expensive drugs still not included. • Request from civil society for the government to issue CL since 1999 (ddI). Similar situations in many countries • The use of the flexibilities become a need in the post-TRIPS context. More than 1 million women, men, and children have contracted HIV in Thailand, and more than 500,000 have died of AIDS since the outbreak of the epidemic. In spite of successful prevention efforts, there are still around 20,000 new infections each year.

Capability of countries to use CLs • The Doha declaration established countries rights to use CLs. • Using this provision from the WTO TRIPS agreement is not technically difficult. • But the vast majority of developing countries have no experience. • The political context is still difficult (some rich countries and pharmaceutical companies try to prevent developing countries from making use of their rights). So far few countries took advantages of CLs • Thailand, Brazil, Mozambique, Zambia, Indonesia, Malaysia, etc.

What led to the use of CLs in Thailand • Implementation of global access to HIV/AIDS drugs, National health coverage system. • Important mobilization of civil society and academics. Right to Compulsory Licensing = Right to Live • IP experts advising the Minister – involved in local and international IP debates for a long time. Simultaneous presence of expertise and confidence in a context of needs (investigations in other countries often reveal a climate of “terror” and uncertainty regarding how to use CLs). • Conflicts with the US and pharmaceutical companies, led to: Development of expertise Collaboration among civil servants, academics and NGOs Development of organized resistance to US and pharma pressure.

Reactions to the CLs • Harsh reactions, simultaneously on pro-IP front: -Abbott withdrawal of request for marketing authorization for 7 drugs -Members of US Congress -USTR, Priority Watch List -Letter from European Commissioner Mandelson -Campaign newspapers (Wall Street Journal, dozens of articles in 6 months) -USA for Innovation (NGO with connections to Abbott, same PR company) • Caricature of a sanction mechanism Divisions within pro-IP front: • Isolation of Abbott (“strategic mistake”: Amcham; US Embassy; Merck) • Embassies take distance (US, EU, France, Switzerland) Reinforced solidarity among Thai institutions

Lessons learned • Coherence of national position and collaboration of the various institutions involved (Ministries Health, Commerce, Industry, Justice, Economy et Finance). And with civil society and academics. • Make use of the international and national laws and rights. • Use clear and simple arguments. Experience allowed the Thai gov. to improve its procedures, decision mechanisms, arguments. • Historical, social, epidemiological context compel players to choose camps and voice support : US (Bill Clinton and Members of Congress), France, Brazil, Germany, UK, India, Malaysia, etc. • New balance (cursor moved a little) but a precarious power balance. The international consensus reach in Doha, alliances and a critical mass of countries making use of their rights reinforce developing countries’ positions.