Healthy Skepticism Library item: 8309
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Steinbrook R.
Thailand and the Compulsory Licensing of Efavirenz
NEJM 2007 Feb 8; 356:(6):544-546
http://content.nejm.org/cgi/content/full/356/6/544
Abstract:
Of the many medicines for human immunodeficiency virus (HIV) infection, efavirenz, a nonnucleoside reverse-transcriptase inhibitor that became available in the late 1990s, is one of the most important. For the initial treatment of adults, the combination of efavirenz and two nucleoside reverse-transcriptase inhibitors “has become a standard-of-care comparator in clinical trials,” according to Hammer et al.1 Moreover, efavirenz is available in a fixed-dose combination tablet with the nucleoside analogues emtricitabine and tenofovir; this tablet is taken only once a day. Efavirenz can cause birth defects when taken during the first trimester of pregnancy, so its use is restricted in . . .
Notes:
…Thailand is not the first country to issue a compulsory license for an HIV drug Indonesia, Malaysia, Mozambique, and Zambia have also done so.4 Objections of the pharmaceutical industry and international pressure, however, have ensured that such licenses remain rare. In addition, administering policies regarding intellectual property rights can be
challenging.4 Thailand’s action has received considerable attention because the country has a leadership role in fighting AIDS, it has a domestic pharmaceutical industry, and it has licensed a high-profile medication. The government simply announced the “public use” of the patent without discussing the matter with Merck first…
In issuing the compulsory license, Thailand cited its own laws and the declaration signed in Doha, Qatar, at a 2001 meeting of the World Trade Organization (WTO) regarding the relation between the TRIPS agreement and public health. The Doha declaration clarified that the agreement “contains flexibilities that allow countries to enable both the import and production of generic versions of antiretroviral drugs under patent to protect public health.”…
