In a move that had slipped under the radar, the Indonesian government has caused a stir with its plans to allow generic versions of seven patent-protected HIV and hepatitis B drugs.
Although announced on September 3, it has only just come to light that Indonesia has issued a 'government use' decree - a type of compulsory licence that lifts a patent restriction on generic production - on the aforementioned drugs. The treatments that are subject to the orders are Merck & Co's Stocrin (efavirenz), GlaxoSmithKline's Ziagen (abacavir), Gilead Sciences' Viread (tenofovir), Abbott Laboratories Kaletra (lopinavir/ritonavir), Bristol-Myers Squibb’s Videx (didanosine), and Gilead's fixed-dose HIV combinations Truvada (tenofovir/emtricitabine) and Atripla (efavirenz/tenofovir/emtricitabine).
News of the the decree, which has been signed by president Susilo Bambang Yudhoyono, was revealed by the influential US consumer group Public Citizen which notes that it "may represent the broadest single use of pharmaceutical patent licensing power by a country since the World Trade Organization 1995 Agreement on Trade-Related Aspects of Intellectual Property (TRIPS)".
Indonesia previously made government use of patents in 2004 on two older HIV drugs (lamivudine and nevirapine) and again in 2007 (efavirenz, lamivudine and nevirapine). The order grants the Minister of Health authority to appoint drugmakers to exploit patents for and on behalf of the government and the authorisation will be effective until the end of the term of each patent.
0.5% royalty for drugmakers
Public Citizen notes that government use "does not eliminate or override" a patent but rather facilitates competition, "including potentially generic imports and/or local production of medicines". Indonesia has established a 0.5% royalty for the holders of the patents.
Indonesia’s HIV/AIDS epidemic is one of the fastest-growing in Asia and has an HIV-positive population of 310,000 according to UNICEF estimates. About 23,000 people receive antiretroviral therapy, compared with an estimated 70,000 who need it.
In recent years, a number of countries have issued licenses to improve access to medicines, Public Citizen, including India, Thailand, Brazil, Malaysia, Zambia and Ecuador, among others. The organisation congratulated activists in Indonesia "who are helping advance access in Indonesia".
The move has also been welcomed by the international aid agency Medecins Sans Frontieres (Doctors Without Borders). Michelle Childs, director of policy advocacy for the group's access campaign, said that "Indonesia has set an important precedent, not just for the people living with HIV within its country, who have been campaigning for this, but also for other developing countries".
She added that "the next step is full implementation of the decree. Other countries faced with blocks on access to generic medicines should consider following Indonesia’s lead". The pharmaceutical companies involved have yet to make any public response.