The government of Indonesia issued compulsory licences for seven drugs used to treat HIV and hepatitis B last month, clearing the way for generic competitors to reach the market.
News of the move has only just started filtering through, although Indonesia issued a ‘government use’ decree lifting restrictions on generic production on September 3, 2012.
The originator companies stand to receive royalties of just 0.5 per cent on generic sales in the country, and it is expected that local production of the medicines will start within months.
The drugs covered by the compulsory licence include Merck & Co’s Stocrin (efavirenz), GlaxoSmithKline’s Ziagen (abacavir), Gilead Sciences’ Viread (tenofovir), Abbott Laboratories Kaletra/Alluvia (lopinavir/ritonavir), Bristol-Myers Squibb’s Videx (didanosine), and Gilead’s double and triple HIV combinations Truvada (tenofovir/emtricitabine) and Atripla (efavirenz/tenofovir/emtricitabine).
Three of the older drugs on the list (efavirenz, lamivudine and nevirapine) were already subject to a compulsory license, but the government now says access to these is not adequate to tackle the problem of HIV and hepatitis B in Indonesia.
Lobbying group Public Citizen, which has campaigned for years for greater access to medicines in the developing world, said that the main issue for countries like Indonesia is that treatment options are limited when first-line therapies start to become ineffective.
The move has been welcomed by other access campaigners, with Medecins Sans Frontieres’ (MSF) director of policy advocacy Michelle Childs describing it as “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”.
“As medicines for HIV and hepatitis B are increasingly under patent in developing counties, Indonesia has shown that countries can and should take action to enable the production of low-cost versions of essential life-saving medicines for their citizens,” she added.
Indonesia’s HIV/AIDS epidemic is one of the fastest-growing in Asia, with an HIV-positive population of 310,000, according to UNICEF estimates. About 23,000 people receive antiretroviral therapy in Indonesia today, compared with an estimated 70,000+ people who need it.
Indonesia’s decree comes after a string of patent setbacks for big pharma companies trying to defend their intellectual property in emerging economies.
In recent weeks, for example, Pfizer, Bayer and Roche have all lost legal disputes over patent protection for cancer drugs in India.