Thailand to issue compulsory license for efavirenz

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Thailand’s Government Pharmaceutical Organisation (GPO) said yesterday it plans to apply for a compulsory license to begin making its own versions of efavirenz and lopinavir/ritonavir next year.

Thailand’s Ministry of Health signalled yesterday that it will issue a five-year compulsory license to allow the GPO to manufacture efavirenz, reducing the cost of the drug to $20 a month. The patent holder Merck & Co will be paid a royalty of 1% on sales in Thailand.

GPO Director Mongkol Jivasantikarn told the Bangkok Post that the organisation plans to manufacture indinavir, saquinavir, lopinavir and ddI in the next two years, if necessary under compulsory license.

Glossary

second-line treatment

The second preferred therapy for a particular condition, used after first-line treatment fails or if a person cannot tolerate first-line drugs.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

first-line therapy

The regimen used when starting treatment for the first time.

enzyme

A protein which speeds up a chemical reaction.

Civil society organisations, led by people living with HIV, have been campaigning for the introduction of compulsory licensing of HIV drugs in order to reduce the cost of antiretroviral treatment in Thailand.

Thailand has over 500,000 people living with HIV, and 80,000 are already receiving antiretroviral treatment. The World Bank has estimated that Thailand could reduce the cost of second-line therapy by 90% if it introduced compulsory licenses for all the drugs it needs in second-line therapy, saving itself $3.2 billion over the next 20 years

First-line HIV treatment in Thailand currently consists of GPO-Vir, a Thai generic version of d4T, 3TC and nevirapine. However Thai doctors want to use efavirenz instead of nevirapine in patients with elevated liver enzyme levels.

Thailand’s move follows months of controversy over a free trade agreement between Thailand and the United States that was attacked as endangering access to medicines by Thai AIDS activists and international non-governmental organisations. The US-Thai FTA included clauses providing far greater intellectual property protection than required under the TRIPS agreement – a so-called TRIPS-Plus agreement.

The Free Trade agreement negotiations are currently on hold until a democratically elected government is in place; a military coup in September removed Prime Minister Thaksin Shinawatra, who had been in office since 2001. Mr Thaksin had consistently resisted compulsory licensing, said Thai AIDS activists.