TWN Info Service on Trade and WTO Issues (Aug 07/06)

29 August 2007

Thailand Issues Compulsory Licence to Buy Plavix Generics from India

We wish to bring to your attention that Thailand has once again issued a compulsory licence to break a patent in order to provide affordable medicine to its people.

The Thai government has decided to import a generic version of the heart drug Plavix from India under compulsory licensing, which will cost 1.01 baht per tablet as compared to 70 baht a tablet for the patented drug available on the market. The drug will be supplied by the Indian company M-cure. Patent for Plavix is held by Sanofi Aventis.

Previously, Thailand has issued compulsory licences for two key Aids drugs, Efavirenz and Kaletra and has begun importing cheaper versions of Efavirenz from India.

The government has justified breaking the patents for the drugs, held by Western pharmaceutical companies, by citing budget constraints in providing advanced medication for people living with HIV/Aids. Abbott Laboratories holds the patent for Kaletra while Efavirenz is patented by MSD.

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Bangkok Post, August 23, 2007
Govt buys heart drug from India
Compulsory licensing praised at UN forum

THEERAWUT SATHITPHATTARAKUL, BANGKOK and APIRADEE TREERUTKUARKUL, COLOMBO

The Public Health Ministry has decided to import a generic version of the heart drug Plavix from India under compulsory licensing, a policy praised by a United Nations agency and health advocacy groups as an example for other countries to follow.

The first shipment of two million tablets of clopidogrel is expected in two months, Government Pharmaceutical Organisation (GPO) board chairman Vichai Chokvivat said yesterday.

The heart drug will be supplied by the Indian company M-cure, which entered the lowest of four bids, at 1.01 baht per tablet. The price compares with 70 baht a tablet for the patented drug available on the market.

The ministry has already issued compulsory licences for two key Aids drugs, Efavirenz and Kaletra. It has already begun importing cheaper versions of Efavirenz from India, a major source of generic drugs.

The ministry has justified breaking the patents for the drugs, held by Western pharmaceutical companies, by citing budget constraints in providing advanced medication for people living with HIV/Aids under the universal health scheme, which covers 80% of Thailand's 63-million population.

Abbott Laboratories holds the patent for Kaletra while Efavirenz is patented by MSD, and Plavix by Sanofi Aventis.

"The GPO will import the medicine and ask the firm to register with the Food and Drug Administration as soon as possible," Dr Vichai said. "We will buy two million tablets in the first order and the shipment is expected to arrive in a month or two." The ministry would save about 138 million baht, he said.

An estimated 20.5 million tablets of Plavix are needed for heart disease patients under the universal health scheme.

Only 20% of patients currently have access to the medication. The compulsory licensing policy was hailed yesterday by non-government organisations and a UN agency.

But it was criticised by the United States, the European Union and drug manufacturers, which accused the government of stealing intellectual property and question its spending priorities.

The Eighth International Congress on Aids in Asia and the Pacific, being held in Colombo, Sri Lanka, was told Thailand's decision to run with compulsory licensing was one of the most critical political commitments yet to combat Aids. It was a good example for other countries in Asia and the Pacific heavily affected by the epidemic to follow.

Thailand has made a strong statement by invoking a compulsory licence for the production of second-line antiretroviral drugs.

"It's the right thing to do because we just can't provide those who need with only the first-line drugs because of the high cost," said Prasada Rao, director of the UNAids regional support team.

"I urge countries in Asia and the Pacific region to use the WTO [World Trade Organisation] flexibilities to do more and show more commitment to Aids responses," he told the more than 2,500 participants at the meeting.

The 70 member countries will address the issue in the Colombo Declaration, to be released today at the end of the five-day conference.

The Asia Pacific Network of People Living with HIV/Aids has already released a statement calling on other governments, the UN and other organisations to provide access to antiretroviral drugs, including second-line treatment and other essential medicines, via the Trade Related Aspects on Intellectual Property Rights agreement. It said these were fundamental needs.

It also supported the compulsory licensing policy implemented in Thailand and strongly opposed any free trade agreements which would jeopardise the rights of both HIV-positive people and developing countries to have access to affordable medicine.  Health and consumer groups yesterday condemned US ambassador Ralph Boyce and the European Union's trade commissioner Peter Mandelson for protesting against the decision.

The groups included the Thai Network of People Living with HIV/Aids, the Aids Access Foundation, Oxfam and Medecins Sans Frontieres. Jiraporn Limpananont, president of the Consumers Foundation, said the protest letters were an unwarranted intervention in Thailand's health policy to ensure proper access to health care and treatment.