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COMPULSORY LICENSING

Activists challenge French drug company

Case would test the availability of life-saving drugs in the future



A group of 500 HIV/Aids activists and patients has challenged the France-based Sanofi Aventis - the drug company that produces anti-cancer drug docetaxel, also sold as taxotere- to file a lawsuit with the Administrative Court to prove that the compulsory licensing which the Thai government imposed in January violates intellectual property rights law and World Trade Organisation regulations.

The Thai NGO Coalition on Aids president Supattra Nakapiew said the group wanted to highlight the action of Sanofi Aventis which sent a confidential letter to the Commerce Minister asking for a review of the enforcement of compulsory licensing of its docetaxel drug as imposed by the Public Health Ministry on January 4 this year.

"We want Sanofi Aventis to file a lawsuit with the Central Administrative Court because we want this case to be a test for the enforcement of compulsory licensing of life-saving drugs in the future," she said.

Sanofi said in its letter to the Commerce Ministry that the enforcement of compulsory licensing for docetaxal does not comply with the law and the Government Pharmaceutical Organisation (GPO) does not have any right to import the generic version.

The GPO signed a contract with India-based Dabur Phrama to import 4,500 generic-version injection doses of docetaxel. The original docetaxel costs Bt26,500 per 89-mg injection, but the generic version costs Bt4,000.

On June 9, Sanofi Aventis urged the Commerce Ministry's Intellectual Property Department to ask the Office of the Council of State to scrutinise the process of enforcement of compulsory licensing of its cancer drug, and decide whether or not that process complied with Article 51 of the 1979 Intellectual Property Rights Act. A week later the Intellectual Property Department's director-general followed the request by Sanofi Aventis.

Article 51 allows the state agency to impose compulsory licensing only for life-saving drugs which are not for commercial use. The announcement of compulsory licensing for HIV/Aids, heart disease and cancer drugs is aimed at saving more than 100,000 patients across country.

Supattra has questioned the actions of the Commerce Ministry in response to the request of the drug company, saying that Article 51 allows the state agency to impose compulsory licensing of essential drugs not for commercial use and the recent enforcement of compulsory licensing complies with the law, the World Health Organisation and World Trade Organisation's recommendations.

"Why does Sanofi Aventis not follow international regulations that allow a developing country to impose compulsory licensing of life-saving drugs to save patient's lives? We want to denounce its actions and its efforts to pressure the Commerce Minister," said Suprattra.

Nevertheless, Public Health Minister Chavarat Chanveerakul said that by the end of this month the Public Health Ministry will host a meeting of a joint committee comprising senior officials from the Public Health Ministry, the Commerce Ministry and the Foreign Ministry, and other interested parties such as representatives from civic groups and the Pharmaceutical Research and Manufacturing Association, to find the best solution and mechanism to access cheaper drugs to saves lives across the country.

However, he insisted that the enforcement of compulsory licensing for essential drugs is a key mechanism to negotiate with drug firms to reduce their prices and help poor people save their lives from chronic diseases such as cancer and heart disease.


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