Compulsory license of docetaxel drug dispute

The Council of State will today consider the legitimacy of the compulsory licensing (CL) policy on cancer drugs implemented by the Public Health Ministry. The Commerce Ministry asked the government's legal advisory body to consider the policy's legality in June after the France-based pharmaceutical company Sanofi Aventis sent a letter to the chief of the Intellectual Property (IP) Department, Puangrat Asavapisit, asking for a review of the CL policy. The letter claimed the Public Health Ministry did not have the right to use CL to bypass the patent of its breast cancer drug Docetaxel.

The company cited articles 50 and 51 of the Patent Act, which stipulate that the Commerce Ministry had sole authority to announce the policy. Also, the company could take legal action against the Government Pharmaceutical Organisation (GPO) if its copycat version from India was imported to Thailand without permission.

The NGO also condemned the drug company for not respecting Thailand's rights under the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights, which allows a government to use CL. The group also lashed out at the Commerce Ministry for failing to protect public benefits through access to affordable life-saving drugs.

''Even the World Bank applauds the efficacy of the Thai policy on Aids drugs distribution,'' the group said in its statement released yesterday. ''Without compulsory licensing the government cannot afford to buy expensive drugs for HIV-positive people. Therefore it is the responsibility of every state agency to consciously protect public benefits.''

GPO board chairman Vichai Chokewiwat said he and officials from the National Health Security Office would testify to the Council of State today. He insisted the policy was legitimate under article 51 (2) of the Patent Act, which allows governmental bodies to exercise a compulsory licensing policy. The GPO's legal department and an IP law expert agreed, he said.

''Such a request is nonsense,'' Dr Vichai said. ''The IP Department has the authority only to finalise the royalty fee which the government has to pay to the drug patent owner only.''

Sanofi's Docetaxel is one of the four drugs named under the CL policy announced by former public health minister Mongkol Na Songkhla in January. The others are the breast cancer drug Letrozole and the leukaemia and gastrointestinal stromal tumour drug Imatinib, both produced by Novartis; and lung cancer drug Erlotinib, made by Roche.