[Thai] Government approves four cancer drugs: Compulsory licensing a must, says Mongkol
January 25, 2008
The outgoing military-appointed government will go ahead with the implementation of compulsory licensing (CL) for four cancer drugs, Public Health Minister Mongkol Na Songkhla said yesterday. The minister did not disclose the names of the drugs listed for compulsory licensing, simply saying the decision had been made on Jan 4 following a proposal submitted by the sub-panel chaired by Government Pharmaceutical Organisation (GPO) board chairman Vichai Chokewiwat.
The Vichai [VICHY] panel has advised the public health minister to issue compulsory licences for the breast cancer drug Letrozole and the leukaemia drug Imatinib, both produced by Novartis, the breast and lung cancer drug Docetaxel, produced by Sanofi-Aventis, and lung cancer drug Erlotinib, made by Roche.
The objective is to seek cheaper generic forms of the drugs for treating patients under the universal healthcare scheme, thereby saving the government huge sums of money.
Dr Mongkol said he had thoroughly considered the pros and cons of applying CL to such cancer drugs.
''We would not do it if it's not necessary. But we don't have time for more negotiation. We did the best we can,'' he said, adding that health officials had met patent owners for at least 13 rounds of negotiations over prices without making any significant progress.
The minister said he was certain that generic versions of cancer drugs would be of high quality and that patients under the universal healthcare scheme would receive the best benefits from the state policy on CL.
Letters stating the necessity to bypass patents of cancer drugs would be sent to all sectors involved _ the GPO, the Department of Intellectual Property and pharmaceutical companies owning the patents to the drugs by next week as he would soon finish his term, he said.
''I have faced pressure from several sides by making such a decision, but I am happy that poor patients will not go bankrupt due to the cost of cancer treatment,'' he said.
Cancer ranks as the number one cause of death in Thailand. The male population suffers mostly from lung cancer, whereas breast cancer is the major cause of death among women.
Meanwhile, pharmaceutical giant Sanofi-Aventis has threatened legal action against an India-based generic drug maker chosen to supply Thailand with a generic version of the heart drug Plavix.
Withit Artavatkun, managing director of the GPO board, said the threat was the latest in a series of attempts by the patent owner of Plavix to interrupt the country's CL policy.
Plavix, a blood thinner, is used to treat coronary artery, peripheral vascular and cerebrovascular diseases.
''Sanofi-Aventis' threat will not affect the procurement agreement as the first batch of two million heart drug tablets will be arriving by next week,'' said Dr Withit.
The India-based Zydus Cadila firm was chosen ahead of the other potential supplier Emcure Pharmaceuticals, also based in India, because Emcure had not yet provided bioequivalent documents essential for a registration grant from the Food and Drug Administration.
However, Dr Withit believed a threat from the patent owner was one of the main reasons that delayed Emcure's decision to supply a copycat version of the heart drug to Thailand.
The company last year also sent a letter to Emcure, claiming that selling generic versions of the medicine to Thailand was illegal as the country had not made public its decision to override the patent.
However, the GPO managing director said the ministry had officially declared its policy on the compulsory licensing of Plavix for over a year.
Friday, January 25, 2008