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Drug-licensing revision should be ready by April

The controversial revision of compulsory licensing for four cancer drugs will be concluded by the end of March, said Public Health Minister Chaiya Sasomsap.

Published on February 23, 2008



"The Health Ministry's permanent secretary asked me for two weeks to find out more information about the amount of cancer patients and the accessibility for cancer drugs. I could then make a decision to retain or revoke the recent enforcement of compulsory licensing for cancer drugs," he said.

Chaiya initiated his idea to revise compulsory licensing for cancer drugs immediately after taking up his new position two weeks ago.

His plan was sparked by a confidential letter from the Commerce Ministry that expressed concern over the international commercial status of Thailand with the United States.

Licensing the drugs might see the country put on the high priority watch list.

Chaiya reasoned that the former government's health minister Mongkol na Songkhla had used improper procedures to announce compulsory licensing. The correct process involved approval by the ministers of Commerce, Foreign Affairs and Health.

The four cancer drugs are docetaxel, produced by Sanofi-Aventis, erlotinib, manufactured by Roche, and lectrozole and imatinib, made by Novartis. These drugs are used to treat lung cancer, breast cancer, gastric cancer and leukaemia.

The Health Ministry later withdrew enforcement for imatinib after Novartis offered to provide free cancer drugs to patients who suffered from gastric cancer and leukaemia under the universal healthcare scheme.

However, Chaiya confirmed he would not cancel the recent enforcement of compulsory licensing for the four drugs until he had enough information to consider the impact on patients and international trade from this controversial issue.

"I've never said I would revoke or retain the recent enforcement of compulsory licensing for cancer drugs. I just want to review it so that when someone asks me about this issue I could answer them clearly, particularly in a Cabinet meeting," he said

"I've talked with the Health Ministry's permanent secretary and told him that the accessibility of essential drugs of patient and the quality of drugs must be the first priority.

"If the resolution concludes that it is necessary to retain the enforcement of compulsory licensing to help patients, then we must do it. But if there is any impact on the business sector, the Commerce Ministry would take responsibility for this issue."

Prime Minister Samak Sundaravej has assigned Deputy Prime Minister and Commerce Minister Mingkwan Sangsuwan to hold a meeting with relevant ministries to discuss the issue.

"Please calm down, give me a month to resolve this matter," said Chaiya.

The patients' network cited that the revision of compulsory licensing would affect the import of generic heart-disease drug clopidogrel (trade name Plavix) from India-based Cadila Health Care by the Government Pharmaceutical Organisation (GPO) after licensing was imposed on the drug last year.

Chaiya confirmed he never assigned the GPO to stop the import of the drug.

"It is an obligation of the relevant government's agencies to take responsibility for this issue and it is the duty of the GPO to send an official letter to ensure Cadila that the revision of recent enforcement of compulsory licensing will not affect the import of Plavix," he said.

Meanwhile, GPO director Dr Vithit Attavejchakul said Cadila had informed the GPO that the export of the first lot of 2 million tablets to Thailand would be delayed from March to April due to production and legal processes.

"The action by civic groups around the world will ensure the enforcement of compulsory licensing for cancer drugs. If there is any guarantee that it would not impact the business sector, I will suddenly conclude this controversial issue," he said. "I will not leave patients."

Duankamon  Sajirawattanakul

The Nation


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