Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
Bangkok Post - March 27, 2007
Apiradee Treerutkuarkul
Royalty payments are being offered to the pharmaceutical companies whose patents will be breached when generic versions are produced locally or imported.
Food and Drug Administration secretary-general Somsak Choonharasmi, who leads the negotiations, said yesterday the FDA had informed the patent holders the state was willing to compensate them with only 0.5% of the revenue generated from the generic drug sales.
This was in keeping with Article 51 of the patent law.
But the drug companies did not accept the offer. Representatives said they needed to first discuss the matter with their mother companies before making a decision, he said.
The negotiating committee was appointed by Public Health Minister Mongkol na Songkhla.
It comprises 15 representatives from relevant agencies like the FDA and the Commerce and Foreign Affairs ministries. The committee's first round of talks with representatives of Abbott Laboratories, MSD, and Sanofi-Aventis lasted almost five hours yesterday.
Abbott owns the original Aids treatment Kaletra, while MSD and Sanofi-Aventis hold the patents to Efavirenz and the heart drug Plavix.
The Public Health Ministry issued compulsory licences in November and early January to produce or import generic versions of these costly drugs for emergency use in the country.
So far, MSD has offered to reduce the price of Efavirenz to 726 baht per bottle, but the government can buy the generic version of the anti-retroviral treatment from India at 650 baht per bottle.
Sanofi-Aventis, however, has offered a "special package" for the heart drug to serve the state policy of extending access to medicine, and a special quota of 3.4 million tablets of Plavix for 34,000 patients in Thailand, said Dr Somsak.
The FDA chief, who has asked for more details on the special Plavix package, has insisted that the quality of drugs for sale in Thailand must be the same as the existing versions being distributed in the global market.
On the other hand, Abbott continued to reject the use of compulsory licensing for its anti-Aids drugs and the offer of royalty fees by the government.
It says such a policy would only jeopardise its research and development plans for new drugs.
The company's representatives, however, did not say they would petition the Department of Intellectual Property Rights to review the policy, he said.
The US-based company earlier opposed the government's decision to go for compulsory licensing and threatened to withhold the introduction of 10 new drugs in Thailand, including an improved version of Kaletra.
The firm's decision upset both local and international health advocates.
Religious investors in Abbott Laboratories stock criticised the drug maker's decision saying the move put the health of Thais at risk, and asked the company to reconsider its decision.
Novartis yesterday offered wider access to some of its cancer drugs in Thailand through a philanthropic programme.
The Public Health Ministry was planning to extend compulsory licensing to other drug categories, including cancer, when the company relented.
The company holds the patent for Gleevec which is widely used for treating leukaemia.
Health activists have also protested at the Swiss company's decision to file a lawsuit against a generic producer in India in response to the New Delhi government's rejection of its attempt to patent a new version of the medicine.
Dr Somsak said the committee would open a second round of talks with the drug firms on April 10.
Meanwhile, the FDA said it would not take the snack brand Party off the supermarket shelves because it had no authority to do so.
A boy was sent to hospital on Sunday after drinking chemical substances from a promotional toy which came with the snack.
An FDA expert said the chemicals were magnesium stearate and sodium bicarbonate which could cause stomach ache, irritation around the neck, and chest pain.
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