Abbott shuns Aids drug talks

By Apiradee Treerutkuarkul

The patent holder of the HIV/Aids treatment Kaletra has turned down an invitation by the Food and Drug Administration (FDA) for a meeting to discuss compensation for the drug listed for compulsory licensing.

The rejection of the invitation is being seen by many as the company's attempt to show its disapproval with Thailand's move to break the company's patent for the drug, allowing the state to produce or import cheaper, generic versions.

FDA secretary-general Siriwat Thiptaradol said Abbott confirmed that it would not join tomorrow's meeting, aimed at negotiating the drug price and the royalty fee. Dr Siriwat said Abbott had told the FDA that it found the offer unacceptable.

He said, however, that representatives of MSD and Sanofi-Aventis, patent-holders of Efavirenz and the heart drug Plavix, are expected to attend the meeting.

The session will be the second round of meetings.

The first round, which was held late last month, ended inconclusively as the pharmaceutical firms told negotiators they had to discuss the matter with their parent companies.

Previously, the FDA had informed the patent holders that 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, he said.

The Public Health Ministry issued compulsory licences in November and early January to produce or import generic versions of the costly drugs for emergency use in the country.

However, Abbott bluntly rejected any offer, claiming such a state policy would only jeopardise its research and development plans for new drugs. The US-based drug company earlier opposed the government's decision to go for compulsory licensing and threatened to withhold the introduction of new drugs here, including an improved version of Kaletra.

In February, the drug company made an offer during a meeting with senior health officials at the Disease Control Department to cut the price of Kaletra used at state hospitals from 11,580 baht per patient per month to lower than 4,000 baht. There has been no further discussion on the offer.

"The state has to be responsible for all patients suffering from HIV/Aids and heart disease, while the private firms have to stick to the principle of profit making. Our standpoints are different. That's why we have to discuss this to seek the most acceptable solution for both sides," said Dr Siriwat.

Kaletra's global sales total US$1.1 billion (41.8 billion baht) annually.

However, the FDA secretary-general said he was not worried about resolute standpoint and that health officials were looking for other options of pharmaceutical products made by the company.

Representatives of both MSD and Sanofi have told the FDA all their decisions would come from discussions with their mother companies.

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 just 650 baht per bottle.

Sanofi-Aventis, however, has offered a "special package" for the heart disease drug to respond to the government's policy of extending access to medicines, and a special quota of 3.4 million tablets of Plavix for 34,000 patients in Thailand.

Dr Siriwat said the government also planned to ask Novartis to reduce the price of Gleevec, a leukaemia treatment, instead of adopting a philanthropic programme in order to genuinely extend drug access for patients suffering from cancer.

Bangkok Post

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