Compulsory licensing pressure on pharma giants

By Apiradee Treerutkuarkul

The government is piling the pressure on leading pharmaceutical companies to cut the prices for four cancer drugs or face compulsory licensing.

Speaking after chairing a three-hour discussion about price reductions with Roche and Sanofi Aventis, Food and Drug Administration (FDA) secretary-general Siriwat Tiptaradol said three options had been proposed to the drug firms holding patents for four cancer drugs in a bid to cut prices and widen access to the life-saving treatments.

The drugs being discussed were Docetaxel, Erlotinib, Letrozole and Imatinib.

The first option calls for the drug manufacturers to lower the price of the medicines to what Mr Siriwat said was an ''acceptable level''.

The second option tabled at the talks were for the companies to give voluntary licences which would enable the Government Pharmaceutical Organisation to produce and sell generic versions of the cancer treatments.

If the companies did not agree to either of those options, then the government would be forced to issue compulsory licences for the drugs, he said.

''The prices of their products are very high and only a small number of patients can gain access to them,'' Mr Siriwat said.

''So it's better to give them some choices so that we can find acceptable solutions for both the public and private industry instead of rushing to announce compulsory licensing,'' he said.

Health officials and the pharmaceutical firms that produce the relevant cancer drugs met for the first time after the National Health Security Office (NHSO) last month asked the Public Health Ministry to consider overriding the patents on cancer drugs.

The NHSO wants cancer treatment to be available to all Thais, not just those who can afford it, and hopes to make the life-saving drugs available to the roughly 48 million people eligible for the universal healthcare scheme.

Earlier this year the government angered some of the world's biggest pharmaceutical firms by announcing compulsory licensing for the Aids drugs Efavirenz and Kaletra, and heart drug Plavix.

Compulsory licensing is allowed by the World Trade Organisation in case of a ''national emergency''. This lets the government bypass drug patents and import or produce generic versions of patented drugs for non-commercial purposes.

Roche's Erlotinib is used for lung cancer whereas Sanofi Aventis' Docetaxel is used for treating lung and breast cancer.

The drugs are essential for treating various types of tumours, including breast and lung cancer, major killers in Thailand. An estimated 3,000 third-stage cancer patients in Thailand depend on Erlotinib.

However, representatives from both firms said they had yet to make a decision on the deals proposed by the Thai panel and that they would have to discuss the options with their parent companies.

Only Sanofi Aventis, the maker of Docetaxel, offered to cut the price of its drug by 6-10% and give free treatment for patients under the universal healthcare and the social security schemes after the fifth stage of treatment.

But Mr Siriwat said he still had to consult cancer experts before making any decision to accept the companies' offer. The panel would ask for information regarding the number of lung and breast cancer patients from the Cancer Institute of Thailand first, he said.

Novartis, which owns the patent for the leukaemia drug Imatinib and breast cancer regimen Letrozole, did not attend the talks, claiming it had already provided the medicine to about 900 patients under the universal healthcare scheme.

The drug firm also said it was still in discussions with the Social Security Office to find out if patients who are employees of private firms can also receive cut-price treatment.

The original version of Imatinib costs 900 baht per tablet compared to the generic version which is priced at about 50-70 baht. The injected drug Docetaxel is priced at 26,500 baht per dose of 80mg compared to the generic cost of 4,000 baht. The retail price of Erlotinib is 2,800-3,000 baht per tablet compared to the generic version, which costs between 275-735 per tablet. Letrozole costs about 230 baht per tablet but its generic version is priced at only 7-10 baht.

In the 2006 fiscal year, the government spent more than 1.2 billion baht on about 50,000 cancer patients receiving treatment in the universal healthcare scheme.

Sales of Docetaxel and Imatinib in 2005 were about 140 million baht and 200 million baht, respectively, according to the Food and Drug Administration.