Bangkok Post - February 12, 2008
Apiradee Treerutkuarkul

Despite the uproar, the new Public Health Minister Chaiya Sasomsab's vow on his first day in the office to review the ministerial announcement of compulsory licensing schemes for four cancer medicines, did not come as a complete surprise.

It had been expected for some time that Thailand's new cabinet - allegedly packed with puppets of ousted premier Thaksin Shinawatra - would take a pro-business view on the patent issue.

Mr Chaiya's remarks, when facing protesters last week, that saving only 500-million-baht budget for treating 15,000 cancer patients each year could not compare to the effect on the country's trade and exports worth billions of baht, was evidence enough of the reversed trend.

Former health minister, Mongkol Na Songkhla, signed ministerial announcements on Jan 4 to individually license Letrozole, a breast cancer medicine produced by Novartis, the breast and lung cancer drug Docetaxel made by Sanofi Aventis and Roche's Erlotinib, used for treating lung, pancreatic and ovarian cancer. However, Dr Mongkol struck a deal with Novartis over the leukaemia drug, Glivec, as the patent holder agreed to supply it free to over 900 patients under its philanthropic programme.

The former minister is aware of the controversy and the possibility that all his work may be upended. He emphasised during his final days in office that if the elected policy-makers reversed the policy, aimed at making drugs more affordable for the majority of people, the poor would lose out.

Undoubtedly, drug firms have tried to win back their business profits by petitioning the commerce minister and pressuring the new government.

Puangrat Assawapisit, director-general of the Intellectual Property Department, late last month said she was informed that the Pharmaceutical Research and Manufacturers of America (PhRMA) had threatened to press Washington to take tougher action against Thailand by putting the country on the Priority Foreign Country (PFC) list, which is the most severe US copyright protection category and subject to trade sanctions.

Critics may argue that the previous government's aggressive move to issue licences for several drugs without sufficiently warning each patent holder, unnecessarily led to retaliation by drug firms. However, the former minister had his reasons. The "White Paper," soon to be available on the ministry website, seeks to explain the other side of the controversy.

According to the White Paper, cancer is the main cause of death among the Thai population. An estimated 30,000 fatalities and thousands of new cases are reported each year. The number is higher for lung and breast cancer.

Although the so-called drugs for targeted cell therapy which could cure or prolong the lives of cancer patients are available, they are very expensive - the low and middle-income population usually cannot afford the treatment.

Details in the Paper also show that a patented lung and breast cancer regimen, Docetaxel, costs 25,000 baht per shot, compared to 4,000 baht for the generic version, which is six times cheaper.

Patients suffering from breast cancer who depend on Letrozole have to pay 230 baht per tablet, totalling 6,900 baht each month for the patented version. However the generic version costs only 6-7 baht per tablet or about 30 times cheaper.

For Erlotinib, lung cancer patients have to pay 82,500 baht every month whereas the generic version costs 735 baht. Finally, patients suffering from leukaemia and gastro-intestinal stromal tumour (GIST) have to pay at least 1.3 million baht each year for the treatment, which costs 917 per 100mg. They would pay only 50 to 70 baht per milligramme if they could use the generic version.

The Paper argues that with a gross national income per capita of US$3,000 a year, or roughly one-sixteenth that of the United States, not only the cancer patients and their families but also the Thai health system was under threat of going bankrupt if the government did not try to do anything about the patented drugs prices.

The National Health Security Office (NHSO) running the universal healthcare scheme for 48 out of 64 million Thais, could not afford these drugs and asked the Public Health Ministry to solve the sky-high cost of healthcare via compulsory licensing.

Vichai Chokewiwat, chairman of the Public Health Ministry's panel on compulsory licensing, explained in the online Paper that negotiations were held 12 times with the patent-holding companies on the possibility of lowering drug prices - all of them fruitless. Some pharmaceutical companies did not even join the meetings.

The Paper states that worldwide experience has shown that the issuing of a compulsory licence is often the only negotiating tool drug companies seem to take seriously.

And so it was, that it became the last resort for the interim government to extend access to life-saving drugs to the low- and middle-income population and solve the overwhelming healthcare cost borne by the NHSO.

In addition to the ministry's White Paper, a report by the international trade and health experts which aims to help Thailand extend public access to costly life-saving drugs by seeking flexibility in global trade rules, is expected to reach the newly-appointed government by mid-February.

Seven delegates from the World Health Organisation, World Trade Organisation and United Nations Development Programme made a three-day visit to Thailand earlier this month, to listen to relevant sectors about the Thai policy on CL and lessons learned after putting it into practice.

The new health minister should examine the White Paper and the experts' report before formally reviewing the country's stance on compulsory licensing.

Mr Nimit Tienudom, director of Aids Access Foundation, argued that the new minister's suggestion that poor patients ask for financial assistance from the Ministry of Finance, would pose an impossible task.

"Listening to what the new health minister said makes me feel sad and tired. It seems that we will have to fight for affordable access to drugs for a long time to come, because this problem won't be solved by having a wealthy man who doesn't really understand the health system, working as public health minister.

"The loss of human life cannot be compared to that of business opportunities," Mr Nimit commented.

Another round of discussions between Commerce Ministry officials and pharmaceutical representatives over the review of CL issue has been scheduled for today.

Patients and universal healthcare supporters might have won the first round, but the battle over respecting drug patents versus expanding access to medicine to the poorer segments of population, is going to be a long and arduous one for both the public and the policy-makers.

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