Thailand Avoids Compulsory Licence On Cancer Drug; 3 More Drugs Undecided

By Sinfah Tunsarawuth for Intellectual Property Watch
BANGKOK – The Thai government has decided not to use its right to a compulsory licence on a Novartis cancer treatment drug after the company agreed to provide for free its patented drugs for cancer patients under a major government-sponsored health insurance programme.

However, current Public Health Minister Mongkol Na Songkhla has not yet decided whether he would impose compulsory licences on three other cancer treatment drugs, said Vichai Chokvivat, who chairs a government’s committee on implementing compulsory licences, in an interview with Intellectual Property Watch. Vichai said the minister could make the decision in the next few days.

Thailand has a new government after the general election on 23 December. The new prime minister is still assembling a new cabinet including a new public health minister. New cabinet ministers can officially take office only after being sworn in by Thailand’s monarch King Bhumibol Adulyadej, which could take a few more days.

Vichai said Novartis, which holds the patent on imatinib for treating leukemia and gastrointestinal stromal tumors and markets it as Glivec, has agreed to provide for free its patented drugs to cancer patients under Thailand’s universal health insurance programme, which benefits about 48 million people.

Vichai said each year about 1,000 patients would need imatinib, whose patented version costs 3,600 Thai baht (about US$109) for a 400 miligramme pill. Usually, a patient will take the drug one pill per day every day, which costs about 1.31 million baht (about $39,800) a year.

Had Thailand imposed a compulsory licence on imatinib, the generic version imported from India would cost 150 baht ($4.50) per pill.

A press statement issued by the Ministry of Public Health and posted on its website said Public Health Minister Mongkol decided not to impose the government’s right over the Novartis drug after the Swiss company agreed that a larger number of people will benefit from its free drugs.

Negotiations with the drug company, which lasted for months, have focused on the level of household income of the patients who shall benefit from Novartis’ free drugs. Novartis had earlier said patients whose household income did not exceed three times a country’s per capita income, or about 300,000 baht ($9,100) in case of Thailand, would receive its free drugs, a standard the company applies internationally for its free drug programme.

Under such terms, it meant about 10 million people of the 48 million under the universal health insurance programme would not benefit from the free drugs, Siriwat Tiptaradol, secretary general of Thailand’s Food and Drug Administration who led Thailand’s negotiations with foreign patent owners of cancer treatment drugs, said in a separate interview. “That is unacceptable for us,” Siriwat said.

Novartis then agreed to raise the beneficiary household income level to 1.7 million baht ($51,500), which will cover all the 48 million people.

Siriwat said Novartis (Thailand) has said even for patients whose household income exceeds 1.7 million baht, they would still receive free drugs from the company.

Mongkol has not yet decided on three more cancer drugs that the government has been negotiating for price cut along with imatinib of Novartis. The three include docetaxel for treating lung and breast cancer, which is marketed by Sanofi-Aventis as Taxotere; letrozole for breast cancer, which is marketed by Novartis as Femara; and erlotinib for lung cancer, which is marketed by Roche as Tarceva.

Siriwat told Intellectual Property Watch in November that the three patent holders had made concessions during the various negotiation rounds with his committee.

Negotiations on the four cancer treatment drugs are the latest effort by the Thai government to force price reductions on patented drugs and avoid compulsory licensing, which allows the government to exercise its right over the patent owners – either by producing the drugs in the country itself or importing the generic version from other countries – to cut prices and make the medicines more available to the public. The government would provide certain compensation to the patent owners upon imposing such a measure. Thai government officials have said India is now the country which provides most of the generic drugs.

In late 2006, the Thai government, for the first time, announced its use of compulsory licensing on two patented anti-retroviral drugs for HIV/AIDS patients (efavirenz, manufactured and marketed by Merck Sharp and Dohme as Stocrin, and lopinavir/ritonavir, manufactured and marketed by Abbott Laboratories as Kaletra) and another anti-coagulant for treating heart disease (clopidogrel, manufactured and marketed by Sanofi-Aventis as Plavix) (IPW, Public Health, 12 March 2007).

Sinfah Tunsarawuth may be reached at info@ip-watch.ch.