New Thai Minister May Review Compulsory Licences On Cancer Drugs

By Sinfah Tunsarawuth for Intellectual Property Watch
BANGKOK – Thailand’s new Public Health Minister Chaiya Sasomsup said on Friday he might review the imposition of compulsory licences on three cancer treatment drugs by the previous government.

“But review doesn’t mean cancelling the compulsory licences,” Chaiya told a group of 70 representatives of patients living with HIV/AIDS and cancer, who met him Friday at his office at the Ministry of Public Health.

Still, the pronouncement of a review has raised concerns among patients and activists. “We are worried,” said Nimit Tienudom, director of AIDS ACCESS Thailand, a non-governmental organisation (NGO) working to help patients living with HIV/AIDS, in an interview with Intellectual Property Watch. “It sounds like he might want to negotiate with the drug companies again.”

[Editor’s Note: NGO letter to Chaiya now available here]

Nimit said the NGOs which met Chaiya on Friday wanted to make sure that patients would have access to medicines needed for their treatment. “This does not mean that we are for the imposition of compulsory licences. It’s the access to drugs that we are concerned about.”

Chaiya’s predecessor, Mongkol Na Songkhla, had said he signed four separate announcements to impose compulsory licensing on four cancer treatment drugs on 4 January. However, he asked public health officials to continue negotiation with the drug companies in the hope that they would offer better deals on their drugs.

Since then Novartis, which holds the patent on imatinib for treating leukemia and gastrointestinal stromal tumors and markets it as Glivec, has agreed to provide its patented drug free to cancer patients under Thailand’s universal health insurance programme, which benefits about 48 million people. Its offer prompted Mongkol to decide not to impose compulsory licensing on Glivec.

A senior official at Thailand’s Food and Drug Administration (FDA), who has been involved in negotiations with the patent holders, told Intellectual Property Watch on Friday that the Ministry of Public Health sent Mongkol’s signed announcements to the drug companies in the last week of January, a notification required by Thailand’s Patent Act in government’s imposition of the compulsory licensing.

“The four announcements are for each of the four cancer treatment drugs,” said the official, who declined to be named. “Even for Glivec, we still can impose the measure if Novartis does not keep its word.”

Apart from imatinib, the measure has been imposed on 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.

Nimit said new health minister Chaiya, who officially took office on 7 February, also told the NGOs that the Ministry of Commerce has informed him that the imposing of compulsory licences on patented drugs by the Thai government might prompt the US government to retaliate by resorting to applying import duties on Thai imports.

But the senior FDA official noted that none of the three patent holders of the cancer drugs are American companies. Novartis and Roche are both Swiss and Sanofi-Aventis is French.

“The Ministry of Commerce has always said this whenever we want to impose compulsory licences,” the official said. “But the US is more concerned with our piracy of their song and film CDs than the compulsory licences.”

He said if Chaiya did not agree with the compulsory licenses imposed by his predecessor, he did not have to cancel the announcements. The new minister could simply instruct government agencies concerned not to take any further action, for example, for the state-owned Government Pharmaceutical Organization (GPO) not to order the generic version of the patented drugs.

As Thailand does not have the capacity to manufacture these drugs yet, generic versions of the drugs would most likely be ordered from India, by the GPO. Thai government officials have said India is now the country which provides most of the generic drugs.

Imposition of compulsory licences on the four cancer treatment drugs is the latest effort by the Thai government to force price reductions on patented drugs – 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. The government would provide certain compensation to the patent owners upon imposing such a measure.

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.