By Sinfah Tunsarawuth for Intellectual Property Watch
BANGKOK – Thai government officials said the latest round of negotiations with patent owners of cancer treatment drugs showed positive results with drug companies agreeing to make their supplies more available to certain cancer patients.
But they stopped short of saying that the government would now have no need to impose compulsory licences on these drugs.

“They have made some good proposals, with more concessions than they used to offer,” said Siriwat Tiptaradol, secretary general of Thailand’s Food and Drug Administration, who led Monday’s negotiation with foreign patent owners of three drugs used to treat various kinds of cancer.

Representatives from pharmaceutical company Sanofi-Aventis, which produces docetaxel for treating lung and breast cancer and markets it as Taxotere and Novartis, which produces imatinib for treating leukemia and gastrointestinal stromal tumors and letrozole for breast cancer and markets them as Glivec and Femara respectively, joined Monday’s meeting. Roche, which manufactures erlotinib for treating lung cancer and markets it as Tarceva, did not send its representative.

Siriwat, himself a physician, said Sanofi-Aventis so far has made the most generous offer among the three companies. “I think for Sanofi-Aventis, we are near reaching a settlement,” he said in a briefing to reporters after the meeting.

He said he has asked the company to submit its proposal in writing, which he would then propose to the public health minister for final decision. “It is the minister who can say whether we still need to impose compulsory licences or not.”

Siriwat said for imatinib, Thai authorities have also agreed on “ninety percent” of the issues with Novartis. For letrozole, which is produced by the same company, he said the patented formula did not cost that much, 230 baht ($6.70) per pill, and it was not widely applied to patients suffering from breast cancer.

He said Roche did not join Monday’s meeting because the company said it needed more time to come up with a revised proposal.
The proposals made by the three companies are not simply cuts of their drug prices. Rather, they offer their patented drugs for free to patients suffering from the later stages of the cancer under various government-sponsored health insurance programs.

The government still would have to pay full price of the drugs for patients at an early stage of the disease, Siriwat explained. But on average, treatment of these cancer patients would cost the government less.

At issue with these companies, therefore, is the stage of cancer development that will entitle the patients to free patented drugs and the number of patients eligible for these drugs under the various insurance schemes.

“We have to understand them. If they cut the price in our country outright, their peer companies in our neighbouring countries might start to complain,” Siriwat said. “We need to find a model which will not have too much impact on their global pricing system.”

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 to cut prices and make the medicines more available to the public.

Late last year, 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).

But only efavirenz has so far been imported by the Government Pharmaceutical Organization from India for use with AIDS patients. The Thai government has identified suppliers, also in India, of lopinavir/ritonavir and clopidogrel and is working through the process to import them.

Sorachai Jamniandamrongkarn, a pharmaceutical expert at the National Health Security Office, said earlier in an interview with Intellectual Property Watch that Thailand has in its pipeline about 20 more items of various patented drugs that could be candidates for compulsory licences. The items include drugs for treating hypertension, diabetes and hyperlipidaemia (IPW, Public Health, 2 November 2007).

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