Thailand shelved compulsory licence for Novartis’ Imatinib/GlivecTM. This was decided after the company agreed to provide for free its patented drugs for cancer patients under a major government-sponsored programme which could benefit 48 million people.
In regulatory terms, compulsory licence is a provision under the WTO laws which allows government to force price reductions on patented drugs, thereby allowing government to impose its right over the patent owners - either by producing the drugs dometically or importing the generic version from another country.
Imatinib is indicated for the treatment of leukemia and gastrointestinal cancers. In Thailand, about 1,000 patients would need imatinib each year. The patented version costs 3,600 Thai baht (about US$109) for a 400 mg pill. Usually, a patient will take one pill daily, which costs about 1.31 million baht (about $39,800) a year. Had Thailand imposed a compulsory licence on imatinib, the generic version from India would cost 150 baht ($4.50) only per pill.
The plan to issue a compulsory licence for imatinib was averted through negotiations between Thai FDA lead by its secretary general, Dr. Siriwat Tiptarodol, and Novartis on the basis the deserving patients’ household income – aka means testing in what we our Singapore MOH is currently planning to implement. Specifically for this programme, Novartis intended to apply the company’s international free drug programme by placing a cap on qualifying patients based on maximum household income of not exceed three times the country’s per capita income, or about 300,000 baht (US$9,100) for Thailand. Under such terms, it would only qualify about 10 million of the 48 million covered under the Thai universal health insurance programme; a position which the Thai authority found unacceptable. Further negotiations resulted in Novartis agreeing to raise the beneficiary household income level to 1.7 million baht ($51,500), which will cover all the 48 million people. This averted another controversial compulsory licence debate in Thailand with Novartis.
On the wings, however, 3 more cancer patented drugs could potentially face similar challenge of being issued compulsory licences by the Public Health Minister. The 3 include docetaxel by Sanofi-Aventis (Taxotere); letrozole by Novartis (Femara); and erlotinib by Roche (Tarceva).
With the newly post-military Thai government being elected, it is possible that such decision may not be made so soon, giving some breathing space for drug industry to gather some thoughts in dealing with this increasingly interesting event unfolding in making expensive, patented drugs accessible to the patients of developing countries like Thailand through legitimate, yet highly controversial provision ratified under the WTO laws.
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