Pharma MNCs upset as govt issues more compulsory licences

Source: Business Standard

Reghu Balakrishnan / Mumbai Jan 13, 2013

The government’s move to issue compulsory licences to three more patented cancer drugs in India has left the MNC pharma companies in a lurch. The government plans to issue compulsory licences for cancer drugs such as Trastuzumab (or Herceptin, used for breast cancer), Ixabepilone (used for chemotherapy in breast cancer treatment) and Dasatinib (for leukaemia).

These drugs are sold at an average price of $3,000-4,500 for a month’s treatment.

In last March, Hyderabad-based Natco Pharma had won the compulsory licence to manufacture generic version of Bayer’s patent protected anti-cancer drug Nexavar. The licence enabled Natco to sell the drug at a price of about Rs 8,880 for a pack of 120 tablets (one month’s therapy) as against Rs 2.8 lakh, the cost which Bayer sells Nexavar.

Ranjit Shahani, president – OPPI (Organisation of Pharmaceutical Producers of India), the largest body for MNC pharma companies said, “Issuing compulsory licences is a matter of concern, eventhough there are access programmes by MNCs for medicines which very often bring down the prices significantly.”

According to Shahani, Novartis’ cancer drug -Glivec was given free for 16,000 patinets in India, which is claimed to be about 95 per cent of patients in those category through The Glivec International Patient Assistance Program (GIPAP). “There has to be an interactive dialogue between Indian government and the multinational pharma companies regarding the price difference,” he added.

According to sections 84 of the Indian Patents Act 1970, Compulsory licensing (CL) can be issued in India if the patented drug is unavailable, unaffordable, or not supplied properly. With CL, domestic players can manufacture and market the generic versions with paying a royalty to the patent holding company.

Natco has already locked in horns with Bristol-Myers Squibb over the marketing of Dasatinib’s generic version. Last year, Natco had started selling Dasatinib’s copycat version in India. Natco has priced Dasatinib at Rs 9,000 for a month, as compared to BMS’ Rs 1 lakh for a month’s treatment.

A CEO of Indian generic company which is engaged in dispute with MNCs, said on condition of anonimity, “These cancer drugs cost about $5,000-6,000 (about 3 lakh) per month. How many patients in India, where there is no public insurance facility is available, can afford these prices?” Unless MNCs will be ready to change the strategy for $1.2 billion people in India, issuing compulsory licences will be the only option to make drugs affordable to Indian population, he
added.

The Cancer Patients Aid Association (CPAA) has welcomed the government move.

YK Sapru, founder chairman & CEO, CPAA said, “Giving compulsory licence for a few more anti cancer drugs is a very good move, especially Herceptin which was required by a large number of breast cancer patients who were dying because the drug was not affordable.”

Now government should increase the list of drugs for which compulsory licence is granted as there are several life saving anti cancer drugs which are totally in affordable currently, he added.

In March, Roche had given manufacturing and marketing licence for Herceptin to Pune-based Emcure Pharma. Herceptin, for breast cancer, is priced between $3,000 and $4,500 for a month’s treatment.