ET: NGO to seek compulsory licensing of cancer drugs: March 31, 2008

HEALTHCARE groups, campaigning for access to medicines, are going all out in their fight against drug patents in India. In a move expected to be challenged by global drug makers, Cancer Patients Aids Association (CPAA), a non-government organisation (NGO), is planning to seek compulsory licensing (CL) in India for about 20 cancer medicines of drug majors such as Roche, Pfizer, Astrazeneca, GSK and Novartis, among others. The group has also got support from several Indian and global NGOs such as Oxfam and Médecins Sans Frontières (MSF). CPAA was one of the healthcare groups in the forefront of the successful legal battle against Novartis’ Glivec last year. While the NGO plans to first approach the health ministry for invoking the CL provision, it is ready to go the Supreme Court if the government rejects to the demand

  “There is no point in fighting patent cases for individual drugs. How many patents will we fight against? It is just unaffordable for patients to pay lakhs of rupees for these drugs, in addition to paying for other treatment and medicines. It’s an emergency situation when thousands of cancer patients are being denied their constitutional right to life. Hence, the government can invoke CL in the public interest, “ CPAA president Y K Sapru said. 

   Product patent laws in India and other countries allow national governments to use the compulsory licensing provision to enable non-patent holders to manufacture and sell patented drugs. While the big pharma MNCs say that the compulsory licensing provision can be invoked only in the case of ‘national emergency’, healthcare NGOs say under the Indian patent law the government can use this provision liberally in ‘public interest’ . During the Glivec case, health minister Anbumani Ramadoss had threatened invoking CL in public interest

  The government should allow generic companies to market the drug in the domestic market by making generic companies pay royalties to the patent holder, Mr Sapru added. Generally, these royalties vary from 0.55 to 5%. Some of the drugs identified by CPPA for compulsory licensing include Genentech’s and Roche’s Herceptin (Rs 1.3 lakh per injection, to be taken 10-15 times), Roche’s Mabthera (Rs 1 lakh per injection, to be taken 10-12 times) and Tarceva (Rs 48,000 for 30 tablets, dosage details not known), Novartis controversial drug Glivec (Rs 1 lakh for a month’s treatment), Astrazeneca’s breast cancer drug Arimidex (Rs 3429 for 14 tablets, to be taken for 1-2 years) and Zoladex (Rs 8,910, dosage details not known), GSK’s Hycamtin (price and dosage details not available). 

   “Under the Indian Patent Act, all life-saving and essential drugs which are patented and expensive can be granted CL if it they are unavailable, unaffordable, for government’s use and for public non-commercial use. It is wrong to say that it can be granted only for extreme national urgency or in the case of emergency, “ MSF’s access campaigner in India, Leena Menghaney said. According to industry estimates, global MNCs have filed over 350 patents for cancer drugs in India. It is estimated that there are over 2 million cancer patients in the country. The CPAA is not just targetting MNCs. It also wants prices of expensive generic drugs marketed by Indian companies to come down.

COMPULSORY LICENSING

It allows the government to order manufacture of patented drugs by non-patent holders to respond to public health emergencies. It’s a provision of the Trade Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organization (WTO) that allows member countries to permit firms to make cheaper versions of such drugs. This provision can be invoked by a country if a drug maker is willing to make and supply copies of patented drugs in a medical emergency or to export to least developed countries, which are yet to be covered by the TRIPS regime.

POSITION IN INDIA

India has one of the widest compulsory licensing provisions in the world. The country’s patent law provides for compulsory licences to be issued if the drug in question is not available in adequate quantities locally and also when the government feels the drug is not reasonably priced.

QUOTE, UNQUOTE

It is just unaffordable for patients to pay lakhs of rupees for anti-cancer drugs, in addition to paying for other treatment and medicines. It’s an emergency situation as thousands of cancer patients are denied their constitutional right to life.
YK SAPRU PRESIDENT CPAA

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It is wrong to say that compulsory licensing can be granted only for extreme national urgency or in case of an emergency.
LEENA MENGHANEY CAMPAIGNER MSF

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