Competitive Exams: Current Affairs 2012: Make Drugs Affordable

  • India's use of the compulsory licensing provision under its patents law for the first time to make the patented cancer drug Nexavar available at affordable prices is an essential, although belated step to curb the mounting cost of drugs.

  • The grant of the licence by the Controller-General of Patents, Designs and Trade Marks to Natco Pharma for manufacture of the drug Sorafenib Tosylate (Nexavar) to treat liver and kidney cancer is a landmark event, consistent with the test of public interest that governs such a measure.

  • Under Section 84 of the Indian Patents Act, 1970, any person can make an application to the Controller for a compulsory licence after the expiry of three years from the date of sealing of the patent, on the following grounds-non-fulfilment of reasonable requirements of the public, or non-availability of the invention to the public at a reasonable price.

  • The Trade-Related Aspects of Intellectual Property Rights and the Doha Declaration provide for compulsory licensing in specified circumstances, including concerns on public health or public interest.

  • The question of drug access and prices has become particularly important after India changed over from a regime that recognises process patents for medicines to one of patents for products, since 2005. The effects are expected to be felt most acutely in the case of new drugs, notably those relating to cancer, HIV/AIDS and psychiatric conditions. Further, the Planning Commission HLEG has drawn attention to more possible negative outcomes if enhanced provisions of TRIPS Plus, which would enable ‘evergreening’ of patents beyond 20 years, are applied.

  • Indians consumed about Rs. 56, 000 crore worth of medicines through private chemists in the open market, going by March 2011 figures submitted to the Planning Commission. What is revealing is that the price gap between government procurement of drugs and retail sale can be staggeringly wide-between 100 per cent and 5, 000 per cent. Moreover, the price index for medicines has parted from the index for all commodities and moved steadily upward, since 1997 − 98. This is clear evidence of unethical pricing of many medicines for rising profit, using patents as a cover, as well as lack of regulation.

Courtesy: The Hindu