HC comment may cure drug mkt of pricing ills

NEW DELHI: The recent Delhi High Court observation suggesting that access to cheap drugs is a fundamental right is likely to have a major impact on the way the government enforces laws governing intellectual property rights and the pricing freedom of drug companies, lawyers and experts said.
The commerce department and the ministry of chemicals and fertilizers the key agencies that administer laws relating to drugs and patents — are of the view this has the sanctity of the law of the land and would be a potent tool for curtailing the pricing freedom of companies where the government feels they are abused. To the drug price regulator National Pharmaceutical Pricing Authority (NPPA), this judicial pronouncement provides enough ammunition to bring all essential medicines under price control in one stroke without endlessly waiting for the new drug policy. This observation may also embolden the government to authorize a generics producer to make a cheap version of a patent protected drug (compulsory licensing) as a means of lowering the cost of treatment. The law allows for it under emergencies. This observation will also make NGO voices louder in demanding such authorizations, said an official. While rejecting Swiss drug maker Roche’s plea to block Cipla from selling a low-cost version of its cancer drug Tarceva, the Delhi High Court had held on March 19 it cannot be unmindful of the right of the general public to access life saving drugs that are available. Since blocking Cipla would cause irreparable damage to the patients while the economic damage to Roche can very well be compensated if it wins the case eventually, the court decided in favour of allowing Cipla to be in the market. “If the injunction in the case of a life saving drug were to be granted, the Court would in effect be stifling Article 21,” says the judgment delivered by Justice S Ravindra Bhat. Article 21 of the Constitution says no person shall be deprived of his life or personal liberty except according to procedure established by law. Expanding the meaning of right to life to include access to cheap drugs enables the government to deal with a dynamic market characterized by spiraling prices by bypassing certain procedures. It strengthens the government’s hands to issue a compulsory license without giving the inventor three years to ensure access to the patented product at a reasonable price as prescribed in the law, said a patent lawyer. Some patent attorneys, however, say a more appropriate way to improve access to low-cost drugs is through legislative and statutory means and not by using a patent infringement suit as a platform. “One of the options could be to introduce a negotiation with the company on the price at the time of granting the patent,” a Mumbai-based patent lawyer said.

10 May, 2008, 0237 hrs IST,Gireesh Chandra Prasad, TNN


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