Non availability of life-saving drugs at affordable prices has been a major concern of the governments of developing countries and some of the developed nations for some time now. Spread of life style diseases amongst the middle class and poor sections of the society has aggravated this dilemma as these diseases cannot be cured and medicines have to be taken for life long. And most of the medicines required for controlling the life style diseases are under patent and high priced making the life miserable for the poor patients. There are numerous cases where the patient families have to either finish of their entire savings or sell off properties for treating the life style diseases. Patient groups and social activists have been thus fighting against the patent based monopoly pricing policies of multinational drug companies for some years. Most of the governments world over timidly accept the 20 years patent claim for new drugs of the multinationals without much debate on the pricing policy. And patented drugs always remained outside the price control of governments.
Granting of compulsory licence for the manufacture of cancer drug Nexavar of Bayer to Hyderabad based Natco last week by the Patent Controller in India is thus the first victory against unfair drug pricing. In fact, it is more a relief to thousands of cancer patients of the country rather than an incentive to the Indian generic company. The drug, patented by Bayer in India in 2008, is used for the treatment of liver and kidney cancer, and costs Rs. 2.8 lakh for a month’s dosage. After Bayer’s rejection of Natco’s request for a commercial licence to manufacture Nexavar drug, the Indian company applied for a compulsory licence in September last to make a generic version of the drug. Natco’s argument was that the patent holder had failed to meet the needs of the local market and it was able to provide the drug to only a small group of patients. While granting the Compulsory Licence (CL) under Section of 84 of the Patent Act, the office of the Patent Controller directed that Natco price for the drug should be Rs. 8,880 for a month’s dosage and pay 6 per cent of net sales as royalty to Bayer. That is fair enough. The Patent Controller’s order is the first bold step towards using the flexibilities provided under TRIPS against the abuse of patent rights. For Indian generic companies, the order is a major morale booster and can encourage them to fight monopoly pricing policies of the multinationals in India. It is possible that the order granting CL may be challenged by Bayer as it directly hits excessive profits the company has been making so far on the excuse of high research costs. But such anti people stand may not succeed in the long run.