The Supreme Court order rejecting a plea to grant patent protection for Glivec, a cancer-fighting drug from Novartis, is a landmark. It will greatly strengthen the quest for access to affordable medicines in India. The decision affirms the idea that a patent regime loses its social relevance when a drug is priced beyond the reach of the vast majority of a country’s people. That pharmaceutical companies employ high pricing to limit the number of beneficiaries of “blockbuster” patented molecules and even older “evergreened” medicines is an irony, because making additional copies of a drug is not expensive. On the other hand, cost control and dispensing of essential medications in government-run health facilities is affected, because many States have no centralised procurement system. It is unsurprising, therefore, that less than 10 per cent of medicines sold in India are under patent, while the vast majority are branded generics. The court order should prompt producers of patented drugs to move towards liberal licensing and low cost manufacture in India, the pharmacy of the South that produces Rs.100,000 crore worth of medicines annually and sells nearly two thirds within the country. It is a matter of concern that at least a dozen pharmaceutical innovations used in the treatment of cancer, HIV/AIDS, and Hepatitis B and C are not affordable to even the upper middle classes, and impossible to access for the poor.
It would be a gross distortion to paint the Glivec order, which follows the compulsory licensing of Bayer’s drug Nexavar, as an innovation killer. There is evidence to show that major pharma companies recover more than the cost of innovation of a drug in a single year from the United States market alone. Moreover, the costing done by industry has come in for criticism from scientists and policymakers on the grounds that the bloated, irrelevant investments of recent decades are used as the baseline to make calculations. It should not, as the industry claims, cost a billion dollars (and take a dozen years) to produce a new drug; the informed estimate is a third of that figure. The contested field of drug discovery now calls for greater scrutiny of costs and therapeutic value, and control of prices through various legal avenues available under the Indian Patents Act and the Trade-Related Aspects of Intellectual Property Rights as confirmed by the Doha Declaration. It would naturally strengthen the case for grant of patents and consensus pricing, if the industry opens its books for verification. Until the golden mean is reached, governments with vast populations that are denied access to medicines due to economic reasons can justifiably use unilateral price control mechanisms.