Impact of TRIPS on Providing Easy Access to Affordable Medicines in India

Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement affected on 1^st January 1995 have provided minimum standards for protecting nearly all forms of intellectual property. Product patents were introduced in pharmaceuticals sector in the amended Indian Patent Act (1970) to make it TRIPS compliant. Many eminent IP experts from industry, academia, policy makers, IP practitioners, government officials and regulatory personnel had expressed concern about increase in drug prices, discouragement in R&D, limited manufacturing of drugs and restriction of competition that may impact the access to drugs and new technologies. To curtail the possible adverse impact of patents on access to medicines, flexibilities have been provided in the TRIPS Agreement. These include certain provisions of Indian Patent Act such as compulsory licensing (Section 84), restriction on grant of patent for new use of a known substance as well as for new forms unless they exhibit significant efficacy (Section 3d) and provision of two-tier patent opposition i.e pre-grant and post-grant opposition [(Section 25 (1) and 25 (2)]. Implementation of these provisions has improved access to drugs to some extent in the post-TRIPS era. There are certain regulations concerning interests of the public with which the Government also controls the drug price and the access of drugs to the public. Drug Price Control Order (DPCO) controls price of the drugs in India. The Government has also raised the ambit of DPCO to include all the drugs in the National List of Essential Medicines (NLEM) including the combination drug where one or more drugs fall under NLEM. The procedure for calculating the ceiling price of the drugs has been changed from a cost based approach to a market based approach. Further, an external reference pricing system has been suggested by the National Pharmaceutical Pricing Authority (NPPA) to negotiate the prices of patented medicines so that availability of drugs improves. Keeping several factors into consideration that exerts influence on the drug prices that in turn have a direct effect on the access to medicine to the Indian public, this article mainly discusses the impact of TRIPS on the specific sections of the Indian Patent Act based on flexibilities provided by TRIPS to the developing countries. Contribution of the pharmaceutical industry, the Indian Government, research-based multinational drug companies, medical professionals, drug research policy, drug production, drug pricing on access to medicines is also discussed.