Data exclusivity provisions in India: Impact on public health

One of the contentious issues of intellectual property rights is related to data exclusivity. Data exclusivity relates to protection of data generated by the innovator from disclosure to third party in order to prevent 'unfair commercial use'. The debate has serious implications for pharmaceutical companies where substantial amount of data is generated during discovery and development of a new drug. The data is in the form of clinical trials data, reports of pharmacological and toxicological profile of drug, its use and indications etc. This data which is submitted to regulatory authorities of concerned countries for marketing approval is generally referred by regulatory authorities for approval of generic medicine. Multinational companies based in developed countries argue that this data generated during drug discovery and development needs to be protected in the form of 'data exclusivity' which is mandated under Article 39.3 of TRIPS Agreement. Developing countries state that 'data exclusivity' is not mandatory according to TRIPS Agreement. So far India has not provided for 'data exclusivity'. India's position on 'data exclusivity' with respect to other countries of the world is subject to recommendations and suggestions of the committee set up by the Government of India to look into issue of 'data exclusivity' which is discussed in this article.