Multinational, domestic pharma firms lock horns over R&D data

Mumbai: Multinational and domestic pharma firms are locking horns over the protection of research and development data in India. While the MNCs are pushing for a longer period of data exclusivity, the domestic firms, under the aegis of the Indian Pharmaceutical Alliance (IPA) and the Indian Drug Manufactures’ Association (IDMA), are lobbying for a shorter period of protection.

IPA, a body of 12 leading domestic pharma firms, recently submitted a position paper, to the Prime Minister’s Office and the chemical and fertiliser ministry, on how a longer period of data protection will adversely affect the generic exports from India. Data exclusivity protects research data on toxicology, pharmacology, safety, efficacy, dosage and trials.

In the US, it is provided for five years (from the day of marketing approval of the drug). Industry sources say the MNCs want India to provide data exclusivity under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) obligation for more than five years irrespective of the life of the patent. The foreign pharma firms have also demanded that India, by not introducing data exclusivity from 2000, has defaulted on its obligation to implement the TRIPS Agreement.

However, IPA and IDMA argue that the TRIPS agreement calls for the protection of data against “unfair commercial use,” but says nothing on the period of protection, leaving it to the respective countries. “Canada, Australia, New Zealand and others do not specify the period of exclusivity.”

Says IPA director-general D G Shah: “A longer period of data exclusivity will hit the country’s generic exports. If the launch of generic drugs in the foreign market after the patent expiry is delayed, we will not have the opportunity of obtaining exclusive marketing rights for six months after the patent is over [with a para IV filing for a new usage/treatment].”

But a senior official with a leading MNC pharma firm says: “At present, India does not provide any data exclusivity and this is not moral or ethical. It is unfair to allow Indian firms to use the MNCs’ exclusive data for drug development. We have invested heavily to develop data. There should be a five-year data protection as practised in the US.”