The debate over the appropriateness of granting data exclusivity in drugs is likely to get hotter each day with more organizations and individuals coming forward to support/oppose the move. The renewed interest in data exclusivity is due to the attempts of the Prime Minister's Office (PMO) to put an end to the uncertainty prevailing in this area.
The latest among the formal representations made before the Prime Minister is that of Dr Murli Manohar Joshi, Chariman, Parliamentary Standing Committee on Commerce. The letter cautions against any move to offer data exclusivity in drugs and agro-chemicals sector. "Providing data exclusivity has serious implications for the role of domestic enterprises in the fields of pharmaceutical and agro-chemical products. If data exclusivity is conceded domestic enterprises would be prevented from taking marketing approval on the basis of the data submitted by the first enterprise who had generated the data and submitted the same for taking marketing approval. Even if the domestic enterprise has been granted compulsory licence to use the patented subject matter they would be prevented from taking marketing approval during the period the data exclusivity is in operation", Dr Joshi observed.
Pointing out that the demand of USA and other developed countries for data exclusivity was rejected during the Uruguay Round of GATT negotiations, Dr Joshi said that it was only a bilateral issue between USA and India. "The demand for data exclusivity has been raised at bilateral level with our government by the MNCs and the US government. It is understood that the concerned ministries have been deliberating on this issue for the last 3/4 years and now they are at the verge of conceding to the bi-lateral demand of data exclusivity instead of implementing data protection as stipulated in the TRIPS agreement," he complained.
He also quoted a World Health Organisation document which recommends that developing countries would be well advised to keep the two systems of IPR and drug regulation separate, and to reject any and all efforts to make connections between them. Dr Joshi felt that the WHO recommendation needs an in-depth consideration.
Dr Joshi appealed to the Prime Minister to look into the matter seriously and avoid any kind of TRIPS plus measures being pushed by the ministries for legislation.