The Prime Minister's Office (PMO) has taken serious note of the inability of the high level committee on data protection to finalize its observations on the need for 'data exclusivity' provisions under TRIPS agreement. The PMO has asked the chemicals ministry, which set up the committee, to finalise the report at the earliest. The committee, on its part, is likely to submit its report during the current month itself, it is learnt.

According to sources, the 15-member committee headed by Secretary, Department of Chemicals and Petrochemicals, has almost made up its mind to favour data protection without any 'data exclusivity'. The mandate of the committee is to look at whether data protection can be offered under the existing legal provisions or an appropriate new dispensation is required for this purpose.

Interestingly, during the last two years, the committee held several meetings to discuss the issue. While Chemicals ministry was undecided on whether or not to allow data protection, Health and Commerce ministries were very clear that the data protection should not lead to any data exclusivity provisions. The committee had even opined that it would take a final decision after the Mashelkar Committee instituted to define "new chemical entity" under the patent law submits its report. Though the Mashelkar Panel is yet to come out with its observations, a World Health Organisation (WHO) commissioned report, in which Dr R A Mashelkar was associated as vice-chairman recently advised against developing countries opting for 'data exclusivity'.

"Developing countries need to decide in the light of their own circumstances, what provisions, consistent with the TRIPS agreement, would benefit public health, weighing the positive effects against the negative effects. A public health justification should be required for data protection rules going beyond what is required by the TRIPS agreement. There is unlikely to be such a justification in markets with a limited ability to pay and little innovative capacity. Thus, developing countries should not impose restrictions for the use of or reliance on such data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS," the Mashelkar co-chaired Commission on Intellectual Property Rights, Innovation and Public Health stated.