The inter-ministerial committee constituted by the Ministry of Chemicals and Fertilizers to examine the need of a special provision for protection to undisclosed information is likely to come out with its final recommendations in its forthcoming meeting scheduled on August 25, 2004. While the chances of the committee recommending the need for data exclusivity have been ruled out, there has been a consensus among the members on the need for providing data protection, it is learnt.
According to highly placed sources, the committee is of the opinion that data protection can be offered under the existing legal provisions without introducing the clause for data exclusivity. The committee has agreed to the argument of the campaign managers of Indian generic industry that "data protection" and "data exclusivity" are entirely different terms and the government is not obliged to bring in "data exclusivity" under the Article 39.3 clause of TRIPS. The objective can be met by ensuring "data protection," sources said.
The 14-member panel was constituted to examine if data protection can be offered under the existing legal provisions or an appropriate new dispensation is required for the purpose.
Multinational drug companies have been demanding data exclusivity as a prerequisite to outsource clinical research activities from India. However, the generic drug industry world over and Indian pharmaceutical industry in particular have seen the provision of "data exclusivity" as an unwanted provision, which is only meant to be misused for "ever greening" patent protection and resulting market exclusivity.
The Ministry of Health is also of the opinion that the country already has necessary legal provisions to protect the data submitted by the innovator companies and hence no need for further protection. The committee chaired by Secretary Department of Chemicals and Petrochemicals has members from Departments of Commerce, Industry, Health, Agriculture, Science and Technology, Biotechnology, Legal Affairs and patent experts.