Date:01/02/2005 URL: http://www.thehindubusinessline.com/2005/02/01/stories/2005020100461000.htm

Back Breach of data protection norms may be liable under Official Secrets Act

Nithya Subramanian

New Delhi , Jan. 31

STRINGENT punishment could await persons breaching the proposed new data protection norms. A committee chaired by the Chemicals and Fertilisers Ministry has suggested that any person violating the breach of confidence by making public undisclosed data submitted to licensing authorities could be liable to be prosecuted under the Official Secrets Act, 1923.

The Government is currently working on a `holistic law' on data protection, as the country has to comply with the international obligations contained in the TRIPS Agreement. Under Article 39.3 of TRIPS, member-countries would have to protect data submitted by the originator to regulatory bodies against unfair commercial use.

The committee's proposal is in line with the norms followed by the countries that have manufacturing capabilities but weak drug development capabilities and offer trade secret form of protection for undisclosed data submitted for approval. The developed countries with large pharmaceutical companies involved in advance research and superior manufacturing capabilities for introducing new drugs provide protection of data submitted for approval for a fixed period of time.

According to Government sources, "The committee was of the opinion that providing trade secret form of protection was sufficient to satisfy the obligation under Article 39.3 of the TRIPS. This has been done taking into account the status of the industry as well public interest of making available drugs at affordable cost."

The industry on its part has been divided on the issue of data protection. The Organisation of Pharmaceutical Producers of India (OPPI), a lobby for multinational companies has demanded a five-year data protection time period, while associations such as the Indian Pharmaceutical Alliance, Bulk Drug Manufacturers Association and Indian Drug Manufacturers Association have said that any demand for additional legislation to take care of Article 39.3 of TRIPS Agreement through data exclusivity is uncalled for.

The inter-ministerial committee has suggested that these changes can be made through amendments to the Drugs and Cosmetics Act and the Insecticides Act. But, the Commerce and Industry Ministry will initiate discussions on forming a comprehensive legal framework on data protection covering various sectors.

"There is a demand for data protection from the IT industry as well. A committee in the Communications Ministry is also working on changes in the IT Act. Instead of making amendments to different legislations, the Ministry is looking at the possibility of coming up with a single law," said top officials.

"There was pressure to club data protection with the amendments to the Patents Bill. But the Commerce Ministry was of the view that these two need not be clubbed and can be independent of each other," said Government sources.