Data Exclusivity Concerns in India

Data exclusivity measures are raising concerns in India. Following lobbying from multinational pharmaceutical companies, it has been reported by Sarah Hiddleston in The Hindu newspaper that the Indian government is expected to amend drug registration laws to bring in data exclusivity provisions, without public debate.

An interministerial committee, convened by Ms Satwant Reddy (Secretary, Department of Chemicals and Petrochemicals) is expected to recommend the protection for data for 5 years in a report due to be released in the next 2 weeks. This will lead to a draft bill amending the Drugs and Cosmetics Act to provide for the new measures.

Article 39.3 of the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) relates to "Protection of Undisclosed Information" and obliges member states to provide protection for undisclosed test and other data against unfair commercial use. Pharmaceutical companies have lobbied against the checking of generic competitors against originator's clinical data, arguing that this amounts to "unfair commercial use." This kind of reasoning has been rejected by many groups, contending that the provision relates to anti-competitive conduct and industrial espionage, and should not be interpreted as a provision for the creation of further exclusive rights.

According to The Hindu report, representatives from the the Department of Health, the Department of Economic Affairs and the Indian Council of Medical Research (ICMR) are also opposed to data exclusivity measures.

The Department of Industrial Policy and Promotion has responded with the suggestion of seven safeguards, but at least 3 have been criticised as failing to address the issues. In particular, the problem has been described as being exacerbated by the attempt to integrate two different systems and functions - legal and regulatory. As Senior BJP Leader, Murli Manohar Joshi (pictured at left), argued earlier this year, the government must take account of the World Health Organization (WHO) recommendations to maintain the separation between intellectual property rights and drug regulation. In other words, linking patent protection to what are basically questions of market and regulatory approval is creating significant obstacles to public health and greater expectations as to exclusive rights. On this issue, Hiddleston describes this as an "administratively difficult and ethically questionable" link between drug registration and patent protection. Further, it links regulatory systems to technical expertise on the validity of the patent itself.

Hiddleston suggests that appeals to the national interest will be made to justify the new measures, but as she says, "It also says much about where the government's priorities lie."