USTR pushes for drug data exclusivity [India]

The thorny issue of providing data exclusivity to pharma MNCs has come under limelight. The United States Trade Representative (USTR) seems to be lobbying hard with the health ministry for data exclusivity, which if allowed, will adversely affect domestic pharma companies that are making generic versions of patented drugs. Data exclusivity, if implemented, will stop or delay marketing approval of many generic drugs as the domestic pharma companies will not be able to rely on the clinical data which has been submitted by MNCs to the drug regulator, when they seek approval.

The Indian health ministry has not been in favour of granting data exclusivity to pharma MNCs, which effectively offers monopoly to the developer of a new drug even without a patent, restricting cheaper generic versions for several years. While one round of negotiations have been held earlier this year between USTR representatives and health ministry officials, the issue is expected to come up again soon, sources said. "The focus (of USTR) has shifted to the health ministry which is being urged to take a decision on the issue," sources said. For USTR, a change in the ministry's view is important before WHO-established Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) meets in Geneva this month, to negotiate an action plan for R&D that prioritizes the health needs of developing countries. Data exclusivity can be introduced through an amendment in the Drugs and Cosmetics Act, which is under the purview of the health ministry. The health ministry had then suggested data protection and not data exclusivity, which is compliant with TRIPs. Data protection prevents disclosure of clinical test data to competitors, but allows the drug regulator to use it for granting approval to generic companies. On the other hand, if data exclusivity proposal is accepted, the regulator cannot use the clinical test data submitted by an innovator company, to give marketing approval, which are developing cheaper generic versions.

Says Indian Pharmaceutical Alliance secretary general DG Shah: "India is not obliged to grant data exclusivity under TRIPS. Protecting the originators data against 'unfair commercial use' is agreed by all sections of the industry. So why are attempts being made to get it (data exclusivity) back?" Developing countries along with the WHO, feel that the draft action plan being negotiated in Geneva should focus on a global strategy on health and innovation, and intellectual property should be managed in a pro-public health manner. Intellectual property rights should not become an obstacle to access low cost generic medicines public health groups say.