[Ip-health] India: USTR pushes for drug data protection

[Sarah Rimmington]

http://timesofindia.indiatimes.com/Business/India_Business/USTR_pushes_for_drug_data_protection/articleshow/2951589.cms
The Times of India
USTR pushes for drug data protection
15 Apr 2008, 011
6 hrs IST,Rupali Mukherjee,TNN


NEW DELHI: 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 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. Developed countries like US are protecting intellectual property
for commercial interests.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/