WASHINGTON, Apr 15: Asserting that Indian patent and pharma laws falls within the bounds of what is allowed under the rules of the World Trade Organization (WTO), a top American non-profit consumer rights advocacy group has said Indian pharma laws should not be considered discriminatory.
In a submission to US International Trade Commission (USAITC), ‘Public Citizen’ said yesterday that India’s rules meet the data protection requirements under Trade Related Aspects of Intellectual Property Rights (TRIPS), which is an international agreement administered by the World Trade Organization TRIPS.
USITC is currently conducting an investigation on “Trade, Investment, and Industrial Policies in India: Effects on the US Economy” at the request of US lawmakers.
“The Drugs and Cosmetics Act of 1940 prohibits the disclosure of information received by an officer of the Drug Controllers’ Office, except for the purpose of official business, where it is required by a court of law, or with the permission of an official superior where test data is required when considering marketing approval for a new drug,” Public Citizen said.
It said that the Drugs and Cosmetics Act of 1940 does not prevent the Government from relying on the data presented by the first applicant to assess submissions by the second and subsequent applicants for similar products.
It provides data protection rather than data exclusivity, and is TRIPS-compliant, it added.
“If policies adopted by India are legally permissible under its international trade obligations, then they should not be considered barriers,” Public Citizen said.
“The TRIPS Agreement gives broad discretion to Member countries in determining intellectual property policies and as clarified in the Doha Declaration, allows for wide use of flexibilities in developing these policies to promote public interests, including public health,” it said.
Our analysis shows that Indian law falls well within the bounds of what is allowed under WTO rules and therefore should not be considered discriminatory, the submission said.
In light of this, the Commission’s report should not find these policies to be harming US industrial interests,” Public Citizen said.
Observing that the TRIPS Agreement allows countries to grant compulsory licenses on grounds of their choosing, Public Citizen said section 84 of India’s patent law is somewhat narrower, providing three separate grounds for compulsory licensing, any one of which suffices to warrant a license: reasonable requirements of the public, price, and failure to work a patent in India.
“The sorafenib license is very important to public health. It makes use of each of the three grounds, but reviews of the license have emphasized health interests and price,” it said.
Even if the availability of working failure (which could in some cases relate to local manufacturing) as a license grounds were objectionable as a matter of policy or law, India’s other grounds – price and the reasonable requirements of the public, including health – are precisely the point of the WTO’s Doha Declaration and compulsory licensing in the public interest, it argued. (PTI)
Trending Now
E-Paper
Follow our WhatsApp channel