India’s National Intellectual Property Rights (IPR) policy, unveiled on Friday, could pose a “serious” hurdle to allowing access to affordable drugs and the South Asian nation missed a chance to put in place a progressive policy, according to experts.
The policy left the country’s patent laws intact and specifically did not open up Section 3(d) of the Patents Act, which sets the standard for what is considered an invention in India, for reinterpretation.Doha Declaration
The government has also underlined its commitment to the Doha Declaration, which reaffirmed flexibilities (like Compulsory Licensing) given under TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement to member states. Under compulsory licensing the government allows someone else to produce a patented product or process without the consent of the patent owner.
The policy, while underlining the Government’s commitment to the Doha Declaration and TRIPS agreement, fails to explain how the vision will translate into reality, said Ms. Leena Menghaney, IP law expert and Access Campaigner at humanitarian aid organization Médecins Sans Frontières (MSF).Big weakness
“With so much focus on turning all knowledge into patentable property, the big weakness in the document is that it is pitting innovation against access. There is no clarity in the section pertaining to commitment to Doha Declaration,” she said.
“It is like saying that we reserve the right to give compulsory licences. But what is the point of reserving that right, if we are never actually going to issue licences because of pressure from the industry. Similarly, in the case of drugs for neglected disease, the IP policy fails to acknowledge that IP is a market-driven model. There will be serious impediments to access to drugs with this approach,” Ms. Menghaney said.
The 301 report attacks section 3(d) of the Indian Patent Act, which has enabled the Indian government to establish stricter patentability standards for medicines -- allowing access to affordable generic drugs.
The report came in the backdrop of increased pressure on the Department of Industrial Policy & Promotion (DIPP), the agency that administers IP laws and policy -- to ensure stringent IP enforcement, fast track examination of patent claims of its companies and a moratorium on compulsory licensing.
International drug companies have often complained about price controls and marketing curbs by India.
“Monopolies are loved by those who own monopolies because they give them commercial benefits,” Union Finance Minister Arun Jaitley said after announcing the policy.