India warned against pitfalls in ASEAN trade agreement

As talks for a Regional Comprehensive Economic Partnership (RCEP) — a regional trade agreement among the 10 ASEAN countries — continue in Auckland, Médecins Sans Frontières (MSF) has warned India that it will no more remain ‘the pharmacy of the developing world’ if the proposals in the pact are adopted.

MSF Access Campaign and other civil society organisations are pushing for the removal of harmful intellectual property provisions that could potentially increase drug costs by creating new monopolies and delaying the entry of affordable generics in the market.

“Unless negotiators remove harmful provisions from RCEP, this trade deal is set to follow the dangerous path of the U.S.-led Trans-Pacific Partnership agreement, which is recognised globally as the worst trade deal ever for access to medicines. We appeal to India’s IP negotiators in particular, to stand by the promises made last week by Health Minister J.P. Nadda at the UN High Level Meeting on HIV/AIDS that ‘India is committed to maintaining TRIPS flexibilities to ensure access to affordable medicines. These laws are extremely harmful for countries like India that export drugs” said Leena Menghaney, South Asia Head of MSF’s Access Campaign. A leaked copy of the intellectual property text being discussed at the RCEP negotiations shows Japan and South Korea have made several “alarming” proposals that go beyond the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights.

Two of the most worrying are the demands for ‘Data Exclusivity’ and ‘Patent Term Extensions’ — both intellectual property obligations that Least Developing Countries are exempted from till 2033. Data exclusivity is a form of legal monopoly protection for a drug, over and above the patent protections. “This is given expressly to compensate for the investment made during clinical trials. It implied that regulators cannot approve a similar drug with similar data for the next five years, delaying the entry of generic, affordable versions,” said Prof. Shamnad Basheer, an expert in IP Law and a visiting professor at the National Law School of India University in Bengaluru.

Patent term extensions are given to compensate the company for delays in processing patent applications. “A company gets a 20-year patent monopoly on a drug from the date that the application is filed. Sometimes processing these applications takes time and the companies get only 13 years instead of 20. A patent term extension will give another five-year monopoly to the innovator company, again delaying the entry of generic drugs in the market,” Mr. Basheer added.

For India, agreeing to data exclusivity will mean amending the Drugs & Cosmetics Act (FDA law) so that the Indian Drug Regulatory Authority (DRA) is prohibited from registering a more affordable version of a medicine as long as the exclusivity lasts over the clinical trial data.