Humanitarian aid organisation Médecins Sans Frontières (MSF) has warned India that the country will not remain ‘pharmacy of the developing world’ if the proposals in the Regional Comprehensive Economic Partnership agreement (RCEP) are adopted. The RCEP is a regional trade agreement being negotiated between the 10 ASEAN countries currently in Auckland.
MSF Access Campaign along with 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 US-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,” said Leena Menghaney, South Asia Head of MSF’s Access Campaign.
A leaked copy of the intellectual property text being discussed at RCEP negotiations shows that Japan and South Korea have made several “alarming” proposals to include intellectual property rules that go beyond what international trade rules - agreed under World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) require. Two of the most worrying proposals in the trade deal is the demand for ‘Data Exclusivity’ and ‘Patent Term Extensions’- both intellectual property obligations that Least Developing Countries (LDCs) were completely exempted from until 2033 according to the WTO TRIPS agreement.
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 5 years, delaying the entre of generic, affordable versions,” explains Prof Shamnad Basheer, an expert in IP Law and a visiting professor at the National Law School of India University in Bengaluru. Patent terms extensions are given to compensate the company for delays in processing the patent applications. “A company gets a 20 year patent monopoly on a drug from the date that the application was filed. Sometimes processing these applications takes time and the companies get only 13 years instead of 20. A patent term extension will give another 5 year monopoly to the innovator company, again delay the entry of generic drugs in the market,” Mr. Basheer added.
For India, agreeing to data exclusivity will mean amending the Drugs & Cosmetic 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.
