A European Union proposal that the 20-year exclusivity for drug patents be extended by a further 5 years under a free-trade agreement (FTA) with India would undermine the WTO agreement on TRIPs, analysts point out.
An India-European Union free-trade agreement (FTA) would call for changes in India's patent laws, if it accepts European Union's (EU) proposal for an extended patent term for pharmaceutical products.
EU, which is dead against India's pharmaceutical industry, which churns out the generic equivalents of some of the highly priced branded medicines of Western MNCs, has demanded that patent term for medicines be extended from the current 20 years to accommodate the time taken in regulatory procedures, approvals and delays.
Alternatively, the EU would like the Indian authorities to do away with time consuming procedures for drug permits, so as to facilitate greater market penetration by pharma MNCs.
EU is now demanding a 5-year extension of patent protection to pharma MNCs to keep generic threat at bay for a further 5 years.
Currently, article 33 of World Trade Organisation's (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) provides for 20 years of patent protection from the date of filing of patent application.
The 20-year exclusivity was agreed upon under TRIPs, after taking into consideration the time required for regulatory compliances and the proposed extension of patent period under an FTA would undermine the WTO agreement, say analysts.
Under the proposed FTA, the EU is trying to skirt the provisions of TRIPs outside the WTO agreement.
If EU's demands are accepted, India may have to revise its patent law to accommodate such provisions.
Interestingly, India's patent law was recently lauded internationally because of its provisions to safeguard medicines against evergreening of patents etc.
Various patient groups and health activists today staged protests on the streets of New Delhi calling on the government to reject EU's demands in the FTA with India.
These protests come in the wake of prime minister Manmohan Singh's visit to Germany, with FTA topping the agenda. Commerce minister Anand Sharma is also scheduled to be in Brussels for ministerial level negotiations on 14-15 April to finalise the FTA.
India has already acceded to the global trademarks rules of the West and an FTA with the EU would further imperil its pharmaceuticals industry and harm interests of its citizens.
Civil society is opposing the intellectual property-related issues in the proposed FTA that would impact access to affordable medicines across the developing world.