EU’s demands may impact genericsAfter multinational drugmakers, it's the European Union's (EU) turn to exert pressure on India to agree to provisions that could affect the registration and availability of low-cost medicines.

The EU is pressing India to incorporate two provisions — patent extensions and grant of data exclusivity — in the bilateral free trade agreement (FTA) between the two. These provisions go beyond the stipulations of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement that India has signed.

Experts feel the EU, in asking for greater intellectual property (IP) protection, is overlooking the difference in the levels of development between India and itself.

"Though India has rejected the two demands of patent extensions and data exclusivity in the first round of negotiations which happened earlier in the year, there is every possibility that the EU could exert maximum pressure over India and make it accept these provisions the next time around," said an international IP expert.

The expert said that Article 10 of the EU-India draft FTA would impose on the country the obligation to grant data exclusivity. "Article 9.3 would compel India to extend the monopoly accorded by a patent for up to 5 more years to compensate for the time required to get the marketing approval for a medicinal product. This will delay the entry of generics," he said.

Usually, for registering a generic, the Drugs Controller General of India (DCGI) refers to the clinical trials data of the innovator company. If data exclusivity is granted, the pharma company seeking the registration of the generic would have to itself conduct all the clinical trials required to bring the particular drug into the market. This would not only increase costs but also delay the process of bringing the generic into the market.
Said the expert, "Article 2.1 of the draft FTA states that this chapter shall complement and specify the rights and obligations between the parties beyond those under TRIPS, and other international treaties in the field of IP. Thus, the intention to exceed TRIPS is explicit."

BK Keayla, convenor, National Working Group on Patent Laws, and trustee, Centre for Study of Global Trade System & Development, said the FTA is an attempt to colonise the economic strength of a country. "Why EU is calling for TRIPS plus is the prime question. Such provisions will only lead to India receiving goods, and not being able to export," he said.
Gopakumar Nair, a Mumbai-based IP expert, added that accepting EU terms would be highly detrimental for India. "Any weakness on India's part will affect exports," he said.

Data by Pharmaceutical Exports Promotion Council (Pharmexcil), under the Union ministry of commerce and industry, shows that between April 2008 and January this year, India exported drugs worth Rs 31,608 crore.

Leena Menghaney, project manager, India (Campaign for Access to Essential Medicines), Medicins Sans Frontieres (MSF), said the survival of patients is more important than the European pharma industry's profits. MSF, an international humanitarian aid organisation, buys more than 80% of its AIDS drugs and over 25% of essential drugs such as malaria, tuberculosis and antibiotics, from India, said Menghaney.

Experts felt the EU initiative points to a larger effort by developed economies to stifle the country's generic drugs market. In the recent past, there have been incidences wherein Indian generics have been seized at EU ports en route countries such as Brazil and Colombia on charges of counterfeiting and patent infringement.
Moreover, African countries such as Kenya, Nigeria and Tanzania have been drafting anti-counterfeit laws under which generics of drugs that are patented anywhere in the world would be deemed counterfeit.

The chief executive officer of a Hyderabad-based drugmaker said, "Substandard drugs are the worry of developing countries, including those in Africa. Now turning that worry into advantage, developed countries are trying to term generics of drugs patented somewhere in the world substandard and confuse African nations into drafting such laws."