Data Exclusivity and India-EU FTA: Interview with D.G. Shah of Indian Pharmaceutical Alliance

Interview with D.G. Shah, Secretary-General of Indian Pharmaceutical Alliance (IPA)

New Delhi, 13.01.2011 – This week another round of negotiations between the EU and India on a bilateral free trade and investment agreement (India-EU FTA) is taking place in New Delhi. The agreement is likely to be signed by March 2011. Contrary to public statements the European Commission continues to pressurize India for TRIPS plus provisions, such as ‘data exclusivity’. Patients and civil society groups are concerned, that data exclusivity will hamper registration and WHO pre-qualification of affordable, life-saving quality generic drugs. Mr. Shah, could you help us to understand, what, the proposed data exclusivity means and if there is any reason to be worried? Lets begin with some questions about data exclusivity.

Does data exclusivity work like a patent?

D.G Shah: Yes. Both a patent and DE on a drug effectively prevent generic versions from being available. In some cases, DE can even be worse. An invalid patent can be challenged in the Court of Law, but no safeguard exists in any law to challenge data exclusivity.

Is it a requirement of TRIPS agreement?

Data exclusivity is not mandated by the TRIPS Agreement and this is a TRIPS-plus intellectual property provision. Indian Commerce and Health Ministry till now in all international forum – the WTO, WIPO, the World Health Assembly have opposed data exclusivity strongly.

Will the generic production of patented drugs under a compulsory license be effected?

D.G. Shah: There is a provision in the Indian law to issue compulsory license to override a patent. No such provision exists for overriding data exclusivity on a patented drug. Even for the sake of discussion, if a waiver of DE was included in Indian law the time required for applying for a CL plus getting a waiver on DE would discourage generic manufacturers from undertaking the prolonged and bureaucratic process that is going to be opposed by multinational companies every step of the way.

How will the generic production of new formulations off-patent drugs be effected?

D.G. Shah: To create market exclusivity on new formulations of known medicines or products which are not eligible for patent companies can submit some data and apply for data exclusivity. It will thus prevent Indian domestic producers from introducing generic versions until the period of data exclusivity is over, which is usually several years.

How will data exclusivity in India affect the availability and affordability of generic medicines locally?

D.G. Shah: As mentioned above, it can delay entry of new formulations of Off patented medicines. It will undermine compulsory licensing for generic production for new patented products. In addition, data exclusivity can be used to extend market exclusivity (monopoly) of a product even after the expiry of patent. Public health is ill-served by data exclusivity as it will delay the entry of affordable generics for a significant number of drugs.

Will Data exclusivity affect the supply and export of medicines to other developing countries?

D.G. Shah: Yes. A manufacturing license is needed for producing batches of generic medicines for the purpose of conducting stability tests and bioequivalence data. For the registration of generic versions, stability studies and bioequivalence studies are FDA requirements in other developing countries and the WHO pre-qualification programme. In India, a manufacturing license cannot be issued by the state level Food and Drug administration (FDA), if the drug is not registered by the central drug authority (DCGI). Data exclusivity in India will therefore also impede exports of generic medicines to other developing countries.

The European pharmaceutical industry is claiming that the introduction of higher IP standards like data exclusivity would encourage research and development efforts of the Indian pharmaceutical industry. Do you agree?

D.G. Shah: This is a myth. There is nothing to substantiate such a claim. A EU study shows that investment in R & D has moved from Europe to the USA in spite of higher standards of IP protection in Europe. The R & D investment by the Indian pharmaceutical industry has increased over 20 fold in the last ten years, even without data exclusivity.

Will the introduction of data exclusivity attract more foreign investment from multinational pharmaceutical companies?

D.G. Shah: The data available shows that the maximum foreign investment from multinational companies came during the period 1970-1995 when India had abolished product patent. The investment post-1995 has declined, after India introduced product patent.

Thank you for the interview.

Interview by Meike Schwarz