[Ip-health] donttradeourlivesaway: Data Exclusivity and India-EU FTA: Interview with D.G. Shah of Indian Pharmaceutical Alliance

Thiru Balasubramaniam thiru at keionline.org
Thu Jan 13 05:50:10 PST 2011

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

Posted on January 13, 2011 at donttradeourlivesaway.worldpress.com  

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 drugauthority (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  

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  

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


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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