[Ip-health] donttradeourlivesaway: Data Exclusivity and India-EU FTA: Interview with D.G. Shah of Indian Pharmaceutical Alliance
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
Posted on January 13, 2011 at donttradeourlivesaway.worldpress.com
Interview with D.G. Shah, Secretary-General of Indian Pharmaceutical
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
How will the generic production of new formulations off-patent drugs
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
Knowledge Ecology International (KEI)
thiru at keionline.org
Tel: +41 22 791 6727
Mobile: +41 76 508 0997
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