[Ip-health] Europe's Devious Attempt to Re-Enshrine Data Monopolies in the EU-India FTA

Baker, Brook b.baker at neu.edu
Wed Feb 8 06:40:47 PST 2012

Big Pharma and its proxies in the offices of US and EU trade
representatives love patent monopolies, but they increasingly seek data
monopolies as well.  Formally known as "data exclusivity," the data
monopolies sought by pharmaceutical giants prevent drug regulatory
authorities from registering or granting marketing approval of generic
equivalents of previously registered medicines.  Although the safety and
efficacy of generic medicines should be conclusively established by drug
regulators once they confirm that the generic is indeed "equivalent to"
the original product, data exclusivity requires drug regulators to ignore
the data previously filed or even the fact of prior registration.
Instead, in order to gain marketing approval, even when a patent monopoly
does not exist, the generic company would be required to conduct costly,
lengthy, and presumptively unethical human clinical trials to re-establish
what is already known - that the generic equivalent is safe and
efficacious in addressing one or more health conditions.

In the US, data monopolies (data exclusivity) has an original term of 5
years, but that term can be lengthened by 3-years whenever new clinical
trial data is submitted in support of new uses, new dosages, new
formulations, etc.  In the EU, data exclusivity is longer yet, with an
initial term of 10 years, with the possibility of a further 1-year

India negotiators in the pending EU-India Free Trade Agreement have
steadfastly refused to accede to Europe's demand that India formally adopt
data exclusivity.  Bolstered by an international campaign, led by Indian
activists, Indian negotiators have said "no" over and over again,
eventually causing Europe to announce that it has at least temporarily
dropped its demand for data exclusivity (and its demand for patent term
extensions as well).

But Big Pharma and Europe are persistent.  Their new strategy is to demand
that the EU-India FTA contain the language of TRIPS Article 39.3, which,
on its face, merely demands protection against unwarranted disclosure of
test data and against "unfair commercial use."  However, this demand,
seemingly innocuous (after all, why shouldn't India accept what it is
already bound to do under the 1994 WTO TRIPS Agreement?), is in fact
dangerous.  Why?  Because the EU, like the US, willfully and consistently
misinterprets Art. 39.3 to require data exclusivity/monopolies. Because
Europe would be permitted to initiate direct trade disputes against India
under a ratified FTA, it would have a greater chance of winning approval
for its interpretation of Art. 39.3 in a bilateral panel than it would in
a multilateral WTO panel.

Notably, neither the US nor the EU has ever formally filed a trade dispute
at the WTO because of alleged violations of Art. 39.3.  They have failed
to do so for one simple reason - they would lose, first and foremost
because proposals for data exclusivity were explicitly rejected during
TRIPS negotiations and secondly because many WTO members eschew data
monopolies.  (Note:  the US did impose unilateral trade sanctions against
Argentina in 1997 in retaliation against its refusal to adopt data

Europe is betting that it might have better luck within a bilateral FTA
framework than in the WTO.  Accordingly, the demand for inclusion of Art.
39.3 language is in fact deviously dangerous rather than merely repetitive.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

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