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

Ujjwal Kumar ujjumish at hotmail.com
Wed Feb 8 21:19:37 PST 2012

This is an interesting article by Professor Baker. I have a query: Suppose, 
India agrees to the text/language of Article 39.3 in the EU-India FTA, how 
it can be said that India stands chances to loose in a dispute (where it 
maintains its present interpretation of 39.3) under bilateral dispute 
settlement mechanism, whereas it can win a similar dispute under WTO DSM?

I would be grateful if more light is thrown on this issue.

Thanks and Regards, Ujjwal
Ujjwal Kumar

From: "Baker, Brook" <b.baker at neu.edu>
Sent: Wednesday, February 08, 2012 8:10 PM
To: <Ip-health at lists.keionline.org>; 
<internationaltreatmentpreparedness at yahoogroups.com>; 
<healthgap at lists.critpath.org>
Subject: [Ip-health] Europe's Devious Attempt to Re-Enshrine Data Monopolies 
in the EU-India FTA

> 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
> extension.
> 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
> exclusivity.)
> 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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