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

Ujjwal Kumar ujjumish at hotmail.com
Thu Feb 9 21:13:06 PST 2012


Thank you Professor Baker for this important insight and the de facto disadvantage of India in using 39.3 language in bilateral FTA with EU. One can understand this situation in the present context. However, I feel "strong arm" tactics might not work now in case of India, provided there is no political corruption from Indian side. 

On the contrary, there is also a possibility (particularly viewing India's growing power in the present global economy as well as growing concerns re access to drugs in developed countries, along with present civil society opposition and some conducive judicial decisions in recent years) that India's interpretation of Art. 39.3 can prevail over that of EU (which is legally weak) in a court of law. If that happens the inclusion of 39.3 language would be advantageous from access to drugs perspective for every body, whether in developed or developing country. 

The concern however, is whether the "arbitration" or 'bilateral dispute' process under EU-India FTA would give adequate weight to India's interpretation of 39.3, particularly when the national case laws from countries like US, Canada and even EU tends to give legal support to the Indian interpretation. What can be done so that India's interpretation, which is legally correct interpretation is not bypassed in bilateral dispute settlement?

Looking forward to more discussions on this point from you and from other experts on the list,

Sincerely, 

Kind regards, 
Ujjwal
-------------------------
Ujjwal Kumar
+91-9199030799

--------------------------------------------------
From: "Baker, Brook" <b.baker at neu.edu>
Sent: Thursday, February 09, 2012 9:29 PM
To: "Ujjwal Kumar" <ujjumish at hotmail.com>; <Ip-health at lists.keionline.org>; <internationaltreatmentpreparedness at yahoogroups.com>; <healthgap at lists.critpath.org>
Subject: Re: [Ip-health] Europe's Devious Attempt to Re-Enshrine Data Monopolies in the EU-India FTA

> I think India would have a strong case to argue that it's interpretation
> of Art. 39.3 language, namely that it only requires data protection not
> data exclusivity, would be upheld even in bilateral dispute resolution
> under an EU-India FTA.
> 
> But in bilateral dispute resolution, other countries would not be able to
> enter the proceeding or submit arguments in support of India as they are
> permitted to do in WTO dispute resolution. Likewise, the arbitral
> decisional makers might be more "parochial" in bilateral proceedings and
> they might be swayed by the EU's anticipated argument that India knew that
> Europe has previously interpreted Art. 39.3 language to require data
> exclusivity and thus by signing such language India was implicitly
> assenting to that interpretation. Likewise, Europe might point to the
> growing adoption of data exclusivity globally, a condition on the ground
> that has been imposed on countries by US and EU strong arm tactics in
> trade negotiations, IP-threat lists (like Special 301 in the US), and
> other means.  Finally, the WTO has more inclusive appeal mechanisms that
> include the perspectives of developing countries more broadly, where once
> again India's interpretation is likely to prevail.
> 
> 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
> 
> 
> 
> 
> On 2/9/12 12:19 AM, "Ujjwal Kumar" <ujjumish at hotmail.com> wrote:
> 
>>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
>>India
>>+91-9199030799
>>
>>--------------------------------------------------
>>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
>>>
>>>
>>>
>>> _______________________________________________
>>> Ip-health mailing list
>>> Ip-health at lists.keionline.org
>>> 
>>>http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>>> 
> 
>


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