[Ip-health] [e-drug] IPS: (India) Trade talks with EU put drug manufacturers on Edge

Baker, Brook b.baker at neu.edu
Sun Aug 8 17:38:49 PDT 2010

Professor Light is certainly correct that data exclusivity (and its counsin patent/registration linkage) are high on Big Pharma's agenda with respect to IPRs that extend and deepen monopoly rights.  One slight correction to the statement "Data exclusivity operates regardless of patent status and in all countries in which patents are not registered" is that data exclusivity only works where countries have enacted it into their domestic legislation.  Countries can, of course, avoid data exclusivty and refuse trade agreement-related demands that they amend their national laws to use exclusivity to bar registration of follow-on generics that seek to refer to or rely upon the originator's data during the period of exclusivity.  However, even if countries have ill-advisedly adopted data exclusivity, they should make sure that their legislation allows exceptions to data exclusivity - certainly when a compulsory license is issued but even in the absence of a patent-avoiding CL if the medicine is un-patented or off-patent but still covered by exclusivity.

Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
From: ip-health-bounces at lists.keionline.org [ip-health-bounces at lists.keionline.org] On Behalf Of Donald Light [dlight at princeton.edu]
Sent: Sunday, August 08, 2010 8:38 AM
To: Essential Drugs in English
Cc: ip-health at lists.keionline.org
Subject: Re: [Ip-health] [e-drug] IPS: (India) Trade talks with EU put drug     manufacturers on Edge

Dear Readers,

These so-called free trade agreements have usually raised trade barriers and prices for medicines because they include a strong IP clause, as if IP provisions are not high barriers to free trade. The greatest focus in recent times by the pharmaceutical industry has been on extending protection from normal price competition through "data exclusivity." You all probably know what that is, but essentially IP lawyers for the industry developed the claim that results of trials and tests done for the public regulator belong to the company, not the regulator. (This is not true of the test results on the cars we drive or the planes or buses we ride.) Thus, a generic competitor is prohibited from referring to it or invoking it when applying to market a medicine once patents have expired, even though t!he regulator has the data already! An authoritative article last year in the Journal of Health Politics, Policy and Law (34;6:979) (Adamini et al, "Policy making on data exclusivity in the European Union") details how advocates for the innovative branch of the industry inside DG Enterprise wrote, managed, revised, and got passed the longest data exclusivity protection in the world without any credible evidence that it increases R&D or innovation, only sustains high prices.

Data exclusivity operates regardless of patent status and in all countries in which patents are not registered. Thus, this European law harms most seriously ill patients in developing countries, not Europe. A big win for the industry in the U.S. reforms was to get DE extended to 12 years.

An important study of how these trade restrictions affect access of medicines for seriously ill patients is by Ellen Shaffer and Joe Brenner, "A trade agreement's impact on access to generic drugs," Health Affairs - web exclusive 2009; 28 (5): w957-w968, at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w957 .

The main point for legislators is that there is no credible evidence that longer patents or DE increases the development of therapeutically superior drugs, but there is clear evidence that they extend high prices by transferring more taxpayers' money to profits for drug companies.

Donald W. Light
Professor of comparative health policy
University of Medicine & Dentistry of New Jersey
Lokey visiting professor, Stanford University

Donald Light
Cell: 609-216-0071

On Aug 3, 2010, at 10:42 PM, Suerie Moon wrote:

> E-DRUG: INDIA Trade Talks with EU Put Drug Manufacturers on Edge
> --------------------------------------------
> By Keya Acharya
> NEW DELHI, Aug 3, 2010  (IPS) - Their ongoing negotiations remain shrouded in secrecy, but there are already reports that India and the European Union (EU) will have a free-trade agreement ready by the end of August, and that they will be putting signatures to it before the end of 2010.
> Yet it is a potential development that is causing more
> nervous chatter than joyous jitters here in India, where
> drug manufacturers in particular have raised concerns over
> India's trade interests and intellectual property rights
> (IPR) issues.
> India's 7.5-billion-dollar drug industry is among the
> world's top five bulk medicine producers. It is also among
> the world's 20 top pharmaceutical exporters, with its export
> business growing at 17.8 percent per year.
> A large segment of its reasonably priced generic drugs,
> including life-saving HIV anti-retrovirals and anti-cancer
> drugs, are exported to other developing nations in Asia and
> Africa. But now Indian drug exporters are worried that any
> potential growth for their business overseas is bound to
> disappear should India capitulate to several EU stipulations
> in the trade talks.
> The talks have drawn concern since they began in 2007,
> especially since they integrate bits from other
> controversial bilateral negotiations between industrialised
> nations.
> These include the Anti-Counterfeit Trade Agreement
> (ACTA), the World Customs Organisation's Standards to be
> Employed by Customs for Uniform Rights Enforcement (SECURE),
> and the World Health Organisation's (WHO) International
> Medical Products Anti-Counterfeiting Task Force (IMPACT).
> ACTA, IMPACT, and SECURE have all drawn consistent
> protests from developing countries for being formulated in
> secrecy and without their consent.
> More importantly, countries like India and Brazil say
> that ACTA's definition of counterfeit drugs is ambiguous
> enough to include generic drugs, while SECURE's IPR
> enforcement allows Interpol to decide by itself, or by a
> third party, what is counterfeit and seize it in transit.
> As a result, they say, the definition of generic drugs
> has become restricted, in turn allowing their seizure in
> transit through EU countries. Essentially, such acts
> override previous laws under the Agreement on Trade-Related
> Aspects of Intellectual Property Rights (TRIPS) that allowed
> patented drugs classified as 'essential' or crucial to
> health to be manufactured in developing countries.
> On its website, the EU says that "nothing in the proposed
> agreement would limit India's freedom to produce and export
> life-saving drugs in accordance with the TRIPS agreement…."
> Officials at India's Department of Commerce, responsible for
> dealing with the EU and WTO issues, for their part were
> tightlipped when queried on the matter by IPS.
> In June, however, India's Commerce and Industry Minister
> Anand Sharma, in response to MP Maneka Gandhi's query in
> Parliament on IPR and access to medicines in the India-EU
> talks, said, "Final positions have not emerged and therefore
> no agreement has been reached in any sector including IPRs."
> Still, Gopal Krishnan, adviser to the Mumbai-based Indian
> Drug Manufacturers’ Association (IDMA), notes, "What is
> being agreed on needs to be seen. None of us in the field
> have seen the document."
> The concerns may not be unfounded. In 2009, the Mumbai-based
> Indian Drug Manufacturers Association (IDMA), with over 600
> small, medium, and large Indian pharmaceutical companies as
> members, asked India's Ministry of Commerce to exclude the
> EU's clauses on IPR since these were already included in TRIPS.
> An issue dropped in the World Intellectual Property
> Organisation (IPO), the EU's terms of 'patent linkage',
> whereby one patent is applicable worldwide, had apparently
> reappeared in the terms of the India-EU agreement.
> In the meantime, cases of "fake medicines" have prompted
> global trade regulators to formulate anti-counterfeit measures.
> In 2009-2010, for example, several consignments of fake
> anti-malarial medicines from China to Nigeria, labelled
> 'made in India', caused India take the issue up with China.
> The latter country is reported to have 'apologise' to Nigeria.
> K M Gopakumar of Third World Network in New Delhi, says,
> however, that "the talks are extending the counterfeit
> concept to all IPR." He asserts that the anti-fake
> mechanisms have become more a means of market control by
> richer nations.
> Gopakumar adds, "If India 'gives in' to concerns we have
> raised inside the FTA talks, what consequences will this
> have for ACTA?"
> Yet India has not been taking things sitting down. In May,
> it filed a case against the EU in the World Trade
> Organisation (WTO) dispute settlement court regarding
> repeated seizures, on patent infringement grounds, of
> generic drugs transiting through the Netherlands.
> India says the seizures are illegal under TRIPS.  Brazil,
> Canada, Ecuador, China, Japan, and Turkey have since joined
> in the case's consultations.
> Prominent Mumbai-based IPR lawyer Gopakumar Nair feels
> India's case at the WTO needs to be settled first before an
> agreement on the FTA with the EU can be inked.
> He also points out that in the early 2000s, the Substantive
> Patent Law Treaty within TRIPS, which gave sweeping powers
> on the patent system to WIPO and thus disempowered
> developing countries from formulating their own systems, was
> dropped due to opposition from the likes of India and Brazil.
> "The key issue now," says Nair, who was once IDMA
> president, "is that industrialised nations are bypassing the
> dropping of this Substantive Patent Law Treaty, and the EU-
> FTA provides an opportunity for this."
> In June 2010, another international group of lawyers,
> academics and health organisations signed the Berkeley
> Declaration that called on all developing nations to
> approach intellectual property enforcement and anti-
> counterfeiting initiatives with caution.
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