[Ip-health] US Congressional Committee considers pressure on India over drug patents

Ken Shadlen k.shadlen at lse.ac.uk
Wed Mar 27 09:26:25 PDT 2013

In response to this testimony I was asked to write a guest entry for Gauri Kamath's blog on pharmaceuticals in India. Here's the link:


On 26 Mar 2013, at 03:04, Jamie Love wrote:

> http://keionline.org/print/1689
> US Congressional Committee considers pressure on India over drug patents
> 25. March 2013
> On March 13, 2013, the U.S. House of Representative held a hearing on
> U.S.-India Trade Relations. Among the several topics under discussion were
> "the issuance of compulsory licenses, patent revocations, and other
> policies on pharmaceuticals" in India.
> The hearing was held in the Trade Subcommittee of the House Ways and Means
> Committee, under the new subcommittee chair, Devin Nunes, a Republican from
> the 2nd District in California. The title of the hearing was "U.S.-India
> Trade Relations: Opportunities and Challenges," and it featured testimony
> by Roy Waldron of Pfizer, and four other witnesses who mostly focused on
> other topics. I have provided a youtube.com video [2] of the exchanges that
> involved Waldron. The video of the entire hearing is available here [3].
> Waldron's written testimony [4] included a variety of complaints about the
> India patent law, focusing on the failures to obtain patents for some
> products, including those denied under Section 3(d) of the India patent
> law, the India system of pre-grant opposition to patents under Section
> 25(1) of the India patent act, the Nexavar compulsory licensing case under
> Section 84 of the India patent act, the requirements for local
> manufacturing, and the new proposals to grant compulsory licenses under
> Section 92 of the India patent act. Waldron also asserted that India had
> not complied with TRIPS requirements for the protection of test data, and
> complained that drug regulatory authorities did not block drug approval
> where there are assertions of patent protection.
> The Committee appeared generally sympathetic to the Pfizer complaints,
> despite the fact that Waldron made a number of assertions that were wrong
> or dubious, and Pfizer was recommending actions that would raise drug
> prices for billions of persons living in developing countries. But there
> was no consensus on how best to act, even among the witnesses. Pfizer was
> asking that the U.S. government "review  all  available  policy  tools  in
> light  of  India’s deteriorating intellectual property environment,"
> including increases on tariffs on goods from India. Other witnesses urged
> caution on measures that would be seen as unilateral trade relation, and
> recommended that the U.S. engage India in broader trade discussions.
> In an exchange worth listening to, Arvind Subramanian from the Peterson
> Institute for International Economics noted that India officials did not
> agree with the assessment that they were not in compliance with trade
> standards. Subramanian also was skeptical that certain unilateral sanctions
> would be effective. Subramanian suggested that if India was not in
> compliance with WTO TRIPS rules, U.S. trade officials use the dispute
> resolution procedures within the WTO. (17:15 to 19:13 in the clip above)
> Pfizer referred to the WTO dispute resolution option as a blunt instrument
> with unintended consequences (19:50).
> KEI has repeatedly asked USTR why it continues to assert that India's laws
> on patents or drug registration are not consistent with the WTO's TRIPS
> rules, while it declines to bring a dispute before the WTO, and we assume
> this is because the U.S. thinks it would lose the case.
> The fact that the US never litigates its complaints against India in the
> WTO permits it continue to exaggerate or lie about the WTO obligations on
> India and other countries, and to seek other more political methods of
> achieving its objectives. Some of the witnesses at the hearing seemed
> uncomfortable with the idea of the pharmaceutical industry having an
> excessive amount of influence on U.S./India trade relations, sensing that
> there are limits to U.S. influence, and too much attention for Pfizer's
> efforts to keep drug prices high in India would have consequences for other
> industries that were trying to expand trade with India.
> Congressman Larson quotes Gandhi on behalf of Pfizer
> At 14:50 in the video clip, Representative John Larson (Democrat
> representing Connecticut's 1st Congressional district) had the surprising
> idea to quote Gandhi in connection with Pfizer's recommendation that the
> United States government pressure government officials in India to raise
> prices of drugs for cancer and other illnesses.
> Larson: "I believe it was Gandhi that said I want all the winds of the
> world to be able to blow freely through my house, but I will not be blown
> over by any. And It seems to me, both Mr. Waldron and Mr. Garfield, that
> what you have said, this will enhance their ability to stand with the rest
> of the world."
> In the context of Mr. Waldron's testimony, this was an appalling choice.
> =====================================
> *Witnesses at the March 13, 2013 hearing included:
> Dan Twining, a Senior Fellow for Asia, German Marshall Fund of the United
> States
> Arvind Subramanian, Senior Fellow, Peterson Institute for International
> Economics, and the Center for Global Development
> Ambassador Allen F. Johnson, Founder, Allen F. Johnson & Associates, and
> Former Chief Agricultural Negotiator, Office of the United States Trade
> Representative
> Dean Garfield, President & CEO, Information Technology Industry Council
> Roy Waldron, Senior Vice President and Chief Intellectual Property Counsel,
> Pfizer
> Additional context
> March 22, 2011 The production of generic drugs in India: A new trade
> agreement with the EU would hinder access to drugs in developing
> countries," BMJ 2011; 342:d1694. http://www.bmj.com/content/342/bmj.d1694[5]
> March 12, 2012. KEI Statement on India's granting of compulsory license to
> patents on cancer drug sorafenib (NATCO Vs. BAYER)
> http://keionline.org/node/1384 [6]
> Feb 21, 2013. KEI's February 17, 2013 Statement in Nexavar India compulsory
> licensing case http://keionline.org/node/1657 [7]
> [2] http://www.youtube.com/embed/M46H6bzTOss
> [3] http://waysandmeans.granicus.com/ViewPublisher.php?view_id=2
> [4] http://waysandmeans.house.gov/UploadedFiles/Pfizer_testimony31313.pdf
> [5] http://www.bmj.com/content/342/bmj.d1694
> [6] http://keionline.org/node/1384
> [7] http://keionline.org/node/1657
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