PHA-Exchange> Text of US Congressmen Waxman, Allen, Brown letter to USTR re TRIPS in Hong Kong

[Claudio]

From: "Bala" <bala at haiap.org>
You may wish to give  publicity to this in your country and to the Trade
Ministerial Team from your country that will be going to Hong Kong

> December 5, 2005
>
> The Honorable Rob Portman
> United States Trade Representative
> 600 17th Street, N.W.
> Washington, DC 20508
>
> Dear Ambassador Portman:
>
> We are writing to request immediate clarification of the U.S.
> Government's stance on access to generic medications at the forthcoming
> World Trade Organization Ministerial in Hong Kong. The positions
> reportedly taken by the United States threaten access to affordable
> generics, both for developing nations and for the United States itself.
>
> At issue is the ability of countries to import generic versions of a
> patented drug. The United States has stated that it will not take
> advantage of a process that would allow it to import generics under a
> compulsory license, even if the public health requires it. In addition,
> it has reportedly pushed for provisions that could make it harder for
> all countries, including the poorest, to access generics in this manner.
>
> Our concerns are detailed below.
>
> Background on Intellectual Property and Importation of Generic Drugs
>
> The TRIPS agreement on Trade-Related Aspects of Intellectual Property
> Rights took effect in 1995.[1] The 2001 Doha Declaration states that
> "the TRIPS agreement does not and should not prevent Members from taking
> measures to protect public health."[2] According to the Declaration,
> "the Agreement can and should be interpreted and implemented in a manner
> supportive of WTO Members' rights to protect public health, and in
> particular, to promote access to medicines for all."[3] In August 2002,
> the U.S. Congress passed legislation that directs adherence to the Doha
> Declaration in U.S. trade negotiations.[4]
>
> The Doha Declaration affirmed the right of countries to issue compulsory
> licenses to domestic manufacturers to make a generic version of a
> patented drug when the country deems necessary.[5] However, the
> Declaration did not resolve how countries could access such generics if
> they lack sufficient manufacturing capacity.
>
> Compulsory Licenses for Importation of Generics
>
> In August 2003, WTO members established a temporary mechanism by which
> countries could issue compulsory licenses to manufacturers in other
> nations and then import the drugs.[6] While this addressed an important
> gap in the Doha Declaration, the mechanism has been criticized by public
> health organizations and experts as placing undue burdens on countries'
> abilities to issue such licenses.[7]
>
> Specifically, the protocol involves a separate process for every country
> and every drug, diminishing economy of scale and reducing the incentive
> of generic manufacturers to produce for other governments. Furthermore,
> the procedure has not yet been employed, and there is therefore no
> evidence yet of whether it can work to provide effective and speedy
> access to generic drugs. The high prices of the current generation of
> HIV/AIDS drugs - which will be on patent for years - make these concerns
> even more pressing. [8]
>
> In addition, a Statement from the General Council Chairperson read aloud
> at the 2003 meeting, though of unclear legal status, calls into further
> question the feasibility and usefulness of the mechanism.[9] According
> to the WTO, the Statement was "designed to provide comfort to those who
> feared that the decision might be abused and undermine patent
> protection."[10] One problematic provision would place the
> responsibility of preventing diversion of drugs on both exporting and
> importing countries, which may not have the enforcement capacity.[11]
>
> The United States, along with European nations, declared in the August
> 2003 agreement that it would not avail itself of the importation
> option.[12] Certain other countries, including Hong Kong, China, Israel,
> and Korea, stated that they would only use the system in cases of
> emergencies or extremely urgent situations, but the U.S. "opt-out"
> inexplicably rejected any such safety net.[13]
>
> In the recent Gaborone Declaration, African Health Ministers questioned
> the August 2003 decision, calling for "the Ministers of Trade to seek a
> more appropriate permanent solution at the WTO that revises the TRIPS
> agreement and removes all constraints, including procedural
> requirements, relating to the export and import of generic
> medicines."[14] However, this proposal has not gained traction.
>
> The Current U.S. Position
>
> Despite the August 2003 proposal's apparently unwarranted complexity,
> the lack of evidence that it will be effective, and the concern of
> developing nations most directly affected, United States and European
> negotiators have reportedly insisted that it be incorporated into the
> TRIPS agreement as a permanent amendment.[15] They also reportedly urged
> that the Chairman's Statement from 2003 be incorporated into the
> agreement. Though they appear to have relented on this demand, they have
> reportedly insisted that the statement be read again at the upcoming
> Hong Kong Ministerial.[16]
>
> Furthermore, we understand that the USTR maintains the position that the
> U.S. will not avail itself of the opportunity to issue a compulsory
> license for importation even in the event of a crisis.[17] We believe
> this is an untenable position, especially in light of the current threat
> of an avian flu pandemic. Although the U.S. Government has been working
> with Roche, the sole producer of Tamiflu, to stockpile supplies for
> 2007, there remains concern that the company will not be able to
> manufacture enough of the antiviral drug to fill orders for the United
> States (or other countries).[18] Despite Roche's intention to issue
> voluntary licenses to generic manufacturers to fulfill unmet need, an
> imported generic could theoretically be necessary if, for example,
> another drug is found to be more effective or the pandemic progresses
> more rapidly. In addition, Roche's issuance of voluntary licenses was
> neither inevitable nor precedent-setting. For this and future public
> health problems, the U.S. "opt-out" from compulsory licensing for
> importation could leave our government - and citizens - dangerously
> vulnerable.
>
> Because of the potential threats to public health preparedness in
> developing countries and at home, we request clarification of the U.S.
> Government's position on compulsory licensing for importation.
> Specifically, we would like to know why the U.S. reportedly wishes to
> make permanent a system that has been criticized as overly burdensome
> and has not yet been shown to be effective. In addition, we request an
> explanation of why the United States should foreclose the possibility of
> using the importation mechanism. We would like to know if it is the
> belief of the U.S. Trade Representative that the United States will be
> able to "opt back in" to the compulsory licensing for importation system
> if public health requires. If yes, we request a detailed explanation of
> the procedures that would have to be employed to permit the United
> States to do so.
>
> We request an immediate response.
>
> Sincerely,
>
> Henry A. Waxman
> Member of Congress
>
> Sherrod Brown
> Member of Congress
>
> Thomas H. Allen
> Member of Congress