[Ip-health] Health GAP Exposes Bush's Trade Objectives in Africa: Block Access to Generics

[Mike Palmedo]

Brook Baker sent this message:
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The analysis below highlights a danger to HIV/AIDS treatment access
embodied in the regional free trade agreement currently being negotiated by
the U.S. and the South African Customs Union.  As President Bush arrives in
Africa on July 7, 2003, his trade representatives continue to pursue
heightened intellectual property protections that would undermine the
continents access to life saving generic medicines while preserving market
exclusivity for the hugely profitable U.S. pharmaceutical industry.

* U.S. TRADE NEGOTIATIONS WITH THE SOUTH AFRICAN CUSTOMS UNION UNDERMINE
ACCESS TO MEDICINES AND VIOLATE U.S. LAW*

* Brook Baker
Health GAP
July 7, 2003
*

On November 4, 2002, United States Trade Representative Robert B.
Zoellick formally notified Congressional leaders of the Administration's
intent to initiate negotiations for a free trade agreement with the
nations of the South African Customs Union: Botswana, Lesotho, Namibia,
South Africa and Swaziland. With respect to intellectual property
rights, the negotiations would:

    * Seek to establish standards that reflect a standard of protection
      similar to that found in U.S. law and that build on the
      foundations established in the WTO Agreement on Trade-Related
      Aspects of Intellectual Property (TRIPs Agreement) and other
      international intellectual property agreements, such as the World
      Intellectual Property Organization Copyright Treaty and
      Performances and Phonograms Treaty, and the Patent Cooperation
      Treaty.
    * Establish commitments for SACU countries to strengthen
      significantly their domestic enforcement procedures, such as by
      ensuring that government agencies may initiate criminal
      proceedings on their own initiative and seize suspected pirated
      and counterfeit goods, equipment used to make or transmit these
      goods, and documentary evidence. Seek to strengthen measures in
      SACU countries that provide for compensation of right holders for
      infringements of intellectual property rights and to provide for
      criminal penalties under the laws of SACU countries that are
      sufficient to have a deterrent effect on piracy and counterfeiting.

To meet "standards of protection similar to that found in U.S. law,"
SACU nations would be required to limit compulsory licenses to national
emergencies or to governmental, non-commercial use only. They would be
required to bar parallel trade, to extend patent monopolies for
administrative delays, and to link drug registration rights to patent
status. Finally these nations would be required to enhance protections
for clinical trial testing data by providing five years of data
exclusivity, thereby precluding registration of medicines produced under
compulsory licenses, and to adopt criminal enforcement for patent
violations, including improvidently granted compulsory licenses. In sum,
the proposed negotiation objectives would completely eviscerate the Doha
flexibilities, dramatically increase IP protection, and shamefully
reduce access to more affordable generic products.

More particularly, in the context of the production-for-export problem
left unresolved in paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health, the SACU negotiations could be disastrous.
For example, in another regional trade negotiation, the Free Trade Area
of the Americas, the U.S. is the presumed sponsor of a troubling
bracketed provision that would explicitly prohibit compulsory licensing
for export (8.64 (6) (b)).

PhRMA, the U.S. trade association for the proprietary pharmaceutical
industry, has been very explicit that it seeks this export ban in South
Africa saying: "The USG should seek to limit the scope of Government use
authority to exclude the possibility of Government use for the purpose
of export, or for sale to the general public." (PhRMA 2003 Annual 301
Report to the USTR, p. 71). Basically, PhRMA and the USTR, by limiting
compulsory licenses to national emergency and public non-commercial use,
seek to prevent exports except where there has been an anti-trust
violation. (Note: in this regard, there is a pending case in South
Africa before the Competition Commission challenging excess pricing and
other anti-competitive conducts by GlaxoSmithKline and Boehringer
Ingelheim and seeking, among other remedies, non-exclusive compulsory
licenses.)

If this no-export ban were imposed on SACU nations, then South Africa
would be prevented from being a supplier of standard quality generic
medicines to other SACU nations or to the subcontinent as a whole. Since
regional and international production-for-export of generic medicines is
necessary for countries with little or no efficient manufacturing
capacity, excluding one of the few technically competent Africa
producers would be a huge blow to sourcing affordable AIDS medicines.
Thus, any effort by U.S. SACU negotiators to sabotage pro-public health
interpretations of TRIPS that would otherwise permit the most rational,
pro-public health solution to countries obtaining exported, low-cost
medicines is morally and legally unacceptable.

These intellectual property objectives in SACU negotiations directly
violate the principal negotiating objectives in the Trade Act of 2002,
which requires the U.S. " to respect the Declaration on the TRIPS
Agreement and Public Health, adopted by the World Trade Organization at
the Fourth Ministerial Conference at Doha, Qatar on November 14, 2001."
19 U.S.C. =A7 3802(b)(4)(C).

Similarly, by seeking TRIPS-plus provisions found in U.S. law, the U.S.
Trade Representative is also directly violating Executive Order 13155,
which in relevant part, reads:

    (a) In administering sections 301-310 of the Trade Act of 1974, the
    United States shall not seek, through negotiation or otherwise, the
    revocation or revision of any intellectual property law or policy of
    a beneficiary sub-Saharan African country, as determined by the
    President, that regulates HIV/AIDS pharmaceuticals or medical
    technologies if the law or policy of the country: (1) promotes
    access to HIV/AIDS pharmaceuticals or medical technologies for
    affected populations in that country; and (2) provides adequate and
    effective intellectual property protection consistent with the
    Agreement on Trade-Related Aspects of Intellectual Property Rights
    (TRIPS Agreement) referred to in section 101(d)(15) of the Uruguay
    Round Agreements Act (19 U.S.C. 3511(d)(15)).

Activists in Southern Africa and in the U.S. must unite to beat back
this illegal and largely clandestine effort by U.S. government to
subvert access to lowest cost generic medicines, medicines essential to
reverse the tide of HIV inundating entire communities.

WHAT YOU CAN DO

Activists in the U.S. can contact Robert Zoellick, U.S. Trade
Representative and the White House to condemn efforts to include
heightened intellectual property protections in the SACU negotiations.
The text of any such message might state the following or a variation
thereof:

"In trade negotiations with the South African Customs Union, the U.S.
Trade Representative and the White House should desist from proposing or
imposing any intellectual property terms whatsoever. In particular, the
negotiators should refrain from limiting the grounds for compulsory
licensing, restricting parallel importation, extending patent terms,
linking drug registration to patent status, or limiting rights to export
under a compulsory license. Instead the U.S. should recognize the rights
African countries have under the TRIPS Agreement and the Doha
Declaration on the TRIPS Agreement and Public Health to utilize multiple
flexibilities to access affordable medicines to address the AIDS
pandemic and other public health concerns."

This message can be mailed to Zoellick at the address below or emailed
as indicated.

United States Trade Representative
600 17th Street, N.W.
Washington, DC 20508
United States of America
contactustr@ustr.gov <mailto:contactustr@ustr.gov>

Activists in the South African Customs Union can similarly contact their
trade representatives demanding that they unite to oppose including
heightened intellectual property protections in the Free Trade Agreement
and can also write letters to U.S. consular officials protesting the
U.S. IP trade objectives. The same message above, or one adapted to
local circumstances, might be used.