E-DRUG: New Global Access to Medicines Bulletin
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Dear friends and colleagues,
We invite you to subscribe
<http://salsa.democracyinaction.org/o/1678/t/5144/signUp.jsp?key=2959>
to *Essential Action's new Global Access to Medicines Bulletin* (see below for a plain text version, or click here
<http://www.essentialaction.org/access/uploads/AccessBulletinNo1.rtf>
to download the RTF version).
This free bulletin aims to be a reliable and easy-to-use resource for
those who want to keep up to date on key issues and the latest
developments regarding access to medicines in the developing world. We
will distribute the bulletin electronically every two to four weeks, and
formatted versions will also be available on Essential Action's website.
We aim for the bulletin to be both penetrating and understandable to
people who are expert neither in trade nor patent policy. We want it to
be useful for multiple audiences, including interested citizens,
public health experts, journalists and policy makers around the globe.
Our debut issue focuses on a recent review of how U.S. government trade
policy affects access to medicines in developing countries.
To subscribe to the bulletin, click here
<http://salsa.democracyinaction.org/o/1678/t/5144/signUp.jsp?key=2959>\.
Wishing for peace and justice in the new year,
Sarah Rimmington and Robert Weissman *
*Essential Action
robert weissman <rob@essential.org>
Essential Action's Global Access to Medicines Bulletin
Issue #1 December 21, 2007
Welcome to the first issue of Essential Action's Global Access to
Medicines Bulletin. We aim for the bulletin to be both penetrating and
understandable to people who are expert neither in trade nor patent
policy. We want it to be useful for multiple audiences, including
interested citizens from around the globe, public health experts,
journalists and policy makers in the United States. Our first issue
focuses on a recent review of how U.S. government trade policy affects
access to medicines in developing countries.
Independent Agency Report Shows U.S. Trade Policy Undermines Public Health
A recent U.S. Government Accountability Office (GAO) report
[http://oversight.house.gov/story.asp?ID=1580] highlights highlights
some of the ways that U.S. trade policy undermines access to medicines
in developing countries. The GAO is a nonpartisan Congressional research
agency.
The October 30 report - which was prepared at the request of Senator Edward Kennedy and Representative Henry Waxman - shows that the Bush administration interprets the The Doha Declaration on the TRIPS Agreement and Public Health as "not assign[ing] public health greater priority than IP [intellectual property] protection." The Doha provision of the 2002 Trade Promotion Authority legislation ("TPA" or "Fast-track") designated respecting the Doha Declaration as a principal negotiating objective related to intellectual property.
The Doha Declaration affirms "that the [World Trade Organization's
Trade-Related Aspects of Intellectual Property (TRIPS)] Agreement can
and should be interpreted and implemented in a manner supportive of WTO
members' right to protect public health and, in particular, to promote
access to medicines for all."
The GAO study found that the Bush administration made virtually no
changes in its trade strategy to advance the goals of the Doha
Declaration. As a result, USTR has negotiated pharmaceutical- related
provisions in several bilateral and regional free trade agreements
(FTAs) that public health advocates say limit the ability of trading
partners to introduce public health measures that improve access to
medicines.
"Regrettably, the U.S. trade strategy has prioritized patents over
public health," said Representative Waxman.
In particular, the GAO found that USTR has "vigorously" pursued
implementation of patent term extension, linkage and data exclusivity
provisions in several FTAs including DR-CAFTA (Dominican
Republic-Central America Free Trade Agreement). Public health experts
indicate that these provisions (known as "TRIPS-plus" because they
exceed the requirements of the TRIPS Agreement) could significantly
delay the introduction of lower-cost generic medicines in developing
countries. The GAO report identifies unaffordable prices as a key
barrier to expanding access to medicines globally.
Patent term extensions prolong the standard 20-year patent term in the
event of delays in processing patent applications or approving new drugs
for sale. They are not required under TRIPS. Linkage - also not required
under TRIPS - can result in delays to the introduction of generic
competition by mandating drug regulatory agencies not consider generic
companies' marketing applications if another party claims an existing
patent covers the drug for which approval is sought. Under this
relationship, marketing approval will likely be delayed even if the
patent is invalid or unenforceable. Data exclusivity refers to special,
TRIPS-plus five to ten year monopoly protections for pharmaceutical test
data required to demonstrate safety and efficacy and to authorize a drug
for use. Data exclusivity prevents generic firms from relying on
brand-name company clinical tests, and may delay generic entry even
after patent monopolies have expired or where patents are not in force.
The GAO report also found that USTR does not ask federal health agencies
(such as the Department of Health and Human Services) to provide input
on the public health impact of FTA negotiating positions, and that
formal input on trade positions from the public health community is
limited, while pharmaceutical industry input has been extensive.
"The Bush Administration must stop putting the financial interest of the
pharmaceutical industry ahead of the needs of the poor and sick in
developing countries," said Senator Kennedy.
U.S. Government Conduct that undermines Doha commitments goes beyond
what is outlined in GAO Report
There are other ways in which the U.S. executive branch is working to
undermine the promise of the Doha Declaration for access to medicines
beyond what is mentioned in the GAO report, argue public health
advocates. Essential Action says they include:
* Misguided and poor quality technical assistance that encourages
developing countries to overprotect pharmaceutical patent monopolies
(this is briefly mentioned in appendix II of the GAO report, found at:
http://oversight.house.gov/story.asp?ID=1580);
* Pressure on the World Health Organization (WHO) - including
efforts to suppress important reports - not to advise countries on how
to make medicines affordable. See examples here
[www.ipwatch.org/weblog/index.php?p=409] and here
[http://www.ip-watch.org/weblog/index.php?p=454]; and
* Improper interference
[http://lists.essential.org/pipermail/ip-health/2007-November/011872.html\]
in the WHO Intergovernmental Working Group on Public Health, Innovation
and Intellectual Property (IGWG) negotiating process, including by
pressuring country negotiators not to support positions embodying Doha
Declaration objectives.
These practices act as additional barriers to expanding access to
lifesaving medicines in the developing world, according to Essential
Action and other public health organizations.
Published by Essential Action's Access to Medicines Project
P.O. Box 19405, Washington, DC, 20036, USA
Tel: (1) (202) 387-8030
www.essentialaction.org/access/
An RTF version of this newsletter and additional information can be
downloaded at:
http://www.essentialaction.org/access/uploads/AccessBulletinNo1.rtf
Editors:
Sarah Rimmington srimmington@esssentialinformation.org
Robert Weissman rob@essential.org