[Peace-discuss] Fwd: US/Africa: Still Waffling on Generics

[Alfred Kagan]

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>Date: Mon, 7 Jul 2003 09:37:02 -0500
>Subject: US/Africa: Still Waffling on Generics
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>AFRICA ACTION
>Africa Policy E-Journal
>July 7, 2003 (030707)
>                    
>US/Africa: Still Waffling on Generics
>(Reposted from sources cited below)
>
>As President Bush departs for Africa today, key questions about his
>AIDS policy remain unanswered. By appointing a former drug industry
>executive as his global AIDS coordinator, the president has further
>reinforced doubts that he is willing to allow full use of low-cost
>generic medicines needed to treat AIDS. This posting contains an
>analysis of the appointment from Foreign Policy in Focus, and a
>review of the latest U.S. positions on the Doha Declaration on
>intellectual property rights and public health. Another posting
>today focuses on the gap between promise and delivery in both U.S.
>and South African government commitments of resources to address
>the AIDS pandemic.
>                                        
>For additional documents on issues related to President
>Bush's trip to Africa, see http://www.africaaction.org/desk
>and
>http://www.africaaction.org/docs03/chr03.htm
>
>+++++++++++++++++end summary/introduction+++++++++++++++++++++++
>
>AIDS Appointee Shows that Business Still Rules the Roost
>               
>By Jim Lobe - July 3, 2003
>
>Editor: John Gershman, Interhemispheric Resource Center (IRC)
>
>Foreign Policy In Focus
>http://www.fpif.org
>
>The appointment of a former top executive of a major U.S.
>pharmaceutical company and major Republican contributor as
>President George W. Bush's global AIDS co-ordinator has stunned and
>outraged AIDS experts and activists. Bush's choice of former Eli
>Lilly & Co. boss Randall Tobias was announced at the White House on
>July 1, just a few days before Bush's first trip as president to
>Africa. The U.S. Senate must confirm the nomination.
>
>Tobias, who retired from Lilly in 1998 and more recently has served
>as vice chairman of AT&T, where he also worked before going to
>Lilly in the early 1990s, is supposed to receive the rank of
>ambassador and report to Secretary of State Colin Powell, a major
>force behind a five-year, 15-billion-dollar anti-AIDS
>initiative--called the "Emergency Program"--first proposed by Bush
>last January and approved by Congress in a somewhat amended form in
>May.
>
>Implementation of that initiative, which is targeted at 12
>sub-Saharan African and two Caribbean countries, will be Tobias'
>first responsibility, according to Bush. "Randy Tobias has a
>mandate directly from me to get our AIDS initiative up and running
>as soon as possible," he said.
>
>Surreal Appointment
>
>Prof. Jeffrey Sachs, head of Columbia University's Earth Institute
>and a special adviser to UN Secretary General Kofi Annan on the
>AIDS crisis, called the appointment "surreal" and continued that
>"This is an emergency that requires someone who's worked in the
>field and knows it thoroughly. We don't need someone who raises all
>sorts of questions about commitment and agenda."
>
>Advocacy groups called for senators to closely scrutinize Tobias'
>credentials and philosophy and determine whether, given his past
>ties to the industry, he will be able to fight on behalf of the
>millions of poor HIV/AIDS victims in desperate need of cheap
>anti-retroviral drugs in the face of opposition from the major
>western pharmaceutical companies, often referred to as Big Pharma.
>"This decision is another deeply disturbing sign that the President
>may not be prepared to fulfill his pledge to take emergency action
>on AIDS," noted Paul Zeitz, executive director of the Global AIDS
>Alliance. "It raises serious questions of conflict of interest and
>the priorities of the White House."
>
>"Both the people of Africa and the people of the United States will
>lose if the president's AIDS initiative fails to use the
>lowest-cost, generic medications," Zeitz said, noting that the
>pharmaceutical companies have successfully pressed the Bush
>administration to go back on an earlier pledge to carve out an
>exception in international patent laws that would enable needy
>countries to import generic anti-AIDS drugs.
>
>Others were openly scornful about the appointment. "We know he has
>little experience with AIDS, but lots as a major Republican donor,"
>said Salih Booker, director of Africa Action, a Washington-based
>fusion of several long-standing anti-apartheid groups. "This is
>where U.S. policy on AIDS is; it's with Big Pharma."
>
>A corporate executive throughout his career, Tobias has no
>background in public health and little or no experience with
>working in poor countries. In short remarks at the White House
>Tuesday, he described the statistics of the AIDS toll taken in
>Africa--where almost 20 million people have been killed by the
>disease--as "really nearly incomprehensible."
>
>At the same time, Tobias is known as a no-nonsense businessman who
>is particularly close to the recently departed director of the
>administration's Office of Management and Budget (OMB), a
>bureaucracy that could play a key role in securing the money to
>actually fund Bush's $15-billion program.
>
>"This is clearly a person with tremendous stature and management
>acumen," said Sandra Thurman, who served as former President
>Clinton's global AIDS director and now heads the International AIDS
>Trust.
>
>Three Questions
>
>The key test for many activists, however, will lie in how Tobias
>responds to three major questions regarding the Bush
>administration's global AIDS policies, of which Emergency Program
>is the central feature.
>
>The first concern involves the availability of generic anti-AIDS
>and other life-saving drugs to poor countries under the Program.
>While major pharmaceutical companies have sharply cut prices on
>their brand-name anti-viral medicines for AIDS victims in poor
>African countries, similar generic drugs produced in India,
>Thailand, and Brazil, for example, still cost significantly
>less--as little as under $300 per person per year for triple
>combinations of anti-retroviral drugs.
>
>While the administration has suggested it will use generics in the
>Emergency Program, it has not been made a formal decision. "Tobias
>will have tough questions to answer about whether the Bush AIDS
>Plan will make efficient use of funds by maximizing purchases of
>affordable generic medicines," noted Eustacia Smith of Health
>Global Access Project (Health GAP).
>
>A related question is whether Tobias will push the administration
>to follow through on its promise at the World Trade Organization
>(WTO) ministerial meeting in Doha in November 2001 to permit poor
>countries that face public-health emergencies to import generic
>anti-AIDS and other life-saving drugs.
>
>Under pressure from Big Pharma, the administration has since
>reversed its position by pressing its bilateral trade partners in
>Africa to sign agreements committing them to respect international
>patent laws that, from a practical viewpoint, would make importing
>generics much more problematic.
>
>"It's very difficult to believe that a man coming from the U.S.
>pharmaceutical industry would be willing to respond to the calls
>from impoverished countries to expedite access to life-saving
>mechanisms," said Zeitz. "Purchase of lowest-cost medicines,
>including generics, is a must," according to Asia Russell of Health
>GAP. "The pharmaceutical industry calls that piracy. Which side
>will Tobias be on?"
>
>Finally, activists are particularly worried about the fate of the
>Global Fund to Fight AIDS, TB, and Malaria, a two-year-old
>multilateral mechanism to expedite the funding of anti-AIDS work
>around the world. Although Congress has authorized an annual
>contribution of up to $1 billion for the Fund--which is already
>fast running out of money--the administration has said it intends
>to provide only $200 million a year.
>
>Big Pharma has been cited as a major culprit behind the
>administration's niggardliness towards the Fund because of its
>support for making generic anti-AIDS drugs accessible to all needy
>countries.
>
>"Whether Tobias will push within the administration for the funding
>the Global Fund really needs to even begin to catch up with the
>need will be critical test of whether he's independent," said
>Booker.
>
>(Jim Lobe <jlobe at starpower.net> is a political analyst with Foreign
>Policy in Focus (online at http://www.fpif.org). He also writes
>regularly for Inter Press Service.)
>
>***********************************************************
>
>WTO and Generic Medicines    
>
>Distributed on Healthgap listserv on July 3, 2003
>From:  Brook Baker <B.Baker at NEU.EDU>
>
>This analysis of the recently announced "concession" by the U.S. to
>drop its Doha demand on scope of diseases is timely given Bush's
>pending trip to Africa on July 7. It also demystifies the U.S.
>strategic retreat and analyzes the U.S.'s upcoming plans to
>continue seeking disease restrictions, country restrictions, and
>heightened diversion safeguards. - Brook Baker
>
>For more information: http://www.healthgap.org
>
>HEALTH GAP on WTO medicines negotiations:
>Doha Redux - U.S. Enters New Phase of Bad Faith Bargaining
>
>Brook K. Baker, Health GAP
>
>July 2, 2003
>
>The U.S. Trade Representative and its handlers in the White House
>and in PhRMA are struggling to coordinate their ongoing campaign to
>limit the impact of the historic Doha Declaration on the TRIPS
>Agreement and Public Health. On June 22, 2003, the USTR made a
>"crucial," but ultimately misleading "concession" in World Trade
>Organization talks over the controversy about allowing developing
>nations to import generic drugs to address public health needs,
>saying that it would back off of its unilateral insistence on
>limiting the Agreement to a specified list of infectious diseases,
>primarily AIDS, TB, and malaria.
>
>Instead of insisting on this unwinnable disease limitation, the
>U.S. and PhRMA are returning to the drawing board to accomplish
>three interlocking goals: (1) to come up with a new disease
>restriction that is not as perverse as addressing pandemic
>infections only, (2) to limit the countries that would be eligible
>to import generic medicines produced abroad to least developed
>countries and a few lower income developing countries only, and (3)
>to erect even higher anti-diversion standards that will complicate
>both generic production and importation.
>
>In announcing that it was retreating temporarily from its
>insistence on covering AIDS, TB, and malaria only, the U.S. is
>trying to recover political ground lost at the WTO via its renegade
>rejection of an imperfect compromise reached by the other 143 WTO
>members at December. That compromise, reflected in Chairman Motta's
>text, would have allowed generic manufacturers to produce and
>export medicines that addressed any and all public health needs and
>would have permitted such export to a broad spectrum of developing
>countries that unilaterally determined that they lacked meaningful
>and efficient manufacturing capacity in the pharmaceutical sector.
>
>Unnamed U.S. officials have stated that the U.S. has given up on
>insisting on a specific list of diseases, but U.S. Trade
>Representative Robert Zoellick in a press conference at the
>mini-ministerial held in Sharm El Sheik, Egypt, refused to confirm
>that the U.S. government was dropping this demand. Instead,
>Zoellick paradoxically insisted that the U.S. had never supported
>the idea that agreement could only apply to a "closed list" of
>diseases, referring presumably to the highly stringent language
>that the agreement could eventually cover other infectious diseases
>of similar gravity and scope.
>
>Zoellick's double-speak on U.S. obstructionism is matched, or even
>exceeded, by Harvey Bale, president of the International Federal of
>Pharmaceutical Manufacturers Associations who said "We feel we are
>wrongfully being blamed for holding up progress in certain parts of
>the (Doha) negotiation." Apparently, it doesn't matter to Mr. Bale
>that all investigators agree that industry intervention at the
>White House in November and December of 2002 prompted a hardening
>of the U.S. position on disease coverage and ultimately that the
>industry sponsored the impasse of December 20.
>
>In addition to revising history, the U.S. and its PhRMA
>co-conspirators are hard at work trying to further limit the Doha
>Declaration without re-opening the Motta text. Although the clues
>to their new strategy are imprecise, they suggest that the U.S.
>intends to rephrase the scope of covered diseases, presumably
>returning to the earlier U.S. position emphasizing "grave" public
>health crises, such as AIDS, TB, and malaria. This phrasing would,
>of course, ignore the clear language of paragraph 4 of the Doha
>Declaration that addresses all public health concerns without
>restriction: "We agree that the TRIPS Agreement does not and should
>not prevent Members from taking measures to protect public health.
>Accordingly, we affirm that the 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."
>
>Even more significantly, the U.S. will attempt to further restrict
>the number of countries that can access generic export from
>producer countries. A letter from 22 U.S. and European
>pharmaceutical companies and three trade associations clarified the
>industry's position that any agreement should apply only to the
>world's poorest countries that truly lack pharmaceutical capacity.
>Zoellick referenced this letter in his Egyptian press conference
>and had earlier told the trade minister of the Philippines that, in
>the U.S. view, the Philippines (and presumably Malaysia) would not
>be eligible to import generic medicines from abroad because it had
>sufficient manufacturing capacity. Harvey Bale addressed the
>country-eligibility issue even more directly: "Our focus is on
>helping the countries that the founding fathers of the Doha Agenda
>had in mind." According to Bale, it would be a "gross exaggeration
>and a gross distortion" to give more industrially advanced
>developing countries, such as India and China, the same rights as
>"poor states like Haiti, Namibia or Bangeladesh."
>
>The irony of Bale's formulation is that the Doha Declaration will
>require producer countries like India and China to manufacture and
>export life-saving generic drugs to a broad range of countries with
>insufficient or inefficient pharmaceutical capacity. India and
>China aren't countries that will "take advantage of Doha" to access
>cheaper medicines for themselves, though, of course, it is
>perfectly legal for them to issue compulsory licenses on any
>grounds whatsoever under the flexibilities of the TRIPS Agreement.
>Instead, lowest cost, standard quality generics will ultimately be
>produced in large measure by efficient producers in India and China
>that reach meaningful economies of scale for a broad range of
>public health medicines. To induce generic entry into low-income
>countries, it will be necessary to aggregate markets, including
>markets with large populations and meaningful purchasing power ?
>namely, those of middle-income countries.
>
>But, PhRMA is so intent on making high profits on sales to income
>elites in middle-income countries that it is willing to sacrifice
>the lives of millions of poor people to secure its market hegemony.
>Since U.S. pharmaceutical giants have never seen a penny of
>potential profit that they would willingly abdicate to a generic
>producer, they have chosen to slander the intentions of India,
>China, and Brazil, solely because generic manufacturers in those
>countries are poised to supply standard quality medicines at a
>substantial discount over PhRMA prices. Accordingly, the U.S. and
>PhRMA are scheming on how to coerce countries to voluntarily opt
>out of the system and on defining gross-national-product and
>disease-burden tests to greatly limit country eligibility.
>
>With respect to their product diversion agenda, PhRMA and the USTR
>are allegedly pushing for mandatory special packaging requirements
>and internal policing mechanisms. This mandatory system is more
>stringent than that in the Motta text which merely recommends that
>special labeling and marking be used, but only when such product
>distinction is feasible and does not significantly impact price.
>
>Developing countries can expect no quarter from the U.S. which has
>a long history of bad-faith dealing in Doha negotiations. It will
>keep on pushing PhRMA's agenda while it mouths platitudes about its
>intention to find a workable solution. Despite developing
>countries' reluctant accommodation to the Motta text, they should
>not expect that the U.S. really intends to reach a "compromise."
>For the U.S., others compromise - the U.S. wins.
>
>As Doctors Without Borders and many others have argued, developing
>countries should dump that Motta text and act in good faith on the
>Doha Declaration itself. That Declaration opens the door not only
>for production for export via compulsory licenses but also
>production for export via limited exceptions under Article 30. This
>is the easy, expeditious solution recommended by the World Health
>Organization, the European Communities, multiple NGOs, and many
>developing countries themselves.
>
>While the U.S. and PhRMA dither and dally, while they obscure and
>deceive, millions of lives have been lost. Facing this stark
>reality, the Doha Declaration expressed a degree of urgency,
>especially since limitations on producing newer generic medicines
>for export will arrive with full global force in 2005 (except for
>least developed countries). Global trade rules concerning
>exceptions to patent rights have to be clarified so that developing
>countries can amend their national legislation to make maximum use
>of Doha flexibilities and so that generic manufacturers can reduce
>the legal risk of their still risky economic investments. That
>clarification was supposed to have happened by the end of 2002, but
>now, a full six months later, the U.S. still blocks a global
>accord.
>
>As the President of the U.S. is poised for a trip to Africa - a
>continent decimated by the AIDS pandemic - is it too much to ask
>that he restrain his PhRMA donors and that he chastise his USTR
>bully-boys? Could the U.S. cease and desist from blocking a Doha
>accord and from seeking TRIPS-plus intellectual property
>protections in its trade negotiations with Africa, such as that
>with the South African Customs Union? Could the U.S. actually
>concede that low-cost, standard quality generic medicines are a
>critical component of a global response to the global AIDS pandemic
>whether those generics are purchased under the U.S. bilateral
>program or the Global Fund to Fight AIDS, TB, and Malaria? Do
>African lives really matter, except at press conferences?
>
>+++++++++++++++++++++Document Profile+++++++++++++++++++++
>
>Date distributed (ymd): 030707
>Region: Continent-Wide
>Issue Areas: +health+  +US policy focus+
>
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-- 


Al Kagan
African Studies Bibliographer and Professor of Library Administration
Africana Unit, Room 328
University of Illinois Library
1408 W. Gregory Drive
Urbana, IL 61801, USA

tel. 217-333-6519
fax. 217-333-2214
e-mail. akagan at uiuc.edu