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Africa: Questions on AIDS Plans
AfricaFocus Bulletin
Feb 24, 2004 (040224)
(Reposted from sources cited below)
Editor's Note
The Bush Administration has formally released a plan for
implementation of the President's Emergency Plan for AIDS Relief,
and announced initial grants that will provide $92 million this
year to four U.S. groups working in 14 "focus countries" in Africa
and the Caribbean. But the plan leaves many questions unanswered,
These include policy on the use of generic drugs, funding levels
for the Global Fund, and how U.S. efforts will be coordinated with
other national and global programs.
The Harvard School of Public Health, slated to receive $17 million
under the initiative this year, expects to start treatment for
8,000 people in Nigeria, 4,000 in Botswana, and 3,000 in Tanzania.
Dr. Phyllis Kanki, who directs the program for Harvard, said they
expect to use generic drugs in Nigeria and in Tanzania (Boston
Globe, Feb. 24, 2004). But U.S. Global AIDS Coordinator Randall Tobias
was evasive on this issue when questioned in a press briefing at
the plan's launch.
This issue of AfricaFocus Bulletin contains a summary report from
AIDSMAP News and a press release from the Global AIDS Alliance,
both highlighting unanswered questions about the plan. It also
contains a letter from Human Rights Watch concerning the issue of
generic drugs in the current U.S.-Morocco trade negotiations, and
an urgent action alert from the Canadian HIV/AIDS Legal Network
about legislation on generic drugs now being considered in Canada.
Please note that the action alert requests letters to the Canadian
prime minister from around the world as well as from Canadians.
The 99-page U.S. plan is available at:
http://www.state.gov/s/gac
For a transcript of the press briefing by Randall Tobias, the U.S.
Global AIDS Coordinator, see:
http://allafrica.com/stories/200402231246.html
For press releases from two of the recipient groups, see
http://www.hsph.harvard.edu/hai/news_publications/news_releases
and
http://www.catholicrelief.org/newsroom/news_releases
For a summary report from the Kaiser Daily HIV/AIDS Report,
including a link to a 2-page fact sheet on U.S. federal funding for
AIDS, see
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=22336
For additional related news and commentaries see
http://allafrica.com/aids
For an additional critical commentary from the Center for Health
and Gender Equity, see http://www.genderhealth.org
++++++++++++++++++++++end editor's note+++++++++++++++++++++++
US unveils details of Bush AIDS treatment plan
AIDSMAP News
24 February 2004
Keith Alcorn
[excerpts; for full text see http://www.aidsmap.org]
The US administration is to release US$350 million of funds [over
5 years] in the first wave of support for treatment, care and
prevention programmes in Africa and the Caribbean, US Secretary of
State Colin Powell announced on Monday.
The US will give money in the first wave of funding to
organisations with existing infrastructure that can be used to
deliver treatment quickly. 50,000 people are expected to receive
treatment as a result of this funding, but at present it is unclear
what proportion of the funding allocated in the first round will go
towards treatment.
According to US Global AIDS Coordinator Randall Tobias money will
go to scale up programmes providing antiretroviral treatment,
prevention programmes, including those targeted to youth, safe
medical practices programmes and programmes to provide care for
orphans and vulnerable children. ...
The plan will support treatment, care and prevention in Botswana,
Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia,
Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia. A
fifteenth country outside the Caribbean or Africa will receive
support, but that country has still to be determined.
The President's Emergency Plan for AIDS Relief was announced in the
President's 2003 State of the Union address. AIDS advocates in the
United States have criticised the administration's reluctance to
release large sums of money quickly, but the US administration has
argued that countries may not have the capacity to absorb large
sums of money until vital infrastructure issues such as health care
worker capacity have been addressed.
The US says it will use existing networks and existing treatment
programmes as the focus of its efforts, and move outwards as health
care worker capacity is developed. Technical support will be
provided at the centre, often through partnerships with academic
institutions in the United States and public/private partnerships
that leverage investments from private sector employers. The plan
will also strengthen TB and malaria treatment programmes.
Although the plan contains considerable detail on the approach that
the US will take in implementing treatment and care in the
countries it has chosen to support, many of the aspects of the US
approach that have excited the greatest controversy remain
ambiguous. ...
Development of fixed dose combinations
The US has been criticised for an apparent reluctance to adopt
fixed dose combinations. The plan states:
"The U.S. Government is cosponsoring, with WHO, UNAIDS, and the
Southern Africa Development Community, an international scientific
conference in the spring of 2004 to produce an international
consensus document that will set out principles that need to be
taken into account when considering FDC drug products. The document
will contain definitions of terms and set out principles that
relate to the safety, quality, effectiveness, and ongoing quality
assurance for these products. It will deal with such issues as
bioequivalence, bioavailability, and stability, as well as how drug
regulatory authorities should approach reviews of these products."
Use of generic drugs
It has also been widely suggested that the US government will not
contemplate the use of generic versions of branded antiretrovirals.
The plan says:
"Emergency Plan funds used to purchase products will be directed to
obtaining high quality goods at the lowest possible price. This
could mean bioequivalent versions of branded ARV and other
medications."
However, that statement is qualified:
"All procurement under the Emergency Plan will have to fit within
the parameters of existing Federal and international law for the
protection of intellectual property rights." ...
Global AIDS Alliance: Bush Administration Releases Vague AIDS Plan
Report Fails to Clarify Key Issues
Contact: David Bryden, 202-296-0260 ext 211 or mobile 202-549-3664
[email protected]
WASHINGTON (Feb 23) -- Today the Administration released a
five-year strategy to combat the global AIDS epidemic, but failed
to provide key details of its policies on generic medication and
how it will coordinate with the Global Fund, which is active in 121
countries.
The report released today also said nothing about the debt burden
affecting poor countries or coordination with the Treasury
Department, even though the AIDS bill passed last year by Congress
laid out a means of reducing debts for countries fighting the
disease.
Three senior officials, Secretary of State Colin Powell, Secretary
of Health and Human Services Tommy Thompson and US Global AIDS
Coordinator, Ambassador Randall Tobias, spoke about the
Congressionally-mandated strategy document, but failed to clarify
key questions about the policy.
The report was silent on whether the Administration planned to
follow the will of Congress expressed in last year's AIDS bill
concerning spending on orphans programs. Congress said 10% of US
bilateral funding should go to programs that meet the needs of
orphans and vulnerable children.
"It's remarkable how little new there is in this document and how
vague it is on some of the most critical issues," stated Dr. Paul
Zeitz, Executive Director of the Global AIDS Alliance. "For an
issue the Administration repeatedly says is on a par with terrorism
in significance, the narrow country focus and the lack of
specificity is quite disturbing. It's also amazing that more than
13 months after the president announced the plan, only now is the
first dollar being spent."
It remains unclear whether the US would purchase a generic
formulation that was approved by the World Health Organization and
is already being utilized in successful treatment programs. Despite
rolling-out $350 million, officials failed to clarify which
medications were being purchased.
"Ambassador Tobias was incorrect in his statement today that patent
issues related to AIDS medication have been 'by and large
resolved,'" stated Dr. Zeitz. "It was disappointing to hear that
a decision on generics would have to wait until the FDA could
convene a conference to study the matter, even though a safe
generic is already available and is being widely used."
In last year's AIDS bill Congress said the US should ensure 500,000
people are on treatment through US programs by the end of FY 2004,
but the report made no mention of this target.
Today's report was also supposed to detail how the US would
coordinate its efforts with the Global Fund. But, the report is
vague about how US programs will relate to Global Fund programs in
the field. It failed to explain how the US will help the Fund
obtain the $3.6 billion it needs for 2005, given that President
Bush has proposed cutting the US contribution to the Global Fund by
64%.
In today's press conference, Ambassador Tobias said the need now
was to "get the rest of the world to begin to step up to what
President Bush and this Administration have done." Yet, according
to Administration spending plans, the US will give just 6% of what
the Fund needs in 2005 and less than 20% of UN spending targets
which the US agreed to in 2001.
Ambassador Tobias also stated that "[W]ith young people, the
abstinence message is really the message that has proven to be most
effective over the years in really changing behavior and thus
having an impact on results." In fact, what has been most effective
is realistic and comprehensive sexuality education that takes young
people's views and situations seriously.
Human Rights Watch
US-Morocco Free Trade Agreement
http://hrw.org/english/docs/2004/02/18/morocc7568.htm
Letter to United States Trade Representative Robert B. Zoellick
February 18, 2004
Honorable Robert B. Zoellick
United States Trade Representative
600 17th Street NW Washington, DC 20508
sent via fax: (202) 395-4549
Dear Ambassador Zoellick:
The negotiations surrounding the United States-Morocco Free Trade
Agreement (FTA) provide an opportunity for the United States to
live up to its stated commitment to address the immense suffering
caused by the global HIV/AIDS pandemic. We urge you not to use
these negotiations as an occasion to limit Morocco's ability to use
existing global trade rules to expand access to HIV/AIDS medicines.
At the 2001 World Trade Organization (WTO) ministerial meeting in
Doha, Qatar, the United States affirmed the right of WTO members to
use - to the full - provisions of the WTO Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS
Agreement) that provide flexibility for the purpose of promoting
access to essential medicines. These provisions include the right
to grant compulsory licenses for the production of generic
medicines, the right to determine what constitutes a national
emergency, and the freedom to establish a national regime for the
exhaustion of patents (Doha Declaration, article 5). The
Declaration is clear that these flexibilities are what enable
countries like Morocco, which the national government estimates is
home to at least 16,000 people infected with HIV, to address urgent
threats to public health.
Human Rights Watch is very concerned that the U.S.-Morocco FTA will
make it impossible for Morocco to use the flexibilities contained
in TRIPS - to the full - There are credible reports that the
United States is seeking an extension to the twenty-year patent
term required by the TRIPS, as well as exclusive rights for drug
companies to pharmaceutical test data. Each of these provisions
would diminish Morocco's ability to hasten market entry of
affordable generic medicines. It is hypocritical for the United
States as a member of the WTO to pursue bilateral trade policies
that undercut precisely those flexibilities whose full use the Doha
Declaration encourages.
We are also concerned about the exclusion of civil society
organizations from negotiations surrounding the U.S.-Morocco FTA.
The text of the agreement has not been made publicly available,
unlike the text of other agreements such as the Free Trade Area of
the Americas (FTAA). When representatives of Moroccan civil society
organizations protested the agreement in Rabat on January 28, 2004,
they were forcibly dispersed by Moroccan police using batons,
resulting in the injury of filmmaker Nabil Ayush and the president
of the Moroccan Association for Human Rights, Abd al-Hamid Amine.
Given the United States' clear recognition in the Doha Declaration
of the potential impact of trade agreements on public health, we
urge you to make clear to the Moroccan government U.S. dismay
regarding the violent dispersal of Moroccans protesting the
U.S.-Morocco FTA. We also urge you to release the draft text of the
agreement without delay.
The Doha Declaration has been affirmed by a broad global consensus,
including by the United Nations Commission on Human Rights, the
World Health Organization, and the United States 2002 Trade
Promotion Authority Act. As evidenced by negotiations surrounding
the Free Trade Area of the Americas, the Central America Free Trade
Agreement and other agreements, however, the United States appears
to be alone in using its trade authority to undermine the
achievements made at Doha. We urge that you refrain from
negotiating anti-Doha, TRIPS-plus provisions in the U.S.-Morocco
Free Trade Agreement, and instead promote maximum flexibility for
promoting access to essential medicines in national patent regimes.
Sincerely,
Joanne Csete, Executive Director, HIV/AIDS Program
Joe Stork, Acting Executive Director, Middle East and North Africa
Division
Cc: Mr. Taieb El Fassi El Fihri, Delegate for Foreign Affairs and
Cooperation, Min. Of Foreign Affairs, the Kingdom of Morocco
Cc: Mr. Biadi Ellah, Min. of Health, the Kingdom of Morocco
Canadian HIV/AIDS Legal Network
http://www.aidslaw.ca
February 18, 2004
Please find below an Urgent Action Alert issued today by the
Canadian HIV/AIDS Legal Network regarding pending amendments to
Canada's patent laws to implement the WTO's decision of August 30,
2003 allowing the use of compulsory licensing for exporting generic
drugs to countries with no or insufficient manufacturing capacity.
The alert asks people to send e-mails, letters and faxes to the
Prime Minister of Canada urging changes to the bill, which is
currently before the Canadian Parliament and will soon be the
subject of hearings by a parliamentary committee, in order to
represent a full and fair implementation of the WTO August 2003
decision that civil society groups and developing countries fought
so hard for.
It is important that the government hear not only from Canadians,
but also advocates and concerned individuals and organizations from
around the world, the message that it is important that Canada get
this legislation right, as it may set a global precedent as the
first country to implement the WTO August 2003 decision. As it
stands, a wide variety of Canadian civil society organizations, and
the UN Special Envoy on HIV/AIDS, have welcomed the government's
initiative but have identified that the bill is flawed and requires
changes.
For additional information:
http://www.aidslaw.ca/Maincontent/issues/cts/patent-amend.htm
Sincerely,
Richard Elliott
Director of Legal Research & Policy
Canadian HIV/AIDS Legal Network
URGENT ACTION ALERT
Affordable Medicines for Developing Countries: Tell the Federal
Governement to Fix Bill C-9
First introduced in November 2003 (as Bill C-56) and reinstated in
February 2004, Bill C-9 has the potential to alleviate great
suffering and save many lives by allowing Canadian generic
pharmaceutical companies to make lower-cost medicines and export
them to developing countries that cannot make their own.
Yet this objective will be undermined unless flaws currently found
in the bill are fixed.
The time to act is now! In the next few weeks, Canadians need to
tell their Members of Parliament and the Prime Minister that Bill
C-9 must be fixed before it is passed.
Unless amended, Bill C-9 will not lead to cheaper medicines for
people most in need.
Prime Minister Paul Martin can be reached at:
House of Commons
Ottawa, ON K1A 0A6
Fax: (613) 992-4291; Email: [email protected]
Sample letter:
Right Hon. Paul Martin
House of Commons
Ottawa, Ontario K1A 0A6
Dear Prime Minister Martin:
Re: Bill c-9, Act to amend the Patent and the Food and Drug Act to
permit the export of generic medicines to countries in need
I congratulate the government for its commitment to passing
legislation Bill (C-9) that will allow the manufacture and export
of cheaper, generic medicines to countries needing lower-cost drugs
to deal with public health problems, including HIV/AIDS, TB and
malaria as well as many others.
Canada will set a global precedent with this legislation, so it is
important that we get it right. But Bill C-9 is seriously flawed in
several ways:
- It allows brand-name companies to scoop contracts negotiated by
generic drug makers with developing countries, blocking generic
producers from getting licences to supply cheaper medicines. This
will undermine the very objective of the bill.
- It includes a limited list of pharmaceutical products for
example, many of the AIDS drugs currently used in Canada are not
even on the list, nor are many other drugs frequently needed in
developing countries.
- It excludes some countries facing public health problems with
limited resources, high poverty rates and low levels of access to
medicines, because they do not belong to the WTO.
- It does not allow generic companies to contract directly with
non-governmental organizations that are critical providers of
health care in many developing countries.
I urge you to fix these problems with Bill C-9 before it is passed.
If we get it right, this is an initiative that can make all
Canadians proud. If we get it wrong, the legislation will reflect
poorly on Canada and will be of little benefit to those who
desperately need access to more affordable medicines.
Sincerely,
[your name and address]
AfricaFocus Bulletin is an independent electronic publication
providing reposted commentary and analysis on African issues, with
a particular focus on U.S. and international policies. AfricaFocus
Bulletin is edited by William Minter.
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