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 [type URL on one line] 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 dbryden@globalaidsalliance.org 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: Martin.P@parl.gc.ca - - - - 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. AfricaFocus Bulletin can be reached at africafocus@igc.org. Please write to this address to subscribe or unsubscribe to the bulletin, or to suggest material for inclusion. For more information about reposted material, please contact directly the original source mentioned. For a full archive and other resources, see http://www.africafocus.org ************************************************************