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Aufruf zu weltweiten Demonstrationen am 24. Juni 2004. Friedens- und gesundheitspolitische Gruppen weltweit fordern die US-Regierung auf: Ø Reduzieren Sie die Militär- und Kriegsausgaben: Investieren Sie mehr Geld in die Bekämpfung von HIV/Aids, Tuberkulose, Malaria, Unterernährung und Armut;
Ø Erschüttern Sie nicht länger das öffentliche Vertrauen in sichere und effektive Aids-Generika
Ø Setzen Sie Gelder, die für die HIV/Aids-Bekämpfung bestimmt sind, nicht länger ein, um Minderheiten zu marginalisieren, den Zugang zu Kondomen zu erschweren und das Selbstbestimmungsrecht von Frauen zu beschneiden.
Ø Machen Sie Schluss mit pseudo-wissenschaftlichen Antworten auf die HIV Epidemie;
Ø Untergraben Sie nicht länger die Doha-Erklärung zu TRIPS und öffentlicher Gesundheit durch bilateralen Druck;
Ø Stellen Sie die von Ihnen versprochenen 15 Milliarden US$ dem Globalen Fonds zur Bekämpfung von Aids, Malaria und Tuberkulose zur Verfügung – nicht konkurrierenden Instrumenten wie dem Aids Fonds des US Präsidenten (PEPFAR)].
Wir, die diesen Aufruf unterzeichnenden Organisationen, engagieren uns weltweit für die Menschenrechte, die Bekämpfung der HIV/Aids Epidemie und das Recht der Frau, selbst über ihre reproduktive Gesundheit zu entscheiden. Wir sind zutiefst beunruhigt über die Politik der US-Regierung, die die Prävention und Behandlung von HIV/Aids erschweren. Die Regierung der Vereinigten Staaten hat durch den völkerrechtswidrigen Krieg gegen den Irak die Aufmerksamkeit der Öffentlichkeit von den globalen Problemen Gesundheit und Armut abgelenkt. Hunderte von Milliarden von US$ werden ins Militär investiert, anstatt sie für die Abwehr der heute größten Gefahren für die menschliche Sicherheit einzusetzen: HIV/Aids, Tuberkulose, Malaria, Unterernährung und Armut.
Die Vereinten Nationen schätzen, dass im Jahr 2003 etwa drei Millionen Menschen an Aids, eine Million an Malaria und zwei Millionen an Tuberkulose starben, obwohl diese Krankheiten behandelbar sind. Schätzungsweise 800 Millionen Menschen litten an Unterernährung. Zehn Millionen Kinder sterben jedes Jahr in Entwicklungsländern, die Hälfte davon stirbt an Unterernährung. In vielen Ländern sind Frauen dazu gezwungen, ihr Leben bei illegalen Abtreibungen aufs Spiel zu setzen, da ihnen das Recht verwehrt wird, sich für einen legalen und sicheren Schwangerschaftsabbruch zu entscheiden. Millionen von Menschen werden dem Risiko einer Infektion mit HIV/Aids oder anderen infektiösen Geschlechtskrankheiten ausgesetzt, weil die Benutzung und Ausgabe von Kondomen durch falsche moralische Urteile stigmatisiert wird. Die Verbreitung von HIV wird beschleunigt durch die Marginalisierung von Randgruppen und durch drakonische Gesetze gegen Prostituierte und Drogenabhängige. Um HIV Neu-Infektionen erfolgreich zu reduzieren und mehr Menschen den Zugang zu lebensrettenden Medikamenten zu ermöglichen, ist der Einsatz für die Menschenrechte und Investitionen in die Gesundheitssysteme der Entwicklungsländer unabdingbar. Die Bush-Regierung zeigt jedoch wenig politischen Willen, die Menschenrechte weltweit zu befördern und in die Bekämpfung von HIV/Aids zu investieren.
Im Januar 2003 versprach die Regierung Bush, 15 Milliarden US$ über die nächsten fünf Jahre für die Bekämpfung der HIV/Aids Epidemie bereitzustellen. Menschenrechtsorganisationen und Gruppen, die sich für die Bekämpfung von Aids engagieren, begrüßten diese Ankündigung mit vorsichtiger Zurückhaltung. Die tatsächlich vom amerikanischen Kongress bewilligten Ausgaben als Teil dieser Verpflichtung für das Jahr 2004 betrugen allerdings lediglich 2,4 Milliarden US$. Die Gesamtausgaben der US Regierung für Hilfsprojekte im Jahr 2004 belaufen sich auf 17,55 Milliarden US$. Das bewilligte Militärbudget für 2004 beträgt bereits zu diesem Zeitpunkt 368,3 Milliarden US$. Und hier sind noch nicht die von der Bush Regierung zusätzlich beantragten 87 Milliarden US$ berücksichtigt. Große Teile dieses Budgets fließen in den sogenannten Krieg gegen den Terrorismus und in die Aufrechterhaltung der Okkupation des Irak. Wir anerkennen die Bedrohung durch den Terrorismus. Doch die weitaus größten Gefahren für die globale Sicherheit sind die, die durch Armut und Unterentwicklung verschärft werden: die HIV/Aids Pandemie, Malaria, Tuberkulose und Unterernährung. Die Bekämpfung dieser Probleme zusammen mit der Verbreitung der Menschenrechte und der Lösung globaler Probleme in internationalen Institutionen ist der beste Weg, globale Sicherheit dauerhaft zu schaffen. Dies hat die Clinton Administration in Teilen anerkannt als sie Ende April 2000 Aids zu einem nationalen und globalen Sicherheitsproblem erklärte.
Unglücklicherweise hat die Regierung Bush bisher kaum Interesse an diesen Problemen gezeigt. Internationale Institutionen wie die Vereinten Nationen, die Weltgesundheitsorganisation (WHO) und der Globale Fonds zur Bekämpfung von HIV/Aids, Malaria und Tuberkulose wurden von ihr weitgehend ignoriert. Die Position der Bush-Regierung zu Prävention- und Behandlungsausgaben konterkariert die Positionen dieser internationalen Institutionen: z.B. werden ein Drittel der Präventionsgelder des von Bush ins Leben gerufenen Aids-Programms PEPFAR für Enthaltsamkeitsaufrufe bis zur Hochzeit ausgegeben. Es kann durchaus sinnvoll sein, die ersten sexuellen Erfahrungen hinauszuzögern, um Jugendliche vor einer Infektion zu schützen, jedoch sollte dies nicht mit moralischen Urteilen über eine Heirat oder auf Kosten von Kondomförderung und -verteilung, besonders bei Jugendlichen verbunden werden. Die US-Regierung weigert sich, den lebensrettenden Wert von Kondomen gegen die HIV-Ansteckung anzuerkennen und Informationen darüber zu verbreiten. Stattdessen macht sie unwissenschaftliche und zweifelhafte Aussagen, welche die Wirksamkeit von Kondomen zur HIV-Prävention in Frage stellen. Informationen über Kondome wurden von der Website des US-Centers for Desease Control entfernt. Präsident Bush führt außerdem die beunruhigenden Richtlinien der Reagan-Ära bei Familienplanungsorganisationen weiter: ihre Mittel werden drastisch gekürzt, wenn diese Organisationen den Frauen Informationen über Abtreibung zur Verfügung stellen. Wir sind darüber besorgt, dass die gegenwärtige US-Politik durch eine religiös-fundamentalistische Tagesordnung dominiert wird.
Außerdem behindert die Bush-Regierung den Zugang zu günstigen Arzneimitteln, indem sie eine Konkurrenz zwischen generischen Präparaten und Markenmedikamenten verhindert. Besonders schwerwiegend ist hierbei die Blockade der generischen Kombinationspräparate, die es den PatientInnen ermöglichen, nur noch täglich zwei bis drei Tabletten schlucken zu müssen. Durch diese einfachere Art der HIV-Therapie könnten gerade in Entwicklungsländern mehr HIV-Positive mit der lebensverlängernden Medizin versorgt werden. Die Bush-Regierung hat eine religiös-fundamentalistische Überzeugung über die Wissenschaft gesetzt und so den Zugang zu Kondomen und generischen Medikamenten unterbunden. Dies hat zu einem kritischen Leitartikel in der wissenschaftlich renommierten medizinischen Zeitschrift The Lancet geführt, der die HIV/AIDS-Politik der Bush-Regierung beschreibt als "eins der besten Beispiele wie Ideologie stichhaltige öffentliche Gesundheitspolitik behindert."* Während die südafrikanische Regierung richtigerweise für ihr unwissenschaftliches Verständnis über die HIV-Epidemie kritisiert worden ist (die sich jetzt langsam zu ändern scheint), gibt sich jetzt die Bush-Regierung als Meisterin irrationaler Antworten auf die Epidemie.
Wir rufen zu einem internationalen Aktionstag am 24. Juni 2004 auf, um der Bush-Regierung zu entgegnen: Investieren Sie in die Gesundheit, statt in den Krieg!
* Lancet: Jul 2002 13; 360 (9327): 97
Dieser Aufruf wird in Deutschland unterstützt von: Aktionsbündnis gegen Aids
BUKO Pharma-Kampagne
Bund für Soziale Verteidigung (BSV)
Evangelische StudentInnengemeinde in der BRD (ESG)
Feministisches Frauen-Gesundheits-Zentrum e.V. ,Berlin (FFGZ e.V.)
Pädagoginnen und Pädagogen für den Frieden (PPF)
Folgende Organisationen unterstützen den Aktionstag weltweit (Unterstützen Sie den Aufruf unter healthnotwar@tac.org.za mit ihrem Oraganisationsnamen)
Action for Southern Africa (ACTSA), UK
Advocators of Processes of HIV/AIDS Programs, Kenya
Africa Action, USA
AIDS Consortium, South Africa
AIDS Law Project, South Africa
AIDS Law Unit, Namibia
AIDS Legal Network, South Africa
AIDS Task Force of Africa Japan Forum, Japan
American Friends Service Committee (AFSC), USA
Association de lutte contre le SIDA (AIDES), France
Basic Income Grant Coalition (BIG), South Africa
Blue Diamond Society, Nepal
BUKO Pharma-Kampagne, Germany
Childolescent & Family Survival Organization (CAFSO)
Community HIV/AIDS Mobilization Project (CHAMP), USA
European AIDS Treatment Group (EATG), Europe
Friends of TAC (FoTAC), UK
Friends of TAC (FoTAC), USA
Gays and Lesbians of Zimbabwe (GALZ), Zimbabwe
Georgian Plus Group, Georgia
Global AIDS Alliance, USA
Globalise Resistance, UK
Grupo de Trabajo sobre Tratamientos del VIH/SIDA (gTt), Spain
Health GAP, USA
HIV i-Base, UK
Housing Works, Inc., USA
International Community of Women Living with HIV/AIDS (ICW), UK
New Mexico AIDS InfoNet, USA
Pan African Treatment Access Movement (PATAM), Africa
Plus and Minus Foundation, Bulgaria
Positive Movement Belarus, Belarus
Positive Muslims, South Africa
Progressive Organization of Gays in the Philippines, Philippines
South Africa Development Fund, USA
South African Communist Party (SACP), South Africa
Treatment Action Campaign (TAC), South Africa
Union Aid Abroad (APHEDO), Australia
Youth Empowered to Succeed (YES), Kenya
Questions and Answers For further details, please phone: +27 21 788 3507 How much money did the Bush Administration pledge to alleviating AIDS in Africa and the Caribbean and how much has actually been given? In his annual State of the Union address in January 2003, President Bush announced the provision of an additional $10 billion to AIDS programmes in Africa and the Caribbean. This should have brought to $15 billion the US government's total commitment following a $5 billion allocation under the Clinton Administration that had yet to be disbursed. The US Congress eventually appropriated $2.4 billion in 2004, and the total amount released so far is just $350 million. To whom is the money being given? Most of the money is intended for distribution through the bilateral President's Emergency Plan for AIDS Relief (PEPFAR), which currently targets 14 countries: Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia. A relatively small portion of the Bush Administration's pledge, just $1 billion over five years, is intended for the GFATM. What is the GFATM? The Global Fund to Fight AIDS, TB and Malaria (GFATM) is an independent, multilateral institution established in 2002 with the purpose of funding programmes in developing countries aimed at treating and preventing the three highest-mortality infectious diseases in the world. Its success is necessary for the WHO to meet its goal of treating three million people with AIDS by 2005. The GFATM aims to constitute a major source of the $27 billion in economic assistance to developing countries that the WHO Commission on Macroeconomics and Health has suggested is needed by 2007 (growing to $38 billion by 2015), yet the GFATM remains underfunded, receiving only $658 million so far in 2004. Partly this is due to the US government failing to commit sufficient funds to it, but the European Union, Canada, Australia and Japan all need to contribute more money to the Fund. How has the Bush Adminstration undermined access to condoms in developing countries? As early as mid-2001, the Bush Administration removed all references to condom effectiveness from the US Centers for Disease Control website. Subsequent funding allocations and policy documents render it clear that the Administratrion views condom promotion as appropriate primarily for so-called high risk groups. In reality, individuals who engage in any kind of sexual activity at any stage of their lives must have the information to protect themselves and their partners and the ability to act on that information through unrestricted access to contraceptives and reproductive choice. While PEPFAR does not openly ban funding for comprehensive sex education or condom promotion, a full 1/3 of the Plan's prevention funds are reserved for promoting abstinence-until-marriage (this restriction is advisory for 2004-5 but becomes mandatory in 2006). This funding structure is unrealistic and refuses to take into account the complex social and economic problems that put young people at risk for early sexual activity and exposure to HIV. How has the Bush Adminstration undermined access to reproductive choices in developing countries? The so-called Mexico City Policy, also known as the Global Gag Rule, was first established by US President Ronald Reagan in 1984, prohibiting any organisation receiving family planning funds from the US Agency for International Development (USAID) from providing information about abortion. The Global Gag Rule was later suspended by President Bill Clinton, but reinstated in January 2001 as one of the Bush Administration's first official acts. In August 2003, President Bush extended the Gag Rule to cover US Department of State funds as well. Many of the affected family planning organisations that choose to reject the Gag Rule's restrictions then find themselves unable to obtain donated USAID contraceptives and are forced to cut services and raise fees. Why is the Bush Administration against reproductive choice and condom access? President Bush and many members of his Administration use religion to excuse intolerant fundamentalist political policies. They believe that abortion and condom use are wrong. They fail to understand that access to condoms is an essential component of any large-scale workable HIV prevention strategy and that reproductive choices, including the right to an abortion, are critical for the empowerment of women in the developing world. What are fixed-dose combination (FDC) antiretroviral medicines? Fixed-dose combination antiretroviral medicines are an important breakthrough for treating people with AIDS, because they combine some or all the antiretroviral medicines a patient has to take into one pill. In general, three different antiretroviral medicines have to be taken twice daily by people on treatment. This used to require patients to take many pills a day -- as many as 18 not being uncommon. Research in a South African hospital has shown that the number of pills patients take a day is a critical factor affecting patient adherence to their treatment. (AIDS. 2003 Jun 13;17(9):1369-75.) Patient adherence is critical to the success of treatment and reducing drug resistance. With the gradual improvement of antiretroviral technology, pill counts have come down for most patients. Some fixed-dose combination medicines reduce the pill count to two pills a day.
Furthermore, because the only three-in-one FDCs are manufactured by generic companies, they are frequently cheaper than the equivalent, but separate, medicines produced by brand-name companies. How has the Bush Administration undermined access to generic fixed-dose combination antiretroviral medicines used for treating AIDS? The US government's undermining of access to cheaper medicines precedes the Bush Administration. The pharmaceutical lobby is a powerful force in US politics and contributes generously to presidential elections, usually to both Democrat and Republican candidates. Its primary interest is to protect itself against competition from cheaper generic medicines, by lobbying for more stringent patent protection both in the US and internationally. Under the Clinton Administration, South Africa was placed on a trade watch-list when it enacted legislation to make medicines more accessible. Following activist pressure, the Administration relented. (Since his Presidency, Mr. Clinton's foundation has worked to reduce the prices of AIDS medicines, particularly generics, as well as monitoring tools.)
The Bush Administration has a worse record on blocking access to affordable medicines than the Clinton Administration. It attempted to stop a World Trade Organization agreement at Doha, Qatar, which improves access to generic medicines for poor countries. Again, following activist pressure and a firm, unified stance by developing world negotiators, the US government backed down. Paragraph 6 of the the Doha Agreement left certain matters unresolved, so the Bush Administration advocated for a resolution of the paragraph that would have restricted access to generic medicines. Again activist pressure coupled with a firm stance by developing world negotiators resulted in the US backing down. Nevertheless, the Bush Administration continues to undermine the Doha Declaration by pursuing bilateral trade agreements with developing countries, reducing the options for making generic medicines more accessible that these countries would otherwise have under the Doha Declaration.
The trend of attempting to foil efforts to access cheaper generic medicines has continued over the past few months. Members of the Bush Administration have undermined public confidence in the safety and efficacy of fixed-dose combination (FDC) generic antiretroviral medicines approved by the WHO. These medicines are an essential, affordable tool for the treatment of HIV on a massive scale. The Bush Administration clearly would prefer to use PEPFAR money to purchase brand-name antiretrovirals, in order to satisfy the drug manufacturers among its campaign donors. The Administration's allegations against generic FDCs, particularly those announced by Mr. Randall Tobias, the former CEO of Eli Lilly appointed by President Bush to be the US Global AIDS Coordinator, are based on pseudo-science. Despite the unity of expert opinion at the US-initiated FDC conference in Botswana this past March that the current standards in place for approving fixed-dose combinations are acceptable, the Bush Administration has persisted with this agenda.
In late April, Mr. Tobias stated, "Maybe [FDC] drugs are safe and effective. Maybe these drugs are, in fact, exact duplicates of the research-based drugs [sold in the United States]. Maybe they aren't. Nobody really knows." (Zavis, Associated Press, 28 April) This is incorrect. The WHO has put in place a stringent process, known as prequalification, for recommending antiretroviral medicines that are safe and effective. The term prequalified is used because it is still the prerogative of each country's own regulating authorities to approve the drugs for domestic use. To date, ten fixed-dose combination medicines have been prequalified. In South Africa, at least one FDC containing an entire antiretroviral regimen is awaiting approval by the Medicines Control Council (MCC), and it is already widely used through special exemptions granted by the MCC. Tobias' statement, made in South Africa, was aimed at fuelling the already confused debate in the country about the safety and efficacy of antiretroviral medicines.
Generic medicines have to be shown to be pharmacologically equivalent to brand-name medicines before they are approved. The usual (and best) way of demonstrating this is through what is called a bioequivalence test. The bioequivalence standard requires similar quantities and availability of the active ingredient in brand-name and generic formulations, and is defined by absorption parameters generally falling between 80% and 125% of those obtained with the brand-name drug under the same testing conditions. The FDCs prequalified by the WHO have successfully passed bioequivalence tests. Mr. Tobias certainly was not questioning the use of bioequivalence for approving generics. Most generic medicines approved by the US Food and Drug Administration (FDA) are approved based on bioequivalence testing. Therefore, Tobias could only have been calling into question the fact that generic FDC antiretrovirals combine the two or three drugs against which they are tested for bioequivalence into one pill. What he and other apologists for the Bush Administration seem to be suggesting is that generic FDC antiretrovirals can only be approved once they go through clinical trials. But this is unacceptable because there is no reason to believe that combining the medicines into one pill materially affects the validity of bioequivalence. Many combination medicines, both brand-name and generic, are approved by regulatory authorities around the world (including the FDA) and there is nothing inherent about drugs being in combination that affects their safety or efficacy. Indeed, one of the most important medicines in South Africa's public health system is a four-in-one tuberculosis FDC. It has been used for a number of years and benefited thousands of patients and it was approved on the basis of bioequivalence, not full clinical trials. It is particularly ironic that the Bush Administration has a sudden concern for the safety and efficacy of extensively-tested essential medicines when it certainly does not show the same concerns with regard to genetically modified foods, which might in the long run prove safe but certainly are not essential.
Following criticism of Mr. Tobias' unsustainable arguments at a recent high-profile WHO meeting, the Bush Administration has retreated and released a statement saying that FDC manufacturers can apply for fast-tracked approval through the FDA to become eligible for purchase through PEPFAR funds. This was to head off further embarrassment at a World Health Assembly meeting. However, while this compromise suggests a position that is more reasonable than the one articulated by Mr. Tobias, it is still insufficient. The FDA is responsible for regulating medicines in the United States, although some other countries take their cue from FDA registrations. WHO prequalification should be sufficient for donors and the decision to distribute FDCs should lie with countries' own regulatory authorities. Applying for FDA approval is usually a time-consuming and expensive process, costing hundreds of thousands of dollars, and it is questionable whether there is sufficient incentive for generic companies to pursue an FDA application. While the statement admitted the possibility of waiving FDA fees and reducing application times to six weeks, this has been stated in vague terms. At least one US official has already stated that six weeks is the best-case scenario and is only realistic for combinations of separate drugs packaged in the same blister packs, which are not the same thing as FDCs.
This latest compromise by the Bush Administration is part of a long history of blocking access to generics and then relenting when faced with pressure. The trend has been that as the possibility of distributing generic medicines has come closer, the US government has done everything it can to create obstacles to their availability.
If the Bush Administration proceeds with its new policy that FDCs must be registered with the FDA before PEPFAR funds can purchase them, then it must at a minimum commit unambiguously to the waiving of FDA fees and registration within no more than six weeks of application. Bureaucratic delays in distributing medicines to developing countries have a very tangible cost: lost lives.
If the Bush Administration donated most of its AIDS relief funds to the GFATM, which can and does fund the purchase of generic antiretrovirals, the issue of PEPFAR being restricted to FDA-approved drugs would largely disappear. What Actions are Planned for 24 June? Organisations in different countries are encouraged to plan their own events. An updated list of actions is available on http://www.tac.org.za/HealthNotWar.htm. To have your action added to the list of events, please send an email with full details of the event to healthnotwar@tac.org.za.
Suggested Actions: Pickets at or marches to US consulates and embassies, letter-writing and fax campaigns to the White House, US embassies and consulates, press conferences, awareness events. The following organisations have called for the International Day of Action on 24 June:
(To endorse this statement, please send an email to healthnotwar@tac.org.za with the name of your organisation and contact details)

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