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Africa: Treatment Access Updates Date distributed (ymd): 020811 Document reposted by Africa Action
Africa Policy Electronic Distribution List: an information service provided by AFRICA ACTION (incorporating the Africa Policy Information Center, The Africa Fund, and the American Committee on Africa). Find more information for action for Africa at http://www.africaaction.org
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Region: Continent-Wide Issue Areas: +health+ +economy/development+
SUMMARY CONTENTS:
At the XIV International AIDS Conference in Barcelona in July, there was little dissent to the overwhelming consensus that treatment (including anti-retroviral treatment) as well as prevention were indispensable and interlinked means to combat the AIDS pandemic. In practical terms, however, only about 30,000 Africans are estimated to be receiving anti-retroviral treatment, while the death toll is over 2 million a year. Post-conference, officials in many countries are still placing practical stumbling blocks in the way of the massive expansion in treatment access that is urgently needed.
This posting contains several short updates on policy in South Africa, the U.S., and Kenya. Notably, South African mining company giant has now pledged to make full treatment available for its workers. But some South African officials still seem to be fighting rear-guard actions against expanding treatment, even for prevention of mother-to-child transmission. U.S. pressure for new bureaucratic procedures is reported to be blocking quick distribution of Global Fund grants already approved. And in Kenya, an anonymously-inserted amendment in the Industrial Property Act has blocked efforts to step up imports of generic medicines. For more details see the excerpts and sources cited below.
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SOUTH AFRICA
(1) Mining Conglomerate Anglo American to Provide Antiretroviral Therapy to HIV-Positive Employees in Southern Africa
Excerpted from: Kaiser Daily HIV/AIDS Report, Aug. 6, 2002 http://www.kaisernetwork.org/dailyreports/hiv E-mail: dailyreports@kaisernetwork.org
Mining company Anglo American today announced that it will provide antiretroviral therapy to its HIV-positive employees in Southern Africa who do not already qualify for treatment under medical aid schemes, Reuters reports. Through its subsidiaries AngloGold and DeBeers, the company employs about 90,000 people in the region (Gush, Reuters, 8/6). An estimated 23% of its workforce -- or 18,000 people -- is HIV-positive, company spokesperson Anne Dunn said. ... Anglo did not provide an overall cost estimate for the program, but Dunn said the company expects to spend about $165 per qualifying HIV-positive employee per year to provide antiretroviral therapy, counseling and treatment for side effects from the antiretroviral drugs. ...
Last month, AngloGold signed an agreement with five labor unions in South Africa to develop strategies to lessen the impact of HIV/AIDS on its workforce (Agence France-Presse, 8/6). ... AngloGold estimated that HIV/AIDS is costing its South African mining operations between $4 and $6 per ounce of gold produced. The company estimated that the cost could rise to $9 per ounce if no measures are taken to help its workforce. Anglo said that the new program will lower costs by reducing absenteeism and reducing medical expenses and pension benefits in the long run (Reuters, 8/6).
For the Anglo American press release see: http://www.angloamerican.co.uk/press/2002/06082002.asp
(2) South African Medicines Control Council Reviewing Safety and Efficacy of Nevirapine
[From: Kaiser Daily HIV/AIDS Report, August 6, 2002]
South Africa's Medicines Control Council last week announced that it is conducting a review of its approval of the antiretroviral drug nevirapine, which is used to prevent mother-to-child HIV transmission, due to "serious concerns" about the drug's safety and efficacy, the South Africa Sunday Times reports. Two weeks ago, members of the MCC asked representatives from Boehringer Ingelheim, the drug's manufacturer, to explain several deaths allegedly linked to the drug during a Ugandan study and why the company had decided to withdraw a U.S. application for approval to market the drug as a treatment for the prevention of mother-to-child HIV transmission (Jubasi, South Africa Sunday Times, 8/4). Boehringer pulled its FDA application in March after FDA regulators said they uncovered problems with a 1999 study performed in Uganda by Johns Hopkins University researchers. The questions related to procedure and not the validity of the study, which found that use of the drug during childbirth can reduce HIV transmission to infants (Kaiser Daily HIV/AIDS Report, 3/25). Precious Matsoso, the registrar of the council, said the MCC is reviewing Boehringer's "compliance" with the South African Medicines Control Act and will issue a final report in September. If the company is found to be in violation of the act, the MCC can ask it to withdraw the drug's registration. ...(South Africa Sunday Times, 8/4).
Advocates Accuse MCC of 'Losing Its Independence'
HIV/AIDS advocates said the MCC's review of nevirapine raised concerns about the board's motivation and signaled that it was "losing its independence," the South African Press Association reports. "There is overwhelming evidence that nevirapine is safe for [preventing] mother-to-child transmission. Not a single serious side effect has been reported when nevirapine has been used for this purpose," Nathan Geffen, national manager of the Treatment Action Campaign, said, adding that his group is "very concerned" that Matsoso and MCC Chair Peter Eagles are "not acting on the basis of ensuring access to safe and effective medicine, but rather with political motivation." He accused the two of trying to "scuttle" the implementation of a court order that requires the government to provide antiretroviral treatment to all HIV-positive pregnant women at public hospitals to reduce the odds of vertical transmission. Nevirapine is the most commonly used drug for this purpose, and the withdrawal of its registration could create a "nightmare" for MTCT programs in the country, SAPA reports. ... (SAPA, 8/4).
(3) URGENT JOINT STATEMENT ON GLOBAL FUND ALLOCATION TO KWAZULU-NATAL
1 August 2002
The following is a joint statement by the following organisations and individuals:
Archbishop Njongonkulu Ndungane; South African Medical Association; Southern African HIV Clinicians Society; South African Academy of Family Practice/Primary Care; Diakonia Council of Churches; AIDS Consortium; AIDS Law Project; Children's Rights Centre; Durban Gay and Lesbian Community and Health Centre; Southern African Fogarty AIDS Training Programme; Professor Hoosen Coovadia, Victor Daitz Professor of HIV/AIDS Research,University of Natal Durban; Professor Quarraisha Abdool-Karim, University of Natal Durban; SANGOCO - KZN; SANCO - KZN; Treatment Action Campaign
For further information, please contact: Loraine Tulleken (Archbishop Ndungane's media liason officer) 011 839 1058; Nonkosi Khumalo (TAC Executive Secretary) 072 2311 422 or 021 788 3507
Centre for Civil Society, University of Natal, Durban, South Africa, http://www.nu.ac.za/ccs
DECLARATION OF SUPPORT FOR FUNDING OF THE KWAZULU-NATAL ENHANCING CARE INITIATIVE
HIV/AIDS In KwaZulu-Natal (KZN)
One in 4 people in KZN live with HIV/AIDS. It is the worst-affected province in South Africa and one of the worst in the world. Already there is immense suffering and death, especially among poor people, and the public health system in the province is struggling to cope with the burden of this disease. If nothing is done, the situation will become much worse.
Enhancing Care Initiative KZN Is a Crucial Step Towards Alleviating the HIV/AIDS Epidemic
The Enhancing Care Initiative KwaZulu-Natal (ECI KZN), in response to two years of research performed in the communities of KZN, brought forward a comprehensive proposal for prevention, care and support for people with HIV/AIDS in the province. It is a joint project by researchers from the Nelson Mandela Medical School of the University of Natal Durban, the KZN Department of Health, the Durban Chamber of Commerce, the National Association of People Living with AIDS (NAPWA) and many other organisations and institutions, both local and international. It includes a comprehensive range of prevention, care and support interventions for combating the HIV epidemic, including vertical transmission prevention of the virus, and highly active antiretroviral therapy. These crucial interventions will save lives and help prevent new infections.
During its initial stages, the ECI KZN project will offer antiretroviral therapy to a fraction of people with HIV who need treatment, but its most important value will be to establish an example of how such treatment can be carried out in South Africa and other developing countries, so that ultimately millions of people in need of life-saving medicines for HIV/AIDS will receive them. To facilitate this, part of the ECI KZN proposal is to assist other provinces and neighbouring countries to apply for funding from the Global Fund in the next call for proposals due on the 27th September 2002.
The antiretroviral projects established by the ECI KZN will be a necessary part of the implementation of a treatment plan for HIV/AIDS and will be a first step to secure the comprehensive provision of antiretrovirals in the province and country-wide. By the fifth year of the ECI KZN implementation, it is envisaged that most public health care facilities in the province will offer antiretroviral treatment via clinics treating Tuberculosis and vertical transmission prevention programmes. This is therefore a critical step in the effort to reverse the HIV/AIDS epidemic.
Global Fund to Fight AIDS, Tuberculosis and Malaria
The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) is an unprecedented international effort to raise funds for developing countries to fight these diseases. The Global Fund has agreed to fund the ECI KZN approximately R700 million (U$D 72 million) over five years.
Unfortunately, there is a dispute between the National Minister of Health, the Global Fund and the ECI KZN over this funding. This is an unnecessary controversy that is damaging South Africa's reputation with the Global Fund and the international community. More importantly, it is causing a delay in the implementation of the ECI KZN which will result in further unnecessary AIDS deaths and new HIV infections. We, the undersigned organisations and individuals are deeply concerned and desire that a just end be brought to this controversy immediately.
End the Controversy. Ensure Global Fund Money Goes to ECI KZN .
We welcome the Global Fund's acceptance of the ECI KZN proposal and congratulate all parties involved in the ECI KZN for the effort they have made to bring it about. In particular, we welcome the leadership role played by the KZN Department of Health with regard to the ECI KZN. We are satisfied that given the constraints under which the proposal was made, it was developed through a reasonable consultative process. When the proposal was sent to the Global Fund for approval, no legally or materially functioning country co-ordinating mechanism representing the interests of people with HIV/AIDS existed in South Africa for managing the epidemic. Such a mechanism still does not exist. If it did exist this controversy might have been avoided.
The Cabinet statement of 17 April on HIV/AIDS was welcomed by all sectors of South African society and by the international community as a clear indication that the National Government will lead the fight against HIV/AIDS. It is now necessary for the National Department of Health to demonstrate its commitment to the implementation of the Cabinet statement. It can do this by:
* Unconditionally endorsing the ECI KZN and allowing the proposal to be implemented as it stands.
* Reconstituting the South African National AIDS Council (SANAC) as a legal, functioning, independent entity that truly represents the interests of people with HIV/AIDS and seeks representation from all sectors of South African society with a real interest in alleviating the HIV/AIDS epidemic.
* Facilitating further proposals to the Global Fund from South Africa and each of its provinces.
Let Us Work Together Against the HIV/AIDS Epidemic
We urge all sectors of South African society to work together to ensure the successful implementation of the ECI KZN. We therefore ask the National Department of Health and all other parties involved to ensure the speedy delivery of Global Fund money allocated to the ECI KZN.
In the words of the 17 April Cabinet Statement, let
us join hands in a campaign of hope. Our combined efforts
are essential if we are to defeat the HIV/AIDS epidemic.
(4) Mandela and Mbeki Meet to Discuss Provision of Antiretroviral
Drugs for South Africans
[From: Kaiser Daily HIV/AIDS Report, August 5, 2002]
Former South African President Nelson Mandela met with South African President Thabo Mbeki Thursday night to discuss the country's role in providing antiretroviral treatment to HIV-positive people, but the two parties agreed not to disclose what was said during the meeting, the South African Press Association reports. Mandela formally requested a meeting with Mbeki on the issue last Monday, following Mandela's meeting with Treatment Action Campaign Chair Zackie Achmat. Achmat, who is HIV-positive, is refusing to take antiretroviral drugs until they are made available to all South Africans who need them (South African Press Association, 8/2). Antiretroviral drugs are "freely available" to South Africans who have private medical insurance, including Achmat, but are not available in state hospitals, which treat most of the country's residents. The South African government has said that the drugs are too costly to give to all HIV-positive South Africans (Kaiser Daily HIV/AIDS Report, 7/29).
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USA
[From: Kaiser Daily HIV/AIDS Report, August 5, 2002]
(1) Bush Administration Demands Stalling Distribution of Grants >From Global AIDS Fund
Although it has approved $1.6 billion in grants for programs in more than 40 countries, the Global Fund to Fight AIDS, Tuberculosis and Malaria has not yet distributed any money, largely because of "demands led by the Bush administration" that the fund create an aid-delivery mechanism "from scratch," the Wall Street Journal reports. The Global Fund has so far received $2.1 billion in pledges; the United States has pledged $500 million of this amount. The fund approved 58 project applications in its first round, including $165.3 million for programs in South Africa and $92.9 million for efforts in Zambia -- two countries with HIV prevalence rates of more than 20%. As the HIV/AIDS pandemic continues to grow, the fund is facing "mounting pressure" to distribute the grants. Global Fund Executive Director Richard Feachem said that he hopes to distribute money to a "handful" of projects by October, although this deadline is also "up in the air," the Journal reports. Most of the grant recipients will not receive any money until the end of the year or later.
Creating a New Distribution System
The Journal reports that several donors to the fund, including the United States and the United Kingdom -- are "dubious" about allocating aid through existing agencies, such as the United Nations and the World Bank. The Bush administration and the U.K. government say that existing agencies have not had enough of a "positive effect" and are asking that the Global Fund "shun existing aid agencies and build its own system," a request that has delayed the distribution of funding. Despite the United States' objections, the World Bank holds the fund's money and has agreed to wire grants to recipients. To create its own distribution mechanism, the fund must implement its own procurement, administrative, auditing and other services in each country for each grant. ... U.S. officials concede that creating this approach will mean "somewhat slower delivery of the aid," but they say that closer monitoring of aid distribution will ensure a greater benefit. ... Feachem and U.S. and British officials say that the fund is making "quick progress" in implementing its new distribution system, but "tension has emerged" between donors and the recipients who want to receive the money as soon as possible. Milly Katana, a Ugandan AIDS activist who represents private charities on the fund's board, said, "I don't see any justification for that kind of excess precaution. ... lives are being lost" (Phillips, Wall Street Journal, 8/5).
(2) Bush Signs FY 2002 Supplemental Spending Bill, Has 30 Days to Decide on Contingency Funds, Including $200M for Global AIDS
President Bush on [Aug.2] signed a $28.9 billion fiscal year 2002 supplemental spending bill (HR 4775) that includes $200 million for international HIV/AIDS programs, CongressDaily reports. However, it is not clear whether the HIV/AIDS funding will be released because it is included as part of a $5 billion contingency package that must be approved separately. Bush has 30 days to decide whether to authorize the contingency funds (Ghent/Koffler, CongressDaily, 8/2). If he fails to make a declaration on the measure, all of the emergency funding, including the $200 million for HIV/AIDS, would be lost. Bush has not indicated whether he will approve the funding (Kaiser Daily HIV/AIDS Report, 7/25).
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KENYA
UN Integrated Regional Information Network http://www.irinnews.org
[This report does not necessarily reflect the views of the United Nations]
NAIROBI, 5 August (IRIN) - Pressure is mounting on the Kenyan government to re-amend the Industrial Property Act to allow for the importation of generic anti-retroviral medicines (ARVs) into the country, as parliament prepares to go into recess until October at the end of this week.
The Industrial Property Act, which became law on 1 May 2002, allowed for the importation of any drugs into Kenya which were registered, and therefore legally available, in another country.
In the case of ARVs - a lifeline for those who are HIV positive or have AIDS - this means a difference in price of 2,000 Kenyan shillings (US $26) per month for generic drugs from India, as opposed to 8,000 shillings for patented drugs (currently available) produced by international pharmaceutical companies.
However, on 7 June, an amendment was made to section 58 of the act, which made it mandatory to seek the "express consent" of the original patent holders of the drugs before importing, the Daily Nation reported on 25 July. Campaigners agree that such permission - to effectively undercut the bigger pharmaceutical companies - is highly unlikely to be granted.
Meanwhile, the ministers for trade and health, and the attorney-general - whose office is responsible for the drafting of all bills - have denied any involvement in the amendment. "It cannot be pinpointed exactly who was responsible for amending the section, but the matter has been raised with the attorney-general," the Kenyan newspaper Daily Nation quoted Health Minister Sam Ongeri as telling parliament.
"This is the first time in Kenyan history that an amendment to a law has been made without the instigation of a ministry," Newton Kulundu, chairman of the parliamentary health committee, told PlusNews. "None of them liked to admit responsibility," he added.
The Kenya Coalition on Access to Essential Medicines (KCAEM), an umbrella group of campaigners, is seeking to have the act re-amended to its original wording, Robert Lettington, legal consultant for the Coalition, said. If this is not possible before parliament goes into recess (which may be delayed until next week due to outstanding issues), another alternative would be for the government to issue an interim order, which would effectively nullify the disputed amendment, until the original wording is reinstated.
Kulundu told PlusNews that parliament was due to discuss the matter this week, and added that Ongeri had been put under "intense pressure" to name those responsible for the amendment.
While the debate rages over responsibility, however, ordinary people continue to suffer. The United Nations estimates that 700 people die of HIV/AIDS and related illnesses in Kenya each day, and only 6,000 people have access to ARVs.
Lisa Kyambo of Cry for the World said not everyone would be able to afford the 2,000 shillings per month for the generic ARVs, but that it would certainly make them a lot more widely available. "It's a progressive thing. They used to cost US $1,000 per month, now they cost about US $100, and we are pushing to get them for US $25."
If the re-amendment to the Property Act were to be effected, pressure on the government would also result in the generic ARVs being widely available in Kenya within two to three months, she added.
In the meantime, the KCAEM is exploring possible courses of action to take. "At the very least, the amendment was made in a very unorthodox manner," Lettington said. "Its legality is a bigger question. We are exploring our legal options in terms of the constitution and whether the amendment would be considered constitutional or not."
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Message-Id: <200208111707.NAA15872@aaserver1.africapolicy.org> From: "Africa Action" <apic@igc.org> Date: Sun, 11 Aug 2002 13:57:57 -0500 Subject: Africa: Treatment Access Updates
Editor: Ali B. Ali-Dinar
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