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SCIENCE AND EPIDEMIOLOGY

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SCIENCE AND EPIDEMIOLOGY Powered By Docstoc
					Dr. Manto Tshabalala-Msimang
Minister of Health
Private Bag X399
PRETORIA
0001
11 June 2001

FAX: (012) 325 5526
BY HAND


Dear Minister Tshabalala-Msimang

MEMORANDUM CALLING FOR COMMITMENT, ACTION AND IMPLEMENTATION
OF PREVENTION AND TREATMENT PLAN

We hope that at this meeting you will finally commit government to real action on the
following issues:
     The implementation of a country-wide mother-to-child transmission prevention
       (mtctp) programme;
     The development of a comprehensive HIV/AIDS Treatment Plan; and
     Applications for voluntary licenses on all essential medicines necessary for
       combatting HIV/AIDS, including antiretrovirals, from the relevant pharmaceutical
       companies.

This memorandum addresses the issue of mother-to-child-transmission and the
engagement of the Treatment Action Campaign (TAC) with your ministry and
government to resolve them.

MOTHER-TO-CHILD HIV PREVENTION PROGRAMMES
Since 1994, organisations that endorse TAC more specifically the AIDS Law Project
and the AIDS Consortium have engaged scientists, clinicians and government on the
issues of mother-to-child HIV transmission and its prevention. In December 1998, TAC
was formed with the explicit aims to ensure that government implement an MTCT
programme nationally and that government treat HIV/AIDS, and that drug companies
lower the prices of antiretroviral drugs (ARVs).

SCIENCE AND EPIDEMIOLOGY
1. Over the last five years, members of the Treatment Action Campaign (TAC) have
   been scientifically and clinically advised by experts in the field, that anti-retroviral
   drugs such as zidovudine, (popular name AZT)—have the effect of reducing and at
   times eliminating HIV from the bloodstream—can be used to significantly reduce
   mother-to-child transmission of the virus.
                                           2




2. Approximately 3 out of every 10 women with HIV will give birth to a child with the
   virus. In South Africa, the Medical Research Council has estimated that 11% of new
   infections are as a result of mother-to-child transmission of HIV.

3. In 1994, the findings of the Paediatric AIDS Clinical Trials Group (PACTG) trial
   PACTG076 were published. These findings established beyond doubt that the
   provision of AZT (zidovudine) after the first fourteen weeks in pregnancy reduced the
   rate of mother-to-child transmission by 67.5%. This gave hope to women with
   HIV/AIDS, health workers and governments. PACTG076 has become the standard
   of care in many developed countries. However, the cost of the drug at 100mg five
   times daily is exhorbitant and beyond the reach of the vast majority of people in the
   developing countries. Thailand and Brazil have implemented the PACTG076
   regimen to reduce mother-to-child transmission because they produce generic AZT
   that is sold at a fraction the price in the USA. Consensus between the government
   and civil society was that the PACTG076 regimen was unaffordable in the South
   African context at then prevailing market prices.

4. On 19 February 1998, the results of the Bangkok Perinatal AZT Study (also known
   as the Thai Study) that tested the safety and efficacy of short-course AZT therapy
   were announced. The Thai Study reduced mother-to-child HIV transmission by 50%
   and used only 300mg twice daily from the 36th week of pregnancy and 300mg every
   two hours during labour. This study offered hope to people in developing countries
   because the shorter course AZT was much cheaper and could be incorporated into
   the prevention programmes of these countries.

5. The results of the HIVNET 012 study on Nevirapine (NVP) in July 1999 showed that
   a single 200mg tablet given to mothers in labour, followed by a single 2mg oral
   suspension to the newborns within 72 hours of delivery demonstrated similar results
   to short-course AZT. The Sunday Independent reported that ―nevirapine cost
   around $4 (about R25) a dose but would cost R35 in South Africa, the manufacturer
   has said. This compares with around R400 for a short-course treatment of AZT—
   the discounted price offered by …AZT manufacturer Glaxo Wellcome—begun in the
   last three weeks of pregnancy.‖

6. In this article, Morna Cornell director of the AIDS Consortium and then a TAC
   executive member said that ―recent meetings with Tshabalala-Msimang have shown
   that the department‘s top priority is women and children‖. She continued:‖so I would
   think they would regard this as a really key issue‖. ―I just hope that we can now
   quickly see if this is applicable here. It certainly does seem to represent an
   unbelievable opportunity for our country to save lives.‖

7. In 1999/2000, 1306 pregnant women with HIV/AIDS participated in the South
   African Intrapartum Nevirapine Trial (SAINT study). The women were assigned to
   two arms comparing 200mg NVP during labour and one dose to mother and infant
   24-48 hours after delivery with zidovudine (AZT) and lamivudine (3TC) during labour
                                            3


   and for one week after birth to mother and newborn infant. The SAINT study
   demonstrated that HIV transmission from mother-to-child during birth could be
   reduced by more than 50%. This also confirmed the safety and efficacy of the
   HIVNET 012 Uganda NVP study.

8. However, the follow-up to HIVNET 012 showed that there may be a problem with
   resistance in a minority of women who take single dose of NVP. This resistance did
   not undermine the efficacy or safety profile of NVP for reducing mtct in the majority
   of women with HIV/AIDS. The follow-up sample was also not statistically significant
   and many more years of study would be required to gain an accurate resistance
   profile. In addition, there was no evidence that NVP negatively affected the health
   of the mother after a single or double dose.

9. Most significantly, the SAINT study confirmed that the drug costs for NVP would be
   less than R30.00 per woman and child. Since then, the manufacturer has offered
   the drug at no cost to government.

ADDITIONAL CLINICAL AND SCIENTIFIC INDICATORS
WOMEN’S HEALTH
10. Several studies have indicated that pregnant women with HIV/AIDS are more
    susceptible to opportunistic infections such as bacterial pneumonia, urinary tract
    infections and tuberculosis than women without HIV/AIDS. Therefore, testing,
    counselling and offering women options related to their pregnancy and following
    their personal health is crucial to public health interests. Because pregnant women
    are not universally counselled about the effect of HIV on their reproductive choices,
    they cannot make effective personal health choices.

BREASTFEEDING
11. HIV can also be transmitted through breastmilk. Therefore, breastfeeding is
   regarded as a risk to a newly born infant. In the scientific community, the majority of
   paediatricians advise women with HIV who have access to alternative feeding NOT
   to breastfeed. Alternative feeding includes formula feed. However, where there is no
   alternative to breastfeeding because of costs or lack of clean water, everyone
   agrees that women should continue to exclusively breastfeed. In this context
   women should be advised about safer breastfeeding methods including avoiding
   infections and treating them. This applies to women and their infants. Currently,
   women with HIV/AIDS are not made aware of the risk of breastfeeding their children,
   and are not given the alternatives to breastfeeding by the government except in
   isolated cases where provincial governments (Western Cape, Gauteng, KwaZulu-
   Natal) have dared to oppose the national Minister’s directives. The Ministry of
   Health has been aware of these issues for years and the failure to advise all women
   of these risks and options on a national scale is negligent.

12. Since 1996, the Joint United Nations Programmes on HIV/AIDS (UNAIDS) advised
    that women with HIV/AIDS in resource-poor areas be encouraged to make an
    informed choice about infant feeding by weighing risks and benefits.
                                             4




MODE OF DELIVERY
13. For many women with HIV/AIDS whose general health is regarded as good, and
   whose access to above average obstetric and health care facilities is guaranteed,
   clinicians have recommended ceasarean modes of delivery because under these
   conditions caesarean births reduce HIV transmission from mother to child.
   Caesarean modes of delivery are very expensive and they can lead to complications
   for poorer women whose access to obstetric care is limited.

NUTRITION
14. TAC is also advised that nutritional deficiencies may increase the risk of mother-to-
   child HIV transmission. Nutritional counselling and public education for poor women
   of reproductive age could assist in reducing risks of transmission through
   supplementing their diet with micronutrients. The Ministry of Health has been aware
   of this fact for many years and nothing should preclude it from having implemented a
   nutritional programme. Again, the Ministry has failed all women and in particular
   women with HIV/AIDS.

COUNSELLING AND SUPPORT
15. Programmes that aim to reduce mother-to-child HIV transmission will use voluntary
   counselling as an instrument to gain informed consent for testing from women.
   Experts are agreed that such counselling has inestimable value in educating women
   (both HIV negative and positive) of their options. They may also assist in preventing
   further HIV transmission by promoting safer sex practices and the education of the
   sexual partners of women. Most importantly, counselling can provide women with
   HIV/AIDS the opportunity to learn about treatment, care and support options. Again,
   Ministerial and government neglect of their constitutional duties have failed women
   and children.

ANTENATAL SURVEYS
16. The Health Department under the executive control of the Minister of Health has
    conducted annual ante-natal surveys at clinics across the country in October 2000
    that show a 24.5% (1999 = 22.4%) national prevalence rate among women
    attending antenatal clinics in the public health services in South Africa. Information
    from this survey projects that there are approximately 4.68 million (1999 = 4.2
    million) people in South Africa living with HIV/AIDS.

17. The HIV/AIDS & STD Strategic Plan for South Africa 2000-2005 (―Strategic Plan‖)
    compiled by the Government’s suggests that:
         The HIV epidemic in South Africa is one of the fastest growing epidemics in
           the world
         Young women aged 20-30 have the highest prevalence rates
    Young women under the age of 20 had the highest percentage increase compared
    to other age groups in 1998 compared to 1997. This changed in the 1999 and 2000
    ante-natal surveys but it is too soon to draw conclusions on its permanence as a
    trend.
                                            5




18. TAC submit that in the light of the evidence presented by the government’s Strategic
    Plan alone, the importance and urgency to implement an MTCT prevention
    programme for women of reproductive age cannot be over-estimated. This
    evidence, known for some time, motivated TAC’s responses and engagement with
    the Ministry and Department of Health and broader government over the last 18
    months.

COSTS OF IMPLEMENTING MTCT PROGRAMMES
19. On 26 March 1999, Dr Malcolm Steinberg and Dr. Anthony Kinghorn of Abt
    Associates SA Inc. wrote extensively in Business Day on the economics of providing
    short-course AZT for pregnant women with HIV/AIDS. They argue: ―Unusually for a
    country in which few health care decisions have been based on clear economic
    criteria, the economics of mother-to-child transmission interventions in SA have
    been quite extensively investigated.‖… They concluded that ―Evidence strongly
    suggests that these programmes, while involving substantial cost, represent good
    value for meony in both the private and public health-care sectors.‖

20. In 1998, Neil Soderlund, Karen Zwi, Anthony Kinghorn and Glenda Gray prepared a
   paper which demonstrated that short-course AZT and formula feed is not only cost-
   effective (less than US$100/per life year) but potentially also cost-saving (less than
   US$0. per life-year saved). Critically, the authors argue that an intervention that
   included counselling, testing, anti-retroviral medication and formula feed would cost
   the government less than 1% of the health budget. Such a programme according to
   the authors would avert most deaths and save costs.

21. In January 1999, the Medical Research Council released a costing study by
    Professor David Wilkinson, Ms Katherine Floyd and Dr. Charles F. Gilks on
    preventing mother-to-child HIV transmission that was summarised as follows:

          An estimated 64 398 paediatric HIV infections occurred from mother-to-child
       transmission in South Africa in 1997. This represents 11% of the estimated
       global total of new infections.
          This study suggests that approximately 37% infections from mother to child
       might be prevented through a national programme which includes short course
       zidovudine, infant milk formula and counselling
          The estimated total cost of the national programme would be R160.54 million
       and is less than 1% of the national health budget or R3.73 per capita
          Therefore the study concludes that a national programme to reduce mother-
       to-child transmission of HIV infection in SA would be an affordable, cost-effective
       and potentially cost-saving public health intervention

22. The study concludes that a national programme to reduce mother-to-child
    transmission of HIV infection in SA would be an affordable, cost-effective and
    potentially cost-saving public health intervention.
                                             6


23. Last year, TAC became aware that the Ministry had commisioned its own costing
   study. This study completed in April 2000 showed that a country-wide programme of
   Nevirapine provision for mtct would potentially save 14 000 babies from acquiring
   HIV at a cost of R87.5 million per year. According to the Hensher study short-course
   AZT would cost R124.8 million. This study emphasised that the government’s
   counselling and testing policy could readily be combined with mtct interventions to
   ensure cost-effectiveness and better access.

24. TAC has also done a study that gives similar results to the above studies. A
    summary of the results of some of this research is shown in the following table. The
    TAC study by Nathan Geffen is attached.




                 Researcher        Cost      Cost/DALY      Preventions
                 Wilkinson (AZT)   R156M     213            23,000
                 Marseille (NVP)   R122M     304            11000-23,000
                 DOH (AZT)         R130M     560            11000- 14000
                 TAC               R145M     344            19000-23000
                 (NVP)

GOVERNMENT RESPONSES
25. The Ministry and government policy on reducing mother-to-child HIV transmission
    has been characterised by a lack of scientific, economic or ethical rigour. Since
    1998, the government and Ministry have at various times agreed to measures to
    reduce mtct, then stopped such measures and publicly contradicted scientific
    evidence. At times, the Ministry and government have argued that cost was the
    primary issue and when that argument ran out of steam, the ground shifted to
    discredited arguments on the lack of efficacy and the alleged super-toxicity of anti-
    retrovirals.

PLANNING AND SHELVING OF PILOT MTCT PROJECTS
26. On 19 February 1998, the same day as the announcement of the Thai results, the
   Gauteng Department of Health had a meeting at the Sizwe Tropical Diseases
   Hospital to plan pilot projects to implement short-course AZT for pregnant women
   with HIV/AIDS. This meeting formed a Task Team. On 9 April 1998, the Gauteng
   Task Team met to plan the implementation of short course AZT. Sites were
   proposed for the pilot projects and tasks allocated to various participants including
   Dr. Glenda Gray. The minutes of the meeting reflect that ―regional managers were
   given the task of talking to top managers of proposed areas about the pilot in order
   to ensure support and effective participation.‖ Over the next few months, training
   had commenced, final sites were selected and sources of funding were identified.
   TAC only has access to minutes for Gauteng proposed pilot projects to reduce mtct
                                            7


   of HIV but we are aware that other provinces were planning to implement pilot
   programmes as well. On 9 October 1998, then Minister of Health, Dr. Nkosazana
   Dlamini-Zuma withdrew support for the pilot projects and they were shelved. This
   was the same day on which the then Deputy-President, Thabo Mbeki announced the
   ―Partnership Against AIDS‖.

27. In January 1999, TAC learnt that the government’s Inter-Ministerial Committee
    supported the decision by Minister Zuma and all the provincial Health Ministers not
    to provide AZT to pregnant women. All these officals and Ministers were aware of
    the following facts since at least April 1998:
     The use of AZT was a safe and effective measure to reduce mother-to-child HIV
        transmission
     The low-cost of a global programme that would include all pregnant women in the
        public sector
     The cost of such a programme included ―the cost of the drug, counselling, HIV
        testing and the cost of milk substitutes for a period of at least six months.‖ The
        summary from minutes of the Inter-Ministerial Committee on HIV/AIDS reads as
        follows:

      2 ― Summary
      2.1     HIV can be transmitted from an infected mother to child. Therapeutic
          interventions being used in the developed world to reduce HIV transmission
          from mother to child had been too costly for under-resourced developing
          countries. A CDC (Centers for Disease Control) – sponsored trial in Thailand,
          results of which were published in March 1998, indicated that a short-course
          regimen with the anti-retroviral drug zidovudine (also known as AZT) during
          the last four weeks of pregnancy has the potential of decreasing the
          transmission from mother-to-child by 51%. A global meeting called by
          UNAIDS and WHO in March 1998 described this intervention as akin to
          ―vaccinating the children of HIV infected mothers‖.

      2.2 A costing study conducted by HIV Management Sevices (Pty) Ltd
          entitled ―Projections of Costs of Anti-retroviral Interventions to Reduce
          Mother-to-Child Transmission of HIV in the South African Public
          Sector‖ released for comment in April 1998, indicates that access by
          all pregnant women to this regimen will consume 0,4% of the current
          health budget, approximately R80 million. This costing incorporates
          the cost of the drug, counselling, HIV testing and the cost of milk
          substitutes for a period of six months.

      2.3 Based on the cost estimates and the limited health budget available,
          with the provincial health departments experiencing financial
          difficulties in providing basic health services, the Health MINMEC took
          a decision on 2 October 1998 not to introduce the AZT regimen at this
          point of time. However, this decision will be continuously evaluated as
          new scientific information on cost-effective interventions appropriate to
                                             8


          our situation in South Africa becomes available including findings from
          the on-going PETRA (Perinatal Transmission) studies which are being
          conducted at the Chris Hani Baragwanath and King Edward Hospitals.
          In the interim, the emphasis will continue to be on preventing HIV
          infection in the first place through focussed programmes aimed at
          young and sexually active people.‖ [END of Summary]

28. From these minutes it is evident that the Ministers and officials had not applied their
   minds in good faith and with rigourous analysis to the real costs of the programme or
   the costs of not providing treatment, nor had they sought alternative sources of
   funding. They also failed to consider giving women the options of seeking means to
   fund such measures from their own sources. In fact, The Sunday Times reported on
   28 February 1999 that ―The Health Department announced it had underspent by
   R90 million and would use that money to introduce the haemophilus influenzae, or
   HIB, vaccine which prevents meningitis in children.‖ TAC welcomes the introduction
   of such a vaccine programme but queries the inconsistent approach to
   implementation of national programmes to prevent disease in children. We have no
   knowledge of any economic feasibility or cost-effective study conducted prior to the
   introduction of the HIB vaccine. It may be that the government used the
   constitutional yardstick of the best interests of the child being paramount in all
   decisions affecting children, but then, this approach is not evident in their approach
   to the prevention of mother-to-child HIV transmission. The Ministry and
   government’s costs arguments are often based on bald allegations and assumptions
   not rigorous analysis or evidence.

29. On 4 January 1999, TAC learnt that the Western Cape Health Department decided
   to go ahead with a short-course AZT pilot project to reduce mother-to-child HIV
   transmission in Khayelitsha. The Cape Times reported that: ―The project was
   conceptualised under the former MEC for Health, Ebrahim Rasool, a member of the
   ANC and survived the transition to the [then] current incumbent, Peter Marais of the
   National Party. It also survived Minister of Health Nkosazana Zuma’s recent
   announcement that all AZT projects would be cancelled because of a lack of funds‖.
   This action by the Western Cape Health Department contradicts the blanket
   assertion in the Inter-Ministerial Committee on HIV/AIDS minutes that ―provincial
   health departments [were] experiencing financial difficulties‖.

AIDS LAW PROJECT AND AIDS CONSORTIUM RESPONSES
30. The AIDS Law Project and the AIDS Consortium are both endorsing members and
    partners of TAC. Over the years, they have engaged government and civil society to
    promote the equal rights of people with HIV/AIDS. The ALP and Consortium have
    been at the forefront of advocacy and educational work on reducing mtct with TAC.

31. Many people who are now TAC members attended a workshop convened by the
    AIDS Law Project in July 1997 on ―The Rights of Pregnant Women in the Context of
    HIV. The seminar was attended by AIDS organisations, health care workers and a
    range of civil society organisations. The National Department of Health’s HIV/AIDS
                                              9


   and STD Directorate and the Gauteng Provincial Directorate were represented at the
   seminar. A committee of experts was formed to draft a Code of Best Practice on
   Pregnancy and HIV that included a representative of the Department of Health.

32. In October 1997, the AIDS Law Project published the Pregnancy and HIV:
    Recommended Code of Best Practice for comment. Recommendations included in
    section 6 on Medical and Therapeutic Interventions read as follows: ―Women
    should be informed of all available medical and therapeutic interventions for
    pregnant women living with HIV, including whether they are provided free of charge
    or not, costs and availability of such interventions, the efficacy of such interventions,
    and the advantages and disadvantages of such interventions. Interventions should
    be concerned with the well-being of the woman’s own health and that of her
    offspring. … A woman should be given information on and the option of undergoing
    antiretroviral therapy. She should be accurately informed of the rates of success;
    the level of compliance required; and the potential side-effects for both herself and
    the fetus (known and unknown, including the possibility of drug resistance
    developing and the lack of efficacy in future pregnancies and for one’s own
    treatment.‖ TAC has endorsed these Guidelines.

33. Following the cancellation of the pilot programmes, Morna Cornell, director of the
   AIDS Consortium accompanied by Professor James McIntyre, Mercy Makhalemele
   and Mary Crewe met with representatives of the Ministry and Department of Health.
   They included Director-General Dr. Ayanda Ntsaluba, Dr. Glaudine Mtshali Chief
   Director: National Programmes and Dr. Eddie Mhlangu Director: Maternal and Child
   Health and Dr. H. Pretorius to discuss the cancellation of the pilot mother-to-child-
   transmission programme.

34. James McIntyre provided a briefing on the safety, efficacy and costs of the different
   AZT regimens used to reduce mtct. Dr. Mahlangu was reminded of his statement
   after the announcement of the Thai Study that ―We won’t let the grass grow under
   our feet. We will look at ways of urgently implementing these results in a local
   setting.‖ The meeting agreed to review all the evidence and to establish a better
   relationship between NGOs and the government.

35. On 24 November 1998, Morna Cornell reported that the AIDS Consortium had sent
   another letter to then Deputy-President Mbeki on the basis of the decision by the
   Inter-Ministerial Committee on HIV/AIDS not to proceed with the pilot projects to
   provide short-course AZT and formula feed. No reply was received.

TREATMENT ACTION CAMPAIGN: PUBLIC MOBILISATION
36. TAC decided that a campaign of public awareness and mobilisation was essential to
   win pregnant women the right to anti-retroviral medication to reduce mother-to-child
   HIV transmission. Since its inception, TAC has relied on the democratic process to
   inform the broader public and civil society on:
    the scientific facts regarding mtct
    the constitutional duties of the government and
                                           10


      the need for public support for HIV/AIDS prevention and treatment

37. On 10 December 1998, the Treatment Action Campaign (TAC) was founded with
   a day long fast at St.George’s Cathedral in Cape Town by more than 20 individuals.
   According to the press statement: TAC aims to ―draw attention to the unnecessary
   suffering and AIDS-related deaths of thousands of people in Africa, Asia and South
   America. These human rights violations are the result of poverty and the
   unaffordability of HIV/AIDS treatment. ―The Treatment Action Campaign calls on the
   Minister of Health, Dr. Zuma and Trevor Manuel, the Minister of Finance to meet
   immediately with the National Association of Persons Living with HIV/AIDS
   (NAPWA) and HIV/AIDS NGOs to plan for resources to introduce free AZT for
   pregnant mothers with HIV/AIDS.

38. The statement continued: ―TAC also calls on the government to develop a
    comprehensive and affordable treatment plan for all people living with HIV/AIDS. ―
    More than 1000 signatures were collected in support of the TAC demands at the
    fast.

39. On 11 December 1999, The Cape Times ran the following report by writer Judith
    Soal: ―HIV Treatment: A human rights struggle‖. ―Yesterday was International
    Human Rights Day, the 50th anniversary of the signing of the Universal Declaration
    of Human Rights. Protests in the city gave an indication of where the new struggles
    are.

   ―Poole, a medical student, was one of ten people who spent International Human
   Rights Day fasting and collecting signatures to call on Health Minister Nkosazana
   Zuma to provide anti AIDS drugs to pregnant women with HIV. ―Poole first
   encountered the disease and discrimination against those who have it while working
   at community health centres as part of his medical training.

   ―I soon realised that this is one of the most contentious human rights issues of our
   time,‖ he said. ―We know that a short course of AZT reduces the likelihood that a
   mother will pass the virus to her child from about 30% to between five and 10%, yet
   the government refuses to adopt the programme.‖ ―The argument that they can‘t
   afford it is full of loopholes because there have been many economic studies that
   show it would be cheaper than caring for the children who develop the disease.‖
   [Extract Ends]

40. Also 11 December 1998, The Cape Argus reported former human rights
    commisioner, Dr Rhoda Kadalie’s presence at the fast. She stated: ―Giving AZT to
    pregnant women to prevent them passing an HIV infection to their babies is a human
    rights issue.‖ Kadalie continued: ―Women‘s rights are a priority. I‘m tired of
    generalised notions of human rights: we have concrete ways to attend to issues that
    affect people with HIV and I don‘t see why we‘re spending billions on arms‖. The
    TAC press statement on 9 December 1998 also called for a fast on Human Rights
    Day 21 March 1999 to ―pressure the government and the pharmaceutical sector to
                                           11


   seriously address the need for equitable and affordable access to treatment and
   care for all people with HIV/AIDS‖.

41. Over the next two years, TAC arranged the following activities:
     Public signature collections in support of AZT and formula feed for pregnant
      women. These took place through civil society organisations and collections at
      public venues such as stations, taxi ranks and shopping centres.
     T-shirts emblazoned with the words: ―HIV-Positive‖ were used to create a climate
      of openness and awareness;
     Distribution of leaflets and newsletters;
     Newspaper articles;
     Advertising at public events;
     On 21 March 1999 fasts and rallies in the East Rand Cape Town, Durban and
      Soweto were held in support of TAC demands for AZT for pregnant women with
      HIV and affordable treatment for all people with HIV/AIDS. The Cape Town fast
      at St. George’s Catheral attracted at least 200 people. They were addressed by
      Gender Commissioner Farid Esack and the ANC’s national health committee
      secretary—Dr. Saadiq Kariem. In Soweto more than 500 people representing
      trade unions, religious bodies, AIDS organisations, the South African Communist
      Party, the National Coalition for Gay and Lesbian Equality gathered outside Chris
      Hani Baragwanath Hospital where they were addressed by Mark Heywood of the
      AIDS Law Project, Zackie Achmat (NCGLE), Dr. Glenda Gray of Baragwanath,
      Bishop Paul Verryn of the Methodist Church, Ms Florence Ngobeni. (NAPWA)
      and Gauteng Provincial Health Department’s Dr. Liz Floyd –Director of HIV/AIDS,
      STDs and Infectious Diseases. On the East Rand more than 120 people
      participated in a community march and fast—AIDS Consortium Director, Morna
      Cornell participated in the event.
     Letters to Members of Parliament 5 February 1999 and 4 February 2000
     Workshops for its members including 4 provincial workshops and a national
      workshop between August 2000 and March 2001 on MTCT.
     Briefings for trade unions, children’s rights organisations, AIDS organisations and
      other civil society bodies.
     Treatment literacy programmes for people with HIV/AIDS and those affected by
      the epidemic.
     10 000 Posters calling on President Mbeki to make AZT/Nevirapine available to
      pregnant mothers with HIV/AIDS were distributed across the country. In addition,
      an advert on the poster was reproduced in the weekly newspaper, the Mail and
      Guardian.
     In November 2000, more than 200 TAC members demonstrated outside the
      Department of Health offices in Pretoria. The Chief Director for HIV/AIDS and
      STDs, Dr. Nono Simelela accepted a memorandum demanding that a national
      MTCT prevention programme be implemented.
     On 12 February 2001 more than 1500 people marched on parliament and
      delivered a memorandum from TAC addressed to the President and yourself to
      Dr. Abe Nkomo MP, chairperson of the Portfolio Committee on Health asking
      among other issues that an mtct prevention programme be implemented.
                                            12


      This call was reiterated at the TAC national conference attended by more than
       169 organisations and 500 delegates on 18-20 March 2001.
      TAC was in the forefront of civil society mobilisation in South Africa and
       internationally to support the government against the drug companies. We were
       also admitted as an amicus curiae in the court case. This shows our support for
       policy actions that are in the interest of poor people and constitutional.

42. Between April 1999 and August 2000, TAC continued to pressurise Glaxo
   Wellcome, the company that holds the patent for zidovudine (AZT) in South Africa.
   Several demonstrations were organised outside the offices of the company while
   TAC members addressed corespondence to and met with executives of the
   company. Over the same period, Glaxo Wellcome reduced the price of AZT to the
   government from R450 per treatment for mtct in the public sector to approximately
   R230 per treatment in the public sector. AZT is already on tender to the health
   department for use in needlestick injuries involving health care workers and patients
   with HIV/AIDS. When the company proposed to merge with SmithKline Beecham,
   TAC opposed the merger or asked that it be made conditional on the grounds that
   generic versions of the drug are much cheaper.

43. In any event, TAC submits that generic versions of AZT from Brazil, Thailand and
    India are available and if the costs of the drug are too high, the Minister must use
    her powers in terms of the Patents Act (No 57 of 1978) to negotiate a voluntary
    licence or to apply for a compulsory licence from Glaxo Wellcome.

44. From February 2000, TAC in association with Health-GAP Coalition, a US based
    alliance of organisations campaigning for HIV/AIDS treatment, organised a
    Global March for Treatment Access at the opening of the International AIDS
    Conference in Durban on 9 July 2000. Access to anti-retrovirals for pregnant
    women to reduce mtct was a central demand of the Global Call for Access to
    HIV/AIDS Treatments. More than 250 organisations worldwide endorsed the call
    and its demands. TAC distributed 20 000 copies of the call around the country.
    The Global Call included a demand on women’s rights:
   WOMEN WITH HIV/AIDS HAVE AN EQUAL RIGHT TO TREATMENT
   Denial of treatment for HIV/AIDS affect women disproportionately because of
   social, political and economic inequality.

      All women with HIV/AIDS have an equal right to treatment, care and support.
      All women have a right to anti-retroviral access to reduce HIV transmission
       during pregnancy.
      All women and other rape survivors have the right to be informed that anti-
       retrovirals may reduce the risk of HIV infection if they are taken within 72 hours
       of being raped.
      All rape survivors have the right to anti-retroviral access within this time-frame.
                                          13


45. On 9 July 2000, TAC also held a satellite conference with Nobel Peace Prize
   winners Medicins Sans Frontieres—MSF (Doctors Without Borders) attended by
   more than 1500 people on access to HIV/AIDS drugs in developing countries. The
   Conference endorsed the need for an mtct prevention programme and MSF
   endorsed the Global March. This meeting was opened by Professor Malegapuru
   William Makgoba. Among all the speakers who endorsed the call for an mtct
   prevention programme was Dr. Farid Abdullah (former chairperson of the Woodstock
   ANC branch and longtime ANC activist) of the Western Cape Health Department
   who supervised the Khayelitsha mtct pilot project. Dr. Abdullah explained that the
   programme was working and would be extended on the basis of the lessons learnt
   from the pilot project.

46. On 9 July 2000, more than 6000 people from across South Africa and many
   international visitors participated in the Global March for HIV/AIDS Treatments.
   They were addressed by speakers including, the Archbishop of Cape Town, The
   Very Reverend Njongonkulu Ndungane, Bishop Emiritus of the Roman Catholic
   Church, Archbishop Dennis Hurley, Ms Patricia de Lille Member of Parliament (Pan
   Africanist Congress), Mrs. Nomzamo Winnie Madikizela-Mandela Member of
   Parliament and President of the ANC Women’s League and Ms Joyce Phekane
   Deputy-President of Cosatu. All the speakers endorsed the demand for AZT or
   Nevirapine for pregnant women.

47. At the end of the March, the Minister of Health in the presence of Professor Hoosen
   (Jerry) Coovadia, chairperson of the XIII International AIDS Conference, and, Dr.
   Peter Piot, Head of the Joint Programme on HIV/AIDS of the United Nations
   (UNAIDS) accepted a memorandum from TAC. The appropriate section of the
   Memorandum read as follows:

   ―We would like to address specific proposals to each of the parties we have called
   here today:
   TO THE SOUTH AFRICAN GOVERNMENT
   ―The South African Government has a unique potential to right the wrongs and
   inequalities that exist around AIDS. Not only is South Africa the worst affected
   country in the world, but you have the moral legitimacy that has accrued to a nation
   that has risen peacefully from apartheid, under the leadership of former President
   Nelson Mandela. In your own words, AIDS is a "new struggle". In the words of the
   Organisation of African Unity¹s recently signed Ouagadougou Commitment (May
   2000) "health constitutes a right and a foundation for socio-economic development,"
   whereas the AIDS epidemic is a major "public health, development and security
   problem for Africa."
   “We call on the SA Government to:
    Immediately implement a country-wide program to reduce the risk of mother-to-
      child transmission of HIV using AZT or neviripine.
    Immediately accept and implement currently offered drug donation programs
      provided there are no strings attached.
                                           14


      Immediately issue a compulsory license for fluconazole. This drug could be
       immediately imported from the lowest-priced producers to extend the lives and
       improve the quality of life of people with HIV.
      Call on other developing countries to do likewise.
      Demonstrate leadership and integrity in the governance of its HIV/AIDS
       programs as a model for developing countries.
      Campaign for the appropriate and transparent use of public funds for public
       need, and especially for the development of health infrastructure. ―

TREATMENT ACTION CAMPAIGN: ACCORD WITH GOVERNMENT
48. During its campaign work, TAC met with the predecessor of the current Minister of
   Health, the now Chief-Director of the HIV/AIDS and STD programme, Dr. Nono
   Simelela and the current Minister of Health, Dr. Manto Tshabalala-Msimang. At
   every opportunity, TAC and its supporters drew attention to the government’s failure
   to address mtct prevention and the medical treatment of people with HIV/AIDS and
   offered to assist in ending the impasse.

49. On 30 April 1999, TAC and the then Minister of Health Dr. Nkosazana Zuma met.
    TAC’s delegation included Zackie Achmat, Peter Busse, Morna Cornell, Mercy
    Makhalemele, Adeline Mangcu, Phumi Mtewa and Colwyn Poole. The Ministry’s
    delegation included Health Minister, Dr Nkosazana Zuma, her advisors Mr.
    Khangelani Vincent Hlongwane and Dr Ian Roberts. TAC handed a written
    memorandum over to the Ministry setting out the history of the issue, drawing their
    attention to the scientific evidence and new costing studies.

50. The following extracts from TREATMENT ACTION CAMPAIGN (TAC)
    MEMORANDUM TO MINISTER OF HEALTH: DR. NKOSAZANA ZUMA
    summarises the context of the meeting and the subsequent agreement between the
    parties.


   Extract: WHAT CAN GOVERNMENT DO?
    TAC urges the Deputy President, Mr. Thabo Mbeki and the Minister of Health,
      Dr. Nkosazana Zuma to reinstate the pilot projects for AZT and formula feeding
      provision to pregnant women with HIV/AIDS, leading to national implementation.
    TAC urges the Deputy President and the Minister of Health to publicly express
      their support for these projects and for the intervention generally
    TAC urges the government to set a price for AZT and a price for milk formula
      which it can afford and to challenge the drug companies to meet this price
    TAC urges the government to convene a meeting with labour, employers, civil
      society, religious bodies to pressure Glaxo-Wellcome, other pharmaceutical
      companies and the producers of formula milk to make AZT, other medications
      and formula milk available at the lowest possible price to deal with the HIV/AIDS
      emergency in Southern Africa.
                                            15


   WHAT WILL THE NAPWA TAC DO?
    TAC will assist the government and any agency to mobilise public support and
     opinion to provide AZT for pregnant women.
    TAC will intensify its campaign for lower costs of drugs and formula feed, and join
     the growing body of international advocacy on compulsory licensing
    TAC will promote treatment literacy, openness and non-discrimination in our
     campaign to save our lives and that of our children.
    TAC will mobilise communities of people living with HIV/AIDS to play an active
     role in building an affordable and quality health care system for all people in
     South Africa. Extract ENDS

51. The memorandum set out TAC’s demands and formed the basis for discussions with
    the Ministry. The discussions lasted more than two hours. Following a productive
    meeting, the parties drafted a joint statement that was released to the press and that
    constituted an agreement between the parties. Below is a joint statement issued
    by the Minister of Health and the Treatment Action Campaign on Friday 30th
    April 1999:

   1. The Minister of Health, Dr. Nkosazana Zuma and a delegation from the NAPWA
      Treatment Action Campaign agreed that affordable treatment for HIV/AIDS and
      all medical conditions is a basic human right.

   2. The Minister assured the Treatment Action Campaign that government would
      name an affordable price for the implementation of AZT to pregnant mothers and
      report within six weeks on the price and other issues pertaining to the prevention
      of mother-to-child transmission.

   3. The Minister of Health calls on business, labour, religious bodies, women's
      organisations and all sectors of civil society to pressurise Glaxo Wellcome and all
      pharmaceutical companies to unconditionally lower the price of all HIV/AIDS
      medications to an affordable price for poor people and countries. The
      Treatment Action Campaign agrees with the Minister that pressure on the drug
      companies and the producers of formula feed such as Nestle is a key objective of
      all civil society bodies.

   4. The next meeting between the TAC and the Minister of Health is scheduled
      for mid-June 1999.

52. Media reports over the next few weeks reiterated the statements that the excessive
   price of AZT was the only obstacle that prevented the Government’s’ implementing
   mtct prevention programmes. Statements were made by the Ministry of Health and
   the office of the then Deputy President Thabo Mbeki that the only obstacle was
   price.

53. On 9 May 1999, The Sunday Times reported that South Africa’s biggest hospital,
    Chris Hani Baragwanath in Soweto, would implement an AZT mtct trial based on a
                                           16


   donation from UNAIDS with the support of the First Respondent. The article stated,
   ‗Speaking on behalf of Zuma, Khangelani Hlongwane said: ―We did not stop anyone
   from making those donations … We do not dispute the studies or the economics, we
   dispute the price that AZT is simply unaffordable. We are continuing to negotiate
   with the manufacturer, Glaxo Wellcome.‖‘

54. On 10 May 1999, the Cape Times carried an editorial that demonstrates the shift in
   public opinion and the stance of the government until then. Over the next four
   months, government spokespersons repeatedly stated that drug costs were the only
   problem.

55. On 18 July 1999, the results of HIVNET 012 and the feasibility of Nevirapine as an
    option became available. (Discussed above) During that period the SAINT studies
    were undertaken at various sites in South Africa.

56. On the 1 August 1999, TAC held an inter-faith service in St. George’s Cathedral in
    Cape Town. The new Minister of Health was invited but sent a representative Ms.
    Lynn Brown MPL because she was visiting Uganda where she would meet with the
    researchers on HIVNET 012. The Cape Town newspapers reported the service:
    The Cape Times reported on the interfaith service organised by TAC on 1 August
    1999. Extracts from the article: ―Yesterday’s service was organised by the Treatment
    Action Campaign, a group formed to campaign for treatment for people with HIV. Its
    supporters include religious leaders, Cosatu, the Black Sash, the Union of Jewish
    Women and the New Women’s Movement. …―We can no longer silently witness the
    hardships and deaths caused by AIDS,‖ a resolution read. ―We say the government
    has a duty to provide moral and political leadership as well as financial support to
    end the HIV/AIDS pandemic.‖

57. The Cape Argus also reported on the inter-faith service organised by TAC on 1
    August 1999. Extracts from the article: ―Western Cape Religious leaders are
    supporting calls for the Government to provide affordable drugs to curb mother-to-
    child transmission of HIV. … The action group was lobbying AZT subsidised to
    reduce the price from R400 to R260. Government representative, Lynne Brown,
    speaking on behalf of the Minister of Health, Manto Tshabalala-Msimang said cost
    was the major problem in the treatment of HIV and AIDS.‖ Extract ends

58. Following the general election June 1999, TAC directed several requests to meet
   with the new Minister of Health. The meeting was granted on 29 September 1999.
   The Ministry and Department were represented by Minister Mantho Tshabalala-
   Msimang, Director-General Ayanda Ntsaluba, Dr Ian Roberts (Special Advisor to
   Minister) and HIV/AIDS and STD Directorate—[Celicia Serenata attended on behalf
   of Dr. Simelela] (Apologies: Dr. Nono Simelela). The First Applicant was represented
   by Zackie Achmat, Bart Cox, Mark Heywood, Mazibuko Jara, Lydia Masemola,
   Lucky Mazibuko and Phumi Mtetwa.
                                             17


59. The Minister of Health Dr Manto Tshabalala-Msimang emphasised that the
    government was committed to implementing a programme on mtct but their main
    concern was cost, sustainability and unrealistic expectations. All government
    representatives indicated the affordability of the Nevirapine options but needed
    further scientific evidence of safety and efficacy. These they hoped would be
    provided by the SAINT trials. The Minister of Health reiterated her full support for
    the clinical trials on Neveirapine.

60. TAC stated that government support and leadership was essential to implement a
    programme and that they would not pursue action against the Ministry.. Instead, they
    beilieved that the Minister would act in good faith on the SAINT studies which were
    ethen xpected in March 2000. The Minister of Health promised to make a time-table
    on implementation available once the studies were available.

61. TAC also stated that it did not believe that short course AZT was unaffordable but
    given the very low cost of Nevirapine, it would give the Minister the benefit of the
    doubt. However, were Nevirapine not to show the desired scientific results, TAC
    would expect the government to announce a phased-implementation plan of short-
    course AZT.


62. On 28 October 1999, President Thabo Mbeki told the National Council of the
    Provinces that AZT was a toxic drug and should not be used in the public sector.
    This dramatically altered and crippled the course of government policy. Government
    justification for not providing anti-retrovirals to reduce mother-to-child transmission
    shifted from cost to the so-called ―danger to health‖ argument.

63. On 16 November 1999, the Minister of Health Dr. Manto Tshabalala-Msimang made
    a statement to the National Assembly ―On HIV/AIDS and Related Issues‖. The
    statement focused on the ―toxicity‖ of AZT as a reason for refusing to provide this
    drug to pregnant women. In addition, it focused on the most expensive ―triple
    therapy‖ as the only option available to people with HIV/AIDS. The Minister stated
    that

   ―We simply cannot afford AZT. At current market prices the cost of triple therapy
   drugs alone, for the treatment of four million South Africans, would be 10 times the
   total South African health-care budget, and 140 times what we spend on
   pharmacueticals in the public sector. Let me show you what I mean. The triple
   therapy would cost about R6000 per person per month or R72 000 per person per
   year. If we multiply this by 4 million people, we reach a figure of R288 billion, per
   year. The total health budget for South africa for this year is R22 billion.

   So, before we can even begin to consider the appropriateness of the drugs, we fall
   at the hurdle of affordability. Nevertheless, let us deal briefly here with the issue of
   appropriateness, for the sake of completeness.‖
                                            18


   ―Nevirapine was markedly more effective. Nevirapine was also safer, less expensive
   and more practical than AZT or any other drug tested so far, in preventing MTCT.
   Nevertheless, Nevirapine is still not registered in Uganda for mass administration for
   the prevention of MTCT.

   ―In terms of affordability, the cost of the short course of AZT, as given in the Thai
   study that showed a 50% reduction in transmission, would be approximately R400
   per mother. The cost of Nevirapine, by comparison, would be aproximately R30 per
   mother and child.

   ―This will mean that many countries that could not adopt drug strategies that
   involved AZT, because of the cost, could now adopt a strategy with Nevirapine,that
   could lower the rate of MTCT.

   Comparative studies are currently underway in South Africa to look at Nevirapine as
   compared to the short course in AZT (the Thai trial) and the short course in AZT plus
   3TC (the PETRA Trial). The findings of these cost –effectiveness studies are
   expected in March 2000. They will provide critical information for policy making
   around MTCT of HIV in South Africa.‖

64. On 10 December 1999 the Minister published a proposed policy on HIV testing in
    terms of the National Policy for Health Act 116 of 1990. The policy provides for
    voluntary testing and pre and post-test counselling. TAC pointed out the policy’s
    failure to provide for the special needs of pregnant women to appropriate counselling
    regarding their options.

65. On 11 January 2000 a letter was sent to the Minister of Health by the Legal
    Resources Centre, on behalf of TAC, asking the Minister of Health to respond to the
    following questions:
    1. Whether the Minister of Health and the Government have decided on a policy in
        respect of the provision of voluntary HIV tests for pregnant women?
    2. If there is such a policy, a copy is required;
    3. If there is no such policy, when will it be determined?
    4. Whether the Minister and the Government have decided on a policy for the
        provision of anti-retroviral medication to HIV positive pregnant women to reduce
        mother-child transmission of HIV?
    5. If the answer is yes, when will such medication be made available to pregnant
        women?
    6. If the answer to is no, full reasons for the decision are required.

66. To date, there has been no rational, ethical or scientific reply from government on a
   national programme.

67. On 9 February 2000 The Star reported that ―Health Minister Manto Tshabalala-
    Msimang said yesterday that she rejected two reports from the Medicines Control
    Council on the toxicity of AZT because she did not find them satisfactory.‖ The
                                            19


   report of the MCC was eventually accepted and there is no scientific argument
   against the use of short-course AZT. The discredited viewpoint of Duesberg,
   Mhlongo, Gecsheckter and a host of crack-pots is a smoke-screen for neglect by
   government.

68. TAC maintained at this stage that the decision to deny anti-retroviral treatment to
    pregnant women was NOT taken ―in the light of the best available evidence and the
    special social and economic circumstances of our country‖.

69. On 3 March 2000, TAC, in a press statement, asked the Minister of Health to make
    available the evidence of any any scientific studies which proves that AZT is not
    cost-effective or that it has significant long term toxicity to mother and child when
    given to pregnant women in the last trimester of pregnancy. There was no response
    from the Minister of Health to this request.

70. On 5 April 2000 the Minister of Health made a speech in parliament on Nevirapine,
    in which she stated the following:
    ―Studies on the safety and efficacy of Nevirapinefor mother-to-child transmission in
    HIV-infected pregnant women, have alreaedy been conducted in Uganda. These
    studies have not yet been concluded with respect to long-term safety.

   ―In South Africa, a study known as SAINT is currently comparing Nevirapine with
   short course AZT and 3TC for safety and efficacy for mother to child transmission.
   We have been told by the scientists concerned that the results of this study will not
   be available until June/July of this year.

   ―The MCC has not yet registered Nevirapine in South Africa for paediatric use.
   Before we can reach a policy decision on the use of Nevirapine, we require the
   medicine to be registered, as well as the results of the SAINT study.

   ―It would be immoral and unethical for government, despite the numerous requests
   that we are receiving, and the demonstrations that have been staged, to attempt to
   make policy decisions regarding the issue of Nevirapine in our country, until the full
   results of the clinical trials of the drug are available.‖

71. The Minister of Health included in her speech an inaccurate report on the FTC 302
    clinical trial that suggested Nevirapine caused death in people who used the drug.
    This speech deliberately confused the use of Nevirapine as treatment on a daily
    basis for life with Nevirapine as a single dose ―prophylactic‖ to reduce mother-to-
    child transmission.

72. The researchers of the SAINT team released preliminary findings on the efficacy of
    Nevirapine to reduce mtct at the 13th International AIDS Conference in July 2000.
    These results showed that a single dose Nevirapine to mother and child reduced
    HIV transmission by 50%.
                                            20


73. The Ministry and Department of Health equivocated and said further studies were
    necessary to determine the effect of resistance to Nevirapine. Resistance affected a
    very small proportion in the Ugandan HIVNET 012 study. It became clear to TAC
    that elected representatives and certain officials were not interested in provision of
    anti-retrovirals to pregnant women, and were prepared to use any excuse to avoid
    implementing an mtct pogramme.

74. Condemnation from the world scientific community, the public outcry and a press
    conference threatening legal action by TAC led to a public reassessment by the
    Minister and her various supporters of their position.

75. On 12 and 13 August 2000, representatives of the Minister and government
    attended a Strategic Planning Meeting on HIV/AIDS in Benoni. A report was
    presented summarising the information presented on various issues, including mtct,
    at the 13th International AIDS Conference in Durban from 9 to 14 July 2000.
    Following the meeting, the Minister of Health made an announcement that
    Nevirapine could not be used outside approved research environments, and added
    that provinces were allowed to select two sites each for further research on
    Nevirapine. Mark Heywood, then deputy-chairperson of TAC was invited to attend
    part of the meeting.

   In a Cape Times report on 14 August 2000, the Minister of Health was quoted on
   this issue:

   ―We believe we should expand the research sites on Nevirapine to all the provinces,
   so that we can improve our understanding of the operational challenges that would
   attend the introduction of anti-retrovirals to prevent mother-to-child transmissions in
   the public health system‖

76. On 29 August 2000, the Western Cape Provincial Government announced that it
    would extend the Khayelitsha mother-to-child prevention project to ―five new sites‖.
    It was pointed out by Nic Koornhof, the Health MEC for the Western Cape
    government that they are ―not testing the efficacy of the drugs concerned, but rather
    extending a programme which has been implemented and proven over a period of
    20 months‖. Pitfalls such as lack of drug supplies have been identified and the
    statement boasts that they have been ―remedied‖.

77. TAC, in response to the statement by Koornhof, demanded that:
    1. All pregnant women who know that they have HIV should be provided with
       AZT/Nevirapine on request.
    2. The programme of anti-retroviral provision for pregnant women to prevent
       transmission to their children must be extended to all of the Western Cape with
       ―high-prevalence‖ areas prioritised for immediate implementation. Areas with
       lower prevalence should be phased into the programme over the next six
       months.
                                            21


   3. The Western Cape government must publicise treatment guidelines for people
      with HIV/AIDS immediately.
   4. Anti-retrovirals for rape survivors should be made available on request
      immediately.

78. The Western Cape government proposals for extension of the Khayelitsha project to
   five additional sites by April 2001 failed to address the urgency of the HIV crisis. It
   also fails to prioritise public expenditure appropriately and does not allocate the
   necessary resources to reduce and eventually eliminate mtct from within available
   provincial funds.

79. In any event, the Minister of Health and the governments of all the provinces could
    allocate emergency funds with the national government taking leadership and
    responsibility to assist provincial health departments with implementation of mtct
    programmes where these lack the capacity.

80. At the International AIDS Conference in July 2000, the Minister of Health re-affirmed
   the principles of the NACOSA National AIDS Plan (1994) in its Strategic Plan:
    People with HIV and AIDS shall be involved in all prevention, intervention and
       care strategies.
    People with HIV and AIDS, their partners, families and friends shall not suffer
       from any form of discrimination.
    The vulnerable position of women in society shall be addressed to ensure
       that they do not suffer discrimination, nor remain unable to take effective
       measures to prevent infection.
    Confidentiality and informed consent with regard to HIV testing and test results
       shall be protected.

81. The Department of Health requested the AIDS Law Project and Mark Heywood, in
   November 1999, specifically to convene a Human Rights Task Team to develop
   actions and recommendations necessary for the next five years and to be
   incorporated into the National AIDS Plan (2000-2005).

82. Participants in the Human Rights Task Team included the Department of Health
    HIV/AIDS Directorate; UNAIDS; ILO; UNICEF; Cosatu and Nactu; SA Business
    Council on AIDS; Eskom and SAFCOAL; the Anglican Church; AIDS Consortium;
    AIDS Law Project; AIDS Legal Network; and the Treatment Action Campaign.
    Various recommendations were made which was subsequently incorporated in the
    National AIDS Plan.

83. One of the key and immediate objectives identified by the Task Team read as
    follows: ―It is recommended that the phased implementation of parent-to-child
    transmission on the basis of Nevirapine be expedited and a plan be formulated
    immediately‖. This recommendation was not included in the National AIDS Plan.
                                            22


84. Between July 2000 and June 2001, the Health Ministry has at various times
   equivocated on and misrepresented the issues of mtct. Most recently, the Minister
   of Health changed the decision taken in August 2000 on pilot sites so-called
   ―research sites‖ and asked Cabinet to give final approval. Then, Western Cape,
   Gauteng and now Kwa-Zulu-Natal have moved ahead without Cabinet approval.
   The Minister gave a post-hoc reply allowing these authorities to go ahead.

POLICY AND LEGAL GROUNDS OF TAC DEMANDS ON MTCT
85. TAC advises the Minister of Health that she and the government are acting
   unlawfully and unconstitutionally on the following grounds.

86. In his address to parliament on 24 May 1994, after his inauguration as the first
    democratically elected President, Nelson Mandela set out a policy on children and
    pregnant women that remains government policy to this day: ―Children under the
    age of six and pregnant mothers will receive free medical care in every state hospital
    and clinic where such need exists.‖

87. The recently adopted Patients Rights Charter (―The Charter‖) of the Department of
   Health sets out several grounds on which women with HIV are entitled to
   information, counselling and treatment. The Charter states:
   Access to Healthcare
   Everyone has the right to access to health care services that include:
   i.
   ii.
   iii.   provision for special needs in the case of newborn infants, children,
          pregnant women, the aged, disabled persons, patients in pain, persons living
          with HIV or AIDS patients.
   iv.    Counselling without discrimination, coercion or violence on matters such as
          reproductive health, cancer or HIV/AIDS.
   v.
   vi.
   vii.   health information that includes the availibility of health services and how
          best to use such services and such information shall be in a language that is
          understood by the patient.

88. The Charter also has a policy on informed consent that mirrors the requirements of
    the Pregnancy and HIV: Recommended Code of Best Practice.

   ―Informed consent: Everyone has the right to be given full and accurate information
   about the nature of one’s illnesses, diagnostic procedures, proposed treatment, and
   the cost involved, for one to make a decision that affects anyone of these elements.‖

89. The Charter is binding on government as a public policy that requires pregnant
   women with HIV/AIDS to be given full information and counselling regarding all
   options including termination of pregnancy, anti-retroviral treatment to reduce mtct,
                                             23


   treatment for opportunistic infections, mode of delivery, breastfeeding and any other
   information that will impact on the health of the woman and her newborn infant.

ACCESS TO INFORMATION
90. The Government’s failure to provide information and counselling to women on HIV
    and the options related to pregnancy not only undermines informed consent but is a
    violation of the constitutional right to access to information required for the exercise
    and protection of their rights. This includes their right to decisions regarding
    reproductive choices, dignity, access to health care, and their newborn infants best
    interest. (Section 32(1)(b))

91. The Health Department officials are representatives of the state and they have had
    access to the information women need to reduce the risk mother-to-child-
    transmission of HIV for more than four years. Failure to make this information widely
    accessible in language than everyone will understand is a violation section 32(1)(a)
    of the Constitution.

REPRODUCTIVE CHOICES
92. The Government’s refusal to provide information, counselling, anti-retrovirals and
    formula feed to pregnant women with HIV/AIDS violates the right of women and men
    of reproductive age to make decisions concerning reproduction, as well as the right
    to control over their bodies. This is a breach of section 12(2) of the Constitution.

ACCESS TO HEALTH CARE SERVICES
93. The Government’s failure to provide information, counselling, anti-retrovirals and
    formula feed to pregnant women with HIV/AIDS violates the right to have access to
    health care services including reproductive health care (s27(1)).

CHILDREN’S RIGHT TO BASIC HEALTH CARE AND NUTRITION
94. The Government’s failure to provide information, counselling, anti-retrovirals and
    formula feed to pregnant women with HIV/AIDS violates a newborn infants rights to
    basic health care services and basic nutrition as set out in section 28 of the
    Constitution.

BEST INTERESTS OF THE CHILD
95. The Government’s failure to provide information, counselling, anti-retrovirals and
    formula feed to pregnant women with HIV/AIDS violates the constitutional right of
    newborn infants to have all decisions made in the ―best interest of the child‖ (section
    28).

EQUALITY
96. TAC believes that the refusal of the Government to provide information, counselling,
    anti-retrovirals and formula feed to pregnant women with HIV/AIDS violates section
    9 of the Constitution and constitutes unfair discrimination on the grounds of
    disability. Because of their HIV status pregnant women who are HIV positive do not
    receive information and treatment indicated for their condition that will reduce the
                                             24


   risk of transmission to their newborn infants. In addition, poor and black women
   carry the burden of giving birth to infants with HIV/AIDS. Middle class women of all
   races with access to private health-care are given the option of preventing mother-
   to-child-HIV transmission.

DIGNITY
97. The Minister of Health’s refusal to provide treatment to reduce HIV transmission
    from mother-to-child is violates section 10 of the Constitution. The violation of the
    human dignity of women with HIV may result in physical, emotional and
    psychological trauma.


JUST ADMINISTRATIVE ACTION
98. The refusal of the Government to accept the scientific, medical, legal and economic
    advice of experts constitutes arbitrary and irrational action that undermines the
    constitutional rights to just, lawful and reasonable administrative action. In addition,
    the failure of the Government’s to submit adequate written reasons to TAC and to
    public requests for information constitutes procedurally unfair action in terms of
    section 33 of the Constitution.

EMERGENCY TREATMENT
99. In situations where women have premature births or similar complications, or, have
    not taken anti-retroviral treatment prior to delivery, the provision or choice to take
    such treatments will potentially avert harm to the newborn infant and will constitute
    emergency treatment. Government’s failure to provide access to anti-retroviral
    treatments in such emergencies constitute a violation section 27(3) of the
    Constitution.

INTERNATIONAL COVENANTS
100. The Government’s failure to provide information, counselling, anti-retrovirals and
   formula feed to pregnant women with HIV/AIDS violates various International
   Agreements which have been ratified by the South African government and places
   certain obligations on them:

UNIVERSAL DECLARATION OF HUMAN RIGHTS
101. Article 25 provides that everyone has the right to a standard of living adequate
   for the health and well-being of himself and his family, which includes medical care.
   It is further provided that motherhood and childhood are entitled to special care and
   assistance.
102. Article 1of the UDHR holds that ―All human beings are born free and equal in
   human dignity and rights‖.

INTERNATIONAL COVENANT ON ECONOMIC, SOCIAL AND CULTURAL RIGHTS
103. Article 12 states that the States Parties to the Covenant recognise the right of
   everyone to the enjoyment of the highest attainable standard of physical and mental
   health. Steps should be taken by the Parties to achieve the full realisation of this
                                               25


   right, including in particular a) provision for the reduction of stillbirth-rate and of infant
   mortality and for the healthy development of the child; and c) prevention, treatment
   and control of epidemic, endemic and other diseases.

AFRICAN CHARTER ON HUMAN AND PEOPLES’ RIGHTS
104. Article 16 provides that every individual shall have the right to enjoy the best
   attainable state of physical and mental health. State Parties to the Charter must take
   the necessary measures to protect the health of their people and to ensure that they
   receive medical attention when they are sick.

CONVENTION ON THE ELIMINATION OF DISCRIMINATION AGAINST WOMEN
105. Article 12 states that States Parties shall take all appropriate measures to
   eliminate discrimination against women in the field of health care in order to ensure
   access to health care services, including access to family planning. States shall
   ensure further that women receive appropriate services in connection with
   pregnancy, confinement and post-natal period, granting free services where
   necessary, as well as adequate nutrition during pregnancy and lactation.

CONVENTION ON THE RIGHTS OF THE CHILD
106. Article 24 states that States Parties recognise the right of the child to the
   enjoyment of the highest attainable standard of health and to facilities for the
   treatment of illness and rehabilitation of health. States Parties shall strive to ensure
   that no child is deprived of his right of access to health care services.

107. It is further specified that States parties shall pursue full implementation of this
   right and, in particular, take appropriate measures including:
 To diminish infant and child mortality;
 To ensure the provsion of necessary medical assistance and health care to all
   children with emphasis on the development of primary health care; and
 To ensure appropriate pre-natal and post-natal health care for mothers.

CONCLUSION
We hope that these arguments will finally convince you to act in good conscience,
promotion of life, equality and dignity and on the basis of science. If you fail to do this,
TAC and its allies will be forced to embark on a programme of mass mobilisation locally
and globally to reverse the current iniquitous policy of your Ministry. However, should
the Ministry and government choose the correct approach, TAC will do everything in its
power to assist with education, awareness and action to prevent mother-to-child-HIV
transmission.

Yours faithfully
                                26


Zackie Achmat     Siphokazi Mthati     Mark Heywood

TAC Chairperson   Deputy-Chairperson   Secretary