IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION) In the matter between TREATMENT ACTION CAMPAIGN First Applicant HAROON SALOOJEE Second Applicant CHILDREN'S RIGHTS CENTRE Third Applicant and MINISTER OF HEALTH First Respondent MEC'S FOR HEALTH Second to Tenth Respondents AFFIDAVIT I, the undersigned, HAROON SALOOJEE do hereby make oath and state that: 1. I am the Second Applicant in this matter. I am an adult male paediatrician, employed in the Department of Paediatrics and Child Health at the University of the Witwatersrand, Johannesburg. 2. The facts set out herein are, except where expressly stated otherwise, within my own personal knowledge and are true and correct. To the extent that I rely on the information received from others, I believe that such information is true and correct. 3. I have read the founding affidavit of Siphokazi Mthathi. I confirm the correctness thereof in so far as it refers to me or to Save Our Babies, which I represent. 4. As is set out in that affidavit, I act in this matter in my own interests as a medical practitioner; as a member and representative of the members of Save Our Babies; on behalf of new-born babies who are being or will be born in the public health sector to mothers with HIV; and in the public interest. 5. I respectfully submit that I am by my training and experience duly qualified to express the views and opinions which I shall express in this affidavit and to assess the repute, opinions and reliability of other persons that I refer to. I attach hereto a copy of my curriculum vitae marked as HS1. 6. I am a qualified medical practitioner, having obtained my MBBCH degree from the University of the Witwatersrand in 1984. I was registered as a paediatrician in 1991 after having obtained Fellowship of the College of Paediatricians of South Africa. I am head of the Division of Community Paediatrics, in the Department of Paediatrics and Child Health, at the University of the Witwatersrand. I am also a Principal Specialist at Chris Hani Baragwanath Hospital. 7. I have been a member of the Childhood HIV working group in Gauteng province and have been part of the task team which has written the provincial guidelines for preventing and managing HIV in children. I have published papers in national and international medical journals on the prevention and treatment of HIV in children. 8. In November 2000, I along with a number of concerned paediatricians, launched a campaign called "Save Our Babies". The purpose was to declare our stance as paediatricians on HIV/AIDS issues particularly in relation to children. The campaign arose from our perception that although paediatricians dealt with the effects of the HIV/AIDS epidemic on a daily basis, our opinions on these very issues were not being effectively voiced and where they had been communicated to the Ministry of Health, our suggestions had been ignored. 9. "Save Our Babies" organised a petition campaign during two weeks in November 2000, which collected 273 signatures from paediatricians and child health practitioners around the country in support of the implementation of a mother to child transmission reduction programme. 10. On 1 December 2000, World AIDS Day, "Save our Babies" organised a march and press conference at Chris Hani Baragwanath Hospital, where a memorandum expressing the same views as set out in this affidavit was handed to a representative from the Ministry of Health. There has been no response from the Ministry to this memorandum. A programme was held at Tygerberg Hospital, Stellenbosch and the Red Cross Children's Hospital that supported the demands of the "Save Our Babies" campaign on the same day. A copy of this Memorandum and the list of doctors who supported the petition is attached as HS2. I attach marked HS3 a press report on this event. 11. I have been mandated by "Save Our Babies" to represent paediatricians and other health-care professionals in these proceedings. Attached as HS4 is a letter sent by me and two other paediatricians, inviting recipients to endorse our direct participation and application in this matter. I refer the Honourable Court to Annexure HS5 attached which contains the names and designations of the constituency of Save Our Babies who endorse and support this application. Included amongst the petitioners are internationally renowned scientists such as Professor Hoosen Coovadia, Victor Daitz Professor of HIV/AIDS Research at the Nelson Mandela School of Medicine, University of Natal. In 2000 Professor Coovadia was the chairperson of the 13th International AIDS conference held in Durban, South Africa. 12. As a medical doctor, I also have a direct interest in the outcome of this matter. 13. I have worked in the paediatric wards at Chris Hani Baragwanath Hospital from 1987 to the present. I was Head of the Neonatal unit at Chris Hani Baragwanath Hospital from 1994 to 1998, and continue to work in the unit presently. In that time I have seen a sharp increase in the admissions of infants and children with HIV to the paediatric wards. 14. As a paediatrician, I care for the ever-increasing numbers of sick children with HIV/AIDS on a daily basis. Paediatricians in South Africa have to deal with dying children at hospitals and clinics around the country. I, and my colleagues, have to inform parents of their infant's positive HIV status knowing that the risk of HIV infection may have been greatly reduced if the parents had been counselled, and mothers offered antiretroviral therapy such as Zidovudine (AZT) or Nevirapine (NVP), in the final stages of the pregnancy, and also if their infants had received the same drugs as prophylaxis after birth. The difficulties that confront us in our work are accurately described in an article by a paediatrician that appeared in the Mail and Guardian newspaper on 5 July 2001. This is attached as annexure HS6. 15. In addition, the diagnosis of a child with HIV in such a situation also means diagnosing one or both parents with a life-threatening condition. 16. I concur with expert consensus from the consultation of the World Health Organisation and UNAIDS, which at a meeting in Geneva in 2000 concluded that: a. antiretroviral regimens for preventing mother-to-child transmission (MTCT) of HIV are safe and efficacious; b. the prevention of MTCT should be included in a minimum standard of care for HIV-positive women and children; c. there is no justification to restrict any of these regimens to pilot projects or research settings. 17. Nevirapine is an antiretroviral drug that has been approved and registered by the Medicines Control Council (MCC) for use in the reduction of mother-to-child transmission of HIV. Nevirapine costs less than R30.00 per treatment. Its use could reduce transmission of HIV by HIV-positive mothers to their infants by half. 18. The regimen to be followed for the use of Nevirapine for this purpose consists of 2 doses, viz. one to the pregnant woman during labour and one to the newborn child within 72 hours of birth. When a woman knows her HIV status this simple regimen can be followed even if the pregnant woman does not book in at a clinic for antenatal care before the birth and only arrives at the hospital or clinic when she is in labour. 19. I believe that most major urban hospitals and some periurban and rural centers have the resources to implement this programme. 20. This preventive regimen has been shown to reduce mother-to-child transmission by up to 50 percent. If implemented nationally this approach could save approximately 35 000 babies from acquiring HIV annually. 21. The cost savings that would be achieved by this intervention, as well as the scientific data on its efficacy, leave no doubt that a policy and programme to implement it nationally should be drawn up with immediate effect. It is far cheaper to prevent a child being infected by HIV than to treat the effects of the disease, even when the costs of antenatal counselling and testing for HIV are included. In this regard I refer the Court to the studies which are referred to by Professor Nicoli Nattrass in her affidavit in this matter, namely the costs study by Skordis and Nattrass entitled "What is affordable: "The Political Economy of Policy on the Transmission of HIV/AIDS from mother to child in South Africa"; the paper by Dr David Wilkinson, et al and titled "A national programme to reduce mother to child HIV transmission is potentially cost saving: Evidence from South Africa"; and the costs study by Soderlund and Zwi entitled "Preventing Vertical Transmission of HIV - A cost Effectiveness Analysis of Options Available in Developing Countries". 22. Children with HIV present at our hospitals for treatment of, inter alia, pneumonia, gastroenteritis, malnutrition and tuberculosis. Children with HIV have a longer median length of hospitalization and require more frequent readmissions than HIV-negative children. Here I refer the Court to KJ Zwi et al "Paediatric hospital admissions at a South African urban regional hospital: the impact of HIV, 1992—1997" Annals of Tropical Paediatrics (1999) 19, 135—142) At Baragwanath Hospital, HIV-related paediatric deaths during a hospital stay increased from 11 children in 1992 to 111 deaths in 1996. (See also KJ Zwi et al "HIV infection and in-hospital mortality at an academic hospital in South Africa" Archive of Diseases of Childhood (2000) 83: 227-230) There is little doubt that this number has increased significantly in the last five years. ACCESS TO INFORMATION AND INFORMED CONSENT 23. The Patients Rights Charter outlines the state's policy of informed consent in the following way: "Everyone has the right to be given full and accurate information about the nature of one's illness, diagnostic procedures, the proposed treatment and the costs involved, for one to make a decision that affects anyone of these elements." In my opinion it is the right of all prospective parents to be informed of the risks of mother to child transmission and the available options to reduce HIV transmission, including antiretroviral therapy and feeding options, as HIV can be transmitted in breast milk. This is an essential part of the ethical and legal doctrine of informed consent. Failure to provide such information is not only a breach of the ethical and legal duties of the government but in contravention of the First Respondent's own policy. 24. In addition, it is the constitutional duty of a doctor, particularly those of us employed by the state, to provide women who are pregnant with all the medical information so that she can protect and exercise her rights. These rights include her constitutional rights to dignity, life, freedom and security of the person, access to health care services including reproductive health. The unnecessary ill health and premature death of a child undermines the dignity and psychological integrity of parents and caregivers, particularly women. A denial of information to prevent mother-to-child transmission of HIV and the denial of anti-retroviral treatment is a violation of her right to access health care services. 25. The failure by the Minister of Health to implement a countrywide policy to prevent mother-to-child HIV transmission is a violation of the constitutional duty to act in the best interest of the child. Once a woman has decided to have a child, it is in the best interest of that child to take preventative measures against HIV and any other health condition that may be transmitted to that child. Health care professionals will also fail in their duty to uphold the best interests of the child by remaining silent in the face of this failure of policy by the health ministry. CLINICAL INDEPENDENCE AND INTERESTS OF THE PATIENT 26. The Minister of Health's refusal to implement a countrywide programme to prevent HIV transmission from mother-to-child undermines the clinical independence of health care professionals. 27. In this regard I would refer this Honourable Court to the statements of the World Medical Association (WMA) which is an international organisation representing physicians. The Association, founded in 1947, strives to ensure the independence of physicians and to work for the highest possible standards of ethical behaviour and care by physicians at all times. The WMA is an independent confederation of free professional associations, funded by the annual contributions of its members that comprise physicians' associations in approximately seventy countries. Copies of the original conventions and declarations of the WMA which are referred to can be made available to the Court if required. 28. The WMA Declaration on Physician Independence and Professional Freedom (1986) holds that: "Physicians must have the professional freedom to care for their patients without interference. The exercise of the physician's professional judgment and discretion in making clinical and ethical decisions in the care and treatment of patients must be preserved and protected. "Physicians must have the professional independence to represent and defend the health needs of patients against all who would deny or restrict needed care for those who are sick or injured. "The World Medical Association and its national medical associations therefore rededicate themselves to maintaining and assuring the continuation of professional autonomy in the care of patients which is an essential principle of ethics." 29. The WMA has identified twelve principles for the provision of health care in any national health care system, principle (xi) reads: "xi) In the higher interest of the patient there should be no restriction on the physician's right to prescribe drugs or any other treatment deemed appropriate by current medical standards." 30. The WMA International code of Medical Ethics states inter alia: "A physician shall in all types of medical practice, be dedicated to providing competent medical service in full technical and moral independence, with compassion and respect for human dignity. A physician shall always bear in mind the obligation of preserving human life. The health of my patient shall be my first consideration." 31. As I have stated earlier, the World Health Organisation and UNAIDS has stated categorically that there is no justification to restrict the use of anti-retroviral therapy to prevent mother-to-child HIV transmission to pilot projects or research settings. As doctors who place the health of our patients first, we would act against our constitutional right to freedom of conscience and against our ethical duty of clinical independence, if we were to deny women the right to use anti- retroviral therapy to prevent mother-to-child transmission of HIV. The current policy that restricts provision of anti-retroviral therapy to pregnant women to "pilot" and "research" sites deny women this right and undermines the doctor-patient relationship. 32. I am a member of the South African Medical Association (SAMA). At present some 70% of the doctors in both the public and private sector are members of SAMA, which has approximately 16 500 members. The objectives of SAMA include the following: - To represent doctors with authority and credibility in all matters concerning their interests in the health care environment - To promote medical education, research and academic excellence - To influence the health care environment to meet the needs and expectations of the community by promoting improvements to health reform, policy and legislation 33. SAMA functions through various committees, one of which is the Human Rights, Law and Ethics Committee. 34. I attach marked HS7 a copy of 'Medigram' Vol 9 No 13 of 30 July 2001. This is a regular publication of SAMA. 35. As appears from page 2 of that publication, the SAMA Human Rights, Law and Ethics Committee has recently considered the question of provision of Nevirapine to pregnant women. The Committee expressed its support for the rights of patients to be fully informed about their specific medical condition and treatment; their right to receive the necessary treatment with their informed consent; and the right of all HIV positive pregnant women to receive the best available proven treatment to reduce mother to child transmission. The Committee further urged government to make an unequivocal statement that all pregnant women who are HIV positive and have received the necessary counselling, be fully investigated, and after having given their informed consent, be provided with the necessary treatment. COST EFFECTIVENESS 36. Given the cost-effectiveness of a Nevirapine regimen to reduce mother to child transmission and its proven efficacy, it is rational for the Ministry of Health to immediately provide this treatment at all centres which already have the capacity to implement it. 37. In addition, I believe that infrastructure and facilities must rapidly be developed at hospitals and clinics currently unable to introduce programmes to prevent mother to child transmission. 38. Pilot studies may be necessary primarily to identify difficulties with implementation and delivery. Pilot studies are not required to identify the possible need for such a programme. The need, cost-savings and effectiveness are clear. 39. In my view it is imperative to make Nevirapine available in the public health sector, and to implement this programme as soon as possible. Children's lives matter. 40. I respectfully ask that the Court make an order as set out in the Notice of Motion. ________________________ DR. HAROON SALOOJEE Signed and sworn to before me at_________________________ on the day of August 2001, the deponent having acknowledged that he knows and understands the contents of this affidavit, that he has no objection to taking the prescribed oath, and that he considers the prescribed oath to be binding on his conscience. ________________________ COMMISSIONER OF OATHS 1