Honourable Chairperson and members of the Portfolio Committee on Health,

On behalf of the AIDS Law Project (ALP) and the Treatment Action Campaign (TAC), I would like to take this opportunity to thank the Committee for the opportunity to participate in these public hearings on the National Health Bill, B32—2003. In the time allotted, I will not be able to go through our written submissions in detail, but will rather use the time available to me to address some of the key issues and concerns we have raised.

In making this submission, we are mindful of the fact that the HIV/AIDS epidemic worsens—on a daily basis—the circumstances that give rise to the need for the transformation of the health care system. We recognise that the HIV/AIDS epidemic exacerbates poverty and inequality, placing unsustainable pressure on the delivery of health care services to all.

With this in mind, we take this opportunity to welcome Cabinet's commitment to the development and implementation of a detailed operational plan to provide antiretroviral therapy in the public health care sector. We pledge to put our full weight and support behind the successful implementation of all interventions aimed at dealing comprehensively with the HIV/AIDS epidemic. We commit to working with government to save lives and to build a better health service for all. It is in this context that our submissions are advanced.

In making our submissions, we recognise the importance of the Bill in providing "a framework for a structured uniform health system … taking into account the obligations imposed by the Constitution and other laws". We support the purpose and objects of the Bill and trust that it will be enacted and promulgated within the foreseeable future.

In offering general support for the Bill, however, we would like draw to the Committee’s attention that in certain respects the Bill not only potentially undermines the right of access to health services, but also its own stated objectives. In addition, we believe that a number of provisions in the Bill raise concerns relating to constitutionally entrenched rights to privacy, bodily and psychological integrity, academic freedom and freedom of scientific research. It is in respect of such provisions that this submission is primarily concerned.

But before concentrating on these issues, we would like to raise a number of general comments regarding the Bill’s establishment of key national and provincial health structures, including the National Health Council, the National Health Advisory Committee, and the National Consultative Health Forum, and their provincial counterparts. We recognise that these structures are necessary if the objects of the Bill are to be realised. In our view, however, there appears to be an unnecessary and problematic overlap of functions and membership of the various bodies concerned.

In respect of the national structures, for example, we believe that this is easily remedied by ensuring that—

• The National Health Council is primarily responsible for the development of health policy and health legislation;
• The National Health Advisory Committee is primarily responsible for the co-ordination of policy implementation and the making of recommendations to the NHC on matters arising from such co-ordination; and
• The National Consultative Health Forum provides an opportunity for key stakeholders and civil society organisations to engage constructively with policy makers and implementers.

In our view, the membership of each structure should reflect the functions to be performed, as well as the need to "promote a spirit of co-operation and shared responsibility among public and private health professionals and providers and other relevant sectors".

The Bill has the potential to undermine access to health care services (and its own objectives) in three ways: the granting of broad discretionary powers, the requirement of a certificate of need and the failure to ensure that public health establishments are in a position to deal adequately with the costs of negligence claims. These three issues are dealt with in turn.

In terms of section 3(1)(d), the Minister "must, within the limits of available resources ensure the provision of … essential health services to the population of the Republic as may be prescribed after consultation with the National health Council". In essence, the provision empowers the Minister to determine which health care services are to be considered as essential, without any legislative guidance regarding relevant factors to consider in making such a determination.

Given that the majority of people in South Africa are reliant on the public sector for the provision of health care services, it is questionable whether a power to determine what in effect will be the extent of health care services that most people receive should be exercised without guidance from Parliament. In our view, not only is Parliament’s role desirable, it is also constitutionally mandated.

In a similar fashion, section 4(1) empowers the Minister to prescribe which of the essential health services provided at public health establishments will be available free of charge. This is in contrast with section 4(2), which sets out a number of considerations in respect of which the Minister must have regard in prescribing any conditions subject to which access to such free health services is controlled. In our view, section 4(1) should similarly provide guidance for the exercise of Ministerial discretion.

In principle, we recognise the important objective served by the requirement in section 41(1) that certificates of need be obtained before any person may "establish, construct, modify or acquire a health establishment or health agency; … increase the number of beds in, or acquire prescribed health technology at, a health establishment or health agency; … [or] provide prescribed health services". In its detail, however, the section has the potential to undermine the actual provision of health care services.

It lacks sufficient clarity and certainty, potentially serving as a disincentive for private sector investment in the health care system. It also draws no distinction between public and private health establishments, failing to recognise, for example, that the rationale for placing restrictions on the provision of health care services may differ between sectors.

In our view, this can be easily resolved by a redrafting of section 41(5) so that in respect of an application for a certificate of need relating to a private health establishment or health agency, the Director-General must issue or renew the certificate of need, unless he or she has good reason to believe that—

• the issue or renew of the certificate of need would constitute a serious risk to public health;
• the health establishment (or the health agency) is unable or unwilling to comply with minimum operational norms and standards necessary for the health and safety of users; or
• the health establishment (or the health agency) is likely to obstruct the State in fulfilling its obligations to progressively realise the constitutional right of access to health services.

Linked to the requirement of a certificate of need is the power granted to the Office of Standards Compliance in section 82(2)(a) to "order the total or partial closure of a health establishment or a health agency if a certificate of need was not issued in respect of that health establishment or health agency prior to any activities contemplated in section 41 being undertaken."

The Bill is silent on what factors are to be taken into account in ordering any closure, failing to consider the implications of such action for the provision of health services. The effect of such a closure may be to the severe detriment of users, notwithstanding the non-compliance with the requirements regarding certificates of need. Section 84(6), dealing with failures to comply with notices of non-compliance, raises similar concerns.

In our view, sections 82(2)(a) and 84(6) should be redrafted so that they do not permit any closure of a health establishment or agency if the action is likely to result in serious or irreparable damage to users.

In terms of section 51, all private health establishments are required to "maintain insurance cover sufficient to indemnify a user for damages that he or she might suffer as a consequence of a wrongful act by any member of its staff or by any of its employees." While this provision is to be welcomed, it must be seen in a context where users of public health establishments are not similarly protected.

As a result of new regulations issued by the Treasury in 2002, state institutions are now required to cover the costs of negligence claims, for example, out of their budgets. Despite the Regulations defining as institution as "a department or a constitutional institution", the obligations to cover the costs of such claims in the health sector, for example, have effectively been passed onto public health establishments.

As such establishments are not permitted to take out indemnity insurance, the costs of any damages claims must be borne by the health establishment budget. This can only have a negative impact on service delivery, further increasing disparities between users of the public health system and their private sector counterparts.

In our view, the state has two possible options in this regard. It can either amend the Treasury Regulations so that public health establishments are clearly not responsible for covering the costs of negligence claims out of their budgets, or, if the state is intent on devolving responsibility in this regard, the Bill could permit public health establishments to insure against the risks in question.

The Bill potentially undermines rights to privacy and bodily and psychological integrity in the manner in which it regulates three key issues: children and informed consent; access to health records; and the duties of users.

The purpose of section 6 is to give effect to the rights of users to "bodily and psychological integrity", by ensuring that users are empowered to make informed choices about their treatment options. Yet section 6 is problematic in that it relies on section 1’s definition of "user", which in respect of a person "below the age contemplated in section 39(4) of the Child Care Act, 1983 … includes the person’s parent or guardian or another person authorised by law to act on the [child’s] … behalf".

Section 6 is therefore problematic because section 39(4)(a) of the Child Care Act provides that any person over the age of 18 "shall be competent, without the assistance of his [or her] parent or guardian, to the performance of any operation upon himself", with section 39(4)(b) lowering the age of consent to 14 in respect of "any medical treatment" falling short of operations.

Thus in respect of a 16-year-old who wants to terminate her pregnancy, for example, section 6 of the Bill requires that a health care provider inform her parent or guardian of the girl’s health status and the various options available to her. This is clearly in conflict with the provisions of the Choice on Termination of Pregnancy Act, 92 of 1996.

The context of HIV/AIDS may further complicate matters. A health care provider must inform the same 16-year-old girl, if she tests positive for HIV, of her various options regarding the prevention of mother-to-child transmission of HIV. One of these options—delivery by caesarean section—cannot be characterised as anything other than an operation. In such circumstances, it is unclear whether the 16-year-old girl and her parent or guardian must be informed of all her options.

In many cases, the distinction section 39(4) of the Child Care Act draws between operations and other medical treatment is problematic. With this in mind, it is important to note that section 146 of the draft Children’s Bill (which will ultimately replace the Child Care Act) has done away with the distinction between treatment and operations.

In our view, the setting of the age of consent at 18 for operations is an unjustifiable limitation on the rights of many teenagers to bodily and psychological integrity. A less invasive means of limiting the right would be to set the age of consent at 14 for all medical procedures, provided that any child under 14 who is of sufficient maturity and has the mental capacity to understand the benefits, risks, social and other implications of the treatment or operation, would be able to grant informed consent.

In addition to the problems already raised, section 6 of the Bill also fails to make provision for children who are living with caregivers who are not legally authorised to consent on their behalf. For many children who live with extended family members, members of their communities, in child-headed households, in informal or unregistered children’s homes or on the streets, there is no person who may lawfully consent on their behalf.

As section 6 is currently drafted, it would be necessary to obtain an order from the High Court, as the upper guardian of all children in its jurisdiction, before any health service could be provided to such a child. We recommend that the National Health Bill adopt a similar approach to that adopted by the draft Children’s Bill, empowering a broader category of caregivers to consent on behalf of children on whose behalf no adult is currently able, in law, to consent.

Section 15(1) of the Bill regulates access to the health records of a user in a manner that leaves open the question of whether or not such access must be necessary for the health care worker concerned to discharge his or her duties. This lack of clarity has the potential to undermine users’ rights to privacy. In our view, the provision needs to be tightened to ensure that any person working for or on behalf of any health establishment or any health care provider has access to the health records of a user and may disclose such personal information to any other person, health care provider or health establishment only if such access or disclosure is necessary for discharging his or her duties and is in the interests of the user.

Section 16(1) of the draft National Health Bill, published for public comment on 9 November 2001, set out the circumstances in which a person who holds parental authority over a user who is a minor was to be refused access to the health records of that user. Section 16(1)(b) made it plain that a user’s consent would always be required for the contents of his or her health records to be disclosed to a person holding parental authority over him or her. In our submission to the Department of Health on the draft Bill, we recognised the importance of such safeguards, particularly insofar as information relating to sexual and reproductive health is concerned.

The new Bill does not contain any similar provision. Instead, by relying of a broad definition of user insofar as children are concerned, the Bill automatically provides access to such records to all persons holding parental authority over children under 14, and access to such records dealing with operations to all persons holding parental authority over any child. In our view, this unjustifiably limits children’s rights to privacy.

In part, section 19(b) requires a user to "provide the health care provider with accurate information pertaining to his or her health status". This raises concerns relating to a user’s right to confidentiality. For example, it seems to place an obligation on all users to disclose their HIV status to health care providers, regardless of whether or not the health care provider actually requires such information. While we recognise that the disclosure of a user’s HIV status may sometimes be necessary for the purpose of diagnosis, we do not believe that the health care provider concerned should have access to such information if it is not necessary for the provision of treatment or other health services.

The Bill potentially undermines the right to academic freedom and freedom of scientific research largely in the manner in which it regulates the use of tissue, blood, blood products or gametes removed or withdrawn from living persons, as well as in its regulation of health research ethics. In addition, the Bill potentially has a negative impact on the integrity, independence and efficacy of the Medical Research Council.

While we recognise the importance of regulating the use of tissue, blood, blood products or gametes removed or withdrawn from living persons, section 61 of the Bill raises many problematic concerns about academic freedom and the freedom of scientific research, both entrenched in section 16(1)(d) of the Constitution. While there may well be justification for limiting such forms of research, we do not believe that constitutional guarantees can be limited in the manner proposed by the Bill.

Our concerns are threefold. First, section 61(1) empowers the Minister to regulate the purposes for which "tissue or gametes removed or blood or a blood product withdrawn from a living person" may be used, without any guidance in the Bill as to how such a power is to be exercised. This raises considerations relating to Parliament’s obligations to provide a framework for the exercise of such a power also arise.

Second, certain types of tissue, blood, blood products or gametes may not be "removed or withdrawn … for any purpose contemplated in subsection (1)", unless Ministerial authorisation has been obtained. Insofar as "tissue, blood, a blood product or a gamete from a person who is mentally ill" and "tissue which is not replaceable by natural processes from a person younger than 18 years" are concerned, this is not problematic. However, concerns arise particularly in respect of section 61(2)(a)(iv), which deals with "placenta, embryonic or foetal tissue, stem cells and umbilical cord".

Third, the Minister’s authority to permit such conduct is granted largely in the absence of sufficient guidance as to how such a power is to be exercised.

In terms of section 36(1) of the Constitution, rights may only be limited if the limitation takes place by law of general application and "the limitation is reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom, taking into account all relevant factors". In terms of section 36(2), if these conditions are not satisfied, a constitutionally entrenched right may not be limited.

It is highly questionable whether the manner in which the Bill limits freedom of scientific research satisfies these requirements. According to the Constitutional Court, a limitation of rights will be justified only if the purpose of the limitation is proportional to its impact. In assessing proportionality, a court will consider the nature and importance of the right concerned, the extent of the limitation, as well as the availability of less restrictive means to achieve the same purpose.

While it is clear that the use of tissue, blood, blood products and gametes removed or withdrawn from living persons for the purposes of scientific research raises complex ethical issues, it is difficult to understand why this particular form of limitation is required. In particular, it is difficult to understand why their use for research purposes requires ministerial permission, and not the permission of health research ethics committees registered with the National Health Research Ethics Council.

Section 78(2)(a) of the Bill empowers health research ethics committees to review research proposals and protocols to ensure that research conducted at all health establishments promotes certain goals. Alongside the promotion of health as one of these goals, the section 78(2)(a) expressly mentions "the prevention of communicable or non-communicable diseases or disability" and "cures for communicable or non-communicable diseases". The omission of "treatments for communicable or non-communicable diseases" from the expressly mentioned list of health goals is cause for concern. As the provision currently reads, it unjustifiably violates the right of access to health care services, as well as the right to academic freedom and freedom of scientific research.

Further, health research ethics committees are not required or even empowered to receive the results (whether complete or partial) of research conducted on human subjects. This severely limits the efficient and effective functioning of both health ethics committees and the National Health Research Ethics Council, for without information relating to these results, there is no mechanism for updating, re-evaluating and setting appropriate ethical guidelines, norms and standards.

The introduction of a comprehensive regulatory framework within which health research will be conducted is to be welcomed, particularly given the inadequacies of the current regulatory framework. Yet in dealing with national health research and information, the Bill potentially affects the integrity, independence and efficacy of the Medical Research Council (MRC) in three ways.

First, in terms of the South African Medical Research Council Act, 58 of 1991 (MRC Act), the MRC is expressly empowered to "undertake research of its own accord", to "undertake research on behalf of the State or any other authority, or on behalf of any person or institution, or support such research financially", and to "regulate and control research on or experimentation with humans, animals or human or animal material performed by … employees of the MRC; or … persons performing such research or experimentation for or on behalf of the MRC, or with research aid by the MRC."

In terms of section 74(3) of the Bill, however, the National Health Research Committee is tasked with determining what health research is to be carried out by public health authorities, as well as developing "an integrated national strategy for health research". Clearly, the scope of the MRC’s research will be affected by decisions of the National Health Research Committee, a body whose membership does not necessarily include any representation from the MRC.

Second, section 77 of the Bill sets up the National Health Research Ethics Council, the functions of which include setting "norms and standards for conducting research on human and animals, including norms and standards for conducting clinical trials". This potentially conflicts with section 17(2) of the MRC Act, which empowers the MRC to "determine ethical directives which shall be followed in … research [on] or experimentation [with humans, animals or human or animal material]." As is the case with the National Health Research Committee, the National Health Research Ethics Council’s membership does not necessarily include a representative from the MRC.

Third, the Bill is silent on the nature of the relationships between the MRC and the National Health Research Committee and the National Health Research Ethics Council. This potentially creates unnecessary tension and uncertainty. The objects of the MRC, as set out in section 3 of the MRC Act, are primarily, "through research, development and technology transfer, to promote the improvement of the health and the quality of life of the population of the Republic". Placing certain of its key functions subject to vague and unclear lines of control, while simultaneously creating the potential for the exclusion of the MRC from the decision-making authorities tasked with exercising control over such functions, severely compromises its independence as well as its ability to realise its objects.

In conclusion, I would like to thank the Portfolio Committee on Health for the opportunity to make these oral submissions on behalf of the AIDS Law Project and the TAC. We trust that our comments and recommendations will assist the Committee in ensuring that the National Health Act of 2003 plays a significant role in giving effect to the transformation of the health care sector, whilst at the same time respecting, protecting, promoting and facilitating the fulfilment of the right of access to health care services, the right to privacy and bodily and psychological integrity, and the right to academic freedom and freedom of scientific research.