The preamble should be reformulated to make it compatible with the bill of rights, one of South Africa's remarkable contributions to constitutional law.

Further, the preamble states that no one may be refused emergency medical treatment.

We request that thought be given to defining "emergency", so that the concept is removed from the realm of speculation and perception.

We believe that there needs to be a delicate rewording of section 2(a)(ii) [pg 8] which states "best possible health services that available resources can afford". This wording is problematic in that it invites a totally inadequate health budget to dictate affordability.

Further, the committee needs to note that the carefully balanced provisions of section 28 of the bill of rights suggest a progressive realization that a right of access to health care imposes duties on the state to look beyond what is currently affordable.

Section 7(d) identifies public health grounds for the forcible treatment of a patient when there is 'serious risk to public health.' Whilst we agree that there may be a need to control serious contagious or transmissible disease, we suggest that the wording of this clause is too vague and opens the health services up to charges of acting in violation of human rights without adequate justification.

We suggest that the Minister, in consultation with cabinet, be empowered to issue regulations in terms of which such a decision could be made; regulations which are based on international best practice and mindful of balancing the rights of individuals with the need for public health control of infectious or communicable diseases.

Section 14(2) [pg 11] outlines disclosure of information. We welcome the important emphasis placed on confidentiality. However, we are concerned that disclosure of information for bona fide reasons may be overlooked in the present provision. For example, if a patient is Hepatitis antigen positive, this may materially affect management and indeed health care.

We would recommend more consultation with stakeholders to formulate an appropriate provision that protects confidentiality, is mindful of the Bill of Rights but also ensures appropriate public health measures and good clinical practice in the individual.

The provision on "Access to health records by health care provider" [pg 11, S16(a)-(b)] flies in the face of international best practice and would prevent the conduct of a large amount of essential public health research and clinical audit, without which the development of inter alia appropriate public policy would be severely constrained.

We are, however, to the "spirit" behind this provision, and support the need for a degree restraint with regard to access to clinical records. We propose a qualification on the term "authorisation of the user" :

• Change to "authorisation by head of institution and duly constituted ethics committee"

Section 23(1)(2) [pg 14] provides for the establishment of a National Health Advisory Committee and outlines the composition of the Committee. As it stands, the Committee will consist of many government officials with no representation from the health care providers.

We recommend that the Bill be amended to include appropriate representation from the health care provider sector compatible with the authority and influence borne in that sector.

The Bill provides that Provincial health departments will "plan, manage and develop human resources for the rendering of health services" [pg 15, S27(2)(h)].

We support this provision whole-heartedly.

The establishment of Provincial Health Advisory Committee is provided for in section 30(1)-(3) [pg 17]. Health care providers are not included in these Committees.

It is unacceptable that decisions be made without consultation with health care providers and a missed opportunity to have authoritative and expert clinical input at management level.

The Bill provides that the general functions of National and Provincial departments of health will include the promotion of "community participation in the planning, provision and evaluation of health services" [pg 13, Chapter 3, S20(2)(h); pg 16, Chapter 4, S27(2)(t)]. The Bill also specifies that "community participation" will be an important criterion to consider in the division of health districts into sub-districts [pg 18, Chapter 5, S35(2)(i)]. However, the Bill does not clearly define what the term "community participation" will mean in practice.

We propose, therefore, that the Bill include a definition of what is meant by "community participation".

The Bill provides that the general functions of National and Provincial departments of health will include the promotion of "community participation in the planning, provision and evaluation of health services" [pg 13, Chapter 3, S20(2)(h); pg 16, Chapter 4, S27(2)(t)]. The Bill does not clearly define what the term "community participation" will mean in practice.

We propose that the Bill include a definition of what is meant by "community participation".

The Bill provides that the Minister may "determine the establishment of the hospital board and the management system of [a] central hospital" [pg 20, S40(b)].

We understand that the Committee of Medical Deans will be making representation in this regard. We note that between 1991 and 1993, UCT, cognizant of a changing political environment and the opportunity for developing a new and insightful structure within the healthcare environment, held wide-ranging and in-depth consultations on the subject.

The position of the University of Cape Town in this regard is as follows :

We urge that there be a high-level review of Academic Health Services Complexes Act (Act 83 of 1993) with a view to incorporating the best elements of that bill into the current draft.

We note that the then management of the University of Cape Town Academic Health Complex considered evidence and prepared extensive recommendations for government. We urge that these documents be reviewed and their best elements be considered for inclusion in the current draft.

We note that the Moodley Commission (October 1994) proposed amendments to the Academic Health Services Complexes Act (Act 83 of 1993). We suggest that this document should be reviewed.

The provisions in section 46(1)-(9) [pg 22] give the Minister unilateral powers in determining the provision of health services and some of the practical applications of health care.

We propose a system of checks and balances be put in place, and that the Minister should be expected to consult with relevant structures when deciding on critical matters such as the range of services to be provided at a particular facility.

Section 56(a)-(b) [pg 26] of the Bill provides that the Ministers of Health and Education may, at their discretion, establish Academic Health Complexes (AHCs) to educate and train health care personnel and to conduct research in health services. The AHCs would consist of one or more health establishments and one or more educational institutions. The Bill also provides for establishment of co-coordinating committees to perform prescribed functions of the AHCs.

Our previous comments above refer. Specifically we urge that academic complexes should be centrally managed but in association with universities and provincial health departments. Only in this manner will a "global" perspective be brought to bear on a highly complex environment.

As it stands, the Bill does not guarantee representation of the National Health Laboratory Service (NHLS) on the Academic Health Complexes co-ordinating committees [pg 26, Chapter 7, S56(b)], the National Health Research Committee [pg 32, Chapter 9, S74(1)-(5)], the National Health Research Ethics Council [pg 33, Chapter 9, S77(1)-(7)] or the provincial committees to be established that will set-up and operate health information systems at provincial and local level [pg 34, Chapter 9, S80].

We suggest that there should be provisions in the Bill that would guarantee adequate representation from the Faculties of Health Sciences to represent Faculty opinion, their staff, clinicians, scientists and laboratory services on key issues. These should include inter alia the retention and use of human tissues and images for teaching; training of morticians; and ensuring that a person's ID number and hospital number are one and the same.

The Bill designates the National Blood Transfusion Service as a "non-profit organization" [pg 27, section 58(1)].

We propose that the Bill should explicitly make provision for the continued existence of Provincial Blood Transfusion Services, all be they under a central authority.

Section 61(2)(a)(iv) [pg 27] provides that, subject to the Minister's discretion, "placenta, embryonic or foetal tissue, stem cells and umbilical cord, excluding umbilical cord progenitor cells" may not be used for the purposes of section 61(1), i.e., medical or dental purposes.

The Bill should provide for the use of these materials in appropriate therapeutic settings, with appropriate ethical oversight to ensure adherence to internationally-acceptable ethical standards.

However, we are ill at ease with the whole chapter that addresses highly complex and currently poorly understood issues.

We believe more consultation is necessary before these provisions are signed into law. We urge that a high-level commission be constituted to address the biological, ethical and practical issues and offer definitive advice thereon.

Section 66(3) [pg 29] provides that the Minister must authorize in writing the transplantation of an organ "into a person who is not a South African citizen or a permanent resident of the Republic."

Though are totally sympathetic with the "spirit" behind the provision. However, in truth, we are perplexed by the inclusion of this clause in the Bill and question whether it is necessary or indeed desirable.

In section 65 (1)(a) [pg 28], reference is made to "the importer," but the Bill neglects to provide a definition for what an importer is, which is a concern for us.

The regulations that the Minister may promulgate regarding the above are inordinately vague (pg 31, Section 73) except in that they give the Minister enormous powers. We are particularly concerned that if promulgated as is, we will continue to operate without good guidelines in our clinical practice.

In section 73(1)(f) [pg 31], the Bill provides that the Minister may make regulations regarding "the supply of tissue, organs, oocytes, human stem cells and other human cells, blood, blood products or gametes." If the regulations are promulgated, they may contain guidelines for the procurement and allocation of organs for transplantation, as well as the possible regulation of the Bone Marrow Registry and regulation of cord blood for transplantation.

Since these regulations may prove to be far-reaching, we believe more authoritative consultation is necessary before these provisions are signed into law.

The Bill provides a very directive role for the National Health Research Committee to determine research agendas. [pg 32, section 74(3)(a)-(d)]. We consider that this function is undesirable and potentially flawed in that it has the very real potential of constraining academic freedom, stifling creativity and discouraging entrepreneurial and scientific endeavor.

If the Committee is actually necessary we suggest that a more valuable role would be to advise the Minister on matters of national priority, ethics, international trends and the likes, promote research and facilitate the researcher.

The relationship between this Committee and the Science Councils needs to be clarified.

Section 74(3)(a) [pg 32] is ambiguous as to whether it contemplates that research will be conducted "in" health facilities (done by others) or "by" public health authorities.

We suggest therefore that this subsection be removed from the Bill.

Section 75(2)(d) [pg 32] "the health needs of communities" should be expanded to include "and specific patient populations". Certain uncommon conditions may still require locally generated knowledge and interventions.

The Bill does not make clear who will be responsible for financing health information systems at the different levels mooted.

We believe that this is important to clarify as can be anticipated that it will prove to be very expensive to establish, implement and maintain such a system, and, in the current dispensation, provincial and local budgets will be found wanting.

The term "within its available resources" appears in the Preamble to the Bill. This is a concern because resources may be minimal and then the quality and the effectiveness of care will be compromised.

We propose that it would be far better to set basic minimum standards, which are periodically revised as the resources [the two major determinants - financial and human] become available.

We believe that it is imperative to ensure representation of academic and other bodies at appropriate levels of the health services. Representatives of the Committee of Medical Deans should sit on any committee that might influence provision of facilities for learning/teaching medicine.

We are concerned by the lack of representation from health carers and members of the Academic Complexes on many of the structures.

We are concerned about some areas in the Bill that imply the Minister and/or the National Department of Health will exert too much control without recourse to meaningful consultation. We do not want to return to a previously prevalent mindset. Governing by regulation is undersirable as it causes uncertainty regarding future process and direction.

We have highlighted areas of the Bill where adequate definitions are not provided.

We note that the Bill does not include in its provisions attention to the basic requirements for the health care of health care providers themselves, an important oversight. Here we cite the example of a person working within the field of Obstetrics and Gynaecology having immunization against rubella or being known to be rubella antibody positive because if infection with rubella is passed on to the patients, this can result in devastating fetal anomalies. Similarly many units demand that all obstetricians/gynaecologists/transplant physicians and nurses should have immunization against Hepatitis B.