National Health Act: SA Medical Association concerns about Section 46 & Chapter 8 regulations

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05 June 2013
Chairperson: Dr B Goqwana (ANC)
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Meeting Summary

The South African Medical Association (SAMA) had asked for an opportunity to address the Committee on its concerns around the definitional problems and possible conflicts, in respect of Section 46 of the National Health Act and in the Regulations based on Chapter 8 of the Act. The regulations were gazetted in March 2012.

Firstly, there was a need to clarify what a ‘private health establishment’ meant, from the perspective of section 46 of the National Health Act. Every private health establishment must 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, but that raised the question, firstly, of whether individual or group medical practices were included, particularly when they rendered diagnostic or therapeutic interventions in consulting rooms, and what kind of cover was intended, whether it would indemnify the user, or the establishment, and whether it was insurance or indemnity. There was, furthermore, no definition of the cover, nor of any cap, and it was not clear who was included within the definition of ‘staff’.

The second concern was the apparent inconsistencies between Chapter 8 of the National Health Act, which had to do with storage of human tissue, and the Regulations. The Act said that ‘tissue’ was used as a collective term, to refer to cells and tissue, but it excluded gametes, although the Regulations on Use of Human Biological Material included gametes in the definition of ‘biological material’ and the Regulations on Tissue Banks said that ‘tissue’ also included ‘cells’. Secondly, there was uncertainty around the question of giving of informed consent, as although the consent for the removal was covered, the use was not, and it was unsure who would own the tissue, once removed for research or study, what information the user must get in order to give consent, and what would happen if tissue was used outside of that initial consent. Medical practitioners had expressed concern and confusion and the meaning and practical implications of possession, custodianship, database rights and intellectual property relating to human tissue would have to be clarified.

The Department of Health had not been able to be present and Members and the Parliamentary Legal Advisers were of the view that the Department’s input was necessary, and, although already requested by the Parliamentary Advisers, had not been received. They concluded that this meeting should be regarded as preliminary only, and later meetings would be arranged with the Minister and Department in attendance, for feedback and further debate. It was also noted that the use of body parts for muti was another issue that perhaps needed to be covered, and questioned why these concerns had not been raised when the Act was first passed.  It was also noted that in future delegated legislation would be referred to a separate committee for scrutiny.

Meeting report

Chairperson’s opening remarks
The Chairperson noted the presence of the South Africa Medical Association (SAMA), but noted also that the Department of Health (DoH or the Department) was not present. The SAMA delegates had attended to outline their concerns about the National Health Act (the Act), but reminded them that this Committee alone may not have the legal technical skills to fully appreciate these concerns without further input. There were, however, representatives from the Parliamentary Law Advisers.

Ms P Kopane (DA) advised Dr Goqwana that she was concerned that this Committee would not be able to effectively engage or understand the delegates immediately, and noted also her concerns that the topics for discussion had changed since the initial notification. She also expressed her concern that the Members had only received the presentation on the previous evening, and had not had sufficient time to receive input from the researchers or Parliamentary legal advisers, nor even to go through the document in depth.

The Chairperson commented that he was not sure why the documents were received so late, and reminded all presenters that in future they must be received more timeously. He said that the topic originally set for discussion at this meeting had been remunerative work undertaken by health officials, outside of their public service duties, and that would only have been able to be discussed in the presence of the Department of Health, which had unfortunately not been able to attend the meeting. In addition, the Minister of Health was apparently currently engaging with the various Deans of the faculties of health sciences to have more comprehensive discussions.

The Chairperson asked SAMA to brief the Committee on the concerns.

National Health Act: Section 46: Briefing by South African Medical Association
Dr Mark Sonderup, Vice Chairperson, SAMA and Senior Specialist from the University of Cape Town noted the apologies of the Chairperson of SAMA, who was undergoing surgery at this time. He noted the earlier mention on the topic of remunerative work outside the public service and said that SAMA too was interested in engaging on it, but was awaiting the appropriate forum to be arranged to address that topic.

However, his briefing today would highlight two small points in the National Health Act that may have negative impact. He noted that SAMA’s Legal Counsel, Mr Julian Botha, would speak to them.

Mr Julian Botha began by outlining that section 46 of the National Health Act defined the obligations of private health establishments. Specifically, it stated that ‘every private health establishment must 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.’ This raised two questions; the first was whether individual or group medical practices were included under the concept of “private health establishments”, whilst the second question related to the type of damages and wrongful acts the insurance cover was required to indemnify.

Mr Botha noted the definition of a ‘private health establishment’ as a venue that was not owned or controlled by an organ of state, and the current definition covered an institution, either in part or as a whole, whether for profit or not, that was operated or designed to provide inpatient or outpatient treatment.

Mr Botha then went on to state that a ‘user’ was defined as a person receiving treatment in a health establishment, including receiving blood or blood products, or using a health service. A “person” was defined as including an individual, or, in the case of minors, parents or guardians.

Mr Botha noted that general practitioners and medical specialists diagnosed and provided some therapeutic interventions in their consulting rooms, and said this raised the question of whether their rooms fell under the definition of ‘health establishment.’ Moreover, Mr Botha emphasised that even physiotherapists engaged in rehabilitative services in their rooms, and this could render their rooms as ‘health establishments’ in terms of the definitions.

In essence, therefore, the current wording of section 46 raised various concerns. He noted that there was no definition for ‘insurance cover’ and no ceiling or cap for the cover was stated. Staff or employees may also be medical or other healthcare providers. He reiterated that clarity was needed on whether private medical practices were considered ‘private health establishments.’ Moreover he asked the Committee to clarify whether indemnity or insurance was intended to indemnify the private health establishment, or the user of the services. He questioned if the cover was intended to be liability or insurance cover.

Mr Botha then presented the second concern in the National Health Act, relating to Chapter 8. This concern revolved around the ethics of storing health tissue. Mr Botha began by noting the definition of ‘tissue’ as human tissue, which included flesh, bone, a gland, an organ, skin, bone marrow or body fluid, but which excluded blood or a gamete. Mr Botha then defined biological material as material from a human being including DNA, RNA blastomeres, polar bodies, cultured cells, small tissue biopsies and growth factors from the same material. Mr Botha then went on to add that ‘tissue’ may also be defined as a functional group of cells. He stated that the term was used collectively in regulations to indicate both cells and tissue. Additionally, Mr Botha stated that a ‘substance’ may also mean tissue, blood, blood product and gamete. A ‘body specimen’ meant any body sample which could be tested to determine the presence or absence of HIV infection.

Mr Botha said that the National Health Act and medical terminology currently in use appeared to be contradictory. The National Health Act definition of ‘tissue’ excluded gametes, but the Regulation on Use of Human Biological Material included gametes under the definition of biological material. Moreover, the Regulation on Tissue Banks recognised tissue as including both tissue and cells. Ultimately the National Health Act and regulations did not provide for the legal classification of ‘human tissue.’

A further problem in relation to the definitions was apparent in connection with ‘informed consent’. There was some confusion in determining what was informed consent within the scope of the National Health Act, although ‘informed consent’ for the removal of human biological material from living and deceased persons for research or study purposes was adequately dealt with. He said that a distinction must be drawn around specific informed consent relating to the future use of human biological material, and this was not currently provided for in either the Act or Regulations.

Another fundamental question that was raised by Mr Botha related to ownership, and said that this determined who owned the tissue, once it was removed from a person. There were some doubts as to what information must be provided to the user when obtaining informed consent. The Regulations were silent on this matter, with the exception of the Regulations relating to the artificial fertilisation of persons. If ownership of tissue was transferred to a research facility, the tissue may be used for purposes other than that for which informed consent was initially provided. Mr Botha also highlighted that in most cases the donor was not entitled to a share of the revenue streams arising from the use of his or her tissue.

He concluded that there was significant confusion amongst medical practitioners about the meaning and practical implications of possession, custodianship, database rights and intellectual property relating to human tissue. Further confusion was created by the conflicting descriptions and definitions of human tissue and related concepts in the National Health Act and Regulations in the sector.

The Chairperson thanked the delegates for the presentation, and added that another point that was not mentioned, but needed to be added, related to the use of body parts for the use of muti (black magic), which was prevalent in South Africa, particularly in the townships.

The Chairperson noted the concerns raised by SAMA but said that the legal drafters from the Department of Health who had first drafted the Act and regulations would need to be included in the process of discussion and debate. However, he asked the Parliamentary Legal Advisers to provide comment.

Mr Gary Rhoda, Parliamentary Legal Adviser, said it was difficult to choose a framework within which to understand and interpret and law as raised in the debate. He had been in touch with the Department of Health to get comment on the issues of SAMA, but had not yet had a response. He felt that it was necessary to wait for this response and believed that it would also be beneficial for the Committee to engage with the DoH directly. The points raised were quite academic and technical, and it was likely that legislative amendments would be required to provide absolute certainty.

The Chairperson agreed that this was essentially a matter of legal interpretation.

Ms M Segale-Diswai (ANC) commented that it was vital that the members received the documents well in advance, so as to be able to engage fully with the delegates. She asked if SAMA had raised these points already with the DoH, and the Minister, when the difficulties were first discovered.

Ms M Dube (ANC) asked why these issues were not addressed during the drafting of the National Health Act, as if the clarity had been sought at that time, Parliament could have ensured that the wording adequately covered the issues.

Ms P Kopane (DA) said that whilst this presentation was very interesting, the Committee itself could not proffer an answer, and clearly the DoH comment and intervention was required. The Committee could not deal with every issue that came before it, on its own.

Ms D Robinson (DA) commented that she had for a long time felt that this Committee was not fully aware of what exactly was going on with the Department and called for a closer link between the Committee and the Department.

Ms B Ngcobo commented that the Department should bring subsidiary legislation to this Committee for ratification.

Mr Rhoda answered that there was now a Joint Committee on Delegated Legislation, responsible for the scrutiny of all delegated legislation and said that it was necessary that regulations and similar matters come to it, and that concerns were referred by this Committee.

Dr Sonderup, in responding to the points raised by Members, said that the SAMA had only been notified that this meeting had been arranged three days previously, but in future he would try to provide documents earlier.

He confirmed that there was constant interaction and meetings between the SAMA and the Department of Health, where these kinds of concerns were discussed. During the creation of the National Health Act, the parties were concerned with the main issues, and matters such as this were held back for a later stage. That was why they were being brought to the attention of the Committee only now.

The Chairperson reiterated that the only way to address these issues adequately would be to call the Department of Health to give a response to the concerns posed by SAMA.

The meeting was then adjourned.

Section 46 of National Health Act
Obligations of private health establishments  
46. Every private health establishment must 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.


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