The Department of Health said the Medicines and Related Substances Amendment Bill [B6-2014] amended the Medicines and Related Substances Control Act 101 of 1965. The Bill had been published on 20 February 2014 to establish a new South African Health Products Regulatory Authority (SAHPRA). The amendment of the Bill looked to provide for the establishment of a SAHPRA Board, address good governance structures for running the SAHPRA, and provide for transitional matters from the current Medicines Control Council (MCC) structure. The amended Bill also seeks to allow for the regulation of medical devices and in vitro diagnostics devices (IVDs), scheduled substances and complementary medicines.
The Committee asked questions relating to the removal of ‘scheduled substances’ in Section 35 of the Bill, and how the Bill should be adopted – clause by clause or as a blanket approval. A Member pointed out that the Bill had been tabled as a Section 76 Bill and not as a Section 75, as the Department had indicated in its presentation. Another Member expressed concerns that the amendments might open up spaces for corruption, and that there were not enough qualified, or skilled, people in the country to implement the Bill effectively.
Minutes of Committee meetings were adopted with a few minor changes. However, the Committee suggested that the Department should respond to concerns which had been previously raised by the Committee.
Department of Health (DoH) briefing
Dr Joey Gouws, Registrar: Medicines Control Council (MCC), said the Medicines and Related Substances Amendment Bill [B6-2014] amended the Medicines and Related Substances Control Act 101 of 1965. The Bill had been published on 20 February 2014 to establish a new South African Health Products Regulatory Authority (SAHPRA). The amendment of the Bill looked to provide for the establishment of a SAHPRA Board, address good governance structures for running the SAHPRA, and provide for transitional matters from the current MCC structure. The amended Bill also seeks to allow for the regulation of medical devices and in vitro diagnostics devices (IVDs), scheduled substances and complementary medicines.
The Minister of Health, Dr Aaron Motsoaledi, had tabled the Bill as Bill 6B of 2014 for its second reading on 13 August 2015. It had been tagged as a Section 75 Bill and had been referred to the National Council of Provinces (NCOP). After the Bill had been discussed by a number of legislators, some amendments had been made. However, the Bill had been voted in favour, as Bill 6D of 2014.
The amendments by the NCOP, as per Bill 6C of 2014, included:
- Technical amendments to Section 28 to correct sub-section 3.
- Technical amendments to omit the wording “Medical Devices” and replace it with “Scheduled Substances, medical devices” in Section 35(e).
- Editing of the numbering to refer to both sub-section (5) and (6).
- Editing to correct numbering and to delete 2 and replace it with 3.
- Technical correction to omit reference to “food control.”
- Editing to correct numbering and to delete 4 and replace it with 5.
- Editing to correct numbering and to delete 5 and replace it with 6.
- Editing to correct numbering and to delete 6 and replace it with 7.
- Editing to correct numbering and to delete 7 and replace it with 8.
The Bill 6D of 2014 was intended to consolidate Bill 6B and Bill 6C.
Dr Precious Matsoso, Director General: Department of Health (DoH), added that the Department had also participated in the public hearings which had been organised by the Select Committee.
Mr A Mahlalela (ANC) corrected the Department, and said that the Bill had been tabled as a Section 76 Bill and not as a Section 75, as the Department had indicated in its presentation.
Mr I Mosala (ANC) said that he had been under the impression that the presentation would indicate the amendments which had been presented by the Portfolio Committee and the NCOP to the National Assembly. He thought that department would indicate the different proposed amendments which had been made by the different legislatures, and the State Law Advisor (SLA) would explain which proposals had been chosen so that the Bill could achieve its goals.
Mr H Volmink (DA) asked, in terms of procedure, whether the Portfolio Committee would have the opportunity to go through each of the amendments proposed by the NCOP.
Ms Matsoso replied that the Department had consulted with the State Law Advisor on the different proposed amendments, and had discussed which amendments fitted the Bill correctly for the purpose which it wanted to achieve.
Mr Volmink said the amendment of Section 35 of the Bill 6D proposed the removal of scheduled substances. What was the rationale for this amendment and what was the purpose of the separation of scheduled substances and medical devices?
Dr Gouws said that when one looked at the regulation on scheduled substances, it talked about fees which were paid to the Authority for the registration of medical devices and IVDs, and this also included the registration of scheduled substances. The Authority was not intent on registering a scheduled substance, since it was an active ingredient -- they could not register a substance that was used to make medicine. The Bill would be registering only medicines, and not substances, and the separation of medical devices and scheduled substances allowed for the Minister to establish separate legislation for which each product could be regulated.
The Chairperson said that the Bill needed to be adopted.
Dr P Maesela (ANC) moved the adoption of the Bill, with its amendments.
Dr W James (DA) seconded the motion for the adoption of the Bill.
Mr Mahlalela said that he thought the Committee would go through each clause of the Bill, and adopt each clause separately.
Dr Barbra Loots, Parliamentary Legal Advisor, said the actual changes to the Bill could be adopted altogether, but the Chairperson could decide on how the Bill was to be adopted.
Dr James said that he seconded the adoption of the Bill as a blanket approval.
Dr H Chewane (EFF) agreed with Mr Mahlalela that each clause of the Bill should be adopted separately. The Bill was good and should already have been implemented, but he did have some objections and the Committee should note them.
The Chairperson said that the objections were noted.
Mr Mosala said that Dr Chewane was making a different statement from the one that he had made in the National Assembly, where he had agreed with the amendments to the Bill. However, now he was saying that he had objections to the Bill.
The Chairperson said she was glad that another Member of the Committee had picked up that Dr Chewane had changed his statement regarding the Bill.
Mr Mahlalela asked what the ideology was to which Dr Chewane was referring to. What did ideology have to do with technical amendments to a Bill?
Dr Chewane said the idea of improving the MCC through the Bill was accepted by the Economic Freedom Fighters (EFF). The EFF rejected the Bill on the basis that it would open up spaces for corruption and there were not enough qualified, or skilled, people in the country to implement the Bill effectively.
Dr Maesela said that Dr Chewane was missing the point of the meeting. The issue of whether there were enough qualified people in the country to implement the Bill was not up for discussion at the meeting. The agenda of the day was to adopt the Bill.
The Chairperson concluded that the Bill had been adopted and the objections of the EFF had been noted -- although it was not clear as to what the EFF was objecting to.
Dr Chewane said the Chairperson could not close the meeting by saying that the EFF had objections to the Bill. That would be seen as a form of oppression.
Dr James said that the proper procedures for adopting the Bill had been followed, so the Member could not object to the adoption of the Bill.
Adoption of Minutes
Minutes of 27 May 2015
Dr James moved the adoption, and Dr Maesela seconded.
Minutes of 10 June 2015
Dr James said that the last bullet point under number four should be included with the words “lack of access”.
Mr Volmink moved the adoption, and Mr Mosala seconded.
Minutes of 5 August 2015
Dr James moved the adoption, and Dr Maesela seconded.
Draft Minutes of 12 August 2015
Dr James said, referring to the agenda, his surname should be written without the apostrophe ‘s’.
Mr Volmink said that the reservations which had been raised by himself and Dr James should be added under number four.
He moved the adoption of the minutes, and Mr Mosala seconded.
Minutes of 21 August 2015
Mr Mosala moved the adoption and Ms L James (DA) seconded.
Dr James pointed out that Ms James had not attended the meeting, therefore she could not propose adoption of the minutes. He seconded the adoption himself.
Minutes of 13 October 2015
Dr Chewane said that his surname had been spelt incorrectly in all the minutes. He asked that this be corrected.
Mr Mosala moved the adoption, and Mr Volmink seconded.
Minutes of 14 October 2015
Dr Maesela moved the adoption, and Mr Volmink seconded.
Minutes of 15 October 2015
Mr Mosala moved the adoption, and Ms James seconded.
Minutes of 27 October 2015
Ms James moved the adoption, and Mr Mosala seconded.
Dr Maesela asked what would happen to the concerns which the Committee had raised. Would they be followed up and would the Department submit in writing to the Committee on what they had done to resolve their concerns.
The Chairperson replied that the Committee staff would make a follow up with the Department.
Dr Chewane said he agreed with Dr Maesela that a follow up had to be done, and the Committee’s concerns, as well as the responses from the Department, must be captured in the minutes as well.
The meeting was adjourned.