The session was attended by the Minister and Deputy Minister of Health, as well as representatives from the Departments of Social Development and Health.
The final mandates were presented from the provinces in respect of the Prevention of and Treatment for Substance Abuse Bill. A special delegate from Kwazulu-Natal informed the Committee that she had no authority to vote on the Bill, as this province considered that it could not confer a final mandate before it had seen a Bill with amendments. This point was debated, and it was agreed that in future it would be useful to send through a draft C-version to the provinces. Western Cape and Limpopo had some concerns but had supported the Bill. The Bill was adopted by eight of the nine provinces.
The Committee then received public submissions from the Treatment Action Campaign and Innovative Medicines South Africa on the Medicines and Related Substances Amendment Bill. Each highlighted what it saw as the shortcomings. The Treatment Action Campaign noted what it regarded as an inappropriate allocation of unchecked powers over the regulation of medicines and other health products to the Minister. The Bill failed to provide Parliament with appropriate oversight over the new body tasked with the registration of medicines, and to ensure that the South African Health Products Regulatory Authority would function as an independent government agency. The Campaign proposed amendments to the structure and mandate of the Authority, criteria and processes for the appointment of the Chief Executive Officer and other Authority staff, and the power of the Minister to exclude medicines or other health products from aspects of regulation. It further proposed that two clauses be inserted to strengthen and guarantee the Authority’s independence, and ensure that Parliament retained oversight over the Authority.
Innovative Medicines South Africa was concerned that the appeals process would not be implementable, and raised constitutional and administrative challenges. The success of the appeals process depended on clarity on the structure of the Authority, and on decision-making powers and timelines.
The Department of Health agreed that some of the proposed amendments could be included in the Bill. It then proposed amendments to the revised Section 2 of the principal Act (Clause 2 of the Bill), noting that the Authority was an organ of state outside the public service, and must perform its functions without interference from any person. It also proposed a new Section 4, dealing with the powers and functions of the Advisory Committee around governance. The Department conceded that there was problem with the structure of the appeals committee, and suggested that the Minister, not the Authority, appoint the appeals committee. Members were concerned about the proposed new Section 2(4), noting that it would surely be unconstitutional for the independence of the Authority to be too broad. Members called for clarity on the disqualification for appointment to the Authority, why the Department proposed giving the responsibility of the appeals process to the Minister, further clarity on the Advisory Committee and its real powers, and the necessary checks and balances. The DA urged the ANC to learn from previous mistakes and be very cautious in the wording of the Bill. It was decided that the Department must revert to the Committee on the following day, with new wording to incorporate the suggestions from Members and the public submissions.
The minutes of the meeting on 14 October were adopted.
Prevention of and Treatment for Substance Abuse Bill (the Bill): Final Mandates
The Chairperson asked the provincial delegates to read out their final mandates.
Ms A Qikani (UDM, Eastern Cape) informed the Committee that the Eastern Cape voted to adopt the Bill without amendments.
Mr T Setona (ANC, Free State) stated that the Free State voted in favour of the Bill without any amendments.
Ms F Mazibuka (ANC, Gauteng) stated that Gauteng voted in favour of the Bill, without amendments.
Ms S McKay (Special delegate from Kwazulu-Natal) informed the Committee that her province had noted the agreed amendments in the draft minutes of the Select Committee. However, this province had not received an amended Bill containing these amendments. The province therefore agreed not to confer its final voting mandate until it had received a Bill as amended in accordance with the agreed proposals. She pointed out that it was difficult for provinces to proceed with final mandates if they did not have the amended Bill.
The Chairperson asked the State Law Adviser to comment on the matter.
Mr Malusi Ncolo, Senior State Law Adviser, Office of the Chief State Law Adviser (OCSLA), stated that it was often difficult to draw up a C-version or D-version of the Bill for the provinces to consider. An internal discussion was needed for Members to rectify the situation.
Ms McKay stated that the province had never given a mandate on a Bill that they had not seen, and in this regard she believed they had followed the correct processes. The province could not accept a Bill if they had not seen the final version of it.
Mr M Thetjeng (DA, Limpopo) stated that provinces were sometimes “compromised” when the Committee wanted to save on time. He added that the Committee needed to follow the correct procedure when it came to final mandates.
The Chairperson supported Mr Thetjeng’s statement, as the Committee could not rush finalising the Bill.
Ms Phumelele Ngema, Senior State Law Adviser, OCSLA, explained that when the Bill was sent to the provinces, there was still the possibility of further amendments. Therefore, it was not viable to have the D-version of the Bill drawn up at that particular time. The final mandate should be based on the C-version of the Bill and the proposed amendments. It was impossible to have a D-version while Members deliberated on amendments.
The Committee Secretary stated that there was no problem with having a draft C or D-version. The Committee Section was willing to have draft Bills ready for the provinces when they discussed their final mandates.
Mr B Tolo (ANC, Mpumalanga) agreed that this would be a good idea.
The Committee concurred.
Mr Thetjeng stated that the Limpopo province had voted to adopt the Bill, but had made a few recommendations. It recommended that the Bill should create a coordinated programme to control liquor outlets and ensure the enforcement of law governing liquor and drug sales. The legislation should consider institutions for prevention of substance abuse and the Bill should state how the Community Home Based Caregivers would be compensated. Liquor stores should have regulated standard opening and closing times, and the collaborative approach amongst government departments and other stakeholders involved in combating substance abuse should be regulated.
Mr Tolo informed the Committee that Mpumalanga voted in favour of the Bill, with the proposed amendments.
The Chairperson stated that the North West resolved to accept and support the Bill, without making further amendments.
Mr M Sulliman (ANC, Northern Cape) stated that he was concerned that he had only received the province’s mandate during the meeting. He preferred receiving the mandate before the time so he could study it. He stated that he would have to sort out this issue with his province. The Northern Cape voted in favour of the Bill with the proposed amendments.
Ms H Lamoela (DA, Western Cape) stated that the Western Cape supported the Bill, but recommended that certain amendments be made to sections of Chapter 1, 6 and 8 in the Bill, as set out in the final mandate (see attached final mandate for details).
Mr Tolo reminded the Committee that the if the various provinces’ proposed amendments were not included in the final amendments, then it meant that the proposed amendments were not agreed. The provinces’ had to vote for or against the Bill in their final mandates; and should not be bringing further proposals in those final mandates.
Mr Sulliman suggested that the provinces receive some time to deliberate on the C-version of the Bill.
Mr Setona disagreed, saying that if the Committee agreed with Mr Sulliman’s proposal, they would be delaying the process.
Ms Mazibuka stated that there were more than six provinces that had final mandates supporting the Bill; the Committee could therefore proceed with the Bill.
Mr Thetjeng reminded the Committee that the amendments were available to the provinces. KwaZulu Natal could have used the document setting out the proposed amendments together with the Principal Act, to draw up its final mandate.
Ms McKay stated that the province had acted on the advice of a legal adviser to the province.
The Chairperson asked if there were six mandates in favour of the Bill.
The Committee Secretary answered that the Western Cape had some concerns with the Bill, however they supported the Bill. Even without the KwaZulu Natal vote, there were therefore eight out of nine provinces that supported the Bill.
Mr Ncolo pointed out a technical error in the Bill. He noted that the Bill spoke of “state organs" in Clause 3(1), but stated that this must be changed to “organs of State” as this was the way it appeared and was defined in the Constitution.
The Chairperson stated that the error should be corrected.
The Chairperson read out the Motion of Desirability, which Members agreed to.
The Chairperson then read out the amendments clause by clause, and Members agreed to them.
Members thereafter adopted the Bill.
Medicines and Related Substances Amendment Bill (the Bill): Public submissions and deliberations
Public Submission by Treatment Action Campaign (TAC)
Mr Zackie Achmat, founder and Chairman of the Treatment Action Campaign, stated that the Treatment Action Campaign (TAC) and the AIDS Law Project (ALP) welcomed the opportunity to make submissions on the Bill. The TAC was available to assist the Department of Health (DoH) and Parliament to ensure that the Health Products Regulatory Authority (the Authority), as envisaged in the Bill, was appropriately empowered to fulfil its mandate, free from political and commercial interference.
Mr Achmat noted that the TAC wished to highlight a few shortcomings in the Bill. The first was the inappropriate and arguably unconstitutional allocation of broad unchecked powers over the regulation of medicines and health products that was being given to the Minister of Health. The second shortcoming was the replacement of the Medicines Control Council (MCC) with an authority that was initially designed to operate as a line function within the DoH, rather than as an independent government agency. The third matter was the Bill’s failure to provide Parliament with appropriate oversight over the new body that was tasked with the registration of medicines and other health products.
The Bill fell short of ensuring that the Authority would be able to function as an independent government agency. The Bill needed to provide more detail on the structure and nature of the Authority, and the appointment of the Authority’s Chief Executive Officer (CEO). Parliament should be given a much stronger oversight role. The Bill failed to address concerns regarding the Minister’s power to exclude medicines and other health products from the operation of all or part of the Act. The Authority would now be able to make recommendations to the Minister about the exclusion of medicines and other health products. The TAC was concerned that the power to exclude could be used inappropriately to advance political or commercial interests.
The TAC therefore suggested that there was a need to amend the structure and mandate of the Authority so that it was truly independent, and so that Parliament retained primary oversight over the Authority. Greater independence demanded greater accountability. The Bill made no mention of a governance structure for the Authority, which Parliament could call upon to account. Instead, the Authority was required to report and account directly to the Minister of Health. It was inappropriate for such broad discretions to be allocated to the Minister. The TAC asserted that while the Authority should liaise with the DoH and report to the office of the Minister, it should account directly to Parliament.
The TAC also wanted the Committee to amend Clause 3 of the Bill, which dealt with the appointment of the CEO. It would like to see additional checks and balances placed on the Minister’s powers over the appointment, management and supervision of the Authority’s staff. The National Assembly (NA) should play a central role in the appointment of the CEO. Further clarity was needed on the qualifications for appointment to the Authority.
Mr Achmat then turned to Clause 41 of the Bill, which looked at the power of the Minister to exclude medicines or other health products from regulation, at the recommendation of the Authority. This again did not reflect the right checks and balances, because instead of an independent body making the recommendation, the CEO, who reported directly to the Minister, would make that recommendation.
The TAC also proposed that two new clauses be inserted in the Bill. The first would deal with the recognition of other stringent regulatory authorities in certain limited circumstances. If agreed to, this would allow for increasing access to products of proven quality, safety and efficacy. The second addition dealt with access to information in accordance with the Constitution, and was designed to ensure greater transparency and accountability of the Authority.
Mr Tolo wondered if the TAC thought that a Board was needed to oversee the Authority’s functions.
Mr Achmat stated that it was critical that the Authority had a body that would perform an oversight function. A body was needed to assist the CEO in the Authority, to see that regulation processes were followed properly. This would then enable Parliament and the Minister to ensure that the Authority’s functions were being fulfilled.
Innovative Medicines of South Africa (IMSA): Submission
Ms Val Beaumont, Executive Director, Innovative Medicines South Africa stated that the main concerns of Innovative Medicines South Africa (IMSA) centred around the appeals process in the Bill, set out in the proposed Section 24A. IMSA was concerned that the process would not be implementable and would lead to litigation and challenges based on administrative law and constitutional law. It therefore requested further clarity on this process, as set out in their written submission (see attached document).
IMSA was concerned also that the CEO would be appointing the appeals committee, although the CEO was already involved in the process. It was recommended that the Appeals Committee be appointed by the Minister of Health, and that its members be appointed from amongst experts in the specific field that formed the subject of the complaint.
IMSA also wanted the Bill to clarify the powers of the Authority, CEO, staff and committees. It called for Clause 30 of the Bill to be reviewed and amended to create certainty as to who would make final decisions, and who would make final recommendations. It sought more clarity on what “accountability” entailed in the clause. IMSA suggested that the provisions of Clause 30(1) to 30(3) be removed, as these violated many administrative law and constitutional law principles. IT questioned the rationale was for an appeal process against the Director General (DG) to be dealt with differently from the appeal process against the decision of the Authority. It proposed that both types of appeals be dealt with the same way.
Mr Tolo asked if the TAC’s proposed amendment to Clause 2 of the Bill would satisfy IMSA.
Ms Beaumont stated that Clause 2 could be structured in such a way that all parts of the structure of the Authority would be clearly defined, and she recommended that there was a necessity to achieve the clear definitions.
The Chairperson stated that the Committee would deliberate on the presentation and respond to IMSA.
Department of Health Briefing
Mr Sello Ramasala, Head: Legal Services, DoH, tabled and read through the amendments made to the Bill by the Portfolio Committee on Health.
Mr Ramasala informed the Committee that the Bill introduced a regulatory authority that would replace the MCC. The Authority was subject to the Public Finance Management Act (PFMA), which would mean that it would become a public entity. The Authority would regulate medicines, medical devices and foodstuffs containing medical products.
The Chairperson noted that the Committee could not deliberate on the Bill in the short time that was left for the meeting, and therefore asked that the Department return later in the day, and in the meantime look at the recommendations made by stakeholders, to see if they could be incorporated in to the Bill.
On resumption of the session later than afternoon, Mr Ramasala noted that a number of amendments proposed by the TAC and IMSA could be incorporated into the Bill, as they would enrich it and make some of the concepts more clear. He proposed that this Committee could consider making amendments to the process of appointment of the CEO to the Authority and the body or structure that would assist in the governance of the Authority.
The Department proposed that Clause 2 should be amended. The proposed replacement Section 2(1) of the Medicines and Related Substances Act (the principal Act) should be amended to include the words “as an organ of state within the public administration but outside the public service” after the word “established”. The proposed new Section 2(2)(c) would be deleted. Two more subsections would be included, before the new Section 2(3), which would then be re-numbered. The first new subsection (3) should read: “The Authority may enquire in to, report on and make recommendations to the Minister on any matter relating to the implementation or application of this Act”. The next new subsection (4) would state “The Authority shall perform functions assigned to it in terms of this Act without any interference from any person”. The numbering of the former Section 2(3) would then become 2(5).
The Department also addressed the concept of the Advisory Committees. It proposed to include a section on Advisory Committees, which would substitute the existing Section 4 of the principal and would address governance issues in the Authority. (See document of Proposed Amendments) The Minister would establish advisory committees to advise him or her and the Authority on matters concerning the governance of the Authority. The Advisory Committee would consist of eight persons who were not connected to the Authority in any way. The Minister would appoint a Chairperson and Deputy Chairperson of the Advisory Committee after consultation with all the members in the advisory committee. The members would have the appropriate skills, knowledge or experience and the ability to perform effectively. Even though this Committee would advise on governance issues, it would not interfere with the functions of the Authority.
The Department also acknowledged that there were problems with the way that the appeals committee was structured. They proposed that it would be possible to revert back to the process where the Minister appointed members to the appeals committee.
Mr Setona wanted more clarity on what the Department was proposing for the new Section 2(1). He was also concerned that the Authority was too independent and was not accountable to the public. The proposed new Section 2(4), which stated that the Authority was to carry out its functions “without interference from any person”, was disturbing, as it meant that not even the Minister could interfere.
Mr Ramasala explained that the South African Health Products Regulatory Authority (SAHPRA) would be established as an organ of State, within the public administration. This meant that the Authority would not be part of the private sector. It would have a public mandate and be established in the public sector.
Mr Setona stated that this sounded clumsy.
Mr Ramasala stated that the Department understood that the new Section 2(4) was not an easy issue to address. However, the Authority had to be able to exercise its functions without interference.
Mr Thetjeng thought that the changes the Department was proposing would assist at governance level. He addressed the new Section 3(2)(c) and asked for more clarity on what “and sentenced to imprisonment without the option of a fine” meant. He also suggested that the Department could classify the type of offences that they were referring to.
Mr Ramasala answered that usually when people were found guilty of offences without the option of a fine, it meant that they were involved in serious offences. The Bill was trying to exclude those people convicted of serious crimes from applying for positions in the Authority.
Mr Thetjeng recommended that the proposed new Section 2(4) be rephrased. In terms of the appeal committee, there were still some issues that needed to be resolved. The Committee still needed clarity on appeal procedures.
Mr Sulliman also addressed the proposed new Section 2(4), saying that the part stating “without any interference from any person” was unconstitutional, as Parliament had the authority to call anyone to account to it. He also wanted to know why it was necessary to give the responsibility of the appeal process to the Minister.
Mr Ramasala stated that the Minister previously had the responsibility over the appeals process, as it was structured this was in the principal Act. The new Authority would appoint members to the appeal committee. However, if the Committee was not happy with this, they could revert back to the previous situation, in terms of which the Minister appointed the appeal committee.
Mr Ramasala pointed out that in terms of the appeals process, regulation of medicines was part of policy implementation. Therefore, the Minister had to be involved, being part of the Executive and responsible for implementing policy. This meant that the Minister also had to be involved in the appeals process.
Mr Setona stated that he understood the difficulty with the proposed new Section 2(4). He understood that the functions of the Authority could not be interfered with. However, he felt that the Department needed to find a middle road, as the Authority needed to be accountable to somebody. The Authority was an extension of a selected Executive. Currently its independence was too broad, and this would constrain the Minister in the future.
Mr Tolo stated that he needed more clarity on what the concept of “Advisory Committee” meant. He suggested that a definition of this must be included in the Bill. He also wanted more clarity on what “public administration” meant.
Ms Ntombe Mnyikiso, Senior State Law Adviser, OCSLA, stated that the concept of the Advisory Committee would be included in its own section, and not under the more general definitions in the Bill.
Mr Ramasala suggested that the new Section 2(4) should read “as an organ of State outside the public service”, as including the words “public administration” would be tautologous.
Mr Thetjeng stated that it seemed that the Advisory Committee was a “toothless body” that would only be needed when the Minister required it. He still did not think that there was proper governance in place. He thought that the Advisory Committee was proposed just for window dressing and it did not really address any of the governance issues. He urged Members not to adopt a principle that they would eventually regret. He noted that the CEO was still not accountable to anyone except the Minister. Furthermore, the roles in the Advisory Committee had to be defined.
Mr Ramasala stated that the Advisory Committee’s mandate was clear, and a Board or Council would not be created. The Committee would simply advise the Minister and the Authority. The Advisory Committee did not make decisions, but it simply advised on matters. The Authority was a public entity; therefore oversight by Parliament would be executed through the Minister. He did not see this oversight role being diminished in any way.
Mr Thetjeng responded that he was not calling for a board or a council. There were checks and balances needed for the Authority to be accountable. The CEO of the Authority should be accountable to Parliament and report to the Minister. He found the accountability process lacking.
Mr Tolo noted that the reference to the Authority as an “organ of State” meant that it was accountable to Parliament and subject to the PFMA.
Mr Setona agreed, saying that Mr Thetjeng had to look at the definition for “organ of State”. It presupposed accountability to Parliament.
Mr Thetjeng urged the Committee and the Department to learn from the issues being raised. This Bill had to serve the community, and Parliament had to be able to hold its executives accountable. The governance issue in the Bill was still worrisome. He stressed that the Advisory Committee that the Department proposed was unacceptable, as it was not even defined.
Mr Sulliman pointed out that Mr Thetjeng was speaking on behalf of the DA, and not on behalf of the entire Committee.
Mr Thetjeng then corrected his previous comment, saying that, in his capacity as a DA Member, he believed that the ANC should learn from previous mistakes. The Authority that the Department proposed was unacceptable. There should be an Authority and CEO who would be accountable to Parliament. Checks and balances were needed.
Mr Setona asked if Mr Thetjeng could come up with a proposal that the ANC could deliberate on.
The Chairperson asked Mr Thetjeng to give his proposals to the State Law Adviser so that she could prepare a document. The Department would then deliberate on the proposal. She also noted that the Committee also needed formal proposals from other Members. She said that the Bill would be finalised on the following day.
Adoption of Minutes
The minutes of the meeting on 14 October 2008 were adopted.
The meeting was adjourned.
- Department of Health’s Proposed Amendments
- Innovative Medicines South Africa submission
- Department of Health’s Report on Amendments made to the Bill by Portfolio Committee on Health
- Treatment Action Campaign submission
- Western Cape Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- North West Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- Northern Cape Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- Mpumalanga Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- Limpopo Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- Kwazulu-Natal Final Mandates on Prevention of &reatment for Substance Abuse Bill
- Gauteng Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- Free State Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- Eastern Cape Final Mandates on Prevention of &Treatment for Substance Abuse Bill
- We don't have attendance info for this committee meeting
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