The Committee continued with its deliberations on Clause 4 to 10 of the Medicines and Related Substances Amendment Bill which proposes that the regulation of medicine and related substances should be controlled by a new entity, the South African Health Products Regulatory Authority, responsible to the Minister, rather than by the Medicines Control Council. Members felt that the independence of this body might be questioned but a discussion on the degree of independence was deferred. It was agreed that the Bill needed to provide more definition on the Authority as what was in the Bill was all about the legal structure but there was nothing about its operational and implementation structure.
The Director General noted that all reference to certification would be omitted. It would be kept as registration only. This would simplify the legislation. Registration would be defined.
There was much discussion on the need for clear definitions of ‘medicine’ and medicinal ‘product’. It was agreed that a lot of rewording was needed and that there were many consequential amendments.
The Committee continued deliberations on the Bill, keeping in mind the public submissions and the Department's amendment document:
Clause 4 Repeal of sections 4, 5, 6, 7, 8, 9 and 12 of Act 101 of 1965
The Chairperson said that Clause 4 suggested that Sections 4, 5, 6, 7, 8, 9 and 12 of the principal Act (Act 101 of 1965) should be repealed. Innovative Medicines SA (IMSA) had made a counter-suggestion that these sections should in fact be retained.
Dr R Rabinowitz (IFP) said that a recommendation had been made by Pharmaceutical Manufacturers' Association of South Africa (PIASA). PIASA had recommended that the Bill look to set standards. They should also help the Authority to retain a degree of independence. So much money and time had been spent on the South African Medicines and Medical Devices Regulatory Authority (SAMMDRA) Act that it was sad that it had been ditched on a technicality.
Ms R Mashigo (ANC) asked if the Committee could be given clarity on the reason for these sections being repealed.
Mr Thami Mseleku (Director General (DG), Department of Health (DoH) said that the principal issue was that this would be a different kind of authority. The current arrangement was that there was a Council in place, and members were appointed to serve on this Council. Section 4 of the principal Act determined the period of office and remuneration of these members. The Council would no longer exist. In its place the Authority would be established with an Executive Committee and sub-committees. There was therefore no need to refer to the Council or a board. Section 5 of the Act dealt with the Chairperson and the Vice Chairperson. The Authority would be of a more permanent nature. All of the sections mentioned in Clause 4 were applicable to the Council.
He said that the Authority would employ officials and appoint advisory committees. There would be an Executive Committee under a Chief Executive Officer (CEO). The DoH had taken the approach that they would not establish an agency which was totally separate from the Department, so the PIASA proposed amendment was not needed. The Executive would be accountable to the Minister. No governing structure was needed.
The Chairperson said that a paradigm shift was needed. The Authority would have an Executive which would have certain powers.
Ms Mashigo said that Section 12 of the principal Act referred to the role of a registrar. The new Authority would register medicines, but she asked who the registrar would be.
The Chairperson said that registration would be submitted by the CEO.
Ms S Kalyan (DA) asked if there was any precedent for the establishment of an authority. This body would have executive powers. She asked where these were mentioned in the Bill. She could only see references to the CEO’s functions.
Mr M Walters (DA) said that this clause would repeal sections of the principal Act, but nothing was there to replace anything. There was one chapter in the Bill regarding the CEO, but nowhere was the structure of the Authority described.
The DG said that there were agencies such as the South African Social Security Agency (SASSA) which had a CEO and supporting staff. This body did not fall under the DG of the Department of Social Development, but had a direct link to the Minister. The South African Revenue Service (SARS) was a similar body. The only way to capture all the powers of the Authority in one place would be to write a clause.
He said that on page 3 of the Bill there was provision for the appointment of the CEO and other staff. On page 4 there was a provision that the CEO could appoint suitably qualified staff. There was a distinction. Structural arrangements would be left to a decision by an advisory committee. Section 3(7) gave the CEO the power to appoint committees. It would be a collective authority with a staff establishment and supporting committees.
Dr Rabinowitz said that this debate had been held already. The DG had undertaken to bring amendments to the Bill about various criteria. There were issues on pages 6, 7 and 8 of the Bill. She asked if the submission by PIASA had been incorporated. The Authority needed a vision and goals by which it could be judged.
The Chairperson said that the SALDA submission had made him think
Dr Rabinowitz said that the Bill was all about the legal structure of the Authority but nothing about the operational and implementary structure.
Mr Walters said that there were two separate issues. The comparison of the Authority to SASSA and SARS did not take into account that the Minister did not have so much power with these bodies. SASSA only conducted a pension test after which those who qualified were processed by the Department. He suggested that professional bodies should decide on medication.
The Chairperson said that the Members were trying to put the “horse before the cart”.
Mr Walters said that if the principle was not accepted then the Committee could not debate the structure.
The Chairperson said that they were not there yet. They were still defining the Authority. Mr Walters wanted to define already what would happen subsequently. They would get there later.
Ms Kalyan said that she would defer the question of independence. In the presentation made by the DoH it was said that there would be a CEO and four sub-committees. She wanted to know about the qualifications of those who might be appointed to these committees. It was only said who could not be appointed. She asked what the minimum qualification would be. In order to have an efficient, functional body the minimum qualification should be prescribed.
The DG said that he wanted to go back a bit. The Committee could not decide, in his opinion, on the size of the Authority in terms of numbers. The law should prescribe qualifications. The powers granted to the Authority would lead to accountability. Therefore the role of the CEO would be to act as the accounting officer for the body. This person should be empowered to bring structure to the organisation. Termination of service of any member would have to be in accordance with the labour laws and the provisions of the Public Finance Management Act. The Committee would have to strengthen these areas.
He said that Section 3(1) of the Bill mentioned that the CEO must be a suitably qualified person who would be appointed by the Minister. The qualifications necessary in any organisation were dependent on the phase of development it was going through. There were a whole range of issues involved. A person should be suitably qualified in a broad sense.
Section 3(3) dealt with the appointment of staff. They should be suitably qualified. Anyone could challenge the credentials of such people but the person making the appointment should make the final decision. Different skills were needed at different times. Various functions of the Authority would become manifest in the text of the Bill.
The Chairperson noted that the CEO of SARS was in fact a qualified pharmacist, and that of SASSA a lawyer. The DG was correct. A person was appointed at a given time to address a given need. What the Committee might consider was the capacity of the Authority, and if any person could in fact do the job of furthering the efficiency and safety of the body.
Mr Humphrey Zokufa (Managing Director, BHF) emphasised the need for safety, efficiency and quality.
Dr Rabinowitz heard what the DG had said and accepted his point in many respects. If there was not an insistence on qualifications, then government should try to create a body that was efficient and safe. The structure was not clear to her. People would come and go. The DG should write an amendment to this Clause. This would describe the functioning of the Authority and provide guidelines. She did not have the feel of a fixed, accountable and durable structure. This might be contained in an amendment to the Bill.
The Chairperson said that this might become an albatross around government’s neck. The Act was there to regulate all aspects of drugs. One could look at the factors which might disqualify a person. PIASA had recommended a two tier system. Philosophical and political discussion was needed over this.
Ms M Madumise (ANC) said that they should move with a two tier system.
The Chairperson said that this had been recommended in the submissions. PIASA had expressed the need for assurance. The process ended when the Authority would certify a product. He mandated the DoH team and the State Law Advisors (SLAs) to draft alternative wording. Clause (1) said that the Authority was responsible for the safety and administration of drugs. There might be objections. The Authority could not be God. Stakeholders might want to challenge decisions. There had to be an open loop of objections to the Minister.
Mr Ngculu said that Clause 3(7) dealt with a faster resolution mechanism. The Minister could set up a committee to look at these matters and objections. The Authority was given those powers in the regulation of drugs. The legislation had to allow objections being lodged with the Minister, who could set up an advisory body.
Dr Rabinowitz said that this was an excellent proposal. The Chairperson was not a doctor himself but showed an understanding of the issues. The Minister should have an active role.
Mr Walters was very happy with a single tier system. The Authority would register medicines. There was a right of appeal to the Minister. A fixed period should be set to lodge such objections. He feared that the devil might be found in the detail.
The Chairperson noted the support of opposition parties for this proposal and also noted the support of ANC members.
Mr Lello Ramasala (Chief Director, Legal Section, DoH) asked if the proposal was that any person who was unhappy could appeal to the Minister or to a committee.
The Chairperson said that the appeal would go to the Minister who would appoint a committee to investigate.
The DG said that in that case the principle could be taken for granted in the further discussion of the Bill. They could not discuss the Bill without this provision.
Dr Rabinowitz said that if the Minister were to appoint a committee there should be some qualification for membership. The committee could not simply be a mouthpiece for the Minister.
The Chairperson asked the Members if they agreed not to repeal the sections in the principal Act.
Dr Rabinowitz said that they could not be left out until the DoH had given the Portfolio Committee an amendment.
Mr Walters said that there were many amendments to the Bill. The deliberations would flow quicker if the Members had an updated document in front of them.
Dr Rabinowitz said that they should continue with the meeting. They were teasing out more issues, and would have to return at a later stage in any event.
Mr Walters said that Clause 4 should be flagged.
The Chairperson said that this body would now be a single Authority. It was no longer a board, and it was a completely different situation.
Mr Walters said that the sections could not be repealed until the Members could see what would succeed them.
The Chairperson said that PIASA had made proposals for a two tier structure and the role of the Minister. He would like to tease these out. There were a number of consequential amendments. The sections to be repealed by this Clause were no longer relevant.
Dr Rabinowitz supported this proposal. The sections should be repealed. The DoH would provide an amendment.
The Chairperson said that this input was helpful.
Ms Ntombebandla Mnyikiso (SLA) said that they had looked at the amendment and would study it in greater detail.
The Chairperson said that the Committee agreed that the sections mentioned in this Clause should be repealed.
Clause 5 Substitution of section 13 of Act 101 of 1965
Mr Mseleku suggested that 13(a) and (b) as it appeared in the Bill could be combined. Sub clause (a) dealt with certification and (b) with registration.
Ms Kalyan said that a product could be certified for use in South Africa and in other countries. In the latter case it might not be registered in South Africa. She asked what protection there was to prevent loopholes from being exploited.
Dr Rabinowitz asked if there could be a situation where a medicine was certified but not registered. She asked if this could apply to traditional medicines or even to substances such as marijuana.
The DG said that it could be kept as registration. All reference to certification would be omitted. This would simplify the legislation. Registration would be defined. Sub clause (a) could then be deleted and the current (b) reworded to read “registered by the Authority”. There were reciprocal arrangements with other countries. There was a risk built into agreements. They had access to documents issued by the FDA, but there was limited liability. Registration would suffice.
Dr Rabinowitz said that it would be useful to decide on a definition. All the categories of product being addressed by the Bill had a different process. Clarity should reside in the Bill and not be left for the regulations. Medicine had to be defined. There was a good definition of complementary medicine and medical devices.
Mr Ramasala said that the South African Medical Database (SAMED) and SALDA had each provided thick documents.
The DG said that the issue of definitions had been flagged. They should perhaps define medicine in a broad fashion. This could include complementary and African traditional medicines amongst other aspects. There was a broad concept of a product. Medicine could be anything. They would have to define the sub categories as well.
The Chairperson said that medical devices would be deleted from the definition of a product, and would be defined separately. They had come up with this conundrum but this change had made things easier.
Dr Rabinowitz said she was trying to get clarity on this cloudy issue. They would have to deal with a difficult situation. They had said that the issue would be dealt with by scheduling. This was not an appropriate vehicle as scheduling only dealt with the handling of the product. Since the 1960s there had been an issue of the claims made by manufacturers of medicine. If the definition was removed then what was simple would become complicated. Returning to her example of marijuana, she said that this was a product which was not recognised as medicine but yet it was claimed to have medicinal effects.
She said that a different approach was needed and asked why this could not be achieved by legislation. It could not be left to the regulations. People such as herbalists and traditional healers had grouped together. Herbs were seen as being traditional medicines. Some substances fell outside the definition. She asked how they could ensure that all were covered.
The Chairperson said that when medicinal claims had been deleted from the Bill they had not left a void. This had been substituted by medicinal substances. Certain substances were already addressed.
Dr Rabinowitz said that there were many discrepancies in the scheduling process. They were arbitrary systems.
The DG said that he was afraid that the two issues had already been debated. Medicinal claims had been interpreted in the courts. Many products had been claimed to have medicinal benefits. An example was yoghurt. Some foodstuffs were claimed to have health benefits. The DoH wanted to restrict some substances. Even Schedule 0 was still a Schedule. Medicinal claims were complicated and could not be easily proved. It was a losing argument. The Authority should determine the rules.
He said that there was a question of how to deal with homeopathic medicine. This was related to the issues of African traditional and complementary medicines. This had led to a whole range of disputes between experts. They could not legislate on this and the DoH could not say what the rules should be.
Mr Waters asked if any foodstuffs were tested. If vitamins and other products were classified as Schedule 0 he asked if these were tested to prove their medicinal claims.
The DG said that the current Council had tested a whole range of scheduled substances. If anything contained scheduled substances over a certain threshold level, then it had to be registered. If this was not done, the product could be directed to a schedule. The schedules could change as well. This was trickier than the claim of medicinal benefits.
The Chairperson said that this was happening with Dr Raath.
Ms Mandisa Hela (Chief Director and Registrar of Medicines Control Council, DoH) said that the classification was based on the risk posed. An important factor was the package size.
Dr Rabinowitz said that the same point was being made. Scheduling was not the same as medicinal claims. The DG had not said that registration was needed for complementary medicine. This was not in the regulations. She asked if this was being done then what was in the regulations. The country needed transparency and clarity. The DG had given proposed documents relating to nutrition and health but not to medicine. This seemed to be a logical conclusion.
The DG asked why the claims of distributors were not so neatly addressed. Slimming products were a particular concern. The Department would have taken this route if it were that logical. Some qualification had to be attached to a slimming tablet. The point of the restrictions was to make sure that nobody made medicinal claims. A foodstuff was excluded if it fell within the definition of the Foodstuffs Act.
The Chairperson said that they were making comprehensive progress.
Mr Ramasala said that they were using the body of the Act. There was no reference to complementary medicine. The regulations in the principal Act were a way to control complementary medicine where they fell within the classification of medicine. It would not be necessary to define this. There were definitions for product and medical devices.
The Chairperson said that Section 13(a) and (b) would be combined.
Ms M Manana (ANC) pointed out that all references to certification should be deleted. The only requirement was for registration.
Ms Kalyan said that Section 13(c) referred to the holder of a certificate. That should also be deleted.
The Chairperson agreed. This reference should be to a certificate of registration. All members appeared to all agree. The DoH would make the necessary amendments.
Clause 6 Substitution of section 14 of Act 101 of 1965
Mr Ramasala said that all consequential amendments would be made.
The Chairperson said that the issue was to use the updated document of amendments together with the Bill and comments by organisations which had made submissions. Consequential amendments had to be incorporated. They must not proceed with a tautology.
Mr Walters said that it still came back to the definition of ‘product’. This had been flagged.
The Chairperson said that the Committee had dealt with this issue for the last half hour. The only issue had been complementary medicine. The issue was closed.
Ms Kalyan asked what exactly the Chairperson meant by saying the issue was closed. The matter had been discussed and flagged for a look at the definition.
The Chairperson said that the discussion had included medical devices and products. There might be consequential amendments. A principled position had been taken.
Ms Mashigo asked if the wording in 14(2) should be ‘medicine’ or ‘product’.
The Chairperson said that it should be ‘product’ and not ‘medicine’.
Ms Kalyan said that they were going back to the categorisation of medicine. She asked if this was a question of ‘medicine’ being replaced by ‘product’ in the wording. She asked what categories of which products were under discussion.
Mr Ramasala said that the definition of ‘product’ included medicine, cosmetics and food.
The Chairperson said that 14(4) should remain as medicine.
Clause 7 Substitution of section 15 of Act 101 of 1965
The Chairperson said that there had been a number of suggestions pertaining to Clause 7.
Dr Rabinowitz said that Section 15(4) should refer to a certificate of registration.
The DG said that the principle decision was affected by this clause. There should be a period for objections. The action lay in this section. He felt that the legal team should go through this clause first before the Committee dealt with it.
The Chairperson said that various organisations had commented on this clause. The Members agreed that the DoH should reconsider this clause.
Clause 8 Substitution of section 15A of Act 101 of 1965
The Chairperson said they were making progress. It was a tough process.
Mr Walters said that Section 15A(1) contained a phrase relating to the approval of the Minster. This should be omitted.
Clause 9 Substitution of section 15B of Act 101 of 1965
The Chairperson said that suggestions had been made by PIASA, the Pharmaceutical Council and other organisations on Clause 9. IMSA had commented on the transfer of certificates. The reference to certification should be removed.
Dr Rabinowitz said there should be time lines included in Section 15B(3). This should be set in regulations.
The Chairperson said that this was an administrative function.
Dr Rabinowitz said that this was where the strength of the Bill should be. She noted that 98% of medicines were not registered because of practical problems. There should be a reference to regulations.
Mr Ramasala said that there were rules which would provide for this.
Dr Rabinowitz was happy with that.
The Chairperson took it that the Members agreed on this Clause.
Clause 10 Amendment of section 15C of Act 101 of 1965
The Chairperson said that references to medicine in Clause 10 should be changed to product.
Mr Ramasala said that a SAMED document covered the definition of product.
The Chairperson concluded that the Members agreed to this clause. The Committee would continue to deliberate on the Bill the following week.
The meeting was adjourned.
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