The Committee had heated discussions on various procedural issues, as well as issues raised in the Bill.
The Committee heard a brief synopsis of the Task Team report on the Review of Medicines Control Council and Recommendations on the New Regulatory Authority. Professor R Thompson (Special Advisor to the Minister) provided a brief background to the reasons for the introduction of a new Regulatory Authority.
Members welcomed the fact that the term “in respect of which medicinal claims are made” would be replaced by ““which contains a Scheduled substance” in various sub-clauses of Clause 1. They felt that this encapsulated concerns raised by the public during public hearings.
There was a view that complementary medicines should be included in the definition of “medicine”. The Member felt that the issue of complementary medicine should be dealt with specifically to allow it to be dealt with in accordance with the rules governing that very specialized area.
There was a debate regarding the admissibility of a document submitted by the Treatment Action Campaign to Members on that day. The Chair felt that it was not admissible since the period of public consultation had passed.
There were concerns regarding the independence of the Regulatory Authority and the DA proposed a clause to this effect. The clause was not accepted as some Members felt that the fact that the body was a juristic person subject to the PFMA would ensure that it would be treated similarly to any Chapter 9 institution.
The issue regarding the two-tier process of registration was flagged to be discussed at a later stage.
Medicines and Related Substances Amendment Bill
The Chair reminded the Committee that the Department, South African Medical Devices Industry Association (SAMED) and South African Laboratory Diagnostics Association (SALDA) had been mandated to deal with the section of the Bill regarding “medical devices”.
Mr Thamsanqa Dennis Mseleku (Director-General: Department of Health) said that this response had been prepared and was ready for distribution.
The Chair referred to the various issues which had been raised during public hearings on the Bill.
These included transitional arrangements, clauses relating to marketing, the two-tier system of registration and clauses relating to certain definitions.
Mr M Waters (DA) said that the Chair had promised that the Committee would hear the report of the Task Team which was headed by Professor R Thompson (Special Advisor to the Minister of Health) at that meeting. He was interested in hearing how the proposals raised in the report differed from the Bill.
Ms M Matsemela (ANC) said that the Department did the report two years ago already. People had already heard the report. In addition Members already had some insight into what the report had said.
Ms S Kalyan (DA) pointed out that the report had referred to the elimination of the two-tier system. This issue had been raised in every submission at the public hearings. She also proposed that the report be dealt with at that meeting. In fact perhaps the Committee could just flag the recommendations made in the report which differed from the Bill for further discussion.
Mr Waters insisted that the Chair had promised that the Professor would present at that meeting.
The Chair responded that the Task Team report was just part of the framework of proposals to be considered. It should not be regarded as the ‘gospel truth’. The report should just be treated as a reference document. The final decisions would still rest with the Committee.
Mr Waters argued that the Chair had given his word twice and had reneged on both occasions. He pointed out that the Report had recommended a single tier system. Also it had recommended an independent regulator.
Ms Matsemela said that the report could not become an obstacle in the process. The report could merely be noted. Failure to allow the presentation of the Report would not impact the process negatively.
Prof Thompson pointed out that the Report had been on the Department’s website for months already. A short presentation would not do justice to such a lengthy report.
The Chair suggested that the Professor should provide the Committee with a brief synopsis of the Bill.
Brief Synopsis of the Task Team Report
Prof Thompson highlighted the background to the Bill, saying it was borne out of the challenges experienced by the current Medicines Control Council (MCC) and Medical Regulatory Authority (MRA). There had been complaints with regard to the efficiency and outputs of the MCC. These bodies had operated in a very disjointed fashion and there was a lack of clarity regarding who the MCC and the MRA were respectively. The MCC had been introduced in 1965 and therefore was not capable of dealing with the scientific advances (especially in Radio-Pharmaceuticals and Biotechnology).
Prof Thompson referred the Committee to the document titled “Report on the Ministerial Task Team: Review of Medicines Control Council and Recommendations on the New Regulatory Authority” for further detail on the report. He said that the proposed Structure of the Regulatory Authority could be found on the Department’s website.
The question relating to the appointment of the Head of the Regulatory Authority differed from country to country. The Head of the United States Food and Drug Administration (FDA) reports to the Secretary for Health and to other relevant Secretaries as well. The South African model was based on the Australian and Canadian model. The appointment would be done in conjunction with the Department of Public Service and Administration (DPSA) and National Treasury (NT). The Minister would not act on her own in this regard.
Referring to the
Mr Waters asked if the Task Team had done a costing exercise of each model.
The Chair said that this information was in the Memorandum.
Prof Thompson added that the costing depended on the structure chosen. Once the Bill was passed the process could be fast-tracked.
Mr Waters asked when Prof Thompson envisaged the Agency having sufficient staff to perform its duties. He asked when the CEO would be appointed and when other appointments (made in terms of the PFMA) would be made.
The Chair interrupted, saying that the question was unfair, as the legislation was just being drafted and this process could only commence once the Bill became law.
Further Deliberations on the Medicines and Related Substances Amendment Bill, 2008
Mr Mseleku referred the Committee to the document titled “Amendments to the Medicines and Related Substances Amendment Bill,2008”. This document incorporated the amendments effected to the Bill based on public submissions received.
He said that much discussion had taken place with SALDA and SAMED regarding the definition of ‘medical devices’. The words “medical device or IVD” would be inserted after the word “product” in lines 11 and 19 on Page 2 of the Bill. The term “medical device would be defined in clause 1 (g).
Mr Mseleku referred to debates around the term “in respect of which medicinal claims are made”. This term would be changed to “which contains a Scheduled substance” in order to incorporate suggestions by the public. These changes occurred in lines 4, 9, 10 and 14 on page 3 of the Bill. This change would ensure that products like Flora margarine would not be regulated by this Bill.
Mr Mseleku said that the term “in vitro diagnostic medical device” would be defined in paragraph (f) of the Bill.
Mr Waters proposed that Clause 1 (c) be changed by omitting the reference to “certification” and simply referring to “registration”. This would allow for the elimination of the two-tier system (of certification and registration) and simply replace it with a one-tier system (of registration).
Ms Matsemela disagreed, saying that it did not make a difference.
Mr Waters argued that if the medicine was certified, it did not mean it was registered. The registration still had to be done by the Minister in a separate step.
The Chair suggested that this matter be flagged.
Mr Waters referred to the fact that the Chair had asked certain presenters to submit concrete proposals regarding the submission. He asked if this had in fact been done.
The Chair disagreed, saying that he had not asked organizations to do so. The Treatment Action Campaign (TAC) had volunteered to assist. The Committee had not asked them to do so. The only additional input requested had been around the definition of “medical devices”. Allowing the presenters to submit further inputs after the hearings would be against normal procedure.
Ms Kalyan asked if issues raised by presenters had been flagged for discussion by the secretariat. If issues were identified and tabulated, it would assist the process.
The Chair asked if Ms Kalyan was suggesting that the meeting be suspended until the inputs were tabulated.
Ms Matsemela said that the Department had done their part. It was now up to the Members to do theirs.
Dr R Rabinowitz (IFP) said that there had been a huge amount of submissions. It was impossible to remember who had said what, even if one had read all the submissions. A succinct summary of submissions would be helpful.
The Chair sympathized with Members’ apprehensions regarding the magnitude of the submissions. He agreed that the Committee section could categorise proposals to make work easier. This would be done by the following Tuesday.
Ms Kalyan did not feel that the Committee could examine and write the definition of “medical devices” into the Bill at that meeting. It would take at least a month to do.
The Chair argued that this issue had to be dealt with at that meeting.
Dr Rabinowitz agreed that the Committee could proceed to incorporate the definition of “medical devices into the Bill.
Dr Rabinowitz proposed that the Committee discuss the inclusion of complementary, alternative and traditional medicines in the definition of “medicines”. The terms “complementary medicine”, “alternative medicine” and “traditional medicine” could then be defined separately in the Bill.
Ms Matsemela asked if this was covered in the new definition of “product”, which includes cosmetics or foodstuffs “which contain a Scheduled substance”. Since complementary medicines were Schedule 0 substances, she asked if this new definition did not address this issue.
Mr Mseleku said that the Department had opted against mentioning specialized categories (like complementary medicine) in the definition, for fear of excluding a possible category. This did not mean that complementary medicines would not be regulated. Regulations on legislation dealing with complementary medicine would be published that Friday. It was preferable to keep the definition of “medicine” as broad as possible.
Dr Rabinowitz referred to the fact that Vitamin C is generally not a medicine but would fall under “foodstuffs”. However when 1000mg of Vitamin C is given in an intravenous drip, it was no longer a “foodstuff”. She was concerned about leaving this definition to regulations. Failure to deal with the issue of complementary medicines had resulted in previous Departmental decision-makers making really poor decisions on the issue, due to their lack of knowledge about this field. She requested that the Committee flag this discussion.
The Chair agreed.
The Chair asked Members to comment on the definition of “in vitro diagnostic medical device (IVD).
Ms Matsemela asked if this definition did not tamper with the definition of “medical device” in the principal Act.
Mr Sello Ramasala (Legal Officer- Department of Health) said that the definition in the principal Act had been inadequate. There was thus a need for this to be redefined.
Ms R Mashigo (ANC) agreed, adding that the old definition was outdated in the light of new scientific advances.
Dr Rabinowitz referred again to the replacement of “in respect of which medicinal claims are made” with “which contains a Scheduled substance”. She felt that the phrase which contains a Scheduled substance” would not always be appropriate. Scheduling was based on something concrete, for example the medical claim made and the level of the ingredients of which the medicine was composed. It was important to deal with areas like complementary medicine, traditional medicine and alternative medicine separately; as one needed to treat these differently.
Mr Mseleku responded that the term “in respect of which medicinal claims are made” are not used when referring to medicines but foodstuffs or cosmetics. As such, it does not belong in this Bill. There needs to be a more concise distinction regarding what was being regulated in terms of this Bill. There was greater certainty if one dealt with Schedules. Even vitamins beyond a certain amount fell into a Schedule.
Dr Rabinowitz said that complementary medicines could not be treated exactly the same as ordinary medicines. For example, the requirement for clinical trials could not be met regarding complementary medicines, as its use was not based on these trials, but on the fact that it had been used for generations. She asked at which point complementary medicines could be distinguished from ordinary medicines.
Mr Mseleku replied that once registered, the Authority could publish rules relevant to the different areas of medicine.
Dr Rabinowitz was concerned that that the Department of Health had in the last 20 years made ‘ridiculous’ decisions regarding complementary medicines. While this particular Team was enlightened on the subject, it needed to be specified in the Bill to prevent the past from recurring if this Departmental team were to be succeeded by one that did not understand complementary medicine. At the very least, there should be a clause stating that Parliament could review the regulations dealing with complementary medicine periodically.
The Chair referred the Committee to Clause 2 and asked what presenters had proposed regarding this clause.
Dr Rabinowitz asked if she could read a document which had been submitted by the TAC that morning. Their proposed amendments to Clause 2 were contained in that document.
The Chair refused permission, saying that it would give that organization an advantage over other presenters.
Dr Rabinowitz responded that they had merely responded to the Chair’s request for them to submit actual amendments instead of a generic document.
The Chair said that he could not accept the document as a matter of principle.
Mr Waters suggested that the Chair should then at public hearings refrain from asking presenters to submit concrete proposals at a later stage.
The Chair denied that he had done so. He said that the presenters themselves had volunteered their assistance. It was acceptable for organizations to submit their views to individual Members (including the Chair) but he would not be able to present the document formally to the Committee. The Chair proposed that the Committee proceed to deal with Clause 2.
Ms Matsemela said that she had no problem with the clause as it stood.
Ms Rabinowitz pointed out that all presenters at the public hearings had proposed that the Regulatory Authority should be independent. This should be provided for in the clause.
Mr Waters concurred. He said that 99% of the submissions had proposed the independence of the Authority. He said that he had prepared an amended Clause to ensure that this independence was addressed. He asked the Chair if he could propose it formally.
The Chair agreed.
Mr Waters submitted that the SA Products Regulatory Authority would be
(1)established as an organ of State within the Public Administraton but outside the Public Service
(2)(a) a juristic person; (b) subject to the PFMA, Act 1 of 1999 and Parliamentary oversight; (c)accountable to and headed by a CEO appointed by the Minister in terms of the Act and report directly to the Minister; (d)independent and subject only to the Constitution and the law; (e)impartial and perform its functions without fear, favour or prejudice; (f)function without any political or commercial interference and (g)at all times act in accordance with provisions of the Promotion of Administrative Justice Act and values and principles governing the Public Administration as contemplated in S195 of the Constitution
(3)exercise powers and perform functions conferred on and assigned to it by the Act and where appropriate (a) report matters to the Minister relating to the implementation and application of this Act; and (b) inquire and report to the Minister on matters concerning the purpose of this Act
(4)where appropriate the relevant organs of State should assist to maintain the independence and impartiality of the Regulatory Authority; and to enable it to carry out its powers and duties efficiently and effectively.
Ms Matsemela argued that a juristic person by its very nature is independent and derives its powers from the Constitution. This was in fact the purpose of Chapters 8 and 9. The issue, in her opinion, was to whom this body would report and it was obvious to her that the Regulatory Authority should report to the Minister.
Dr Rabinowitz wished to endorse Clause 2 (e) proposed by Mr Waters. She also said that usually such bodies would not report to the Minister, but to the Director General. Reporting to the Minister would only take place in a nominal capacity.
The Chair said that everyone agreed that the Authority was a juristic person and that it must be subjected to the PFMA (and therefore was subject to Parliamentary oversight). The PFMA required such bodies to report quarterly and annually. It was therefore pointless to repeat this in a separate clause in the Bill.
Mr Mseleku pointed out that the issue of independence relates to the Minister’s decision regarding whether or not to register medicines. This should be distinguished from the argument that the organization as such should be independent. One should consider what an independent body would entail. It seemed to him that the independence everyone was referring to related to the decision regarding registration and not independence of the body itself. He could not see how a body could be subject to the PFMA and still be independent. The issue regarding the independence of the decision should be dealt with when dealing with the issue of registration.
Mr Waters said that the main issue was then whether or not there would be a two-tier system of registration.
Ms Matsemela pointed out that when the MCC was established in 1973 no one had a problem with the body accounting to the Minister.
Mr Mseleku said that in terms of the principle Act, the MCC was an independent body, which did not report directly to the Minister but to Parliament.
Mr Waters said that the Minister’s interference in the MCC had been a problem, since the Minister had made questionable decisions in the past, for example her decision to register the toxic drug Virodene.
The Chair said that the current Act had had inherent inadequacies. The Committee could rest assured that the Minister too was accountable to Parliament.
Dr Rabinowitz said that the problem with the Minister appointing the CEO was that this person would obviously enjoy a relationship with the Minister and would therefore always be more accountable to him/her than to Parliament. It seemed like the new Government was like the old Government, since they also did not want an independent body. It was necessary for Members to have a role in appointing the CEO.
Ms Matsemela argued that Members of Parliament appoint Boards and not CEOs. She criticised Members for not supporting the proposals in the Bill, which were aimed at correcting the fragmented approach of the MCC. She asked if these Members had a problem with change. She also referred to the fact that the body would account in terms of the PFMA and said that the only place to account for public finances was to the Ministry. She also referred to fears that the Minister would interfere in decisions of the Regulator and asked why Members thought the Minister would want to get involved in all the business of the Regulator. She suggested that those Members let go of the mistrust on which apartheid had been based.
Mr Mseleku agreed that the Parliamentarians would play a role in the appointment of a Board and said that Government had decided against having a Board for various reasons. He also placed on record that Government had never interfered in the business of the MCC and referred to the fact that the MCC had registered Neviropene despite Cabinet policy. He again cautioned that the issue of independent governance should not be confused with the independence of registration. Perhaps the specific functions of the Authority could be qualified.
Mr Mukesh Vassen (Parliamentary Legal Advisor) pointed out that a body could be accountable in terms of the PFMA and still be independent (like Chapter 9 institutions). Whether or not this body should be independent would be based on a policy decision.
The Chair said that not a single submission had supported the two-tier system. Members should remember that the Minster was also accountable to Parliament. This would be flagged until the clause dealing with registration of medicines was dealt with.
Mr Ramasala suggested the substitution of “shall” for “may” in Clause 3 (7) on page 4.
The Committee agreed.
Dr Rabinowitz said that the Bill did not state the requirements for persons serving on the body. She felt that complementary medical practitioners should be included as well. If one wished to regulate an area one needed people in the body who had knowledge of it.
The Chair cautioned that by specifying certain areas one could run the risk of leaving out others. He asked if “suitably qualified” was sufficient to address this concern.
Mr Mseleku agreed. In addition the body would not only employ medically trained staff, but also accountants and engineers etcetera.
Mr Waters referred the Committee to the new Clause 3 (2) as proposed by the Department on page 2 of their document. He felt that there should be two additional exclusions from the post of CEO. These were (1) an exclusion based on an applicant having a financial interest in any pharmaceutical company and (2) an exclusion based on the person being an office-bearer or partisan to a political party.
Mr Mseleku said that everyone had the right to be employed in the public service. There was nothing preventing a person from applying, but the rules of the Regulator would bind the person once appointed, for example, the person would not be able to hold shares in a pharmaceutical company. There was however nothing preventing the person from applying. There could be a conflict of interest clause for persons once employed by the body.
Mr Waters felt that this should be included in the Bill.
The Chair agreed, but cautioned that the drafters would have to be careful with the phrasing of this provision. It should not be exclusionary.
Mr Waters proposed that Parliament must appoint a suitably qualified person as CEO. Alternatively, the Minister should appoint the CEO based on recommendations by the National Assembly. There should be a transparent process. Parliament could shortlist candidates and submit a list of three suitable candidates to the Minister for consideration.
Mr A Madella (ANC) said that Mr Waters was confusing this process with that of a Board appointment.
The Chair agreed, saying that a powerful Member could perhaps influence the appointment process if done by the Committee.
Mr Waters insisted that at least the process would be transparent and not behind closed doors.
The Chair appealed for Members to trust in the bona fides of the parties involved in the process. If the Authority failed to perform its duties, it would have to account to Parliament. The body would have to submit an Annual Report, an Auditor Generals Report, etcetera.
Mr Waters asked that this issue be flagged.
The Chair agreed.
The Chair adjourned the meeting.
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