Medicines and Related Substances Amendment Bill [B6-2014]: deliberations

Meeting report

Chairperson's opening remarks
The Chairperson welcomed the Members back and reminded them of the rules of the House. She noted apologies and Mr Mahlalela's request to be excused early.

She reported that the Traditional and Natural Health Alliance (TNHA or the Alliance) had written a letter to the Committee requesting a second chance to make proposals on the Medicines and Related Substances Amendment Bill (the Bill), read out their letter and asked for comments from the Members.

Ms L James (DA) said the Committee should, as a matter of principle, give all the organisations a chance to make full proposals on the Bill and suggested that the TNHA must be given another chance.

Dr W James (DA) agreed in principle with Ms James's comments aimed at full participation. However, he cautioned that other organisations could see it as being unfair if the Committee also did not give them a second chance as well.

Ms C Ndaba (ANC) agreed with the proposal to allow TNHA another chance, because they were clearly confused about the Bill, and it was agreed previously that they might be given that opportunity. The TNHA could also prepare to hold a workshop with the Department of Health (DOH) so that it could understand what the impact of the Bill would be for the Alliance and so that the Alliance could explain how traditional medicine was used, so that the Department could be better informed on how to include those elements in the Bill.

Mr A Mahlalela (ANC) said all organisations were given a chance to make proposals and it should not be the Committee's responsibility to ensure that they had understood the Bill, and the TNHA should have, like other organisations, gone through the Bill before making proposals. He did not remember whether the Committee had promised the Alliance that it would be given another chance to make proposals, and did not think that it was recorded in the minutes. He agreed that offering a chance to one could cause problems if other organisations also made requests to resubmit their proposals. This process had been dragging for too long and this would take up further time.

The Chairperson replied the intention was not to open up another briefing session but merely allowing the Alliance to submit another proposal, because there were areas in the Bill that directly affected it, and which would have to be changed. The Committee could not risk being taken to court by the Alliance because this would certainly detract attention from being focused on the activities of the Committee. The Alliance had in fact already been offered a date to make a re-submission on Wednesday 25 February 2015.

Mr H Volmink (DA) supported the views of the Chairperson but said that this submission must have new information, different to what had been presented previously. The Committee should not be willing to listen to the same information that was previously given by the Alliance.

Dr James agreed with Mr Volmink that the Alliance should refine its work in the second proposal.

Ms James said traditional medicine was shunned because of some of its practices.

Committee Members Ms James and Ms Ndaba agreed with the Chairperson.

Revised Working document: Briefing by Parliamentary Legal Advisor
Dr Barbara Loots, Parliamentary Legal Adviser, said the Working Document now included the proposed amendments made by the organisations, the Committee and the Department of Health. The amendments included technical jargon and were in no way binding to the Committee.

She took the Committee through the new version. The objective of the Bill was to amend the Medicines and Related Substances Act, 1965, so as to define certain expressions and to delete or amend certain definitions, to provide for the objects and functions of the Authority, to provide for the composition, appointment of chairperson, vice-chairperson and members, disqualification of members, meetings and committees of the Board of the Authority. It was further to replace the word ‘‘products’’ with the word ‘‘medicines’’ and expression ‘‘Scheduled substances’’ in order to correctly reflect the subject matter of the principal Act. It would further effect certain technical corrections, and provide for connected matters.

Clause 1 of the Bill sought to amend Section 1 of the Principal Act dealing with definitions. It would clarify the definitions relating to “advertisement”, “cosmetic” and “foodstuff”. There was an intention to extend the definition of “medicine”. Other amendments in Clause 1 would be the inclusion of definitions for “biological medicine”, “Board” and “complementary medicine”, and therefore the definitions to “advisory committee” and “product” would be deleted. The definition of “foodstuff” should stay as reflected in the 2008 Amendment Act; and the amendment in the tabled bill will be deleted.

Clause 2 of the Bill sought to amend Section 2 of the principal Act, dealing with the establishment of the South African Health Product Regulatory Authority (SAHPRA). This amendment will help to clarify that SAHPRA is an organ of state within the public administration, but outside the public service. Other relevant amendments to be added were that “The Authority acts through the Board” and not any other stakeholder or body.

Ms Precious Matsoso, Director General, Department of Health, said the Foodstuffs, Cosmetics and Disinfectant Act included a section awarding powers in determining who could regulate products included in the Act. The only people who have been given that authority were the Director General and the officials of the Department. It would have been problematic to delegate SAHPRA which does not have the authority to do the job. She requested that the drafters should add a clause before Section 2, that the Authority may enter into agreement with "another authority" to regulate foodstuffs, cosmetics and disinfectants.

Dr Loots continued with her presentation. Clause 3 of the Bill sought to insert new Sections 2A to 2I in the Principal Act. The purpose was to help provide for the objects of SAHPRA, the function of SAHPRA, the composition of the Board, the appointment of the members of the Board, the appointment of a chairperson and the vice-chairperson of the Board, disqualification from membership of the Board and vacation of the office, meetings of the Board and the dissolution of the Board.

The objects of the Board would also include “scheduled substances”, and reference would be made to “IVDs”, and to regulatory oversight of foodstuffs and cosmetics. Amendments have also been made to the functions of SAHPRA. It would now be empowered to assess, re-evaluate and “ensure that evidence of existing and new adverse events, interactions, information about [pharmacovigilance is] post-marketing surveillance and vigilance being monitored”.

The only significant amendment made under the appointment of members of the Board was that if the Minister received no nominations, or an insufficient number of nominations within the period specified in the notice referred to in subsection (1), the Minister may either re-advertise or, in any other transparent manner, appoint the required number of qualified persons. If a suitable person or the required number of persons were not nominated in terms of subsection (1), the Minister "must appoint an appropriate person or persons who qualify to be appointed] in terms of this Act”.

Clause 4 of the Bill would amend Section 3 of the Principal Act, dealing with the Chief Executive Officer (CEO) and other staff of the SAHPRA. The reason for this was to empower the Board to appoint the CEO after it had consulted with the Minister, to require the CEO to conclude performance agreement with the Board, to make the CEO accountable to the Board and to empower the CEO to appoint committees in consultation with the Board. Therefore, all the areas of the previous draft which give the Minister power to appoint a CEO and be accountable to the Minister had been deleted.

Clause 5 of the Bill sought to repeal Section 4 of the principal Act, dealing with the establishment of the Advisory Committee. The Advisory Committee would fall away with the amendment that resulted in the appointment of the Board.

Clause 6 of the Bill amended Section 13 of the principal Act, dealing with the registers for medicines. The clause would empower the CEO to publish the registers for medicines. Dr Loots noted that the DOH had  agreed to the deletion of the reference to “scheduled substance” in sub clause (1)(a), but made a suggestion that it should perhaps also then be consequentially deleted in subclause (1)(b) as it made reference to “such particulars”.

Clause 7 of the Bill sought to amend Section 14 of the principal Act, dealing with sales prohibitions. The amendments of this clause were effecting technical amendments. For the most part, this clause was replacing the word "product” with “medicine”.

Clause 8 of the Bill was seeking to amend section 15 of the Principal Act dealing with the registration of products. Section 15 empowered SAHPRA to issue registration certificates and reject applications under certain circumstances. Since the Bill would now also include the phrase “and in the case of a medical device and IVD performs as intended”, it must be amended because medical devices and IVDs were to be regulated as well.

Clause 9 of the Bill sought to amend Section 16 of the principal Act, dealing with the cancellation of registration. SAHPRA would be empowered to cancel registration if it was of the opinion that it was not in the public interest for a product to be made available to the public. A new sub-section (c) would be included, to read: “is of the opinion that it is not in the public interest that any medicine, medical device or IVD shall be available to the public”, under the cancellation of registration clause.

Clause 10 of the Bill would amend Section 18 of the principal Act, dealing with labels and advertisements to prohibit the sale of products that were not properly labelled. The amendment would read: “No person shall sell any [product]―
(a)        medicine or scheduled substance unless the immediate container or the package in which that [product] medicine or scheduled substance is sold bears a label stating the prescribed particulars; and
(b)        medical device or IVD unless the medical device or IVD, or its packaging, bears a label, where practical, stating the prescribed particulars.
(2) No person shall advertise any [product] medicine or scheduled substance, medical device or IVD for sale unless such advertisement complies with the prescribed requirements”.

This wording followed the previous recommendation by the Committee.

Dr Loots added that there was a proposed additional amendment to Section 18A of the principal Act, dealing with Bonusing. It was important to note this because the Bill as tabled had not sought to amend section 18A.. Therefore, in terms of the National Assembly Rules, the Committee would not normally be permitted to amend the clause, without requesting prior permission from the House, although it was possible to put forward an argument that, due to the general scope of clause 23, this clause was open to amendment, due to the required “product” amendment. She said that she would consult with the NA Table and revert back to the Committee on that point.

Clauses 11 to 20 of the Bill sought to amend section 19 of the principal Act, dealing with prohibition on sales for technical amendments. Clause 11 and 12 would change the word “product” to “medicine”. Clause 13, dealing with section 22A would include “medical devices and IVDs”. Clause 14 aimed to include “scheduled substances” in section 22B. Clause 15 would include “practitioner” and “veterinarian” under Section 22C. Clause 16 related to section 22H, and would include references to “medical devices, IVDs and scheduled substances”. Clause 21 related to section 35, where it sought to insert references to “medical device or IVD”.

Clause 23 of the Bill dealt with the substitution of the word “product” and “products”.

Clause 24 of the Bill would replace section 44 of the 2008 Amendment Act.

Clause 25 of the Bill was setting in place transitional provisions, for operational reasons, and Clause 26 of the Bill dealt with the Short title and commencement.

Discussion
Dr James wanted to clarify if the document given to the Committee was the original amendment Bill.

Mr N Matiase (EFF) asked if the Committee was now at the stage of reviewing the Bill, or whether it was still necessary to consult with legal advisers who were not part of the Committee.

The Chairperson replied that the Committee was now in the process of going through the proposals and the amendments made to the original version of the Bill, which were done by the Department and Parliament's legal unit. The Committee's responsibility at this time was to make suggestions on the content of the Bill. and this was not the final stage of the Bill. The Bill would only be in its final stage once Members were happy with the contents of the Bill.

Mr I Mosala (ANC) said Committee should be mindful that it was to have another briefing in the next week and thus no final changes could be made to the Bill at present. He asked the Chairperson to explain how the proceedings would follow if the Committee allowed the TNHA to present again.

The Chairperson replied that any further proposals by TNHA should not hinder the process of the Bill. Members should not be worried about holding some deliberations before listening to that proposal, and Members must be upfront on their feelings to allow the Alliance a second chance because the Committee had indicated it did not plan on shutting them out of the process.

Mr Matiase said he would be submitting a proposal on the amendments to the Bill, but he agreed with the Chairperson that the TNHA should be given another chance to brief the Committee.

Dr James said he did not understand how TNHA briefing could compromise the process of deliberations. He thanked the legal adviser for the comprehensive submission, and said that it dealt directly with the Committee's concerns.

The Chairperson interrupted Dr James, asking him, for the moment, to confine his comment to allowing the TNHA a second chance to brief the Committee.

Ms James said she agreed on allowing the TNHA a second chance as it would not hinder the process; the Committee would be continuing its deliberations afterwards.

Ms Ndaba said she thought Mr Mosala was proposing that the Committee should wait for the submission of the TNHA before continuing these deliberations. She also said that Mr Matiase's statement about submitting a proposal to the Committee had her confused, because normally Members gave their comments during the meetings and not on paper.

The Chairperson said she chose not to respond to Mr Matiase’s statement, but agreed that everyone should give their comments on the Bill during the meetings rather than through written submissions. She requested that Mr Mosala to clarify his question to the Committee.

Mr Mosala said he did not intend to indicate any disagreement on the decision of the Committee to allow the TNHA to present again, merely wanted clarify the process, since the Committee had diverged from its plans.

The Chairperson noted that, and requested that Members now make comments and suggestions on the Bill.

Dr James said the definitions of “biological medicine” and “complementary medicine” had been amended and clarified very well. He still had some issue with the fact that the definitions would be in the Regulations but also questioned why they were removed from the Bill.

Mr Volmink said there was a clause around the Minister's appointment of Committee members and the issue of not being able to appoint suitable people due to a lack of response when the positions are advertised. The clause stated that the appointment should be done in a “transparent manner” but it did not specify what this meant.

Mr Volmink also wanted clarify on the section of the Bill referring to "veterinarian" and pointed out that the the Bill also spoke about animals and people in the same sentence. There was no clear direction in the clause.

Mr Volmink commented that the issue of the Pricing Commission spoke about the Minister consulting with the Commission on which Acts were acceptable and which were not, in terms of pricing, and asked what method for direction the Minister would use. It would be impossible to take out all the pricing Acts.

Mr Matiase said the objective of the original Bill was for the establishment of South African Health Product Regulatory Authority (SAHPRA) but the objective in the amended Bill has failed to capture that. In the previous draft of the Bill the minimum members who would be appointed as part of the SAHPRA Board was 10, but this had now changed to 15 members. He asked if members from stakeholder organisations were also included in the Board.

Mr Mosala said he was hoping that Mr Volmink would explain what his concerns were with consulting the Pricing Committee.

Mr Mosala asked why the legal advisers had decided to take “scheduled substance” out of the Bill, and why were “cosmetics” and “foodstuffs” regulated by the Authority and not the Units which it was originally said would be established.

Dr Loots replied that some of the questions related to content, and these would have to be answered by the Department.

On the question of transparency with the appointment system, she agreed that some of the clauses sounded very vague but this allowed for contextual application and specific circumstances. It might be that the Minister needed to appoint only one person, or five. The new wording would helps decide what a transparent process would need at that time, and essentially meant that the process should not be done behind closed doors.

Answering the question relating to medical device and medicine in relation to the reference also to veterinarian, human body and animal, she explained that medical devices can be used both on animal and human bodies. the Authority was now trying to look at how the device worked, and not necessarily what effect it had on a human or animal.

Dr Loots clarified that the objective of the Bill did not change, the focus was still the same, but a brief summary of the Bill had been included so that the public could understand what has been included in the Bill.

Ms Matsoso added that it was difficult to be explicit on some issues because of new developments. It was not possible to call some medicines “traditional” as they were the same as “modern” medicines, or he same as the Chinese medicine, which in turn was not indigenous to China. She explained that a medicine would be classed as "traditional” only once it was linked to cultural practices of cultural groups. If something was not in a formulation form, then it cannot be regarded as a medicine and the Bill dealt only with products which were in their formulation form. The Regulatory Authority would need people with skills in different medical practices. SAHPRA had requested the use of broader terms in the Bill so that it did not create the impression that only one type of skill was needed.

Dr Anban Pillay, Deputy Director General, Department of Health, clarified that the device industry operated differently from the medicine industry. With the amendment of the Bill, SAHPRA would deal with pricing matters and the regulation of medical devices.

The Chairperson said the Committee would still hold more meetings where Members could deliberate on issues of the Bill. The Department and the legal unit would still make more amendments and the Committee will have further discussions and make comments.

Mr Matiase said there was no clarity whether previous legislation had been consulted when formulating this Bill. The only Bill which was mentioned as having been consulted was the Medicines and Related Substances Act, 1965 but the recent ones had not been formulated in the current draft.

Mr Mosala said Mr Matiase must not undermine the work of the Committee and insinuate that Members did not know how to do their work. If he had picked up that the Bill did not refer to other legislation then he was requested to put this forward in the right manner. She asked that he not respond on this point. She stressed that the Committee's responsibility was to go through the documents, and make comments on the language which had been used if they were not happy. These comments, however, should not detract the Committee's focus away from what needed to be done.

The meeting was adjourned.