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

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11 March 2015
Chairperson: Ms M Dunjwa (ANC)
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Meeting Summary

The Portfolio Committee deliberated on all the amended clauses of the Medicines and Related Substances Amendment Bill [B6-2014]. The focus was largely on the definitions of the Bill, with particular emphasis on the inclusion of the policy development advisory function on “foodstuffs and cosmetics” in Clause 1, Section 1(e) and 1(f), for which the South African Health Products Regulatory Authority (SAHPRA) would be responsible. The Committee was largely in favour of the removal of “foodstuffs and cosmetics” in totality from the Bill, due to the conflict that arises between the Principal Act and the Act no. 54 of 1972, which regulates the toxicity of foodstuffs and cosmetics. The Department noted that it would be necessary to streamline “foodstuffs and cosmetics” into the functions of SAHPRA, along with appointing an expert in foodstuffs and cosmetics, in order to serve as an advisor to the Minister with regard to foodstuffs and cosmetics policy. The Committee moved largely to remove “foodstuffs and cosmetics,” and the Department of Health (DOH) concurred, saying it would find other ways to regulate and have policy development around foodstuffs and cosmetics.

The other big change was the deletion of “pharmacovigilance” and it being replaced with “vigilance.” in order to have a broad understanding and application in the Bill to include all forms. The appointment of the board was also a contentious issue, as the Committee was concerned about who would be responsible for the screening of the members of the board and their level of appropriateness for the board. The Committee also suggested that there be a way for them to be involved in this process, but the Department pointed out there was legislation which governed the manner in which boards were appointed.

Most of the amendments were supported without comment or query. However, there needed to be further enquiry into Clause 10 Section 18(1) over whether it was appropriate to still have the word “product” used there, and also whether the Committee would be able to amend it with the permission of the National Assembly. The Committee elected to have another meeting to deliberate further on Section 18 and to begin the voting process on the Bill, as most sections had been largely unopposed.

Meeting report

Medicines and Related Substances Amendment Bill: deliberations
As deliberation were about to begin, Dr W James (DA) requested the Chairperson to ask the Department of Health (DOH) and the legal advisors to distribute all the necessary documentation, including the amendments and additions which the Department wanted to propose, to allow the Members to follow with ease as the deliberations proceed.

Mr I Mosala (ANC) agreed with Dr James and proposed an adjournment of the meeting until the Department and legal advisors could have the additions and amendments working documents available on the projector. The Chairperson adjourned the sitting for 30 minutes to allow for this to take place.
When the meeting resumed, the deliberations began with the amendments working document on the projector, and Members were led to page 2 of the Bill, which dealt with the Long Title and Clause 1 Definitions.

Long Title
The Chairperson called for comments on the Long Title.
Dr W James (DA) enquired what the Members had to comment on specifically.
The Chairperson replied that process was that the Members would be going clause by clause so if the Members did not have any queries or changes to suggest, then they could continue to the next section so that the process could run smoothly.

Mr A Mahlalela (ANC) said that there was an inclusion to the long title, thus there needed to be a check whether the Committee agreed with the inclusion, as that inclusion had not been reflected when the discussions were taking place.

The Chairperson noted the suggestion and asked the Committee whether they agreed or not with what Mr Mahlalela had highlighted.

Dr James said the recommendation was to include the addition to the long title with regard to the relation between the Minister and the authority, stating: “to require the Minister to consult with the Pricing Committee when prescribing acceptable and prohibited acts in relation to bonusing.” He would support that.

The Committee then proceeded to the first clause.

Clause 1 Definitions
The Chairperson called for comments on Clause 1, pointing out that the Clause had sub-sections from A to H.

Dr H Volmink (DA) said that in Section 1(a), the only noted change was the addition of “electronic media”.

Mr Mosala agreed with Dr Volmink.

Dr James requested the legal advisor to point out where changes had been made. It was very hard to follow, because the Members were handling various documents at the same time. When an issue needed to be highlighted, it was best done by referring to the screen. However, when looking at this particular clause as a whole, the word “product” had to be removed throughout the clause. He supported replacing “products” with “medicine and scheduled substances.” Furthermore, other changes were needed. The insertion of the definitions in Section 1(c) and Section 1(d) of complementary and biological medicines, was tricky. Dr Volmink had already spoken about the insertion of electronic media in Section 1(a). There was also the deletion of the definition of Advisory Committee in Section 1(b), and the insertion of the definition of the board.

He suggested that the definitions of complementary and biological medicines be removed. Section 1(e) and Section 1(f), which dealt with cosmetics and foodstuffs, should be removed all together instead of removing only the “which contains a scheduled substance,” because he believed it did not belong in the Bill. He acknowledged the change from “in vitro medical devices” to “in vitro diagnostic” in Section 1(g)(b), and supported the change. He noted that the definition of medicine, in Section 1(h), had included veterinary medicine, and he supported this. The definition of medical device, in Section 1(i) of the principal bill, would be supported with the changing “in vitro calibrator” to “reagent for in vitro use.” In the addition of “for humans [beings] or animals, for one or more of the following: [-]”, he suggested that animals be removed, because it was intended only for humans and of “[in or on the human body]” in section 1(i)(b) was supported.

The Chairperson said that there had been a suggestion to speed up to give the legal advisors the chance to address the queries. She called for further commentary.

Ms C Ndaba (ANC) called for clarify about the inclusion of “foodstuff” and what the parliamentary legal advisor had to say about it, to serve as a reminder for the Members before they started to deliberate.

Mr Mahlalela said the Committee should have deliberated upon the issue of the foodstuff and cosmetics in Section 1(e) and Section 1(f) before the deliberations on the Clauses. However, it was necessary for clarity to be given so that the Members could understand why these sections were still there, because it had been agreed that foodstuff and cosmetics would be removed from all sections of the Bill. This was the indication that had been given by the Director General during briefings, because it appeared as if the Sections had been included in error. There was also a need for an explanation for why animals had been included, and why this had subsequently been removed.

Dr P Maesela (ANC) said that the Foodstuffs, Cosmetics and Disinfectants Act of 1972 (Act no. 54 of 1972) may cover the regulation of the stipulated products, but there may be some loopholes that subsequently could be covered by this Bill to avoid having to return to the Bill and amend it again. This was due to fact that some products under the Act included scheduled substances, which would render them as medicines, but if foodstuff was removed then they would not be covered and this would provide an opportunity for manipulation.

Dr James said that once one removed Section 1(c) foodstuffs and 1(d) cosmetics, and kept the sub-definitions under the medicine definition, then one had a generic definition. This removed the need to have Section 1(e) and 1(f) in the Bill, because the provisions of Act no. 54 of 1972 were consistent with the adoption of the definition of medicine.

Dr Barbara Loots, Parliamentary Legal Advisor, said that Act no. 54 of 1972 did not make reference to medicine, which was why it had been included in the Principal Act. The Principal Act made provision for the regulation of scheduled substances that could be found in foodstuffs. However, the amendments made to Clause 1 made the inclusion of foodstuffs and cosmetics contradictory. The deletion was to align the change in the Clause. Furthermore, the foodstuffs which were found to include scheduled substances would then need to fall under the generic definition of medicine. The Department had explained that a foodstuff with scheduled substances would be medicine. However, retaining foodstuffs and cosmetics would not change the regulation of toxicity under the Act no. 54 of 1972. The Department wanted to include the regulation of foodstuffs under the foresight of the authority which was stipulated under Clause 3 (2B)(3), but only for research purposes and not as a way of regulating the quality or toxicity. This would speak to the regulatory mandate of the South African Health Product Regulation Authority (SAHPRA). The issue of the inclusion of animals would be further discussed by the Department.

The Chairperson said there were new people who had joined the meeting, and the individuals introduced themselves.
Dr Yogan Pillay, Deputy Director General, DOH, said that the definition of foodstuffs was part of encompassing regulation of a sector which did not want to be regulated. There needed to be a clear path as to how and what the regulators would regulate.

Dr Joey Gouws, Chief Director, DOH, said Act no. 101 of 1965 controlled only medicines. In 2008, the Department had wanted to expand the scope of the Medicine Control Council by turning it into an authority. This authority would regulate foodstuffs and cosmetics because it was closely linked to medicine. The issue with Act 72 of 2008 was that the Department realised there were aspects that were not clear. Looking at the definitions of the foodstuffs and cosmetics which were in the Principal Act for the purposes of SAHPRA regulation, the legal advisors had recommended that foodstuffs and cosmetics be included in Clause 1, so that it did not seem random under the Clause 3 (2B).

When the Bill was drafted, the definition used for “medical device” was an internationally accepted definition. The control of medical devices had to be for both humans and animals.  

The Chairperson noted the response.

Dr Volmink said he appreciated the clarification on the definitions, but more clarity was needed on the functions of SAHPRA in the regulation. The research oversight function needed to be clarified further because one could be opening a flood gates, as the purpose of SAHPRA was to streamline everything. This should be taken into account.

Mr Mahlalela said that when the Director General had spoken on the foodstuffs and cosmetics, she had given the indication that foodstuffs had been added in error, and that SAHPRA would have nothing to do with the regulation of foodstuffs and cosmetics. One of the functions of SAHPRA which had not been included was that of policy development, but the Director General had given a different impression on the matter. When foodstuffs were used as medicine, then they would be regulated as such. If there were gaps in the Act no. 54 of 1972, then it would have to be amended accordingly, but the gaps should not become the responsibility of SAHPRA.

Dr James supported the inclusion of animals in the definition of medical devices. He sought further clarify about the relationship between foodstuffs and cosmetics and the functions of SAHPRA, and why it would be appropriate for SAHPRA to regulate.

Ms Ndaba agreed with the other Members on their stance on the foodstuff and cosmetic clause, because if there was a gap, the Act no. 54 of 1972 would need to be amended.

Dr Maesela said there were some cosmetics and foodstuffs which had adverse health effects on the human body, so regulation under SAHPRA would be appropriate. The definitions of foodstuffs and cosmetics showed that the Department had taken into account the fact that they were regulated by another act. If the gap now emerged with the Act that regulated them, it would be a waste of time to go through the process of amending the Bill.

Mr Mosala said the response should be focused on the “Objects of Authority” Clause 3(2B), which had not been a feature in the briefing, but seemed to be an important feature of the deliberation today. What had been the change and why had it been changed? It was hoped an answer would clarify the issue.

The Chairperson agreed with Mr Mahlalela about why the foodstuffs were included in first place, and the motivation for their inclusion.

Dr Loots said [that with a Scheduled substances] had been added in error in the Principal Act. Furthermore the foodstuffs and cosmetics regulation had always been in the Bill -- it was not the 2014 Bill that incorporated these sections. The deletion of “product” throughout the Bill made the use of cosmetics and foodstuffs redundant, because all that was left of the definition was [that with a Scheduled substances], which the Director General had noted. The Committee was within its power to remove the sections pertaining to the regulation of foodstuffs and cosmetics. The 2008 version brought them in, and the 2014 amendment focused on broadening the scope.

Looking at the Objects of Authority and Functions of Authority, the inclusion of policy development was a result of the inclusion of foodstuffs and cosmetics. This was not the authority’s main functions, highlighted in Clause 3 (2B)(1)(a), which states that ”ensure the efficient, effective and ethical evaluation and registration of medicines, medical devices and IVDs that meet defined standards of quality, safety, efficacy”. In (2B)(3) it is stated that there was a need for policy development within the authority, but this was largely around the medical devices. The Department wanted this function to be in the authority. The exclusion of foodstuffs and cosmetics would have an effect, but it was up to the Committee to decide whether there should be an exclusion or not.

The Chairperson said that the Department wanted to regulate things that had scheduled substances, and the removal of scheduled substances in the definition of foodstuffs and cosmetics. The Department was not intending to delete these sections entirely. She urged the Committee to take this into account.

Dr Volmink enquired about the reason behind the policy development scope of the authority and why the Department saw it necessary to give this function to the authority. He also commented on the fact that the Bill sought to address all that was related to health, and therefore looked at products which affected health, but overloading SAHPRA with functions would defeat the purpose of wanting to streamline it. The Department should take this into account.

Dr Pillay said that the Department did not seek to regulate foodstuffs and cosmetics, which was why there needed to be the amendment to the definitions. In terms of the SAHPRA, it would serve as an advisor about foodstuffs and cosmetics, not as a regulator. The policy development was a way of going about the intended advisory role of the authority with regard to foodstuffs and cosmetics.

Mr Mahlalela said the Department was almost seeking to confuse the Committee. Returning to the composition of the Board, he said foodstuffs and cosmetics had been included. In the previous meeting there had been an understanding that foodstuffs and cosmetics would be removed, but today there was a reference to the Board being a policy development space for foodstuffs and cosmetics. There was no need to have experts on foodstuffs and cosmetics, because the board would not be advising the Minister. He returned to the previous consensus about foodstuffs and cosmetics being added in error and being taken out of the Bill. The Department seemed to be pushing in the direction of retaining foodstuffs and cosmetics in the definitions, which was highly contradictory.

The Chairperson recommended that there should be a ten minute break for further consultation between the Committee, the Department and the legal advisors.

Dr James said that this was an important piece of legislation because it created a new regulatory entity and regulated all forms of medicines and products that made medicinal claims. Toxicity was regulated by another Bill, and did not necessarily have to be regulated by the Medicine and Related Substances Amendment Bill. It did not belong in the Bill.

The Chairperson wanted the Department and the Committee have consultations, and wanted to hear from the Department.

Dr Pillay said the definition of cosmetics and foodstuffs were for the purpose of the functions of the Board, and not for the regulation of the Authority. The Committee wished to see the complete removal of foodstuffs and cosmetics throughout the Bill. The issue was that foodstuffs and cosmetics were closely related to medicine, which was why the Authority would have advised on them, but not directly regulated them.

Dr Loots said that with the definition of foodstuffs and cosmetics being removed, the rest of the Bill be would be affected. She referred to Section 2A, where the terms would be deleted, and Section 2B(3) would be deleted in its entirety

Mr A Shaik-Emam (NFP) said this would be come up again when looking at the composition of the Board, which would need to be changed, based on the deletion of the foodstuffs and cosmetics.

Dr James agreed with Department’s changes and said that the problems that would arise as a result of the deletion would be dealt with as they came.

The Chairperson said that they were still on Clause 1, and there were no further comments or questions.

Clause 3

Dr James supported the changes in Clause 3.

Ms Ndaba suggested that the Department should meet with the Committee at a later stage to discuss the structure of the Board.

Dr James said that there was a problem with the structure of Section 2B(1)(d), because it was not grammatically clear. It stated “ensure that evidence of existing and new adverse events, interactions, information about post-marketing surveillance and vigilance being monitored, analysed and acted upon.” He recommended that the sentence should be changed to “ensure that evidence of existing and new adverse events, interactions, information with regards to post-marketing surveillance and pharmacovigilance being monitored, analysed and acted upon,” and a change from “vigilance” to “pharmacovigilance.”

The Chairperson noted the suggestion and asked for comment.

Mr Mahlalela said there had been a discussion that “pharmacovigilance” should be removed and replaced with “post-marketing surveillance.” Why did Dr James want to retain it? He wanted to understand why it had been removed in the first place

Mr Shaik-Emam said that the regulation for pharmacovigilance was around the safety of medicine, especially homeopathic medicine. There was international regulation and globally there were specific terms, but in this Bill generic term were used.

Dr Volmink enquires how post-marketing surveillance and pharmacovigilance related, in terms of the substitution that had taken place in the Bill.

Dr Pillay explained that post-marketing surveillance was about when a product had been registered. However, in the case where products had not been sold, there needed to be a creation of that which was market appropriate.

Dr James agreed with the explanation from the Department, but proposed a grammatical change.

Mr Mahlalela wanted confirmation that Section 2B(3) would be deleted.

Dr Loots assured the Committee that this section would be deleted from the Bill.

Mr Mahlalela asked whether foodstuffs and cosmetics would be deleted?

Dr James commented that in Section 2C(2)(a), pharmacovigilance should remain, but there should be an inclusion of post-marketing surveillance.

Dr Loots replied that foodstuffs and cosmetics would be removed in their entirety from the Bill.

Dr Pillay said that to be consistent, there would be an inclusion of “post-marketing surveillance.”

The Chairperson noted that there were no further comments on Section 2B and Section 2C from the Committee.

Dr Loots said that the proposal under Section 2D was to add more transparency to the appointment of the members of the Board. The stipulation that the Minister must re-advertise if a suitable candidate could not be found for the position under Section 2D(d) had been deleted, but there was a move to rephrase the sentence.

Dr James said he was in support of Section 2D, and recommended that the Committee adopt it. In Section 2C(a), “pharmacovigilance” could be removed and replaced simply by “vigilance,” because it had a broad scope.

Dr Pillay suggested there was a need to include “post-marketing surveillance,” because the functions already called for expertise in vigilance, so “post-marketing surveillance” must be removed.

Dr James agreed with the suggestion.

Dr Volmink enquired whether there would be a need to insert a definition of “vigilance.”

Dr Pillay replied that vigilance had a generic definition, so it was not necessary to define it under Clause 1.

The Chairperson said there needed to be agreement that Members would stick to the original changes in this regard.

Dr James argued that there needed to be a definition of vigilance, so that there was no opportunity for loopholes.

The Chairperson moves on to Section 2D.

Dr Loots pointed out where the changes were due to the complexity of medical terms.

Dr Pillay said a definition of pharmacovigilance had been inserted.

Mr Mosala referred to Section 1, saying it would end at Section 1(i) instead of 1(h).

Dr Loots said that the deletion of various definitions in that section would result in other definitions moving up, so it would not necessarily end at (i) when the changes had been included.

Ms Ndaba enquired about the Board and the role which the Committee would play in its structuring, to avoid problems with other boards.

The Chairperson noted that the Committee had moved on from Section 2C and Section 2D.

Ms Ndaba asked who would be responsible for the screening of board members.

Mr Mahlalela said there were issues which had not been clarified, and he did not think it was appropriate to have deliberations if there were still issues with the Bill.

The Chairperson noted Mr Mahlalela suggestion.

Dr James supported Section 2D.

The Chairperson moved on to section 2E.

Dr James supported Section 2E.

The Chairperson moved on to Section 2F.

Mr Mahlalela noted that in the deliberations, he had raised an issue about who was not allowed on the Board -- whether public servants and MPs were allowed to sit on the Board -- because this was unclear.

Dr Pillay said that the appointment the members of the Board was governed by legislation that prohibited the appointment of MPs and public servants. There would be a process by which the Department would screen candidates ensure their appropriateness.

The Chairperson noted the response from the Department.

Mr Mahlalela enquired whether Section 2D covered the query he had raised, but he understood how this section could deal with the issue he had raised.

Mr Shaik-Emam enquired about how conflict of interest amongst the members of the board would be dealt with.

Dr Pillay’s said his understanding was that the Public Entities Act governed the appropriateness of the members of the Board.

The Chairperson excused the secretary of the Committee, as she had to organise a venue for the Committee meeting taking place at 5pm. There Committee moved on to section 2G

Mr Mosala endorsed Section 2G, along with the additions.

Dr James also endorsed Section 2G, along with the additions.

The Chairperson moved on to Section 2H.

Mr Mahlalela agreed with section 2H.

The Chairperson moved to Section 2I.

Dr James agreed with Section 2I.

Clause 4

The Chairperson said that this Clause dealt with the appointment of the CEO and the repeal of Section 4 of the Bill.

Mr Mahlalela agreed with the Section 3(1) which dealt with how the CEO was appointed.

Dr James supported Section 3 and the repeal of Section 4

Clause 5

Mr Mahlalela agreed with the removal of “Advisory Committee”, and all references to it.

Dr James agreed with Mr Mahlalela.

Clause 6

Mr Mosala agreed with the amendments and additions.

Dr W James also agreed.

Clause 7

Mr Mosala agreed with the changes.

Dr James also agrees with the changes.

Clause 8

Dr James agrees with the changes, because it empowered the functions of SAHPRA.

Mr Mosala also agreed.

Clause 9

Dr James endorsed Section 16.

Mr Mosala agreed with the changes.

Clause 10

Mr Mahlalela said there was a legal problem with Section 18. Proposals that the Committee had made to the Department were not included in the current deliberations, so he was wondering whether the deliberations should continue. There was no clear indication of what was happening with Section 18, and he sought clarity from the legal advisor.

Dr Loots said the Committee did not need to stop the deliberations because of Section 18 (1)(a). She had worked with the Committee secretary to ensure that it did not stop the technical deliberations while she worked on getting the National Assembly to give permission for the Committee to amend this section. The reason for opening the section was to allow for clarification of the mandate for SAHPRA.

The Chairperson said if the deliberations did not affect Section 18, there would be no need to open the Section.

Mr Mahlalela, referring to Section 2G, said there was a section which dealt with consultation with the Pricing Committee. He wanted to know what this implied.

Dr Loots explained that the Pricing Committee in this section referred to the relationship between the Minister and the Pricing Committee.
The Chairperson said that this was very technical. When something was in the Principal Act, there needed to be clarity about what would be amended and what would remain the same.

Dr James supported the explanation and clarification.

Mr Mosala supported Dr James.

Clause 11

Dr James found no difficulty with Section 19.

Mr Mosala agreed with Dr James.

Clause 12

Dr James agreed with Section 20.

Mr Mosala agreed with Dr James.

Clause 13

Dr James endorsed Section 22A.

Mr Mahlalela agreed with Dr James.

Clause 14

Dr James supported Section 22B.

Mr Mahlalela agreed with Dr James.

Clause 15

Dr James found no difficulty with Section 22C.

Mr Mosala agreed with Dr James.

Clause 16

Dr James supported Section 22H.

Mr Mahlalela agreed with Dr James.

Clause 17

Dr James supported Section 28.

Mr Mosala agreed with Dr James.

Clause 18

Dr James supported Section 29.

Mr Mosala agreed with Dr James

Clause 19

Dr James supported Section 30.

Mr Mosala agreed with Dr James.

Clause 20

Dr James supported Section 31.

Mr Mosala agreed with Dr James.

Clause 21

Dr James supported Section 35.

Mr Mosala agrees with Dr James.

Clause 22

Mr Mosala pointed out that “products” had not been fully removed in its entirety from the Bill, and was worried whether this would not be contradictory.

Dr Loots replied that “products” had to stay in a certain context, from a policy perspective of the Department.

Mr Gideon Hoon, Principal State Law Advisor, said that “products” was used in a context-specific way, and not in a way that required it to be defined in the Bill. The change could not be a blanket change, but rather had to be context-specific.

Mr Mosala accepted the explanation and supported Section 36.

Dr James also accepted the Section.

General Comments

Dr Maesela said that pensions were a problem and asked for clarity about how pensions were to be rolled out. Where there was a problem, would the CEO be the one to appoint experts?

The Chairperson said that the CEO would have to work in consultation of the board, rather than independently.

Dr Volmink said that in Section 1, under electronic media, radio and television be cited.

Mr Shaik-Emam asked whether SAHPRA worked with other boards to avoid loopholes.

Dr Pillay replied to the pension issue, saying that those who were on the board, and the CEO, were part of the government pension scheme. However, they had the autonomy to choose what form of pension they wanted, and it was not advantageous for them to use a commercial fund.

The Chairperson returned to Section 18 to get consensus from the Committee.

Mr Mahlalela said that Section 18 still needed to undergo consultation with the National Assembly.

Mr Shaik-Emam said he did not have clarity on the overall changes.

Dr Pillay replied by pointing out that “foodstuffs and cosmetics” would be removed from the Bill and the regulation mandate of SAHPRA.

The Chairperson said that that the legal advisors needed to go through the consultation process on the changes that the Committee had suggested, and there would be further discussion on Section 18. Members would vote on the changes at a later meeting.

Adoption of Minutes

The minutes of 25 February 2015 were adopted without change.

The meeting was adjourned


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