Medicines & Related Substances Amendment Bill: public hearings

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Health

05 August 2008
Chairperson: Mr LV Ngculu (ANC)
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Meeting Summary

The Committee heard public submissions on the Medicines & Related Substances Amendment Bill.

Pick ‘n Pay recommended the exclusion of all foodstuffs in the Bill and suggested that the a ‘medicinal claim’ should be defined. The word ‘product’ should be removed from the Bill. There were concerns that this Bill was duplicating procedures that already applied under other legislation and was not conducive to certainty.

The National Association of Pharmaceutical Wholesalers focussed on the accessibility and affordability of medicines and explained the supply chain in detail. This Association proposed amendments to the principal Act by replacing the word ‘medicine’ with the word ‘product’ in Section 22G. It said that the Bill should go further to amend the provisions of the Act as the proposed amendments did not go far enough, and proposed new wording.

The South African Medical Association (SAMA) expressed strong support for the introduction of an authority to deal with certification and registration of medicines. However, it raised concerns with the authority that would be conferred on the Minister in respect of the registration and certification of foodstuffs, cosmetics, medicines and medical devices, feeling that the Minister should not be allowed to micromanage the processes. 

The National Association of Pharmaceutical Manufacturers submitted that it was seeking to achieve an effective and efficient Regulatory Authority. It made substantial proposals for amendments to Section 22G of the existing Act, and said that the pricing regulations were currently inappropriate because they were based on an ineffective provision of the Act.

The Consumer Goods Council of South Africa raised the need for control over health claims to protect consumers. However, it noted that proposals had been made to exclude foodstuffs, and these appeared to have been ignored. The detailed effect of including foodstuffs was set out.

Danone Clover similarly expressed concern with the definition of ‘foodstuff’ in the Bill and its implications. They proposed regulations relating to the labelling and advertising of foodstuffs.

Massmart proposed new definitions for ‘wholesaler’ and ‘medicinal claim’. The Pharmacy Stakeholders Forum proposed that the dispensing fee should be incorporated into the National Health Act for proper compilation of a National Reference Price List.

Since most of the submissions had raised problems with the definitions of “medicinal” and “medicine” claims and the alleged duplication or inconsistencies of the Medicines and Related Substances Act and the Foodstuffs, Cosmetics and Disinfectants Act, the Chairperson requested all Members to give serious consideration to these issues.

Meeting report

Medicines & Related Substances Amendment Bill (the Bill): Public hearings
Pick n Pay submission
Mr Janusz Luterek, Attorney with Hahn and Hahn, representing Pick‘n’Pay presented the submission. He noted that Pick’n’Pay, in addition to operating supermarkets, also stocked certain health products, and operated a chain of pharmacies, primarily in the hypermarkets. He noted that supplements and vitamins were considered to be essential for those suffering from immune deficiency, and their inclusion into the Medicines and Substances Act would exclude a number of poor people, particularly in rural areas, from accessing them. He noted the effects of clauses 12 to 14 of the Bill and said that this was likely to lead to a decision by Pick’n’Pay not to stock the items. He called for the exclusion of all foodstuffs from the Bill. He noted that any foodstuffs making a “medicinal claim” were already dealt with elsewhere. He proposed a new definition for ‘medicinal claim’ as
claims directed at the curing or healing of a recognized medical condition or illness of the human body by a foodstuff’. (see attached presentation)

Discussion
Dr R Rabinowitz (IFP) stated that regulation was required to avoid dishonest claims as there was a grey area where medicines of no effect were sold with nonsense claims. She asked who would be managing the tests being spoken of.

Mr Luterek stated that it was quite clear in terms of foodstuffs or vitamins why there was a need to had them re-approved every five years. Foodstuffs and vitamins should be separated from medicinal items. The drafting of regulations was a separate matter and should be regulated under the correct directorate.

Ms M Madumise (ANC) asked what other sources were being referring to.

Ms M Matsemela (ANC) said that a number of issues had been raised by this presentation, which had caused some confusion. Pick‘n’Pay seemed to be saying that this Bill was taking away some privileges when referring critically to the Foodstuffs, Cosmetics and Disinfectants Act. She asked further if there was a problem with the definition of a product.

Mr Luterek said that the Directorate of Food Control would deal with this Act.

Dr Rabinowitz stated that the two Bills should talk to each other. She commended Pick ‘n’ Pay on the proposed definition of a medicinal claim.

Ms S Kalyan (DA) asked if the new definition of a product should be looked at, or should left out.

Mr Luterek said that as he was representing Pick ‘n’ Pay, he did not want to get into the field that the pharmaceutical manufacturers would be dealing with, and Pick ‘n’ Pay tried not to tamper with definitions. He recommended that the other way to deal with the matter would be to unravel the definition of a ‘product’, and merely list the products independently. In trying to had one term per product the drafters could end up dragging foodstuffs into other sections.

In terms of food labelling regulations, there was a proposed procedure similar to the Medicines Control Council (MCC) type of procedure. These regulations already had that in place. He was concerned that if this was to be duplicated, then this would create inefficiency in the system. Mr Luterek suggested that one should work with the regulations already in existence without causing further delays. When it came to medicinal claims, the Oxford dictionary offered the same definition as Pick ‘n’ Pay and his suggestion thus followed the principle that any word in law should preferentially first be interpreted according to its regular meaning. 

Mr A Madella (ANC) raised concerns with regard to transitional provisions, and asked for an elaboration.

Mr Luterek stated that certain exemptions and leniencies had been granted in terms of the Bill. This was more to do with what the Council did, because once the Council ceased to exist it was uncertain whether these measures would continue.

The Chairperson asked if Pick ‘n’ Pay was supplied by wholesalers.

Mr Luterek said that Pick ‘n Pay did source certain products itself, most likely vitamins and supplements, and not necessarily only in the pharmacies. Medicines had to be purchased through existing supply channels.

The Chairperson said that the end result was that Pick ‘n Pay was able to open pharmacies as a result of the same legislation that was amended. The Chairperson asked Members to de-link foodstuff legislation from the current legislation and asked for a response to the issue of the consequent dangers regarding foodstuffs and medicines.

A representative from the Department of Health said that there would be cross-linking, and the intention was to manage those matters that would fall between the cracks. Serious claims were clearly directed at serious conditions. The intention was not to do away with the Foodstuffs legislation and the control associated with this.

Mr Luterek said that the Department of Health would regulate the matter in any case. The point was that this had gone so far already from the food control side. The enforcement of food control was at the municipal level and was much simpler to enforce. It was a lot simpler just to add to existing regulations, in his view, than to try to duplicate matters through different legislation.

The Department of Health said that it was important to note that the regulations referred to were draft regulations, and the reason for the delay was to make sure there was a line between foodstuffs and medicinal claims.

Ms F Mathibela (ANC) asked how certain foodstuffs were going to be controlled and monitored.

Mr Luterek said that there was no one monitoring them, other than the retailers themselves. Pick ‘n’ Pay did monitor these things. It was only possible statistically to test for compliance, and there was a large degree of self-regulation in the food industry.

The Chairperson said that somehow an understanding was being developed that there must be loopholes, and that these must be closed. The main area of concern was that ‘medicinal claim’ needed to be defined. There was a suggested definition from the Oxford dictionary. The Chairperson invited Members to just engage with this view to define a medicinal claim, so as to have a benchmark from which to move.


Prof Rodney Green-Thompson, Special Advisor to the Minister of Health, emphasised that turf wars should be avoided and that Pick ‘n Pay agreed that there had to be regulation. There was a big difference between food and medicinal claims, and this was a global challenge to which the Food and Drug Administration in USA had been applying its mind.

National Association of Pharmaceutical Wholesalers (NAPW) submission
Mr J Rustoff, an attorney from Tshwane, represented the NAPW, noting that he would focus on accessibility and affordability of medicines.

He noted that the Bill proposed only one amendment to Section 22(G) of the Principal Act, and that was that the word ‘medicine’ be replaced by the word ‘product’. This amendment was not enough. The Bill should go further to amend the provisions of Section 22(G)(2)(c) of the Medicines and Related Substances Act. If this did not happen the government would not succeed in its stated objectives to make medicines more accessible and more affordable to all South Africans on a sustainable basis.

Mr Rustoff proposed that Section 22(G)(2)(c) be deleted and be replaced with the new wording that he suggested (see attached presentation). Section 22(G) dealt with the critical aspect of the pricing of medicine, and allowed the Minister to make regulations on three aspects: firstly, a transparent pricing system for medicines through the Single Exit Price; secondly, appropriate remuneration for wholesalers and distributors, which the Minister had sought to do through the introduction of fees for logistical services by logistics providers; and thirdly, appropriate remuneration for dispensers of medicine, which the Minister sought to do with the introduction of a dispensing fee through the SEP. 

Mr Rustoff said that because Section 22(G)(2)(c) was inappropriately worded, the pricing regulations promulgated in terms of Section 22(G) were defective insofar as the logistics were concerned. This must be amended to ensure that the pricing regulations could also be amended in time.

Mr Rustoff asserted that pricing regulations actually defined both wholesalers and distributors as logistical service providers, who should be treated in exactly the same, but they were not. The wholesaler was vastly different, and the fundamental issue was to understand the problem in the supply chain. The wholesaler would buy products from the manufacturer for sale to the retailer. The distributor, on the other hand, was an extension or agent for the manufacturer. It never bought the product from the manufacturer, but merely acted as distribution channel.

Mr Rustoff said that there were approximately 20 genuine wholesalers, so when the wholesalers wanted products, they advised the manufacturer. These products were some 18 000 lines supplied by 500 manufacturers, which were then delivered to wholesalers in a bulk format, with shippers and wrappers on a flat bed truck. It was a relatively inexpensive function to move products from the manufacturers to the wholesaler.

Mr Rustoff said that once the wholesaler received the product, he must now unpack the bulk of it, check it, control it and shelve the products, and then take orders from 3 000 retailers, and then invoice for and delivers the product. Besides the two functions being totally different, the bulk distribution was to the benefit of the manufacturer upstream. Fine distribution was to the benefit of the retailer downstream. The pricing regulations unfortunately defined both these functions as logistical services, with no differentiation, and this was a serious matter.

The single exit price was the price that applied throughout the entire supply chain and it was a regulated price. There was one regulated price for medicine, with three components. The first was the manufacturer net price, to compensate the manufacturer. Out of this the manufacturer must recover overheads and earn a reasonable profit. Added to that was the logistics fee component. This was supposed to compensate the logistic service provider for provision of logistical services, and nobody else should be sharing in this. The third component was the part that went to the government. Those three components together made up the exit price, which was regulated, so that the manufacturer net price was also regulated.

Mr Rustoff said that the pricing regulations now provided that the logistic fee component must be negotiated between the manufacturer upstream and the logistical service provider, with the wholesaler and the distributor in the middle. Mr Rustoff stated that all services were not performed upstream for the manufacturer, as only the bulk distribution was for the benefit of the manufacturer. Distribution downstream was to the benefit of the retailer and ultimately the patient. The problem was that the manufacturer was actually determining what the logistic fee component was. It had to be negotiated with each and every logistical service provider. Mr Rustoff said that effectively there were two single exit prices, whereas there should only be one.

This process was not regulated properly because the logistics fee component was not fixed. This was apart from  perversities in the supply chain which resulted in the wholesaler not earning appropriate remuneration.

Mr Rustoff said that the retailer then adds a dispensing fee. The only add-on to SEP was the dispensing fee of the retailer.
The money flow was more complicated because the manufacturer would sell the product to the wholesaler who immediately paid for it, thus paying the whole of the SEP. The South African model was complicated by the introduction of distributors, who were agents for manufacturers. Either a manufacturer who had a warehouse would deliver to the wholesalers directly, or the manufacturer would make use of distributors who had warehouses to get products to wholesalers.  That was difficult. The manufacturer would not transfer risk, because ownership was never transferred, and for that reason only the wealthy manufacturers with the necessary cash flow could make use of distributors.

He summarised the flaws again and noted that to cap, or put a maximum fee, would not help to solve the three problems he had identified. The best solution was to fix the logistics fee component, and this could be done by the pricing committee. This Committee would, firstly, do this by determining the fee for bulk distribution, and then a logistics fee for fine distribution, then add the two together and have a fixed logistics fee.

He therefore proposed that the definition for Section 22(G)2c should be: ‘a reasonable and appropriate logistics fee was to be paid for the provision of logistical functions, which fee should (1) differentiate between bulk distribution and fine distribution; (2) differentiate between wholesalers and distributors; and (3) the effect for wholesalers in relation to fine distribution’.

Discussion
Ms P Tshwete (ANC) wanted to know whether distributors had the right to jump the distribution chain to the wholesaler, and if the distributors paid logistics fees.

Mr Rustoff said that distributors also distributed directly to the retail market through by-passing wholesalers. The fewer products received by wholesalers, the more the costs became for the wholesaler. In order for the wholesaler to be successful he must distribute all products in competition with the distributor, but he must have access to those products. This practice was being abused. Distributors also were undertaking fine distribution for a fee, and this was provided for in the pricing regulations.

Ms Tshwete asked whether the bulk of work was being done by wholesalers, and if distributors also did intensive labour.

Mr Rustoff said that where distributors did fine distribution, it would be more or less of the same labour intensity, bearing in mind that distributors only did distribution for 15 or 20 manufacturing companies. The maxim of low volume / high value applied here.

Ms Madumise asked when distributors came into play.

Mr Rustoff said that the first distributors had set up business in around 1993 and were owned by the manufacturers. Mr Rustoff added that as wholesalers, they should be allowed to compete on an equal footing for the benefit of the patient.

Ms Matsemela asked if the NAPW were suggesting that Section 22(G)2(c), should be revoked by way of the current Bill. She asked further for clarify as to how the pricing committee, which was located within the Department of Health, was dealing with the whole matter.

Mr Rustoff said that regular discussions with Department had taken place, and accordingly indirectly with the Pricing Committee. The problem was that regulations were a subordinate form of legislation and could not be used to interpret the Act. The regulations were faulty because the Act was faulty. Now, he suggested, was the right time also to remedy the principal Act, and once it was remedied, the regulations would therefore also have to be remedied.

Mr Madella asked if what was presented would indeed be in the interests of the patient, and if it would be better if there was no distributor.

Mr Rustoff said that the distributor was necessary in the supply chain, but because of a badly worded Act and badly worded regulations people would suffer. The end price may be cheaper to a patient under certain circumstances. It should be born in mind that the logistic fee was a component. If the wholesaler was not compensated he would fall by the wayside, and if the manufacturer was not compensated, he would also fall by the wayside. Both would have a devastating effect on the patient. Only the rich companies would then exist, and they tended to be those with higher-priced medicines.

Dr Rabinowitz stated that from the presentation it was clear that the payment channel did not follow the distribution channel. However she queried if the wholesaler would be paying less to the manufacturer if the changes were made.

Mr Rustoff responded that the NAPW was not saying that the single exit price should change in any way, but that the logistics fee should not be open to negotiation, because that was where the abuse occurred, but it should instead be fixed. When fixing it, provision should be made for bulk distribution and fine distribution, to ensure that the people who performed these functions were remunerated accordingly.

Ms Kalyan asked whether the point was academic or not. She queried whether the Committee would be able to do anything about it if it was not included in this Bill.

The Chairperson said that guidance was needed on this point. The submission had highlighted certain gaps in the regulations, and these gaps could have a severe impact on the consumer or patient.

Mr Mukesh Vassen, Parliamentary Legal Advisor, said that  according to Rule 249(3)(B) of the NA rules, the Committee would be able to deal with Section 22(G), even thought it was not included in the Bill, if so approved by the National Assembly.

South African Medical Association (SAMA) submission
Mr R Kibble, representative of the South African Medical Association, noted that this Association was a professional body for doctors in South Africa. He expressed strong support for the aspect of the Bill that talked to the introduction of an authority to deal with certification and registration of medicines. This would reduce delays in registration of medicines without decreasing  high standards required for approvals. The structure of the proposed authority was also supported, as headed by a CEO who would be accountable to the Minister [see document]. However, SAMA was concerned about the authority that would be conferred on the Minister in respect of the registration and certification of foodstuffs, cosmetics, medicines and medical devices. The Minister might not have expertise in this field. The CEO was not precluded from conferring with the Minister. Whilst the Minister could provide generic advice, the SAMA felt that the Minister should not micro-manage the process.

Discussion
Ms Matsemela asked, with regard to the two-tier system of certification and registration, if the body that was raised in the presentation should be an independent one, and what were seen as the problematic areas regarding the Minister registering a medicine.

Mr Kibble said that there was no problem regarding the independence of the body. Once the Minister had appointed a group of experts, that group could apply the necessary expertise to the problems. He agreed that the Minister should be consulted on issues with political overtones, or those of policy. He emphasised that this was the most efficient way of working.

A member of the delegation stated that the written submission from SAMA contained more detail than the oral presentation, and highlighted the concerns about the over-involvement of the Ministry with technical matters.

Nutrition Society of South Africa and the Association for Dietetics in South Africa (NSSA) submission
Prof Johann Jerling, Executive Member, NSSA, said that the Association represented around 2 000 dieticians and nutrition scientists in South Africa. It supported the creation of the Agency and agreed that health claims on foodstuffs should be regulated. However, it was concerned with duplication, pointing out that draft regulations of the Food Legislation Advisory Group (FLAG) dealt extensively with health claims. It questioned the consultation process, indicating the number of concerned stakeholders in South Africa. It said that the principal Act did not provide a definition for ‘medicinal claim’, and that the definition of Health Claim in the Foodstuffs Act was problematic. It called for the removal of ‘foodstuffs’ from the current Bill until inclusive consultation had taken place with all stakeholders to merge, unify and align parallel processes in the Department, to formulate clear definitions and fully assess the impact of the proposed changes.

Discussion
Ms Kaylan asked if the organisation would be happy to leave foodstuffs as defined in the Foodstuffs Bill, but have another definition in this Bill which would refer to food supplements and food additives.

Prof Jerling said that it would be best to first get a proper definition of a food supplement, as he was not sure that one existed. There might be an existing definition to categorise vitamins and minerals that were added as food, but there was not certainty that they could be food additives. In the interim, Prof Jerling said that it should be removed.

Ms R Mashigo (ANC) said that the presenter had referred to ‘free food’. She asked in what context that had been used. She asked also whether it was true that food had been incorporated into legislation since 2004.
 

Prof Jerling explained that the free food samples spoken about were emergency relief and school feeding schemes, where food was distributed. In 2004 the possibility of foods being regulated was spoken about in a FLAG meeting, but nothing had been mentioned since.

Dr Rabinowitz asked how the public was supposed to be protected and the call that ‘Product’ might be removed because it because it caused confusion. There was no reason why the definition for foodstuffs as contained in the Foodstuffs Act could not be brought into this Bill. There was no definition for products in between, and Dr Rabinowitz asked the Department to provide a definition that would indicate, for example, where foodstuffs started and traditional medicines ended, and what sort of supplementary foods were included. This would assist in following the regulations clearly.

The Chairperson asked if there were similarities between the defined ‘medicinal claim’ and a ‘health claim’, or were there qualitative differences between the two.

Prof Jerling said that one could have Vitamin A in a physiological role, or in therapeutic doses for therapeutic purposes. With the advent of functional foods, or foods that had been enhanced and might have very specific measurable physiological functions, regulators did not know what to do, because the substance now on the market was neither strictly a food nor strictly a medicine. He suggested that there was more and better guidance from international countries regarding this matter.

Mr Thami Mseleku, Director General, Department of Health, stated that the Department did not want to repeal the Foodstuffs Act, but wanted the two Acts to work in parallel.

Prof Jerling said that when the first draft was produced in 2004, the NSSA did make a submission, but there was the general feeling that there had not been much consultation.

National Association of Pharmaceutical Manufacturers  (NAPM) submission
The NAPM’s representative submitted that the NAPM aimed to champion affordable healthcare by providing generic medicines and to promote the development of the South African Pharmaceutical industry. It set out its Members. It was seeking to achieve an effective and efficient Regulatory Authority (RA). The two--tier registration process was seen as inefficient, costly and as complicating the process. The issues around intellectual property were examined, and a description of the South African patent system was given, stressing that generics did respect patent rights, and would only be introduced once the patent had expired. Patent term extensions were not of benefit to the poor people of South Africa. A detailed exposition was given (see attached presentation). The NAPM suggested that all issues around IP should be removed from the ambit of the regulators, who should instead stick to scientific principles of safety, efficacy and quality. The processes between generics and originators were also described. It was submitted that the proposed changes were wide reaching and could result in further delays if this was not managed properly. It suggested that the Bill should be clear, contain more details and non-core functions should be removed, including the two tier process and intellectual property matters, and finally that the regulations to be established must give full support to the process.

Discussion
Ms Kalyan asked which part of the amendment was being referred to regarding intellectual property.

The NAPM said that section 35 was referred to, and that the changes being proposed could easily be accommodated. A lot of restructuring had come through the Ministerial Task Team.

The Chairperson requested that Members deal with the aspect of intellectual property. He said that Members were not consulted or represented in that Ministerial Task Team.

Mr Mseleku said that if the NAPM was honest, it was presenting this issue in anticipation of another group raising it. This matter was not in the Bill. It was raising opposition to be sure that there was no way that that section had anything to do with data protection.

The NAPM said that the report they received last week stated that the Department would have a close relationship with the patent office.

Mr Mseleku requested asked that the NAPM not respond to the Ministerial Report. The MCC worked with the patent office and this had nothing to do with data protection. There was nothing in the Bill that would allow the Minister to make regulations on data protection.

The NAPM responded that this pointed to vagueness of the Bill. This needed to be clarified so that this issue was not raised outside this hearing.

The Chairperson said that Section 29 dealt with false claims and penalties regarding particular medicines.

The NAPM said, as far as the current requirements were concerned, that where there was a generic it must be proven that there was an originator. There were instances where the originator project was not available and this was presented to the MCC in some or other form.

Mr M Waters (DA) said that it may mean that there had not been an application for registration. He asked if generics would be denied later on.

The Chairperson stated that the slide in question did not reflect the absolute truth at all times.

NAPM said that it could never be true in all circumstances. The current approximate price deteriorated with increases in inflation.

The Chairperson referred to page 7 of the presentation and asked the NAPM to deal with the transitional phase and indicate whether this aspect would be better placed in the Bill or in the regulations.

The NAPM said that it had asked for direction on how to manage transition. This was not covered in this Bill at all, and therefore the proposal was to include it.

The Chairperson said that what had been done in the MCC would be carried forward in the programme. The MCC was functioning and getting submissions. He asked for agreement that the work would happen within those competencies.

Consumer Goods Council of South Africa (CGCSA) submission
Mr Nigel Sunley, member of Consumer Goods Council of South Africa, noted that the Council represented manufacturers and retailers of fast-moving consumer goods, such as food, cleaning materials and toiletries. He noted that it also worked on supply chain issues and would act as communication body between manufacturers and retailers. In principle the regulatory authority was supported. However, there were concerns over the wide ranging nature of product categories and the end result of this on food products. The provisions in relation to foodstuffs were virtually identical to proposals put forward in 2004, and that at that time the food industry and related science bodies had motivated that foodstuffs not be included. No definition had been made for “medicinal claim” and this was of concern, as it gave rise to the danger of arbitrary inclusion of foodstuffs in the categories, leading to complex and costly requirements. Whilst it recognised the need for control over health claims to protect the consumer from inaccurate and misleading statements in regard to the potential health and nutritional benefits of food, these controls were already in place under the foodstuffs legislation and because there was no cross-referencing, this would lead to duplication. It therefore proposed a clear delineation and definition  between food and medicines. Specific procedures should be required for foods and the body to assess them should include both food scientists and medical practitioners. If the Bill was passed in its present form, it would affect many products on the market, lead to increased costs and disadvantage to consumers. Further specialist resources would also be required. This would include products such as maize meal, yoghurt, margarine and breakfast cereals, and samples and promotions would not be allowed; furthermore the supermarkets would have to register as pharmacies to sell these products. No other country had such distinctions and there could be technical barriers to trade. It therefore proposed that all references to foodstuffs be removed, although it did concede that standardisation of administrative procedures would be helpful.

Discussion
Ms Kalyan asked if the in-store promotion of, for instance, margarine, would not be permitted under this law.

Mr Sunley said that this was where the definition became very important, and went back to the point that this was clearly not the intention of Bill when it was drafted. Mr Sunley said that these were just called the labelling regulations. Broadly speaking any provisions would also apply to foodstuffs and could be called into play with any promotional activity.

Ms Kalyan asked if incentives would be stopped with this Bill.

Mr Sunley expressed fear that they might be. Clarity was needed regarding what would not be covered by the Bill.

Mr Green-Thompson said that the argument should be put to rest. The difference between food and food supplements was clear.

The Chairperson asked for guidance regarding uncertainties in interpretation and unintended consequences.

Mr Sunley said that if the guidelines were consulted and a substance was consumed to satisfy hunger, then that would explain to some extent what the definition of food actually was. That could be an example of the sort of criteria that would assist with the differentiation, and could be the starting point for making a clearer definition.


Dr Yogan Pillay, Chief Director:Strategic Planning, National Department of Health, said that the solution lay in clarifying the definition of a medicinal claim.

Danone Clover submission
Ms Jane Badham, Consulting Dietician, Clover, noted that Clover was the leading processor in South Africa of yoghurt, cultured milk (maas) and desserts, as well as producing cheese and yoghurt. She expressed concern with the definition of ‘foodstuff’
 in the Bill and the implications this potentially had for the food business and the promotion of health for all South Africans. She gave details of the Codex Alimentarius, which was formed in 1963 to develop food standards and codes, and set out what it covered. This Codex had already defined both foodstuffs and health claims, and she submitted that these issues were thus already covered and were being constantly updated and revised. She compared the text of the regulations and legislation already in force. She set out what a manufacturer of yoghurt or bread might in future have to do if, for instance, the product was fortified with calcium, and how there was still uncertainty. She also raised the issue of consultation. Finally, she summarised that Danone urged the Committee to remove foods from the Bill as health and nutritional claims were being addressed in the regulations relating to labeling and advertising of foodstuffs.

Discussion
Ms Kalyan asked about the illegal use of the Department of Health logo on foodstuffs.

Ms Badham said that the Heart Foundation would have to apply to the Director-General (DG) to endorse this and show they were doing generic health promotion.

Ms Kalyan asked if the onus lay with the manager to prove whether a product was promoting health.

Ms Badham said that the Heart Foundation should prove to the DG that they were involved with generic health promotion.

Ms Tshwete asked what the concern was.

Ms Badham said that there were many companies with a vested interest, and the loopholes were being closed with regard to that. There had to be an understanding of what was meant by generic health promotion.

Massmart Holdings submission
Mr Graham Rebello, Channel Executive, Massmart, presented the submission. Massmart set out its structure, which included several large retail outlets and smaller cash and carry stores. Similar to other presentations, this one set out the existing regulations. It repeated that there was likely to be much duplication under the current proposals. Massmart were wholesalers in the definition of the Act, and they proposed that wholesalers be exempted from Section 18(A) and 22(G) of the Act, and that this should be made explicit in the Bill. Many of its outlets were in the rural areas and they would have to discontinue a number of lines should the Bill be passed in its current form. The consumers would only be able to get products such as fortified wheat cereals, margarine and some milk products in pharmacies. Massmart called for the introduction of a definition of wholesaler which clarified the position of companies such as Massmart. It also called for the exclusion of all foodstuffs and cosmetics from the Bill was recommended. IF that could not be done, then it recommended that there must be alternative definitions for ‘medicinal claim’ and ‘wholesaler’ and that amendments be made to Sections 27 and 78 of the Act (see document for proposed wording).

Discussion
The Chairperson asked if the definition being proposed had been thoroughly considered.

Mr Rebello said that the definition was primarily in the context of basic foodstuffs and Schedule 0 medicines. The implications for wholesalers were included in the Bill.

The Chairperson asked if there were any dangers regarding the definition that Massmart was proposing.

Mr Rebello said the products Massmart currently sold fell into Schedule 0. Current exemptions around Schedule 0 were being referred to here. Mr Rebello expressed uncertainty about rewriting the definition, as it was not just Massmart that was being legislated for.

The Chairperson said that Massmart had presented a benchmark, which could act as a guide.

Mr Mseleku said that the argument was advanced that the current Section 27 was a problem. He recommended that with regard to Massmart’s problem, the word in the definition should be replaced by ‘medicines’, as medicines would be more inclusive. 

Mr Rebello was not in agreement and said that this was the Department’s fallback position. The emphasis was rather to provide a clear definition as to what was meant by a wholesaler.

Pharmacy Stakeholders Forum (PSF) submission
Mr Sham Moodley, Coordinator, Pharmacy Stakeholders Forum (PSF) said that the PSF represented about 80% of independent pharmacies in South Africa. It supported the principle of a transparent pricing system and said that the Bill should provide the opportunity for a proposal on the process relating to the determination of the dispensing fee and how it related to the Dispensing Act. The PSF proposed that the dispensing fee, currently regulated in terms of Section 22(G) of the Medicines Act should be incorporated into the National Health Act process, for compilation of a National Reference Price List. The motivation was fully set out, and the conclusion and motivations were similarly summarised in detail. The PSF then summarised some additional items for consideration (see attached document).

Discussion.
The Chairperson said that the matters that were being raised were sub judice. The Department and the PSF should solve this problem.

Mr Moodley asked Mr Mseleku if he had a problem with the situation.

The Chairperson said that the Court would resolve the matter if there was no resolution between the parties, and that he was happy to learn that there was a particular interaction between the PSF and the Department.

Mr Moodley said that the PSF had expressed that if a resolution could be found before the court date then this would be fine. If legislation was amended as proposed then the Court case became irrelevant.

Mr Mseleku said there was difficulty with this matter, as that kind of amendment would affect other parties. He added that it would be difficult to discuss a matter of this nature because other people would be affected.

Innovative medicines in South Africa (IMSA) submission
Ms Val Beaumont, CEO, Innovative Medicines in South Africa, presented the submission which called for the removal of the two-tiered registration system. The lack of adequate empowering provisions in the Bill was raised. There was also concern that there was no specific provision for publication of regulations around timelines, and that there was also no addressing of regulations on marketing. She illustrated the current situation around approval of medicines in South Africa. The two tier process would add nothing to what could already be used effectively, and it was therefore suggested that the existing definition of public interest apply, that the proposed new definition not be granted, and all references to the two tier process be removed, and that certain wording around ‘public interest’ be tidied up. She noted that distinction should be made between essential medicines, medicines for burdensome diseases and general therapeutic medicines. Concerns were raised with the proposed SAPRA structure and with registration timelines. The obligation of the Department to publish the marketing code was also raised. In each case, detailed proposals were made for improvements (see document).

Discussion
The Chairperson said the problems raised about the MTT report would have to be discussed as some aspects were incorporated in the report and some were not. Regarding the proposal to create links to the principal Act, he noted that the  best process would be to go through all of these aspects and see why the Department decided to repeal the sections.

Mr Mseleku said that regarding the issue of registration and the timeline, it was difficult to see where this would come in although the proposal said it should be added to Section 15(2).

Ms Beaumont clarified the numbering of the Bill and Act, and that she was referring to clause 7 of the Bill. Ms Beaumont added that IMSA would like to see enabling regulations that showed key steps in the process for amendments and updates.

The Chairperson asked if Section 4 was flagged for processing. 

Ms Beaumont said that the MTT report was used for key things that were felt should be addressed.

Mr Mseleku said he suspected that the directive from IMSA would be useful. The deletion of all those subsections would only occur if there was to be acceptance of the views regarding the two-tier system. There were ways to regulate timelines, one of which was that the Minister would have to publish them. There should possibly be an enabling clause which directed the authorities to publish timelines, and this might be a better solution.

Mr Waters said that Mr Mseleku had confused him as he did not think that the Minister could in fact prescribe timelines.

Centre for the Aids Programme of Research in South Africa (CAPRISA) submission
Mr Andy Gray, Consultant Pharmacist to Caprisa, noted that Caprisa was a research organisation and had substantial experience in the use of unregistered medicines in clinical trials. He noted that there were unclear definitions like ‘product’ and missing definitions like ‘medicinal claim’ and traditional medicines. He cited the Raath
case in support of his submissions. He noted that the costs were a factor that needed to be considered, and outlined the HR costs and advisory functions were outlined. Although the proposals might be in line with international practices, they were not considered to be feasible. There was a need to better define the functions and relationship of the full time staff and the advisory Committees.  Its greater concerns was with the proposed two-stage registration process, and said that proposals in other legislation had not yet been fully implemented.

The Chairperson suggested that the 2-tier system be the subject of discussions when the Bill was deliberated upon. He said he was trying to understand some of the issues that were presented. He decided that it would be better to define medicine rather than product.

Caprisa then went on to note the difficulties in interpretation that the Bill presented. It also took issue with the political accountability and day-to-day functions, which seemed to be blurred in the Bill. Furthermore there were many problems with the existing Act, and other issues identified by the Task Team, which the Bill did not appear to address. Caprisa therefore recommended that the entire Bill be re-drawn, as in its present form it had the potential to destroy the scientific basis for registration of medicines in South Africa.

Retailers Association briefing
The representative for the Retailers’ Association set out in brief who it represented, and said that these submissions were in addition to individual submissions that may be made by members. It raised concerns regarding duplication and over-regulation, for example with overlaps in the Foodstuffs, Cosmetics and Disinfectant Act and their regulations. It was suggested that there should be further consultations with the Department of Trade and Industry. Concerns were expressed over the lack of clear definition for “medicinal” and “medical” claims, and a detailed exposition of the current processes. Not only would this affect the sales, but also the advertising. It was pointed out that many cosmetics were being sold on incentives basis, and this would also be affected by this Bill. There was a possibility of constitutional challenge on this point alone. Proposals for new definitions were included.

The Chairperson stated that Committee Members should apply their minds to the proposed definition of 'medicinal claim' before the meeting to process the Bill.

The meeting was adjourned.

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