Medicines and Related Substances Amendment Bill: public hearings

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05 August 2008
Chairperson: Mr L V Ngculu
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Meeting Summary

The Self Medication Manufacturers Association of SA expressed concern about the registration process for medicines outlined in the Bill. They also wanted a clearer definition for ‘product’ as used in the Bill. They called for the registration of complementary medicines, and the exemption of these medicines, as well as Schedule 0 medicines from the application of S18A and S22G.

Members debated the definition of “product” in the Bill and many felt that the core definition should be in the Bill itself, while the detail should be in regulations.

In their joint presentation, the Aids Law Project and Treatment Action Campaign expressed concern about the broad powers given to the Minister of Health in the registration process. All the presenters felt that the process should be based on criteria of safety, efficacy and quality. They felt that this issue could result in the Bill being challenged on the basis of unconstitutionality. They were also opposed to the proposed location of the regulatory authority within the Department and argued that this body should be independent.

Members criticised the Aids Law Project and Treatment Action Campaign for basing their proposals on their relationship with the present Minister. They also found it contradictory that the presenters spoke about the dire need for the regulatory authority, but then argued that the process establishing such body be halted due to it being flawed.

The Pharmaceutical Industry Association of SA had three key concerns about the Bill. These were: 1) the two-tiered regulatory review of health products; 2) the omission of empowering provisions for key regulations and (3) the lack of adequate transitional measures.

Members had questions regarding criteria for registration, effects of a parallel registration process and the effect of the number of staff members on expediting the registration process.

The South African Medical Device Industry Association highlighted the fact that the Act did not consider the very different supply chains between medicines and medical devices, and proposed a separate chapter for a definition for devices. The South African Laboratory Diagnostics Association called for a framework to be established by the Act to ensure effective regulations in the interest of public safety. They proposed a definition of an In Vitro Diagnostic medical device (IVD) and the deletion of ‘medical device’. Mr Dooms, a pharmacist, recommended that Section 22(G) should be moved to Chapter 10(A) of the Act. The Free Market Foundation (FMF) called for regulations that would enhance competition. The boundaries of a medicinal claim were questioned by the FMF as they were no longer clear.

The Pharmaceutical Task Group (PTG) proposed initiatives to eliminate perversities from the market place. It suggested that compliance had to be mandatory for all companies and for all products to protect patients. The PTG requested finalisation and publishing of the South African marketing codes and to provide for regulations to Section 18(A) and (C) of the Act. Discovery Health called for a more comprehensive registration process to ensure price effectiveness and allow for risk sharing arrangements to assist in maintaining a comprehensive register. Discovery Health also requested that the certification process be strengthened. Unilever felt that foodstuffs did not had a home in Act 101 of 1965 and that the Bill did not differentiate between a ‘medical’ and ‘medicinal’ claim. Unilever referred to lapses in the drafting of the Bill. Pharmaceuticals Made in South Africa (Pharmisa) called for the re-introduction of predictability and certainty into the sector and empowering provisions and timelines into the Bill. Pharmisa proposed that the marketing code should be mandatory.

Members debated the Minister of Health’s involvement in the registration of medicines as presenters were calling for a separate body or authority to carry out this task. The two-tier system was discussed extensively and the Department committed itself to publishing the regulations.

Meeting report

The Chair said that the Committee was supposed to hear a presentation on the report from the Task Team headed by Prof RThompson (Special Advisor to the Minister of Health) on the Bill. This would however not be dealt with at that meeting.

Mr M Waters (DA) said that it was important that this report be discussed as it was vital for Members to see how the proposals in the report differed from what was in the Bill.

The Chair said that the report could be dealt with in-house. It did not have to be dealt with at that meeting, which had been scheduled for public hearings. Doing so would inconvenience the members of the public who had taken the time to present at that meeting.

Self Medication Manufacturers Association of SA submission
Ms Nicola Brink (Chairperson of the Self Medication Manufacturers Association of SA) said that Self Medication Manufacturers Association of SA (SMMASA) supported the registration of medicines according to a scientific and technical process by a specialist body.

SMMASA criticized the definition of ‘product’, which was described to mean “medicine or medical device, or any cosmetic or foodstuff in respect of which a medicinal claim is made”. They asked if it included toothpaste, yoghurt and cereal, all of which claim to have health benefits. They therefore felt its inclusion in the Bill to be unnecessary and confusing and therefore proposed its deletion.

They proposed the registration of the thousands of complementary medicines which have not been registered. They felt that these should be called up and assessed for quality, safety and efficacy.

SMMASA also proposed the exemption of Schedule 0 medicines from the application of S18A and S22G. This exemption should also apply to complementary medicines.

SMMSA expressed concern that S22H effectively prohibited wholesalers from selling products to other wholesalers. This means that big cash and carry wholesalers could be prevented from selling to some spaza shops.

Dr R Rabinowitz (IFP) asked why it was necessary to formulate ways to deal with complementary medicine when it had already been debated extensively during the deliberations on the South African Medicines and Medical Devices Regulatory Authority (SAMMDRA) Act, No. 132 of 1998.

Ms R Mashigo (ANC) asked for more detail on SMMASA’s concern regarding the prevention of selling products between wholesalers.

Ms Brink said that this provision referred to Schedule 0 and complementary medicines, for which this should be allowed. Failure to do so would result in the chain in supply of these medicines would be broken. It would then become difficult for rural areas to access these medicines.

The Chair asked if SMMASA was suggesting that the definition of ‘product’ in the Medicines and Related Substances Amendment Act (‘the Act’) would suffice.

Ms Brink said that there needed to be clarity on the meaning of product “in respect of which a medicinal claim is made”. Failure to do so would subject toothpaste to the provisions of S18A and S22, since toothpastes often purport to give the user healthy gums.

The Chair argued that manufacturers of toothpaste did not claim that toothpaste would treat any disease. Yoghurt manufacturers also did not make any medicinal claims.

Ms P Tshwete (ANC) added that neither toothpaste nor yoghurt was prescribed by doctors, nor were they stocked by doctors for provision to patients.

Ms Brink agreed, saying that this was precisely the reason that this definition needed to be clarified. It would ensure that the definition excluded products such as toothpaste and yoghurt.

Ms S Kalyan (DA) referred to yoghurt with probiotics, which claimed to reduce gastrointestinal infections. Also, there was milk with calcium additives, which claimed to provide strong bones and teeth. She asked how these should be dealt with.

Ms Brink said that this was already dealt with in the Foodstuffs, Cosmetics and Disinfectants Act39 of 2007 (“the Foodstuffs Act”). It was unnecessary to include these in this Bill as well.

Ms Allison Vienings (Executive Director of SMMASA) added that SA was the only country in which anti-bacterial soaps and tooth whiteners were registrable.

Ms Rabinowitz said that there needed to be a clear definition and that the detail should be dealt with in the regulations. This had already been debated extensively when the Committee had dealt with the SAMMDRA Act.

The Chair wanted clarity on what the presenters wanted regarding this issue.

Ms Brink responded that they wanted clarity regarding this definition.

The Chair asked if the definition in the Medicines Act should be retained, while details should be included in regulations.

Ms M Matsemela (ANC) asked if the problem identified by SMMASA was that registration was done by unqualified people.

Ms Brink answered that the problem was that complementary medicines were not registered at all. Anyone could manufacture a vitamin and start to sell it immediately.

Ms Matsemela asked if SMMASA had a problem with who would register medicines in terms of the Bill.

Ms Brink replied that they merely wanted registration to be based on efficacy, safety and quality.

Ms Rabinowitz suggested that this problem could be solved if there were a clear definition of ‘complementary medicines’.

Prof Thompson said that internationally these details were dealt with in regulations. It was preferable, as its inclusion in regulations enabled departments to keep up with the scientific advances without having to amend legislation.

The Chair was not comfortable with the idea of including the definition in regulations.

Prof Thompson said that there should be a balance between what went into the Bill itself and what was included in regulations.

The Chair suggested that the main definition should be included in the Bill while the details should be in regulations.

The Chair requested detail on their suggestions regarding the exemption of Schedule 0 medicines from S18A.

Ms Brink said that SMMASA had applied and obtained this exemption based on an impact study they had done.

Dr Rabinowitz pointed out that the Bill did not say that there would not be an exemption of these medicines.

Ms Brink agreed, but explained that they wanted to ensure that this exemption would continue.

Mr Pillay (Department of Health) said that introducing a lifetime exemption could introduce a market dynamic which cannot be corrected.

Ms M Hela (Acting Cluster Manager: Pharmaceutical Policy and Planning- Department of Health) said that regulations on complementary medicine would be published for comment on the following Friday.

Aids Law Project and Treatment Action Campaign Joint submission
Mr Zackie Achmat (Chairperson- Treatment Action Campaign) showed Members a product purchased at a retail outlet, claiming to contain antioxidants and assist the body with any toxic effects. The product leaflet made clear medical claims. He referred to the fact that the recommended dosage for a child was one tablet daily. This would be very costly for a poor person, given that the product was sold for R88, 00. This was particularly problematic since the product had not undergone clinical trials and there was in fact no way of proving its efficacy. He said that this situation was only possible due to the lack of an independent regulatory authority.

The Treatment Action Campaign (TAC) emphasized the need for a strong independent regulatory authority. The Medicines Control Council (MCC), he argued, was struggling to discharge its mandate due to its lack of independence.

Mr Achmat felt that the process was being rushed unnecessarily. He referred to the fact that the process was flawed since inception, with the appointment of the Ministerial Committee which had started the process. Transparency had been a problem and TAC had to threaten to institute legal proceedings to obtain access to information before the committee report was released.

TAC wanted the Task Team report to be the basis of further public consultation. In essence they called for an oversight body (to regulate medicines) which would be accountable to Parliament and not to the Minister. This provision was not aimed at the present Minister, but at the fact that one could not be certain that one would always have a good Minister holding that position.

Mr Jonathan Berger (Senior Researcher-Aids Law Project) said that the Bill would not ensure the effective and efficient regulation of medicines and other health products. It could undermine the scientific governance of medicines and other health products by:

(1) inappropriately allocating broad powers to the Minister- This allocation of powers could possibly be open to constitutional challenge. The presenters opposed the two-tier process of registration, as it went beyond the criteria of quality, safety and efficacy. While these factors would be considered during the certification process, further issues would then have to be considered by the Minister before registration would be allowed. Although these issues were legitimate concerns, they should not form part of the decision whether or not to register medicines. They should instead be dealt with elsewhere, for example, issues of industrial policy should be considered by the Department of Trade and Industry (DTI). There is no reasonable basis for excluding products which satisfy the criteria of quality, safety and efficacy. The decision should be made by suitably qualified experts free from political interference.

(2) changing the structure of the regulatory authority by locating it within the Department
This would in effect amount to replacing a semi-independent MCC with a regulatory authority which would operate as a line function within the Department. This would not be a problem if the Department had shown itself to be capable of operating independently (which it had not). This would also require the Department to be rehabilitated first. In addition the Bill removes any reference to a governance structure. The Authority would instead by headed by a CEO, who would report directly to the Minister. Thus the Authority’s direct links to Parliament would be limited.

Mr Berger said that the Bill was fundamentally flawed and could not be redeemed by deliberating on it line by line. The stakeholders should use the SAMMDRA Act and the Task Team Report as a starting point for further engagement.

Ms Kalyan referred to Mr Achmat’s assertion that the consultation process had been flawed. She asked if he was referring to the process involving the Ministerial Task Team or that involving the Bill in its present form.

Mr Berger responded that both processes had been flawed. The published Bill and the tabled Bill were almost identical, despite extensive public comments on the Bill. This showed that very little consideration had been given to public input on the Bill.

Mr Achmat added that very important stakeholders had been left out of the consultation process. There needed to be input from the scientists dealing with areas such as nanotechnology etcetera; as well as Pharmacology departments at the various universities.

Ms Kalyan asked if Mr Berger felt that the Bill in its present form would withstand Constitutional challenge.

Mr Berger replied that the Bill was open to Constitutional challenge on many grounds. These grounds were evident from the Doctors for Life case and the Pharmaceutical case (among others). There was sufficient expertise in that room to ensure that the Bill would not be challenged on Constitutional grounds.

Dr Rabinowitz asked if the process would be assisted by referring to issues raised in SAMMDRA and the Task Team Report.

Mr Berger said that these reports should have been the starting point of the process. In addition the report by Professor Thompson should have been released earlier.

Dr Rabinowitz felt that location of the Regulatory Authority within the Department was not the problem, but rather how it was structured.

Ms Madumise asked what the role of the Portfolio Committee would be with regard to oversight of the CEO.

Mr Berger answered that the CEO of the regulator would account to the Minister in a way that statutory bodies of this nature usually do not.

Ms Matsemela criticized the presenters for “undertaking a path traveled before” and basing their views on their past relationship with the present Minister. She said that Mr Achmat had stated that they welcomed the restructuring of the Regulatory Authority, but that the presentation delivered by Mr Berger had not assisted the Committee to achieve this goal.

Mr Berger said that they supported the goal of restructuring but not in the manner proposed by the Bill. They were under the impression that they were assisting the Committee by providing constructive criticism of the Bill. He reiterated that there were other agency structures upon which the regulator could be based. He also added that their proposals had nothing to do with their relationship with the present Minister, but were aimed at limiting the powers of any Minister who would succeed her.

Ms Matsemela asked what he meant by saying that the Department needed to be rehabilitated.

Mr Berger answered that the Department was already struggling with skills retention. There would be a need to hire the best and the brightest to ensure the effective functioning of such Authority. Locating it within the Department would not attract skills. He referred to the way in which the Council for Medical Schemes (CMS) was able to attract skills by functioning outside the Department. He asked why they could not use such statutory bodies as a model for the structure of this Authority.

Ms Tshwete asked why the presenters were concerned about the qualifications of the CEO, as this would be dealt with when advertising for this post and therefore did not need to be dealt with in the context of this Bill.

Mr Berger answered that there needed to be guidelines regarding the appointment of the CEO. Parliament needed to play a greater role in the process.

The Chair said that there were inherent contradictions in the approach of the presenters. On the one hand they recognized the dire need for the regulatory authority, while on the other they were proposing that the process be halted. Since the Bill sought to address the challenges facing the country regarding the issue of medicines registration, he thought that Aids Law Project and TAC would support it.

The Chair also referred to the criticisms regarding the structure of the regulator. He said that there was no way the agency could be located outside Government. The body would need to be subject to the provisions of the Public Finance Management Act (PFMA) and accountable to Parliament. In addition, the authority would not account to the Minister on scientific and technical issues, but would account to the Minister regarding their compliance with the laws of the country.

Mr Waters said that the inefficiencies in this area started in 1997. It was also at this point that there was political interference in the sphere of medicine registrations. This emphasized the need for an independent body. It was also unacceptable that despite the medicine meeting the criteria of quality, efficacy and safety, the Minister could still refuse to register it.

Mr Achmat said that their organizations were willing to provide technical expertise for the following two weeks to ensure that the Bill was not left open to Constitutional challenge. He also added that the fact that the MCC had not been properly funded had presented a huge problem. He therefore emphasized the need to ensure that this body would receive adequate funding.

Mr Achmat also wished to use the opportunity to highlight the importance of the Medical Schemes Amendment Bill. Insurance companies would be able to establish their own health products which could destroy the medical aid systems as it currently existed. This would undermine access of the lower income groups to medical aids.

Mr Berger agreed that there was a dire need for the regulator but said that there was no need to move away from the approach used for statutory councils. He could not understand why it was not possible to structure the regulator in the way the CMS was structured instead of having it operate as a line function within the Department.

The Chair said that presenters should provide the Committee with proposals regarding the process for registration of medicines. Regarding the use of the CMS as a model, he said that even this body had to account to the Portfolio Committee and submit Annual Reports to the Minister.

Pharmaceutical Industry Association of SA submission
Ms Abeda Williams (Medical and Technical Affairs Director- Janssen Cilag and Representative of Pharmaceutical Industry Association of SA) said that PharmaceuticalIndustry Association of SA (PIASA) had expected the Bill to expedite the approval process, hereby ensuring better access by patients to medicines. They supported many of the amendments proposed in the Bill (listed on page 1 of their presentation document under the heading “Positive Amendments Proposed in the Amendment Bill).

Their key concerns were:
1) the two-tiered regulatory review of health products
2) the omission of empowering provisions for key regulations and
3) the lack of adequate transitional measures

Regarding the two-tiered approval system, PIASA felt that the requirement that the Minister consider “public interest” prior to registration of the medicines, created an additional barrier for health products and would delay patient access to medicines. All health regulatory authorities approve medicines on the basis of safety, efficacy and quality. Price regulation and reimbursement were separate and did not hinder broader patient access. PIASA requested that the Committee review the additional criteria of “public interest”, which could delay or deny public access to medicines. Economic/ financial considerations had to be examined by the appropriate bodies (but not as part of the registration process). The two-tier process would deny patients access irrespective of affordability. Also it could be deemed to be anti-competitive since it would limit the number of products on the market. Fewer approvals would also affect the pipeline for future generic products, as the generic could not be registered due to the failure to register the original product. Also, patients would not be able to benefit from new uses developed for a product which had been refused registration.

They therefore proposed a single step registration which is based on science and looked at safety, quality and efficacy of the product. Considerations of “public interest” should be dealt with separately and should not be part of registration. They also said that the transition between the current MCC and the new Authority should be clarified.

Ms Matsemela wanted clarity on the question of public interest in relation to policy.

Ms Williams said that this included economic factors and those of cost effectiveness, which should actually form part of a pricing discussion. Government already deals with the issue of access to healthcare for vulnerable groups in terms of the Essential Drugs List (EDL) and this should not be done during the registration process as well.

Ms Mashigo asked if parallel registration of medicines did not in fact increase the accessibility to generic medicines.

Ms Williams explained that if new medicines were blocked from registration, their generics would not be able to obtain approval.

Mr Waters said that the Bill was supposed to improve the efficacy of the Authority, but the extra step added to the delays in the process. He asked if the presenter had done research on the effects of the Brazilian model on the pharmaceutical industry.

Ms Williams replied that she was waiting to obtain access to that report.

Ms Madumisa asked if the increase in staff from 138 to 482 employees would not address the delay in registrations.

Ms Williams said that while it would help, one should remember that the backlog still had to be cleared before new registrations could be processed. In fact, given the inclusion of traditional medicines, complementary medicines and medical devices in the definition, the 482 staff members would probably not be enough.

Afternoon session

PIASA Discussion continued
The Chairperson said that regarding Clause 6 on certification and registration of products, the crux of the matter could be discussed, and this could had a knock-on effect on other submissions. The organization had suggested that the processes were registration and pricing, and the Committee did not had a problem with this, but there had been a suggestion around the function of registration, and fears of further delays. The Chairperson asked if PIASA wanted to did away with registration.

Mr Waters said that once the authority had tested the product for safety and efficacy, it would be registered. The Minister could not be involved.

Ms Kalyan said that there was a body with the necessary competency who was supposed to do the work, so it should not be necessary for the Minister to have to micro-manage the whole process.

Ms Matsemela said that in certain countries like Australia the Minister was not involved in registration, only in the exemption of registration of therapeutic goods. In Nigeria there was an agency and a registrar, who would register. The Ministers in other countries that the Task Team had reported on did not have a say in the registration of products. In India the central government established another body to look into the products critically. South Africa did need to look critically into registration and certification.

Ms Kalyan said that if the Minister was given the power to register, and someone did not agree, hey must put in an appeal to the Director-General, and this person would have to re-apply to the Minister again.

Ms A Williams said that because there was a double process involved, the Minister was always involved, so once there was registration, the Minister could disallow this. PIASA’s argument was that the Minister should not be involved in registration of medicines. It should be the authority, or an agency as an independent body, that looked at the science of medicines.

The Chairperson asked if PIASA was suggesting that if the two-tier system was resolved, the registration by the Minister would be resolved.

Ms Williams stated that only the authority designated should make the decision.

The Chairperson asked where the oversight role of the Minister would come from.

Ms Williams said that when an authority reported to the Minister, and this authority made a decision, the Minister could not change the decision.

The Chairperson asked what would happen if, in the interest of national health policy, the Minister may find that a particular drug had no national interest.

Ms Williams said that if a product was on the essential drug list of the Minister of Health, then registration should be done. However, matters were reviewed separately in different in government structures.

Mr Madella noted that in terms of the principal Act the Minister was involved. If the Minister deemed it necessary, and in the interest of national health, then he/she could approve that such registration take place.

South African Medical Device Industry Association (SAMED) submission
Mr Mike Howe-Ely, Chairman of SAMED, defined a medical device and the practical considerations regarding such devices. He outlined the differences between medicines and medical devices and the complex value chain of medical devices. Mr Howe-Ely highlighted the fact that the Act did not consider the very different supply chains between medicines and medical devices and submitted that there was a need for, amongst other, a separate chapter and a definition for medical devices. Further proposals were contained in the written submission.

Ms S Kalyan (DA) asked if devices were also classified into categories and if medical professionals were involved in any way.

Mr Howe-Ely stated that internationally devices were put into classes, and In-vitro diagnostic products had also been separated into classes. They varied enormously in terms of who dispensed what products. A medical technician or patient would have access to such a device.

Ms Matsemela wanted clarity on the definition on a product. A device at the end of the day was a final product. In the principal Act the two had been separated into medical devices and medicines, but the current Bill was talking about a product.

Mr Howe-Ely said that there was no definition with regard to a product per se. Problems arose when there were certain unintended consequences like the labeling requirement and the dispensing requirement. His concern was not with the definition, but with what flowed from the definition.

The Chairperson noted that the definition of a product meant medicine, medical device or cosmetic substance in respect of which a medical claim was made. In the principal Act there was a definition of a medical device and a definition of medicine, and the way the principal Act defined medical device was more or less the explanatory submission from SAMED.

Mr Howe-Ely responded that the belief was that the definition was bit outdated as it had not been updated for 35 years. The new international classification and definition of a device was probably more appropriate, and this had been referred to in slide 5 of his presentation.

Dr Rabinowitz asked for understanding from SAMED and clarity from the Department regarding the request for a different body altogether for medical devices, as for the Department it was a completely different matter to approve and regulate devices and required expertise and different sorts of technicians. She asked if in the current Bill, there would be scope for that separate body to exist as a committee, or as a body set in to place in the regulations, or was it understood as the same people who were approving medicines who were then supposed to approve medical devices, or even people on the same committee.

Dr Rabinowitz asked the Department how they intended to take on board all of the issues which made medical devices a completely separate issue as these were much more complex than an ordinary product. She asked for some indication of how it was being done at the moment, and whether, for example, a CE classification was adequate to prove of the viability of a device. If, as some had suggested, it was merely a formality, then she asked what sort of capacity was needed to incorporate that into this Bill, and under what section it would fall. Dr Rabinowitz wanted to know why it had taken so long to regulate medical devices.

Mr Howe-Ely said that ideally SAMED would like to see a separate wing or body that focused on medical devices, as this was most appropriate. There were indeed very different needs, different requirements, and slightly different skills sets, and that would be strongly supported.

In answer to whether SAMED was protected, Mr Howe-Ely said that they were not protected at all, with the exception of two classes of devices, one of which was a combination device such as a stent. Combination devices were regulated by the Medicines Control Council and electro-medical devices were controlled by the Department of Health Radiation Control. Other than this there was nothing to stop anyone from dumping a product of dubious quality on to the South African market and exposing people to it.

Dr Rabinowitz asked SAMED to address the CE classification on all device products.

Mr Howe-Ely said that their view was slightly different, as the quality process meant that the product had undergone some inspection, evaluation and quality assessment. Products were sourced from the United States, which were FDA approved, and from Europe which were CE marked. He suggested that products which were CE or FDA marked would meet quality standards.

A member of the delegation said that if the number below the CE mark on a medical device meant that that CE mark had been given to that company to market that product in the European Community by a notified body. This meant that it had gone through a quality assessment audit and would have to have a technical dossier that met the requirements in Europe. This then gave some comfort regarding its efficacy and quality. If it did not have the number below the CE mark, it meant that it was a low risk medical device and had been self-assessed, and the company had been trusted to put it on the market.

Mr Madella (ANC) expressed the opinion that there was a lot of merit in reviewing the definition of medical devices as currently contained in the old Act. He also indicated that ways should be found to strengthen the current definition.

Given the fact that this was a fast paced industry, and it was indicated that the principle of re-registration every five years was not supported by everyone, Mr Madella asked what appropriate period of re-registration would SAMED recommend to the Committee.

Ms Mashigo asked if other countries had a separate chapter on medical devices.

Regarding the issue of a separate chapter, Ms Mashigo asked further if the Department had considered the issue of the inclusion of engineers and training in this matter.

Ms Madumisa wanted to know if, instead of looking for a separate body to deal with medical devices, there were some ideas on who would be the regulatory authority and if this would include people with knowledge of medical devices. The Department could look for people with the required qualities.

Mr Howe-Ely answered, in respect of the queries around the re-registration period, that this would depend on the category of the device, for example categories 1a, 2, 3 or 4, and the different categories of risk classifications and devices.

Other countries had a separate chapter. SAMED did not have a full list, but some of them included Canada, Australia, Brazil, the United States, Korea and the European Union.

Mr Howe-Ely suggested that perhaps instead of a separate body the 480 members could deal appropriately with devices. SAMED’s experience in the past had been that in fact they were ill-equipped to deal with questions of medical devices. Ideally SAMED would like to see a separate totally focused body of people handling medical devices.

The Chairperson asked if SAMED wanted a separate definition, because the Bill sought to introduce a new definition called ‘products’. The problem arose with SAMED’s own suggestion as it seemed to be just transposing what was defined, and then seeking to it put into the Bill. The principal Act sought to make certain definitions and some were incorporated here. SAMED wished to include specific references and this definition sought to encompass it in a different way.

Mr Howe-Ely stated that the definition was at an international standard and used broadly across the world. It was more updated and somewhat more comprehensive and if a new definition was being brought in and was inserted in new regulations, then the time was appropriate to update our own definition.

The Chairperson referred to page 9 of the Bill, and page 5 of the submission, which read: ‘….bears a label stating the prescribed particulars’. If a medical device may be imported and was already in a sterilised package, he asked how could a label be put on it.

Mr Howe-Ely stated that for almost any sterilised medical device there was an inner package and it was covered by an outer package or an overwrap. All wrapping was done under sterile conditions. An amendment or new labeling which would be different from that currently on the product would be impossible.

Mr Anban Pillay, Cluster Manager: Department of Health said that the approach of the Department was to use Section 36 of the principal Act when dealing with the difficulty of labeling for pharmaceutical products and packaging.

Mr Howe-Ely said that it would be easier to include the matter in new legislation rather than to make exemptions.

Mr Mseleku, Director-General: Department of Health stated that the operative word was ‘prescribed’, which was the legal word for regulation. The law did not have to be re-written.

Dr Rabinowitz asked if it would not make it easier if the word ‘immediate’ was taken out. SAMED had not given clear proposals for amendments. The Department was asked what it was envisaging to regulate devices separately; and if it would be hard to put framework legislation into the Act or Bill.

Mr Howe-Ely said that SAMED had submitted a detailed document to the Department of Health on amendments.

Ms Mashigo asked if, in regard to the definition, it was intended that some of it would be in the regulations and if the regulations would also cover health professionals.

Ms Matsemela said that, regarding the issue of labeling, if a device had been imported, and had violated the Act, the Minister would have to be consulted regarding re-labeling. She asked for the context in which this was raised.

Mr Howe-Ely responded that the basic issue was SAMED’s belief that many imported products would technically violate the provisions of the Act in terms of inner container labeling. It might be simpler and easier to change that part of the legislation, which SAMED had made a recommendation about in writing to the Department, rather than continuing to apply for exemptions.

The Chairperson asked SAMED if references to regulations would deal with some of their concerns, rather than putting all the details of labeling in the Bill itself.

Mr Howe-Ely acquiesced.

The Chairperson referred to page 7 of SAMED’s submission and asked for an explanation regarding the references to bonus systems and incentive schemes.

Mr Howe-Ely said it was SAMED’s belief that for medical devices it was appropriate to offer a volume discount for a volume purchase. With sampling especially, it was imperative, for example, when a new dressing came on to the market, for people to see if and how it worked before a purchase was made.

The Chairperson asked for an explanation regarding matters of perversity.

Mr Howe-Ely explained that there had been perversity in the past, when there was a rebate system. The medical device industry had moved away from this and had mandated that any discount offered must appear on the invoice and must be totally transparent. Any company who violated the rules would be expelled from SAMED. SAMED had worked with the Department of Trade and Industry (dti) and testified to the Consumer Council to support and outlaw the practice of rebates.

The Chairperson referred to issue of pharmaceutical training, which SAMED raised as a requirement, as per Clause 23(b)(2) of the Bill and asked how and where, given certain requirements and qualifications in terms of medical devices, would SAMED want people.

Mr Howe-Ely said that there was a lack of pharmacists who had skills and expertise. SAMED suggested that provision should be made in the regulations for some kind of inspectorate where health professionals and technicians should be subjected to some kind of review by SAPRA.

The South African Laboratory Diagnostics Association (SALDA) submission
Mr G Northfield, CEO of SALDA, presented on the need for a framework to be established by the Act to ensure effective regulation in the interest of public safety. He outlined what ‘product’ covered now in the new amendment. Mr Northfield proposed the insertion of a definition of an In Vitro diagnostic medical device (IVD) in the Act and the deletion of ‘medical device’, and explained the IVD value chain. The importance of risk classification was emphasised, and bonusing, sampling and rebates were explained. Mr Northfield explained the perversities that drove up costs in the IVD sector and proposed specific wording changes to made the Act implementable. [see document]

The Chairperson asked if there was a agreement to incorporate the gaps that had been identified into the Bill and confer with the Department with regard to this submission.

Mr Rene Dooms, citizen and pharmacist’s submission
Mr Dooms stated that he represented himself as a citizen and pharmacist, and would like to address two issues in this presentation. He stated that firstly he supported the Bill and the reason was that the MCC function had come to an end. A stage had been reached where the MCC had become dysfunctional and did not service the needs of the people of this country. Mr Dooms said he had spent 37 years in this industry and as a technical advisor to the World Health Organisation, and found that there was no future place for the MCC. Therefore a system must be adopted that was more suited to protect the interests of South Africans. He re-asserted his support for the Minister’s intervention in this Bill.

Mr Dooms made the point that the Medicines Act was quite clever, in that it was an Act that allowed for other legislation to talk to other issues relating to health care. The Minister’s authority came from Section 27 of the Constitution.

The Minister of Health was the head of health in this country and should not be asked to get involved in the registration of medicines, as access to health care services had been expanded in terms of the National Health Act, over which the Minister similarly exercised authority, to ensure that there would be a free flow of essential medicines.

Essential drugs in South Africa were being manufactured offshore, but could be manufactured locally. Mr Dooms asserted that South Africa was not looking after its inherent resources. Transparency had been created through the Public Finance Management Act (PFMA), and the purpose of the Medicines Act was to look after people and not after the pharmaceutical industry. The Bill needed to be supported as it had fantastic mechanisms for alternative dispute resolution.

As soon as Bill had been assented to, the Minister could put infrastructure in place to implement it.

Mr Dooms expressed unhappiness about being treated unfairly as a pharmacist. The Medicines Act had been modified 15 times since its inception and there was interference in economics. The pricing concept was added to a highly technical piece of legislation, and this had a dramatic effect on its administration to the point where the courts had indicated that something was wrong. Mr Dooms added that the Minister and the Department had published Chapter 10 of the National Health Act, which was a good piece of legislation for a number of reasons, primarily because it looked after health economics.

Mr Dooms said that the National Health Act followed directly from the Constitution and Chapter 10 was adequate to control the pricing of all health care services in this country. The fact that the Department of Health, through its economic division, had put together an exceptionally well-thought out model, could only add to the adequate determination of health care services.

Mr Dooms expressed concern at not being able to negotiate his professional fee, because the pricing committee had to be consulted, and although every other health care provider was entitled to bargain collectively and negotiate. He questioned the difference between the concept of negotiation and consultation, saying that the way the Medicines Act was structured at the moment took away the rights of professional persons. He proposed that this Bill and the Minister be supported.

Mr Dooms added that the proposed Section 22(G) was concerned should be moved to Chapter 10(A). He pleaded that he should be treated as treated in the same way as other health care professionals in this country. This would allow for positive forward movement and allow for medicines to be supplied at affordable prices.

The Chairperson asked for agreement that Mr Doom’s submission referred to matters outside the purview of this Act, but the oral submission did deal with it in part. He added that the same logic regarding the MCC and the Minister would apply to the pricing committee, but that it could not be dealt with today.

Mr Waters asked if, in the event that a particular medicine failed the quality and efficacy test but the Minister still decided to register it, it would not be preferable to leave it to the professionals to decide which drugs should be registered and which not. Mr Waters asked further if Mr Dooms had ever done work for the Department of Health.

Mr Dooms responded that he had consulted with the Department of Health and assisted the Registrar of Medicine for two years. He said that he had worked with the World Health Organisation (WHO) in Geneva and had consulted with every pharmaceutical company in country.

He noted that Virodene failed the certification process, which was the MCC option at the time, and as far as the public interest was concerned it was written into Sections 1 and 4 of the Act, because the concept of public pricing in Section15(4) was introduced. Quality, safety and efficacy related specifically to the certifying body or authority, but the rest of it related to economic issues. Mr Dooms said that as far as disinvestment was concerned, there was a certain premium that the public would have to pay. The political will had not been what it should have been and this was why the Minister needed to get involved.

Ms Matsemela asked how Mr Dooms viewed the registration of medicines by the Minister.

Mr Dooms said that it was not for the Minister to intervene in every certification, as the Minister was involved in policy, other than for an exceptional circumstance that would impact on a problem.

Free Market Foundation (FMF) submission
Mr Leon Louw, Executive Director, Free Market Foundation said that the view of the Free Market Foundation (FMF) was that there should be regulations. However, the best form of regulation was competition, and the best boss was the consumer. The extent to which regulation of the market was replaced by regulation by decree could harm the interest and level of protection that consumers enjoyed.

Regarding certification, Mr Louw said that the Bill plunged the world of health care into a world of uncertainty. A whole new set of definitions were required to be interpreted, and these had been very poorly drafted, and did not comply with the minimum requirement of setting clear objectives for which a power was created, and describing the extent to which that power was exercised. The purpose of certification was vague and contradictory.

Mr Louw said that if the Department of Health thought that the courts could not perform then it should take this matter up with the Department of Justice, and not try to replace judicial interpretation with legislation.

Mr Louw referred to subclause 1(f) of the Bill and questioned that clause relating to the definition of a product, which stated: ‘product means medicine or medical device… respect of which a medical claim was made’. He felt that this wording could result in costly complex and uncertain legal interpretation. Whenever a law was made, courts were obliged, under South African law, to assume that the legislature wanted to make a change. This wording meant things other than health products. This would imply that the Department of Health was longer regulating health products, or was regulating health products, but in unclear ways. He urged the Department and Committee to not depart from tried and tested meanings of words, unless there was a very good reason for doing so, and that if it did change, it must replace the old definitions only with unambiguous words or phrases that left no doubt as to why they were being introduced. Some of the old terminology remained in the Act, so ‘medicinal’ and ‘medical’ was not complete, and would plunge the law into needless confusion.

Regarding the issue of what a medicinal claim was, Mr Louw questioned the boundaries for such a claim, as he said that the issue had now been clouded.

Mr Louw said that the Minister needed to know, and the legislation must say, what was meant by the requirement for the appointment of suitably qualified persons. The precise meaning, the purpose for which the qualification was required, the expected outcome, and the criteria considered appropriate for the qualification should be clearly spelt out. Mr Louw said this was bad legal drafting and it was not fair of the Department of Health to include such vague terms. Mr Louw argued for a very clear and unambiguous definition and encouraged the Department to rather stick with what was known to work, unless there was good reason to depart from it.

On the question of medicines, Mr Louw said that this provision allowed for the government to ban any foodstuff or cosmetic product. Anything that was not a medicine could be regulated and banned or an exemption could be granted. He stated that health law should be clear about products that dealt with health.

The proposed Section 15(3) was simply a repetition of common law. Anything that was already in the law should be removed from the Bill, because the court would otherwise have to assume that legislators wanted to change existing principles.

With regard to the powers of the Minister, Mr Louw said that the Act envisaged that the Minister should seriously apply her mind to registrations and certifications. This was a meaningless provision, as it required the Minister to merely act as a rubber stamp. This should be changed to allow the Minister to have the power to intervene when she had reason to do so.

Mr Louw asserted that it was an extraordinarily tenacious myth that one could have benefits without costs. The laws of economics did not allow one to reduce prices without reducing the supply. What was really needed was a move away from price control. This Department had not caught up yet with the lessons of the past – not to mess with prices!

Dr Rabinowitz said that the industry did not self-regulate and just wanted to made a profit. She asked, in the event that the common law be left to look after this, then who would test and prove that claims were valid. Dr Rabinowitz asked if the Free Market Foundation was trying to say that that the definitions had been disturbed because the definitions of ‘medicines’ and ‘medical devices’ had been taken away.

A delegate from the Free Market Foundation said that the health care industry was firstly a business for profit. There had to be an understanding that the Minister functioned to facilitate a policy environment that had to proliferate business.

Mr Louw said that there were ways to protect the consumer from fraudulent products. Products had to be certified in advance, and this presupposed that the government had accepted that it was responsible for efficacy and safety. Government was not trying to do this, so this legislation was diluting the duty, and attaching it to anyone who made a claim. The legitimate healthcare sector was then put in a position where all sort of products crept through and did not perform the function of efficacy and safety.

If a claim was made it must be substantiated. The Act, as it stood, said that before a claim was made the Minister must certify. The new terminology was in effect placing the Courts in a position that they must assume that what had been in the Act did not carry the same meaning.

The Chairperson said that an ideological debate regarding the functions of the market in a market economy must be guarded against. This Bill wanted to deal with situations where poor people were getting duped that some products had medicinal claims. The government had the responsibility to protect the public. This Committee must deliberate on certification.

Mr Louw said that this was what the FMF had in mind. If a false or fraudulent claim was made, then he invited the Portfolio Committee to accompany him to prosecute them. This legislation reduced the defence that the consumer had against fraudulent claims.

Mr Waters asked who protected the individual.

Mr Louw said that the Department of Health had the power to call for substantiation and evidence and had the resources to deal with it.

Mr Mseleku said that a competent body existed to assess the evidence, and if the claims and evidence showed that the claim was correct, then the product was registered.

Ms Mathibela said that the pricing of medicines was intended to control prices so that medicine would be affordable to the poor.

Mr Louw said that the only way to do this was to unleash free competition, and drive anyone who charged high prices out of the market, and allow those with lower prices in.

A delegate from the Free Market Foundation said that an investigation into affordable pricing in any industry would show that more competition was needed.

The Chairperson stated that the problem was that the Committee was going to be diverted from its task if this matter was pursued, and there would be perversities in the market. It was difficult to easily agree with the vagaries of the free market, and this was why there was a pricing committee.

Pharmaceutical Task Group (PTG) submission
Ms Maureen Kirkman , Pharmaceutical Task Group, presented the submission. Ms Kirkman stated that the PTG started the initiative to eliminate perversities from the market place. Perversities in the market place were related to marketing of medicines and other health products. The legal gaps and the marketing Code were outlined and it was illustrated that there was no provision for regulations to support Section 18(A) which was creating loopholes and opportunities to get around the ban on incentives. Ms Kirkman emphasised that compliance must be mandatory for all companies and for all products, to protect patients. It was recommended that an empowering provision was needed for the legislation’s section18(A) and Marketing Codes under section 18(C). The PTG requested finalisation and publishing of South African Marketing Codes and regulations to Section 18A and Section 18(C) [see document].

Mr Mseleku stated that the Task Team was not synonymous with the Department. The Task Team proposal had been attached, and regulations had to be made. In relation to the marketing code, he said that this was in the process of being developed, including the regulations.

Ms Kirkwood indicated her pleasure regarding the publishing of the regulations.

Mr J Ringer, PTG representative, stated that there was a great degree of urgency on the part of the different competitors to endorse a common code as a real testimony to how important it was for this to be put into the regulations. Publishing could lead to fast progress in this matter and to improved marketing practice in the industry.

Mr Pillay stated that the marketing code was easy to implement when it came to advertising, but it was not so easy when talking about perverse behaviour, because someone had to be sitting at a point where a deal was done to check this. Initially there were many reports of perverse behaviour, and then there was a decline in the reports. The perverse behaviour suggestions would be difficult to implement.

Dr Rabinowitz indicated her suspicion as to whether there were good intentions. The point had been made that the industry wanted regulation because manufactured prices had not dropped, and the extra burden of costs was carried by the consumer. This system of fixed pricing protected the industry, because more generics were being brought on to the market.

Ms Mashigo wanted clarity regarding the level at which this was happening, the retailer or manufacturer level, and if this process was leading to compliance.

Mr Ringer stated that it was important to break up the problem into marketing practices and claims being made which the industry would like to address in the marketing code, and the creation of a mechanism of self-enforcement, with the back-up of the Department of Health. This was related to marketing claims and not pricing. The mere publication of a marketing Code could lead to improvements in the ethical marketing of all medicinal products.

The pricing, as Mr Pillay had suggested, had many ways for the free market to try to gain a competitive edge. Mr Ringer added that what the industry was asking for in this law was the ability to have the Department prescribe, in more detail, what was more acceptable. There was not enough detail in the regulations around acceptability of pricing. The reason for less complaints was that nothing would ever happen if there was a lack of clarity around what could be enforced. The FCP merely set the price under the guise of logistical fees. Perversities could occur. The PTG would like a self –enforcing body to police it initially.

Mr Waters said that the solution was the opening up of the market to competition and letting the market decide.

Dr Rabinowitz said that it would better if there was a maximum exit price, so if needed, it would be possible to compete below it. She asked if the PTG was saying that medicine law against bonusing had not been implemented because of a lack of regulation.

The Chairperson asked if, with regard to the aspect on bonussing, PTG was saying that marketing regulation had not come up.

Mr Ringer suggested a differentiation between marketing practices, marketing claims and pricing. Players in the market had the ability to lower their FCP price, not raise it, and so there were competitive market forces at play. Hence, to gain a competitive advantage to access the distribution system, they had chosen not to lower prices, but to give extra incentives to the distribution chain. This did not benefit the patient but did benefit the middle man. The competitive system was actually working because prices could be lowered, but the patient was not benefiting. Mr Ringer added that merely allowing the Department to define the illicit practices would always allow for creative solutions. The industry, in collaboration with the Department, could have further regulations which could eliminate some of the perversities. The Department should be allowed to prescribe regulations with proper empowerment.

Dr Rabinowitz said that the best policeman was the competitor, and unless there was some kind of penalty, the perversities and incorrect practices would not stop. She appealed to the Department to prescribe definitions to eliminate perversities.

Mr Pillay stated that medicine pricing regulations did provide a definition for perversity. If competitors got together there would not be effective implementation.

Mr Mseleku said that there were two issues on the table. The one issue was that in the current legislation there was a ‘must’ clause, and industry was saying it had been implemented. These codes were in the process of being finalised. The issue related to the legislation itself as an amendment. The industry was suggesting the ‘must’ clause should be changed to a ‘may’ clause, but the ‘shall’ clause should perhaps also be changed to a ‘may’ clause. Mr Mseleku stated that this matter would be discussed by the Department and would be published.

Mr Mseleku added, for the sake of clarification for the Chairperson, that the clause was in the B-Bill, and Section 18(A) must be read with Section 18(C). The issue of whether the ‘may’ or the ‘shall’ would be used would be discussed further.

Ms Kirkwood stated that the PTG was suggesting that in Section 18(A) the definition of rebates and bonuses should be expanded because, as Mr Pillay had just mentioned under pricing regulations, a number of perverse incentives were described, and legally there was a disconnect between pricing regulations and Section 18(A), with the ban on incentives.

Discovery Health (DH) submission
Ms Mandi Mzimba, DGM, Regulatory and Policy Affairs, Discovery Health welcomed the aims and objectives of the Bill. Discovery Health was calling for a comprehensive registration process to ensure price and cost effectiveness and allow risk-sharing arrangements to assist in allowing for the maintenance of an accurate comprehensive register. Ms Mzimba said that the certification process should be strengthened. Other undesirable practices in the industry were also addressed (see detailed document)

The Chairperson asked if Discovery Health was suggesting that an authority and advisory committee should be appointed by the Minister.

Ms Mzimba said that the job of evaluating all the criteria listed in the Bill could be very technical for the Minister, and that she should be assisted by an advisory committee.

Mr Mseleku stated that the advisory body that Discovery Health had recommended should definitely be considered. The Portfolio Committee must consider very carefully the relationship between the statement about the single exit price as a maximum price made by Discovery Health, and the National Health Amendment Bill. There was an assumption of the possibility of levelling the playing field, which could work for Discovery Health if they wanted to negotiate the price down. A mechanism was needed to complement the amendment.

Ms Mzimba agreed with Mr Mseleku that different players were not on the same competitive level and would not get the same discount. She added that the power of risk sharing arrangements should not be over-looked, as it was not just a case of getting a lower price. It was also about being able to establish such arrangements.

The Chairperson asserted that this submission made very good suggestions for risk sharing arrangements. The recommendation for an advisory authority also had to be considered very carefully by the Committee as this did have implications for the Bill. The Chairperson added that adding new definitions was also a matter for serious consideration.

Mr Waters asked for clarity on why Discovery Health was calling for an advisory group to advise the Minister on whether drugs should be registered or not.

Ms Mzimba stated that one of the points that Discovery Health had made in the detailed submission was that the three criteria that were used for registration were insufficient, and that cost effectiveness should be added to those as a fourth criteria.

Regarding why an advisory body was needed, Ms Mzimba stated that the criteria the Minister would look at before certifying the product would include access to health care and economics. It was felt that an advisory body could assist the Minister, as some of these issues were very technical.

Mr Pillay added that currently in the legislation, the pricing committee was tasked with determining whether a drug offered value for money, which was the cost effectiveness test. However, what it did was currently not technically part of the registration process. The Committee had never had a complaint about whether a product offered value for money or not. The Committee had not used it but it did exist.

Mr Walter stated that Discovery Health talked about cost effectiveness, and asked why it supported the principle of every drug being registered, as this prevented some people from getting the drugs.

Ms Mzimba responded that fundamentally the expertise on whether a drug was worth what it cost did not reside with the common man, as it took quite a lot of expertise to evaluate if a drug gave value for money. It was the business of Discovery Health to get the most cost effective solution for its members, and cost effectiveness was the primary concern.

Unilever submission
Adv Cedric Puckrin, Practising Advocate from Tshwane, represented Unilever and gave their submission. He believed that foodstuffs should not have their home in Act 101 of 1965. There was a lapse in the drafting of the Bill, as it spoke, on the one hand, of a medical claim, and on the other hand, of a medicinal claim. Medicinal probably had a wider import than medical and such a claim would of course cover prophylactic drugs and therapy. In the case of most cosmetics and foodstuffs it could be assumed that it was the prophylaxis element that was at the fore rather than the therapy.

Adv Puckrin referred to CODEX, which had compiled exhaustive and complete categories of foodstuffs, and these categories were the subject of draft regulations published under the Foodstuffs Act, which had not been enacted as yet.

Adv Puckrin referred the Committee to Regulation 61, as this dealt exhaustively with enhanced function claims and created a framework which would permit persons who sold foodstuffs to make certain claims. Adv Puckrin read Regulation 62 and 62A to the Committee, noting that these dealt with claims regarding a reduction of the risks of disease.

If these sorts of claims regarding foodstuffs were introduced into Act 101 of 1965, an administrative monster would be created, as all the constraints of the Section 22 requirements would go with registration. This set up inclusion rather than exclusion, and had ramifications for international trade in food. Adv Puckrin suggested that the real home for control of any form of medicinal claim was the Foodstuffs Act, and that such claims were already being dealt with under the draft regulations which, if enacted, would fact achieve the very aim of the Department and the legislature.

Adv Puckrin said that cosmetics fell under a different characterization, because there was no international classification or characterisation for cosmetics. It was Unilever’s belief that ‘cosmetic’ may find a home under Act 101 of 1965, and he suggested an amendment to the Bill to avoid confusion.

This Bill included within its purview the phrase ‘cosmetic’ as defined in the Foodstuffs Act. Unilever would submit that to alleviate confusion, instead of simply requiring that the cosmetic proclaim a medicinal claim, it should ‘primarily; have a medicinal claim. This would permit a cosmetic that proclaimed that it was a cosmetic, but perhaps referred in passing to some form of prophylaxis in a secondary fashion, to avoid the possible conflict with Act 101 of 1965.

Adv Puckrin said that there appeared to be a lapses in the drafting, as cosmetics and foodstuffs were defined in line with their definition in the Foodstuff, Cosmetic and Disinfectants Act, whereas ‘product’ (which included cosmetics and foodstuffs) meant medicine or medical device in respect of which a medical claim was made. He suggested that if the Bill were enacted in its present form it would have merit only for lawyers who would have a lot of work in disputing and interpreting it. The requirement of ‘just legislation’ meant that it must be understandable to and capable of interpretation by the public.

 Adv Puckrin reiterated that the Unilever stated that a cosmetic should be defined as follows: ‘…means a cosmetic as defined in terms of the Foodstuffs, Cosmetics and Disinfectant Act respect of which primarily a medicinal claim was made’.

The Chairperson stated that the prefix: 'primarily a medicinal claim' should be defined.

Mr Pillay asked how it would alleviate the problem if there was a secondary claim, because a member of the public did not differentiate between primary and secondary claims.

Adv Puckrin said that it was unfortunately not possible to protect the public from itself in every single instance. Unless a medicinal claim was defined, persons who sold would be left in the dark. At least with foodstuffs there was a definition of a medicinal claim.

The Chairperson said that there were vulnerable people in the public who should not be treated in a cursory fashion. Act 101 of 1965 never protected the people. It was difficult for the ordinary person in the street to understand the dangers associated with a product.

Adv Puckrin said that one could not legislate to prevent all forms of abuse. To protect the public, he suggested that ‘medicinal claim’ had to be defined, or the medicinal aspects had to relate to a primary rather than secondary claim.

Adv Puckrin suggested that in line with Section 231 of the Constitution, the way to do this was to adopt CODEX and introduce it into the Foodstuffs Bill.

Pharmaceuticals Made in South Africa (Pharmisa) submission
Mr Stavros Nikolau, Chairperson, Pharmisa, and Shadrack Shuping, Deputy Chair, Pharmisa, presented the submission to the Portfolio Committee. Pharmisa was driven by principles of transformation in industrialisation and the need to create certainty and predictability in the industry. There was a need to build a strong export base and ensure supply security. Mr Nikolau said that Pharmisa welcomed and supported the Bill, as it would enhance access to healthcare for all of those who lived in South Africa. Mr Nikolau emphasised that Pharmisa wanted to address the re-introduction of predictability and certainty into the sector.

Mr Shuping stated that Pharmisa would like to address the lack of empowering provisions, and timelines in the Bill. The proposed new amendment sought to improve on the inefficiencies of the previous authority, so that the regulations clearly spelt out timelines for the registration process. Whilst there was an awareness that timelines could not be legislated for, provision should be made to specify timelines.

On the two-tier phase registration process, the first phase was a scientific process and there should be a balance between the scientific process as well as the public interest. Mr Shuping said that there were times when the State needed to intervene in terms of specific interests when it comes to registration.

The Minister of Health should have no discretion with regard to scientific evaluation, which was clear in terms of the first phase, but authority and discretion in the public interest should be applied consistently. Some of the issues of discretion should be referred to the various experts concerned, for example economic and strategic issues of government, but there should also be an element of accountability to government. Mr Shuping said that there should be transparency, and reasons should be clearly spelt out. For example, in Section 22(G), the regulations regarding annual price increases had been applied in an inconsistent way and this had led to inconsistency in the system and the denting of consumer confidence.

Mr Shuping said that regarding Section 18(C), the marketing code should be mandatory, so that market perversity could be eliminated. It should compel the Minister to make provisions for the marketing code, rather than the current language, which did not allow for mandatory application. The word ‘may’ should be replaced by ‘shall’ in order to give effect to this process.

Mr Shuping stated that Pharmisa did not support the issue of data protection, as it would affect the increase in patent life cycles and reduce access to treatment in terms of new products coming in. The proposed Section 42(1) and (2) talked about changing the ‘old’ into the ‘new’, to ensure that work in progress was not lost. There needed to be more specificity for existing applications pending registration. Those in the pipeline should be reorganised and subjected to new timelines, so that there was no loss in the timing of the process.

Mr Shuping said that Pharmisa supported exemptions regarding Schedule 0, in respect of Section 18(A),(B) and Section 22(G) of the proposed amendments set out in the Bill.

In conclusion, Mr Shuping expressed support for the Bill because it enhanced access to treatment and contributed to the creation of a more stable health care environment and would stimulate investment and growth.

Mr Waters said that on the issue of the two-phase system of registration, Pharmisa mentioned that the Bill did not require the Minister to consult any expert. He asked if Pharmisa was proposing an amendment.

Mr Nikolau stated that obviously the Minister was the Executive Authority, and whatever criteria were applied the Minister would have to have full accountability to parliament. Mr Nikolau added that a preferred amendment would be one that would result in the Minister consulting with an appropriate expert. This was not clear in the current amendment.

Ms Kalyan asked for suggestions from Pharmisa regarding certification and whether automatic or renewal certifications would suffice.

Mr Nikolau said that Pharmisa had submitted a revised submission on the wording of the Bill.

Ms Mashigo said that Pharmisa had made a proposal for timelines and mentioned the lack of empowering provisions in terms of timelines. She asked if the amendment to Section 20 would not make the required impact as far as timelines were concerned.

Mr Shuping said that it should also allow for forward movement in terms of how the MCC found itself with a backlog of issues in the past. The Bill should have a clause to the effect that timelines should be spelt out in the regulations.

Mr Nikolau said that Pharmisa did not see the regulating of timelines in the Bill as practical, but saw them as very much a part of the regulations. In the detailed submission Pharmisa had recommended that probably the best punitive sanction would be a reduction in registration fees if timelines were missed.

Ms Mathibela asked what Pharmisa thought should happen to avoid an increase in patent life cycles.

Mr Nikolau responded that there were attempts at data protection, but alerted Members to motive forces becoming unbalanced. With increases in patent life cycles, medicines were denied to the people and this was counter-productive.

The Chairperson asked if Pharmisa’s detailed submission should not be used now.

Mr Nikolau said that the original submission was in line with the Gazette version. Pharmisa had submitted a second submission, which captured more appropriately its intentions.

Ms Tshwete said that under Veterinary medicines, consultation with the Minister of Agriculture was mentioned. She asked if reference was being made to timeframes or the people involved.

Mr Nikolau said the credentials of Ministers were not being questioned. The Ministry would have to had access to the necessary expertise, which might delay matters. The Health Ministry was sufficiently skilled to handle all pharmacological access.

The meeting was adjourned.



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