The Committee met briefly to hear public submissions on the Medicines and Related Substances Amendment Bill (the Bill). Most of the submissions related to what was included in the Bill and definitions, and gave clarity on possible gaps.
The Regulatory Discussion Group (RDG) said its concerns with the Bill were largely centred on the definitions in clause 1. It did not agree with the definition of "complementary medicine" and felt that it was too ill-conceived and misplaced. Whilst it was pleased that complementary medicines should be covered, it suggested that, rather than attempting to create a definition that encompassed all types of medicine, (for a product was classified as a medicine if it met the defined criteria, rather than the use to which it was put), it would be preferable to include something either in the regulations or in the Medicines Control Council policies, which would allow for changes to be tracked and updated more easily, and would make it easier to classify. The Committee questioned its understanding of complementary medicine, pointing out that traditional and complementary medicine differed, and said that its explanation of the difference between medicine and biological medicine was not clear. The Committee also noted that there must be clarity in the legislation as to what exactly was being regulated.
The Health Products Association of Southern Africa (HPA) noted that there were contradictions between the Bill when read together with the General Regulations to the Medicines Act and Related Substances Act, for each had a different definition of complementary medicine. There were also further contradictions with the guidelines of the Medicines Control Council. It suggested that other categories of medicines and clauses should also be provided with definitions. There should be a link between the Pharmacy Act and the Medicines Act for various licensing purposes. Special attention was needed to how scheduled substances were defined, for they were not controlled in the same manner as medicines. It was suggested that time be given for companies to prepare, with definite roll out periods stated. The Health Professions Regulatory Authority (SAHPRA) Board should include at least two people with knowledge of the different medicines which were provided in the Bill. The Committee felt that there was some confusion around the role of the SAHPRA, asked how the Association felt that food supplements should be dealt with, and made the point that the naming was not as important as clarity on what exactly was being covered. They agreed with the importance of ensuring that the board was able to handle the regulatory tasks and handle the finances correctly.
Trade unions COSATU and NEHAWU made a joint submissions, noting that they broadly welcomed the Bill. However, they said that there was a need for clarity on the role and status of the SAHPRA, if it was still to be an organ of the State but operate outside the public service, for accountability for public funding was very important and there should be sufficient Ministerial controls over the funding aspects. It supported the replacement of the MCC, and made the point that the regulating authority's role was critical in providing assurance to the health sector. Members called for more clarity on the points made about SAHPRA, but agreed with the need for accountability for public funding.
The Southern African Laboratory Diagnostics Association (SALDA) represented companies that supplied in vitro diagnostic (IVD) devices to the healthcare system in South Africa. Its main concerns were that medical devices and IVDs had been included under clauses that previously dealt only with medicines, and explained that this would cause practical problems. In relation to the SAHPRA, it commented that there were no provisions in relation to its structure to deal with medical devices and IVDs, and felt that there should be specific recognition of these, and possibly the appointment of two registrars, to avoid the situation where the Board was not able to make proper decisions on these specific devices. It also felt that the time frames for compliance were too short, and that more defined dates were needed in relation to the regulatory activities, and that penalties for non-compliance should be included. SAHPRA must be independent, except with control over budgets and service delivery. The inclusion of foodstuffs, cosmetics and disinfectants into the ambit of the Act was problematic, and it strongly recommended that "grandfathering clauses" continue until the Bill came into effect. Members questioned whether the Bill could also be interpreted as regulating smart phones with medical devices, and questioned how food and water regulation was dealt with.
MEDI-Q explained that it was a company that could re-process devices that were currently labelled as single use devices (SUDs), "intended not to be reprocessed", but was strongly recommending that the Bill make provision for certain medical devices and IVDs to be re-used and re-processed, as was done elsewhere in the world. Many SUDs were declared as such without taking into account changes that had been made from the initial versions, or were declared for single use in some countries, but not others, or were declared for purely commercial reasons, or simply to avoid liability and costs. Examples of devices that could be re-processed were ultrasound machines, face masks and others, and the advantage was that many doctors simply could not afford the new devices. In order to allow for this, clauses 1, 8, 11 and 16 would need to be amended. It was pointed out that advanced technology would be used to track and trace products through every phase of their reprocessing and use, with a unique device identification code as prescribed by the Bill. The Committee was surprised to hear of this process, asked for more detail on countries using it, and whether there was any health risk to the patient.
Medicines and Related Substances Amendment Bill [B6 - 2014]: Public hearings Regulatory Discussion Group submission
Dr Rene Doms, Regulatory Discussion Group, clarified that his organisation (RGD) was not a trade organisation, nor was its membership limited to any specific vocation. It engaged with informed role players from diverse disciplines to augment understanding and offer insight into the fundamental aspects under review at any one time. Its aim was to inform role players about regulatory mechanisms that could assure South Africans have access to therapeutic and consumer products that were safe, efficacious and of acceptable quality, while respecting the constitutional imperative of freedom of choice, philosophy and cultural diversity.
The purpose of the current submission was to recommend changes to clause 1 of the Medicines and Related Substances Amendment Bill (the Bill), which aimed to amend the Medicines and Related Substances Act No 101 of 1965 (the Act). The Bill's definition of a complementary medicine was inflexible, ill-conceived and misplaced and should be removed from the proposed changes and the existing definition of "medicine" in the Medicines Act should stay unchanged. That definition has stood the test of time and legal change. It was broad in scope and sufficed to serve the purpose of protecting public health and interests when reasonably interpreted and so was justifiable in an open and democratic society. The words now proposed to be added to the definition of medicine: "and includes any biological medicine, complementary medicine and veterinary medicine" were unwarranted and superfluous. These medicines were only a species and sub-classification of the genus "medicine" and were thus already included in the definition of a medicine.
By way of contrast, however, he suggested that this could possibly, in order to increase the definition's scope and reach, and to match current trading practices for "modern" and traditional complementary medicines, be included in regulations or through the Medical Control Council's (MCC) administrative policy guidelines. If this was done, then it could be easily changed as the regulatory controls matured over time, without reverting to amending the principal Act, which was a lengthy process.
RGD also supported the Minister's efforts to regulate complementary medicines, but the Bill's definition was problematic and fraught with complications. A product was classifiable as a medicine in terms of the Medicines Act if it met certain criteria, provided each product was evaluated on its own merits and in context. If there were any doubts whether a product was a foodstuff, cosmetic or a medicine at the borderline interface, then the Medicines Act would prevail, in the interests of public health and safety, as the more restrictive interpretation was warranted for more control. A medicine was therefore a substance or mixture of substances used or supporting to be suitable for use or presented for: the diagnosis, treatment, mitigation, modification or prevention of disease, restoring, correcting or modifying any somatic or psychic function, if an ingredient in the product was listed in Schedule 1 or higher to the Medicines Act, or the product was indicated for vulnerable groups.
Dr W James (DA) asked what kind of medicine RDG would describe Zmapp (the treatment used for the Ebola virus) to be.
Mr H Volmink (DA) said that RDG had proposed that some definitions be deleted from the Bill but the South African Health Products Regulatory Authority (SAHPRA) had to be clear about what it was regulating. Surely that meant that definitions of all types of medicines should be included.
Mr N Matiase (EFF) said he was not impressed with the definition of "complementary medicine" that was proposed, and furthermore, there had been a conflation of the concepts of "complementary" and "customary". He asked whether the presenters would think that traditional and complementary medicine should be added into the Bill.
Ms Henriette Vilnings, representative, RDA replied that she would assume that Zmapp, simply because of the way it was manufactured, was a biological medicine; it had been manufactured using a living organism. There was much more flexibility in regulations to revive and amend definitions. However, if these were put in the Act, this limited the bodies in their abilities to address new matters as they arose. It was from a practical perspective that RDA had proposed that the precise wording should be in the secondary legislation rather than in the principal Act. The RDA had not defined African traditional medicine in the presentation, but only mentioned that the way in which traditional medicine was practised formed a certain type of relationship between the practitioner and the patient, and that relationship was not governed by the Medicines Act, like other types of medicines were.
Dr James asked what the difference was between medicine and a biological medicine.
Dr Doms replied that a medicine was a substance used for therapeutic purposes, and its source was irrelevant, or it could be a substance that mediated or effected a physiological function. The Medicines Act was not substance-based, but it was the "use" base that determined the classification of the medicine. Once a medicine, for example, met the requirements of a treatment of a disease, then it fitted within one of the classifications for a medicine which was controlled by regulation 25.
Health Products Association of Southern Africa submission
Mr Norman Fels, Representative, Health Products Association of Southern Africa, said the Health Products Association (HPA) was concerned that when the Bill was read together with the General Regulations to the Medicines Act and Related Substances Act, the portions of the Regulations that now dealt with complementary medicines, and certain additional Guidelines published by the MCC, inherent conflicts arose between the Bill and the Act, on the one hand, and the Bill and the General Regulations, on the other. HPA also noted that the proposed definition of "complementary medicine" in the Bill was different from the one that had been amended for comment, within a second set of proposed amendments regulations to the General Regulations. HPA noted that the regulations associated with the Bill should be amended to make provision for the various categories and classes of medicines; and this would mean definitions for Aliphatic products, and medicines which could not normally administered without further conditions should be given definitions as well. A major problem which had to be addressed arose out from the link between the Medicines Act and Pharmacy Act, the requirements for various licenses and the designation of "a responsible pharmacist" as applicant for product registration. The inclusion of "scheduled substances" would also be problematic as these were not registered and could not be controlled in the same manner as medicines. HPA believed that the the inclusion was to control accessibility of products rather than to indicate how the product was registered, advertised or marketed.
The time periods seemed to be very long, therefore, a defined roll-out plan needed to be published for comment. The absence of any transitional measures was of concern. HPA believed that these should be provided for in order to allow stakeholders a period within which to achieve compliance.
Although the Bill intended to replace the Registrar with a Chief Executive Officer, there was still a need for experts who were technically conversant on the subject matter, so HPA suggested that at least two qualified people with knowledge of complementary medicines should be part of the board and there should be clarity on the role of the board.
Dr James said the governments' only role was to ensure that regulations were made and so he did not understand why health supplements should be categorised. The Bill's intention was to make sure that medicines were regulated, and he thought that what names these were given should not be important.
Dr P Maesela (ANC) also added that it did not matter how medicines were categorised but it was important that they were safe for consumers.
Mr Fels replied that HPA would like to have food supplements fall under the food legislation, which was a general global practice elsewhere. The amended regulations did introduce health supplements under the definition of complementary medicines. Although HPA was not sure exactly what this meant, it was said it would be made clearer in the guidelines. HPA agreed with the Committee that naming products was not important, but it was proposing that labels on the medicines should be clear, and the particles should be clear as well.
Mr I Mosala (ANC) asked how the coupling of the legislation would ensure the safety of patients.
Mr Fels responded that a mere coupling of the legislation in itself would not ensure the safety of patients but it complicated the logistics and the requirements of conformance. HPA understand that South African Health Professionals Regulatory Authority (SAHPRA) would have to be a self-funding organisation and it had heard some inputs proposing that it should be a parastatal. HPA's only concern was that the board should have people that were could manage the money and a team.
Mr Matiase said the Committee would have to have a re-look at all the Acts that had been passed by Parliament, especially those that dealt with the control of medicine. It would be a mistake to ignore the economies of medicine in this subject.
COSATU and NEHAWU joint submission
Mr Matthew Parks, Parliamentary Coordinator, COSATU, said that both COSATU and NEHAWU trade unions supported the Bill and its objectives, as the Bill proposed to replace the MCC with a new body that would better reflect the many changes that had occurred in the industry, and would be established in such a way that there would be a marked improvement in turn-around times. They believed that SAHPRA would play a critical role in providing assurances to the health sector that the quality of medicines intended for human and animal use, the medical devices required by those who were differently abled, and that in vitro diagnostics (IVDs) as well as foodstuffs used by heath practitioners would be of higher standards. The two entities were therefore in strong support of the proposed roles and powers of the SAHPRA. They believed that the replacement of MCC would speed up the registration of medicine. The indication of co-operation agreements with selected foreign regulatory authorities was commended, as it would enhance the work of the Authority, and reduce the duplication of work.
The two unions also supported the amendments that had been made to the structures. The original version of the Bill established SAHPRA as an organ of the state, but outside of the public service, which would allow flexibility in the remuneration structure to attract top talent as well as retaining scarce skills. However, the introduction of the phrase "within the public administration" and the accountability of the Authority to the Minister was key to preventing the Authority from becoming completely independent of the state. COSATU and NEHAWU also supported the constituting of the Board by experts whose knowledge would be pertinent to the functioning of the Authority.
Mr Matiase asked how having an organ of state was different from the MCC.
Dr James said he felt the report was on the right track, but also wanted more clarity on the description of the MCC as an organ of the State.
Dr Maesela thanked both of the organisations for supporting the Bill.
Mr Parks replied that some of the phrases used in a previous version of the Bill made the unions uneasy, and one of those was the concept that SAHPRA would be out of the public service framework. They were happier with the new wording in the current Bill. The two unions did not have a problem with the regulator being privately funded, but they were worried that there would be a lack of accountability. They felt strongly that if public funds were being used, then there must be accountability in terms of the Public Finance Management Act (PFMA).
Southern African Laboratory Diagnostics Association submission
Ms Robyn Craven, Representative, Southern African Laboratory Diagnostics Association, said that this association (SALDA) represented companies that supplied in vitro diagnostic (IVD) devices to the healthcare system in South Africa. SALDA advocated for appropriate IVD legislation that facilitated access by South African patients to safe IVDs that performed as intended and were of good quality.
Their immediate concerns were that medical devices and IVDs had, seemingly in error, been included under clauses that previously only pertained to medicines. This would cause practical problems and unintended consequences for supply under section 35. The SALDA felt that the proposed structure, funding and independence of the Regulatory Authority did not accommodate appropriate and efficient regulation of medical devices and IVDs. It felt that it was necessary to set up separate and different regulatory processes, separate staff allocations with different skills, separate but appropriate Committee structures and a Board where one product's representatives could not outvote others. Under this Bill, the criteria for evaluation of medical devices and IVDs remained aligned with medicines, which should not be the case. There was no accommodation of medical devices registered via other local regulatory bodies under legislation.
SALDA felt that the time frames provided for companies to obtain the necessary requirements were too short. The Act should make it mandatory that SAHPRA publish time-lines for various regulatory activities, and penalties should be built into the system to ensure that time lines were adhered to. SALDA recommended the appointment of two Registrars in the SAHPRA organisation, one for Medicines and one for medical devices and IVDs. The legislation should also ensure the independence of SAHPRA, with control only over budgets and service delivery to prevent a backlog of submissions, once registrations of medical devices and IVDs commenced. The inclusion of foodstuffs, cosmetics and disinfectants into the ambit of the Act was problematic. SALDA also strongly recommended that "grandfathering clauses" for products already on the market should be included when the Bill came into effect.
Mr Mosala asked if SALDA was suggesting that smart phones should be regulated as well, because some of them had health devices.
Dr Maesela asked what type of regulations SALDA was suggesting for food and water.
Ms Craven replied that in fact the current Bill did allow for the regulation of smart phones with health devices. She explained that in vitro diagnostics only played a supportive role in food and water testing, which were governed by other legislation; an example was the South African National Standards Act for drinking water specifications. SALDA had laboratories in the water supply companies, like Umgeni Water Amanzi and Johannesburg Water, and it used IVDs for early detection of cholera.
MEDI Q - Sustainable Healthcare Solutions submission
Mr Ebrahim Jappie, Chairman, Medi-Q, said a single-use device (SUD) was defined in the draft regulations, and was phrased that it was "intended not to be reprocessed". However, an SUD was not defined in terms of broad identifying characteristics or delimitations, design parameters, material characteristics, usage or purpose factors, handling, processing or disposal techniques or methods, manufacturing techniques or methods, accreditation, certification or licensing criteria, absolute prohibition of reprocessing per se, or any other legal considerations. The reprocessing of SUDs or prohibition of this was currently still not specifically described, prohibited, nor contra-indicated. There were some clauses in the draft legislation that made allowance for "modification" and "refurbishment". The decision to reprocess was also mitigated by the fact that many SUDs were declared as such without any change from the previous re-usable versions. Other devices might be declared SUDs in some countries but not in others, or were admittedly declared for commercial reasons, or simply to avoid liability and costs.
Medi-Q planned on using cutting edge technology to track and trace products through every phase of their reprocessing and use, after which these products would join the medical waste stream. The body would also assign to each a unique device an identification code, as prescribed by this Bill.
Medi-Q's specific comments therefore related to the need to look again at clause 1, which did not provide a definition of reprocessing of products, clause 8 relating to the conducting of business, clause 11 that spoke to the application process for manufacturing goods, and clause 16 that did not make provision for definitions of processes of disposal.
Mr Volmink asked how effective it was to re-use disposable products or sell them to someone else. He asked whether this would not detrimentally affect people's health.
Ms N Ndaba (ANC) asked if the practice of re-using disposable products was done anywhere else in the world.
The Chairperson said it was very worrying to know that medical devices or products were being re-used, and she also asked for examples of products that could be re-used.
Mr Jappie replied that there were no maintenance procedures provided for in the main Act. However, it was suggested that there should be provision specifically included in the legislation to cover disposal and second hand markets. The re-use of certain medical devices and products would help doctors who could not afford the devices at the current market price, and examples of medical devices which had been, or could be re-used were ultra-sound machines. The United States of America was one of the countries which had made provision for the re-processing of some products, such as face masks, because there was a limited resource of them.
The Chairperson said the submissions had been interesting and the Committee has learnt from the submissions. She was still surprised to hear that medical devices and products were being re-sold.
The meeting was adjourned.
- MEDI Q - Sustainable Healthcare Solutions presentation
- MEDI Q - Sustainable Healthcare Solutions submission
- Southen African Laboratory Diagnostics Association (SALDA) presentation
- Southern African Laboratory Diagnostics Association (SALDA) submission
- Regulatory Discussion Group (RDG) - presentation
- Regulatory Discussion Group (RDG) - Medicines Amendment Bill 2014 submission
- Health Products Association of Southern Africa (HPA) presentation
- Health Products Association of Southern Africa (HPA) submission
- COSATU, and NEHAWU joint presentation
- COSATU, and NEHAWU joint Submission
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