The Committee met briefly to continue to hear the responses of the Department of Health (the Department) on the submissions made by different stakeholders during the public hearings on the Medicines and Related Substances Amendment Bill.
The Department did not support the proposal that the Chairperson of the Board should be a revolving appointment between representatives of different sectors, for one year at a time, as this was not common global practice and was not considered workable, although he did point out that the Board would have representatives from a number of different disciplines and this would benefit the South Africa Health Practitioners Regulatory Authority (SAHPRA). He cited a number of proposals made by different commentators that either could not be included at this stage because they related to sections of the principal Act that were not being amended, or that had already been dealt with in previous amendments. A number of other proposals, particularly the finer points of definitions or details on specific areas, were not considered by the Department to be appropriate for inclusion in the Bill but would be dealt with under the regulations or guidelines. Regulations would, for instance, define the skills of members of the Board, the requirement for fast-tracking of registration of medical devices and in vitro diagnostics (IVDs) and timelines for registration.
The Department pointed out that SAHPRA would be making an effort to form working relationships with other South African regulating authorities, and it was suggested that the words "may" or "must" must be re-considered in this context, but it later emerged, during the discussion when Members questioned this point, that SAHPRA would be consulting for the purpose of sharing information. It was pointed out that many of the staff members of the former Regulatory Units will now form part of SAHPRA as permanent staff, and the regulation of the Food Act and the Hazardous Substances Act would be transferred to SAHPRA. For this reason, the Department did not support many of the proposals on separate regulatory systems for food and cosmetics. It was also clarified that the structure would change and so the proposal for a definition for a Registrar was not applicable, since there would be a Chief Executive Officer instead, who would be responsible for all the Units in SAHPRA; and the heads of the Units will report to that person. The proposals on marketing were not supported because that was not being dealt with in this Bill. The Department pointed out that no definition was needed, as had been suggested, for Advertising Standards Authority as this was already included under other legislation and it was only the current
The Committee questioned the comments on the use of "may" and "must". They stressed that communication between the units would be very important, and all units must be agreed on what was to be regulated. The Committee suggested, but the Department did not agree, that the Board appointments should involve the Committee. Members also asked how SAHPRA would be listed under the Public Finance Management Act, reiterated earlier concerns that since it would be using public funding it would have to be regulated in line with requirements. They also asked about the relationships with other departments, particularly the Department of Trade and Industry, the control of medicines being imported to and exported from the country and what controls there were over potentially addictive substances that might be on open shelves. Questions were posed on the criteria for regulation. Although the meeting had to be closed, the deliberations would continue in the first weeks of the next term.
In the absence of the Chairperson, Ms M Dunjwa, who was attending a conference in Paris, Committee Members duly elected Mr A Mahlalela (ANC) as Acting Chairperson.
Medicines and Related Substances Amendment Bill [B6-2014]: Department of Health further responses
The Acting Chairperson noted that the Department of Health (DoH or the Department) had been asked to continue briefing the Committee on its response to the submissions made during the public hearings on the Medicines and Related Substances Amendment Bill (the Bill), giving reasons where it did not support the submissions. He reminded Members that they should not be debating the content of the Bill at this meeting.
Dr Anban Pillay, Deputy Director General, Department of Health, said his presentation would continue to outline the comments that were raised by stakeholders during the recent public hearings and responses to those comments by the Department.
A submission had been made that the appointment of a Chairman of the Board for one year, with expertise rotating between medicines, medical devices and in vitro diagnostics (IVDs) was not supported by the Department, and was believed to be unworkable as well as not being in line with common global practice. The task of Chairperson would, as a prerequisite, require appropriate skills and qualifications. The Board would consist of a number of members with expertise in various areas of medicine, and the Regulations to the Act would further define the skills of Board members. He noted that they would, for instance, include members with expertise in orthodox, complementary and biological medicines, and he had already dealt with the amendments to the composition of the Board to allow for the appointment of two experts in complementary medicines.
There had been a proposal to delete the definition of Foodstuff and Cosmetics. There was also a proposal that the South African Health Practitioners Regulatory Authority (SAHPRA) should not have regulatory oversight over foods and cosmetics, as this would increase its workload. However, Dr Pillay pointed out that the mandate to regulate Foodstuff and Cosmetics was already part of SAHPRA, as it was set out in the Foodstuffs, Cosmetics and Disinfectants Act, No 54 of 1972. The Bill would seek to combine all the legislation related to medicines. The proposal that SAHPRA Committees should not evaluate cosmetics and foodstuffs was apparently based on a misunderstanding, as the activity would remain with the relevant units that dealt already with foods and cosmetics. He referred Members to subclause (3) of the new section 2B, at page 4, line 28.
In relation to another proposal, Dr Pillay pointed out that the new Bill did not intend to regulate electronic-medical and radiation devices, and therefore there was no need to amend the Hazardous Substances Act, as one submission suggested.
Another comment related to the inclusion of time-lines for evaluations and registration of medicines, medical devices and IVDs. .However, he noted that this was already provided for under section 35(1) in Act 72 of 2008, which mentioned timeframes for the consideration of an application by the Authority. He added that time lines would also be addressed in the General Regulations, as well as the Guidelines that would address the operational matters.
Dr Pillay noted that the inclusion in this Bill of abbreviated and expedited registration processes with the recognition of decisions taken by other national regulatory authorities would be unnecessary because it would be dealt with by the regulations. Regulation 5 of the General Regulations made provision for an expedited registration process. Additionally, under the portion dealing with the "Functions of the Authority" provision was made for the Authority to liaise with other national authorities to allow for the exchange of information. It remained the prerogative of SAHPRA to seek assistance from other national regulatory authorities. He noted that the word "may" must be changed to "must", to explain that SAHPRA must at all times liaise with other regulators.
Dr Pillay noted that the staff who were currently responsible for administering the Food Act and the Hazardous Substances Act would be transferred to SAHPRA, as it would remain the Regulatory Authority's responsibility to have an oversight role over the duties and functions of staff members responsible for managing the two Acts.
The Department of Health was not in agreement with the suggestion to appoint separate registrars to deal with medicines, medical devices and IVDs, Cosmetics and Foodstuffs. He pointed out that the operational structure of SAHPRA was outlined in the Business Plan, and this made provision for Heads of the different units to report to the Chief Financial Officer.
He further noted that the suggestion to include a definition for "Registrar" was not supported, because the role of the Registrar would become obsolete. The role of the Chief Executive Officer was listed in the new section 3(4).
Dr Pillay reiterated that the composition of the Board was defined in the legislation under the new section 2C(2), and the skills required would be further defined in the Regulations. The Board would identify as many committees as deemed necessary for its work and this would also allow the Board the prerogative to increase the number of committees, depending on the expertise needed.
There had been a suggestion to amend section 22 to require SAHPRA to publish, on receipt of an application for registration. However, he pointed out that this provision was not part of the new amendment Bill. The functions of registration and pricing were separated in the Medicines Act.
Similarly, he reported that the proposal to amend section 21 to allow the Department of Health and an NGO to apply for the use of unregistered medicine, solely on price, was also not possible, because what had been in section 21 was not being carried over into the new legislation. The mandate of the Regulatory Authority was to protect patients against the use of substances and medicines by ensuring that medicines complied with standards for safety, quality and efficacy. Price could not be considered as the sole reason to authorise the use of an unregistered medicine if information relating to safety, quality and efficacy was not available.
The proposal to amend section 15(a) of the principal Act was similarly not possible at this stage, as this wording was not up for amendment in the new Bill.
A proposal had been made to require SAHPRA to review and examine all new pharmaceutical patients. Reviewing pharmaceutical patients was not part of the mandate under the legislation.
Dr Pillay referred to the proposals made for the inclusion of a definition for IVD, and said that since this definition was already included under Act 72 of 2008, there was no need to include it also in the Bill. AS for the definition of "Borderline Medicine Devices", that would be included in the Guidelines on Medical Devices. He pointed out that the intention of a guideline was to clarify so called "borderline" matters.
The Department was not in agreement with the proposal to separate the requirements for medicines, medical devices and IVDs. He pointed out that the current practice enabled Regulations applicable to these products to be promulgated, in line with the requirements of section 35.
Proposals had been submitted to do with the transitional arrangements for the registration of medical devices and IVDs as well as Foodstuffs and Cosmetics. However, Dr Pillay stated that the transitional arrangements for registration or oversight of these products should be dealt with in regulations rather than in the Bill, in line with the current practice.
He submitted that the inclusion of a definition for "family of medical devices" should not be included in the main Bill, but again should rather be left to be clarified in the General Regulations addressing Medical Devices.
The submission to amend section 22H to allow for keeping of consignment stock and importation by different importers had already been covered, since all importers were required to be licensed by SAHPRA. The keeping of stock and distribution of medical devices and IVDs by a wholesaler was addressed in the Guideline documents on Wholesaling and Distribution.
Submissions had been made in relation to the fast-track registration of medical devices and IVDs. This was addressed in regulations and the corresponding Guidelines, therefore it was not necessary to have them included in the Act.
Insofar as the submissions to clarify under what circumstances medical devices and medicines may be returned to a wholesaler, Dr Pillay noted that this was already made clear in the relevant Guidelines, and did not need to be incorporated into the Bill.
The Department did not agree with the proposal to include the concept of manufacturing of single-use medical devices, to allow for re-use, in the Bill, on the basis that it would lead to cost reduction and environmental benefits.
The proposal around deleting the control of scheduled substances from various sections of the Bill was not supported, because scheduled substances formed the basis of the Medicines Act and included medicines in line with the definition for scheduled substances. The Department was also not in agreement with the proposal to control medical devices and IVDs containing scheduled substances in terms of section 22A, because section 18 dealt with the requirements on labelling and advertising of scheduled substances. Section 22A dealt with who may sell scheduled substances, and under what circumstances.
Proposals had been made that the Department should include a sub-section under section 18C, "Marketing of Medicines", but Dr Pillay pointed out that this was not dealt with in the current Bill. In addition, it was the understanding that advertising of medicines included marketing. A definition of "Advertising Standards Authority" was not needed; as the Medicines Control Council (MCC) was only a stakeholder that submitted comments to the Advertising Standards Authority (ASA) on the ASA Code of Advertising practices.
The Department did not agree that the definition of "medical claim" and "medicine" had gaps, and said that these definitions were in line with international practice. The proposed amendment to the definition may cause uncertainty of interpretation. He also noted that the proposal to amend section 20 to deal with false and misleading advertisement was not supported, since the Department did not agree that the current drafting posed any risk of misinterpretation.
Mr H Volmink (DA) said the Bill had given a lot of details about medicines and medical devices but there was little detail on Foodstuffs and Cosmetics. He was concerned that the use of the word "must" instead of "may" could cause difficulties in so far as SAHPRA was concerned. He also noted that since SAHPRA would be operating as a public entity, the possible Board candidates should present themselves to the Committee for evaluation.
Dr P Maesela (ANC) said he was concerned that the exclusion of veterinarians would cause a problem with the pricing of medicines.
Mr A Shaik Emam (NFP) agreed with Mr Volmink that the Department should re-look at the use of "must" and "may" in the Bill. The health sector was very complex and there may be some areas which the Department may not have to liaise with other regulatory authorities. He said advertisements for medicines should also be regulated, in terms of how products were advertised and to assess the truth of the advertising claims. He suggested that there should be communication amongst all the sectors of Health to ensure that they were all in agreement as to how a product would be regulated. He suggested that the inclusion of Unit Heads and a Registrar was a form of duplication, and that it would be costly for the Department.
Ms C Ndaba (ANC) asked if traditional medicines would be dealt with in a separate Bill.
The Acting Chairperson asked if SAHPRA would have the capacity to deal with the challenges that were faced by the Medicines Control Council (MCC) in the past. He added that he was of the view that having a random selection of people to fill the positions on the Board would lead to problems and suggested that the SAHPRA should rather re-advertise the positions that had not been filled, than rush to appoint people who may not be entirely qualified to do the job.
Dr Pillay replied that the Department had chosen to make reference only to South African Regulatory Authorities and not to any from other countries, because the international regulatory authorities had different capacity issues and some would have higher standards than South Africa's standards. The Bill anticipated that SAHPRA would be liaising only with regulatory authorities which were of the same rank as SAHPRA. The Food Control Unit would be working with the regulating of food, and its approach was also very much different from that of regulating medicines and medical devices. It would also be regulating the labelling of foods, but although there were different approaches, this Unit did form part of SAHPRA.
Dr Pillay explained that it may bring bureaucratic challenges and less efficient appointment procedures, should Board members be brought in front of the Committee.
Dr Pillay explained that veterinarians were not included because animal and human medication was not the same and could not be treated in the same way. A pricing committee for animal medicines would have to be established in the near future, to accommodate the needs of the veterinarians.
He also explained that traditional medicines would not be regulated by SAHPRA as a different body for regulation of that aspect was still being developed, but there were plans to look into not only how to regulate the processes, but also the practitioners.
Dr Shabir Banoo, Member of Medicines Control Council, said the strategic move to work with other regulatory authorities was only on the basis of accessing information which the regulatory authority may use. He agreed with Dr Pillay that another body should be developed to deal with Foodstuffs and Cosmetics. The old legislation did not regulate medical devices, but the current version of the Bill did include the regulation of these matters. Before the Bill was developed, all the Units within SAHPRA had been working separately. However, with the Bill having now been drafted, the units were placed under one body and this would ensure proper communication between the Units and the building of a co-operative relationship. In order for companies to import or export medical products, they would have to have a license issued by the MCC, and those companies which were exporting medicines must also have made appropriate arrangements with the regulatory authority of the country to which they were exporting.
Another delegate from the Department explained that the Bill was a combination of all the legislation that was related to the Medicines Act. The Department had not acceded to some of the proposals, as outlined earlier, because many of the amendments suggested were already in the principal Act.
Dr W James (DA) asked how the National Treasury would schedule the Board in terms of the Public Finance Management Act.
Dr Maesela said that prevention was better than cure. He made the point that there were foodstuffs that had been left out of consideration in this Bill, and were not being regulated, such as tobacco and cool drinks containing gas. There were also dangerous steroids being sold on the market, but nobody was thinking of regulating these products.
Mr Shaik Emam asked if the Department of Health and the Regulator would have working partnerships with the Department of Trade and Industry to deal with medical products being exported and imported.
Ms Ndaba asked how the decision was made on what medical products to regulate and what not to regulate, and what criteria were used.
Mr Volmink suggested that in the future the Department should consider putting all the laws together to make one composite piece of legislation. He said that the units and other bodies within SAHPRA should be recognised.
Dr Pillay replied that there were plans in the future to regulate veterinarians but the government was not presently addressing the price of veterinary medicines. SAHPRA had a working relationship with the South African Revenue Services (SARS) to make sure that medical products were tax-registered and assessed by the MCC before they could be exported.
Dr Banoo answered Dr James' question by saying that some of the vacant positions in SAHPRA would be paid by that body, although the regulatory authority and others would be paid from the allocations received from the National Treasury.
Ms Johanna Gouws, Deputy Registrar, Department of Health, said the importation of medical products was done only through the Johannesburg airport, the Cape Town airport and harbour, Durban airport and harbour, and Port Elizabeth airport and harbour. The DoH had recently started working with the South African Police Services (SAPS) to ensure that there were not any unregistered medical products being sold on the streets, and the National Prosecuting Authority had also been involved in prosecuting people who were found to be selling unregistered products.
Dr James asked if SAHPRA placed any obligations on neighbouring countries to have their medical products regulated as well.
Mr Shaik Emam asked if there were control measures in place for harmful medications which could be addictive. He wanted to know why South Africa had not been producing its own products instead of constantly importing them from other countries.
Dr Pillay replied that there were medicines which could be found on the open shelves but others were only available from pharmacists. Those that were only available from pharmacists would need to be regulated properly, because they did have side effects; the law allowed doctors and pharmacists to tell patients about the dangers of medicines, although many of them were not doing so in practice. There were three or four manufacturers in South Africa that produced medicines but due to the lack of skills and resources they were not able to manufacture medication that could be sold directly to customers.
Ms Gouws said that it was difficult for regulatory authorities from different countries to communicate with each other, but SAHPRA's responsibility was to ensure that it would protect the people of South Africa. There were harmful products being imported to South Africa because they had been approved in their country of origin, although they may not have been approved in South Africa yet.
The Acting Chairperson noted that time did not permit for further deliberations and the Committee would continue with the process next year, when the Committee would be making more amendments to the Bill, and when the Committee could raise more questions made on the submissions of the public and the Departmental responses.
On behalf of the Chairperson, he thanked Members for their commitment over the last six months. He noted that the Committee would be dealing with this Bill first, and then also starting deliberations on the Innovation Bill in the first weeks of the first term of 2015.
The meeting was adjourned.