Medicines and Related Substances Amendment Bill: Response by Department of Health to submissions made during public hearings
19 November 2014
Chairperson: Ms M Dunjwa (ANC)
The Committee met to hear the comments of the Department of Health (DoH) on the public hearings on the Medicines and Related Substances Amendment Bill that took place recently.
The Amendment Bill addressed which types of medicines, in vitro diagnostics (IVDs) and medical devices were regulated, and where these products were advertised. The DoH had included that the Regulatory Authority would now also regulate products advertised through electronic media. They had found it necessary to include this amendment because technology was ever evolving, and manufacturers would find other ways to advertise their products. The definition of medical devices had been revised because the Department agreed that the updated definition found in the International Medical Device Regulatory Forum (IMDRF) was more appropriate, as well as the definition of IVDs.
The objectives of the Regulatory Authority amendments included the process of regulating scheduled substances and IVDs, with an oversight role on foodstuffs and cosmetics. The Authority also had to make sure medical devices and IVDs met the standards of quality that had been pre-determined. The Chief Executive Officer should have different registers for medical devices, IVDs and medicines, where each register would monitor the processes of each being regulated. The inclusion of veterinarians would ensure that they could be issued with licences to compound and dispense medicines. Local suppliers would also be acknowledged, since they dealt with unscheduled substances only. The Pricing Committee would be in charge of sections relating to marketing and pricing matters, only as advisors to the Minister.
The Committee were concerned about radio and television being included in the amendment, and asked why the Bill had made provision for a Pricing Committee. It would have been fitting for pricing issues to have their own Bill. There seemed to be no mention of traditional medicine in the amendments, and it was suggested that the Department should have a meeting with the Traditional and Natural Health Alliance (TNHA) to find ways on how their medicines could be regulated. The Bill also did not make a clear distinction between the words that were used, and what the Department had done differently, to make sure that the Bill did not get scrapped like the 2008 Amendment Bill. The Committee also asked about the formulation of the Board, the new definitions, and the inclusion of foodstuffs and cosmetics in the Bill. New suggestions of what should also be regulated were made.
The South African Heath Products Authority (SAHPRA) would regulate only the products mentioned in the Bill, and although there needed to be developments made to how foodstuffs and cosmetics were regulated, they did regulate the labelling of products. The Department had a Traditional Medicines Committee that would help them ensure the effectiveness of traditional medicines regulations, and they had documentation on how they planned to do this. The Department had been working with university professionals, but these professionals were not permanent staff members of the Medical Control Council (MCC). They had already recruited 25 new permanent staff members that would be working for SAHPRA, and were in the process of considering a food agency.
The Chairperson told the Committee that the Department had compiled a list of things they agreed upon from the presentations given by the different companies regarding the Medicines Bill. They would be briefing the Committee on the amendments made and the motives for the amendments. She added that Ms M Scheepers (ANC) and Dr W James (DA) had asked to be excused and would not be attending the briefing.
Briefing by the Department of Health
Dr Anban Pillay, Deputy Director General: Department of Health (DoH), said amendments had been made with regard to Section 1 of the Bill, which speaks to advertisements of medicines. It had been changed to include those medicines advertised through electronic media. The reason for this was because the definition of advertisement referred only to information appearing in newspapers, magazines, pamphlets or other publications. In today's electronic environment, the Bill had to include this kind of advertising as well. Under the definition of medical devices they had inserted the word "reagent" in the definition, and "for one or more of the specific medical purposes" in the subsections. The Department agreed that the latest updated definition as per the International Medical Device Regulatory Forum (IMDRF) be used.
The definition of in vitro diagnostic (IVD) had also been changed to include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles, which are used for example, as an aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, or determination of physiological status. This definition was the same one that was being used by the IMDRF as well. The objective of the Authority would now also include the process of regulating scheduled substances and IVDs, which include regulatory oversight of foodstuffs and cosmetics. Under section 2B, they had added that the Authority must ensure that medical devices and IVDs meet the standards of quality, safety and efficacy and, where applicable, performance because medical devices and IVDs need to meet specific performance criteria and not efficacy criteria, as in the case of a medicine.
The Chief Executive Officer must keep separate registers for medicines, medical devices and IVDs, in which they should record the registration of medicines, medical devices and IVDs by the Authority. Amendments to section 22C added that veterinarians would also now be issued with licences to compound and dispense medicines on the prescribed conditions. Experience had shown that veterinarians lack knowledge on compounding and dispensing of medicine, although it was previously claimed that the pre-graduate curriculum for veterinarians included training on compounding and dispensing.
Distributors such as Cash and Carry and Makro had been acknowledged, since they dealt exclusively with unscheduled medicines. It was not required for these distributors to comply with all the South African Pharmacy requirements or obtain a licence from the Medical Control Council (MCC), as they operated as so-called retailers dealing with bulk products. Therefore, section 22C had included that the Authority may issue licensing of a schedule 1 and higher medicine or scheduled substance.
They agreed that, under section 18A, the Pricing Committee may make recommendations to the Minister and not the MCC, because the current mandate of the MCC was to ensure quality, safety and efficacy, not pricing. Further, the Pricing Committee was to pronounce on marketing, bonusing and pricing matters and advise the Minister accordingly, so no other person should supply any medicine or scheduled substance in terms of bonusing. The Minister may also prescribe acceptable and prohibit acts in relation to subsection (1), in consultation with the Pricing Committee.
Mr H Volmink (DA) asked if "electronic media" also included radio and television, because if it did, then the wording should be changed to "mass media" instead. He added that if foodstuffs were to be regulated, then there should be a different Bill to accommodate those products, since some did not have scheduled substances. He suggested that pricing amendments should have their own Bill as well.
Mr N Matiase (EFF) asked if different kinds of medicines had been included in the Bill. He did not see any amendments being made to accommodate traditional medicines.
Mr A Mahlalela (ANC) said he would not like to see the same mistakes being made with this Bill like he did with the 2008 Amendment Bill, which had not been implemented. How would they ensure that the 2014 Bill was implemented? He also asked if the words "products" and "medicine" could be used interchangeably, because the Bill had used both to describe medication.
Ms L James (DA) asked if the South African Health Products Regulatory Authority (SAHPRA) had enough capacity to regulate more products than they were regulating at the moment.
Ms C Ndaba (ANC) said there were amendments that needed to be made regarding traditional medicines because they could not be regulated in the same way as modern medicine. She suggested that the Department should set up a meeting with the Traditional Health Alliance to find out how traditional medicines were used in order for the Regulatory Authority to see how they could regulate the products. She was also concerned as to whether SAHPRA would have the capacity to perform the duties which were outlined in the Bill.
Mr I Mosala (ANC) said the Bill had not addressed the issues of the SAHPRA Board. How would it compose the Board and who were the members that would be included as part of the Board. The Bill should not be rushed and the Department should ensure they had covered all the issues that had been raised by the different organisations before moving on to implementing the Bill.
Dr P Maesela (ANC) said if the Department had found loopholes in the Bill then the amendments they has suggested should be made.
Ms Malebona Matsoso, Director General: DoH, replied that the Department had published a booklet that explained how it planned to carry out regulations for traditional medicines, and would distribute the booklet to the Committee’s research team. SAHPRA would regulate all products which had been mentioned in the Bill -- those that were processed in laboratories, as well as the plants that were used during the process of making medicines. The Bill had always given the definition of a medical device but it never explained, or made provision for, how the device would be regulated. The reason they had established SAHPRA was because members of the MCC were not permanent staff but merely contributors from different industries who had their other daily jobs. The establishment of SAHPRA would include permanent staff, who would be dedicated to the work of SAHPRA only. She also added that foodstuffs and cosmetics were included under "products" in the Bill.
Mr Pillay said the DoH would make changes to the Bill concerning advertisements and include "mass media" so that it did not have any loopholes. Foodstuffs and cosmetics were currently regulated, but the extent of regulating was not where it should be. There had been concerns in the past with how food was regulated, and the Agriculture Department had been upset when there had been the donkey and horse meat scandal. At the moment, foodstuffs were regulated only in terms of labelling, meaning they are regulated whether what was written on the packaging is what is actually used to make the foods. They needed to go beyond that process, therefore, and start regulating what was in the products themselves.
The DoH had noted the concerns around traditional medicine and planned on dealing with those issues and making amendments where they saw reason to. However, they did have a Traditional Medicines Committee within the Department that would help them to formulate other ways of regulating traditional medicines and suchlike. The most critical thing was that there was a lot of damage happening with products that were not regulated properly, and this made the DoH determined to deal with the crisis. There was also a backlog of products for regulation that needed to be addressed urgently. He concluded that it was important to create a structure that was independent and had enough funds to carry out its duties.
Ms Matsoso explained that the Department had been working with universities in South Africa to regulate products. For example; the University of Cape Town (UCT) had professionals that dealt with the safety of medicines. There was also the Drug Information Unit, and the monographs that had been developed by the World Health Organisation (WHO) were supplied by the University of the Western Cape (UWC). The monographs were used for both the traditional and complementary medicines. The University of North West (NWU) had been at the forefront in regulating the quality of products, and the University of Pretoria (UP) and Rhodes University had been largely involved in biomedical research. The professionals were situated in the universities, so it was important that SAHPRA be developed to get permanent staff.
Mr Volmink said regulating foodstuffs would need a lot of work and other sectors, like the Department of Agriculture, would have to be considered as well.
Ms James said she was hoping the Bill would include plans on how they planned to regulate traditional medicines.
Mr Matiase said he would like to hear from the MCC what they believed were their advantages and disadvantages, and what changes would they like to see being made.
Mr A Shaik Emam (NFP) suggested that they also regulate the circumcision processes, and asked if suppliers could be held accountable if they sold harmful products to the public.
The Chairperson asked about the time frame for training the staff members who would be part of SAHPRA, and if the Traditional and Natural Health Alliance (TNHA) had submitted any proposals to the Department.
Ms Ndaba said the DoH had not included how they planned to regulate medical devices which had been disposed of and re-used again.
Mr Pillay replied that they had recruited 25 new permanent staff to work for SAHPRA. In the past they had considered having a food agency body that would regulate foods, but they would not have been able to regulate the products that were used to make those foods. The formation of a food agency had to be done under the Department of Agriculture. The 2005 Bill did not include the setting up of a Board, but the proposed Board would consist of professionals in the different disciplines of medicine. The DoH agreed that processes in circumcision should be regulated, as well as how to regulate products which had been re-used. The Department had been receiving money from organisations to train people to regulate disposed medical devices and the exporting of disposed medical devices.
Ms Matsoso said the strategic draft gave a background of the extent of the problem with the Regulatory Authority. It described the capacity constraints of the MCC, and went into detail about the backlog and how they planned to address this problem. The 25 new staff members had been recruited from universities and other organisations, and the DoH was busy with training at the moment. The reason why the Department had decided to have the Board was because power was invested in one person -- the CEO -- and they were responsible for all the operations. This did not work, because they found that people were abusing the power that was invested in them, and it did not lead to effective management.
The DoH had not excluded traditional medicines in the Bill because they regulate the plants and products used for traditional medicines. The only things they did not regulate were the processes involved while using the medicines. They had a research team within the Department that was researching these processes so that SAHPRA could plan on how to regulate them. All manufacturers had to comply with the standards of good manufacturing, and people must not conduct their businesses in places that were not clean or suitable for production.
Mr Volmink asked if nutritional supplements should rather be included in the Bill, instead of foodstuffs.
Mr Mosala asked if the Department's legal team and the Committees' legal personnel would combine their report findings to compile a complete document that would make sense for both parties to understand.
The Chairperson said that their legal personnel had provided the Committee with a legal document that explained the procedures of the Bill and the legal framework around the amendments.
Mr Volmink interrupted the Chairperson, saying that his question had not been answered by the Department, and that he would like an answer before the Committee moved on to the next agenda.
Mr Maesela said Mr Volmink should have waited until the Chairperson had finished speaking before asking his question again. His actions were out of order.
The Chairperson responded that Mr Volmink should in future wait until whoever was speaking to finish before raising his hand or making a comment.
Mr Volmink apologised for his actions and continued to speak.
The Chairperson said the Department did not have to answer Mr Volmink's question, because there would be a time for deliberations.
The Department's legal team replied saying they would welcome any legal suggestions from the Committee because in the end they wanted a Bill that was implementable and easy to understand.
The Chairperson said their legal advisor had provided the Committee with all the legal frameworks that applied to the Bill. Although they had circulated the document, it was not up for discussion but would be discussed at a later stage. She asked the Committee legal advisor to give the Members a brief background to the document.
Dr Barbara Loots, the Committee's legal advisor, said there was nothing new in the document that the Department had not already provided to them. The principle Act, as Members knew, was not in operation and the 2014 Act would include amendments from the 2008 principal Act as well. Therefore, the 2014 Act was a compilation of all the previous legislation related to the Bill. The document provided information as to how the previous Act was incorporated into the Bill.
The Chairperson thanked the Department for their presentation and said the documents they had provided would be circulated to the Members. She reminded the Department to look into the issue of traditional medicines.
The meeting was adjourned.
Dunjwa, Ms ML
Jafta, Mr SM
James, Ms LV
Maesela, Dr P
Mahlalela, Mr AF
Matiase, Mr NS
Mosala, Mr I
Ndaba, Ms CN
Shaik Emam, Mr AM
Volmink, Mr HC
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