Traditional and Natural Health Alliance submission on Medicines and Related Substances Amendment Bill: Department & legal advisors response
04 March 2015
Chairperson: Ms M Dunjwa (ANC)
The Department of Health and Parliamentary Legal Advisors presented their responses to a further submission, heard in the previous week, from the Traditional and Natural Health Alliance (TNHA). The Department of Health (DoH) clarified the definition of traditional medicine, and how the regulation of the products, practice and profession of traditional practitioners was done presently, and would be done in the future. The Department pointed out that World Health Organisation (WHO) had several sets of guidelines, which applied in different regions, on how medicines were defined and these had been taken into account by the DoH in drawing up the new definitions. Essentially the references to "medicine" had been replaced and broadened by references to "health product" to allow devices and broader categories to be taken into account. It was noted that the WHO guidelines could provide clarity on points of confusion arising from the previous meetings. These definitions also included classifications, and how and when commercialised medicines would be regulated, as well as providing an indication of when medicines would be regarded as commercialised, and the listing and shelf-life requirements around those. It had seemed that the TNHA had been confused about the distinctions between the classifications in the context of the Bill and the previous Act, and had also not clearly understood that medicines, practices and practitioners were all regulated. The main points of contention appeared to be around governance, implementation of the new Bill, compliance and how the foreign nationals practising as traditional practitioners, who were presently not regulated, would be dealt with. The DoH noted that the regulation of traditional medicines would use the digital listing system and monograms to check their scientific backing, as well as clinical testing to ascertain the chemical and biological composition of the medicine before it could be authorised for mass consumption. The various categories and specification were outlined in the WHO definitions document, and recommendations for different categories, including characteristics such as natural or synthetic content.
The Parliamentary Legal Advisor addressed the constitutional issues which were raised in the previous meeting. She noted that this Bill defined medicine very clearly, and the Department and WHO definitions should be compared. She too felt that the TNHA did not fully understand some of the issues, and was seemingly confused about the different roles of the South African Health Professions Regulatory Authority (SAHPRA). The Constitution allowed for regulation of rights, as well as distinctions for different branches of professions, so the Bill was not discriminatory. Differentiation on standards was also not unconstitutional and the Act made provision for regulations. The DoH added that the definition was clear and broad enough to accommodation other forms of professions, and after discussion, certain categories of medicine had now been removed. The Legal Advisor noted that there was no obligation on the Department to hold a full consultation prior to drawing policy, but that the Committee had complied with its obligations on public participation by holding the public hearings. The proposal to remove the definition of complementary medicines was noted and a further amendment would be proposed. Clarity was given on the persons eligible for appointment as Registrar, and to the Board. The TNHA's proposals on the structure of SAHPRA, and listing process for the Board, would need to be considered by the DoH. The DoH confirmed that it was intending to correct any present disjunctures and explained the differences now proposed, to substitute an advisory committee with a Board and put a CEO in place, to be appointed by the Minister. It was further clarified that South Africa would be migrating to another listing system to fall in line with changes in Australia and Canada, and market surveys were done to clarify usage of medicines and to collect safety data.
Members asked how the DoH would deal with the manuals, given that many traditional practitioners may have difficulty creating them, and asked for clarity on criteria around historical use. Members were interested in how the Department would regulate practice and training, pointing out that strict regulation was necessary to avoid practitioners posing any danger to their communities, and the answers also spoke to foreign practitioners, as well as accreditation of institutions. Members were critical of the fact that the DoH had apparently failed to follow up timeously on some matters, which had opened it up to criticism by the TNHA in the last meeting, and called upon the Department to be punctilious about attending to requests, and do proper consultation. They recommended that the Department conduct inspections in each province to establish how many practitioners were practising, and their origins, and for constant follow-ups. They asked how long the interim arrangement with the Council was to last, whether the DoH was in consultation with the Department of Justice and Constitutional Development to ensure firm implementation, and how it would ensure better knowledge around the legislation. Further questions related to the categories of complementary medicine, how health drinks would be regulated, and the manner of conducting tests, the functions and limitations of the Pricing Committee, and the reasoning behind the change in structure, putting a CEO in place. The Parliamentary Legal Advisor was asked to expand on the process for bringing amendments to the NA, and the Committee wanted more input from the DoH and State Law Advisors as it proceeded clause by clause through the Bill in future meetings. The Committee finally adopted minutes between 29 October 2014 and 18 February 2015.
Medicines & Related Substances Amendment Bill
Department of Health response to submission of Traditional & Natural Health Alliance
Ms Malebona P Matsoso, Director-General, Department of Health, presented the Department's response to the submission of the Traditional and Natural Health Alliance (the Alliance or TNHA) at a previous meeting. The Department of Health (DoH or the Department) had noted the issues that were raised. The Department attempted to get the World Health Organisation (WHO) expert on traditional medicine to present to the Committee, but that could not be arranged. However, that expert had supplied the Department with documents to assist in addressing the uncertainty from the previous meeting. The first document dealt with the question to the Department, specifically asking for clarity on the definitions around traditional medicine and what else had been developed in the African region, to give an indication of what guidelines had been developed. She explained that each WHO region had its own guidelines, and the Department also had the guidelines of the Eastern Mediterranean region, which was geographically the Middle East, along with those for the African region, and both of these would be used in giving background to the presentation.
She noted that in the previous meeting, there was no clear understanding of what the definitions of the WHO were for "medicine" and the definitions were used in a general sense. The Department was advised by the expert, Prof Castillo, who clarified the various definitions that had formed the main bone of contention in the previous meeting. These were outlined in the initial three pages of the WHO definitions document. That document also included the policies that other African countries had adopted on traditional medicines. The definitions which had been given were adopted at both regions.
She added that page 3 also made reference to traditional and complementary medicines regulation, with particular focus on regulating the practitioners, the practice and the products. The regulation of the practitioner and the practice were covered by the Traditional Practitioners Act, but there were products that were intricately linked to the practice which were available in crude form. Section 27 of the Act made provision for the Minister to regulate the products which were available in crude form.
Ms Matsoso drew a distinction between products which were primarily for commercial use and products which were formulated from crude form for commercial use. Both must be regulated as they were classified as medicine. On page 16 of the WHO definition document, there were classifications of how medicine should be regulated. There were four categories that were linked to the method of preparation, indication for use, and extent of development. The first category outlined that a medicine could be prepared, after consultation, in a traditional manner but one which ensured standardisation and safety and efficacy being guaranteed through extended use. Raw materials used to make the medicine were well known, whether they were dried or fresh, but had a short shelf life. The Director General used the example of using traditional medicine for individual use that was prepared in the home, and thus must be regulated by the Traditional Practitioners Act.
Category 2 outlined medicine that was prepared in advanced, packaged and had a batch number, and where the raw materials in its composition were known to the public, and the methods of production used guaranteed stability and standardisation. It would be produced industrially or semi-industrially. Its safety and efficacy would be guaranteed by medical evidence garnered from a long period of use or by open clinical trials if necessary. The main active ingredients were raw materials, and the chemical groups in the raw materials were known. The shelf life of the product was determined through stability tests.
Category 3 outlined products that were prepared in advance, packaged and had a batch number, and were either produced industrially or semi-industrially. The shelf life was determined by stability studies, and the active ingredients were standardised with regard to the extracts. This took into consideration the biological properties of the raw materials or new therapeutic indication, and dynamic formation knowledge with those specifications, particularly knowledge in regard to the molecular structures of the raw materials
Category 4 had the same criteria as the previous two categories, but the medicine that fell under this category needed to be registered in the country of origin. However, it must comply with category 3.
Categories 2, 3 and 4 were aligned with South African Health Professionals Regulatory Authority (SAHPRA).
These guidelines were available to the Committee in the WHO guidelines document, which governed the quality of traditional medicine. The manufacturing process would be in accordance with the WHO guidelines on good manufacturing practices for traditional medicines. In regard to safety, she pointed out that if there was a need for research, then there were guidelines for methodologies for research and evaluation for traditional medicine. When medicine was on the market, the guidelines would apply with regards to safety monitoring. These had been written specifically for traditional medicine. There were other medicines which were chemically different and derived from different synthesis, and they could either be chemical or biological. However, the point was that there should be a regulation of both.
Individual medicine could not be regulated if only used for individual use. However, once it became commercialised, then it would have to be, but in this case there was then a need to distinguish between the different types of medicines. The complementary medicines were medicines such as Indian needles for acupuncture, and Chinese herbal medicines. It was important to address the definitions, in order to have a good background.
Parliamentary Legal Advisors' response
Dr Barbara Loots, Parliamentary Legal Advisor, firstly addressed the constitutional issues raised by the TNHA, in its presentation in the previous week. She noted that the presenters were seemingly confused by the different roles of SAHPRA; on the one hand, its role in regulation of the practice and profession, and on the other the role it had in the regulation of medicines. From the profession's perspective, the Constitution allowed for the regulations of rights, so there was nothing wrong with the legislation in place to regulate the profession of traditional practitioners. Making a differentiation across the various branches of the professions in TNHA was also not discriminatory, contrary to the assertion of the presenters
From the product perspective, when a product was commercialised, the product would fall under the Medicines Act, which regulated its quality and whether or not it met stipulated standards. The differentiation of what constituted these standards and products were also not unconstitutional and the Act made provision for regulations to be drawn in this regard. She pointed the Committee towards the differences (see attached document for full details).
Ms Matsoso outlined that the definition as drafted was clear and broad enough to accommodate the other forms of professions. In summary, it was in line with constitutional requirements, and was appropriate and in line with the Act. A previous discussion with the legal advisors of the DoH had resulted in removal of the different categories of medicine from the Bill. Other distinctions that were already in the Act remained.
Dr Loots continued to outline that, from a constitutional perspective, there was no obligation on the Department to have public participation into policy making. Whether or not to call for public participation was in the discretion of the Department, and the presenters could not challenge the Bill on this point. Parliament had offered the presenters the space to participate in the process by making their presentation, and they could not challenge the fact of the Bill at this point. It now really boiled down to an issue of courtesy.
She noted that the TNHA had raised issues on page 3. The first suggested that the definition of complementary medicines should be removed. An amendment was being prepared to propose to the Committee. The second was that section 2C(2)(a) of the Act dealt with who could be appointed as the Registrar. The section stated that anyone with medical expertise (not just a person with expertise in Western medicine) could be appointed. It was also not limited to someone with qualifications but could include someone with a substantial experience within medicine, as defined in the Act, and the same qualifications applied to those appointed to the Board of SAHPRA.
The Act made no provision for the structure of SAHPRA, and the TNHA had presented a proposal as to how it should be structured. That, however, was something that should be left to the discretion of the Department. The listing process of the board was also to be clarified by the Department, particularly in relation to item 6.
On the issue of access of medicine, it was suggested that if there was no uniform structures for professions and there was not equal access to medicine this needed to be remedied. It was in the public interest that all medicines should be standardised to ensure quality. There was no constitutional issue with having a professional body. There needed to be adherence with the WHO guidelines in the legislation.
Ms Matsoso clarified what the Department had proposed for SAHPRA, saying that the Department wanted to correct any disjuncture that presently existed with the system. Act 72 of 2007 had removed the Medicines Control Council and Registrar and substituted an entity that operated with a Chief Executive Officer (CEO) and advisory board system. There was an attempt to change the advisory committee into an advisory board, because an entity with a CEO always had a board instead of a committee. If there was only a committee, there could be an election whether or not to heed their advice. In addition, with that structure, there was too much pressure on the CEO because s/he had a lot of responsibility, having taken on the functions also of the Registrar. There was an emphasis on governance and ensuring that boards and technical committees were formed.
The replacement of the references to "medicine" with "health product" in the Act was done because a medical device had not been included in the definition of "medicine" and the DoH wanted to revise this. "Health products" would include medical devices. This would also assist the Department to structure the board, particularly in assessing the number of the people who would sit on the board. The issue that the Department wanted to avoid was the problem of apathy in the boards and non-attendance of meetings. Act 72 of 2008 created SAHPRA, but the amendments here were intended to correct and boost the current system.
Ms Matsoso indicated that Australia was moving away from the listing system and following what the Canadians were doing. South Africa was using a digital listing system but there would need to be a migration to another system, due to the Australian changes. The Department had hired an expert to attend to the listing, with the use of monographs and pharmacopoeia references, but otherwise there was a general agreement with what Dr Loots had said.
The market surveillance was done to verify claims that certain medicine had been used for a long time. There needed to be an understanding as to what would happen when there were mixes with other medicine. There was an institution in Sweden that could do this. There needed to be a systematic collection method to collate safety issues about medicines The Department had established three centres which collected this type of information at local academic institutions, at UCT, Medusa and Free State University. The clinical pharmacology department of UCT was the longest standing, the one at Medusa dealt with Anti Retroviral medicines (ARVs) and the one in Free State, still to take off, was dealing with children's medicine.
Dr P Maesela (ANC) pointed out that many traditional practitioners were illiterate and would not be able to create these manuals on their own, and asked how the DoH would make the manual-preparation process more accessible for the practitioners.
Ms Matsoso pointed out that the Department would have the manuals translated into the local languages to allow for greater understand by the practitioners. The manuals would also be written in simple format to encourage compliance of practitioners.
Dr H Volmink (DA) referred the Committee to page 16 in the WHO definition document, specifically category 1.1 and category 2.2, which speaks to the historical use of the medicine. He enquired what criteria were used to determine the points.
Ms Matsoso replied that the WHO had come up with monographs which have been developed. In the pharmaceutical work, pharmacopoeia references put standards to different formulations, depending on how they were made. In traditional medicine there had been a development of monograph by a local academic, Prof Engels. Some local academic institutions had documented the different plants that had been used locally, including their names in the indigenous languages. The specific reference used was published and was produced in collaboration with the Norwegian institutions. The book was released and was led by Prof Quinton Johnson who led the Biotechnology Department at the University of the Western Cape. This had to be checked against the monographs.
The Chairperson enquired how the Department would regulate the practice and register practitioners as the training that traditional practitioners received was very much different from the training of conventional Western practitioners. She added that the regulation must be rigorous, to address those practitioners who posed a danger to the community.
Ms Matsoso pointed out that the Traditional Practitioners Act, on page 20, made provision for an application for registration of practitioners to practice. The Interim Council was supposed to make those provisions, and she assured the Committee that she had faith in the current Council and called upon the Acting Director from the Medicines Control Council (MCC) to elaborate further on the regulation of practitioners.
Prof Shabir Banoo, Member, Medicines Control Council, Department of Health, added further responses around regulation of practice and practitioners, and highlighted that there were different types of training that the practitioners would undertake, as well as how foreign practitioners were dealt with. The Interim Council had to regulate practice and practitioners in relation to the Traditional Practitioners Act. Schools who trained the practitioners were referred to as "training institutions" and the Interim Council also had to regulate those schools in order to standardise training. With regard to the registration of foreign practitioners, the Act only made provision for the registration of South African citizens; however the interim Council would make recommendations on the regulation of practitioners from other African countries to be registered and regulated.
Ms Matsoso noted that in the Traditional Practitioners Act, there was provision for accredited institutions, through the Council, to provide training. The Department was also seeking to have these institutions recognised by the South African Qualifications Authority. The institutions had tutors who who also needed to be recognised in terms of the Act.
Ms C Ndaba (ANC) noted that there was a gap between the Department and the TNHA, because the Department did not do follow-ups that the Committee requested of it, resulting in a gap. She asked that the Department make a firm commitment to do the work which the Committee requested. Last week, the Director-General had been undermined by the Alliance. The Department needed to have consultation, especially with the initiatives which they were now proposing, so that there was not a repeat of what occurred in the previous meeting, with accusations of no consultation.
The Chairperson agreed and added that the Traditional Health sector was very complex. The Department did indeed have responsibility to close the gaps, and avoid any behaviour that would compromise compliance with the law. She hoped that the comments by Ms Ndaba were taken with due consideration. She noted that the complexity of the sector was impacted heavily by the presence of foreign traditional health practitioners, as registration and regulation had not been extended to that group of practitioners. She made a recommendation that there should be inspections of each province to ascertain how many practitioners were operating in each province, and asked how exactly the Department would address the practitioners who were a danger to their respective communities. She also asked that there should be constant engagement between Department and Committee, by the Department giving regular presentations on what was being done by the Department. She also asked how long the interim position was likely to remain.
Ms Matsoso noted that the workshops were tailored for all traditional practitioners, due to the diversity in the profession, and the DoH was aware that all must be invited and it should not work with one group. The Act was not in the interim phase but rather the Council was. The Council had already indicated that it would like to see amendments to the Act, and would work with the Department in preparing such amendments.
Dr Maesela asked if there was a relationship with the Department of Justice and Constitutional Development, to ensure that there was firm implementation of the law, and again asked how the DoH would deal with the lack of knowledge around the regulations and the Act. He asked if there was a full understanding about the complexities of implementing the law. He thought that there was a problem with those who did not know that the practice of traditional healing was regulated, especially foreign practitioners. He concluded by asking what was the vision behind the Act and whether the Department did have mechanism to deal with any unintended consequences.
Ms Matsoso responded by referring to Chapter 4, sections 29 to 42, which dealt with sanctions and provision for complaints. The one reason why the Council wanted the amendments was to formalise the Council and have it become a statutory body. The Council needed a registrar and an office needed to be established, it also needed inspectors and a budget. The Council had a plan which outlined how this would happen.
Dr Loots asked the Committee whether the DoH would be able to respond to the points she outlined in her presentation, in order to give more clarity to the Committee and produce more substantive responses.
In response to a question from the Chairperson as to how the Committee wished to proceed, Mr I Mosala (ANC) asked that the Department be allowed to respond to the points raised by the Parliamentary Legal Advisor later. It was important for the Committee to get a comprehensive response to all points raised.
Dr W James (DA) pointed out there was a spelling error on item 5.
Mr Mosala reiterated that the Department must give clarity.
Dr Maesela asked under which category complementary medicine would fall, pointing out that people could distribute medicine between small groups, without this necessarily being commercialised. The TNHA had been concerned about the approach to be taken by SAHPRA, and had expressed a lot of scepticism.
Dr Volmink asked if the DoH believed there should be a single manner of doing clinic tests, or if there were different approaches to assessment.
Dr Maesela asked whether cold drinks such as Coke or energy drinks could fall under complementary medicines, or even holy water, because they could be regarded as a remedy or a feel good type of substance.
Ms Matsoso responded that these foods mentioned by Dr Maesela were regulated under a different Act, but if something started to make medicinal claims, then it would fall under the Medicines Act. The substances that people consumed in their personal space could not be regulated under the Medicines Act, but when the substance was distributed, then it must be clinically tested and verified. Anything that was considered medicine and that was for traditional use must be in the monographs and needed to be in the listing system. The WHO guidelines supported the use of monographs, due to their scientific basis. There needed to be a listing of the indigenous species, and there must be a regulation the use of the plants.
The Chairperson requested that the Committee refrain from holding "side-conversations". She said that the documents handed out last week would be analysed with the intention of getting clarity through a detailed line-by-line analysis
Dr Volmink asked about the Act itself, looking at the Pricing Committee and asked what its functions and limitations were.
Dr Anban Pillay, Deputy Director General, Department of Health, responded by pointing out that the Pricing Committee made recommendations to the Department of Health about the prices of medicine and was independent of the MCC. The Committee created a stable price system for medicines.
Dr Maesela asked about the Board and CEO. The Minister would appoint the CEO and the Board would appoint the technical committee. He commented that there seemed to be a broad range of people to whom the CEO was accountable.
Ms Matsoso pointed out that the Annual Performance Plans would address what the money allocated to them was intended to achieve. The Minister would appoint these bodies but their powers and functions were outlined in law. The Board could not have one representative, in the form of a CEO, and there was a need to have specific medical experts in committees. The Board must appoint the experts, not the Minister. The experts reported to Parliament and they were to be held accountable
Mr Mosala notes that on page 13 and 14 of the document by the Legal Advisor, it was highlighted that there was a need to consult with the National Assembly. He asked if Dr Loots had been in contact with the NA.
Dr Loots responded that she had spoken to the NA's procedural staff and the Senior Legal Advisors, but she would have to make some further enquiries about what procedure to follow for the amendments. Permission to proceed would have to be obtained in writing.
The Chairperson thanked the presenters and requested that the Department and State Law Advisors must still return to the Committee, so that there could be an analysis of each important clause.
The Committee considered several sets of minutes of meetings.
Minutes from 29 October 2014 were adopted, subject to technical corrections to page 5, paragraph 2, to read better, and the insertion of Dr W James in the list of those attending.
Minutes from 5 November 2014 were adopted with a grammatical change to page 3 in the second last line.
Minutes from 12 November, 19 November, 26 November 2014 and 18 February 2015 were adopted without amendment.
Minutes of 25 February 2015 were adopted with a technical correction to paragraph 4 on page 4.
The meeting was adjourned.
Dunjwa, Ms ML
Jafta, Mr SM
James, Dr WG
James, Ms LV
Maesela, Dr P
Mahlalela, Mr AF
Matiase, Mr NS
Mosala, Mr I
Ndaba, Ms CN
Scheepers Ms MA
Volmink, Mr HC
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