The Committee was briefed on the review performed on the Medicines Control Council and on recommendations for the new regulatory authority. The Department of Health explained why the Council was reviewed, saying that there had been complaints about the efficiency and outputs of the Council and that the Council had never been reviewed.
The Department proposed a new regulatory authority for health products for South Africa. An agency, the South African Health Products Regulatory Authority, would be established for health products for South Africa. Health products included medicines, medical devices, foods and cosmetics with medicinal claims and/or medicine content. The Authority would retain important principles such as good governance, accountability and responsibility and transparency. The Agency would evaluate all medicines, medical devices and other health products. It was also responsible for the certification and registration of all products. The Authority would allow for efficiency gains such as enhanced capacity, good governance and transparency.
The Bill would establish the Authority. Its mandate would be to evaluate the safety, quality and efficacy of medicines and other health products and to certify them. The Minister was then responsible for registering the product after their certification.
Members were concerned about the difficulty in finding qualified staff for the agency and about the backlog of medicines and other health products that still had to be registered. They were also concerned that the Minister had sole authority over which health products could be registered and they questioned the independence of the new agency. The Department explained that there were certain processes that the Minister had to follow in order to register a product and that most agencies around the world were government agencies because governments were liable for the efficacy and safety of medical products.
The Committee wondered why there could not be more competition in the market, as competition resulted in cheaper medical products. They asked for clarity on how the health systems worked in the United Kingdom, United States and Australia. Members also wondered if the new agency would impact on the National Health Act and how the new Authority would be funded. The Committee wanted clarity on the certification and registration of new health products. It was noted that it was important to create clear frameworks on limits and categories for health products.
The Department also provided a clause-by-clause analysis of the Bill. The analysis showed amendments, provisions and repeals that the Department had made to the Bill.
The Chairperson was not convinced by the arguments and explanations of the Department, particularly on the Minister’s sole authority in registering health products. He said that the Department would have to come back to the Committee with better explanations.
The hearings on the Bill will span three days instead of two: 5, 6 and 12 August.
Briefing by Department on the South African Health Products Regulatory Authority and the Medicines and Related Substances Amendment Bill
Mr Thami Mseleku, Director-General for the Department of Health (DoH), informed the Committee that the review of the Medicines Control Council (MCC) came about because of complaints about the efficiency and outputs of the MCC and the Medical Regulatory Affairs (MRA), disjointedness of the MCC and MRA as an operational system, global trends for the review of regulatory authorities every five years and because the MCC had never been reviewed. The MCC was also reviewed because of scientific advances in health products and because of the lack of or weak regulation of some health products.
Mr Mseleku briefed the Committee on proposals for a new regulatory authority for health products for South Africa. The Department proposed the establishment of the South African Health Products Regulatory Authority (SAHPRA). SAHPRA was to be an agency accountable to the Ministry of Health. The agency would retain revenue from fees and have 50% cost recovery, it would have a flexible remuneration structure so as to be able to recruit and retain scarce skills and it would be subject to the PFMA and other legal prescripts.
SAHPRA would be an overarching regulatory authority for health products for South Africa to include medicines, medical devices, foods and cosmetics with medical claims or medicine content.
SAHPRA would include important principles such as good governance, effective project management, accountability and responsibility, transparency, enhanced review capacity, international regulatory cooperation and regular reviews. The agency’s functions would include evaluating all medicines and other health products, certifying health products for efficacy, safety and quality, authorising the conduct of clinical trials, keeping a register of all certified and registered products and licensing manufacturers, wholesalers and distributors. SAHPRA would have relationships with the Ministry of Agriculture, selected foreign regulatory authorities and with other regulatory authorities of products other than health products and professional councils.
The agency would allow for efficiency gains such as enhanced capacity, good governance, retention of revenue, 50% cost recovery, recruitment and retention of staff, transparency and accountability and improved time scales.
The Medicines and Related Substances Amendment Bill would state that SAHPRA’s mandate would be to evaluate the safety, quality and efficacy of medicines and other health products and to certify them. Once the medicine was certified, the application was referred to the Minister who will register the medicine. The Bill would provide for the certification of medicines, medical devices, foodstuffs and cosmetics by the Authority in relation to their safety, quality and efficacy. The Bill would also provide for the registration of medicines, medical devices, foodstuffs and cosmetics by the Minister if it were in the public interest to do so.
The Department conducted a clause-by-clause analysis of the Bill (see document).
The Department commented on the draft Bill process, saying that 32 submissions had been received and studied. The details of the submissions would be covered in the regulations.
Ms R Mashigo (ANC) stated that there were matters from the presentation that were not very clear. It was clear that in-house staff was needed for the agency instead of consultants. The agency that the Department wanted to establish appeared to be very “high-tech”. This was worrying, as currently there were even difficulties in finding qualified people to run government departments. She asked the Department how long it would take them to find the staff for the agency and what they would put in place in the interim. She stated that a lot of what Mr Mseleku had said in the presentation reminded her of the Foodstuffs, Cosmetics and Disinfectants Bill. The Committee was still waiting for the regulations regarding that Bill. She wondered how widely they had consulted on the Bill.
Mr Mseleku answered that one of the reasons that the Department had problems in recruiting staff related to the public service remuneration packages. This was why the Department was currently in the process of reviewing packages for professionals in the public service. The Department has already reviewed nurse packages and were in the process of looking at doctor, dentist and pharmacist remuneration packages. The Department was also focused on finding quality researchers that would understand the environment of clinical trials and chemical formulations. The Department was creating an agency that would have flexible remuneration structures so that it would be able to recruit and pay people market related packages that would enable them to compete with the rest of the world. This would attract expertise from all over the world that the Department was in need of. It would also create a career path for South Africans. The Department was even restructuring pharmacy faculties and the curriculum and they were looking at other means of recruitment. The issues would be addressed with the creation of an agency with flexible remuneration and possibilities.
Mr Hennie Kleynhans, Director for Legal Services: DoH, stated that as far as he knew the regulations for the Foodstuffs, Cosmetics and Disinfectants Bill had been issued. Since the Act was amended, the existing regulations were being reviewed with the purpose of bringing them in line with the new legislation.
The Chairperson stated that the Department and the Committee would have to come back to the issue, as he was not satisfied with the response to the question on the Foodstuffs, Cosmetics and Disinfectants Bill. He stated that the question was about what the Bill was seeking to do versus what the legislation was seeking to do.
Mr Waters addressed the powers of the Minister and the independence of the new Authority. He stated that the new structure had to be “viciously” independent of the Department given the past history with Virodene and the political influence that there was when the Medicines Control Council (MCC) stopped clinical trials. This proved that the new structure had to be independent of the Department and any political interference. The Department had said that this could not be done because of funding constraints. This did not make sense. He added that there could be a “viciously” independent structure that received funding from government. This funding could be phased out over two to four years.
Mr Waters noted that the Minister had sole authority and discretion in deciding whether a medicine or drug could be registered or not. He found this bizarre. The Department had spoken about the fact that they did not want competition from Indian companies. However, Mr Waters felt that the more competition there was in the market, the cheaper medicines became. It was when companies were protected that they could start charging more for products. This went against the Department’s aim of decreasing the costs of medicines. More competition meant cheaper prices. The Department had mentioned that the United Kingdom (UK), the United States (US) and Australia had the same system. The Department had also mentioned the National Health Service (NHS) in the UK, which was a body that advised the UK’s Minister. He asked if the body advised the Minister on NHS drugs and on the private sector. He also wanted to know how the system worked in the US and Australia and if there was any variance.
Mr Mseleku stated that all the advisory bodies in the UK, the US and Australia were government bodies. For example, the Secretary of State in the US was responsible for the Food and Drug Administration (FDA), which was a government body. The reason for this was that the FDA dealt with bio-safety, as the US was quite concerned about bio-terrorism. The FDA was therefore under the direct supervision of the Secretary of State for health. It was not independent of the government at all. Both the UK and Australian bodies were government bodies.
Bodies such as these were seen to be part of a government because they dealt with very serious issues, for which government was accountable. The Government was liable for the efficacy and safety of all medicines. Saying that the Minister had sole authority in deciding whether medicines could be registered or not, was not entirely true. There were processes that had to be followed with regard to how the Minister would or would not register a product. There was a clause in the Bill that outlined that there were five processes that the Minister had to follow in order to register a product. There were administrative processes that had to be followed as well. There were other instruments that guided how Ministers were to exercise their powers.
The issue of competition was an issue of perspective. Currently, the Department was developing some strategic industrial policies. Pharmaceuticals were one of the three strategic areas that would help South Africa with challenges of unemployment. There were also other pieces of legislation that spoke about support for the internal policies of Black Economic Empowerment (BEE) companies. These were policies that could ensure competition but within reasonableness. The Department had to look at South Africa’s interests as well. This was why South Africa was negotiating so strongly at the World Trade Organisation (WTO) trade negotiations. South Africa could not open its markets when other countries refused to open theirs.
The Chairperson stated that the Department would have to come back to this question. He was not convinced by this explanation.
Mr Waters addressed the issue of staffing and the backlog. There was a lack of skills and this was a specialised field. The Department had not indicated what they would need for the new structure in terms of staff. He wanted to know if the Department was setting a deadline for when the backlog issues would be addressed, as the Department was 98% behind on the registration of medicines. He wanted clarity on this matter.
Mr Mseleku stated that the backlog did not have anything to do with the current legislation. Even if the Department wanted to intervene right at this point they could not. He could not go to the MCC and demand that they push their backlog and the MCC could not go to the experts and demand that they finish their research, as they were still busy with other things. It was difficult for the Department to account for the timeframes that the MCC were using. They could not assure the Committee that the backlog would be eliminated within two years. The MCC could make quick decisions but what happened once the issue went to the experts, was another matter.
Ms M Matsemela (ANC) stated that her question was based on the National Health Act (NHA). Section 36 of the Act spoke of Certificates of Need. She wanted to know if the restructuring that the Department was talking about would have an impact on this clause. How would the restructuring impact on pharmaceutical companies? The Department had said that this authority would operate as an agency. She wanted to know if this would conflict with Section 91 of the NHA.
Mr Mseleku assured them that the body that the Department was implementing would not impact on any of the provisions in the NHA. In terms of Certificates of Need, this was an issue that was not yet promulgated in the NHA. The Agency Bill largely determined where the need would be for pharmaceutical companies and pharmacies. This body would register the medicines that the pharmacies would need. Therefore, the process of registration could impact on businesses. The larger issue at hand was the type of national health insurance that the country would have. This would impact on Certificates of Need and other issues. Pharmaceutical companies wanted more transparency from the Department; they wanted the Department to unpack things that would be taken in to consideration by the Minister in terms of public interest issues so that they could prepare themselves.
Mr M Sibuyana (ANC) was concerned that the Department seemed to create many structures that needed a lot of funding. He wanted to know how the Department was going to acquire funding for the structures. He referred to the Minister and independent structures. He wondered if the Minister would have enough power to question accountability and “fix” responsibility in cases where there was misconduct and related matters.
Mr Mseleku stated that the Department was already funding the structure through the Department’s chief directorate. The Department did not expect the funds that would resource the structure to be more than that expected during adjustments in the budget process. The body was also expected to work on a cost-recovery basis. In other words, the structure would have to charge higher fees than they were charging now for registration of medicines. The industry would be willing to pay more in order to gain the efficiency benefits that the Department had outlined. The structure was self-financing in a way.
In terms of accountability and responsibility, this was the oversight role that the Minister had to play on the administration side.
Ms M Manana (ANC) wanted more clarity on certification and registration of medicines. She wanted to understand whether the Department was expected to pay a fee during the certification process in order to receive a certificate and if they were expected to pay another fee during registration.
Mr Mseleku replied that there was only one fee that would be paid to the body that would handle certification and registration of medicines and scientific work. Although certification and registration were recorded as two separate stages, they should actually occur at the same time.
Ms Mashigo addressed the importation of international medicines. She wondered if the international medicine regulations would be adjusted according to South Africa’s situation or if the regulations would stand according to patents and laws from wherever the medicine was imported.
Mr Mseleku replied that, regardless of whether the medicine was registered elsewhere in the world, a submission had to be made in South Africa if you wanted to register the product in the country. The product would be put through certain processes in order to be registered in the country. This Bill did not prevent bodies from entering in to agreements with other countries. The Bill allowed countries to share information about products.
Dr R Rabinowitz (IFP) noted that the Department’s presentation had spoken about “products”. This was very vague. She asked how the Department differentiated between different products. She also wanted clarity on the complementary health matter.
Mr Mseleku stated that the complexities that Dr Rabinowitz referred to were there currently. The Department merely wanted to create a structure that went beyond medicine and medical devices. It looked at health products, including food and other health related products. The new body would be responsible for regulating all these products. The regulations of the Bill would further clarify how medicines and medical claims would be determined, as there quite a number of complexities involved. For example, an X-ray machine was a health product yet the radiation authority regulated it. The Department’s food section currently determined if something qualified as a food or a vitamin. To qualify as a food, a product had to contain a certain amount of milligrams of a vitamin. The product then had to be registered. One had to look at the quantity involved; this could determine if a product qualified as a food. This was not an issue that one could legislate on. You could allow experts to determine where the parameters were and in the future these parameters could be changed. The law, however, did not attempt to make these definitions and distinctions.
Dr Rabinowitz stated that she was not convinced with the explanation, as there was more than ten years invested in this subject. Professor Ronald Green-Thompson, Special Adviser to the DoH, had conducted a great deal of research and there was a very big, costly ministerial task team set up to establish parameters for differentiations. If the body was to be restructured so that it became more efficient, it was important to create clear frameworks on the limits and categories of products. If the Department wanted efficiency and accountability then these issues were to be clearer. There had to be a framework in which issues could be tackled.
Ms Rabinowitz addressed Prof Green-Thompson noting that he had written the Report on these issues. She asked if these issues were incorporated into the legislation.
The Chairperson thought that Members were debating two different issues. The Report that Ms Rabinowitz was referring to looked at an agency, a single authority that would cover all of the issues that were mentioned including all medicinal claims and foodstuffs. The Report, however did not say how a line would be drawn in terms of distinguishing between a food that did not make medicinal claims and a food that made medicinal claims. This could not be done in law. Research and analysis had to decide this. Once it was agreed upon that a food qualified as a medicine, the food was to be registered and certified. The body would be responsible for the registration of complementary medicines.
Mr Waters stated that Mr Mseleku had mentioned two points where the Report differed from what was being recommended. The first was that the Minister had the ultimate say over which medicines could be registered. He asked the Department to brief the Committee on what the Report said. The second variance was about the independence of the MCC. He wanted to know what the Report said about the issue and if they agreed that there should be an agency or a state owned enterprise.
The Chairperson stated that one of the slides in the Department presentation alluded to the findings of the Report itself. He suggested that the Department prepare a short presentation to brief them on the findings in Professor Green-Thompson’s Report. Members could interact with the Department the following week. The matter at hand was the role of the MCC and the authority versus the role of the Minister. The efficiency of the current body had been decreasing over the past few years. Now, in order to improve the efficiencies within the Department, another tier was being included. The Chairperson was not sure how an extra tier would improve matters, as nobody had explained it to the Committee. Furthermore there was no convincing argument for the role of the Minister to register a medicine that was tested a body of scientists. The Minister may decide in the public interest whether or not to register a particular medicine. This “public interest” was not defined. This was a matter that the Committee needed to interact with quite carefully. The Chairperson suggested that the Committee leave the matter for now and wait for the public submissions on the Bill.
Mr Mseleku agreed with the Chairperson. He wanted to assist the Members by referring them to the relevant clause in the legislation that tried to define the issues. He referred the Committee Clause 7 which amended Section 7(4)(d) of the legislation. It stated that when it was in the public interest to register a product, the Minister would take certain issues into account such as economic interests, public health interests, whether the product supported national health policies and goals in the long term, and whether products were likely to improve health care.
Mr Anban Pillay, Cluster Manager for Health Economics in the DoH, stated that he had spent four years in the Australian regulatory authority where he was responsible for the registration of medicines. In the Australian system, they had to report to the Minister of Health. For example, they had assessed Viagra, and it was found that it was not in the public’s interest, as there were more pressing issues on which to spend public funds. These were the kinds of issues that were not peculiar to South Africa.
The Chairperson stated that he was not convinced by the Department’s explanations. He was not convinced that the country needed the Minister to approve the registration of medicines. The Committee and the Department would have to come back to this particular issue.
Mr Waters pointed out that in the Australian example, there was a team of advisers advising the Minister. Here, it would just be the Minister making decisions on her own.
The Chairperson stated that the Department was to look at how the Bill related to the Foodstuffs, Cosmetics and Disinfectants legislation, especially with regard to the definition of medicines. He also noted that there was a problem with the clause that spoke about certification and registration. Certification was defined but registration was not.
The Committee looked over the Draft Hearings Programme for the 5 and 6 August.
Mr M Waters was concerned about how late the public hearings would end. The programme showed that there was a day that Members would be listening to submissions for 12 hours. Experience showed that this would result in “information overload” and Members would not give the last five or six presentations their full attention. Also, it was not guaranteed that there would be decorum right until the end of the submissions. He wondered if the Committee could span the public hearings over three or four days rather than over two.
The Chair suggested that the programme be adjusted to span over three days, as there was no rush to finish the public hearings over two days.
The Members agreed. The Committee programme would be amended.
The meeting was adjourned.
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