Medicines and Related Substances Amendment Bill Departmental briefing
03 September 2014
Chairperson: Ms M Dunjwa (ANC)
The Department of Health and the Medicines Control Council (MCC) briefed the Committee on the Medicines and Related Substances Amendment Bill. Currently, the legislation applicable in South Africa was the Medicines and Related Substances Act of 1965, although an Amendment Act 72 of 2008 had been approved, but had not been implemented, and the current Bill sought to address ambiguities in relation to both pieces of legislation, particularly those around poor regulation that had led to excessively high medical demands. Although the Medicines Control Council had been set up and operating between 2008 to 2014, its administration and business practices were unable to accommodate these issues properly, and it was not able to meet adequately the effective business standards set by the World Health Organisation’s 1999 Effective Regulation Act. Current challenges with regulation in complementary medicines, alternative medicines, African Traditional medicines, in vitro diagnostics, food, cosmetics, and blood products were identified as needing more attention. The amendments now being proposed would enhance management efficiency and provide more regulation in areas where this was currently lacking.
The Bill envisaged that the current MCC would be replaced by a new body, the South African Health Products Regulatory Authority (SAHPRA), and the current MCC Advisory Committee would be replaced by a separate Board and a Chief Executive Officer. Efforts to consolidate had been made already, under Memorandums of Understanding and other business practices with outside entities. For this reason, the Bill had now been drafted to improve business practices and resolve concerns around the 2008 Amendment Act, by building relationships and transitioning the MCC into the South African Health Products Regulatory Authority (SAHPRA), which would be more efficient, would operate as a Schedule 3A Public Entity, with the Board overseeing and approving SAHPRA’s policies, plans, financial statements, performance, and committees, whilst the CEO would have the ability to appoint committees and publish information on specific websites. A more simplified appeals process would be instituted, and relationships with stakeholders in and outside South Africa would help to achieve effective resource use, staff expertise, and good business practices. Some transitional steps had already been taken and it was intended that the new structure would be staffed by around 250 staff, and 25 academics had already begun training. An institute to provide further training was being developed. Draft regulations and resolutions had been published for public comment. Although it was noted that the cost of implementing the Bill would be quite high, and would include hiring expertise and maximizing scientific research, the investment would be justified.
Members commended the Department’s efforts on the Bill, but needed more clarity whether the new body was merely to analyse material, or also to assess the effects on recipients, questioned which entities would be covered by the Bill, and the benefits of the new institute. They were interested in how long the transitional arrangements would take, how the Bill would be enforced, how conflicts of interest could be avoided, and the composition of the entity and how in-house capacity would be enhanced. More information was requested on the costs, time frames, and the extent of the backlog for applications as well as the precise limitations on jurisdiction, the ability and capacity to enforce the law, and whether specific devices did not need to be named, particularly indigenous medicines and how they would be regulated.
Members adopted minutes from a previous meeting.
Medicines and Related Substances Amendment Bill [B62 – 2014]: Department of Health briefing
Dr Anban Pillay, Deputy Director-General, Department of Health, tendered an apology for the Director General and the Minister of Health, and introduced the delegation, which included officials from the Ministry of Health and the Chief Executive Officer of Learn, Develop, Achieve. The amendments being effected by the Bill were aimed at improving the efficacy and safety of medicines in South Africa, so that hospitals, doctors’ offices, and pharmacies could distribute reliable medication.
Ms Mandisa Hela, Chief Director and Registrar, Medicines Control Council, provided some background to the Medicines Control Council (the MCC), outlining its framework, mandate, and history from 2008 to 2014, specifically referring to the National Drug Policy and the Medicines and Related Substances Act of 1965. She noted that the MCC currently had jurisdiction over medical and related substances, and bore the obligation to respond to safety and quality issues in a timely manner (see attached document for further details).
She explained that the Medicines and Related Substances Amendment Bill sought to amend the Medicines and Related Substances Act of 1965, and further addressed certain issues in the approved, but not yet implemented, Amendment Act 72 of 2008. Act 72 of 2008 had emphasised pro-access qualities such as forced admission and transparency prices, and the result was high demand, which in turn led to a backlog and an increase in both generic medication supplies and hospital lines. South Africa’s medical field relied heavily on foreign medical professionals, and it was difficult to supply such a heavy demand. It was indicated that little to no regulation existed in the scope of complementary medicines, alternative medicines, African Traditional medicines, in vitro diagnostics, food, cosmetics, and blood products. Finally, it was explained that, owing to challenges with finances, human resources, transparency, policy, legislation, and regulation, the MCC was unable to meet adequately the standards set by the World Health Organization (WHO) 1999 Effective Regulation Act (see attached document).
For this reason, the Bill had now been drafted to improve business practices and resolve concerns around the 2008 Amendment Act, by building relationships and transitioning the MCC into the South African Health Products Regulatory Authority (SAHPRA). Currently, the MCC had inefficient organisational components, which included a multiplicity of special committees for specific issues, and six-week long decision-making periods, as more clearly explained in the chart describing the Medicines Control Council and Expert Committees. The new SAHPRA would become a Schedule 3A Public Entity, which she explained would operate within the public administration but outside the public service. A Board and a Chief Executive Officer (CEO) would replace the existing Advisory Committee. The Board would have the power to oversee and approve SAHPRA’s policies, plans, financial statements, performance, and committees. The CEO would be able to appoint committees and publish information on specific websites. More consolidation efforts, such as a more simplified appeals process, would also be put into place. Relationship building would be achieved through Memorandums of Understanding and establishment of other relations with outside academics, government departments, and international entities that would increase effective resource use, staff expertise, and good business practices. Overall, the new structure was intended to bridge the gaps that had led to inefficiency, and enhance overall scientific advancement, law enforcement, administrative management, and regulation scope (refer to document).
She noted that there were already some transitional activities under way. There would be about 200 to 250 full-time equivalent start when the new institution was set up. Twenty-five academics had begun training and an institute to provide further training was being developed. A period for comment had already been opened up on the draft resolutions for the regulation of medical devices and in vitro diagnostics. Regulations for Complementary and Alternative Medicines had also been published and phased implementation had begun.
Ms Hela noted that the costs associated with the Amendment Bill, including hiring expertise and maximizing scientific research, would be quite high, but the investment would be justified by the end results.
The Chairperson asked Members to pose any questions of clarity.
Mr P Maesela (ANC) commended the National Department of Health’s efforts on the Bill. However, he noted that it was not quite clear whether the role of the MCC would be merely to analyse the material, or whether it had to assess the effect it would have on the targeted recipient. It was also unclear which entities would be covered by the Amendment Bill. Lastly, he raised a question regarding the benefit of utilising teaching institutes that aimed to prevent diseases before they spread, instead of putting more funding into treating the numerous ill patients.
Ms C Ncube-Ndaba (ANC) asked how long the transitional arrangements would take and how the Bill would be enforced.
Mr I Mosala (ANC) questioned how the Amendment Bill dealt with conflicts of interest, especially at an entry point. He wanted more detail on whether the new body was a public or private entity and how it would operate.
Mr H Volmink (DA) asked how the Amendment Bill enhanced in-house capacity, in relation to the regulatory mandate. He needed more information on the cost evaluation, the time frames, the backlog for applications, with the suggested solution and costs projection.
Dr W James (DA) insisted that geo-economics and development of regulating mechanisms were expensive, and it was difficult to manage the necessary budget with state funding. He noted that there had been mention, in the presentation, of food safety and health regulation, but the precise limitation on jurisdiction was not covered.
The Chairperson wanted clarity about the law enforcement officers’ ability and capacity to enforce the law. Medicines being sold at street markets were one example of poor regulation. There should be a plan for regulation. Also, she suggested that the specific devices being referred to should be named, because there were various types of devices which could be covered. Clear examples of indigenous medicines that were intended to be regulated, and how they would be regulated, should also be given.
Dr Pillay replied that the Amendment Bill intended to create a Commission to deal with the MCC functions holistically. In relation to food control, he said that both regulation and behavior management were important. Although SAHPRA would be mainly concerned with regulation, the two areas were interconnected. Because the new body would be a public entity, there would be strict regulation around conflicts of interests and Board management policies. The new entity arrangement would be more efficient because the MCC currently did not have the ability that the SAHPRA would, to deploy funding to hire expensive experts, but it would be able to avoid incurring some fees. Devices were purchased by the MCC for testing, but because the general public could also import other devices into the country for sale, the devices varied in quality. He pointed out that there was a need to test the devices and machines because markets often sold unsafe and unreliable devices.
Ms M Hela emphasised that safety was the main priority, and for this reason the data from the trials and tests would be analysed, and later used to try to anticipate possible risky impacts on the population, and from this point, targeted areas and risk management plans would then be developed. Unfortunately, the risk and benefit analysis involved subjective questions. The two levels of the peer-review process and other efforts that were being explored could limit subjectivity. Quality was another important aspect. The molecular structure and characteristics of chemicals were of particular interest. She pointed out that in relation to the in vitro testing, the inputs were needed for a much earlier stage.
Ms Hela noted that the “unnamed entities” comprised a variety of regulators that regulated the areas surrounding the country’s borders. Particular types of commodity would be determined by special types of entity. The Department of Health had been asked by Parliament to develop an action plan establishing an Institute. This would help manage the challenge of teaching others, although it would still be complicated. The need for regulations and considerations around the budget understandably delayed the passing of the Amendment Bill, but the Department could not actually give any more specific time-frames until the legislation was passed. There had already been efforts to speed up the process. She said that the transparency could be increased by identifying and communicating conflicts of interest. The application process would also be made more transparent.
She repeated that the cost associated with the Amendment Bill was quite high. Some of the areas would be independently economically sustainable and some areas would need to be supplemented by the public sector. Last year, the DoH had exceeded its R60 million budget, but this year, the budget may be more attainable. The framework for self-regulated and unregulated advertising of medicine was an issue that was currently under development, but the licensing powers had helped with regulated markets. The framework for the outlined devices was also still under development.
Mr Volmink said that his question about the backlogs had not yet been addressed.
Ms Hela responded that the backlog was estimated at about 2 900. There had been a request for funding put in to the National Treasury, but at present it took about two years for the brand-new employees to be certified. The MCC had managed to address some of the delays by more effectively using employees, but many of the problems could not be resolved without additional measures.
Dr Pillay spoke about the influx of generic medicines, and pointed out that although the original and generic products were both derived from the same active pharmaceutical ingredients, they had been reproduced and sold as two different products. Furthermore, manufacturers obtained these ingredients from a specific factory, usually a foreign factory. The MCC had to spend time and resources in separately identifying the generic medicines and inspecting these factories and products.
Ms Hela added that pharmaceuticals fell under universal laws and regulations. As access to these drugs became more restricted, the prices would rise. Registration would be done as quickly as possible. With the synthesis of the source, for generic medicines, a product was reproduced in an attempt to bring prices down.
The Chairperson thanked the Department for an interesting presentation and asked the Department to consider the submissions already received, and the new submissions that would be raised at a public hearing, prior to returning to brief the Committee again.
Consideration of minutes of previous meeting
Members adopted the minutes of its previous meeting.
The Chairperson reminded Members of the forthcoming meeting.
Ms C Ncube-Ndaba (ANC) spoke about the tragedy of a missing child that was recently reported by the media and other Members nodded their agreement.
The Chairperson thanked the Members for devoting their attention to relevant current events.
The meeting was adjourned.
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