South African Health Products Regulatory Authority 2019/20 Annual Report

Meeting report

The Chairperson welcomed the Members and the delegation from the South African Health Products Regulatory Authority (SAHPRA), which consisted of Prof Helen Rees, Chairperson of the Board of Directors, Ms Mandisa Hela, the Vice-Chairperson, Prof Craig Househam, Member of the Board, Mr Regardt Gouws, Chief Financial Officer, Ms Portia Nkambule, Chief Regulatory Officer, and Ms Tumi Semete, Chief Executive Officer.

The purpose of this virtual meeting was for the Committee to be briefed by SAHPRA on its annual report (AR). The second item on the agenda was for the Committee to be updated on the processes related to the National Health Insurance. The Committee also had to consider and adopt its outstanding minutes from the previous meeting of 10 March.

He thanked the delegation from the SAHPRA for attending the meeting and requested that they share details regarding the use of Ivermectin with the Members. While the focus of the meeting was on the AR of the organisation, information regarding the Covid-19 vaccines and interventions must be shared with the people of South Africa, as this was truly relevant to the current situation within the country.

SAHPRA on its 2019/20 Annual Report

Opening remarks
Prof Helen Rees, Chairperson, SAHPRA, thanked the Committee for the opportunity to present the annual report. She said that the staff had excelled at their jobs during the COVID-19 pandemic. There was a high standard in place for laboratory diagnostics in the SAHPRA. The organisation had been extremely cautious and had endorsed COVID-19 tests that have been proved to be effective and of high quality.

She said South Africa was in a global race, competing to acquire vaccines. SAHPRA was in negotiations for vaccine purchases, which was an incredibly competitive space because of the demand for vaccines. South Africa was in a vulnerable position having to compete with wealthier countries which were purchasing more vaccines than was necessary. These countries purchased enough vaccines to immunise its entire populations, preventing other countries from receiving any vaccines at all. The amount of vaccines that had made it past clinical trials showed a remarkable feat of science, but the variants of COVID-19 remained a concern. The global view was that all the effective vaccines for the original variant of COVID-19 would prevent serious diseases, although it would not be equally effective against other variants.

It was widely recognised at the start of the COVID-19 pandemic, that there had to be medicine and drugs available to treat patients with mild, moderate and severe diseases. This included the end-stage diseases, where patients were on ventilators and in intensive care units. It was quite difficult to create a new drug, and instead, thousands of existing drugs had been evaluated for use relating to the COVID-19 pandemic. This evaluation included an assessment of anti-viral, anti-malaria and anti-inflammatory drugs. The first step was to look to laboratories to establish whether these medicines could be used against the COVID-19 pandemic, and clinical trials were conducted for medicines that showed promise.

Ivermectin was one of the drugs that had showed promise for use against COVID-19. A number of clinical trials showed that Ivermectin could have an impact on the COVID-19-virus. However, a study from Columbia showed that there was no impact at all, and this study was better designed and had used a larger sample.

The SAHPRA could not endorse any viewpoint on whether Ivermectin worked, because the regulator did not have enough data to confidently state that Ivermectin had or did not have an effect.

Executive summary

Ms Tumi Semete, Chief Executive Officer (CEO), said the annual report covered the organisation’s second financial year, since its establishment in February 2019. The mandate of SAHPRA was to deliver critical public health services, while balancing the process of change. A new business model and organogram to support growth towards a globally benchmarked health product regulatory authority had been implemented. SAHPRA’s CEO had been appointed in January 2020, and the late appointment had placed a strain on its ability to appoint other incumbents into critical posts more timeously. The state of transition had affected the delivery of outputs, but it was invested in ensuring a long-term improvement in systems and operations. The memorandum of understanding (MoU) between the National Department of Health (NDoH) and SAHPRA to provide critical support was hampered by ongoing labour actions in the NDoH.

Impact of COVID-19 pandemic:

SAHPRA had established a COVID-19 task team, and the implementation of a business continuity plan enabled a remote access work arrangement.

In response to the COVID-19 pandemic, the work of SAHPRA had focused on the regulation of the importation and manufacture of personal protective equipment, the registration of medical device test kits, the registration of COVID-19 related medication, and the timeous approval of vaccine clinical trials. Some of the positive business information technology solutions included the establishment of a fully online submission process for all applications, the implementation of remote access work tools, and the enhanced utilisation of cloud-based services. There had been a reduction in revenue generated from fees owing to fewer applications received than anticipated.

Overall SAHPRA performance

The overall performance of the SAHPRA was that 16 out of 28 (57%) key performance indicators were met, seven (25%) key performance indicators were partially met, and five were not met (18%).

Programme One: Leadership and Support

Three out of eight performance indicators were met, two performance indicators were not met, and three performance indicators were partially met. In building the capacity of the SAHPRA, 110 positions were advertised, of which 85 were for permanent positions. The regulator had also approved and implemented the enterprise risk management framework to manage the risk of the entity, and the COVID-19 business continuity plan was developed and implemented. The information technology (IT) governance policies and strategies were approved and implemented. A focus was placed on building the SAHPRA’s internal and external stakeholder relationships to enhance its operations.

For the financial year under review, the SAHPRA received a qualified audit finding due to the inability to provide sufficient appropriate audit evidence for deferred income and fee income. Finance and supply chain policy standards were enforced, and the service fee structures were revised to align to global trends.

Programme Two: Authorisation Management

All four performance indicators were met. The purpose of this programme was to coordinate the process of registration or licensing or amendment of applications in respect of medicines within a legislative framework that defined the requirements necessary for application to SAHPRA; to receive, record and distribute all documents submitted; and to manage and maintain the regulator’s main registry.

SAHPRA had inherited a backlog of over 16 100 medicine applications. Several initiatives had been introduced to address the backlog, including the optimisation of processes and efficiencies, and the implementation of the reliance and recognition pathways. The regulatory compliance unit was not fully capacitated, but was able to issue 3 819 narcotic, psychotropic and Schedules 5 and 6 import and export permits. The adoption of online submissions for medicine registration had reduced the manual burden and improved document management. All 262 medicine certificates were issued, with 241 were issued within the desired seven-day period.

Programme Three: Inspectorate and Regulatory Compliance

One of the four performance indicators had been met, two indicators were partially met, and one was not met at all. The purpose of this programme was to ensure public access to safe health products through inspections and regulatory compliance. The focus of this programme included assessments of site compliance, with good regulatory and vigilance practices. This programme supported both the backlog clearance project and the Business-As-Usual for all inspections.

The regulator had prioritised cannabis advocacy and remained committed to establishing the cannabis regulation framework. Inspections conducted included 171 quality guidelines and regulations (GXP) inspections and reliance reviews, and 48 inspections of permit holders of narcotic and psychotropic substances, including cannabis. In total, 86 investigations were completed, and 12 had resulted in convictions.

Programme Four: Medicine Evaluation and Registration

Five of the six performance indicators were met, and one was partially met. This programme had to evaluate the safety, quality and therapeutic efficacy of medicines and register them for use in terms of relevant legislation as listed in the legal mandate. This programme fulfilled the greater part of the SAHPRA’s core mandate.

Extensive re-engineering and digitisation was undertaken, which included the development of new policies that would permit applying for recognition and reliance, a focus on building technical in-house capacity, the introduction of an online adverse event reporting portal, and an increased focus on building in-house technical skills. The SAHPRA’s achievements in this regard included 140 clinical trials being reviewed, 980 clinical trials amendments evaluated, 16 936 applications for the sale of unregistered health products, and 5 158 adverse drug reaction reports being processed. Progress was made towards developing a new vigilance framework.

Programme Five: Medical Devices, Diagnostics and Radiation Control

Three of the six key performance indicators were met, while one was partially met, and two key performance indicators were not met at all. Regarding medical devices, the purpose was to implement and strengthen the regulatory oversight of medical devices through the development and maintenance of relevant regulations and guidelines. Regarding radiation control, the purpose was to evaluate and register non-ionising radiation emitting devices and radioactive nuclides efficiently, effectively, and ethically. Medical device regulation and radiation control were new functional areas.

SAHPRA had engaged with the National Nuclear Regulator and the Department of Mineral Resources and Energy (DMRE) on the development of a framework to ensure co-regulation of the radiation control function. The regulator had adopted a phased approach to implementing the medical device regulation framework to align with the World Health Organisation’s (WHO’s) global model regulatory framework. The achievements included issuing 916 licences for medical device establishment, 1 695 for radionuclides, and 1 623 for non-ionising radiation emitting devices.

Report from Auditor-General of South Africa (AGSA)

SAHPRA had received a qualified audit finding from AGSA. The progress made and challenges experienced by the regulator included a reduction of one qualification and four procurement and non-compliance issues. Problems included the inability to retrieve source documents (historical hard copies) required for accurate reporting, incomplete listings and source documents due changes in the sourcing and storing of information (hardcopies compared to softcopies), and the fact that the supply chain management (SCM) unit was outsourced for most of the financial year under review.

Conclusion

Ms Semete said SAHPRA had made good strides since its inception to establish a strong, efficient and responsive regulator. The implementation of re-engineering systems and processes had led to some gains, but, significant improvement was still required.

In an effort to improve performance against its key performance indicators, SAHPRA anticipated that the following measures already in process would mitigate the areas of underperformance:

• Defining key performance indicators as per SMART (specific, measurable, achievable, relevant and time-bound) principles;
• Continued capacitation and resourcing;
• The implementation of systems to support efficient data management;
• The tracking of performance information and implementation of quality management systems; and
• Improved outputs through efficient implementation of the re-engineered processes.

Discussion

The Chairperson thanked SAHPRA for the clear and comprehensive briefing. He said that the information presented had been simple and straight-forward.

Mr A Shaik Emam (NFP) expressed his disappointment that the regulator had obtained a qualified opinion in its audit report. What had happened to the investigation from 2019 by the Special Investigating Unit (SIU) that had been put in place by the President relating to maladministration, looting, and corruption within SAHPRA? He asked whether receiving funding by institutions, such as the Bill Gates Foundation, did not amount to a form of state-capture. These funders had an interest in the work that the SAHPRA did. Was it ethical to accept funding from these funders? How did this influence the regulator’s objectivity and impartiality? There seemed to be a surplus of funding within SAHPRA, making it problematic to take additional funding from private funders.

SAHPRA was the regulating authority that had the authority to register health products in South Africa. The entity had been caught wanting in the situation that personal protective equipment (PPE) that had been approved by the SAHPRA, had been shown to be sub-standard and not effective. This had caused COVID-19 infections and the death of healthcare workers. Why had the SAHPRA not opened criminal charges against its manufacturers in this regard? Why had Prof Lees had not bothered to respond to an expert from the WHO regarding developments that could have saved lives?

He asked whether the SAHPRA had benefited financially from any of the pharmaceutical giants in the world, and whether it had had an impact on its response to addressing the issues related to Ivermectin. What had now changed SAHPRA’s mind regarding authorising Ivermectin? Had any person within SAHPRA received any funding from any institution that may have influenced its decisions? The WHO had stated very clearly that Ivermectin could be effective. Why had the NDoH and SAHPRA been so reluctant?

Mr P Van Staden (FF+) referred to the backlog of over 16 100 medicine applications. He asked for clarity regarding the SAHPRA’s timeline to eliminate the backlog, and why the backlog had arisen in the first place. When SAHPRA appeared before the Committee in 2019, the Members had commended it for its performance, which made it worrisome that the regulator had obtained a qualified audit from AGSA. What were the specific reasons that the entity had not obtained an unqualified audit opinion? What measures had been put in place to ensure that the entity received an unqualified audit in the next financial year?

Regarding the vaccines, he asked Prof Lees for her opinion on whether South Africa had the necessary facilities to store the acquired vaccines at the required temperatures. Had the same methods applied to assessing Ivermectin been applied in the evaluation of the vaccines that were being rolled out in the country? Why could South Africa not work towards creating its own locally produced vaccines? What was the view of SAHPRA regarding the additional doses of vaccines sent from the WHO which were not as effective against the South African variant?

Ms S Gwarube (DA) also expressed concern that the regulator had obtained a qualified audit from the AGSA. It seemed as though the issue involved the lack of records management and ineffective operating systems. These were fundamental problems that could be easily fixed.

She asked for clarity on why the appointment of the CEO had been delayed. On the key performance indicators, there was a crucial issue within SAHPRA, given that only 57% of the targets were met. While the Committee could appreciate that SAHPRA had been established for only a few years, it was problematic that easy-to-achieve targets had not been fully realised. The audit opinions of the AGSA were well established to be an indicator of whether the SAHPRA was a well-run entity.

She requested a list of the applications made to the SAHPRA for the registration of vaccines and the status of each of these applications. The SAHPRA had started to communicate more to the public, but there were still work that must be done. Members got public queries regarding the approval of health products, and the SAHPRA should be more communicative and actively engage with the public on what clinical trials were in progress, and why certain medicines were approved while others were not. An improved public communication strategy must be made a priority of the SAHPRA. Referring to the vaccine updates, she asked for clarity on the Johnson and Johnson (J&J) vaccine and clinical trials. At what point would the J&J vaccine stop being a clinical trial, and be rolled out as a certified vaccine? Did this mean that every approved vaccine must go through the same trial?

Dr S Thembekwayo (EFF) said that when the J&J vaccine was rolled out in South Africa, there had been no mention of a third stage in the clinical trials. It seemed as if the strict approval guidelines were not applicable to Johnson and Johnson. What were the reasons that the senior human resources (HR) position was not filled?

Regarding the key performance indicators, it was clear that there was a lack of resolute HR personnel, which was highly problematic. This would directly impact on the performance of the SAHPRA. Regarding the lack of records management and ineffective operating systems, she asked what measures had been put in place to rectify this situation. The material misstatements made in the audit must be addressed, and SAHPRA needed to submit a coherent plan on how this situation would be corrected.

Ms N Chirwa (EFF) asked whether there was a clinical trial protocol regarding the number of participants that could be included in a vaccine trial. Had these protocols been implemented in the current vaccine trials? What were the criteria for approving a vaccine? What had prevented the approval of the J&J vaccine? Had SAHPRA or any of its personnel ever complained of political influence in the vaccine trials? What was SAHPRA’s view regarding the NDoH purchasing vaccine doses that had been intended for research purposes? Had there been any reported adverse side-effects from the J&J vaccine, and what were the consequences?

Ms A Gela (ANC) appreciated the work and the briefing given by the SAHPRA, especially in the challenging conditions of the COVID-19 pandemic. She commended the entity for filling the senior vacancies in the organisation. It remained worrisome that it had obtained a qualified opinion, with serious findings being made by the AGSA. How would these findings be addressed? What measures were being put in place to ensure that SAHPRA obtained an unqualified audit in the next financial year? When would its approved organogram be fully capacitated, and what was its current staff complement? Had the SAHPRA experienced any other issues relating to corruption, maladministration, or procurement issues?

Ms H Ismail (DA) asked what the requirements were that were necessary for Ivermectin to be more readily available to the public. How much data had SAHPRA gathered regarding the effects of Ivermectin? It was a conflict of interest that SAHPRA was receiving funding by institutions, such as the Bill Gates Foundation. It was concerning that South Africa might be moving towards another incident of state-capture. The task of SAHPRA was to ensure that the vaccines that the country used were safe and effective. On what basis were the vaccines procured? The Committee needed clarity on how the vaccine clinical trials were being conducted.

How was the senior management of SAHPRA appointed, and what were the average years of experience? She agreed with Ms Gela it was worrisome that SAHPRA had obtained a qualified opinion, with serious findings being made by AGSA. How would the findings be addressed? What consequence management measures had been implemented regarding the findings?

She asked the SAHPRA to update the Committee regarding the litigation amounting to R3.82 million ongoing against the entity, which had been lodged by a medical device company. How had the SAHPRA dealt with the corruption issues relating to the procurement of PPE?

Ms E Wilson (DA) agreed with the concerns regarding the qualified opinion and the key performance indicators that had not been met. She agreed that it was a conflict of interest that SAHPRA was receiving funding by institutions such as the Bill Gates Foundation. These types of funding were usually ring-fenced and intended for specific use. On what had the funding from the Bill Gates Foundation been spent, and what had been the consequences or results of the expenditure?

Mr M Sokatsha (ANC) asked whether the phased approach to filling vacancies had affected the service delivery of SAHPRA. More clarity was required on the internal and external stakeholders of the regulator.

Mr T Munyai (ANC) supported the annual report as presented by SAHPRA. He applauded the transparency of the regulator, and commended the work done by the entity. It was important that SAHPRA remained an independent regulatory body that was run by experienced professionals.

The Chairperson asked whether the public health sector had also benefited from the J&J vaccines that could be purchased from research sites.

SAHPRA’s responses

Prof Lees responded that SAHPRA would welcome the opportunity to appear before the Committee to explain its protocols surrounding vaccines and clinical trials. The task of SAHPRA was not to procure or make payments regarding health products and medicines, but to assure the country of the safety and efficacy of medicines. The consequences of an ineffective regulator were organised crime and serious health risks, and even a loss of lives. She assured Parliament that, under the watch of the Board of Directors, any illegal or corrupt activities would not be allowed to foster or thrive within the SAHPRA. There had been immediate action and consequences for such activities that had been reported.

She shared the disappointment of the Committee regarding SAHPRA obtaining a qualified audit opinion from the AGSA. SAHPRA had made good strides since its inception to establish a strong, efficient and responsive regulator, and to address the findings of the AGSA.

She said that the engagements with the SIU had arisen when it was reported that SAHPRA had two inspectors who had engaged in corrupt activity in the course of their work. These allegations were made by a whistle-blower, and SAHPRA had immediately instigated a report and reported the incident to the Minister of Health. It was SAHPRA that had reported the matter to the SIU, after starting its own investigations. There had been no response from the SIU, and SAHPRA continued to engage with the law enforcement agency to rapidly deal with these issues.

SAHPRA would welcome the opportunity to appear before the Committee to explain its protocols surrounding vaccines and clinical trials. She requested that SAHPRA be allowed to schedule a separate meeting to discuss these details with the Members. It evaluated a vaccine based on the data available from the laboratories which analysed the disease, and relied on animal models for the disease to give an indication on whether a vaccine would work in a human setting. No first phase studies had been done for any of the vaccines, which had mostly been conducted in countries in the northern hemisphere. With the J&J vaccine, the third stage studies were focused on comparing the effects of the vaccine in the groups of the participants to determine its efficacy. The number of participants in a clinical trial depended on the purpose of the clinical trial, and there were set protocols in place. SAHPRA continued to collect data regarding the safety and efficacy of the products that were rolled out to the public.

On the questions pertaining to Ivermectin, she responded that there was a lot of data surrounding this medicine. The individual trials were not strong in their quality, as the sizes were small, and the trials had not been well designed. She reiterated her previous comments that a study from Columbia showed that there was no impact at all, and this study was better designed and had used a larger sample. SAHPRA could not endorse any viewpoint on whether Ivermectin worked, because the regulator did not have enough data to confidently state that Ivermectin had or did not have an effect. SAHPRA would then allow off-label use by individual medical practitioners, who had to take responsibility when it was prescribed. However, Ivermectin remained an unregistered product and there was not enough data to sustain the idea that it was effective.

She added that South Africa had the ultra-cool storage facilities available to store the COVID-19 vaccines, but the NDoH was responsible for the storage.

The backlog had been inherited from the Medicines Control Council which had gone unaddressed because of the unsustainable process that was in place to deal with only paper-based applications.

Ms Hela, Board Vice-Chairperson, agreed with Prof Lees, saying that the Medicines Control Council did not have the capacity to respond to the high number of applications received. There were also significant financial constraints in this regard, alongside structural issues.

Ms Semete referred to the investigations by the SIU, and said that the investigation had started only in February, with a slow pace of progress being made.

Regarding the funding received by SAHPRA, the funding from the Bill Gates Foundation was intended to resolve the backlog in medical applications. The funding received was used only for the backlog project and its interrelated activities. This showed that SAHPRA remained underfunded. The funding constraints of SAHPRA, arising from limited budgets allocated by the National Treasury, had caused the entity to seek the help of philanthropic entities around the world for the funding of a wide range of research activities. It had in no other way of benefiting from these types of funding, besides the support for the backlog project.

She agreed with Prof Lees that the SAHPRA would welcome an opportunity to appear before the Committee to explain its protocols surrounding vaccines and clinical trials, relevant to the questions asked by the Members.

Mr Regardt Gouws, SAHPRA CFO, responded that the reasons for the qualified audit opinion obtained related to record management and operational efficacy. SAHPRA had a comprehensive audit action plan in place to remedy the findings made by AGSA.

COVID-19 vaccines update

Ms Nkambule, SAHPRA’s Chief Regulatory Officer, said that the most advanced vaccines that were being developed included those of Astra-Zeneca, Pfizer, Sinovac, Sputnik, Moderna and Johnson and Johnson. The SAHPRA had had various pre-meetings with vaccine providers since November 2020 to review its applications and roll-out plans.

A rigorous review process regarding vaccines was implemented by SAHPRA. Its experts, with extensive knowledge and expertise, were part of the review committee. Extensive collaboration with other regulatory authorities with which SAHPRA aligned itself, as well as the WHO, was ongoing.

Discussion

Mr Shaik Emam reminded the SAHPRA delegation that some of the questions asked by the Members had not been answered. There had been no response on the poor quality of PPE approved by SAHPRA, and no response on why it was only now seeming to change its mind regarding Ivermectin. He asked whether the entity agreed that Ivermectin was one of the safest drugs in use, with no serious side-effects. Would it not be prudent to allow the use of Ivermectin, despite doubts on its efficacy relating to COVID-19, because there would be no serious side-effects? Had SAHPRA had benefited financially from any of the pharmaceutical giants in the world, and whether this had had an impact on SAHPRA’s response to address the issues related to Ivermectin. He restated his concern that it was a conflict of interest that SAHPRA accepted and used funding from the Bill Gates Foundation.

The Chairperson referred Mr Shaik Emam to the statement made by SAHPRA that it could not endorse any viewpoint on whether Ivermectin worked, because the regulator did not have enough data to confidently state that Ivermectin had or did not have an effect.

Mr Shaik Emam referred to various studies on the positive effects of Ivermectin. The question to the SAHPRA was how much more information was needed for the regulator to confirm that Ivermectin could have positive effects and could be used concurrently with other treatments to combat COVID-19 infections.

Ms Chirwa also reminded the SAHPRA delegation that some of the questions asked by the Members had not been answered. She restated her questions. Was there a clinical trial protocol regarding the number of participants that could be included in a vaccine trial? What had prevented the approval of the J&J vaccine? Had there been any reported adverse side-effects from the J&J vaccine, and what were their consequences? It was paramount that the Committee be provided with the necessary details on the questions asked by the Members.

The Chairperson asked the SAHPRA delegation to provide more clarity, and to submit a written response to these questions.

SAHPRA response

Prof Lees apologised for the questions that had not been sufficiently addressed. It was important that the SAHPRA, as a health regulator, was not selective on the evidence and data it used in reaching decisions. South Africa was competing with the rest of the world for vaccines, but SAHPRA had to ensure a level playing field. She said Ivermectin had been reviewed through two randomised clinical trials, and there were significant concerns raised regarding it effectiveness.

She presented the Members with the evidence review conducted by SAHPRA, and said that the documents would be forwarded to the Committee. It had adopted the standards from the WHO from the start to evaluate the COVID-19 tests that were used in the country.

Ms Nkambule said that SAHPRA had received 18 country-wide reports regarding adverse side effects, and had established that 12 of these reports did not pertain to COVID-19 vaccines. The remaining reports were under investigation, but the side-effects predominantly included allergic reactions.

Ivermectin

Ms Nkambule said that, as a regulator, SAHPRA could not give Ivermectin registration based on a lack of data, as no other regulator in the world had registered Ivermectin for use against COVID-19. The WHO had taken the same view as SAHPRA. In the meanwhile, Ivermectin that had been authorised for human use could be used. SAHPRA would allow off-label use by medical practitioners who must take responsibility when it was prescribed. However, Ivermectin remained an unregistered product, and there was not enough data to sustain the idea that it was effective.

Prof Lees concluded that Ivermectin was not indicated nor approved by the SAHPRA for use in humans. There was no confirmatory data on Ivermectin available as yet for its use in the management of COVID-19 infections. In terms of safety and efficacy there was no evidence to support the use of Ivermectin, and SAHPRA did not have any clinical trial evidence to justify its use. There had been no positive recommendations for the use of Ivermectin in the management of COVID-19 infections by any regulatory authority with which the SAHPRA had reliance agreements. The WHO did not currently recommend the use of Ivermectin for the treatment or prophylaxis of COVID-19 infections.

SAHPRA encouraged and supported all well-designed and ethically approved scientific studies. The regulator would continue to evaluate any emerging peer-reviewed publications or data on the use of Ivermectin for the treatment of COVID-19. The SAHPRA’s view on Ivermectin had not changed, as there was still insufficient data. According to the global clinical trials register, more data should become available in the next few months.

National Health Insurance

The second item on the agenda was for the Committee to be updated on the processes related to the National Health Insurance. This agenda item was deferred until another meeting of the Committee.

Consideration and adoption of outstanding minutes
The last item on the agenda was for the Committee to consider and adopt its outstanding minutes for its previous meetings. The minutes of the Committee’s meeting of 10 March 2021 were adopted, after Members had requested minor changes be made.

The meeting was adjourned.