SAMRC & SAHPRA 2022/23 Annual Performance Plans

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20 April 2022
Chairperson: Dr K Jacobs (ANC)
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Meeting Summary


SA Health Products Regulatory Authority

SA Medical Research Council

The Portfolio Committee on Health (the Committee) met virtually with the South African Medical Research Council (SAMRC) and the South African Health Products Regulatory Authority (SAHPRA) to receive briefings on their Annual Performance Plans (APPs) and budgets for the 2022/2023 financial year.

The SAMRC said despite the tight fiscal environment, the SAMRC delivered on impactful science and will continue to do so effectively and efficiently. The presentation covered the priorities per programme for the financial year under review. Regarding the budget, it said only critical new posts would be funded from the reduction in vacant posts. Priority should be given to projects which leverage funding at a rate of at least 1:1 when was funding available. COVID research will continue with significant investment over the MTEF. The SAMRC would continue to invest in infrastructure (buildings, IT and lab equipment) to facilitate high quality research outputs. The budgeted deficit of R18.9m in 2022/23 would be funded from reserves to maintain current contracted funding commitments.

The ensuing discussion by Members raised concerns regarding lessons learned and the response to the pandemic; demand for financial support by SAMRC; percentage of applicants awarded funding for research and academic learning; funding demographics and transformation; translating new knowledge into policies and practices; other income streams to increase SAMRC’s revenue base; scarce critical skills used; source of funding for infrastructure projects; breakthrough for various types of cancers in the country; representation of designated groups across occupation levels, specifically the HR transformation practices; gender and racial disparities in top management posts; progress on implementation of employment equity plan; lack of bio-statisticians; training capacity of SAMRC; Indigenous Knowledge Systems (IKS); lack of synergy between intramural research units; collaboration with National entities to enhance health research and innovation; persisting issue of neonatal deaths; Memorandum of Understanding (MOU) entered into with the National Institutes of Health (NIH) of America; capacity in which SAMRC is funding the NIH partnership; research on adverse effects of vaccination; investigation on the health of vaccinated persons; top 10 causes of death in South Africa; risk of diminishing funding by National Government increasing; decrease in accepted and published journals; how the sugar tax levied by National Government is used; programmes in place to mitigate diseases and assist in terms of treatment; mitigating the causes of mental health; maintaining research in terms of new COVID-19 variants; mRNA project’s role in increasing innovation and optimising on the potential of genomic medicine; intellectual property barriers to full operationalisation of an mRNA Hub; strategic alignment of SAMRC with the Department of Science and Innovation’s (DSI) decadal plan; increasing research and development investment; statistics and causes in terms of the increase in cancer, typhoid, and Parkinson’s disease; SAMRC’s position on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) waivers; and the development of a state pharmaceutical company and the partnership with SAMRC.

The SAHPRA took the Committee through its priorities for 2022/23. It said the majority of targets (70%) are focused on core business (Programme 2 – 5) and 30% are focused on the support services function (Programme 1). The number of targets increased by one compared to the 2021/22 financial year due to the need to include a target focusing on lot release.

The ensuing discussion by Members was around: COVID-19-related products processed, approved and rejected by SAHPRA and reasons thereof; claims from the COVID-19 vaccine injury no-fault compensation scheme and its process; adverse events following immunisation and reported cases; The Supreme Court of Appeal (SCA) ruling that regulations dealing with complementary medicines were invalid, its effect, and SAHPRA’s input; SAHPRA’s current business accommodation and premises and effect of lockdown; backlogs for the registration of medicine and plans to fast-track it; average waiting time and target for registration of products; allocation and decrease in SAHPRA’s budget, plans to mitigate it, and the impact on new technologies and innovations; vacancy rate and plans to fill vacancies; lack of capacity to deliver; World Health Organisation (WHO) maturity level targets; three pillars of implementing mandate; adjustment of ivermectin use based on available evidence; monitoring and adverse reports of adverse effects of vaccinated persons; alleged attempt by SAHPRA to shut down the Natural Health Products industry; SAHPRA’s intention in wanting to regulate natural medicines; lessons learned from the pandemic; systems or process improvement; enterprise architecture; Workplace Skills Plan (WSP); internal authorities with whom SAHPRA reached agreements; awareness on and response to illicit medicine products and expired medicines; IKS; inspectorate and regulatory compliance investigation reports, penalties, and compliance; monitoring and use of medical equipment brought into the country; extra support or resources from the Committee; revenue collection or projection for inspectorate regulations and compliance; development of performance indicators to reduce deferred revenue; training capacity and skill development contributions of SAHPRA; development of a State pharmaceutical company; and regulatory intervention to support domestically manufactured medicines and devices.

The Committee would endeavour to do everything in its power to get SAHPRA the support that it asked for. Further responses from the entities were to be provided to the Committee in writing. 

Meeting report

The Chairperson explained that the Committee was meeting to receive briefings from the SA Medical Research Council (SAMRC) and SA Health Products Regulatory Authority (SAHPRA) on their Annual Performance Plans (APPs) and budgets for the 2022/2023 financial year. He welcomed everyone to the meeting.

Apologies were noted along with those present from the Department of Health (DOH).

The Chairperson reminded everyone that the virtual meeting was deemed to be in the precinct of Parliament and therefore constituted a meeting of the Committee of the National Assembly (NA) for official purposes only. In addition to the rules of virtual sitting, the rules of the National Assembly including the rules of debate applied in a NA sitting.

SAMRC Annual Performance Plan 2022/2023

Prof Johnny Mahlangu, Chairperson, SAMRC, took Members through the presentation covering the areas of human resources and transformation strategy before moving onto the strategic focus of the entity for 2022/23. Priority areas included:

-Funding innovation

-Capacity development in health research

- Increase number of PhDs in the SAMRC

- Increase numbers of National Research Fund (NRF) Research Translation Open Science/Sourcerated scientist and improve ratings

-Data transfer/use/security

-Transformation, incl. Diversity Management

-Research Ethics and Integrity

-Maternal and child health

-Mental health

-Environmental health Research on efficacious HIV and TB Vaccines

-Investment in infrastructure development

Regarding the budget, it said only critical new posts would be funded from the reduction in vacant posts. Priority should be given to projects which leverage funding at a rate of at least 1:1 when was funding available. COVID research will continue with significant investment over the MTEF. The SAMRC would continue to invest in infrastructure (buildings, IT and lab equipment) to facilitate high quality research outputs. The budgeted deficit of R18.9m in 2022/23 would be funded from reserves to maintain current contracted funding commitments.

Financial overview: revenue

From 2018/19 to 2021/22:

-Total revenue increased by 5.1% on average

-Baseline grant increased by 10.9% on average due to project specific allocations, Sisonke and COVID 19 projects

-Sale of Goods and Services (Contract research funding) decreased by 2.1% on average

From 2022/23 to 2024/25:

-Total revenue projected to decrease by 0.3% on average due to decrease in baseline funding

-Baseline funding will decrease by 0.7% on average due to project specific funding for COVID not continuing

-Sale of goods and services (contract research funding) increased by 0.6% on average due to increase in COVID funded projects

Financial overview: expenditure

From 2018/19 to 2021/22:

-Total expenditure increased by 8.1% on average due to increase in baseline allocation

-Compensation of employees increased by 3.4% on average

-Goods and services increased by 9.8% on average

From 2022/23 to 2024/25:

-Total expenditure to decrease by 0.7% on average in line with lower income

-Compensation of employees to increase by 6.5% on average

-Spending on goods and services to decrease by 8.2% on average

22 key risks were identified across all five programmes, including regulatory compliance, COVID-19, quality of research output, transformation and diversity challenges, ability to sustainably grow funding, support for collaborative partnerships and platforms, limited research capacity, and research impact on strengthening policy and practice. Key achievements and highlights include: Sisonke vaccination; high demand for vaccination of healthcare workers; publicity around SAMRC’s response to COVID-19; Wastewater Surveillance & Research Programme Project; SAMRC Scientific Merit Awards; and meeting with International delegations.

(See the attached document for details.)


Ms A Gela (ANC) said that the coronavirus pandemic had illustrated the importance of research and development funding and support for innovation. What lessons has SAMRC learned through the pandemic experience? How can SAMRC sustain a higher level of impact as demonstrated by scientists in responding to the pandemic and other health needs? Programme Four was a critical programme for the Nation in building human capability and capacity and enabling sustainable development. What is the level of demand for financial support by SAMRC? What percentage of applicants get awarded funding for research and academic learning? The year 2020/2021 demonstrated a repeated increase in impact by SAMRC in all four output indicators of programme five, focusing on translating new knowledge into policies and practices to improve health. The current year and outer year were projected to be relatively constant. What support can enable SAMRC to increase its impact in this programme as this programme reflected the impact of research undertaken by it? What will the impact of the projected 0.3% decrease be in the total revenue in the MTEF? What other streams can SAMRC develop in order to increase its revenue base?

Ms H Ismail (DA) thanked SAMRC for the good work that it was doing. She asked SAMRC to advise what kind of scarce critical skills it used. Where is the R 55.7 Million funding required for the eight infrastructure projects going to be sourced from? She asked that SAMRC advise whether any bids had been approved for those major projects. To what extent has SAMRC traversed in finding a breakthrough for various types of cancers in the country?

Dr S Thembekwayo (EFF) had one question based on priority seeking the representation of designated groups across occupation levels, specifically the HR transformation practices. Furthermore, SAMRC expanded the definition of transformation to include past, present, and future. However, under staff profiles for 31 March 2022, specifically under top management, gender disparities still exist. In top management, there were only three black African males versus zero black African females. Why is it like this? When is SAMRC going to ensure that there is gender balance in top management posts?

Mr E Siwela (ANC) thanked SAMRC for its good work. What is the progress on the implementation of the employment equity plan? What challenges does SAMRC experience in relation to transformation? Noting the lack of biostatisticians within SAMRC, what is it doing to ensure that it develops biostatisticians? What is the training capacity of SAMRC? How many graduates are absorbed yearly? What research is SAMRC undertaking on IKS and its promotion? What are the causal factors of the lack of synergy between intramural research units? What are the factors contributing to the lack of exploitation of collaboration with National entities to enhance health research? Which entities are SAMRC currently collaborating with?

Ms N Chirwa (EFF) had seen in the document sent to the Committee by SAMRC that it had noted neonatal deaths as a persisting issue. Besides the usual issues with infrastructure, negligence, lack of HR and public health facilities, what is the other contributing factor to this persistent issue? Regarding the nature of the MOU that SAMRC had entered into with the NIH of America, what is benefitted from it? Why is it important? She asked because the NIH actually listed SAMRC as one of its top funders. Is or was SAMRC funding the NIH and then entered into an agreement? How is it possible that South Africa was funding America through SAMRC? She had seen that SAMRC had put down R45 million as the money being spent on the agreement with the NIH. How much is the NIH investing back into the partnership that SAMRC has with them?

The funding demographics were still not clicking, which was a persisting issue and she would thus be raising issues that had been raised before from 2019. It was important to raise the issues again because they were not being addressed properly. From 2019, what has been the increase in ratio in the number of black people that SAMRC was funding? What is the difference between 2019 and 2022 in terms of the percentage of black people being funded as compared to 2019? Subsequently, is SAMRC still funding more white people at a higher percentage than the ratio that it represented demographically? To say that SAMRC was funding 72% of black people and 20% of white people was still not justice. The Committee and SAMRC were in a country that required equity to fix the mistakes and crimes of the past that have still not been addressed. Equality would be 80% of funding going to black people. Equity, on the other hand, would require a much higher margin, and SAMRC was not reaching this particular margin even though the Committee had been raising it for the past three years. SAMRC representatives were about to exit in six months and had essentially failed in the current term to deal with the issue of transformation.

She said that SAMRC could just make these decisions and fund 80% minimum of black people or entities and fix the issue of top management. The last time, SAMRC reported that it had had a step-aside situation. What has the update been since 2019? How many people have stepped aside since 2019? The fact that SAMRC was still on almost 50% at top management and that it was still the case even today was honestly bad. These were issues that were raised in 2019 and there still was no tangible evidence that SAMRC was working hard to address the issue of transformation. Of all the entities in the Department, SAMRC was the worst performing entity when it came to transformation. What is the insistence? It was not as if SAMRC was telling the Committee new things – these were not new concerns or questions. Why was SAMRC not transforming the top management? There should not be anything peculiar about SAMRC because other entities were doing it – even outside of the Ministry of Health. Why is transformation such a hard thing? Why is there insistence on the part of SAMRC to keep the top management white in South Africa?

Lastly, on the adverse effects of vaccination according to SAMRC’s monitoring, what kind of depth does SAMRC apply to research the issue of adverse effects? What are the monitoring systems for this? Is this information only gathered through the reported cases that were reported to the SAMRC or is there a more in-depth and ongoing investigation and analysis of the health of persons who had been vaccinated? What have been the most common adverse effects in South Africa? How many people of the investigation, analysis or study was this based on? She asked that SAMRC also share the ratio concerning this.

The Chairperson requested that Members switch their cameras on.

Ms M Clarke (DA) said that there was a problem with data as Members’ bandwidths were so low at the moment that they were battling.

Ms Chirwa said that it was loadshedding and that there were network issues in the townships. These were ANC problems. Perhaps the Chairperson should ask the ANC government why it was not resolving these problems that were affecting Members’ work.

The Chairperson said that that was not what he had asked for.

Ms Chirwa said that if the Chairperson was going to ask manipulative questions, then he should expect manipulative answers. It was as simple as that.

Ms Chirwa told the Chairperson to contextualise his questions and that he should not ask Members questions that they did not have power over. Members were struggling with network; they could not make out what other Members were saying and kept getting kicked out because of loadshedding. Did the Chairperson not know that there was loadshedding in South Africa and that it was affecting businesses and Members’ work?

The Chairperson asked that Ms Chirwa respect his position. He said that she did not have the power to talk the way that she did and warned her that he was not going to allow her to do so on the platform.

Ms Clarke said that a major focus mentioned in the APP was a focus on the top ten causes of death. Can SAMRC list the top five current causes of death in South Africa? Under the National Health Insurance (NHI), did SAMRC see the risk of diminishing funding increasing? Does SAMRC have a plan in place to mitigate this risk? For 2022/2023 there was an estimated decrease in the number of accepted and published journals. What are the reasons for this estimated decrease? Once the NHI is implemented, does SAMRC foresee funding for research and innovation diminishing? If so, what are the associated risks? Can SAMRC confirm that the sugar tax levied by national government is used in terms of diseases like obesity and diabetes? What programmes have been put in place in order to mitigate these diseases and assist in terms of treatment, especially in terms of mental health? At many hospitals that Members had visited, it was found that mental health wards were over-capacitated and patients had to be placed into overflowed wards because hospitals could not cope with mental health and substance abuse in particular. What is being put in place to try and assist or mitigate the causes of mental health? She further sought clarity on COVID-19 currently. SAMRC was saying that its funding had been cut by national government. Will SAMRC be able to continue its research? How will SAMRC maintain its research in terms of new variants that emerge?

Mr T Munyai (ANC) welcomed the progress that SAMRC had made beyond any other institution within the Republic. SAMRC was the only organisation that produced a new generation of proudly South African scientists. The Constitution of the Republic of South Africa, 1996, wanted to see the country have black and white diverse South Africans – not one single race over the other. SAMRC’s consideration of the transformation of new scientists was appreciated. There was no need in any way for Prof Gray to step down as he still had a long way to go and if SAMRC was doing great work it had to be appreciated, and she was to stay on and continue to serve the country – especially with the pandemic of COVID-19. The mRNA, being the messenger Technology Transfer Hub, has the potential to develop the product domestically. How is this project going to increase other innovation opportunities in the ecosystems? How can the nation optimise this potential of genomic medicine in the context of the mRNA especially vaccines, as there were issues of genetic transformation?

Ms X Havard (ANC) asked what the strategic alignment of SAMRC is with the Department of Science and Innovation’s (DSI’s) decadal plan. How integrated is SAMRC with the National innovation system? How can SAMRC increase research and development investment in the South African economy? What is the extent of the current impact of SAMRC in relation to research and development? The research grant awarded by SAMRC is constant at 750. Why is this target not on the incline, noting the importance and need of increased funding for research? The projections of programme two focus on leading the generation to new knowledge are relatively declining in relation to the number of accepted and published journals such as articles and book chapters by SAMRC grant holders and journal articles published by the first or last author relevant to previous financial years. Why are the projections declining rather than increasing?

Ms E Wilson (DA) said that SAMRC’s presentations were always extremely thorough and very well presented. The Committee had to give credit to a job that was well done and she thought that SAMRC did tremendous work. Of major concern was an issue raised by Ms Clarke with regards to the high instances of death, and in particular, she was interested in cancer. Over the last couple of years, SAMRC had discussed extensively in its presentations the increase of cancer and the causes of cancer. She asked that SAMRC share with the Committee some of the statistics that it had in terms of the increase in cancer. Big increases were seen at one stage. She was also seeing a huge increase in cases of Parkinson’s disease and said that she would appreciate it if SAMRC had any information that it could share with the Committee on Parkinson’s disease, what the causes were, and why increases in Parkinson’s disease were being seen.

The Chairperson raised the issue around SAMRC’s position on the TRIPS waivers to enable the domestic manufacturing of vaccine therapeutics and diagnostics in the country and the continent to meet Africa’s health needs. What work is SAMRC undertaking in this regard? Noting that in South Africa the full operationalisation of an mRNA Hub has been hampered by intellectual property barriers, what are these barriers? How are they being addressed to unlock growth? How is SAMRC going to ensure that the Chan Soon-Shiong Foundation partnership develops domestic manufacturing value chains in the bio-manufacturing sector to ensure inclusive economic development? What is the level of uptake of research and innovation produced by SAMRC and other Government institutions? Does SAMRC find the uptake at the required level? What are the plans of SAMRC to support the Department on the development, of a functional and effective State pharmaceutical company, Ketlaphela? What partnerships can SAMRC develop with Ketlaphela if none exists? When will SAMRC have the equity and representation corrected at senior level in terms of the demographics in South Africa, without losing any necessary expertise from the organisation?

Ms Wilson asked SAMRC to advise on the possible reasons for increases in typhoid in South Africa. She added that it took many years of studies and experiential work for scientists to reach the levels at which they are represented at SAMRC. It was thus very important to ensure that personnel have the appropriate skill sets, experience, and qualifications in order for South Africa to continue being seen as leading scientists in the world.

SAMRC’s Response

Prof Glenda Gray, CEO, SAMRC, started with Ms Gela’s question on the importance of coronavirus research, what lessons SAMRC had learned, and how SAMRC could sustain the high level of impact. SAMRC had learned a lot of lessons, including the importance of both human surveillance and the surveillance of waste water which could be taken forward in future. It had learned about the importance of investment in local diagnostics and working with SAHPRA to register these diagnostics and make sure that SAMRC supported the introduction of high quality diagnostics in South Africa. SAMRC had also learned about the value of good, robust clinical trials and evaluating other repurpose drugs or new drugs and their role in COVID-19 – as well as the importance of collaborating on COVID-19 vaccines research. These lessons could be taken forward and applied not only to infectious diseases but also to non-communicable diseases.

The surveillance was important, as cancer, increasing incidences of Parkinson’s, and the role of other non-communicable diseases were heard of. SAMRC would need to work with the National Policy Institute of South Africa (NAPISA), if it got established, and with the National Institute for Communicable Diseases (NICD) to ensure that SAMRC understood the burden of disease and how it was changing over time. COVID-19 had helped SAMRC and also highlighted the gap in its ability to make vaccines and drugs. SAMRC could get onto it with the state-owned company and the mRNA Hub and had to invest beyond just establishing the value of drugs or therapeutics but also make sure that they were involved in the manufacturing and distribution. However, therein also lay the issue around the politics of global procurement and how redundancy had to be built in if SAMRC was going to go into the field around vaccine development.

On the issue around capacity development, the question was what was the level of demand and percentage of applicants that got awarded. SAMRC had invested a lot into capacity development and, referring to slide 67, had seen an increase in the budget that it had put into capacity development from R61 million in 2018/2019 to R88 million in 2021/2022. These programmes were peer-reviewed. On an annual basis, SAMRC makes calls for students to apply, there was a peer-review process and a process governed by Steering Committees that evaluated each candidate to make sure that SAMRC funded in the areas, institutions, and demographics that needed to be funded in to take into account all of the issues around transformation.

Dr Mongezi Mdhluli, Chief Research Operation Officer (CROO), SAMRC, reiterated that the question was around the outer years in terms of goal five. Goal five in some instances was embedded in terms of funding within other strategic goals, particularly strategic goal two. The Committee had asked what support was needed in order to increase the targets. This was a new goal that SAMRC did not have before and given the fact that the funding was decreasing, as Mr Nick Buick (CFO) had indicated, SAMRC was a bit conservative in terms of what it could achieve. However, SAMRC was looking at other avenues to allocate funding to this strategic goal and could certainly do so once it had funding. SAMRC could then try to adjust its targets for the MTEF period going forward beyond 2022/2023.

Prof Gray continued on the question about the impact of decreased revenue. This meant more means and less research unless SAMRC could leverage its capabilities with other people. However, SAMRC continued to look at other streams. Ms Ismail had spoken about what scarce skills SAMRC saw. Depending on the area being looked at, SAMRC saw multiple shortages of skills. If SAMRC wanted to position itself for the fourth industrial revolution, its biggest scarcity of skills was in big data, being bio-statisticians, bio-informaticians, and people who could manage metadata, which included IT supports. SAMRC was addressing it in terms of big data. There were other critical skills in genomics, and SAMRC continued to invest in both the wet and dry labs around genomics – which includes virologists, bio-informatics, and people who could visualise pathogens. In terms of clinical research, making sure that SAMRC had well trained clinical researchers was a priority for it and it had a whole aspect of training as indicated by the Bongani Mayosi scholarship.

In terms of the breakthroughs in cancer, SAMRC did a lot of basic and fundamental science on cancer and the role of precision medicine in cancer. A lot of programmes had been funded in terms of SAMRC’s precision medicine programme in cancer that was looking at innovative ways of identifying and diagnosing cancer and breast cancer, as well as looking at cancers around various parts of the country and how to respond. An increase was seen in prostate cancer, and a decline was seen in the diagnosis of breast cancer. The current COVID-19 pandemic had seen a falloff in SAMRC’s ability to use nuclear medicine and other interventions for the treatment of cancer. In terms of SAMRC’s infrastructure, the R 55.7 million infrastructure budget that had been approved was coming from its reserves. In terms of priority six, Dr Thembekwayo had asked about the designated groups and the issues around transformation and gender disparity. SAMRC was a predominantly female organisation. When looking at the staff profile, generally at all levels of the organisation SAMRC was predominantly women. This reflected the health sector all in all. Around 70% of the SAMRC staff were women and around 88% of the staff were black. Overall, around 10% of the SAMRC staff were white. There were 68 White people, 310 Black people, 24 Foreign Nationals, 82 Indians, and 140 Coloureds in the organisation. Thus, SAMRC was a predominantly black and female organisation.

In terms of top management, the Executive Management Committee (EMC) was also predominantly women. 62% of top management were females, with one African, two Coloureds, and two Whites. Of the men, there were two Africans and one White person. In total there were three White people in the EMC, two of which were women. There were also two Coloured people in the EMC, two women, and three African people in the EMC, being one woman and two men. On the issue around top management was the senior management, which excluded the top management. Senior management included unit Directors, most of who had been in the organisation and permanently employed for many years. The 22 white people seen on the senior management slide, the 11 females and 11 men, were mostly people who were exiting the organisation as they retired. There were thus no new injections of white people; these were people who had been in the organisation forever and were near retirement. In terms of Africans in senior management, there were two females and one male. In terms of Indians, there were four females and four males. In terms of coloureds, there were four males and six women. In terms of foreign nationals, there were four males and two females. The distribution equity was around 50/50 between men and women at senior management level. She added that at the next Committee meeting SAMRC will be in a position to supply the ages of people that were representing SAMRC so that Members could get a feel of how the organisation was moving forward.

She said that Ms Siwela has asked about progress in relation to transformation. SAMRC’s challenges included that health research was a particular niche part of society and most people who did health research came from the health system, being doctors, nurses, occupational therapists, and pharmacists. Some of the issues were thus attracting those people into science. In terms of what SAMRC was doing about its weaknesses in bio-statisticians, SAMRC collaborated with the NRF and developed a South African Research Chair in bio-statistics. SAMRC cofounded this with the NRF to bring in a whole pool of bio-statisticians. SAMRC was also addressing it by having specific calls. It also had a collaboration with Belgium where it worked with them to help fast track the SAMRC bio-statistical programme, which has worked out quite well. SAMRC was also looking at bringing in Honours and Master's Students and developing them into bio-statisticians in SAMRC that can help feed universities. It was on SAMRC’s agenda and it had some innovative ways to work with it and would continue to work on it with the various institutions and the NRF in particular.

Regarding the IKS and what SAMRC had been doing, they had put a lot of good programmes on the IKS and were working with a lot of people. SAMRC had been working with a group of traditional healers in Newcastle, who had some compounds that had antiretroviral activities and had been working with the Durban University of Technology and Dem to further evaluate it. SAMRC funded extramural units on IKS and within SAMRC itself it had a whole lot of programmes where it evaluated molecules that had been identified to see whether they had any activities. SAMRC had a whole programme on non-communicable diseases that evaluated IKS molecules to see whether they could work in things like diabetes. Ms Chirwa had asked about the neonatal deaths and what other factors were contributing to neonatal deaths, excluding health system problems. There were a lot of causes for neonatal deaths and a lot of reasons why little progress had been made on infant mortality rates because the neonatal mortality rate drove this.

Causes of death in the neonatal period included things like prematurity, which one had to address through adequate antenatal care and trying to avert prematurity. There were a lot of causes for prematurity, like sepsis, diabetes, and hypertension. There were also issues around sepsis, including group B strep and nosocomial or sepsis that occurred in the hospitals that contributed to death, as well as things like birth asphyxia. However, the driving cause of neonatal deaths was usually infections in that period, often related to children that found themselves in hospital due to prematurity and needed to be ventilated. HIV was also a contributor and other maternal factors like birth asphyxia and hypoxia skin. SAMRC delivered programmes in the neonatal arena. Prof Gray expressed that she thought that how the SAMRC could really decrease neonatal deaths was through the introduction of Group B strep vaccination to try and prevent babies dying from Group B strep.

In terms of the issue with the NIH, SAMRC has a lot of collaborations with many institutions. SAMRC had a collaboration with the NIH, China Centre for Disease Control and Prevention, the British United Kingdom MRC and the Canadian Institute for Health Research. In the programme that was brought up, SAMRC partnered with the NIH. R 45 Million was from South Africa and this was matched one and half times by the United States (US). What was basically done was that there would be a request for applications and South African scientists together with their US counterparts would apply. All of the money in fact came back to South Africa. So even though the SAMRC contributed R 45 Million, the NIH contributed one and a half times more, and all of the money is returned for research in South Africa and not one dime is spent in the US. There was in fact huge benefit for South Africa.

Regarding other benefits for the NIH, if one went onto the NIH website they would see that South Africa was the biggest beneficiary of NIH funding outside of America. On the website, it would thus be seen that billions of dollars were poured into South Africa for research. She gave an example of the COVID-19 vaccine research. South Africa was an NIH-funded COVID-19 Prevention Network site with 33 clinical task sites in South Africa. The funding came directly from the US and had cost around $350 million at a global level. SAMRC also worked with the NIH on a study looking at COVID-19 vaccines in HIV infected people with an mRNA programme. This funding was around $250 Million. It was a lot of money for the R45 million given to the NIH. SAMRC benefited greatly from this collaboration and other collaborations with other health institutions at a global level and not only America.

In terms of the funding demographics, when looking at programme four on slide 56 it could be seen that SAMRC counted so that it could show the Committee as an indicator, the number of black South Africans that benefited from its awards as compared to other demographics and people in the country. It could thus be counted by Members. Since 2014 SAMRC had been evaluating who it funded, where it funded, and how it funded. SAMRC showed the Committee slides with a marked decline in awards that were going to white people and could perhaps show the Committee this year on year. Things have changed since 2019 quite substantially. Perhaps the next time that there is a Committee meeting, SAMRC would show the Committee how the demographics had changed over time. It would thus present pie graphs of self-initiated research grants. Certainly, things had changed since 2019 and there had been an improvement.

Regarding Ms Clarke having asked about the 10 causes of death, during the pandemic COVID-19 had outstripped HIV and TB as the leading cause of death. COVID-19, HIV, and TB remain the top causes of death in infectious disease-related deaths. The next group was the non-communicable diseases, which were a combination of diabetes, hypertension, ischemic heart disease, and stroke, as well as other non-communicable disease-related illnesses like cancer. In terms of NHI research and whether the NHI will diminish research, she did not think so. To have an effective NHI, research was critical to inform it – particularly in its various ambits. The NHI’s focus would be on prevention and primitive health, which the SAMRC could feed into. It would also focus on the early management of non-communicable diseases and SAMRC would be able to monitor the impact of early treatment of things like hypertension and diabetes. It was also critical for SAMRC to work with the Department around the NHI to understand the costing, financial impacts, and output in terms of curative medicine. To execute the NHI efficiently, one would have to work very closely with researchers so that there is a lot of transparency around the value and impact that NHI has.

In terms of mitigating risk around the NHI, SAMRC continued to work very closely with the Department. SAMRC’s scientists worked a lot with the costing, best buys, various interventions and how much it would cost the country. SAMRC has spoken a little bit about the decreased benefit outputs, which was just conservative because it did not know what its budget was going to look like so it had put conservative numbers in. It would be seen over time, particularly on SAMRC’s budget, that it could calibrate better on the number of articles that it would be doing in the future. To re-emphasise, SAMRC did not see that the NHI would diminish the role or amount of money that came into science. In fact, it should increase it because it was critical for NHI to succeed to do health research. The sugar tax went to National Treasury. She thought that it was a good question to ask National Treasury, what proportion of the money the Department and SAMRC received in relation to sugar. However, she could not answer that question at the moment.

Mental health was a big problem in South Africa, particularly post-COVID-19. In this time frame, SAMRC had seen a lot of mental health issues. SAMRC had invested in and had two extramural units that worked in mental health. It had also done surveys at Universities to look at mental health and was doing a lot of other research around mental health. In terms of the health system, SAMRC has invested a lot in Health Systems research to try and support innovative responses in the health system. The Health Systems Research units both at the University of the Western Cape (UWC) and within its intramural domain worked with the Department around addressing interventions that would mitigate mental health issues. In terms of the issue around new generation scientists, new generation scientists were critical and SAMRC continued to ensure that they were diverse. It also focused a lot on HDIs and had spent a lot of work in that area.

In terms of the question around mRNA Hubs, SAMRC hoped that the mRNA technology would go beyond just COVID-19 but would help them develop capacity in HIV, TB, and malaria. Once SAMRC perfected the mRNA platform and how it worked, it could then start looking at putting different genes and immunogens into the platform to look at other diseases like HIV, TB, and even influenza and cancer vaccines. mRNA technology was going to be very critical in helping SAMRC expand bio-manufacturing capability. For SAMRC and South Africa as a whole, this was going to be very important, particularly also around genomic medicine and how SAMRC looked at things like gene editing. Genomic medicine was important, which was why SAMRC had established the whole Genome Sequencing unit in collaboration with the Beijing Genome Institute to create capability and help SAMRC with precision medicine.

There was a question from Ms Havard about whether SAMRC worked with a decadal plan, an innovation system, and the DSI. Prof Gray told the Committee that SAMRC worked very closely with the DSI and had reviewed the decadal plan and gave input into it. She said that she was on the NRF Board and that Minister [of Higher Education, Science and Innovation] Blade Nzimande had put her on the NRF Board. She was also a member of the National Advisory Council on Innovation Board, which had helped develop the decadal plan. SAMRC had thus been integral in helping design the decadal plan and making sure that health is reflected well in the innovation system, as it had put a lot of emphasis on that. In terms of how research could help the South African economy, SAMRC believed in the need to develop local innovation around drug development, vaccines, and drug diagnostics. Diagnostics were horrendously expensive and were more expensive than vaccines, so SAMRC also needed to invest in developing points of care diagnostics and rapid diagnostics for things so that it did not have to pay the huge costs from using various platforms that it had to import into South Africa.

Responding to the Chairperson about the TRIPS agreement and what would work differently in that, she said that it was critical and perhaps SAMRC’s collaboration with the Medicines Patent Pool (MPP) would address some of the TRIPS issues, as well as some of their collaborations with people that actually helped some of the mRNA technology. Part of SAMRC’s scientific steering team consisted of people that actually developed the mRNA technology and that had agreed to support some of SAMRC’s development. In some instances, SAMRC did not have to worry about patents because they were in the discovery zone as they were working in other areas. Sometimes it was important to focus on what was patentable and SAMRC addressed some of that by looking at the lipid carriers, which Moderna talked a lot about. If SAMRC used its own lipid carriers, it could bypass some of the patent issues that some of the companies had put into place, where the MPP had been working with SAMRC where patents were not going to be implementable for certain diseases.

In terms of the Patrick Soon-Shiong bio-manufacturing, SAMRC had to make sure that it was inclusive and that it developed the capacity to do it and make sure that it is able to support bio-manufacturing in South Africa. Of course, it was of great concern because it was just read in the newspapers over the past weekend that Aspen’s manufacturing was under threat because there was no demand for vaccines in Africa. This was when South Africa needed to talk about the governance of global procurement and consider, if a manufacturing capability was created in Africa, the goods would be used, that the drivers of global procurement are understood, and that the issues of cost are not the only issues considered for a product but that it also considered the capacity that it could develop if it was sourcing products from other parts of the world including Africa. This was going to be a very important issue.

Dr Michelle Mulder, Executive Director: Grants, Innovation and Product Development, SAMRC, addressed the question on support for the state pharmaceutical company and Ketlaphela, and what partnerships SAMRC had in place. SAMRC had been supporting drug development and discovery for a number of years through the Strategic Health Innovation Partnerships programme and various other grant programmes. SAMRC’s role was to clean the pipelines and it saw itself as developing those molecules which would feed into a state pharmaceutical entity that would produce Active Pharmaceutical Ingredients in future. SAMRC would also play a role in supporting the clinical development, and it was really poised to support that state institution or state company as soon as it got off the ground. In terms of TRIPS, Prof Gray had mentioned how SAMRC was approaching it. When it came to COVID-19 specifically SAMRC had not seen to date, over the last two years, intellectual property and existing patents as any barrier at all in terms of local manufacture and development. SAMRC had been able to support the development of new diagnostic kits based on existing Polymerase Chain Reaction (PCR) base testing and novel point of care tests. To date, it had thus not been an issue. On the contrary, SAMRC had seen a willingness from intentional companies to do technology transfers and share designs for The Ventilator Project. The TRIPS waiver was important in the grander scheme of things and would be important to ensure local manufacturing. However, to date, SAMRC had not seen intellectual property as a barrier in terms of the development that it had been funding to date.

She mentioned how SAMRC could increase research and development investment into the South African economy and impact particularly in the face of a declining baseline funding. One of the things that had emerged from COVID-19 was SAMRC being able to tap into non-traditional funders. As a result of COVID-19 SAMRC had been engaging with a much broader range of funders who would normally fund more in the health delivery space but were now looking to fund more in the development testing and implementation space. SAMRC had thus been able to really draw in a lot of funding for research and innovation in the country by working with, for example, the Solidarity Fund, ELMA Philanthropies, Michael & Susan Dell Foundation, and others, to be able to bring in these non-traditional sources of funding. Around the COVID-19 lessons learned, what SAMRC had found with its rapid response to COVID-19 was that it had been able to accelerate its processes while maintaining the rigour, scientific review, and Public Finance Management Act (PFMA) 1 of 1999 requirements. SAMRC was able to quickly fund projects and leverage off existing investments that it had over the previous decade or so in the HIV and TB space, which had been able to rapidly pivot to COVID-19 based on the infrastructure, expertise, and skills that had been built over many years through SAMRC investment.

The third thing that the SAMRC had really learned was to work in a partnership model. In SAMRC’s COVID-19 diagnostics projects it met every six weeks to discuss these projects with the Department of Trade, Industry, and Competition, the Industrial Development Corporation, Business for South Africa, Technology Innovation Agency, and the project itself, so that it did not just drive the project through and make sure that it was meeting all targets but also plan for the downstream commercialisation and uptake. This has resulted in at least two of the products being SAHPRA approved. Around the engagement with other National entities, Prof Gray had mentioned a partnership with SAHPRA which had been instrumental in accelerating the vaccine trials, as well as SAMRC’s engagement with SAHPRA on medical devices and registration of new COVID-19 diagnostics being instrumental in assisting with the development value chain, target product profiles, and being able to get these registered and on the market as soon as possible. SAMRC also had engagements with the National Health Laboratory Service (NHLS) and was setting up a meeting in the following week to talk about how they could jointly support projects at historically disadvantaged institutions, which was a key goal for the NHLS.

SAMRC worked closely with the Council for Scientific and Industrial Research (CSIR) and funded some of its projects, but the CSIR was also supporting some of SAMRC’s innovation programmes. For example, the CSIR was providing some regulatory advice and support to SAMRC’s Medical Device Innovation projects. This has had a substantial impact. SAMRC had about 25 companies and innovators going through that programme and receiving advice from the CSIR. On the mRNA Hub and intellectual property barriers, the mRNA Hub was led by the WHO and MPP. The MPP and WHO were involved in substantial discussions at an international level around freedom to operate and had done extensive searches around the freedom to operate, identifying which patents may be a barrier. The MPP and WHO had opened up discussions with companies like Moderna to secure commitments from them to waive their intellectual property rights all together but not to sue for infringement; in other words, to allow freedom to operate. This has been really important and SAMRC had those people who had developed the original mRNA vaccines on its advisory team.

SAMRC was looking at novel lipids and there was one lipid that was proprietary and used in the Moderna regimen which SAMRC was looking to replace with locally developed lipids and was thus finding ways. There were some barriers around intellectual property but SAMRC was working very hard and had an actual intellectual property strategy approved within the mRNA technology transfer hub that was looking at the issues and how to navigate them to ensure that SAMRC had the freedom to operate. Not only would the mRNA Hub expand to other disease areas and allow SAMRC to develop mRNA-based vaccines to TB, HIV, and other diseases of relevance in South Africa, but it was also building product development capabilities. This included the capability to develop and test local vaccines, do the immunology, do the clinical development, and upscale manufacture. Right now it was based on mRNA vaccines but it could be very easily scaled and expanded to include other bio-manufacturing and other bio-molecules.

Prof Liesl Zühlke, Vice President-Extramural Research & Internal Portfolio, SAMRC, started responding to the question about scarce skills and reiterated the fact that SAMRC had identified bio-informatics, genomics, and bio-statisticians as a scarce skill that needed to be developed. SAMRC had developed it not only at a higher level with the NRF and extramural units but also in terms of the emerging scientists that had either been funded or are now part of SAMRC – the majority of whom were also young, black emerging members in that particular area. SAMRC thus also prepared them to be able to lead the front going forward. This tied in with many of the other answers where it either had the capacity themselves or linked two capacities at other institutions around, for example, indigenous knowledge, indigenous health systems, and health systems across all medical questions. She said that Ms Chirwa had spoken about neonatal deaths. The 2021 publication mentioned that new immaturity-related death was at an all-time high at the moment. The stats show 43% infection, 26% congenital, 17% anomaly, and 11% hypoxia – many of which related to the health system. Immaturity was not just prematurity but also gestational proteinuria hypertension and the immature baby born at the end thereof. There was a lot of work going into it not only from the SAMRC’s Maternal and Child Health units but also its Health Systems units to try and address it.

She added that Prof Gray had mentioned a Group B strep vaccine and that hopefully some of the vaccine pipelines would now be able to address some of the other vaccine needs in the country such as Group A and B strep and influenza. On Ms Clarke’s question about the top five causes of death, she alluded to the fact that in the SAMRC’s extramural units they were actually focusing on the intersection between infectious diseases, such as HIV, TB, and now COVID-19, and non-infectious diseases, such as stroke, ischemic heart disease, lower respiratory tract infections, chronic lung and kidney disease, and diabetes. The focus was also on the work that SAMRC’s Burden of Disease unit had been playing in understanding those trends and noting some of the mitigating factors in that regard. This was something that SAMRC was well aware of if looking at global trends of non-communicable diseases. Now they were starting to reach HIV and almost COVID -19 in taking over as the major cause of death.

There was a whole different set of mitigating factors around that that SAMRC needed to consider. A very strong mitigating factor was mental health and SAMRC was well aware of the fact that mental health was a priority at the moment and had a prognostic effect on ischemic heart disease, stroke, and diabetes. She mentioned two particular programmes. The one looked at the mental health of healthcare workers that were involved in COVID-19 and the other looked at the mental health of older people. These were two very important programmes looking at those two focus groups and considering innovative ways of addressing mental health and understanding the various mitigating factors were there. On the issue of journal articles, what SAMRC did not show was the impact factors of some of the articles that had been presented as per the cumulative number and it could certainly do so and what it also knew was that globally over the last two years some of the journal areas had gotten lower as people pivoted to COVID-19 research and there were more COVID-19 publications. The SAMRC had also found that what they had seen in their performance appraisals was that there were many more papers that had higher impact and also impact related to policy.

Responding to the question Ms Wilson had asked about cancer and cancer statistics Prof Zuhlke said that this was very interesting. Looking at the different parts of South Africa, the cancer instances were different. Prostate, lung, colorectal, breast, and cervical were still the most common. Here, SAMRC was also thinking about the impact of screening for example, especially on breast and cervical. On vaccines, SAMRC saw differential rates of cervical cancer according to differential rates of vaccines – again raised by SAMRC’s Cochrane review, some of the systematic reviews pointing to this, and the Burden of Disease research unit. On the comment about Parkinson’s disease, she told the Committee that SAMRC again had differential numbers for Parkinson’s disease across Africa. What SAMRC did know was that Parkinson’s is associated with a longer life span and so it was able to see more Parkinson’s as they had a longer life span. However, it was also strongly associated with genomic notations. The glucocerebrosidase mutation was the single largest risk factor and as SAMRC was understanding precision medicine and genomic research, hopefully, it would be able to address those as well.

Prof Gray said that there was one outstanding question about vaccine side effects, but those were well published and well observed both passively and actively. The SAMRC thus had a good handle on the side effects and SAHPRA could perhaps in the following meeting also address some of those issues because it also received direct reports around vaccine side effects.

The Chairperson thanked SAMRC for its presentation but had to cut it short as there was going to be loadshedding. He said that SAMRC had given the Committee very wonderful and proper responses to Members’ questions. It was also good to listen to all of the sciences and hear what the programmes were that were being performed by it, as well as the collaboration between the different research entities, institutions, and universities. He informed Members that SAHPRA had requested to meet at 15h00 because of a challenge it was experiencing. As there was no strong disagreement, the Committee would resume the meeting at 15h00 for the follow up.

Prof Gray said that SAMRC had heard all of the Member’s questions and would also respond and put it in its next interaction when it met with the Committee.

SA Health Products Authority (SAPRAH) Annual Performance Plan 2022/23

Dr Boitumelo Semete-Makokotlela, Chief Executive Officer, SAHPRA, thanked the Committee for inviting SAHPRA to the meeting and for accommodating its schedule. She introduced the new SAHPRA Board members who were present at the meeting.

Prof Helen Rees, Chairperson, SAHPRA, thanked the Committee for its time and for accommodating her calendar as she really appreciated it. Overall, SAHPRA had new colleagues on its Board which was made up of old colleagues who were great for continuity, and newer colleagues who were very rapidly learning the ropes. She was delighted to see that some of the newer colleagues were joining the discussion to get a sense of the kind of questions that Parliament was interested in. SAHPRA remained an incredibly important regulatory body and it could be pretty confident that it was making progress. In particular, one of SAHPRA’s ambitions was to get to a maturity level from the WHO. This was something that the WHO was now doing, as it also recognised the importance of having capable, competent regulatory authorities worldwide and not just in the Northern hemisphere. The WHO had developed a way of assessing the level of experience and ability that a regulator has. SAHPRA was in the process of doing this and would be getting a maturity level awarded to them later on in the year.

Dr Semete-Makokotlela introduced the presentation and said minor revisions were made to the Strategic Plan to ensure alignment with the MTEF targets in the APP which included the outcome indicators, five year targets, and method of calculation in the Technical Indicator Descriptions.

A summary of the targets per programme for the year was outlined. The number of targets per programme:

Programme One: leadership and support – 8 targets

Programme Two: health products authorisation: 6 targets

Programme Three: Inspectorate and Regulatory Compliance – 3 targets

Programme Four: clinical and pharmaceutical evaluation – 5 targets

Programme Five: Medical devices and radiation control – 5 targets

The majority of the 70% targets are focused on core business (Programme Two to Five) and eight (30%) are focused on the support services function (Programme One). The number of targets has increased by one compared to the 2021/22 financial year due to the need to include a target focusing on lot release.

The MTEF budget projections for 2022/2023 to 2024/2025 reflect total revenue of R349 million for 2022/2023 which is a decrease from the previous year and a slight increase in the following year mainly due to the backlog deferred revenue and is similar in the total expenditure. The Department grant shows a year on year reduction in overall percentage increase. Own revenue generation has increased significantly and is mainly utilised to fill vacancies and support the employment of new staff. There is a reduction in office rental and operational expenditure.

The significant increase in the Cost of Employment related to the filling of vacancies. 55 vacancies were filled since 1 April 2021. Available funds to fund the full SAHPRA structure decreased over the MTEF. Based on the MTEF projections, SAHPRA will only be able to fill a limited number of vacancies for 2022/23 (31 positions costed at R14 million pro rated) and will not be able to reach full capacity in the next five years. There was a reduction in office rental expenditure due to alignment of the budget against awarded contracts. Contracted services relate to cost of service for laboratory testing by the South African National Control Laboratory for Biological Products. There was a reduction in operational expenditure due to the prioritisation of filling of vacant positions. Capital expenditure mainly relates to the procurement of software products to assist with the regulatory process and tools of trade for vacancies to be filled during the year.

53% of revenue was generated in Programme 2 which was hugely impacted by the products retention fees and new medicine registrations. Programme 3 related to the inspectorate unit. Budget assumptions were adjusted for the 2022/23 year based on the average hours charged for per inspection. Programme 4 main revenue contributions relate to clinical trial evaluations and post registration amendments and biological testing. Programme 5 main revenue contributions relate to medical device licenses and retention fees. Medical device registrations are anticipated to contribute to revenue generations during quarter 4 of the 2022/23 financial year.

67% of the budget was allocated to SAHPRA core programmes (2-5) and 33% to administration for the 2022/23 financial year. Programme 2 goods and services related to the backlog project to be completed in the 2022/23 financial year.

Key budget constraints:

- Year on year reduction in the overall percentage increase of the operational grant, placing constraints on financing digitising systems and filling of vacancies.

-As at 28 February 2022, SAHPRA had 153 vacancies. The estimated cost to fill these vacancies once off will amount to R111 million per annum.

-SAHPRA required an electronic application system (Regulatory Information Management System) to enable the adequate recording, tracking, allocation of resources and storing of supporting documents to eliminate process inefficiencies and increase application process turnaround. The initial estimate to procure/develop such a system amounted to R37.5 million to develop and maintain over a two-year period.

-Various other software modules and integration with the RIMS system such as Pharmacovigilance and UN Organised Crime Division software will also be required in amounting to R7.7 million for installation set up and three-year maintenance.

-Year on year deferred revenue increase of R90 million indicated the inability of SAHPRA to timeously process applications and recognise revenue due to capacity constraints and inefficiencies due to SAHPRA processes being manual and not able to accommodate the large volumes of data.

-SAHPRA required financial support from NDoH and National Treasury to fill the vacant roles to be able to improve its efficiency and thus reduce the deferred income.

As COVID-19 continued to have an impact, it forced SAHPRA to be agile in its response and fast track priority health products to protect and save lives. To keep up with the changing landscape, SAHPRA was continuously re-engineering its business processes and digitising them. SAHPRA’s continuous partnership with international regulators and the WHO enabled it to apply international best practices. Partnerships continue to be strengthened whilst also leveraging on the expertise of scientific experts to create world-class systems and initiatives, whilst remaining locally relevant. SAHPRA will continue to focus on the three pillars of safety, quality, and efficacy, whilst evolving in ensuring that it is an enabler and not a barrier in the health sector.

(See the attached document for details.)


Ms Ismail asked how many COVID-19-related products, including Personal Protective Equipment (PPE), treatment, or vaccines, SAHPRA had processed. How many were approved and how many were rejected? If they were rejected, could SAHPRA advise on the reasons? As the country’s regulatory body, what role is SAHPRA playing in supporting local vaccine production. What percentage of new molecular entities and generics were currently being registered within the targeted periods? Could SAHPRA inform the Committee regarding Adverse Events Following Immunisation (AEFIs)? How many cases were reported in their severity? How many people actually claimed from the COVID-19 vaccine injury no-fault compensation scheme? She asked that SAHPRA provide the Committee with a breakdown of this information. On what basis was it actually justified or not? The SCA had recently ruled that regulations dealing with complementary medicines were invalid. How does this affect consumers and manufacturers? As a regulatory body, what was SAHPRA’s input thereon? She asked that SAHPRA update the Committee on its current business accommodation and premises, as well as how the lockdown affected its operations. This was very important as the entity was very important and so that the Committee could know how SAHPRA would be managing going further.

Ms Clarke asked what the reasons were for the vision, mission, and values of SAHPRA not being inserted into its APPs. Backlogs for the registration of medicine had been a major challenge. What plans have been implemented in order to fast-track such backlogs? How effective have these strategies been? What is the current average waiting time for the registration of products? What is the average target that SAHPRA was working towards to achieve this objective? What plans are in place for 2022 to ensure that this objective is reached? On Programme Five, medical device and radiation control, there had been a significant decrease of new license applications for radionuclide authorities issued within 30 days from 70% to 50%. What were the reasons for such a decrease? What were the reasons for the overview of SAHPRA’s budget and MTEF estimates being left out of the APP? For 2022/2023 there was a real decrease in the budget of 41.2%. This is a significant decrease. In what way will this negatively impact SAHPRA’s operations and objectives with clearing approval backlogs? What plans does SAHPRA have to mitigate this reduced budget while still trying to meet its objectives? In what way will this decrease impact new technologies and innovations? What is the current vacancy rate at SAHPRA? What plans are in place to fill these vacancies?

Dr Thembekwayo said that mention was made of a positive shift. It was said that SAHPRA was growing into maturity. What are the principles of SAHPRA’s positive shift? How does it support enabling working conditions? Mention was made of the WHO and that maturity level four was obtained. What are the positives or advantages of this level? On the three pillars of implementing mandate, what Dr Semete-Makokotlela had talked about did not in fact include that important information. Could the SAHPRA send the Committee the notes on those three pillars? The very same important aspect had been included in the conclusion. The Committee needed to refer to it so that when SAHPRA came and presented the next time it would be able to be well informed on those aspects.

Ms Chirwa wanted to know how many COVID-19-related products, tests, PPE, treatment, or vaccines SAHPRA had processed so far? How many were approved and how many were rejected? Why does the administration receive the largest portion of the budget as opposed to Programmes Two and Four which dealt with medicine registration and the backlog? She wanted an update from SAHPRA on the Phindile Dube situation that she had raised with them over a year ago on the Johnson & Johnson surgical mesh and transvaginal mesh issues that had been raised countless times in the Committee? SAHPRA had said that it would investigate and look into it. How far was the investigation? What happened a year later? Regarding the adjustment of ivermectin use, SAHPRA had said something a while back in that it would adjust the use of ivermectin based on available evidence. Could an update be received on this? SAHPRA had touched on it a little but she did not really get what the update was. What has been the evidence so far? What has been the analysis and research done by SAHPRA so far? She also wanted to find out about the anti-COVID-19 pill. Could SAHPRA provide the Committee with more information on how this assists in the fight against COVID-19? Is this readily available in South African pharmacies and hospitals? What is the process of acquiring that particular medication? What is the process of treating the symptoms of COVID-19 with it?

She asked about the outcomes of SAHPRA’s talks with Pfizer over the leaked document of adverse effects. Has it had any impact on how SAHPRA initially read its safety level and approved it on that information and on that basis, which was incomplete information? What is the severity of that particular situation? What has been done? What have the actions of SAHPRA been regarding this issue? Has SAHPRA strengthened the monitoring of persons who had received the Pfizer vaccine, especially citing that SAHPRA also noted that not efficient public education has been done on reporting adverse effects? What has SAHPRA’s intervention been as an entity in this regard? How many reports have it received so far, citing or concerning the adverse effects of vaccination? These were not investigations but just the number of reports or grievances that SAHPRA had received so far. What was the matter regarding the alleged attempt by SAHPRA to shut down the Natural Health Products industry? What was its intention in wanting to regulate natural medicines? Which medicines were these exactly? Why is there a need to regulate them? What were the court outcomes regarding this attempt by SAHPRA? Who did this benefit when now wanting to regulate the use of vitamin C?

Ms Gela said that the Committee really supported SAHPRA for the good work that it was doing for the country. SAHPRA had played a significant role in the fight against the coronavirus pandemic. What lessons has SAHPRA learned from the experience of the pandemic? What systems or process improvement would be infused into the operations of SAHPRA? What is the problem situation that the enterprise architecture would address? How will a low implementation of WSP impact SAHPRA and its workers? One of the provisions provided by the Medicines and Related Substances Act 101 of 1965 (Medicines Act), as amended, was the ability to enter into agreements to cooperate with any regulatory authority in order to achieve the object of the Act. With which internal authorities had SAHPRA reached agreements as a result of the coronavirus pandemic response? If such agreements existed, how will this enhance or improve licensing turnaround periods? Has SAHPRA been working and cooperating with regulatory bodies of BRICS countries? What outcomes have been realised?

Ms Havard asked how SAHPRA ensured awareness of illicit medicine products in the market and expired medicines. Is SAHPRA’s response adequate in responding to the problem? What programme is SAHPRA implementing in creating systems for IKSs and their promotion? How many device establishment license applications does SAHPRA receive annually? What have the drivers been for the rapid increase of revenue of medical devices and in vitro transcriptions? What growth potential does it have?

Mr Siwela asked what the benefits and threats of agreement were with other regulatory authorities internationally. On regulatory compliance investigation reports, what type of negative finding does SAHPRA find? What action does it undertake to ensure compliance? What penalties are applied where applicable? The overall target of Programme Three on the indicator of inspectorate and regulatory compliance targets being 70% and below reflected the lack of capacity to deliver 100% as per the performance standard of the outcome indicator. What are the limitations? What interventions will be required to perform optimally, as inspectorate and regulatory compliance were also at the heart of the mandate of SAHPRA? What challenges confronted SAHPRA in the main, on its inspection? What threats existed and how were they being addressed?

Ms Wilson said that people who had now had very bad reactions or suffered personal damages from the vaccine may now apply for funding against a fund that was established for that. The Committee was hearing from people who had applied and who were now being told no and that it was not as a result of the vaccine. Could SAHPRA provide the Committee with some idea of what the process was that was being followed here? How does one go about proving that it was a result of the vaccine or not? It was very easy to say that it was not a result of the vaccine even though there was somebody who had been severely disabled straight after a vaccine shot. Dealing with the issue of machinery, in particular, Ms Wilson explained that she was talking about imaging and machines that were used by forensic laboratories etc. The machinery was controlled and investigated by SAHPRA, including articles of machinery and equipment that went into laboratories, theatres, and dentist rooms. She said that her question was based on information that the Committee was receiving. In one of the forensic laboratories, machines were delivered some time ago but they did not work in the South African context and there were not sufficient people in the country who were qualified to work with them in the first place. What is SAHPRA’s involvement in the monitoring and use of medical equipment that is brought into the country?

Mr Munyai congratulated SAHPRA for being firm against intimidation to produce a political outcome. He asked that SAHPRA not be influenced by politicians. Science and scientific outcomes should thus guide the SAHPRA in its work, within its mandate. He thought that SAHPRA used to have a huge challenge as there used to be huge challenges before. However, it seemed as if SAHPRA had stabilised to majority. He liked this point a lot because the Committee understood the old Medical Controls Council and what it used to be and knew that SAHPRA was brought out of a very difficult position to be what it was now. He knew that resources were not endless. What extra support or resources does the Committee have to advocate for, to make sure that SAHPRA did its work successfully and independently?

The Chairperson raised some questions of his own. Why has it decreased in the current year projections and the outer years, while having experienced an increased revenue collection before? On the development of performance indicators to reduce deferred revenue, reflected a major and critical lack of capacity to create efficiency and effectiveness. Is this what was seen or is SAHPRA supposed to be developing those performance indicators? How is SAHPRA working with the DSI and its entities as their mandates were strategic alignment? What is the training capacity of SAHPRA? How many graduates have trained annually? What skill development contributions does SAHPRA make to institutions of higher learning and education? What are the plans of SAHPRA to support the Department in the development of a functional and effective state pharmaceutical company that was known as Ketlaphela? What regulatory intervention can SAHPRA develop to support domestically manufactured medicines and devices? Does the county have capacity and capability to grow its domestic production? How can regulations be developed to encourage transformation of the value chain of medicine and medical device manufacturing status?

SAHPRA’s Response

Dr Semete-Makokotlela said that SAHPRA may not have some of the numbers to the tee because of COVID-19 numbers not being included. However, it would come back to the Committee with its annual report that would reflect a lot on the COVID-19 numbers and targets. As SAHPRA was requested to use that strategic plan and APP, it did not include those numbers but would attempt to respond to the questions where it could get those numbers in quickly and would definitely cover it in their annual report. She reflected on the question of local manufacturing and whether the country had capacity. In terms of SAHPRA’s role in supporting local entities, it had been doing so for a while where it was engaging with them. A number of the local entities needed to be made aware of what the regulatory requirements were, and so SAHPRA had been a lot more open in terms of engaging with applicants. It had also created mechanisms for what it called pre-submission meetings wherein before the local entities submitted applications to SAHPRA, it could meet with them and indicate what the regulatory requirements were. For COVID-19, for example, a vaccine called Sinopharm that SAHPRA had authorised was brought in by one of the local entities that it had met with prior to their submission and SAHPRA had taken them through what the regulatory requirements were.

On whether the country had capacity, if looking at the sites that SAHPRA had authorised and the discussions that it was having, it believed that there was definitely some pocket wherein capacity could be built. A question was asked about the work of the DSI. SAHPRA engaged with the DSI, particularly in the areas of manufacturing. With COVID-19 diagnostic tests, SAHPRA had authorised quite a number of locally manufactured COVID-19 tests – one of them being a Polymerase Chain Reaction (PCR) and one being an antigen test. SAHPRA was certainly quite cognisant of engaging with local entities. As a regulator, there was only so much that SAHPRA could do because it had to ensure that these companies were compliant. While SAHPRA advised and provided some recommendations, its role could be limited in terms of supporting local entities. However, certainly, from an awareness perspective, it did support local entities. SAHPRA had also had discussions with the Black Economic Empowerment (BEE) Commissioner, but then this was one of the questions that were also raised. SAHPRA had had a discussion with the BEE Commission which had advised it on what was needed to do to ensure that it was compliant with the BEE legislation.

SAHPRA had thus been in discussions and had made a submission to the Department of Trade Industry and Competition. As had been indicated in the past, the Medicines Act as it currently stood was silent on matters of BEE. Hence, this was one of the elements that SAHPRA was looking at as it was looking at an overhaul and reworking the Medicines Act. She continued on to the questions around COVID-19 vaccine safety. SAHPRA had had a number of webinars that it had engaged the public and various stakeholders on and it had educated the public in terms of how to report and what mechanisms there were for reporting. SAHPRA currently had a microsite that could be accessed on its website and indicated what AEFIs had been reported. It even went into detail to explain, particularly, the questions around death cases that had been seen post-vaccination. The statistics were available on SAHPRA’s website and anyone could go and view it. SAHPRA explained the difference between an adverse event and an adverse effect and it had done a lot in terms of educating but it could never say that it had done enough.

Ms Chirwa raised a point of order, saying that the answer could not be that she must go on the SAHPRA website. She said that she was asking the question on this platform because she wanted it to be said on this platform and in this meeting. She asked that the question be answered and said that the other things were not important.

Dr Semete-Makokotlela said that she had not finished her response to the question and asked for allowance to go into detail. As she had previously indicated, SAHPRA was requested to present the strategic plan and APP. She said that she had been very clear that SAHPRA would not have all of the numbers at the present moment because what it was asked to present was what was brought in. However, Ms Portia Nkambule, Chief Regulatory Officer, SAHPRA, would come in later and get the exact numbers. On the question of the adverse effect around awareness, SAHPRA had done webinars and radio interviews but could never do enough. One of the areas that it had tried to do a lot more on was around doing the radio shows in indigenous languages. SAHPRA had worked with some of its staff members to ensure that it reached communities that it would typically struggle to reach if the webinars were in an English medium.

There was a question in terms of the level of reporting of AEFIs or any adverse event for both the Johnson & Johnson and Pfizer vaccines that were being made available in the country at the moment. SAHPRA was getting reports of close to 0.017% when it considered the number of vaccines that had already rolled out. This information was also available on the website. SAHPRA had shared the information with other colleagues on the African continent and it was well within what they were also observing. This was the percentage of reports that were seen, but she went on the exact numbers. In total there were about 5 500 AEFIs reported. For the Pfizer vaccine, there were about 4 300 AEFIs reported and for Johnson & Johnson, it was about 1 300. This then resulted in the percentage that had been indicated to the Committee. Regarding the Pfizer report, SAHPRA had engaged with Pfizer and the US Food and Drug Administration (FDA). That report was called a periodic safety report. SAHPRA had taken the public into the whole process and indicated what type of reports it had been getting from Pfizer. However, SAHPRA still said that based on the data that it had and the period safety report presented to it, the benefit of vaccines continued to outweigh the risks. The risks were there but were also articulated to the power of healthcare professionals.

In terms of the SCA, she clarified that SAHPRA was not trying to shut down any industry – that was not the role of a regulator. As a regulator, its functions were to ensure that every health product within its mandate, that is available in the country, is safe, a quality product, and effective. What the ruling by the SCA said was that in SAHPRA’s regulations wherein it was defined what a complementary medicine was, its definition of a complementary medicine extended beyond what and how medicine was defined in the Medicines Act. The ruling said that the definition had to be narrowed sufficiently to ensure that SAHPRA was adequately regulating those complementary medicines defined as medicines and that they are medicines as per the definition in the Medicines Act. There was a definition that was captured, that it must be used to diagnose, treat, or mitigate a disease etc. The ruling thus said that the SAHPRA needed to narrow the definition; it did not say that the sector must not be regulated, as that would be completely incorrect.

The judgment has been made available to the public through various fora, and if one looked at it one would see that it clearly said that medicines needed to be regulated and that SAHPRA needed to ensure that the definition only catered for those that were medicines. For those that were not catered for as medicines, there were other entities that would then regulate that. SAHPRA did have an Act for food stuffs and cosmetics, so those would then fall under that. It did not mean that there were not going to be regulations but stated who then and under which Act is that area going to be regulated. There was no intention to shut down any industries whatsoever. It was to ensure that the public had safe products that it was able to access. What the court ruling said was clear in that within the next 12 months the regulations that SAHPRA had, still stood and it then had 12 months to amend those regulations. However, it was a court decision that could be appealed as a regulator. SAHPRA was currently consulting with its legal team and, once it had concluded thereon, it would then communicate with the public and industry on what the way forward would be here. She spoke to some questions about the APP per se in terms of the vision and mission. These were captured in the actual Word document but SAHPRA was happy to then include those in the document presented.

Ms Nkambule responded to the question that was asked on COVID-19-related products that talked about vaccines, therapeutics, PPEs, and test kits. Regarding vaccine applications, SAHPRA had received about 10 of those. It had received one Sinovac-CoronaVac, which it had approved through section 21. SAHPRA had also received one COVID-19 vaccine CoronaVac, which was still under review as it was recently submitted to it. SAHPRA had also approved Pfizer Comirnaty, which was approved under section 21 and was also recently given conditional registration. Conditional registration was also given to the Johnson & Johnson vaccine and SAHPRA had also approved the AstraZeneca, Statens Serum Institut ChAdOx, in January 2021, which was the section 21 approval that was granted then. There were also two Sinopharm vaccine applications – one was given conditional registration on 31 January 2022, being the MC Pharma one, and the second one was at the very advanced stage of review and finalisation. There was also an application for Lagevrio, which contained molnupiravir, and which was approved through section 21 on 15 February 2022.

An application was also received for interferon alpha-2b, which was not recommended or approved as the data submitted did not support the therapeutic claim. An application for Cordavol was also not approved as there was no data submitted to support the therapeutic claim. There were several applications for ivermectin that SAHPRA had approved through the ivermectin controlled compassionate use programme. There were various applications using various trade names, ranging from Stromectol to Ivermectin Tablet USP etc. An application was also received for Nitazoxanide, which was under review, as well as several applications for remdesivir which came through using various names, and which were approved and subsequently registered for COVID-19 treatment. The SAHPRA also had favipiravir applications, which were rejected because there was no data to support the therapeutic claim submitted. The next application was convalescent plasma, which was submitted and rejected due to there being no data to support the therapeutic indication. Lastly, there was an application for medicinal cannabis that was using the trade name Leaf Critical Kush Dried and Cannabis Flower, and various other names used for this particular application, which was also rejected due to lack of data to support the therapeutic claims.

Regarding PPE, SAHPRA had not rejected any PPE applications coming its way. About 141 applications were received for the antigen test kits, of which 82 had been approved and 59 rejected. There were still five applications with the NHLS. The reasons for rejection were that they did not meet performance specifications, failed performance with the NHLS, and in some cases, there were insufficient documents that were submitted. Regarding the antibody test kits, about 227 applications were received. SAHPRA had approved 54, rejected 173, and four were still with the NHLS. The reasons for rejection were the same as indicated above. For molecular testing, about 148 applications were received. SAHPRA had approved 122, rejected 26, and two were still with the NHLS and undergoing testing.

Dr Semete-Makokotlela said that around the surgical mesh product SAHPRA had provided a report after the last meeting that it had had with the Committee. She hoped that Members had received it but reiterated that SAHPRA had sent that report. If not, the Committee was to let SAHPRA know as it would be happy to reshare it. She did not presently have the details as she did not prepare to engage on the matter, but at the next meeting, she would be able to give an update. Regarding ivermectin, indeed SAHPRA had said that it would continuously review it and it was exactly what had been done. Members may have noted the studies that were purporting to indicate that ivermectin is effective, which have subsequently been recalled because the data was fraudulent. SAHPRA had looked at all of that and there were more studies that had come out that had indicated that ivermectin does not have a clinical benefit. There was thus not the situation of a clinical purpose. SAHPRA had reviewed it, had engaged with experts internally, and was now engaging with its legal team because it needed to consider the court ruling on the matter. SAHPRA would be communicating an outcome on ivermectin quite soon.

SAHPRA had not obtained maturity level four at this point but it was the plan for 2024/2025. The aim was to achieve maturity level three in the current financial year. The notes on the three pillars would be provided but they were also in the actual Word document of the APP that was shared through the Department. She reflected on the work of regulatory compliance and told the Committee that SAHPRA received reports through a whistle-blowing facility that the public could utilise to report any illicit use of medicines. The public also emailed SAHPRA, and at times would call its offices. What SAHPRA typically did when it received a report was that it would send its inspectors to go assess the facility or establishment that was making these products available. Typically, SAHPRA would go with the South African Police Services (SAPS) because it did not know what to expect and for the safety of its team. When one was found to be non-compliant on the spot, SAHPRA then investigated the matter. Once investigated, it would then be handed over to the police services. It would be noted that the most recent complaint in the Western Cape had been arrested because it was very clear that it was not licensed and they did not have a responsible pharmacist at the facility, so on the spot, it was then detained. Working with the police services, SAHPRA was then able to conclude on these matters and it would then hand it over to the police services for further sanctions.

In terms of participating with other BRICS regulators, SAHPRA had indeed been working with a number of them and it had an MOU in place with Andisa which was its counterpart in Brazil. SAHPRA also had one, particularly from an area of the inspectorate, with its counterpart in Russia. SAHPRA had been working over the years with India and China as regulators. All of them worked together through the international fora, wherein they were all represented. SAHPRA thus worked with the BRICS counterparts but also with other regulators on the African continent. On the state pharma, SAHPRA had had engagements with them around 2020/2021 wherein they were guiding them in terms of what the regulatory requirements would be for them to be compliant with the Medicines Act. She had not had any recent engagements with the state pharma, so if there were any discussions that were to be held with them she was happy for the Committee to refer it to SAHPRA and she was happy to engage.

Mr Gordon Mtakati, Executive Manager: Human Resources, SAHPRA, touched on the vacancy rate as well as the training and WSP. When it came to the vacancy rate, it had to be understood that in SAHPRA’s fit for purpose structure it had 53 positions that were vacant and funded. There were then 89 positions that were vacant but not funded. This led SAHPRA to a vacancy rate of 12%. To have an organisation that had so many vacancies, especially vacancies that were funded, made it a tough time for its employees. When it came to training, SAHPRA had 17 community service graduates who were in the organisation. Those 17 graduates were called comm serves, which were Doctors and Master's graduates who had finished their internships and were now working at SAHPRA for community service. All of them had graduated and finished their training programme at SAHPRA but for the new coming fiscal year, it would not continue because it did not have funds to continue with the programme and it wanted to direct the few funds that it had to the vacancies and trying to recruit as much as possible. SAHPRA employees within the organisation had opportunities for training and their individual development plans that identified what the gap was that needed to be closed when it came to training. Therefore, SAHPRA did provide that training. Regarding the WSP, SAHPRA for the first time in the financial year that had just ended had registered with the Health and Welfare Sector Education and Training Authority (HWSETA). SAHPRA had its WSP and had managed to submit it for the first time in the past financial year.

Responding to the finance questions, Mr Regardt Gouws, CFO, told the Committee that on the overview left out in the APP, there was an overview per programme. More specifically on page 22 of the APP, there were resource considerations there and it was broken down under each programme, such as the financials or the budget and the MTEF projections per programme under programme resource considerations on page 32. This was in line with National Treasury templates issued for completion of the APP. On the percentage reduction, this related to Programme Two and the reduction there, which further related to the backlog clearance programme. The reductions could be seen in 2021/2022 to 2022/2023 and then 2023/2024, which was as the project came to an end. It was a very specific project with dedicated resources for the project. It would thus not have an impact on business as usual operations in terms of that funding decrease.

Regarding the 33% for Programme One, how SAHPRA’s budget was structured was that it was a centralised support budget. There were thus high-value items within the support budget or Programme One budget that provided overall support to all of the programmes – for example, the expenditure allocated for office accommodation would be under Programme One, as well as legal fees which was also a big budget item for SAHPRA at this point in time. Other items included the audit expenditure, data, and communications monitoring. This was why the 33% was high in relation to other programmes. The overall budget split was still 67% across all of the core units compared to the 33% which was a good balance to have. The question on the extra resources to advocate for was also touched on in the presentation and was mainly because of SAHPRA’s HR capacity constraint. It was the most expensive budget line item for them and it would definitely make a significant impact if there was some sort of bridging finance so that SAHPRA could be fully established. Together with that was capital investment for adequate systems to bring SAHPRA on par with other regulators and entities.

On the question of Programme Three and why the reduction, looking at slide 24, SAHPRA had noticed that in the development of the previous budgets that there was an overestimation for 2021/2022. When looking at the actual revenue for 2021 under the projected revenue for 2021/2022, it was more aligned. The reason why the budget was overestimated in 2021/2022 was mainly that an assumption was used that an inspection would take, for example, 40 hours which was the maximum hours. However, in the real world, an average inspection would take 23 hours. The budgets were thus just realigned to make that work and make sure that SAHPRA did inject correctly and would be able to meet those budget targets. There was a comment on the reduction of deferred revenue and the specific target for that. The reduction in deferred revenue mainly related to the core units meeting their targets in terms of their turnaround times within 30 days, 150 working days, or whatever the case may be. If those targets were achieved, that would in effect assist SAHPRA with reducing its deferred revenue liability and increasing its revenue turnaround time.

There was a question on business operations or premises, which he thought related to SAHPRA’s regional footprint and how that was impacted. SAHPRA had regional offices in Cape Town and Durban, with its Head Office in Pretoria. There was a new lease entered into in 2021 for the Head Office and it had used the Department’s already existing contracts for its regional offices. One of the regional office leases had expired by the end of March 2022 and SAHPRA had successfully replaced that premises through a tendering process, and the Durban lease would be expiring in May.

Prof Rees commented on the maturity levels. Level four provided things, like the US FDA with huge resources. SAHPRA was looking at a level three where it would probably be one of only two regulators in the continent at the moment. That would be level three for a whole number of things because the regulator would not just be level three but a level three for many things. What SAHPRA would include would be vaccines because it was one of the few regulators in the region that had been looking at the regulation of vaccines for a considerable period. Another question that was asked was how involved and relevant a regulator was. The regulator would not get involved with industry development, but what was important for industry was to have an effective regulator. It was known that one of the reasons that the mRNA Hub was awarded to Cape Town was because SAHPRA was seen as a highly effective regulator. There would not be industry growth unless there was a highly effective regulator. Indeed, SAHPRA was making progress but it was not yet there. If people were keen to see the industry grow locally, job creation, income generation, and provide the needs for the region, and if that was where the SAHPRA wanted to go, the regulatory authority had to be supported.

One of the biggest overarching problems was the shortage of funds. The industry was quite rightly saying to the regulator that they were happy to pay them but that they had to provide the service. In order to provide the service, SAHPRA had to be fully instituted in terms of HR, IT, and technology. All of these things were needed and Members had seen the costs attached to them. SAHPRA was talking to National Treasury and had highlighted this with the Minister of Health. The Committee was right to hammer SAHPRA and it was no problem at all as it had to give Members these answers, however, its appeal would be to say that it knew where it was going but what it needed was additional resources to get there. This would not only help the industry but also contribute to safety. Many Members had raised questions about safety, particularly around vaccine safety which was high on people’s agenda. SAHPRA has done it intensively with a number of partners, including the Department and the Ministerial Committee on Vaccine Safety, for COVID-19 vaccines and did it for all vaccines. However, SAHPRA wanted to strengthen that.

If SAHPRA was going to be able to do proper safety monitoring to the level that it would like, strengthen all of these things, and also protect the public and give the public the surety that the medicines it had in all categories were safe and effective, then it needed to proper capacity to do that. SAHPRA’s appeal would be to ask Parliament and the Committee whether they could support SAHPRA in its appeals to government to see if it could get more funding despite the fiscus being so tired. SAHPRA has made huge progress in many areas but in order to tip itself up into the next stage that it wanted to be, it needed to be properly resourced. SAHPRA had a business plan. It knew how many staff it needs and in what categories, but as was heard it did not have that staff. SAHPRA was asking people whether it was doing enough inspections, regulating enough, and if it was fast enough. SAHPRA wanted to hit that level, which it wanted to get to, it had to be properly capacitated.

She reiterated that SAHPRA’s appeal to the Committee would be to support it in its attempts to raise additional funds. With time SAHPRA could then, as a highly effective regulator, have fees which would then start to come in and the reliance on government would go down even more, which was definitely where the entity wanted to be. SAHPRA would never want to be total fee-dependant because the fear would be that it would then be too dependent on commercial industry and one always wanted to get the balance right between the sources of income. Some of the areas that SAHPRA had been asked about rested with other entities. For example, the insurance fund that was set out for the COVID-19 vaccines did not rest with SAHPRA it did the scientific evaluation together with the WHO and other local entities but the actual decision about that rested with the Department and the structures that the Minister of Health had put in place.

This also included traditional medicines, as SAHPRA did not regulate traditional practitioners – there was another entity responsible for that. The only time that SAHPRA would become involved with traditional medicines would be if they were commercialised. The UWC had an entity that was looking at whether some of the molecules in traditional medicines could be converted into commercial entities for local businesses. Similarly, mention was made of research. SAHPRA did not do research but rather said to applicants what data was needed and that they must bring the data. It is then up to the applicant to do that research or find that research and bring it to the entity. She said that if any questions were not responded to, SAHPRA would be happy to do so.

The Chairperson thanked SAHPRA and said that he had a note from Ms Chirwa asking that it send to her in writing which the entity said it did not have. He allowed SAHPRA to make a final comment.

Prof Rees thought that the questions were really insightful and could see what people wanted to hear. People would like to hear what had actually happened with COVID-19 and all of the applications. SAHPRA could also think about having memos for the Committee that gave them updates on really critical issues and it had taken note of everything and in fact, did reply on the question of the vaginal film. She was surprised that it did not get through because SAHPRA did actually discuss that and the importance of actually replying to a specific concern about safety. That reply was sent and SAHPRA would make sure that the Member received that reply. She asked if the Committee could in any way help SAHPRA in a very difficult financial situation. The Committee had understood its appeal, being whether the Committee could give SAHPRA support to get more funding so that it could be properly staffed. SAHPRA already had a highly competent but limited regulatory authority for the reasons explained and would greatly appreciate it.

The Chairperson agreed that SAHPRA was a wonderful regulatory authority. He said that he had also raised the point of the sales of schedule five and six drugs which had been spoken about but which he had not raised in the current meeting. However, the Committee and SAHPRA could talk about it again. He congratulated SAHPRA for having brought the organisation to where it was currently and said that the Committee would endeavour to do everything in its power to get it the support that it was asking for. He continued on to the announcements. There had been requests for oversight visits and other requests for physical contact meetings as the Committee. Requests for physical meetings were requests that the Committee had to make to Parliament to receive authorisation. Having received the list of chambers which were available from Ms Wilson, it was also noted that the rooms were very small. Nevertheless, the Committee would have a discussion on this albeit not in the current meeting. The Committee Secretary and himself would write to the relevant authorities to hear what the regulations were with regards to having meetings with physical attendance.

He said that everyone had had their eye on the floods in KwaZulu-Natal. The visit by the President of the Republic of South Africa and the Minister had been noted, as well as the declaration of a national state of disaster as a response to the flooding. The visit of the Minister of Health, the Deputy Minister of Health, and the Director-General of the Department to KwaZulu-Natal that day, together with the MECs for the Provincial Department of Health and other officials of both the National and Provincial Department of KwaZulu-Natal, was also noticed. The Committee further noted the visits of Government Departments. All of these had the intention to give support to the people of KwaZulu-Natal, and the Committee had also seen requests for assistance in various means and ways for the people who were destitute and struggling after the severe floods. He also noticed the content of the briefing that the Minister of Health had done that day, which spoke to the damages to health facilities and infrastructure, effects on service delivery, and the constitution of a health team of National and Provincial Department officials to address the challenges.

He mentioned that he had then spoken to the Chair of Chairs because his view was that the Committee needed to get an opportunity for work to be done, for assessments to be made and repairs to be instituted in order for services to be brought to the people very quickly and to be corrected. The Chair of Chairs had informed him that there would be oversight visits by some Portfolio Committees, including the Committee itself, but that the Committee should really consider two or three things. One was for Members to allow the Departments to do their work, to be mindful of the leave periods that started the following week and rather hope to postpone such a visit to the first week in May in order for the Committee to also be able to assess the work that was being done and the plans that were being made. This would allow the Committee to get an idea of the correction of the damages so that services are provided to the people.

The Committee talked specifically about health but of course, it was known that other services had also had some challenges with regard to the flooding. This was his view that he wanted to pass on to the Committee. The Committee was fully mindful that it would be one of the Portfolio Committees which would be doing that oversight. Where Limpopo was concerned, it would go slightly on the backburner considering that the Committee would be instructed by Parliament itself to make the oversight visit to KwaZulu-Natal. On Friday, the Committee would be receiving the Department to do its presentation on the APP and budget for the financial year 2022/2023 at 09h00. After the leave period, on 4 May the Committee would be doing consideration. He thanked Members for the meeting and said that there would be further discussions on Wednesday, 4 May, as to any logistics or arrangements that needed to be made.

The meeting was adjourned. 

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