CCOD, OHSC, SAHPRA on their Mandates & Annual Performance Plans 2019/20

Meeting report

Briefing by Compensation Commissioner for Occupational Diseases (CCOD)

Dr Barry Kistnasamy, Commissioner: Compensation Commissioner for Occupational Diseases, said one of the roles of the Commission was to provide medical assessments for eligible current and ex-mineworkers for occupational lung diseases. They also provided post-mortem services for deceased mineworkers where cardio-respiratory organs were involved, and were also involved in the certification of claims by a medical panel. They made payments for the certified claims, and also collected revenue through levies on risk shifts in controlled mines and works.

He described the statistics and highlights for the CCOD during 2018/19. (See presentation)

Their focus areas for 2019/20 include amendments to the Occupational Diseases in Mines and Works Act, 1973. They also need to expand the database of the current and ex-mineworkers. They had also updated the actuarial valuation report and submitted the annual reports and financial statements for 2016/17 and 2017/18. (See presentation for financial statements, MTEF budget, financial performance and their financial position).

He then went on to state their 2019/20 objectives. (See presentation)

The problem they were facing was that they were facing difficulties in estimating the number of workers and former workers as there was no surveillance system to track and trace, as well as to ascertain the labour history.

It was hard to find data on occupational injuries and diseases in South Africa. In instances where the data was found, it was difficult to interpret as it was mainly incidence data, where one could not link the data rates. Another problem was that the data was sitting in databases in different Departments and agencies.

Some of the occupational diseases were not diagnosed, or misdiagnosed. There was also a lack of adequate knowledge. Another problem was that occupational diseases were also masked by other diseases. Sometimes it was difficult to find the cause, and there was often an issue with long lag times as well as under-reporting. There was a need for special investigations.

There was also an issue with occupational diseases in mineworkers. With the mining sector plus indirect services contributing to almost 20% of the economy, with a mineral wealth of R25 trillion, ex-miners were still neglected. Another challenge was the deadly cocktail of HIV/silicosis and tuberculosis. Of concern was that there was little data on injuries.

There was also a legacy of neglect and system collapse. They had a backlog in audited financial statements and annual reports. 30% of source documents were not found. They had outdated technical resources. Additionally, they had inadequate human resources and infrastructure. A further issue was that everything was centralised in Johannesburg.

The Commission had developed an evidence base covering size, shape, scope and geographic distribution, piloted innovations in services, mobilised ex-mineworkers through outreach and awareness programmes, adopted a rights-based approach and monitored outputs. They had also developed a consensus on approach and interventions with mining companies, trade unions, government and social partners. They have also made amendments to the Occupational Diseases in Mines and Works Act, 1973.

Dr Kistnasamy went on to provide the statistics of ex-mine workers by province for the period 1984to 2013, and the statistics of the disease burden in ex-mineworkers. (See presentation).

On the issue of tuberculosis in the mining sector, he said that mineworkers were exposed to multiple risk factors that compounded their TB infection risk. They had twice the risk of the general population. Those with HIV had three times the risk of getting TB. Those with silicosis were six times at risk. Mineworkers with both HIV and silicosis were eighteen times at risk of getting TB.

The innovations they had introduced or were doing included:

• Database, and information technology (IT) system -- www.health.gov.za/ccod;
• Precision mapping of claimants’ district;
• Use of computer-aided diagnosis/ artificial intelligence;
• Defined minimum package of services that was sustainable -- health, compensation, social protection;
• Cross border delivery of services and continuity of care;
• One-stop shop (OSS) service under one roof to meet the needs of mineworkers/ ex-mineworkers and families;
• Use of unemployed graduates;
• Link to financial services;
• Multi-stakeholder involvement.

The CCOD had established one-stop shops in the Eastern Cape (Mthatha), Gauteng (Carletonville), Northern Cape (Kuruman), Limpopo (Burgersfort), the Global Fund (10 OSSs in neighbouring countries), and mobile units.

Legal amendments had been drafted for the Compensation Fund (DOH) to cover current and ex-mineworkers. New workers would go to the Compensation for Occupational Injuries and Diseases Act

(COIDA). There was a new governance and administration model, and a levy to cover the costs of administration, medical assessments and health care. He added that they also had a class Action Settlement of R5b, which covers silicosis and TB -- a minimum of two years’ working in mines for TB, cover for dependents, coverage and response to track and trace claimants, legal costs, alignment to the Department of Health, and covers services and medical assessments.

 

Discussion

Mr M Sokatsha (ANC) commented that Dr Kistnasamy had said the claimant process was too long. He fully agreed that it was very long, because some of the Members died in the process without having benefited, including their families. The Department had said they were trying to shorten the process. He asked where they were with that process now.

The second question was based on the one-stop-shops, which they had indicated were in different areas. He asked if they could give the Committee more information about the particular location of the offices, and if they were effective.

He referred to the settlement payments and the administrative cost. The Department had said that the settlement was not a once-off payment. He wanted to know that if a member died during that process, the family benefited from the payment.

Mr T Munyai (ANC) asked if the services that Dr Kistnasamy was putting on the table about artificial intelligence would come from his organisation, and not from the workers' money.

He commented that the kinds of sicknesses described earlier did not occur only at the former gold mines. They also arose from other mines, like rare earth minerals, which were most dangerous in that regard. The key issue for him was that big corporations had been mining all over South Africa, although some had closed and some had been sold. He suggested that they should be brought on board to respond to this horror that had happened in the past. He was not trying to be stuck in the previous era, but as a process of trying to respond to the benefits of those that died, he said it would be very helpful.

He said that the CCOD data should be made available to those countries whose citizens may have possibly been here, such as Zimbabwe, Botswana and across the Southern African Development Community (SADC) region. If they used only South African print media to advertise, it may not be enough, as they may need a rigorous media process within and beyond the borders. There was a need to work closely with the embassies that were based in South Africa from those countries, as this could be of much help, because their governments may have data about their nationals to back up the CCOD’s main data.

Mr P van Staden (FF+) referred to figures that were missing from the presentation, and commented that he hoped their offices were no longer like those depicted on one of the slides. However, this should be taken up with the Department of Public Works (DPW), because the Department’s buildings were in a terrible state.

Regarding the court cases mentioned, he asked if there was just one big class action and whether it had been settled now, or if there were pending cases. If there were still pending cases, he asked how many there were.

How far had the Commission progressed on the issue of asbestos in schools?

Ms E Wilson (DA) observed that they had mentioned about 236 controlled mines that they were working with at the moment, and asked how many there were in total. What percentage did that 236 represent, and in the bigger picture, how many were not controlled, because those that they could not control could have a serious impact on health?

She also asked if asbestosis fell under “progressive mass fibrosis,” since it was disconnected from other diseases such as tuberculosis, pneumoconiosis and silicosis on the CCOD slides.

She said that there were problems which they were finding in schools and clinics made from asbestos. Therefore, apart from the mine challenges as far as asbestos was concerned, their challenges were far bigger than mines. The use of asbestos led to asbestosis exposure, not necessarily in the mines alone.

Ms A Gela (ANC) needed clarity about the people who were residing in areas that were affected by dust coming from the mines. Sometimes the dust was seen coming from the ground like smoke. Mines would say they had a social labour plan and promise the community things, some of which were happening, and some were not. She said there was a need to communicate with the municipalities to get information, because some people did not go back to their original homes after retirement, and just decide to stay in those areas.

The commented that the settlements were not covering the miners who had worked on the mines before 1965. She asked if it was possible for them to come up with a mechanism so that families of those people also benefited. She also noted that the 400 000 mentioned in slide seven had excluded the ex-mineworkers, and wanted to know why they were not covered.

Mr K Jacobs (ANC) said his question emanated from a YouTube video he saw about a Russian gold mine and the processes they follow there. When the miners arrive in the morning, they get a full medical screening before entering the mine. They also have tests to ensure that they have not taken any alcohol. When they are leaving the mine, they also get the same chest x-ray. Additionally, they got 76 days off, because it was recognised that dust exposure in the mining industry was a danger to the health of a person. He commented that in 2019 they had a settlement, and asked what processes were in place to prevent these things from happening in the future.

Dr P Dyantyi (ANC) asked how many mining companies had not yet come on board, since they had talked about only six mining companies.

She asked if there were people who wanted to opt-out of the settlement. The settlement was small, as it was only R5 billion. However, if they were never compensated, she knew the pain the miners would go through. This was particularly the case for those that came from the Eastern Cape to Johannesburg, and even if one had lost their husband, they still had to collect paperwork and come to the mines and claim. Also, some of them did not have a clue about what they were supposed to do. She asked them to speed up every process that could alleviate the pain of the mineworkers.

Ms M Hlengwa (IFP) said she agreed with Dr Dyantyi about the pain that mineworkers go through. Her question was what a family was supposed to do if their beloved ones were deceased. She asked if they had to bring their identity documents (IDs) or death certificates. She also asked which year they had started, as well as what happened to those who were still alive but sick, as some of them were lying in hospitals and helpless.

Dr S Thembekwayo (EFF) said that her first comment emanates from the document that dealt with occupational lung diseases -- the settlement of silicosis and TB+. She said this was the most important document, as it governed how the money would be paid out according to the court of law. Therefore, what they had expected as Members of the Committee was not just to be told by word of mouth about this very important information. There was a need for a summary on PowerPoint that informed them of the whole process from beginning to end, so they did not have to be confused.

On the issue of compensation, she said that for some workers the amount allocated in compensation was insufficient to satisfy all the levels of injustice that mining families had suffered historically for the past 100 years. She asked why there was a limit, from R70 000 to R500 000. It was not necessary for them to close the bracket at R500 000 – they should rather have increased it to R1 million, because R500 000 was nothing to a person who had worked for more than 35 years at a mine. She acknowledged that an agreement had reached, but asked if there was any way that some miners could qualify for more than R500 000.

She also wanted to know if they had guaranteed the proper management of the distribution of the money, because in South Africa, when people are given billions to manage or to distribute, half of that money never gets used for what it was intended for.

She added that within the boundaries of each mine one would find not only families of miners, but also black people staying there as a community, although they did not have families or people working at the mines. They were also affected by these ailments such as silicosis and tuberculosis. She asked how they could be accommodated in the programme

Ms N Chirwa (EFF) said the after-effects of mining were dysfunctional family units. They were fathers and brothers who had been taken away from their family units and sent to the mines to die. It was absolutely tragic that the means of acknowledging their deaths, loss and sickness was what they had here.

She asked what the precise challenges were in setting up one stop shop services.

How would the families of the mineworkers be made aware of the system in place -- would they give them pamphlets, or would they go to their families and talk to them?

She asked if there were any preventive methods in place, or did people have to live with the fact that they were going to die with diseases like silicosis and tuberculosis if they got into mining.

Lastly, she pointed out that it was not only tuberculosis and silicosis that resulted from mining. Research into sulphur dioxide emissions -- where Mpumalanga was ranked second highest in the world -- showed that it caused other ailments like diabetes and strokes. She asked what could be done for people who were affected by these situations, beyond just the miners. Were the people living in the area at liberty to claim?

Mr K Mileham (DA), from the Mineral Resources and Energy Portfolio Committee, observed that the presentation indicated that the second-highest percentage of ex-mineworkers was in the North West province, yet there was only one OSS service centre there, and asked for an explanation.

He also referred to the pictures of their offices and the condition in which they found them. In 1994-1996, he had worked in the medical bureau for occupational diseases as an intern, and part of his job had been capturing of files on to a database system. He asked what had happened to that database system.  

The Chairperson commented that South Africa was ranked at number eight as a gold mining country. He wanted to know how the other countries had been managing. Although it was being said that tuberculosis and silicosis were all over the SADC countries, its head was in South Africa. Mines in South Africa had actually contributed to the spreading of these diseases in Lesotho, Mozambique, and other countries. This was something that they not proud of, despite the gains made through mining.

Department’s response

The Department said there were only 40 doctors with the specialist skills or qualifications who had to look after the health of all the mineworkers in South Africa, which was a challenge.

With the settlement fund, even if the mineworker was deceased, the dependents would get access to the benefits. The only problem was that some documentation was needed. For example, if someone was not in the system (not part of the database), that would obviously cause a problem. However, it was something they would have to tackle. They were also providing for the living mineworkers who were eligible, hence the establishment of fixed One Stop Shop centres and mobile stations that would help.

He said gold mining and silicosis had been highlighted, but the presentation could not cover everything about coal workers (pneumoconiosis). Legislation made provision for six dust-related diseases, and this showed there was a gap in the legislation.

If someone contracted asbestosis from the schools, for example, that was not covered by their Department. This was similar to the problem they were having regarding environmental exposure. One of their challenges was that the asbestos mines had closed down in the 1970s, but no records were kept, and it became a problem to work out the mortality rate if there was no database. They were therefore appealing for that database to be set up.

A big problem was that there were other departments that dealt with these issues, such as local government and Environment Affairs, and unfortunately there was a policy gap regarding community exposure to sulphur dioxide. The Mineral Council was doing work on clean coal technology and how this could be used to meet the energy needs of the country.

In 2016, the Human Rights Commission had held a hearing on mining’s effects on the community. It had laid out directives as Chapter Nine institution to be followed, and one of them had been about doing respiratory and mental health assessments in mining communities. The CCOD had asked their Department and Mineral Resources and Energy to commission those epidemiological studies, which required a follow up on how those communities were affected.

Regarding the use of asbestos in housing, human settlements or education, the CCOD could only assess and say there was a problem, but they could not intervene in sorting out new rules or new housing because that was a different policy framework and a different mandate.

Their fund covered ex-mineworkers and current mineworkers, and likewise the other funds from the Department of Employment and Labour would also cover ex-employees and current ones. The problem they faced was that they did not have a system to track in the Department of Employment and Labour when people exited the workforce. Those were the policy gap issues that needed to be worked on.

There was an electronic system to deal with payment claims which was going to help shorten the processing of documents such as identity and registration documents, and linking up with Home Affairs. They were also talking to neighbouring countries’ governments about how they were going to link up with them.

The implementation of preventive measures was the responsibility of the Department of Mineral Resources and Energy. The CCOD did not have the resources to police that.

The issue of controlled and non-controlled mines was a vexing matter. This also did not fall under their Department, and they should not be running this fund. This was part of the Department of Employment and Labour, and it was by chance that they had landed up with it. However, they were trying to do the best they could, and that was why they were asking for amendments. The CCOD would come back to the Committee regarding those amendments, and their movement to the Department of Employment and Labour.

The One Stop Shop service centres had been started because previously the mineworkers had had to travel from as far as the Eastern Cape to Johannesburg, which had been very painful. They had established these units to be like gateway clinics.

The Commission wanted to do study visits to mining countries like Brazil, which had a 15-year span for workers in the mining sector, after which they were retired from the mining sector. They would talk to the Committee about this in detail at another time.

Regarding the split between benefits and administrative costs, the whole trust and settlement had been drafted in such a way that there would be no dipping into the benefits to cater for administrative costs.

With regard to the class action, the legal process had been finalised in respect of the six gold mines that had been mentioned -- that process had been completed and finalised. There had been a question relating to how many gold mines formed part of the settlement, but essentially the agreement involved the big six gold mining companies.

Communication had involved thousands of advertisements, not only in South Africa, on radio and in the press, that had publicised the settlement and where claimants had to go to.

The Department said that the six companies did not cover the whole industry. The significant factor was that the Mineral Council, which represents most of the mining industry, was also present. The Mineral Council had started the compensation work in 2003 when it was then the Chamber of Mines, and they were in the process of extending the support first of all to the Commissioner’s department, to try and improve the services and all the systems of the mining companies.

They also confirmed that they were committed to supporting the Compensation Commissioner in terms of improving business efficiencies and processes at the CCOD. To that effect, they had committed resources for the next three years that would support some of the systems that they had.

Mr S Luzipo (ANC), Chairperson of the Portfolio Committee on Mineral Resources and Energy, said they might have to break these issues into three categories. The first would be the compensation for the historical effects (legacy issue); the second would be the future approach, dealing with one compensation system; and the third category would be the most complex one, which was the outcome for the gold working group’s settlement. The main problem with the last category was that they would have to get a declaration of the court to be legally binding on all parties.

When they dealt with these issues, they should not leave out the Department of Labour. He commented that some of the things that were happening were a result of the non-application of the proper law. There was a danger when the government operated in silos. Although some the work was left for the Department of Mineral Resources and Energy, the Department of Health (DOH) should also make a contribution as to what it thinks would be better measures to deal with occupational health diseases. Although the primary responsibility lay with the Department of Mineral Resources and Energy, there should be DOH input because at the end of the day the consequences of the failure of the legislation would also go back to health as a liability.

Briefing by South African Health Products Regulatory Authority (SAHPRA)

The Committee was told that SAHPRA had been established in terms of the Medicines and Related Substance Act (Act 101 of 1965), as amended, to replace the Medicines Control Council (MCC).

The challenges SAHPRA had faced since its launch in February 2018 included finding a fit-for-purpose building, progressing the appointment of a new executive team, nearing the finalisation of the transfer of staff, and the re-engineering/automation of Section 21 processes.

2019/2020 was the second year of the transition period, and SAHPRA was busy with capacity building so that it could perform to its full potential. They had inherited an operational but partially capacitated core business, since SAHPRA had to also establish its own corporate services capabilities. It would take three to five years for them to realise their full potential.

A balanced approach was needed to address both the operational difficulties of the entity derived from the medicines backlog, and newly adopted functions of the medical devices and radiation control functions, while simultaneously growing a brand-new corporate services programme.

A critical first task for SAHPRA was the clearance of the inherited medical products backlog, defined as “all applications submitted which were yet to receive final approval (including certification) as of 31 January 2018).” The facts about the inherited backlog were that they had 16 000 applications which consisted of 50% new registration and 50% variations. 1992 was the year of the oldest backlog applications. Also, 50% of the new registration applications were older than five years. In addition to this inherited backlog, SAHPRA receives 4 700 applications per year, but only processes 2 550. Therefore the backlog was not only a historical problem, but was an ongoing challenge. Therefore at their current capacity, it was going to take them eight years to clear this backlog assuming no new applications.

However, SAHPRA had made an innovative step change to rapidly eliminate the existing backlog whilst simultaneously reforming its operating model to address the challenge of submission volumes exceeding absorption capacity. Their ambition was to clear the backlog in two years.

What they have done so far was that the backlog clearance programme had officially been launched on 1 August 2019, which covered procurement, customisation and the testing of the new digital systems, including workflow tracking software. They had also recruited a backlog team with the majority of on-boarding and training completed. They also had regular, constructive engagement with industry and other health system stakeholders.

Ultimately, a health regulator benefited all South Africans. It led to increased access to medicines, local job creation opportunities. It also leads to safe, effective, high-quality health products, and investor confidence in South Africa’s pharmaceutical industry. Lastly, it also provided for health services and clinical research in line with global best practice.

Cannabis for medicinal and research purposes

Prof Shabir Banoo, SAHPRA board member, presented on the status of cannabis for medicinal and research purposes. The legal status of cannabis in South Africa was that it was currently in line with the 1961 Single Convention on drugs, and was listed in the schedules 7, 6 (tetrahydrocannabinol, THC) for therapeutic use, and Schedule 4 (cannabidiol, CBD) as a supplement in a limited dose. Section 22A (9)(a)(i) of the Medicines Act provides that no person may acquire, use, possess, manufacture or supply a Schedule 7 or Schedule 8 substance. This section also provides for the Director-General to issue a permit authorising a medical practitioner, analyst, researcher or veterinarian to use cannabis on the prescribed conditions for the treatment of a patient, or for the purpose of education, analysis or research.

He said that the access to cannabis for medical use framework enabled patients who were in possession of a valid prescription for medical use to access the product in the following ways:

• Pharmaceutical cannabis products registered by SAHPRA.
• Cannabis pharmaceutical products that were not yet registered by SAHPRA may be obtained under section 21 of the Medicines Act by authorised medical practitioners for their patients.
• Controlled and quality-assured herbal cannabis products obtained from licensed producers, which have standardised levels of cannabinoids and tested to be free of harmful contaminants.

He went on to state accesses for use of cannabis according to section 21. (See presentation)

Patient eligibility for medicinal cannabis included the following conditions:

• Severe muscle spasms or severe pain in patients with multiple sclerosis.
• Severe nausea, vomiting or wasting arising from cancer and HIV/AIDS.
• Severe epileptic seizures where other treatment options had failed or had intolerable side effects.
• Severe chronic pain conditions.

Prof Banoo said that SAHPRA had established a medical cannabis working group to develop an enabling regulatory framework for access to medicinal cannabis. They had also had consultations with intergovernmental departments and external stakeholders to ensure an integrated approach to the policy framework. There had been engagement with the provincial governments, rural farmers and traditional healers to support the development of enabling mechanisms for the cultivation and access to cannabis for medical use. He warned that the growing number of unlicensed outlets and individuals selling unregistered cannabis products for medical use remained a concern and required an integrated approach by all law enforcement agencies. A Ministerial advisory committee was proposed to address the wider cannabis policy issues, including the legislative and regulatory amendments required.

Discussion

Ms E Wilson said she was totally opposed to testing on animals, and asked if they practised this in South Africa.

Ms S Gwarube (DA) asked them how they intended to use technology to work on the backlogs.

Mr Jacobs said it was concerning that they still needed to put clinical trials into place. Clinical trials were important, so they might need to look into that and speed it up a bit.

They had been talking about the cannabis situation for a long time. As a medical practitioner, he was concerned about them wanting to reschedule cannabis. If they were going to discuss the topic of rescheduling cannabis, they needed to get many people on board, like academics.

Dr Dyantyi asked what the fee for service was. She also asked them to explain to the Committee about the radiation control unit.

Mr Munyai said seven countries had been mentioned on slide 24. He asked if this referred to historical colonial relationships, or if it was about the reliance that they had over time on the consumption of the drugs from Europe. South Africa was part of the BRICS (Brazil, Russia, India, China, and South Africa) grouping, and if they were to speak about HIV/AIDS drugs, India would be one of the countries that could be vital, and perhaps some of the European countries could import their drugs from them. Considering there had been a shift in relations by South Africa to the BRICS countries, why had they not been considered?

He said that about 70% of the information that had been presented had referred to legislative issues. He suggested that on such issues they needed to get legal minds to help with the constitutional issues, legislative processes and the interpretation of the law.

He asked why SAHPRA would accept applications when they have not promulgated an Act, and commented that they had not yet approved the schedule that they were talking about. He also urged that they should also engage with the Nuclear Energy Corporation of South Africa (NECSA) on the issue of licensing.

Ms M Sukers (ACDP) asked if there was a specific reason why the mandate of the Department had specifically alluded to including reproductive health care as a mandate from the constitution, or had it been mention within the overall framework of the provision of services

Ms Chirwa asked for the names of the manufactures that had been given cannabis licenses.

Dr Thembekwayo said reference had been made to the academic applicants within SAHPRA. She wanted to hear about the status of the academic applicants with reference to gender equality applications’ success, inclusive of the racial segregations. She asked them to specify the percentage per gender and also per race.

She said there was a problem in having an acting CEO. The presentation had mentioned something about the capacitation of the organisation’s executive senior management. She pointed out that the CEO was part and parcel of the organisational executive. “Acting” in a position did not give a person the freedom and capacity to explore his or her contribution to the success of SAHPRA. She asked when there would be a full-time CEO.

Lastly, she commented that there were a number of countries with which they had some working relationship. Why had they not made mention of Cuba, since it was performing better than other countries, especially on the infant mortality rate?

Ms Hlengwa asked why other medicines were not paid for by the medical aid schemes.

The Chairperson said there was a problem in the country with regard to codeine which was found in cough mixtures, and there had been a suggestion that maybe codeine should be scheduled higher so that people did not just go into any chemist and easily buy it. He asked who was going to assist them in making sure that it was rescheduled upwards.

He also commented that they had a very ambitious plan to deal with the backlog. They had said that they were getting over 4 000 applicants per year and were dealing with 2 500 per year, meaning that every year they were dealing with a bigger backlog. How exactly were they going to deal with this, and if they were really being honest when they said they were going to deal with this in twenty-four months?

Department’s response

The Department responded that they were trying to move away from testing on animals, but sometimes it was unavoidable because they had to use something that was closest to humans.

The issue of rescheduling drugs was based on the safety and risk of the particular medicine, so whether the regulator would reschedule up or down would depend on the indication of what it was going to be used for, who was going prescribe it, and what the monitoring procedures were going to be. This was what determined how and when they were going to reschedule.

SAHPRA acknowledged that their aim to clear the backlog in two years was ambitious, but they had gone into the details of how long it took to assess a product and used those factors to come up with the number of months to clear the backlog. In terms of technology, they have now adopted E-applications so that they could be easily accessible by anyone from different provinces, unlike in the past.

They had taken note of the need for prioritising clinical trials, and would make sure that they automated them.

Regarding the backlog budget, the challenge they were currently facing was the disconnect between the fees they were currently charging and the service they were providing.

With regard to the fee for service, SAHPRA charged various fees for services rendered for different applications that they receive, such as for evaluation, inspections and investigations. All these fees were published in a document called “fees payable in terms of the provisions of the Medicine and Related Substance Act,” which was on their website.

With regard to radiation control, they had been doing the evaluations and inspections without charging any fees. They had now constituted a working group that would be working on establishing the fees that needed to be charged for the services that were being provided by the radiation control unit.

On the issue of gender and race equality on the success of applications, they said that the mandate lay with the Medicines Research Council. However, they also promoted transformation and as applications had been submitted, they were also sending questions back to the applicants asking what was being done for those who had been historically disadvantaged, to enable them also to participate in research.

The manufacturers that were given the cannabis licences were Felbridge in Paarl, Western Cape, Pretoria, Leaf Botanicals, and House of Hemp in KZN.

On the issue of using the regulatory countries, they said that these countries had been chosen because of their maturity. Cuba was not at the required maturity level for regulatory standards.

Briefing by Office of Health Standards Compliance (OHSC)

Dr Siphiwe Mndaweni, Chief Executive Officer: OHSC said that they seek to protect and promote the health and safety of users of health services by monitoring and enforcing compliance by health establishments with norms and standards prescribed by the Minister in relation to the national health system, and ensuring consideration, investigation and disposal of complaints relating to non-compliance with prescribed norms and standards in a procedurally fair, economical and expeditious manner.

OHSC inspectors were qualified health professionals registered with professional bodies such as the Allied Health Professions, Health Professions Council of South Africa, South African Nursing Council, or South African Pharmacy Council. Their inspectors, complaints assessors and investigators were capacitated through a compliance officer training programme as required by the procedural regulations pertaining to the functioning of the OHSC and the handling of complaints by the Ombud.

The types of inspections they conducted include routine inspections, additional inspections -- done to make sure that non-compliance had been remedied -- and risk-based inspections, which were targeted for persistent or critical non-compliance triggered by an early warning system and Ombudsman findings.

She went to describe their mandate and the processes they follow. (See presentation)

Health Ombud

Prof Malegapuru William Makgoba, Health Ombud, said there had been an explosion of mental health issues throughout the world. There was a need to establish a committee on mental health to advise the Minister and the Parliament, particularly in South Africa where they had had 365 years of trauma through colonialism and apartheid, which had created all kinds of mental health scenarios. At the moment, they had one of the highest gender-based violence rates, which was normally associated with the trauma suffered and the neglect which was given to children. All these factors related to the way they were socialised. As Parliamentarians, he wanted to leave them with the message that there was a mental health epidemic in the world, and they had better wake up to this, as they had much more reason to address it because of their history.

Another issue was that the Ombud reports directly to the Minister, which affects the office’s independence. On the one hand, Parliament expects him to be independent, but how could he be independent if he had to report to the executive? He had applied to join the Office of the International Ombuds Institute, and the questions he had to answer included whether he was independent, because Ombud offices all over the world reported to Parliament directly, not to Ministers. There was a need for clarity on this issue of independence from the sixth Parliament.

The other issue he was facing was that he did not have staff, and at times had to rely on the staff from OHSC. For example, if he was in need of inspectors, he had to use inspectors from OHSC, but if there was also work that the inspectors were needed for in the OHSC, they gave priority to the OHSC and not the Ombud, which was really problematic on his side.

Discussion

Mr Munyai commented that they should have what was called ‘continuous monitoring’ which was intelligence-led, because if they had to have more inspectors they would close the office because they did not have money for this to be sustainable. He suggested that an increase in budget to this institution was important, because 5% was not enough.

Mr Van Staden said that he needed clarity on their mandate, as this would help them understand what they saw as their mandate and if it complied with state hospitals and clinics. Did they do inspections on a regular basis at these institutions -- and what did they consider as a regular basis? How many hospitals and clinics had had their certification withdrawn in the last financial year? How many inspectors were currently in service? If a report was available of all the inspections throughout South Africa’s state hospitals and clinics, the committee should be provided with it.

He commented that during the previous week (29 August) it had been reported that all hospitals and clinics in Gauteng had failed the safety order. He asked if the safety order also fell under their mandate, and how many state hospitals and clinics did not comply. What would happen if state hospitals and clinics did not comply with the National Health Insurance (NHI) rules?

Mr Jacobs said the Committee understood the challenges the OHSC and the Ombud were facing. They also have challenges with finances. He asked how they were going overcome this?

Dr Thembekwayo said their vision referred to safe and quality health care for all South Africans. However, there were not only South Africans living in South Africa who needed health care, so their vision was not inclusive of all the people living in the country.

The OHSC had highlighted the discouragement and penalising of the abuse of power and negligence in the presentation. She asked about the cases which they received in their Department, such as the case of the lady who had been tied to a chair in Mamelodi Hospital. If they received such cases, did they take action, because this would have an impact on the hospital personnel and indicate to the hospital itself that they were dealing its compliance with standards. There had also been a case of a patient who had been wrongly injected, which had led to the loss of use of her arm. She asked how open they were to such cases, and what help they could offer to those particular patients.

She pointed out that if one went on Google to search for the OHSC call centre number, there were three numbers which appeared, two of which had Pretoria code numbers. She asked how reliable those numbers were to the public for them to get help, because this was contradictory -- they could not have three different numbers that were part and parcel of one call centre. A call centre should have only one number that was effective.

She asked if they in-sourced security services and if not, was it because this saved money? If there was a still possibility for in-sourcing, when could it be done?

She had noticed that expenditure had doubled -- what was it that was making the budget increase that much?

Dr Dyantyi referred to inspections and certification, and asked if they ever experienced resistance, particularly from private institutions. She also asked about some of their experiences from people who did not comply. Had they closed any of the institutions because of non-compliance? What informed the validity of the four-year certificate? How long did it take for them to go through all the facilities to inspect them? Regarding self-assessment, did they also encourage peer assessment?

Ms Chirwa asked why the appeal timeframe was limited to only 30 days after an inspection. Was there a follow trail for places they were inspecting, and if it was public knowledge, how could they access it?

What participation rate of the public in different areas was required that would result in a successful consultative workshop? What was the average number of cases lodged, and what was the rate at which they dealt with them? Could they get a list of facilities that were complying and those that were not, and could they access the list of inspections that had been done and see how easily accessible they were?.

Ms Gwarube said she understood some of the inspections OHSC did were centred mainly on the issue of compliance, and were not necessarily a qualitative and substantive view or assessment of the public health facilities. For example, they had spoken about how they would have a checklist or a questionnaire when conducting their inspections. The problem with that was that there was a whole aspect of the health facility which was not being looked at, which was the qualitative standard of health care which was being delivered. A hospital may have certain types of equipment, yet the experiences of people may still be poor. She asked if they were going to have a more substantive function than they currently had so that they could begin to look a quality rather than compliance.

Ms H Ismail (DA) asked how many facilities the OHSC had recommend to the Health Minister to be closed -- that is, how many clinics and how many hospitals, including private hospitals. She was not only concerned about the building standards which they were checking on for compliance, but also what their limitations were on how far they could go with their checks on maintenance.

They had been told about the registration app, where they wanted all the patients to be recorded as they entered a facility. She asked if there could be a survey added to this registration app so that once the patients were on it, they got the opportunity to say what the service was like at a particular health facility. She asked how many hospitals have been inspected thus far and those that had been shut down.

Ms Wilson referred to the certification of health establishments that complied with prescribed norms, and standards, and asked the OHSC to tell the Committee what their relationship was when licensing of them. She commented that the licensing of hospitals and clinics was usually done at the provincial level. They were receiving complaints from all over the country that people were failing to get their licences, and that sometimes it took two to three years for them to get them. Sometimes there was no response. She added that she was worried about the kind of money they were paying on leases, since with that kind of money they could buy a building.

The Chairperson commented that the OHSC was inspecting both public and private facilities. If a public hospital was asked the percentage of caesarean sections it performed, it would be around 30%, but in private hospitals it was 80% and the reasons which were given were not really medical reasons. He asked what they did about those kinds of situations.

There had been information that in private hospitals that patients had to sign forms indemnifying the hospitals for whatever they did. The reason they give is that the doctors that have to look after the patients were private doctors, and not the hospital’s doctors. He was astounded that they had to actually sign to go to a theatre, for instance, and then come back and be connected to a machine with no oxygen, and therefore should not have to indemnify anybody.

He observed that in their presentation, they had not mentioned what an ideal clinic should look like.

He asked if they were advising the Department of Health that staff of clinic A should not go and borrow equipment from clinic B so that they could impress the inspectors and pass the compliance test. How did they deal with such situations, and what advice would they give the Department?

Department’s response

The Department responded that the quality issue had been the one thing that worried them. At the moment, they were measuring numbers – like there were 30 complaints or 30 cases. However, what they had not grappled with was the quality of the impact that they give to the promotion and protection of the patients. They had not been paying much attention to that aspect, and there was a need to look at the impact of their activities as opposed to just the numbers.

Within a health institution, there was a need for doctors and nurses to be able to provide comprehensive care, looking at attitudes and all of the softer side which was critical to medicine. They could do that only in an environment that allowed them to do that. They had to have buildings which worked, and that had all the kind of environmental factors that made it comfortable for staff but also reduced infections. In addition to that, there was a need for technology that allowed them to identify when there was a problem, and that technology should also tell them when things were going right. Staff also had to know how to use technology.

From there, they needed to look at the staffing component, and whether the staff were able to do their jobs. This could be done through inspecting to see if they actually had the necessary equipment. In addition, if they wanted to look at the outcomes of care, to see how many adverse events there were -- like what the infection rate was, and what was going on with regard to incidents like rapes in the hospital -- just by doing proper inspections at the hospitals.

There was a need to move from giving answers such as yes or no. They needed to start taking steps where they had to ask themselves that if it was a no, what the problem could be, and from there give recommendations. This was the direction that the office was currently trying to move towards.

There was also a need to continuously monitor performance. The OHSC office was in the process of developing a work-based information system which would allow hospitals to enter their own data when they were trying to improve their quality improvement programmes. The idea that they were working towards was to try and ensure that the database was available to people who were privileged to have it, like hospital managers and departments within a hospital. This would help them to look at their performance and start to also look at what they were doing and whether it actually stimulated change.

They had just developed a compliance status framework which they would use in their new inspections for the coming year. It was important for the Committee to know that they had an inspection report for 2018/19 ready, but they could not give it to them yet. They would, however, come and present it to them in Parliament so that they could interrogate it.

They had not yet started inspecting the private hospitals. As their CEO had said, without the norms and standards they could not go into the private hospitals. However, now that they had the norms and standards, they would go into the private hospitals. They could therefore not yet say what the difference was between private and public hospitals. There had been some research done by various universities, so there was a lot of information that was available for them to make up their mind on which care was better. It all depended on whether a person wanted nice curtains and food, or if they wanted competence. The OHSC looked for competence and making sure that they minimised infections, and that the patients' rights were adhered to.

Before February 2018 they did not have regulations, as they were using the national core standards based on the documentation and policy of the National Department of Health. However, they were working as the fully-fledged regulator now that they had the regulations promulgated which would start from the current financial year’s inspections, which meant that the enforcement action they had described would now be properly administered. Based on the national core standards, they had reports that were available on their website. When they were called again to come and share the reports for 2017/18 and 2018/19, they would go into detail as to how many they had found which were complying and how many were not, but this would be based on national core standards, not the regulations. This was the reason they could not go into the private sector, but now they could certainly go because they had the regulations.

The mandate of the Office definitely expands into the private sector. Regarding the vision of the OHSC not including non-South Africans, they had just finalised the strategic plan for the next five years, and indeed it had been one of the things they had changed -- from all South Africans, to all health care users that were accessing health care services in the country.

Regarding the ideal clinic, the OHSC had programmes to ensure there was an overall quality improvement. Therefore, the ideal clinical realisation involved a continuous quality improvement programme, where they were coming as a regulator to give quality assurance. The report they would generate would be looking at those broad issues which they would have identified as an organisation, which related to quality assurance.

Regarding the allegations of hospitals borrowing equipment, if they found hard evidence that they were being given misleading information, it would actually be an offence.

On the issue of appeals, there was nothing they could do because the process was stipulated in the legislation and they could not operate outside of that.

The four-year validity period of the certificate of compliance was also regulated and legislated. It was prescribed by the legislature that the certificate should be valid for a certain time not exceeding four years.

Regarding licensing, they said that the provinces license the establishment and development of new hospitals, and the OHSC comes as a regulator to look at the quality of the services that would be rendered in that health establishment. Both processes were different. The province had the mandate from the legislature to say that they had to look at the development of health institutions within their provinces. The OHSC only comes to see if they had fulfilled the quality requirements, and certify that they were compliant to the norms and standards.

With reference to the Mamelodi hospital incident, they had investigated the matter and made recommendations to the National Department of Health. They hadalso sent a report to them so that they could follow-up on the matter. Regarding the patient who was mistakenly injected, they had not received that information, and requested that it be forwarded to them so that they could deal with it.      

Regarding the number of the call centre, the other numbers had been removed and the only one they were using was the direct call centre number which had been launched in 2006 and was publicly communicated.

The average number of complaints they received were around 65 a week – about 230 a month.

One of the challenges they were facing with medico-legal cases was that they had seen a trend of legal firms lodging complains on behalf of users of health care services, and this was one of the legislative gaps they had found. If one looked at regulation 32 (2) of the procedural regulations, it allowed any representative to lodge a complaint on behalf of a user.

Regarding machinery equipment, most of it was electronic, and over time it needed to be replaced, and this was why they budgeted for it. They had leased accommodation because they did not have the funds to make an outright purchase at the time they moved into the buildings, but it was something that they were considering going forward.

They had been outsourcing their security for a year, but planned to start in-sourcing as recommended.

The meeting was adjourned