National Health Insurance (NHI) Bill: public hearings day 14

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20 July 2021
Chairperson: Dr S Dhlomo (ANC) Acting Chairperson: Dr K Jacobs (ANC)
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Meeting Summary

Video: Portfolio Committee on Health, 20 July 2021

NHI: Tracking the bill through Parliament

In this virtual meeting, the Committee continued with its public hearings on the National Health Insurance (NHI) Bill. Five organisations presented oral submissions. All the entities welcomed initiatives to improve access to quality healthcare services to all South Africans, and proposed a number of amendments to improve the Bill.

Action in Autism highlighted the strengths and challenges present in the existing public health system, specifically the provision of healthcare to persons with autism. A number of suggestions were made on how the healthcare system could be strengthened, including increasing the number of specialist doctors in hospitals and the proper training of nurses and auxiliary staff about autism. The organisation emphasised its support for the Bill, and stressed the need for expanded provision of care, particularly for neurodevelopmental conditions. A number of recommendations were made to improve the Bill, principally to recognise autism spectrum disorders as part of the basic package of prescribed minimum benefits under the NHI. It was suggested that the Board include expertise in mental health and neurodevelopment.

The Committee asked why the presentation had focused on autism when the presenter was part of the Presidential Working Group on Disability, which covered all disabilities. Clarity was requested about Action in Autism’s proposal to strengthen the health system. A Member asked why it supported National Health Insurance when the presentation had highlighted more 'cons' than 'pros.' How well were psychiatric support services included in the Bill. Given the shortages of qualified healthcare practitioners who specialised in psychiatric care, could adequate care be provided to persons with autism under the NHI? A Member asked whether Action in Autism was advocating for the institutionalisation of persons with autism.

The Society of Private Nurse Practitioners provided an overview of the Society. Nursing and regulatory challenges were outlined, which included the lack of recognition of nurses as independent practitioners and employers. Concerns were raised about representation on the Ministerial Committees, as well as about the prices/fee structures under the NHI. The Society raised concerns about the need for certification to register, which excluded parts of the population from accessing healthcare. The Society had reservations about the composition of the various structures outlined in the Bill, commenting that limited consideration was given to preventative, rehabilitative, palliative or community-based care.

The Committee asked whether the establishment of the Health Care Benefits Pricing Committee and the technical analysis of the price of healthcare benefits in the Fund would cover the concerns raised by the Society. A Member asked what other challenges were faced by members of the Society that the Committee should look out for when working on the Bill. Clarity was requested as to whether the Society was aware that the NHI White Paper spoke about accreditation and contracting private providers to supply a comprehensive range of services. Was the South African Nursing Council providing adequate regulation of private nurse practitioners? A Member asked whether the Society had a proposal of how nurse practitioners could align themselves with referral pathways, as outlined in clause 7 of the Bill.

Doctors without Borders, otherwise known as Medicins Sans Frontieres (MSF), outlined its functions and programmes in South Africa. The plight of refugees was outlined on a global scale. The presentation focused largely on chapter two of the Bill, specifically the exclusion of asylum-seekers and undocumented migrants, and the implications of requiring registration of users of the Fund. It was suggested that chapter two of the Bill reduced access to a critical population by excluding services to asylum seekers and undocumented migrants and requiring registration documentation, despite the need for safeguards of such information.

The Committee asked why there was no indication of how to rectify the problems highlighted. The Chairperson asked whether there was any country in the world where anyone could access a full package of services, irrespective of where one was from. Further clarity was sought about the exclusion of users resulting from a lack of documentation. What was the organisation’s opinion on how South Africa was addressing the challenges of refugees, in the face of the limited resources in the country? Did it have suggestions on how the financial capacity of the NHI should be balanced to avoid a collapse, due to providing healthcare to people from other countries?

Johnson and Johnson suggested that the Bill offered a ‘narrow health system.’ Particular reference was made to the limitation on medical schemes, ‘necessary care,' and strict formulary adherence. A number of challenges were outlined that included the potential for discontinuation of care for patients who had discretionary funds at academic facilities or through medical schemes. It emphasised that the rights of patients could be impacted by the strict enforcement of the formulary, health technology assessment and procurement systems. Specific suggestions were made to aspects of the Bill, focusing on patients' rights and suppliers. The presentation emphasised that the Bill appeared to have different and contradictory proposals about medicines and medical device pricing in the NHI system. Johnson and Johnson proposed a number of changes to the Bill, such as the removal of all reference to the single exit price in the schedule to the Bill. A number of suggestions were made about the definitions in the Bill. Centrally, it emphasised that the sustainability of the NHI was concerning. The National Health Service (NHS) in the United Kingdom was highlighted as a case study to consider financial sustainability.

The Committee requested clarity on Johnson and Johnson’s view on the fragmentation of healthcare funding in South Africa. Was it not important to ensure alignment of funding to avoid double-dipping? They asked about the concept of ‘average patient,’ and their coverage. Questions were asked about overseas court cases against Johnson and Johnson products. Given that Johnson and Johnson had defined universal access very differently to that of the Bill, did it support the principles as defined the NHI White Paper? A Member asked how the single purchaser model would affect the sustainability of the NHI. Questions of clarity were asked about discretionary funding, and Johnson and Johnson’s advocacy of it.

The South African Medical Technology Industry Association emphasised its support for universal health coverage, given the inequities in the current healthcare system. The Association suggested that a milestone approach was required. It highlighted that policy integration was essential to the successful implementation of the NHI. Concerns about potential legal challenges delaying the implementation process were outlined. Clarity was requested about the accreditation process and a number of recommendations were made in this regard. Key considerations were outlined about the Office of Health Products Procurement, which included the need for transparency and accountability, as well as the need for a specific knowledge of MedTech.

The Committee asked how the Association had demonstrated its commitment to sustainability and transformation in the MedTech sector. Clarity was sought about the risks of the proposed method of appointing the Board according to the Bill. A Member asked whether a pilot study was required to ensure the success of the NHI. Did the Association think that health technology assessment was necessary to identify the most appropriate medical devices for use in health facilities?

Meeting report

Submission: Action in Autism

Ms Liza Aziz, Chairperson and Funding Member of Action in Autism presented to the Committee.

She said that according to the Diagnostic Statistical Manual (Fifth edition), authored by the American Psychiatric Association, there are now three levels of severity:
Level 3: Requiring very substantial support;
Level 2: Requiring substantial support; and
Level 1: Requiring support.

Common co-occuring conditions with autism are Attention Deficit Disorder (ADD), Epilepsy/Seizure Disorder, anxiety disorders, Obsessive Compulsive Disorder, mood disorders (depression), bipolar and sleeplessness.

Communication disability

More than 50% of autistic people are non-speaking, therefore providing an alternative means of communication is pivotal to ensure the rights of persons with autism to communicate and contribute to society.  
Alternative augmentative communication (AAC) encompasses the communication methods used to supplement or replace speech or writing for those with difficulties in the production or comprehension of spoken or written language.
The most common and effective communication tool for non-speaking autistics is the Ipad, with tailored software programmes that enable speech generation and communication.
Autistic people were historically excluded from the public schooling system and were victims of institutionalised discrimination, stigmatisation and neglect.
Some of the barriers they face in society are negative attitudes to and stereotyping of differences, inaccessible and unsafe built environments, and inadequately and inappropriately trained health care professionals and educators.

Strengths that exist in the current public health system

Medication is free at public hospitals;
Some therapy, although infrequent is provided;
Autistic patients are given priority in some places;
More people have knowledge about autism;
There are facilities, even though this is not enough;
Some doctors prioritise treatment, and understand autism;
Acts of kindness towards our children are valued.

Challenges that exist in the current public health system

Exorbitant costs at private hospitals;
Too few experts in the field – diagnosis is then given too late;
Overmedication of psychiatric drugs;
Hospitals are noisy and sometimes smelly places – more awareness is needed around sensory differences of people with autism;
Our constituency endures long waiting periods;
The health sector is not trained on autism;
No understanding of disability, specifically neurodevelopment disability amongst health professionals;
Patients see new doctors and interns at each visit – care and management is therefore difficult;
There is dysfunctional and, in some case, no medical equipment at some hospitals, i.e. MRI scanners not working;
Management of medication is haphazard when one sees a different doctor at each consult;
Security guards are called in to hold patients down for blood tests, for example.

How the system can be strengthened to serve our community

Increase the numbers of specialist doctors in hospitals – many children are seen by general practitioners in public hospitals;
Train nurses and all auxiliary staff better;
There is an urgent need to train health care professionals across the value chain on autism spectrum disorders;
There is a strong need for a holistic approach to patient management from a multidisciplinary team;
There is also a strong lobby to provide multidisciplinary home team visits;
To eliminate queues for autistic people, the recommendation is that consultations should be based on appointments, or to prioritise our constituency so they do not have to queue;
Healthcare workers should be more sensitised to girl children who can sometimes mask the symptoms of autism. The recommendation is that home visits could address this;
There is a strong feeling in the House to lift the moratorium on all the therapy posts in hospitals and to employ more therapists, like speech-language therapists with an augmentative alternative communication background, occupational therapists with a sensory integration background and psychologists who have an understanding of autism;
Further development of therapists already in employment in the public health sector is required;
There is a need to provide a service for the caregivers of autistic people who are admitted into hospital and have no one to care for their child;
There is also a call to provide transport to and from the hospital;
A recommendation has been made to provide a dedicated waiting room set aside for autistic people – a calm, quiet space with few chaotic sight-lines;
There is also a strong recommendation that mothers/main caregivers must be kept informed every step of the way in terms of hospital treatment and management;
Immunisation cards/ Road to Life cards should include neurodevelopment assessments;
There is a need for disability support officers to be employed in every hospital.

Response to the Bill

Action in Autism is firmly supportive of an NHI Bill -- an equitable healthcare system that serves all citizens in South Africa.
Currently a lot of money is spent on healthcare. This amounts to almost 9% of the gross domestic product (GDP), but it is currently spent very badly. Neurodevelopment conditions like Autism Spectrum Disorders and mental health has particularly suffered from poor medical treatment, mismanagement and poor resource and infrastructure.
The Life Esidemeni Tragedy continues to haunt this sector of health care, and is a sad indictment on the lack of service and care in the South African Public Health system. In a recent study of the state of health care and social adult care in England 2018/2019, which has its own national health insurance, it was found that “services for people with mental ill-health, or people with a learning disability or autism …are finding it hard to get the support they need, when they need it. This might mean they end up in mental health services, but this could have been avoided if they had been helped sooner. For example, too many people with a learning disability or autism are in hospital, because there are not enough specialist services with the right staff where they live.”
(October 2019, How good was health care and social care in England in 2018 and 2019).
The autism community who have fundamentally a communication disability -- those who are non-verbal and are unable to speak for themselves -- are particularly vulnerable and receive poor medical intervention and treatment. Action in Autism’s first concern is about early diagnosis of our people. The greatest challenge is the paucity of qualified diagnosticians and clinicians for autism spectrum disorders. Autism is a condition that needs to be diagnosed and managed, and families and the community need to be supported and up-skilled on best practice methods for lifelong support for people with autism. The NHI Bill must ensure an increased pool of qualified diagnosticians that are easily accessible, with an efficient referral system.

Another huge problem that has been identified is the lack of a multi-disciplinary approach in the public health system. Doctors do not have a broader understanding of the socio-economic or psychological context of the community from which a patient comes. Ultimately, it is about treating society. People who are socially integrated, economically active and psychologically stable should be the goal. Currently, most of our people come from poorly resourced, impoverished backgrounds, whose health care needs are not being met. In the current system their mental health is neglected and our people with autism are particularly vulnerable to neglect. Healthcare has failed to integrate into the social system. It is not talking to schools, political structures and broader society. Medical intervention is a small proportion of the needs of our community -- the rest is optimising other aspects of life, and trying to create a better place for them in the world.

For the small percentage of people in our constituency that do have medical insurance, Autism Spectrum Disorder is not part of the prescribed minimum benefits of any scheme. Our community suffers because of this. Many services come out of day to day benefits, exhausting this meagre amount early in the year, with the main member having to cover the costs of most treatments. Therapies like speech-language therapy and occupational therapy are most often not covered by insurance and the medical and mental health of the community is exacerbated without these basic supports.

Amendments and additions to the NHI

We strongly and urgently request that Autism Spectrum Disorder is recognised as part of the basic package/ prescribed minimum benefits of the NHI.

In terms of the Constitution and the composition of the 11-member Board of the Fund (Chapter 4, Section 13, subsection (5) (b)), we strongly urge that expertise on mental health and neurodevelopment management and care be included. This high-profile appointment will ensure that persons with disability and mental-ill health are prioritised. These mental health and neurodevelopment experts must be cascaded down to all committees:

In the appointment of an expert technical committee for the sector (chapter 6, Section 24).
The advisory committee, established by the Minister, chapter 7, Section 25, subsection (2) must include a person with expertise in disability, mental health and neurodevelopment conditions and autism.
Inclusion of an expert in the Health Care Benefits Pricing Committee (Chapter 7, Section 26, Subsection (2)) must likewise include a person with expertise that understands the disability sector and specifically the mental health sector.
The Stakeholder Advisory Committee must include a disability expert (which must be a person with a disability) and be a person who has experience serving those with mental ill-health and developmental disabilities (Chapter 7, Section 27).

Our community requires a one-stop, multi-disciplinary team approach, with people who are knowledgeable, and who can support our community from a health and lifestyle perspective. We therefore request that the primary health unit, as indicated in Section 37, subsection 2, must include multi-disciplinary ward-based teams. Our caregivers and parents need to be strengthened and empowered on how to support their people with autism. We require an out-of-hospital, multidisciplinary team that helps with end-to-end management of our people with autism.

The office of Health Products Procurement must include knowledge on the essential medicine list and essential equipment list for autism (Section 38, subsection (4)). This should include basic communication devices and sensory equipment.

The establishment of the Appeals Tribunal (Section 44, subsection (1)) should include a person with knowledge on alternative, augmentative communication systems, for people who cannot speak for themselves and for those with unreliable communication systems.


Autism Spectrum Disorders is a unique condition. The path for this extremely vulnerable community needs to be optimised. When their social, psychological, health and educational needs are met, it impacts on generations to come.

As they grow, the needs of our community also change. This needs to be recognised across the health value chain. Currently, this community is suffering immense health and psychological trauma.

When the Australian health system, from the president down, decided that mental health was a priority for the country, the entire country benefited.
(Crossroads: rethinking the Australian mental health system,10 March 2014).
We want the same for our people. Our people need to be recognised as a vulnerable group that requires targeted support that is part of the primary minimum benefits of the National Health Insurance.


Chairperson Dhlomo noted that Ms Aziz had stated that she was part of a presidential task team on disabilities, and asked why she had presented only on autism and not more generally on persons with disabilities.

Ms Aziz responded that the presentation came solely from Action in Autism, and did not represent other disabilities.

Chairperson Dhlomo said that Action in Autism was largely calling on the Department to strengthen its health systems. With or without the NHI, the strengthening of health systems was a matter that needed to be attended to. He requested clarity on Action in Autism’s proposal about that.

Ms N Chirwa (EFF) said she was curious as to why Action in Autism was in support of the NHI, when there were more 'cons' than 'pros' presented in the presentation. The presentation highlighted the issues in townships and rural areas – the NHI Bill did not propose solutions for these specific challenges. It did not propose solutions at an infrastructural level nor in terms of specialist staff, such as occupational therapists (OTs). There was a crisis of there being an insufficient number of Early Childhood Development (ECD) centres in townships and rural areas, specifically to cater for children on the autism spectrum. What was the basis for their support, given that the NHI did not cater for the problems experienced?

Ms H Ismail (DA) asked how well the Bill included psychiatric support services. In the presentation, it had been highlighted that there was a shortage of qualified healthcare practitioners, such as diagnosticians and those that specialised in psychiatric care. Did Action in Autism feel that under the NHI, the Department could adequately accommodate individuals with autism, given the shortages? What were Action in Autism’s three major concerns about the NHI, specifically those of the autism community.

Dr S Thembekwayo (EFF) commented that Action in Autism was based only in KwaZulu Natal (KZN). Autism did not occur only in KZN -- there were people with autism in all provinces of South Africa. Why was the good work Action in Autism was doing, such as the resource centres, educating parents and accessing schooling etc., not spread throughout the provinces of South Africa? This would be beneficial, specifically given the problems around schooling for persons with autism.

Dr K Jacobs (ANC) asked whether Action in Autism would want autism spectrum disorders to be included in the package of the NHI. This matter would be raised with the Department for consideration. The Bill did not list the services to be provided. The services would be included, as specified, in the transitional arrangements, outlined in clause 57(4) of the Bill, which stated that services would be purchased. This included services for persons with disabilities and rural communities, such as audiology and speech therapy etc.

Ms M Hlengwa (IFP) asked for clarity as to why the presentation represented only one disability. She noted that autism was not included specifically in the Bill. There was a Department of Women, Youth and Persons with Disabilities that catered for all disabilities. She asked why autism was not covered by the Department. She asked whether the ‘treatment’ for autism was chronic – would life-long care be required? Did autism require a medical diagnosis, or ‘could lab tests' assist in this condition?

Mr T Munyai (ANC) said that Action in Autism had outlined a spectrum of signs and symptoms of autism. There was an array of manifestations that could be expressed as an ICD-10 diagnosis. What relationship did Action in Autism have with the organisations such as the South African Association for Social Workers in Private Practice (SAASWIPP) and the National Association of Social Workers (NASW)? He asked this, as social support for families was crucial. He would have expected that the Social Workers Association would be an integral part of the solution proposed by Action in Autism. Was Action in Autism a national organisation, or was it based only in KZN? If the organisation was based only in KZN, was there any intention to nationalise the organisation? He requested clarity about what type of technical support was offered by Action in Autism for support of individuals with autism. Action in Autism had expressed a view that suggested that the health system should ensure the availability of suitably qualified professionals who understood autism in all facilities, instead of creating special facilities. Was this correct? He requested clarity on that.

Dr X Havard (ANC) said that Action in Autism had indicated that persons with disabilities should be included in the various structures set up by the NHI. This may not be feasible, as every profession wanted to be represented. Was there another way to be included, without being represented on all the structures mentioned?

Mr M Sokatsha (ANC) asked whether Action in Autism was advocating for the institutionalisation of sufferers of autism. Was this the best form of providing care for these individuals? Or was Action in Autism suggesting institutionalisation in circumstances where immediate care was needed by individuals living with autism?

Ms A Gela (ANC) said that the NHI would provide comprehensive health services for its population under a single payer health system. Based on Action in Autism’s experience in the current two-tier health system, how did they anticipate comprehensive health services being fulfilled under NHI?

Chairperson Dhlomo requested clarity about the mention of ‘healthcare workers sometimes failing to make a diagnosis.’ He was not sure whether healthcare workers ‘failed’ to diagnose autism or whether this was done deliberately. Instead of diagnosing autism, they diagnosed schizophrenia – and this had various implications. Action in Autism had made recommendations that specialist expertise should be included, with special knowledge of autism on the NHI Pricing Committee. Was this not a narrowed focus? Why not instead make provision for expertise on broader disabilities? He asked that Action in Autism outline how this would have a positive impact on people with autism.

Action in Autism's response

Ms Aziz responded as to why Action in Autism supported the NHI, when there seemed to be more 'cons' than 'pros.' Action in Autism supported the NHI because it was an equitable system, and because it wanted every person diagnosed with a neurodevelopmental condition and/or any disability to be given the same support and healthcare provisions that were provided for by the constitution. One needed to ensure that equitable healthcare services were provided to all. That was one thing that Action in Autism had been lobbying for strongly. Within the educational system, as an example, there were private schools, with parents who had medical aids who were able to access some of the support and care involved in supporting individuals with autism. However, it should not be solely for them -- they should not be the only people able to access the professionals or the therapy required. There should be a service available for every single person born with autism across South Africa. That was why Action in Autism supported the process, even though they were concerned about the management structure at public health facilities. There were also financial concerns about the NHI. However, Action in Autism still believed in the system, specifically in terms of providing the same level of service to all.

Regarding the inclusion of psychiatrists in the Bill, as well as support services, Action in Autism suggested that the NHI should strengthen this system to ensure that there was greater support provided. If she understood the Bill correctly, those in private service would have to provide to all under NHI. That was extremely important. There were a sufficient number of therapists in the country, and a large majority of them had been servicing people with medical aids – the percentage of the population that could afford those services. With redress and redistribution, there would hopefully be a greater number of healthcare professionals that would be able to support the population.

Action in Autism had three major concerns about the NHI. Firstly, the power held by the Minister. Secondly, the distribution of resources and infrastructure - how that would happen and whether it would be centralised, or if the provinces would be able to make decisions. Thirdly, the financing of the NHI was a huge concern.

Action in Autism was based only in KZN, as the organisation did not have the capacity nor infrastructure to be in other provinces. It worked in partnership with Autism South Africa. While Ms Aziz was a member of the Presidential Working Group on Disability, and had insight into all disabilities, it was important to note that neurodevelopment, mental health and psycho-social conditions were largely marginalised disabilities in the country. These conditions needed to be taken seriously. There were a high percentage of persons with disabilities globally. In South Africa there were no formal statistics about that. One was looking at approximately one in every 65 people having a neurodevelopmental condition. That was important to bear in mind when providing services to this particular population. At present, Action in Autism did not have the capacity or infrastructure to provide services across all provinces. That was a concern, as there were many provinces that were not getting support or did not have the right provisions. There was no one lobbying for services for those people within the provinces.

Action in Autism was proposing that the autism spectrum be considered in terms of primary minimum healthcare benefits. It was proposing that these be provided in the transitional arrangements. If one considered the issues around the Life Esidimeni scandal, there were many individuals with autism amongst that group who had died. This was a huge concern for Action in Autism. Within the Department of Women, Youth and Persons with Disabilities, whilst there was an attempt to represent all disabilities, there was limited agency and a small budget. It was important that Action in Autism ensured that they went directly to the Department of Health to ensure the needs of persons with autism were not left behind.

She noted the statement about the International Classification of Diseases (ICD)-10 diagnosis. She said it was crucial for Action in Autism to partner with the NASW. One needed to move away from the understanding that healthcare was just the ‘servicing’ of an individual. One needed to look at a human rights approach –so that Action in Autism did not serve only the individual, but served society. If one empowered the main caregiver in understanding the condition – whether autism or another condition – one was serving the community by ensuring lifelong service and support was provided to that person. Public healthcare services could provide that. When the child was diagnosed with autism, a trans-disciplinary team approach could be adopted to ensure that the main caregiver was equipped. This could then be passed on to all the other caregivers, including the community, to ensure that the mental health of that child, as well as the entire family did not reach crisis. One needed to rethink healthcare solely on a medical level and on a one-on-one basis. One also needed to think about how to service entire communities and society at large to ensure that there was no mental health crisis in the country. Action in Autism had partnered with other organisations in the other provinces to ensure that some services were provided in the rest of South Africa.

In terms of persons with disabilities being mentioned in the various structures of the NHI, this was pivotal. According to Statistics South Africa (StatsSA) 2013, seven percent of the population had disabilities in the Country. That statistic was likely to be an underestimation, as a lot of the neurodevelopment, psycho-social and mental health conditions were not included in that seven percent. If one considered that seven to ten percent of the population would need to be provided with essential healthcare services, it was essential that there was a person that understood disability, disability rights and neurodevelopmental conditions. There needed to be healthcare professionals who were experts in those fields. If comprehensive health services could be provided – that would be pivotal in serving communities.

Regarding healthcare workers mis-diagnosing, she was referring specifically to the private healthcare system, where neuro-paediatricians and psychologists were diagnosing childhood schizophrenia in order to access the chronic medication. The medical aids did not consider those medications to be chronic unless professionals gave a diagnosis that was recognised by the ICD-10. It was only in that respect that a diagnosis of schizophrenia would be given so as to ensure that the patients got the medication they needed. In terms of specialist expertise, Action in Autism agreed that there needed to be broad representation, not only of autism, but all mental health and developmental conditions. She had provided the list of conditions.

Mr Sokatsha asked whether Action in Autism was advocating the institutionalisation of ‘sufferers’ of autism, or recommending that this applied only to circumstances where immediate care was needed by individuals living with autism.

Ms Chirwa said that she was more confused by Ms Aziz’s response about supporting NHI ‘because it was equitable,’ when the concerns raised spoke to the fact that the NHI was not equitable. The kind of constituency Ms Aziz represented was one of the most dejected constituencies in the public healthcare sector. The NHI did not resolve any crisis of the constituency Ms Aziz was speaking on behalf of. The point about the NHI being equitable did not necessarily mean that the application/implementation thereof would be equitable. The people in rural areas and townships would still be left destitute because the referral system required that people started at their closest healthcare facility. This would not be resolved by the NHI being put into effect. Who was it equitable for? It was not equitable for people with autism, nor for children with autism, in the townships and rural areas. It was not equitable for the three-year-olds who had to wait until they were eight years old to go for certain tests. It would not resolve the problems, as presented by Action in Autism. Who would the equity benefit, as it would not benefit those who Ms Aziz was representing in this meeting? The NHI would not resolve the crisis that was prevalent for people ‘suffering’ from autism – they were not catered for. On what basis was Action in Autism suggesting that the NHI would be equitable, if it was not equitable for those she was representing?

Mr Munyai stated that he was covered by the questions raised by Mr Sokatsha and Ms Chirwa.

Ms Aziz said that Action in Autism was not advocating institutionalisation -- it wanted to move away from institutionalisation. She was specifically referring to institutionalising in terms of points of crisis. She understood the issues raised by Ms Chirwa. She knew that the health system was extremely fractured. On paper, the policy was a ideal to support the healthcare needs of every single person in the country. Therefore, if one looked at it in terms of the Constitution, and all other legislation, one needed to support it. Measures could then be put in place to ensure that the roll-out of the NHI would be as equitable as possible. One needed to ensure that the right watch-dogs were in place to ensure that the system was rolled out in an equitable way. The NHI on paper was a really excellent system - wanting to meet the needs of the South African people. The current system was not doing that. A large proportion went to the private sector, and Action in Autism wanted to make sure that everyone got the same kind of service. She understood that it was a completely fractured service and that the healthcare system was in chaos at present. At the same time, there was hope in a system that on paper was democratic, equitable and humane. That was why they were fighting for it – like one fought for the Constitution of this Country. The right technical expertise and support needed to be provided. One needed to ensure that the right monitoring and evaluation of the system took place. One also needed to find out where the money went, so that at least there was an extreme attempt to redress the imbalances in the country.

Chairperson's comments

Chairperson Dhlomo said Ms Aziz would likely find a lot of people who would support her thinking that the health system needed to be strengthened across the globe – specifically for mental health. Mental health was sidelined, particularly when there was a shortage of resources. He suggested that outside the meeting, the Committee needed to find a space to meet with the Portfolio Committee on Women, Youth and Persons with Disability. Some of them were under the impression that this Portfolio Committee was involved in programmes across government departments. Were there programmes in all government departments focusing on women, youth and persons with disabilities?

Submission: Society of Private Nurse Practitioners (SPNP)

Dr Nkhensani Mukoki, National President of SPNP, and Ms Debbie Regensberg, Honorary Secretary and Treasurer, presented to the Committee.

They said the SPNP represented nurse practitioners who practice independently and interdependently throughout South Africa, and supported the call to provide affordable and accessible health care in line with Article 12 of the United Nations Covenant, the African Charter on Human and People’s Rights, and our Constitution, as noted in the preamble to this Bill.

They choose to work as self employed nurses as it gives them the privilege of providing a level of quality care which puts their patients and their needs at the centre of their practice.

Private nurse practitioners were professional nurses and midwives, registered by the South African Nursing Council, and provide nursing care on a fee for service basis, which was reimbursed directly or indirectly by the patient or non-governmental organisations (NGOs).  They did not include practitioners who are salaried, such as agencies (duty nurses), doctors consulting rooms, pharmacy nurses or occupational health clinics nurses on salaries. However, these practitioners also contribute towards a reduction of cost of care, and face most of the challenges being presented.

Nursing challenges

Nursing legislation continues to restrict recognition of expertise and skills of critically skilled practitioners, such as in primary health care – prescribing of the Essential Drug List (EDL),or issuing sick certificates;
Recognition of nurses as independent practitioners and employers, not only employees;
Inclusion in NHS/ NHI/Prescribed Medial Benefits (PMB) policy setting processes was limited to the South African Nursing Council (SANC) or the Department of Health (DOH), limiting perspectives and recognition of different challenges and practice contexts.

Regulatory challenges

There were the challenges of conflicting legislation, often due to outdated information, and the focus was on facilities not services. Areas which presented challenges included the Nursing Act, particularly S56 (6) and the Medicines and Related Substances Act, and regulations covering the Certificate of Need (in comment phase) and the Office of Health Standards Compliance. Various nursing regulations were in process

Technological challenges

These included advances in health services and health care provided by nurses which were not recognised or reimbursed by funders, and were not available in public sector; clinic facilities not aligned to draft regulations but approved for services – ideal clinic standards and outreach units, such as mobile clinics and portable prefabricated containers; and telehealth – providing referral pathways.


The SPNP recommends that the Fund must design health care services as advised by the relevant committee
. The composition of Ministerial committees should include registered nurses, who provide “the backbone” of healthcare, but had one representative across all committees through the SANC. They did not believe that this one person on their own could represent the healthcare needs of all the different patients, and therefore questioned the value of the nomination and selection processes.

Prices/fee structures

The Bill provides for the determination prices annually after consultation with health care providers, health establishments and suppliers in the prescribed manner and in accordance with the provisions of this Act, and for ensuring that health care providers, health establishments and suppliers are paid in accordance with the quality and value of the service provided to users at every level of care. SPNP's experience had shown that fees have been set against public sector salaries, not taking into account overhead costs of business. Other concerns were the omission of nursing representatives on the relevant Ministerial committees, and differentiation between levels of care – generalists vs. specialists -- which, if based on SANC criteria, would exclude services such as advanced wound care, stomatherapy, lactation consulting, and similar services which are not linked to academic requirements for registration as specialists

Payment of providers

S39 refers to the payment of primary service providers at health establishments that must be funded on a "risk adjusted capitation basis.”

The provision of home-based (domiciliary) nursing service in the public sector is critical to a reduction in in-patient admissions, facilitation of early discharges and provision of appropriate levels of community based care. South Africa's public health services do not provide these nursing services, particularly for more advanced nursing needs. The range of PMBs published to date have very limited reference to nursing care. Many rural areas do not have access to, or are not serviced by, medical practitioners, and public clinic services are provided once or twice weekly.

The Society seeks clarity on the proposed capitation structures and who would qualify as the “primary service provider,” and the allocation of services against this capitation fee in areas where nurses currently practice. This appears to be in contrast to the content of S52 (2) (b), which requires the Minister to make regulations for “mechanisms to enable the payment of individual health care workers and health professionals.”

Registration, licensing or accreditation

The Bill refers to monitoring the registration, licence or accreditation status, as the case may be, of health care providers, health establishments and suppliers. The current Nursing Act (2005) and supporting regulations do not recognise or enable appropriately skilled nurses outside the public sector to diagnose and prescribe in terms of S56(6) of the Act. S11 (5) and S33(1) of this proposed legislation states that treatment protocols and guidelines will be developed and must be followed. Will this requirement be accepted by the SANC, the South African Pharmacy Council (SAPC) and the DOH to recognise the role of private practitioners, and provide an environment in which licences to practise in terms of S56(6) may be granted? 
Particular areas of concern are reproductive health, primary health care, including maternal and child health, Nurse Initiated Management of Antiretroviral Treatment (NIMART), and palliative care

Right to healthcare

S7 (3) acknowledges the right of access to NHI services for various categories of users who are registered with the provider, subject to having an official identity document, birth certificate or valid documentation from the Department of Home Affairs (DHA), or be a dependent. The Society is deeply concerned that there is no recognition of children or other persons without valid birth certificates.  While it did not have the figures for this group, experience had shown that these children would be at risk if excluded.

Composition of the Board and committees

The Society has reservations and expresses concern at the composition of various structures:

S14(5). There appears to be no requirement that the Board should have an appropriately qualified / registered health care professional at the highest level of the Fund.
S25(2). The Benefit Advisory Committee includes two representatives of the private hospital sector, but no representative of private community-based professional organisations.
This has the potential to continue to embed the focus of private health care in the curative milieu, without due consideration for preventive, rehabilitative and community-based curative and palliative needs.

Accredited service providers

In S38(2), the omission of social workers from the potential list of accredited services providers is a further concern, given their role in the provision of health care and prevention of disease and infirmity.

Transitional arrangements

The Society wishes to see an expansion of the inclusion of private nurse practitioners in Phase 2 (S54) to complement the services provided, as is currently practiced in selected provinces and local authorities, to ensure that affordable and effective health care can reach every member of the community.


Ms Gela said that the presentation had highlighted important issues about price and fee structures. Clause 26 of the Bill spoke about the establishment of the Health Care Benefits Pricing Committee which would, amongst other things, undertake a technical analysis of the price of healthcare benefits in the Fund. Would this committee not address SPNP’s concerns? Medical professions would be represented on this committee.

Ms Hlengwa asked what other challenges were faced by members of SPNP that the Committee should look out for, when working on the NHI Bill.

Dr Jacobs said that the Bill outlined that the Benefits Advisory Committee would determine the service benefits to be funded by the Fund. Part of that committee would include medical professionals. Would SPNP want more clarity to be included in the regulations? Was SPNP aware that the NHI White Paper spoke about accreditation and contracting private providers to supply a comprehensive range of services?

Mr Sokatsha said the SPNP seemed to be advocating for sole practices for nurse practitioners in the private sector. How did SPNP see this proposal fitting into a multi-disciplinary team practice?

Mr Munyai asked whether the SPNP thought the South African Nursing Council was providing adequate regulation of private nurse practitioners. Did the Nursing Council license private nurse practices? If not, what was the SPNP’s proposal on including this, so that they were aligned to clause 39(2)(a). Did it have a suggestion on how the SPNP would align themselves to the referral pathways, as in clause 7(2)(d)(ii) of the Bill. It seemed to be advocating duplication of the same healthcare services. Was it recommending that the status quo be maintained? What specialisation did the SPNP members hope to offer in an NHI environment? It had highlighted the UN Convention and the preamble to the Constitution of South Africa -- did the SPNP support the principles of solidarity and equitable healthcare? Alternatively, did they believe that the two-tier system should continue – one for the private sector, and one for the public sector?

Dr Havard asked whether they had a proposal of how nurse practitioners could align themselves with the referral pathways, as envisioned in clause 7(2)(d)(ii) of the Bill.

Chairperson Dhlomo asked how many nurses the SPNP was representing in the country, as well as which provinces they were based in. He noted that the Society had mentioned that it was part of the Nursing Council. The Nursing Council had presented their view on the NHI Bill to the Committee. The SPNP had raised the issue of representation of nurses on the various proposed committees. It was said in the presentation that one nurse was not adequate – what would be a fair number of nurse representatives? He had raised this issue, because each profession and each specialist would want to be represented.

The fee for service model was known to be part of the reason why the South African health system was unaffordable, particularly within the private sector. Could the SPNP indicate why, under the NHI, such a model should be ‘condoned,’ as opposed to the introduction of other models (i.e. capitation). Under the NHI, it was proposed that there be a single system, therefore the reimbursement model would be used for better use of the pool of funds. Would that be an accommodating approach for the SPNP, or would that be a challenge going forward? There was reference in the presentation to the South African Nursing Council regulations, licensing and registration – these functions should stay under the control of the Council. He requested clarity on their concerns about that so that the Committee knew how to support and respond to them.

SPNP's response

Ms Regensberg said that the SPNP currently had just over 500 paid-up members. It was unable to establish how many nurses there were in private practice in the country – it had been a debate for many years. Research had been done but had provided limited accuracy because of the way in which people defined ‘private practice,’ as opposed to the ‘private sector.’ The SPNP practised from the extreme north of the country to the extreme south-east and west. There were practitioners all over, but they offered different services depending on their fields of expertise and the context in which they found themselves. Its relationship with the South African Nursing Council, particularly over the past few years, had been strengthened.

There was some frustration about the Nursing Act of 2005, as there was an extended period of over ten years when no progress took place, and none of the regulations were promulgated. In trying to work through them, the Council was looking at priorities about the scope of practice, education and attending to the basic regulations. The SPNP was in discussion with the Council about the licensing of private nursing practitioners, which was conflicting. The Nursing Council licensed nurses to be nurse practitioners, irrespective of the setting in which they worked. One did not see pharmacists, doctors or physiotherapists having to get a special licence from their professional body in order to become a private practitioner. The certificate of need was going to address this requirement. Why would one then say that the Nursing Council should decide who should qualify to be a private nurse practitioner? It was a debate, due to the fact that there did not seem to be a way forward with the certificate of need. As a result of the conundrum over the licensing of private practitioners, the SPNP had been working with the Nursing Council on this. Her previous question applied, ‘why should it be, when every other health professional would be licensed by the NHI Office of Health Standards and Compliance?’ Nurses would be the only ones who would need to be licensed for private practice through their professional council.

The SPNP supported a single tier system and the concept of universal healthcare – affordable and accessible healthcare. The problem that arose was that there were so many services that were not offered by the public sector. In geographical areas which the public sector could not get to regularly enough private nurse practitioners were providing district nursing type services at an affordable and equitable price to members of communities who needed them. There would be a number of services that patients might need under the NHI which were not included, or there were patients that might not be included. Whilst the SPNP would like to see a single-tier system, there would be people who would be excluded from the NHI who would still need care. The SPNP would want to be there for them, outside of the complementary services that the Bill spoke to.

In terms of the fee structure, SPNP’s experience had shown in the past that nurses tended to be seen as ‘employees’ and ‘support staff,’ not practitioners in their own right. Therefore the SPNP did not know the answer of how to ensure that when nursing care was required, particularly in geographic areas where there was no multi-disciplinary team available, those services would be reimbursed. It did not need to be on a fee for service basis. There was no reason why nurse clinicians or practitioners could not be the recipient of a capacitated fee to provide the services.

The nurses had for many years argued strongly against the requirement of the Health Professions Council of South Africa (HPCSA) that members ‘may not go into partnership with a person who was not registered by the Council.’ This had led to the exclusion of pharmacists, nurses and social workers legally from a multi-disciplinary team. That was a rule of the HPCSA which excluded nurses from being part of an inter-disciplinary practice or team. In the current situation, nurses would be excluded from taking part – in terms of a capitation fee – because of the way the system functioned.

The SPNP did not propose that existing services be duplicated. It was aware that many of the services were over-run. Clinic services were not at convenient times or in close proximity to where patients lived. Patients had to leave work to get to the doctor or nurse in order to bring their children in. Therefore, after hours, late in the afternoon, evening clinics and weekend clinics were very popular. This enabled parents to provide for their children. The SPNP was not looking to duplicate services, but looking to supplement or complement the services offered by the current public health services. This would reduce the load on nurses in the public sector.

The SPNP believed that they had the right and obligation to be included in the referral pathways. A patient with a severe wound, such as in the case of diabetics with severe ulcers, required the skills of an advanced wound practitioner. That service was not provided across the public sector. It might be provided in an isolated hospital setting, but what happened when that patient returned to the community. The SPNP believed that the nurses and the types of services needed to be fully analysed and needed to be incorporated into the referral pathways.

The Society wanted to be part of the multi-disciplinary NHI. It was asking to be included as ‘medical.’ They were not part of the HPCSA, and did not want be treated specially. The service that nurses offered was one that made the difference to patients in terms of quality of life. Patients were kept out of hospital through many of the services offered by nurses. That was what the SPNP wanted to bring to the NHI.

Chairperson Dhlomo said that during the time he previously served on the Health Professions Council, there were continued bilaterals between the Council and the South African Nursing Council -- among other things -- to align some of the issues that the SPNP had just raised. He hoped that these engagements had continued. He did not think that the Health Professions Council should be seen as a ‘competitor.’ The SPNP was playing a complementary and supportive role. These bodies were playing a critical role in the delivery of healthcare services in the country.

Mr Sokatsha said that the Nursing Council was responsible for the regulation of the nursing profession and the scope of practice of nurses. Did the SPNP propose that under the NHI, Parliament should propose legislation that would redirect the mandate of the Nursing Council? In the presentation, there were suggestions that the NHI Bill should address issues around the scope of practice of the nursing profession. He asked whether he had understood this correctly.

Ms Regensberg said the SPNP was not advocating that Parliament should take on the functions of the Nursing Council. It had a deep concern that the regulations were not moving forward. The Nursing Council required assistance and support, and no one was able to identify why there had been no progress. The SPNP asked that the Portfolio Committee, outside of the meeting, assist in enabling private nursing practitioners. It wanted this to move forward in the way it was envisaged in 2005, but it had not yet been fully implemented. The SPNP believed that the way in which the Nursing Council had focused on Masters degrees had excluded many of the older nurse practitioners who had qualified prior to 1984, and were still practicing. How did one ensure that the ‘grandfather’ clause and the education system were brought into the relationship? It was not the role of Parliament to ensure that the Nursing Council addressed that. These were some of the challenges that needed to be looked out for. The Nursing Act, Act 33 of 2005, should be reviewed, and should come back to this Committee. These were things that the Committee should be looking out for.

Submission: Doctors without Borders / Medecins Sans Frontieres (MSF)

Mr Vinayak Bhardwaj, Regional Migration Adviser/Referent, MSF South Africa, said MSF's mission was to provide medical relief to the victims of war, disease, and natural or man-made disaster, without regard to race, religion, or political affiliation. It acted with impartiality, actively seeking out the most vulnerable and assisting populations regardless of their race, religion, political affiliation etc. It was independent of political, military, economic and religious powers.
Humanitarian action was peaceful by nature, so it refrained from taking sides in a conflict.
MSF did not take funding from governments, religious organisations or any private corporations from specific industries.

He described ten highlights during the 20 years MSF had been in South Africa:

2000-2003 -- The fight to treat HIV in South Africa;
2000-2003 -- Prevention of mother to child transmission (PMTC), saving mothers' and babies' lives with anti-retrovirals (ARVs);
2019 -- Beating the targets: How community partnership helped Eshowe exceed 90-90-90;
2008-2015 -- Access denied: Migrant health needs and responding to xenophobic violence;
2006-2020 -- Closer to home: Decentralising tuberculosis (TB) care into communities;
2011-2018 -- Fighting for access to essential drug resistant TB drugs;
2016 -- Responding to sexual and gender-based violence (GBV) as a medical emergency;
2018 -- Safe abortion care: Essential to women’s survival and reproductive health;
2004-2020 -- Every step of the way: Supporting South Africa's HIV treatment programme;
2013 – 2020 -- When the medicines run out: The "Stop Stockouts" initiative.

Mr Bhardwaj said that globally, the United Nations High Commission for Refugees (UNHCR) estimates that there are 82.4 million people worldwide who are displaced. There are over 26 million refugees around the world, and a further 4.1 million asylum-seekers, people whose claim for refugee status has not yet been determined. Lower-income nations host 85% of the world’s refugees.

The SA government, bound by its Bill of Rights, as further interpreted by the Constitutional Court’s decisions (in addition to the judiciary at large) in relation to the National Health Act and the Refugee Act, has a clear obligation of health service delivery towards any and all individuals that reside within its territory. Despite these legal assurances, there are numerous daily reports of migrant struggles to access the health system, even for critical health needs.

MSF had two specific submissions on the Bill in relation to Chapter 2 – the exclusion of asylum-seekers and undocumented migrants -- and the registration of users of the Health Fund.

Chapter 2 states that access to health care services – population coverage 4(2), asylum-seeker or ‘illegal’ foreigner, is entitled only to (a) emergency medical services; and services for notifiable conditions of public health concern. This ends up reducing access to health care for a critical population. The memorandum on the objects of the NHI Bill 1.2 state that the aim of the coverage is to provide “South Africans” with a) access to needed health care of sufficient quality to be effective; and b) financial protection from the costs of health care. It would appear that the restrictive language applies only to South Africans. The memorandum of objects refers only to South Africans and the Bill itself limits coverage in Chapter 2. This also contradicts the Covenant on Economic, Social and Cultural Rights (1966) and the World Health Organisation (WHO) global action plan to promote the health of refugees and migrants, preventing inequities and public health considerations of host populations. Excluding a part of the population from health care services is not only negative for the individuals concerned, but can also have negative public health consequences for society overall.

MSF had concerns on the registration of users of the Fund related to population coverage in 4(2):

“A person seeking health care services from an accredited health care service provider or health establishment must be registered as a user of the Fund as provided for in section 5, and must present proof of such registration to the health care service provider or health establishment in order to secure the health service benefits to which he or she is entitled.” According to section 5(5), the individual must provide his or her biometrics and other such information including fingerprints, photographs, proof of habitual place of residence and (a) identity card as defined in Identification Act 1997; (b) an original birth certificate; or (c ) a refugee identity card in terms of the Refugee Act. This poses a barrier for access to care for those individuals who are not documented and may require medical treatment, and may well deter them from seeking medical treatment at all, as they may see the registration process as a way to collect information on their migrant status and share these with deportation authorities.
MSF urges that the registration process must have the necessary safeguards in place to ensure confidentiality of patient data, including documentation status, guaranteeing no third party stakeholders such as immigration authorities are able to access the information. Health care service providers – public or private – should not be expected to play the role of immigration authorities, as it further erodes the trust between patients and health care professionals.


The Bill would appear to create financial barriers for vulnerable migrants and prevent those who need healthcare from accessing it;
This can force already vulnerable families into making impossible choices between healthcare, food or housing;
Language barriers and access to information also impede access to health care;
Limiting access to services for a part of the population prohibits achievement of universal health coverage;
Health care should be provided on the basis of need, and not conditional on residence status.
MSF therefore recommends rectifying any and all clauses that limit access to services provided by the NHI for any and all vulnerable groups within South Africa, highlighting that specifically for asylum seekers and undocumented migrants. 


Chairperson Dhlomo stated that on the last slide, there was no indication of how to rectify the problems. It was just said that ‘all clauses that limited access should be rectified.’ Various presenters all over the country, when doing country-wide public engagements, had highlighted the other extreme about the provision of healthcare for migrants. They asked where the country would get money to fund the NHI if people from outside the borders of the country would also be included. It had been asked how those migrants would contribute. He suggested that Mr Bhardwaj offer precedents from other parts of the world about that. Was there anywhere in the world where anyone could access a full package of services, irrespective of where they came from?

Ms Ismail asked whether in MSF’s opinion the registration requirements could result in exclusions to accessing healthcare. The Committee was aware that many people did not have identification documents (IDs), so if people could not produce the required documentation, would the Bill prevent them from accessing services? Would MSF view the Bill as potentially xenophobic in the type of exclusions or inclusions of asylum seekers and refugees? She asked this question specifically about the provision of universal healthcare.

Mr Munyai said that on numerous occasions, South Africa had been considered to have porous borders which were deemed to contribute to inward migration and threatened the domestic security of the country. MSF appeared to support inward migration of undocumented migrants and asylum seekers into the country by stating that the NHI Bill should provide full coverage to this population. What was MSF’s opinion on how South Africa was addressing the challenges of refugees in the face of the limited resources in the country?

Mr Sokatsha asked what international experience MSF could share with the Committee on how countries with limited health resources had dealt with such problems, such as massive inward migration. What role should organisations, such as the United Nations (UN), African Union (AU) and Southern African Development Community (SADC), play in assisting with the funding of undocumented migrants and asylum seekers?

Dr Jacobs noted that most of the presentation was about healthcare provision to asylum seekers and refugees. He had hardly heard anything about what MSF did, and their thoughts on the various provisions in the Bill. What legislation or regulations did MSF operate under in South Africa? It would be good to hear MSF’s views on the regulation of such organisations in an NHI context in terms of ensuring transparency in the South African health system.

Dr Havard referred to the presentation where it made reference to chapter 2 clause 4(2) of the Bill. She requested clarity about the statement that asylum seekers or illegal foreigners were entitled only to emergency medical services and services for notifiable conditions of public health concern.

Ms Hlengwa said that one of the issues affecting the healthcare sector in South Africa was the immigration of people from neighbouring countries who came to seek medical care in South Africa. Under the NHI, this might become a bigger problem and could cause financial strain on the NHI. Did MSF have suggestions on how the financial capacity of the NHI should be balanced to avoid a collapse as a result of providing healthcare to people from other countries?

Chairperson Dhlomo said that MSF had made a presentation to the Committee requesting rectification of certain clauses, but had not shared how the Bill should be rectified per clause. The Bill spoke about the registration of all South Africans for the effective allocation of health services. The issue of registration was key. There was already a challenge of unregistered people globally – the registration process was not only to assist people to access healthcare services in the country. What could be done in instances where a person was admitted without documentation? Should such cases be handled under the NHI in terms of the provision of care for undocumented persons, who might be foreign immigrants?

MSF's response

Mr Bhardwaj responded to the question raised by Ms Ismail about the registration process leading to exclusions, decreased access and xenophobia. Some of that language was emotive. MSF would like to treat the Bill in the same manner in which it was intended – in terms of providing universal healthcare coverage. MSF’s submissions were intended to fulfil the promise of what appeared to be the initial premise of the Bill. To require registration as a condition for access to health had the potential to reduce access to healthcare services, and would result in exclusions.

He responded to the question about the potential for an explosion of inward migration. This was a complex question. In terms of suggesting whether there was a jurisdiction that had dealt with this appropriately – there were none. It would be dishonest of MSF to pretend that there were perfect legislators that were able to do this. However, it could offer, from direct observations on the ground dealing with undocumented migrants and refugees, that to turn the health system into another branch of the authorities was costly. It would be costly not only for the migrants and refugees, but also for the health professionals and domestic citizens who may be the ‘appropriate users’ of the health services.

MSF was trying to present that the challenge of migration was being felt worldwide. There were some of the highest numbers of migrants and refugees globally at present due to a number of reasons, including the climate crisis. There was an inevitability of people moving from one place to another. People would always move. Migration was as natural as the human condition. ‘We are all migrants of some sort or another.’ How did one then best address the needs of migrants, while acknowledging that there may be a need for certain security measures in order to prevent certain types of challenges that had been highlighted by the Members? MSF, as a health-related organisation, believed that creating legislation which then required a doctor or nurse to become a branch of Home Affairs, was unlikely to promote access to universal health coverage.

He responded to the question of what MSF did outside of providing care to asylum seekers, of which he had tried to provide some indication during the presentation. It had worked in collaboration with the Department of Health for the past 20 years, mostly on issues of Human Immunodeficiency Virus (HIV) and tuberculosis (TB), but also on issues of access to medical and psycho-social care for victims of sexual and gender-based violence. MSF also provided urgent medical care in the event of emergencies, such as COVID-19 and the recent disturbances around South Africa.

In terms of the legislation that MSF fell under, it was a registered trust in the country. He could obtain the information about the relevant regulations – he did not have them at hand, and apologised about that. It was an interesting question as to whether MSF should be made to operate under the NHI. As a non-legal expert, he could not offer an opinion on that. MSF tried to provide medical care for free in areas where catalytic change could be influenced, or where it could provide care of last resort.

He requested clarity on the question about clause 4(2) of Chapter 2 of the Bill.

Dr Havard said she had asked whether the provision of clause 4(2), about the provision of coverage for emergency medical services and the services of notifiable conditions, was not sufficient.

Mr Bhardwaj responded that one of MSF’s concerns about the Bill was how coverage was addressed. This was addressed well in one of the submissions that MSF had endorsed. He referred to Section 27 of the Constitution. This outlined in more mechanistic detail what might happen. For example, it said that asylum seekers and undocumented migrants under the NHI would be excluded from emergency treatment because they would be able to get up to only a certain point of care, and no further. The exclusion of medical emergency treatment beyond pre-hospital care not only violated Section 27(3) of the Constitution as it applied to asylum seekers and undocumented migrants -- it placed patients in real danger and the staff of ambulance services in the horrible position of having to leave people in need of care at the roadside once the limit of what could be provided in transit was reached. For example, a mother may not be able to deliver a baby as an emergency service or as a maternal health service because it was not an emergency if she walked in, but she would be regarded as an emergency if an ambulance was required to collect her. That was one of the examples MSF had given in their submission.

He responded to the question by Dr Hlengwa. MSF believed that the current regime, which was stipulated through the National Health Act and the Constitution, did not allow everything to everyone, apart from the basic package of emergency care, primary health services and maternal healthcare services. The rest of the services, especially for Southern African Development Community (SADC) citizens was provided on a means test basis, similar to what South Africans had to pay for. While MSF did not imagine that this would incorporate every imaginable need, it thought that this offered a suggestion of a way forward.

He responded to the questions raised by the Chairperson about how the clauses could be rectified, and the issue around the registration of citizens and non-citizens could be dealt with. MSF was not a law-based organisation. Its role was to provide medical care, and through such medical care to develop firsthand testimony which could then be shared with decision-makers such as the Portfolio Committee. It was not in a position to offer an alternative Bill -- that was outside of their competence.

Registration was important to track the kind of care patients were receiving. MSF saw the value of having a unique patient identifier in the Western Cape for HIV and TB patients. Their treatment could be traced across facilities, and treatment refills could be ensured. This also ensured less disengagement from care. It would not be helpful to make registration a determinant for access to care, as it posed a barrier to accessing care if one did not have the necessary documentation, in terms of immigration specifically.

Mr Sokatsha said that his question had not been answered. What experiences could MSF share with the Committee about countries that experienced high inward migration? The second part of his question was on the role that other bodies, such as the AU, SADC and the UN could play as far as funding was concerned, to assist with migrants and asylum seekers.

Mr Bhardwaj said that Mr Sokatsha was right, as he had not answered that question sufficiently. In terms of the international experience, there were mainly negative lessons. There was a study that was included as part of MSF’s written submission, which looked at the damaging financial impact of not providing sufficient care to migrants. The study took place in 2015 by the EU Agency for Fundamental Rights (FRA). The study looked at examples of hypertension and pre-natal care in Germany, Greece and Sweden. It showed that by not granting people regular access to services, it meant that preventative services were no longer accessible. The patients presented with more acute conditions at a later stage, which required more emergency care that created a higher financial impact.

He responded to the question about the contribution that could be made by other multi-lateral bodies. This was not something that he knew much about. He was happy to do further investigations and share that knowledge with the Committee. One example that could be looked at was a cost sharing mechanism that was proposed by one of the EU Commissioners – he had read this in a popular journal – and this could be shared with the Committee. In terms of an actual existing policy on how the multi-lateral bodies could assist , he did not know, and would be happy to be guided by the Committee on that. MSF had engaged with SADC on previous occasions about the potential for a cross-border health passport which could allow continuity of care within the SADC region. MSF had not had any positive outcomes from that. This would definitely be a good idea and was worth taking up beyond the NHI discussion.

Submission: Johnson and Johnson

Mr Aluweni Museisi, Director: Government Affairs and Policy, J&J, said that at Johnson & Johnson they believe that good health is at the heart of human progress. It enables children to thrive, women to succeed, families and communities to prosper, and countries to rise from poverty and achieve economic security. That is why they had a promise to relentlessly drive better health for all. Ensuring universal health care did not mean that provision of care must be free or that a single-payer system is the best or only solution, but it did require sustainable financing for both suppliers and providers, and those needing care. The presentation would focus on the patients’ perspective and the industry perspective, particularly medical devices, pharmaceuticals and consumer health sectors.

Referring to the progressive realisation of health rights, he said the NHI proposed a narrow system, with limitations on medical schemes (clause 33), only “necessary "care (clauses 6(a), 7(2)(c), 8(2)(c)), and strict formulary adherence (clause 7(4)(c)).

NHI Bill challenges

Patients who had had cover for care, such as through discretionary funds at academic facilities or through their medical schemes, would no longer have this cover;
Patients who had care that might now be deemed more than what would be “necessary” care under the NHI, would no longer receive this care.
Academic facilities, where sophisticated training and care must take place.

Proposed changes to the Bill: formularies & rights

The wording in the NHI Bill should be amended to not exclude or limit social security mechanisms and the care it covers, such as that provided for by medical schemes (clause 33), or through the Road Accident Fund (RAF) or Compensation Fund (CF), as the RAF and Compensation for Occupational Injuries and Diseases (COID) benefits' limitations were being proposed in the Schedule to the Bill.

Where “comprehensive”(1) or “necessary”(2) care is listed, as well as the benefits associated with it, it should be made clear according to which principles benefits will be set -- see, for example, the principles outlined according to which the PMBs are determined, reviewed and updated.

Any existing rights afforded to patients should not be removed.

The “progressive” realisation should be entrenched in the Bill by, for example, outlining the use of information relating to health outcomes, epidemiology, human- and other resource availability, etc, in a programmatic expansion of health care rights, along the lines of how the Constitutional Court has ruled on such matters.

Formularies and Health Technology Assessment (HTA): Limitations to patient rights

The Essential Medicines List (EML) and Environmental Exposure Limit (EEL) are only the “essential” medicines and devices. Currently, in public sector, a lot more than what is on the EML is available on tender and buy-outs.
The content of the EML and EEL, as well as an HTA Ministerial Advisory Committee (MAC) are set in another law – the National Health Act.
Clause 35(4) states that the Office of Health Policy and Planning (OHPP) formulary will only “comprise the EML and the EEL” (no options for anything but these); and there may be a complementary list “approved by the MoH: (clause 7(4)(c)"; providers will be penalised if they do not adhere to the formulary (clauses 7(4) and 39(8)(d)).
Clause 7(4)(b) assumes that all medical devices would have undergone an HTA, or they would not be funded.
Clause 57(4)(d) refers to an MAC to conduct the HTA. This should be a separate independent statutory body, and not an advisory body to the Minister.
J&J’s medical devices are widely used in emergency care (trauma) in both the public and private sectors: Healthcare professional training.
Timely availability of the products, including theatre sets.
Patient need: Medical devices are not necessarily interchangeable.
The rights of the patients could be impacted by the strictly enforced formulary, the HTA and procurement systems (training and theatre sets)

Proposed changes to the Bill: patient rights and suppliers

Emergency care should be included in the setting of the NHI benefit package as an absolute right, the wording relating to compliance with the rules of the NHI Fund should ensure that emergency care is not delayed or limited, and that suppliers are measured against relevant criteria such as (a) appropriateness of care in relation to the injury, (b) healthcare professional training and (c) ability to deliver to sites when required.

Reproductive care must be included in the benefit package as a result of its specific listing in section 27(1)(a) of the Constitution, and given effect to in line with the principles of appropriateness of care and evidence-based medicine.

The procurement of, and linkage between, ambulance services which must constitutionally be provided by provinces to establishments and providers where healthcare services are rendered, must be clear.

Mr Museisi gave examples of patient healthcare rights that that could be affected if the NHI Bill is passed and implemented in its current form, with unintended consequences of mandated adherence to formularies:

In the field of mental healthcare, patients with schizophrenia are vulnerable, and unless adequately treated, suffer relapses that permanently deteriorate their condition.
These relapses are also costly, as it leads to increasing incidences of hospitalisation, for longer periods of time.
The high levels of hospitalisation of patients living with mental health conditions had recently been cited in a report as increasing healthcare spending.
Part of this vulnerability is related to the administration of oral medication, where patients are non-compliant.
Injectables, and in particular injectables with research showing speedy treatment effects and lower hospitalisation rates, should be available.
Although not on tender, various public mental health facilities do use these products. Under the NHI Bill, where there is no possibility to deviate from medicines that are on the Essential Medicines List, these patients would no longer have access to this treatment option, and patients who are at crisis points as known defaulters on oral medication, would not have access.

Principles on setting benefits

As per the NHI White Paper, benefits are determined on the basis of “evidence-based medicine," and every patient is entitled to “appropriate care”, irrespective of what most patients, or the average patient needs. What is evidence-based and appropriate is determined by persons who are professionals in that specific field, e.g. for mental health it would be psychiatrists, occupational therapists and psychologists, while for broken bones, it would be orthopaedic surgeons, orthotists and prosthetists, and physiotherapists. The BAC can therefore not advise without the input of the specific professionals registered (legally authorised) in a particular field.
This means that the determination of benefits, and the formularies that flow from them, are always evidence- based, appropriate and set in consultation with the right professionals

He gave examples of patient healthcare which will be impacted with the use of formularies in procurement decisions. An example of applying the principle of evidence-based medicine, and deviations from formularies, is in prostate cancer. Although chemotherapy may be adequate for some patients in the treatment of prostate cancer, many men cannot tolerate the side-effects and would need access to hormone blockers, such as abiraterone or enzalutamide outside of the protocol/formulary and the EML. These products therefore had to be available in order to ensure appropriate treatment for these men who did not react well on other treatments. This group of patients also had the right to be appropriately treated.

Pricing of medicines

The NHI Bill appears to have at least five different, and contradictory, proposals in relation to the pricing of medicines and medical devices in the NHI system, namely:

A set, or regulated, single price as “the only” price of sale into any market in South Africa (section 58 and the Schedule to the Bill), only applicable to medicines;
A bid price, under the Public Finance Management Act (PFMA) and National Treasury (NT) regulations (clause 38(7));
A negotiated price, to be negotiated with the Fund at the “lowest possible price” (clause 11(2)(e));
Possible inclusion in the “all-inclusive fee” payable to specialists and hospital services based on performance of, amongst others, the “health goods” (clause 41(3)(b));
A “rate” for, amongst others, suppliers, determined annually by the NHI Fund (clause 10(1)(g)).

The NHI cannot create a procurement system that is contradictory to the constitution. Section 217 of the Constitution, recognised in clause 38(7), states that procurement by any organ of state must be fair, equitable, transparent, competitive and cost-effective. The exclusion of competition law from the Act is therefore problematic.

The Single Exit Price (SEP) is no longer suited for the introduction of innovative technologies in the various South African markets. J&J, along with other companies, has proposed risk-sharing-, managed entry, patient access and other such programmes to facilitate access in the South African market. Further engagements are required with the Department of Health on these proposals.

Proposed changes to the Bill
The removal of all references to the SEP in the Schedule to the NHI Bill. The possibility of negotiations with the National Department of Health on the suitability of the current SEP in an evolving market should not be excluded, but the correct place to do so is under the Medicines Act and within the broader framework of the Supply Side Regulator for Health discussions, as recommended by the Health Market Inquiry (HMI).
The removal of “suppliers” in all clauses referring to price / rates / fee determination, which refers to providers and not suppliers.
Allowing for negotiations with specialists and hospitals that are not organs of state, to participate in all-inclusive fee negotiations, based on health outcomes and health good performance (clause 41(3)(b));
Allowing price negotiations with the National Health Insurance Fund (NHIF) OHPP on the basis of alternative reimbursement models, risk-sharing programmes, portfolio trade-offs, health outcomes, patient assistance programmes, training- and other product support, etc., to be added as a new sub-clause under clause 38(5), within the framework of the PFMA and the Preferential Procurement Policy Framework Act (PPPFA);
Allowing differential pricing in non-NHI markets.

Proposed changes to definitions

The definition of “health good” should be redrafted as referring to “products regulated in terms of, and as defined by the Medicines and Related Substances Act, 1965, the Hazardous Substances Act, 1973; the Foodstuffs, Cosmetics and Disinfectants Act, 1972; the National Regulator for Compulsory Specifications Act, 2008; and the Standards Act, 2008; and any other law regulating and/or controlling the manufacturing and/or importing and supply of goods used in the diagnosis and/or treatment of users.”

The definition of “health related product” be redrafted as “products that are not health goods, but which are used as part of the delivery of healthcare services, or which are used by the NHI Fund in the execution of its powers and functions.”

That where investigations and complaints are concerned (clauses 6, 11 and 42ff) and suppliers are at stake, the fallowing wording be inserted to replace current powers of investigation: “The Fund must refer allegations of fraud, corruption, theft or any other crime to the appropriate authority,” and “complaints in relation to health goods must be referred to the relevant authority with jurisdiction over the specific health good.”

Clause 10 1 (l) should be amended by the underlined addition: “monitor the registration, licence or accreditation status, as the case may be, of health care service providers, health establishments and suppliers and, where applicable, to verify the requisite registration or accreditation of any specific health good, where so required by legislation.”

Clause 41(3)(b) should be amended to read: “In the case of specialist and hospital services, payments must be all-inclusive and based on the performance of the health care service provider and/or health establishment, including all input costs associated with the provision of such services,” and the phrase “or supplier of health goods, as the case may be” can be removed.

Private sector providers and private sector health establishments should be allowed to procure independently from the NHI, subject to their services being evaluated on patient outcomes;


Based on the strict adherence requirements of the NHI Formulary for medicines and medical devices, the emphasis must be on the lowest possible price. While the Essential Medicines List is important for prioritising medicines and managing budgetary constraints, there is a need to have a pathway for integrating innovative medicines in the healthcare system. In its current form, the draft NHI Bill does not address how innovative medicines or medical devices will be adopted into the health system.

There are also obligations placed on suppliers of health goods, such as J&J, which it cannot fulfil, because such fulfilment would contravene other laws. For example, the regulations (clause 55(1)(d) and (e)) require the supply of personal and health information to the NHIF on adverse events.

The setting of “best practices” in relation to the payment of suppliers (clause 11(1)(i)(ii)) could also potentially contradict the payment rules set under the PFMA and NT Regulations, which require payment within 30 days from date of invoice. Similarly, procurement must (and not “may” as per clause 11(2)) be underpinned by a contract, and the conditions of supply listed in sub-clause (2) are in any event part of the General Conditions of Contract (GCC) and Special Conditions of Contract (SCC) as set under the PFMA for supply to organs of state.

The National Health Laboratory Service (NHLS), as a provider of pathology services to the public sector, is in itself a schedule 3 entity under the PFMA, and would undertake its own procurement of health goods and other products. Private or public hospitals and private providers would already have acquired capital equipment (classified as medical devices) that form part of the goods used.

Further, if an “all-inclusive fee” (clause 41(3)(b)) is to be paid, establishments and providers should be free to determine the inputs that go into the provision of that service, also as such establishments and providers will be paid on performance and should be accountable for all aspects of the care delivered.

Clause 38(6) also refers to the Formulary as being inclusive of “suppliers.” We believe this is a drafting error.

There are circumstances, in line with the principle of evidence-based medicine, which was firmly entrenched in the NHI White Paper, 2017, and that requires deviations from formularies in order to ensure appropriate care for a particular patient, and most importantly, to protect vulnerable patients in line with the constitutional principles as set out above under paragraph 3.1.

Sustainability of the NHI

The finalisation of this Bill should be done concurrently with a funding proposal to ensure that sustainability questions are addressed in the design process of the NHI. In its recommendations to the Finance Minister on the NHI, the Davies Tax Committee noted: “Given the large (fiscal resources) at stake, it would be critical to manage the fiscal risk by linking expenditure outlays to available fiscal resources. Here credible cost scenarios play a pivotal role and their absence could compromise the goals of the NHI.”

Consideration of the financial sustainability of the NHI is important, as even well- established universal health systems face financial challenges. In its 2016 report, the UK’s National Audit Office highlighted the financial challenges faced by the National Health System (NHS) by noting:
“The messages in our two previous reports on NHS financial sustainability have been consistent and clear in stating that the trend in NHS trusts’ and NHS foundation trusts’ declining financial performance was not sustainable. In 2015-16, the trusts’ financial performance worsened considerably. Efforts to get NHS finances on track, such as large savings and efficiency targets, have damaged the trusts’ financial positions and contributed to the current situation. With more than two-thirds of the trusts in deficit in 2015-16, we repeat our view that financial problems are endemic, and this is not sustainable…”

Proposed way forward: financial impact assessment of the Bill
Increasing spending on health should consider the long-term fiscal space and not threaten the government’s long-term solvency, or be to the detriment of investments in other sectors that are critical for comprehensive progress towards the Sustainable Development Goals (SDGs). The implementation of the NHI should be preceded by a full fiscal impact assessment and the impact on individual taxpayers. Due consideration should also be made for the loss of benefits medical schemes members would forgo, while there is an increase in the tax for the NHI.


The Chairperson said that one would think that Mr Museisi was presenting that medical schemes represented a perfect system in South Africa – the situation was opposite to that. In terms of comprehensive care, no specifics had been referred to. The Bill spoke about the Benefits Advisory Committee, which would have experts who would decide what benefits to include for South Africans. Why would one be scared, when reference was made to the fact that experts would make these decisions about what should be included? He requested Mr Museisi’s views on that.

Mr Munyai noted Mr Museisi’s recommendation that the NHI Bill be amended so as not to exclude or limit social security mechanisms within the medical schemes. What was J&J’s view on the impact of fragmentation of healthcare funding in South Africa? Was it not important to ensure alignment of funding to avoid double-dipping? What was J&J’s view about those patients who claimed the same health benefit from multiple funds. Would consolidation of these funds not reduce administration costs significantly? In the introductory slide, why was J&J saying that it was their responsibility, firstly to doctors, nurses and patients? He hoped this did not mean that these were the only stakeholders J&J was willing to collaborate with. Was there any reason for this - as this approach was troubling him? Should it not be promoted and agreed to under the NHI?

He was not clear about J&J’s recommendation on slides 13 and 14, which addressed pricing. He got the sense that J&J proposed that under the NHI, transparency should be removed. Again, differential pricing was being raised in this slide. He was not sure whether J&J was suggesting that it be supported or not, and he asked that the proposed pricing policies be clarified. He got the sense that J&J believed that South Africa had adequate social and health security and coverage. This view suggested that the NHI was an unnecessary intervention for the country – had he understood Mr Museisi correctly?

J&J seemed to believe that there were categories of patients. He struggled to understand the concept that the ‘average patient’ was covered under the NHI. Surely, every patient was just a patient. He got a sense that J&J was advocating for different categories of patients. It had stated that it provided some products for children. Was it true that J&J had been ordered to pay US$4.7 million in damages for 22 women who allegedly developed ovarian cancer as a result of J&J talc powder which contained some form of asbestos? Was it true that in 2013, J&J had been given criminal and civil fines over allegations that drugs that were not approved to be safe or effective by the United States Food and Drug Administration (FDA) were on the market? He raised these issues, as they had been on television a few days before. He asked that these issues be clarified. He was not raising these issues to tarnish the image of the organisation.

Ms Hlengwa asked what J&J’s plan was to support the NHI to ensure that the aims and objectives of the NHI were fulfilled.

Ms Gela asked about the limitation imposed on medical schemes, according to clause 33. She said that some of the stakeholders had informed the Committee that over the years, the cost of private healthcare had been increasing. Medical scheme members were not well protected -- they were running out of benefits before the end of the year. There were also complaints of serious governance challenges in the industry. These observations had been made by the Health Market Inquiry -- in J&J’s view, did this situation threaten achievement of universal health coverage? She referred to slide 16 of the presentation, and asked why it was deemed unnecessary for the Fund to have any internal investigative capacity to look into matters of fraud and corruption of suppliers and providers? The Fund could investigate a matter and hand it over to the relevant authority – was that not the case?

Mr Sokatsha referred to slide five, where reference was made to the NHI introducing challenges to academic facilities where sophisticated training and care needed to take place. Clause 7(2)(f) clarified how academic facilities or institutions would be used for the benefit of the entire country, and not certain provinces. He asked whether this clarified Mr Museisi’s concerns. J&J appeared to be making proposals that were subject to the whims of the market – there were control measures in its power to undertake strategic purchasing, as currently outlined in the Bill. Was the intention that South Africa should continue with the current fragmented two-tier health system that benefited companies for profit at the expense of the health and well-being of most of the vulnerable people in the country?

Dr Havard said that in the introductory slide, ‘universal care’ was defined very differently to the key tenets of the way the NHI Bill was written. Did J&J support the objectives of the NHI Bill and the principles, as defined in the NHI White Paper? It was not clear to her what it was about innovative medicines that made them unsuitable for implementation of the single exit price provisions, and the transparency in this specific category of medicines, under the NHI. She asked that this be clarified.

Ms Ismail said that the presentation had made mention of a single purchaser system. How would this affect the sustainability of the NHI? Where did J&J foresee the NHI failing in its implementation? What were the biggest barriers to healthcare access via the Bill? Did J&J support the NHI Bill as it currently stood? With the number of Special Investigating Unit (SIU) investigations in the Department of Health and government, what was J&J’s view on the Bill, giving the Minister the right to establish the Board and related entities? Would J&J agree that this should be included in the Bill, or would it agree that the boards be elected by, and be answerable to, Parliament to avoid any chance of corruption? What was J&J’s view of the impact of the R104 billion in legal costs due to medical negligence? Taking this into account, what was J&J’s view on how the NHI would be negatively impacted in the long-run?

Acting Chairperson Jacobs asked a question about health products procurement. He noted that J&J were concerned about ‘necessary care’ in clauses 6(a), 7(c) and 8(2)(c) of the Bill. He further noted that J&J had mentioned clause 35(4) of the Bill in connection with the issues about the Office of Health Products Procurement. He thought that J&J probably intended to refer to clause 38, which stated that the Office of Health Products Procurement would support the Benefits Advisory Committee in the development and maintenance of the formulary, comprised of the essential medicines list and essential equipment list, as well as the list of health related products to use in the delivery of healthcare services, as approved by the Minister in consultation with the National Health Council and the Fund. He hoped that the sections mentioned would address J&J’s concerns.

How could J&J be ‘presumptuous’ as to say that medicines would be excluded, as stated in their case study on prostate cancer? Whilst he heard that most of the provisions were unacceptable to J&J, as they related to the essential medicines list he had heard very little about proposals aimed at improving the Bill. Was J&J aware that the tender system and the essential medicines list did take into consideration the burden of disease in the country? That information was publicly available.

Chairperson Dhlomo said that he was a medical doctor who had trained in a particular academic hospital and medical school. There were people, like Mr Museisi, who would visit a particular specialist to ask that specialist to research or promote a specific product for the creation of a discretionary fund. This was a fund that Mr Museisi had said was given to academic institutions – but how? This was one area where protection was required. It would be serving the interests of the pharmaceutical sector – this was how it would be created. The discretionary fund was not a fund that came from ‘somewhere.’ It was a fund that got created by professors and specialists because they worked with companies such as J&J. It was understood from the presentation that this was something that J&J would want protected. He suggested that J&J was probably not the right company to advocate for that, as they were the creators of the discretionary funds through the way they operated.

He said that Mr Museisi seemed to be advocating that South Africa implement an NHI that was very porous, with unlimited health benefits, to the advantage of suppliers and providers. Where in the world did it operate like that?

J&J's response

Mr Museisi said that any questions he was unable to answer within the time given, would be responded to in writing. J&J was participating in these engagements as the Company wanted to contribute to building a sustainable system and to build a system that met the needs of patients in South Africa. The proposals were made on that basis.

He responded to the questions about the medical schemes, and it being a ‘perfect system.’ He did not think that anywhere in the presentation it was stated that the medical scheme system was perfect. The Health Market Inquiry came with a set of recommendations that stated how one could make the medical scheme system work to the best of its ability. In the presentation, he had stated that there needed to be space given to medical schemes in the future, to continue to support universal access to healthcare. That was a similar conclusion reached by the Health Market Inquiry. At the moment, the prescribed minimum benefits system that was provided by the medical schemes provided the best coverage against catastrophic spending in healthcare. It was not said that the ‘system was so perfect that it did not require reform.’ It was stated that it was a system that was imperfect, that required reform, but offered its own good. Just because it was not perfect, did one need to destroy it and say it was not needed?

He responded to the questions about the Benefits Advisory Committee and the essential medicines list. The current Bill did not provide any provision about how the Benefits Advisory Committee would consult with industry or civil society. It was not clear in the Bill. It would be important to get to the point where the Benefits Advisory Committee would be able to consult with different and various stakeholders in order to come to a conclusion.

He responded to the questions raised by Mr Munyai. One needed to ensure that a robust impact assessment took place – particularly of the wording and funding. Administrative costs could be limited by having a consolidated framework, but he would not venture into saying whether a consolidated framework would be good in terms of saving funds, when no impact assessment was done to look into the effect thereof. This was something that the Committee could consider doing – to look at the potential impact.

He responded to the question as to whether J&J was responsible only for doctors, nurses and patients. Those words were taken from the credo of J&J, which was really the value system that drove the company and everything it did. That spoke to the stakeholders that J&J interacted with, but they were by no means the only stakeholders they considered in their interactions. He was happy to share the entire J&J credo with the Committee, which would outline all the stakeholders that J&J interacted with.

When it came to transparency in pricing, the single exit price was not the only type of transparent pricing system. Under the National Treasury regulations, under a tender system, it was still transparent. It was not a price that was pre-set. J&J was by no means proposing that pricing should not be transparent. J&J was proposing a price that was flexible and competitive. One of the challenges in the industry presently was that the single exit price got adjusted annually, based on inflation and the exchange rate. Most of the time the adjustment did not reflect the actual cost of each product. If one looked at the exchange rate appreciation or depreciation for a particular product, and the adjustment that one got that was blanketed across the industry, it assumed that everyone had similar cost structures. In terms of the price differential and the current realities, in the current Bill there was a proposal to have a single exit price that would apply to both public and private sectors. No impact study had been done to understand what would really be the long-term impact of this to the sustainability of the industry. When one started thinking about access to healthcare, it had to be balanced between affordability and availability. The courts had ruled on this. If one created a dynamic where the industry was not sustainable, then there would not be availability. Thus, long-term sustainability needed to be assessed and ensured.

He addressed the question about sufficient coverage in South Africa. J&J believed in universal health coverage, and was not suggesting that the existing coverage was complete and the best. Since coverage was not complete in South Africa and was not the best, how could this be made to work better in the long term for everybody? They were thus debating all of these issues.

He said that perhaps the Committee had not understood J&J’s discussion points about classifying patients. The essential medicines list was usually based on the majority of patients that one had in a population who might suffer from a certain condition, and one needed to provide for them in the essential medicines list. That was what one would refer to as an ‘average patient’ -- it had nothing to do with affluence or class or ability to pay. It was on the basis that to treat a patient, such as a cancer patient, particular medicines were needed and needed to be provided on the essential medicines list. J&J was asking what would happen if one had a patient who was not responsive to the medicine that might fall on the essential medicines list. That would be a patient that would be considered to not be an ‘average patient.’ For example, if Panado fell on the essential medicines list and the patient had adverse effects to paracetamol, one needed to be able to provide other medicines instead, such as ibuprofen. One needed to ensure that one made provision for both the ‘average patients’ and the ‘non-average patients’ in terms of provision and access to medicines.

A number of questions had been asked about ongoing court cases that were taking place globally. He was not sure what the relevance of those questions were to the NHI, but he could provide further details about them in writing as he did not have such information. He had thought the focus of this engagement would be about the NHI.

He responded to the question asked by Ms Hlengwa about what J&J would do to meet the objectives of the NHI. J&J was passionate and committed to serving patients in South Africa. One of the first ways that showed J&J’s engagement and commitment to the NHI was that it was involved in this conversation to ensure that they were giving input to build a system that was robust enough to serve the patients of South Africa. At the same time, J&J was well-invested in South Africa. Based on what J&J did best, which was to bring new and innovative products to the market to treat patients, they would continue to contribute to the NHI system.

The cost of healthcare had been increasing over time, and the Health Market Inquiry had covered this. That was why it was important to implement the recommendations made by the Health Market Inquiry. One of the things that was very clear was that the current private health insurance system was not sustainable unless there were interventions that were regulatory, that would allow the system to work best. This was the responsibility of Parliament and the National Department of Health.

J&J was not suggesting a principled position in stating that the Fund should not have investigative powers – the Fund should also be able to refer such matters to appropriate authorities, such as the South African Health Products Regulatory Authority (SAHPRA) or other state entities.

It was not clear how the academic institutions would continue to be funded according to the Bill, in the context of the NHI. This was a question of clarity rather than a position of stating that J&J thought it would not work.

He responded to the question about the two-tier system, which was a tough question. A two-tier system did not equate to a lack of universal health coverage. For instance, China had three tiers of universal health coverage. In those three tiers, one had different levels of benefits in the different systems. This related to the sustainability of the NHI. A proper assessment needed to take place. If there was a single-tier system, what was the sustainability of the system? If there was a two-tier system, what was the sustainability of such a system? The Bill offered a two-tier system, where medical schemes would be able to offer complementary cover. The two-tier system needed to provide that kind of universal health coverage to citizens.

He responded to the question about innovative medicines. Without innovative medicines, a lot of the conditions that one was able to treat today would not be treatable. Therefore, one needed a system that allowed for innovative medicines to enter the system. If one was sitting in the 1980s, most of the medicines that were available today would not be available. A typical example of this was looking at HIV, where anti-retrovirals had a lot of side-effects and involved taking a lot of pills. Through innovation, one got to a point where the side-effects were limited and the effectiveness of the medicines improved with time. Thus, people could lead more productive lives.

The sustainability of the NHI was one of J&J’s central concerns. If one looked at the sustainability of all the industries that supported healthcare, it was important to have a system that was sustainable in the long-term.

Regarding barriers to access, if one’s needs were not deemed necessary, according to the Bill, then the NHI would not cater for one. Only that which was necessary would be treated and receive reimbursement from the NHI. The other side was that only medicines contained on the essential medicines list would be procured.

Regarding the involvement of the SIU and board elections, this should be guided by the general structure of more institutions, but there needed to be consideration of how there could be greater oversight over those structures.

Medico-legal claims was a difficult issue. In Gauteng over the last couple of years, when the state was behind on payments, many suppliers were not paid for the services provided. This was a very concerning issue. The medico-legal issue related to the quality of care that people received. The Health Market Inquiry had led the way in terms of how to move to a system that had outcome measurements to minimise such spending.

In terms of the necessary care and the essential medicines list and the formulary, in the current system there was a mechanism for ensuring that what was procured was done in line with the population. J&J’s presentation was clear in saying that the essential medicines list was not really up to date – it was shown in the presentation that there were medicines that were on tender that were not contained on the essential medicines list, which showed its limitations. If one did not have the ability to procure outside of the essential medicines list or formulary, that would limit patients' treatment. In the prescribed minimum benefits settings there were principles that governed what should be included. One could have a formulary, but if a patient did not respond to a particular treatment, in the current regulations, one had to make provision for that patient outside of the formulary. If one had a patient who was sick and was not responding to a particular treatment contained in the essential medicines list, then there should be provision for them outside of that list or formulary. The formulary was important in terms of managing the budget, but one needed to ensure that the patient was properly cared for in such situations.

There were questions asked about the discretionary fund, and the ‘perversity’ there -- that J&J would not be seen in a good light if they were advocating for them. For patients in South Africa, who had multi-drug resistant TB, they were able to access the latest kind of treatment that saved lives. J&J was proud that through working with discretionary funds and academic hospitals, they were able to do research that was necessary in order to bring the most innovative drug in more than 50 years in the TB space, into South Africa. This was done through the collaboration with professors who generated the evidence and data that was required to make a decision on whether or not the medicine was important or not. Regarding the ‘perversity’ referred to by the Chairperson, it would be important to make sure that they were at a place where they could manage such ‘perversity,’ and make sure it was prevented. It showed results even at a population level, such as the example with multi-drug resistant TB.

He understood the view that it might sound as if J&J was supporting the ideas that were beneficial for the industry, but it was important that the industry was able to articulate their views as members of society, particularly because they played an important role in the healthcare system of the country. If J&J saw areas where it would not be sustainable, for instance, to continue to support patients, it needed to be able to raise those issues. One of the worst situations was in instances where there were concerns, but they were not raised and such issues might result in companies closing their doors, which would have a number of ramifications. It would then later be said that nothing had been raised during open discussions. J&J was not advocating a porous situation. The exceptions proposed by J&J related to patient treatment.

Mr Munyai said that there seemed to be a selective use of evidence from the J&J side. In one section of the presentation, J&J had used the United Kingdom (UK) National Health Services (NHS) as the positive example in terms of it prioritising access to innovative medicine – that was indicated on slide 18. When J&J made reference to the sustainability of the NHI Fund, slide 25 showed the NHS and how the NHI would not be sustainable for South Africa. This was the selective and inappropriate use of evidence to support a particular narrative. He asked that Mr Museisi respond to this.

In 2004, when single exit price regulations were started, each company was given the opportunity to set its own manufacturer's price and then to add its own logistic fee, plus Value Added Tax (VAT). Subsequent percentage price increases since 2004 were imposed as per the regulations. Mr Museisi had been wrong to state that single exit prices were ‘imposed.’

Mr Museisi responded to the question about single exit prices. He had not stated that single exit prices were ‘imposed.’ He had referenced the fact that single exit prices had their own challenges, particular when one looked at the single exit prices and annual increases of the cost. If one took the year referred to, when single exit prices were set up in 2004, it would be difficult to prove that the annual increases were reflective of the cost for each product. For some products, the single exit price increases had not been sustainable long-term – that was essentially what he had said previously. He was not suggesting that the system was imposed. He believed that having single exit prices for both the NHI and markets outside of the NHI would make things very difficult.

Regarding the UK example, he had not said that the NHI would not work -- he had said that the sustainability of the NHI needed to be considered. When it was said that he used ‘selective examples,’ he would argue contrary to that. He had not used selective examples, he had used the same examples from the NHS and highlighted areas where the NHS was doing well and highlighted areas where the NHS was not doing so well. It was important to learn the good and bad lessons that one could take from the NHS. This was the purpose of this kind of conversation – it was to look at evidence that showed both the good and bad – and to state that as South Africa built the NHI, it should not fall into the same traps as others.

Submission: South African Medical Technology Industry (SAMED)

Ms Tanya Vogt, Executive Officer: SAMED, Mr Marlon Burgess, Chairman, and Ms Ruwaida Shaikh, Vice-Chairperson, presented to the Committee.

They said SAMED was a not-for-gain voluntary industry association, founded in 1985, which had grown significantly to more than 250 members. Its diverse membership was reflective of a highly complex industry comprised of multinationals, distributors, wholesalers and local manufacturers.
It was committed to enabling a sustainable, ethical and transformed medical technology industry that ensured patient access to quality technologies and innovative solutions. Its mission was to provide the industry with a collective, objective and credible platform for engaging with all stakeholders. SAMED was committed to sustainable and on-going transformation within the medtech sector.

Regarding universal health coverage, SAMED supports the principles and objectives of the NHI, recognising:

The inequities of the current healthcare system;
A well-formulated NHI is crucial to greater equity;
Both private and public healthcare face challenges;
A milestone approach is required;
Adequate implementation will affect the patient;
SAMED is a vital stakeholder and committed to public-private collaboration.

Key focus areas of its submission were the Constitution and legal framework, definitions of medical technology, accreditation of medtech suppliers, procurement, HTA and governance of the NHI Fund.

Its key observations were that policy integration was essential to the successful implementation of the NHI, and that should be phased implementation through measurable milestones. There was a risk of legislating uncertainty which would delay implementation, and there was a need for resolution of corporate governance concerns and overlaps on procurement.

SAMED was concerned about potential legal challenges delaying implementation and prolonging uncertainty in the sector. It recommends clarification on the residual functions of provincial health departments, public accountability structures for healthcare, and the preservation of Constitutional principles.

It pointed out misalignment challenges, such as the absence of alignment of the NHI Bill with other legislation, such as the Procurement Bill, and said there were outstanding details on the finance model, the benefits package and the procurement process.

SAMED recommendations were that the Portfolio Committee should undertake:

A review of the entire legal framework of the proposed NHI system;
Amendment of 11 laws in the Bill Schedule;
Present draft regulations for comments
Facilitate inter-ministerial collaboration, policy integration and alignment of legislation to provide certainty and for the NHI to succeed

Referring to accreditation, SAMED said there was no indication of accreditation requirements, the process and the period of accreditation, and the definition of “accredited” was applicable only to service providers and not suppliers. It recommended that the process should be relevant and provide for a diverse range of products and service providers in diverse geographical locations, and avoid an administrative burden. There should be alignment with SAHPRA and the Central Supplier Database (CSD) on information already collected and reviewed. All suppliers must be accredited and/or vetted before entering the procurement process

There were disadvantages of central procurement for Medtech. Its items were not simple “commodities,” and their purchase involves maintenance, servicing, spares, and training and ongoing support to healthcare providers. It had to cater for customised delivery for patients and specialist doctors. The majority of small, medium and micro enterprise (SMME) medical technology suppliers lacked a national footprint. Diversified supply involved multiple and non-exclusive contracts. The best practice in Medtech procurement centred on a holistic definition of “value”. This took account of the life-time benefit to the patient (not merely short-term), the benefit to health care professional, and broader efficiencies in the health system (better diagnosis, shorter admissions, fewer complications etc).

Medtech procurement needed to accommodate rapid innovation cycles. Innovation in MedTech was more rapid than in pharmaceuticals -- for example, the ventilator options in the COVID period -- and often contributes to better health outcomes and efficiency. Flexibility in procurement is necessary for health systems to benefit from innovation

Key considerations of the Office of Health Products Procurement

Transparency and accountability for procurement are vital to checking corruption, and specific knowledge of Medtech is required to procure effectively and employ best practice. Thus, SAMED recommends that in Clause 25(2), the membership of the Benefits Advisory Committee, appointed by the Minister, must consist of persons with specialist knowledge of medical devices and in vitro diagnostic (IVD) devices, in addition to the stipulated technical expertise.

To ensure transparent and robust procurement, there was a need to adopt an open contracting data standard. The CSD should be maintained with input from SAHPRA on licensed companies in the future system. Provincial health departments and contracted service providers should explicitly be permitted through measures for exemptions, which must be stated and expressed in law. All suppliers would be expected to be signatories of the adapted medical device and pharmaceutical codes of conduct.

SAMED acknowledges the relevance of Health Technology Assessments for MedTech. HTA is a tool supporting decision-making at different levels in the healthcare system. SAMED acknowledges that HTAs are an essential component for evaluation and procurement under the NHI. It therefore recommends that an HTA process for MedTech should:

Enable access/not restrict access;
Be appropriate based on the complexity of the product;
Be transparent;
Be an Independent agency;
Not be costly or lengthy;
Be a multi-stakeholder forum;
Aligned with other related legislation;
Have gazetted terms of reference;
Be resourced sufficiently to prevent market delays.

 The proposals on HTA as found in the HMI Report should be considered.


SAMED recognises the inequities of the current fragmented health care system, and is an eager partner in the mission to improve the nation’s health care and achieve universal health coverage. It is committed to building the required capacity and skills, and finding ways to effectively address the health care needs of all South Africans


Ms Hlengwa said SAMED had stated that they were committed to sustainable and ongoing transformation within the MedTech sector. Was that commitment supported by evidence, and what had SAMED done since 1996 to demonstrate its commitment to transformation?

Ms Ismail referred to slide 16, where SAMED had recommended a public parliamentary process for appointing the Board. What risks did SAMED foresee in the existing proposed method of appointing the Board, as contained in the Bill? She referred to slide 20, in which SAMED had recommended that the Department should conduct a pilot study to test operational feasibility. How important did SAMED feel a pilot study was to the success of the project? Was it something that could be by-passed? Did it think that processes had been adequately put in place to check for corruption? Why did it feel that phased implementation through measurable milestones was better than implementation based on a due date?

Mr Sokatsha said that in the interests of transparency, it was important to regulate the prices of medical devices in a national health insurance environment. What was SAMED’s view on that statement? Was it aware of the fact that the Department had previously reported on the existence of an Inter-Ministerial Committee (IMC) on the NHI that had been in existence since 2009, when the Green Paper was first mooted?

Ms Gela asked whether any of SAMED’s members engaged in any corporate social responsibility programmes in South Africa. If so, which programmes? It had selectively made reference to Section 114, without making reference to Section 99 of the Constitution. SAMED did not make reference to clauses 31 to 33 of the NHI Bill on the roles within the Department of Health and on the future role of medical schemes. This section referred to a structure within the NHI Fund.

Dr Thembekwayo asked for clarity on the proposed milestone approach, and how it could best be utilised by the NHI Bill – for amendment purposes. In terms of clause 25(2) of the Bill, which deals with membership of the Benefits Advisory Committee, SAMED mentioned that persons with specialised knowledge on medical devices needed to be represented. Under clause 25(2), it clearly stated that the membership of the Benefits Advisory Committee, appointed by the Minister, must consist of persons with technical expertise in medicines, public health etc. Did ‘technical expertise in medicines’ not cover them? Why should it be replaced with ‘specialised knowledge of medical devices?’

Dr Havard asked whether SAMED believed that health technology assessment was necessary to identify the most appropriate medical devices for use in health facilities, particularly in an NHI environment. She asked whether it was not sufficient for regulations to clarify sections of the Act.

Mr Munyai said the Committee had been made to understand that the majority of SAMED members were against the implementation of the regulation of section 18(a) of the Medicines and Related Substances Act, which prohibited incentive schemes during the sale of medicine supply in South Africa. If this was true, what informed this position? He asked that in SAMED’s response they should provide the Committee with an indication of how SAMED saw this section of the Medicine Act being implemented, particularly in an NHI environment.

Chairperson Dhlomo echoed the question asked by Ms Gela. Section 99 of the Constitution provided that a Cabinet Member may be assigned any powers or functions in terms of an Act of Parliament to a Member of a provincial Executive Council (MEC) or to a Municipal Council. Why did SAMED not make reference to this, and make reference only to Section 114 of the Constitution?

His understanding was that the registration and licensing of health products was the sole responsibility of SAHPRA. Did clause 39 of the Bill not address this, in terms of accreditation? Was SAMED suggesting that the Bill should deal with that differently? The NHI Fund recognised healthcare providers for thr NHI. Could SAMED provide their understanding of those two components? One of the reasons the Bill proposed central procurement was, among other things, to look into the economies of scale. Did SAMED support the current fragmentation that existed, and suggest that this should be maintained? He asked that SAMED provide clarity about their transformation path to meet the requirements of clause 38(7) of the Bill, which made reference to Broad Based Black Economic Empowerment (BBBEE) and provincial procurement.

SAMED's response

Ms Vogt responded to the question about transformation. The industry had certainly not transformed as much as it should have, as it was still very male and pale. There was still a long way to go. Having said that, SAMED had recognised it as a strategic imperative. There was a dedicated transformation committee, and they had carried out a landscape analysis of the BBBEE of SAMED’s membership. It was about to embark on a skills development initiative, where it would identify the critical skills shortages that existed in the sector, and implement projects to fill those skills gaps. SAMED had entered into a partnership with the Youth Employment Service (YES) Programme, where they were actively supporting the programme and the uptake of school-leavers and graduates, who would then participate in learnerships amongst the member companies. SAMED recognised that they still had a long way to go, but they were committed. All SAMED members would be of the opinion that they were there to provide products that supported and benefited patients. That was what medical technology did -- it was used in diagnosis and treatment. It was used to support peoples’ lives so that they had a longer and healthier life.

She said that the company that Ms Shaikh represented had done some incredible work. This was despite being a multi-national, and being unable to sell equity. SAMED had shared a lot of principles, regulations and legislation. Forums had taken place with SAMED members to educate them and create awareness around the need to transform. It would continue to do that.

Ms Shaikh said that part of the initiative, in terms of transformation in the industry, was that they wanted to look at where the National Department of Health had particular challenges. The company she previously worked for had approached the Department in order to establish what those areas were. In terms of primary healthcare and community healthcare workers, there was a dire need for support. The previous company she worked for, had worked with both the National Department of Health and the YES Programme, to create a programme in which the industry could fund community healthcare workers in under-served communities in Mpumalanga. That was one of the initiatives where they looked to transformation as a tool to impact healthcare delivery in the country. As an industry, they were committed to transformation within the constraints of ownership. They had made specific efforts in order to ensure that the enterprise and supplier development programmes were meaningful and contributed to the addition and inclusion of Black-owned businesses in the value chains. In addition, a significant amount of money was spent on skills development. This was ongoing medical education in order to ensure that healthcare professionals were supported. Transformation had to be ingrained in what they did, to ultimately impact the delivery of healthcare.

The Bill allowed for accreditation of healthcare providers, but the accreditation process for suppliers was not stipulated in the Bill. SAMED was proposing that this accreditation process had to include the regulatory scrutiny that was provided by SAHPRA in order to ensure that the supplier companies were registered and complied with a quality management system that was specific to medical devices. Hence, currently the Bill did not create the framework for what that accreditation should be for suppliers. This accreditation process was critical in order to ensure that they had products of the right quality in the market.

The registration of products was something that was critical. Whilst SAMED understood that the process currently in place was managed by SAHPRA, SAMED needed to speak to this process already. There was a level of regulatory scrutiny that was applied by SAHPRA in order to approve products to ensure that the products that they had on the market were of the right quality in order to serve the South African population.

The Health Technology Assessment was recognised internationally as a critical tool to evaluate health technology. More important was its appropriateness. When one considered the concept of ‘value,’ one was looking beyond the acquisition price. One was looking at the impact on the patient and more importantly the outcome for the patient. In a value-based procurement model, one needed to look at how to improve the delivery of healthcare and how one ascertained what the best outcome was. The procurement was based not only on acquisition, but also on outcomes and the monitoring thereof. Such monitoring was recommended by the Health Market Inquiry. When one looked at value-based procurement, one needed to look, for example, at a person being away from work over an extended period, in addition to the basic acquisition price. Outcomes and outcomes monitoring were emphasised in order to ensure that procurement took place in a way that provided the best outcomes for the patient.

Mr Burgess said that it was about striking the right balance between price and outcomes. SAMED would welcome continued engagement and debate as new evidence came through with regard to the evolution of healthcare and the products and services that were currently being engaged in the system.

He responded to the question about the milestone approach to the roll-out of the NHI. SAMED’s thinking was that it would take an all-out government approach. It could probably be led by the Presidency, with the support of Parliament, who would put together a project team to roll-out the NHI. Parliament could get a view of how the project was unfolding according to the parliamentary cycle – whether the team was meeting the milestones that were laid down for the roll-out and implementation of the NHI. There could be a fifth pandemic wave that delayed its roll-out. Thus, a milestone approach may be more conducive. It could incorporate the uncertainties internationally that the country was likely to face.

In terms of corporate governance, and the appointment by the Minister versus Parliamentary oversight, the thinking was that this was the biggest contribution of government from a fiscal perspective. It needed a high degree of oversight and checks and balances in the system in order for the public to be confident in the implementation of this project. That was why they had recommended that approach. SAMED did not want to side-step the Constitutional arrangements that Members had alluded to. It was requesting that there be a high degree of oversight over the process. It welcomed further engagement on the project.

Mr Munyai asked whether SAMED subscribed to the principle and objectives of the NHI to meet the healthcare needs of all South Africans.

Ms Ismail asked a question about the pilot projects. She said that on slide 20, SAMED had recommended that the Department should do a pilot study to test the legal and operational feasibility, so how important did SAMED feel a pilot study was for the success of the NHI? Was it something that could be bypassed? Had the processes been adequately put in place to check for corruption?

Mr Burgess said he believed the pilot project was absolutely necessary to engender a sense of confidence in the process. Due to the high level of complexity, pilots were needed and had to be tested in alignment with processes that were presently in place. Healthcare was being delivered in both the public and private sectors. If one ran a pilot in a selected province, incorporating the legislative changes and the operational changes that were recommended in the Bill, it would prove the effectiveness of the implementation in one instance. It could correct the problems that were likely to be encountered. Any change management process brought unforeseen challenges to the system. Currently there were not enough checks and balances in the system to prevent corruption. This was why they had recommended parliamentary oversight of the process – particularly the functioning of the Board. SAMED would advocate a pilot, and they would like to see stronger corporate governance in the implementation of the Bill and the NHI. It absolutely supported the NHI in terms of delivering equitable healthcare to all patients in the country. It had tried to identify the areas they were concerned about in their mandate of medical technologies.

Ms Shaikh said SAMED believed that they were part of the ecosystem that was responsible for healthcare delivery in the Country. Healthcare delivery was for all South African citizens. It was committed to achieving that.

Regarding the Benefits Advisory Committee, SAMED was suggesting that in addition to the technical expertise, specific knowledge of the devices from an engineering perspective needed to be represented on the Board. This was needed in order to ensure that the specialist knowledge was applied to the process of the selection of products.

In terms of the regulations, in order for the implementation of the Bill to be successful, there were 11 laws that required amendment. SAMED was suggesting that it was critical to have complete oversight of all of the legislation that needed to be amended, and that the amended legislation should be provided for public comment in order to ensure that the Bill could be implemented without protracted challenges.

The meeting was adjourned.


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