National Health Insurance (NHI) Bill: public hearings day 12

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13 July 2021
Chairperson: Dr S Dhlomo (ANC)
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Meeting Summary

Video: Portfolio Committee on Health, 13 July 2021

NHI: Tracking the bill through Parliament

In this virtual meeting, the Committee heard oral submissions on the National Health Insurance Bill from three organisations who all welcomed initiatives to improve access to quality healthcare services to all South Africans and proposed a number of amendments to improve the Bill in line with their written submissions.

The Pharmaceutical Task Group highlighted the Group’s support of a universal healthcare system for South Africa, however a number of challenges were outlined. This included the need to find the right balance of access, equity, affordability and sustainability, as well as the need to leverage the strengths of the public and private sectors to address such inequalities. The Group’s four key positions included that the single payer, single purchaser model would not meet the medicine treatment needs of all South Africans, the need for a flexible hybrid medicines pricing framework, their opposition to the proposed rationing under National Health Insurance and the Group’s support of complementary health insurance. These positions were discussed in detail. Issues on the formulary and essential medicines list were outlined. The Group’s position on the governance structure, specifically the Benefits Advisory Committee (BAC) was emphasised as well as the need to ensure a sustainable medicines industry. Their concerns about the implementation of the Bill were outlined.

A number of questions were asked by the Committee. Members highlighted that the pharmaceutical industry would be one of the biggest beneficiaries under NHI; they questioned how the Group planned to use its benefits to contribute to transformation, in terms of medicine supply in the Country. Given the Group’s opposition to the single payer, single purchaser model, how did the Group propose competitive pricing of medicine could be achieved under NHI? Further information/sources about the inadequacy of the single pricing model was requested. Members asked how the single payer model would negatively impact job creation and economic growth, as suggested in the submission. They asked if the accreditation system would further widen the inequality gap. Did the Group believe that a hybrid system would be more effective at creating equitable access to healthcare? It was further asked how this would improve health outcomes. Members asked if the 500 medicine molecules included generics. Clarity was requested about the Group’s opinion on a hybrid system, in terms of utilisation, across the public and private sectors. They asked if the details on the formulation of the Benefits Advisory Committee should be contained in the Bill or regulations. Clarity was requested if the Group’s concern about new technologies and innovation was covered under clause 57(3)(c) of the Bill.

Systagenic Wound Management South Africa highlighted the right to access healthcare and social security as well as the limitation of rights as contained in Section 27 and 36 of the Constitution. It was suggested that principles needed to be included in legislation to guide the governance structures of NHI. It noted that there was insufficient inclusion of evidence-based medicine and health outcomes on product procurement, in the Bill. It emphasised that the Bill was silent on how innovative medical devices would be adopted into the system. It suggested that Health Technology Assessment should exist independently of NHI.

The Committee asked how the lowest possible price would affect health outcomes. Given that Systagenix was a global entity, it asked if there were any countries where similar models of NHI had succeeded. Members asked how the Bill would negatively impact innovation. They queried if there were gaps in the Bill, specifically constitutionally in the implementation of the Bill. Clarity was requested if Systagenix was suggesting that there should be no internal Health Technology Assessment capacity in the Fund. Members asked if clause 57 of the Bill allayed their anxiety about the transitional arrangements toward NHI. Clarity was requested on the statements made about wound treatment at different levels of the healthcare system. They asked if Systagenix was aware that the Bill mentioned health and quality outcomes 35 times for accreditation, contracting, data collection and payment of services.

The Becton Dickinson Medical Device Company supported the principles and objectives of NHI, particularly given the inequalities that existed in the current healthcare system. The role of the private sector was outlined and it noted collaboration between the two sectors allowed for more rapid innovation and constructive progress toward NHI objectives – with a number of examples given from the Company’s experience. It requested that the medical technology industry be recognised under NHI and within the Bill. Recommendations were made about the procurement of medical technology, including decentralised procurement, where necessary. The Company supported the establishment of an independent Health Technology Assessment Agency. It suggested that the South African Health Products Regulatory Authority should remain the only regulator for medical devices and in-vitro diagnostics, and its independence maintained. Freedom of choice in accessing healthcare services should continue under NHI and that the benefits and services should be reviewed at least annually. It suggested that any limitation of existing rights should meet the criteria set out in Section 36 of the Constitution. It proposed that the phased implementation should take place according to milestones, instead of time-based goals and consideration be given to the need for investment to improve the existing health system / infrastructure. It emphasised strong governance structures representative of all health sectors and that there needed to be transparency in the financing and flow of money under NHI.

The Committee suggested that there seemed to be inherent assumptions in the Becton Dickinson submission that only the private sector could achieve rapid innovative and constructive progress to implement NHI. Given the potential for corruption, Members asked about governance structures and if Parliament should oversee and elect the NHI committees. What expertise should be included in the advisory structures? Clarity was requested if clause 57 of the Bill covered its concern about the establishment of an independent Health Technology Assessment Agency. Given Becton Dickinson’s experience in Africa and internationally, what lessons could be provided to the Committee, on the delivery of cost-effective healthcare? Clarity was requested about the various approaches mentioned in the submission, which included the tailored, substantive potential and value-based approaches. Members asked about its proposal to include medical schemes and if this was exclusive to the transitional period.

Meeting report

Pharmaceutical Task Group (PTG) submission
Dr Stavros Nicolaou, PTG Chairperson, Mr Gavin Bauer, SANOFI Head of Market Access, and Mr Rhulani Nhlaniki, President of Innovative Pharmaceutical Association of South Africa (IPASA), presented to the Committee on behalf of PTG.

Overview of PTG
- Established in 2004 to respond to the Transparent Pricing Regulations
- PTG is an umbrella body for pharmaceutical associations on issues of common interest.
- Members of associations are involved in the manufacturing and/or sale and distribution of health products within South Africa.

PTG supports a universal healthcare system for South Africa however…
- NHI challenge is finding the right balance between access, equity, affordability and sustainability.
- The current levels of healthcare financing inequality are unsustainable and undesirable
- A more equitable healthcare system is supported
- A more equitable distribution of healthcare resources to achieve the constitutional mandates that underpin this goal, are supported
- The strengths of the public and private sectors should be leveraged to address the inequality that currently exists
- The Pharmaceutical Industry is one of the only healthcare players that currently provides healthcare solutions for both the Public and Private Sector Patient

PTG four key NHI positions:
1.         PTG respectfully submits that a Single Payer / single purchaser model will not meet the medicines treatment needs of all South African patients.
2.         PTG calls for the adoption of a flexible hybrid pricing framework for medicines to improve South African patient access and health outcomes.
3.         Rationing of the NHI medicine benefits to lower than the current patient benefits available will compromise patient care and health outcomes.
4.         PTG support for complementary health insurance will ensure: sustainable patient access to treatment; a sustainable healthcare sector; improved health outcomes and lower patient out of pocket payments

Implications for NHI
- A single payer/purchaser model does not mean that >R60 billion will be spent on NHI medicines
- NHI needs to procure more than 500 medicine molecules to address SA patient disease burden
- A single payer, winner takes all procurement system will not improve health outcomes, economic growth or job creation
- Industry sustainability is key to NHI success
- PTG submits that a Single Payer / single purchaser model will not meet the medicines treatment needs of all South African patients
- The interdependence of the public and private sectors to deliver a secure and sustainable supply of affordable medicines, should be acknowledged by the NHI

Flexible hybrid pricing framework for medicines
- PTG calls for the adoption of a flexible hybrid pricing framework for medicines to improve South African patient access and health outcomes

Amendments to section 22G of the Medicines Act should be removed from the Schedule to the Bill:
- A single pricing dispensation is not appropriate for medicines to be procured by the Fund
- A flexible pricing framework that allows differentiated/responsive pricing is proposed:
- This allows responsiveness to the needs of geographical areas, levels of care and negotiations directly with providers, as envisaged by section 38(6) of the Bill

The proposed flexible hybrid model for medicines pricing should be based on these principles:
- patient access to medicines;
- security of supply of medicines;
- the ongoing sustainability of the pharmaceutical industry.
- A flexible hybrid pricing framework, that allows differentiated | responsive pricing, effectively reduces inequality as it leads to a sustainable medicines supply chain

Flexible hybrid system
Recommendation: ensuring a sustainable medicines industry
While retaining a competitive procurement system in order to obtain ‘value for money’:
- The Fund will be bound by the procurement processes as set out in the PFMA and the PPPFA
- Review the intention for an SEP system as envisaged in the proposed amendments to S22G of the Medicines Act
- Consider a differentiated and responsive pricing system within a flexible framework for discussion between the medicines industry and the NDoH

Rationing of the NHI medicine benefits to lower than the current patient benefits available
- The Formulary and Essential Medicines List must be set on the basis of evidence-based medicine, ensuring access for patients to appropriate medicines
Access must be progressive and not regressive, in line with constitutional principles:
- Current access to medicines and molecules by patients prior to the implementation of the Bill, must not be reduced or limited post implementation of the NHI Scheme
- Post implementation of NHI scheme, patients who are stable and well controlled on existing medicines should continue access to such medicines in line with these constitutional principles
Proposed principles applying to Formulary development and Essential Medicines List (EML):
- Procurement should not be based exclusively on the Formulary. Patients who are unresponsive to treatment or experience treatment failure must have access to medicines to address their needs
- The Formulary should include innovative medicines and a sustainable choice of generics

Formulary and essential medicines list proposed actions:
- Procurement outside of the formularies should remain possible in the NHI system in the interests of patient access to appropriate medicines and optimal patient care
- The Bill should facilitate a multiplicity of suppliers by allowing procurement to address the needs of all patients
- Formularies should be set on the basis of evidence-based medicine
- Reference is made to the National Drug Policy 1995, which provides for the Formulary and its envisaged complementary list (section 7(4)(c))
- There should be appropriate exceptions for patients who have failed formulary treatments, or who experience adverse effects
- Patient medicine access must be progressive and not regressive, in line with constitutional principles

Benefits Advisory Committee: proposed principles to guide the decision-making:
- Access should be allowed to new technologies and innovations, based on value assessments
- Access should be allowed to a sustainable choice of generic medicines
- The Benefits package should ensure continuing patient access to the kind of benefits to which there was prior access
- The Bill must specify the factors that the BAC and the Fund must consider when determining what healthcare services and medicines should be included in the benefits package
- Potential confusion between ‘comprehensive benefits’ and ‘medically necessary’ should be explicitly resolved
- The absence of explicit governance, process and guidance could result in a benefits package that is arbitrary and negatively impacts the ability of suppliers to satisfy requirements

Ensuring a sustainable medicines industry
- Where the NHI benefit is unable to provide the kinds or quality of healthcare services required to improve patient outcomes, South Africans should not be deprived of the right to access healthcare services in the private sector
- The interdependence of the public and private sectors to deliver a secure and sustainable supply of affordable medicines, should be acknowledged by the NHI
- Investment and overheads are covered largely by revenue from the private sector, which allows lower prices to the State. Economic growth and investment will reduce if this dynamic is disrupted.
- Medicine supply at the ‘lowest price’ as envisaged in the Bill or at the price level currently supplied to the State alone, is not sustainable, even if volumes increase
Unless innovative medicines are procured by the NHI Fund:
- The pharma industry will not be sustainable and availability of generics in the future will be diminished
- Generics follow on after innovative medicines are registered in South Africa; launched and used in the local market
- Allowing patients to purchase voluntary complementary health insurance will ensure a sustainable medicines sector to support NHI

Implementation of the Bill
- NHI implementation is envisaged in two phases
Strengthen the health system first:
- The underlying health system strengthening initiatives need to be completed before full implementation of the NHI scheme
Don’t take away rights:
- The Bill of Rights gives the State an obligation not to limit, diminish or take away people’s existing access to healthcare services
Ensure continuity of access:
- Nine million people make use of medical schemes to access quality healthcare. Until the NHI scheme is fully implemented, there is a risk these nine million people could lack continuity in access to these services, constituting a regressive measure
- A milestone approach rather than a date-based approach to NHI implementation
- The interventions set out in the Presidential Health Compact for each Pillar should be pre- conditions for full implementation of the NHI scheme
- The Fund should be sufficiently liquid before full implementation

- PTG respectfully submits that a Single Payer / single purchaser model will not meet the medicines treatment needs of all South African patients.
- PTG calls for the adoption of a flexible hybrid pricing framework for medicines to improve South African patient access and health outcomes
- Rationing of the NHI medicine benefits to lower than the existing patient benefits available will compromise patient care and outcomes
- PTG Support for complementary health insurance will ensure : sustainable patient access to treatment, a sustainable healthcare sector, improved health outcomes and
- lower out of pocket payments

Ms M Hlengwa (IFP) stated that the pharmaceutical industry would be one of the biggest beneficiaries under NHI, it would have to increase its supply of medicine to accommodate millions of new consumers in the healthcare sector. There would be new consumers who would find themselves able to access healthcare under NHI. How would PTG plan to use its benefits under NHI to contribute to transformation in the supply of medicine in South Africa.

Ms A Gela (ANC) said that PTG proposed that rationing of NHI benefits would compromise patient care and health outcomes. The only clause in the Bill that made reference to rationing was clause 39(5) requesting reasons from providers for rationing. She asked PTG where in the Bill it stated that benefits would be rationed. What gave PTG the impression that healthcare provisions and medicine supply would be threatened or not sustained? Did PTG have examples of where this had happened in other countries. Given the lack of support for the single payer, single purchaser model, which came with benefits of economies of scale, how did PTG suggest that competitive prices of medicine were gained under NHI, if the country continued with fragmented purchasing methods?

Ms N Chirwa (EFF) requested clarity on what PTG suggested was inadequate and problematic about single pricing of medicine. If there had been research on this, could this be forwarded. She heard the reasons given by PTG, but she wanted to know if there was other research that was conducted on that.

Ms H Ismail (DA) asked what were the key features of the NHI that would result in more equitable access. Her concern was that it would further widen the inequality gap due to the accreditation system. What was PTG’s thoughts on this? She referred to the PTG comment: ‘rationing of the NHI medicine benefits to lower than current patient benefits available, would compromise patient care and health outcomes.’ She asked it elaborate on that. What was meant by rationing of medicine benefits, and how did PTG foresee this actually having a negative impact on health outcomes?

PTG said the single payer model would negatively impact job creation and economic growth. In what ways did PTG foresee this having a negative impact? PTG supported a more hybrid system; did PTG believe that a hybrid system would be more effective at creating equitable access to healthcare? How would it improve health outcomes? In what ways did PTG foresee the Fund being vulnerable to corruption? How sustainable was the single payer, single purchaser model in its view? What outcomes did PTG anticipate? As NHI stood, how did PTG anticipate the quality of care under NHI? It could be argued that it would create equal access, but what was PTG’s views specifically on the quality of healthcare?

Ms X Havard (ANC) asked what the value was of the top therapeutic category in the private sector. Could PTG explain what the 500 medicine molecules included? Did it include generics as well?

Dr K Jacobs (ANC) said that PTG had made the recommendations about continuity of care and phased NHI implementation. Clauses 57 and 33 spoke about this in the Bill. What was PTG’s view on these clauses covering their recommendations? Clause 57 clearly outlined that there was a phased NHI implementation and clause 33 stated that only once the NHI had been fully implemented, medical schemes would offer complementary services only. PTG spoke about a hybrid system when it came to purchasing of medicines. What about a hybrid methodology on utilisation – between the public and private sectors, especially given that the current status quo would no longer be in place and no differences would exist between public and private sectors?

PTG raised a concern about NHI jeopardising the pharmaceutical sector – the independence between patients and providers was also discussed. Was it PTG view that NHI should regulate the prescribing model or the standard and international protocols for accredited healthcare providers to ensure certain practices would maintain the sustainability of the pharmaceutical industry? Did PTG believe that expanding access to healthcare, provided for in Section 27 of the Constitution, was regressive? If timeframes were not acceptable for NHI implementation, was it acceptable to achieve a percentage of milestone measurements, so that the country did see a transformation of the healthcare system.

Mr T Munyai (ANC) said that given the lack of support of the single payer, single purchaser system, which came with economies of scale benefits, how would PTG ensure that the country gain benefits for competitive prices of medicines if fragmented purchasing methods were continued. The NHI Bill suggested that the establishment of key structures, including the Benefits Advisory Committee, Pricing and Stakeholder Committees. The Bill allowed for the inclusion of persons with technical expertise in medicine. Was PTG in agreement that the inclusion of the pharmaceutical sector in the committees would adequately represent their interests? Given that the budget allocation would inform purchasing behaviour, what did PTG propose be done to replace the Essential Medicines List (EML) and formulary systems currently in place? Was it acceptable that the details of how the Benefits Advisory Committee (BAC) would set its criteria, ia contained in the regulations and not the Bill? How did PTG envision hybrid pricing working – in terms of a transparent pricing system – which was contained in the Medicine and Related Substances Act?

Dr S Dhlomo (ANC) echoed the question by Ms Gela and Ms Ismail in rationing of the NHI medicines. He would have been happier if PTG had stated that they would like to be on the Benefits Advisory Committee. PTG was assuming that what they had was appropriate for both the public and private sectors. PTG should state that they would want to be part of the Benefits Advisory Committee to setup a benchmarks medicines package. Someone would argue that there would need to be a benchmark. Clause 38 spoke about roles and responsibilities. PTG introduced a phrase ‘flexible pricing framework’ – this was embedded in these various committees. If one considered all of that, did it not address the flexible pricing framework PTG was proposing?

PTG mentioned that access should be allowed for new technologies and innovations based on value assessments. Was this not fully covered under clause 57(3)(c) which outlined transitional arrangements including that the Ministerial Advisory Committee on Health Technology Assessments (HTA) would be established to regularly review a range of health interventions and technology by using the best available evidence on cost effectiveness, allocative production and efficiency. Did this not adequately cover PTG’s concern? PTG spoke about the large market for supply of medicine. The Committee was aware that there was a large market for the supply of medicines via various non-governmental organisations (NGOs), how did PTG propose that the NGO sector be accounted for? He referred to Section 27 of the Constitution, ‘everyone had a right to have access to healthcare services including reproductive healthcare...’ How did PTG find that section of the Constitution to be regressive? He got a bit of a surprise when he heard that. On transparency in the pricing of medicines, an important aspect introduced through the Medicines and Related Substances Act, in particular the single exit price, how did PTG propose transparency, while at the same time removing this model?

Pharmaceutical Task Group response
Mr Gavin Bauer replied about hybrid pricing models, or hybrid flexible pricing models, that the implication that came from the Bill was that the ‘lowest price winner takes all tenders’ seemed to be the preferred mechanism for medicine procurement. PTG did not think this was appropriate as it would not be sustainable. PTG proposed a situation where certain types of medicines were procured on a certain basis – where there were multiple manufacturers for a medicine, where a lowest price could be secured. This could be a tender mechanism, not unlike what existed presently.

There were then innovative medicines, where there was a sole supplier, that would need to be procured on a different basis because having a tender for only one supplier, did not make logical sense. Then there needed to be a negotiation between the company and the NHI Fund, or the Central Procurement Office. There would then be certain medicines, where the level of evidence, was not mature yet to clearly demonstrate the value of the product through an Human Development Index (HDI) process. Those medicines needed to be evidenced through an outcomes-based arrangement, like in the United Kingdom where their cancer programme worked on that basis. When a new innovative medicine came to market, its value was not completely clear as the data was immature and the National Institute for Health and Care Excellence (NICE) procured that medication based on outcomes demonstrated through the use of the medication in the population to address a met need. This gave an indication of what PTG believed a flexible hybrid medicine procurement system, or pricing system, should look like in the NHI. There was international literature that could be provided to Ms Chirwa on hybrid flexible pricing arrangements.

On rationing, PTG was unclear about what the comprehensive benefit package looked like – PTG understood the balance between the Bill and the regulations which would provide more explicit insights later. PTG was concerned that there was no assurance that NHI, from a procurement of medicines point of view, would procure more or less medicines. This was the concern that was raised around rationing. PTG did not want patients, who were currently in the public sector on a treatment, to be compromised, if a treatment ‘fell-off.’ This might also be the case in the private sector where a patient could be on a treatment that might not be part of the NHI package and that member might not be able to afford a complementary health insurance package. The rationing comment was about the uncertainty of the comprehensive benefits and medical necessity as prescribed in the submission. PTG did not make the assertion that NHI was regressive in terms of section 27 of the Constitution. What PTG had presented, was that PTG did not want the benefits package to be regressive versus what current patients were being treated with. There was a misunderstanding about the intention of that comment.

PTG believed that HTA was required, as long it was independent and done on an explicit basis where the rules of inclusion or exclusion were known. Ms Hlengwa had suggested that the pharmaceutical industry would be a net gainer under NHI; currently PTG was unable to state if that was the case as it was unsure what the benefit package would look like. It was thus unclear if there would be a net gain within the pharmaceutical industry as a result of NHI.

PTG agreed and supported inclusion on the Benefits Advisory Committee and it was appropriate for the pharmaceutical industry to be represented on it. On a different model to EML, the underlying burden of disease needed to be reconciled and healthcare needs of both sectors needed to establish what medicines would be required. The PTG view was ‘EML plus’ going forward – it was not doing away with EML. It was taking a broader view across the whole South African patient population to meet unmet needs.

On NGO purchasing, PTG’s understanding was that there were some NGOs that provided medicines in South Africa, but that sector was quite marginal and small versus total procurement by provinces and the national department. Those purchases should be factored into the NHI Fund. On quantum and how it should work, this should be left to the Fund to establish because it was quite small in the greater scheme of things.

Dr Stavros Nicolaou replied about the impact of NHI on the pharmaceutical industry. The pharmaceutical sector together with the medical equipment and devices sector was the only one that provided products to both public and private sectors. This was therefore different to the hospital and medical schemes industries who only did business in the private sector. The perception that there would suddenly be a doubling of volume, or a growth in volume, was not necessarily true by their assessment. There was already extensive volume that resided in the public sector. If one were to combine the volume of the public and private sectors, one would not get a significant growth of economies of scale or volumes in the country . The impact of combining the two and defaulting to a particular position was that one could be disrupting the existing cross-subsidisation between public and private sectors. The public sector presently had some of the lowest prices in the world. It was a very efficient system at procuring medicines. PTG was concerned that a disruption of that could mean that there would be certain medicines that were no longer viable to keep in the market. This was seen in other markets – such as New Zealand for example. New Zealand defaulted to a single system where a number of medicines became unavailable in New Zealand. The concern was that the health outcomes and the health metrics that were measured also become affected in that instance. Further, if certain medicines or categories became unsustainable it would disincentivize companies from wanting to introduce new medicines into the market. In the medium to long-term the health system would not benefit from that – in fact it got prejudiced because it was no longer economically viable to sustain certain companies and/or products in the market. PTG was concerned that if one had a single payer, single buyer system, it would disrupt the dynamics of the pharmaceutical market industry.

On security of supply, the pharmaceutical industry required a uniquely South African solution, part of that solution resided in where the country was presently between the private and public sectors. On the question on the 500 molecules and if it included generics – it was in fact mainly generics.

Mr Rhulani Nhlaniki replied about the introduction of NHI and how the pharmaceutical industry was likely to drive transformation. On the availability of more medicines, PTG believed that there was a sweet spot that existed in between 500 molecules and 1000 in the two sectors, where both sectors would have greater access. There would be a lot of generics within NHI. The companies in the country and existing local manufacturers would be able to benefit from that perspective – not only from a pharmaceutical point of view, but in terms of good quality healthcare across the board.

Dr Stavros Nicolaou replied that those 500 molecules were made up predominantly of generics. More detail could be provided in writing. On medicine pricing transparency, the 2004 amendment to the Medicines and Related Substances Act in section 22(g) introduced transparent pricing to the system. It was one of the most successful pieces of healthcare legislation in recent times. It had significantly managed expenditure in the private sector on pharmaceutical pricing and benefits. It had also introduced transparency in pricing through benchmarking and other instruments. These prices were all benchmarked globally and manufacturers were required when new medicines were introduced to make reference to benchmark prices. Unanswered questions would be answered in writing to the Committee. The pharmaceutical industry remained committed on an ongoing basis to the healthcare outcomes of the nation, most especially the current vaccine roll-out for getting on top of the COVID-19 pandemic.

Systagenix Wound Management SA submission
Mr Norman Tillema, Systagenix Sales Director and Mr Mark Brand of Brandtech Health Technology Consulting, presented to the Committee.

Delivering solutions across the care continuum in SA
- Leader in wound care and related products – history of innovation
- Delivering world class products to every corner of the country
- Supplying innovative and transformative medical devices to our entire population
- Believe that everyone should have access to healthcare, regardless of funding mechanism
- Health economics matters! As do clinical outcomes – cheaper not always better.

Right to access healthcare and social security and limitation of rights in Constitution
- The NHI Bill would have to, in its application, limit the rights of individuals. This would also be the case in its gradual implementation.
- The question therefore is, on what basis will the NHI Fund, through entities such as the Benefits Advisory Committee, the Benefits Pricing Committee and the Office of Health Products Procurement (OHPP), make these decisions that would have to limit rights?
- No such principles to guide the limitation of rights are set out in the Bill and specifically in relation to the supply of medical devices.

Our proposal: include principles in the legislative criteria to be applied by NHI structures
- The limitation of rights must be evidence-based, by the inclusion of evidence-based medicine as the criterion on which the BAC and OHPP, and in the end the NHI Fund make their decisions on formularies and treatment guidelines.
- Not only 'the lowest possible price’ in clause 11(2)(e) but health outcomes must be considered.
- Create mechanisms whereby deviations (and not rigid complementary formulary) is permissible, by healthcare professionals and entities to act in the best interest of patients, in particular with complex wounds, the inadequate treatment of which could lead to sepsis, loss of limbs, etc.

Evidence-based medicine and health outcomes
Apart from the absence of entrenching evidence-based medicine and health outcomes in products procurement, our concerns are with:
- Clause 36(6): direct delivery (currently in the public sector we deliver to depots)
- Clause 41(3)(b): all-inclusive fee to specialist and hospitals: will that include our products and they are held accountable for outcomes?
- Clause 38(6); 34; 4(7)(c) and 8(2): formularies appear to be strict, with no room to respond to health needs that may fall outside of such lists

- The NHI Bill is silent on how innovative medical devices will be adopted into the system.
- Introduction of new technologies constitutes an important facet of healthcare service delivery.
Innovative devices may provide:
- Treatment for previously untreated conditions or improve devices where other devices have failed or where there were no further treatment options
- Reduced overall length of treatments, fewer admissions, reduced length of stay, quicker recoveries, improved quality of life and overall productivity.
- An example in advanced wound dressings (AWD), healing time can be 40% quicker.
- We support a mechanism for assessing and introduction of technologies to ensure timeous access by patients and specialist in their fields.
- This needs to be underpinned by HTA.

Health Technology Assessment (HTA) in 57(3)(d) under Transitional Arrangements
- The Ministerial Advisory Committee on HTA for NHI will advise Minister on HTA as precursor to the Health Technology Agency that must regularly review health interventions and technology by using best available evidence on cost-effectiveness, allocative, productive and technical efficiency.
- World Health Organisation (WHO) definition: Systematic evaluation of the properties and effects of a HT, addressing the direct and intended effects of this technology, as well as indirect and unintended consequences, aimed mainly at informing decision making on HT. HTA is conducted by interdisciplinary groups that use explicit analytical framework drawing on a variety of methods.
- ISPOR definition: An evidence-based, multidisciplinary process intended to support healthcare decision making by assessing properties and effects of one or more new or existing health technologies in comparison with a current standard. Aiming at determining added value, HTA uses explicit analytical frameworks to determine the value of a health technology at different points in its lifecycle, based on research and the scientific method in a systematic, transparent, unbiased way. It s aim is to inform decision-making for an equitable, efficient and high-quality health system.

HTA should not sit within the NHI
- The NHI cannot be a producer and consumer of HTA recommendations.
- Naturally influenced by the perspective of the NHI.
- Fit for purpose
- Independent – avoids the bias of the ‘owner’
- Dependent on life-cycle of the technology
- Avoid a one size fits all methodology: inappropriate to use pharma assessment methods for non pharma such as devices
- Adaptable and pragmatic and consultative
- Guides clinical practice therefore must be frequently updated.
- Balance natural (burden of disease) and innovation (access to best care) priorities.

Ms Ismail asked in what ways would the lowest possible price negatively affect health outcomes? She noted that Systagenix was a global entity; where else in the world had it seen this type of NHI model succeed? How would this Bill negatively impact innovation?

Dr Jacobs noted that it proposed that the justification for any limitation of rights be included in the Bill. Did Systagenix appreciate that the Constitutional Court had extensive jurisprudence on the limitation of rights in Section 36 of the Constitution. This was not included in the legislation specifically. Those cases were available for Systagenix to study on the justification for a limitation of rights that was reasonable and justifiable in an open and democratic society. He asked it to comment on this. Systagenix made reference to evidence-based medicine and cost effectiveness. Why did it seem to be implying that this was not considered in the NHI Bill? On slide 7, it stated that ‘the Bill was an enabling legislative framework aimed at establishing the NHI Fund.’ The principle referred to was more appropriately covered in the regulations than the Bill. It applied to the point raised about the provider/payment mechanisms on slide 13.

Ms Gela referred to the right to access healthcare and the limitation of rights. Was the Systagenix view that there were gaps in the Bill where constitutional matters about NHI implementation were not effectively addressed? The Bill’s preamble stated that NHI implementation was consistent with the constitutional commitment for the state to take reasonable legislative and other measures within its available resources to achieve progressive realisation of the right to have access to healthcare services. Did this not address its concerns?

Mr Munyai said that there seemed to be an assumption that complex cases and high-skilled personnel able to attend to wound care – were not catered for in the primary healthcare model. He asked for clarity on this. He referred to slides 17 and 18, saying there was no provision in the Bill that stated HTA would be used to restrict access to services. Was Systagenix suggesting that there should be no internal HTA capacity in the NHI Fund? It must have this capacity to be able to assess what was recommended to inform other processes. Systagenix stated that only a separate external entity would work? Why was this? Was it suggesting that health technology should not be used to enlist care products into the formulary list? Currently, pricing and the supply of wound care products were not in any way regulated. Was it suggesting that the status quo be retained, or some form of regulation be implemented?

Dr Dhlomo requested clarity on the Systagenix suggestion on primary, secondary or tertiary burns that the cases be sent to the appropriate levels. He did not understand this as not all burns were treated at a secondary or tertiary level. One classified burns and then sent them to the appropriate level of care based on the assessment. The Ministerial Advisory Committee on HTA would be part of the transitional arrangements. Clause 57 stated it was precursor to the HTA Agency. It would definitely translate into a permanent agency.

The concerns about the roll-out and the role of the medical schemes was noted. Clause 57 of the Bill did allay their anxiety because it spoke about the transitional arrangements, which included the phased approach to NHI. Clause 33 stated that the role of the medical schemes would be limited to complementary services, once NHI was fully established. It would allow for medical schemes during the transition – was Systagenix not comfortable with that?

Ms Gela asked about the Systagenix recommendation that not only cost but health outcomes be considered by the Fund – was it aware that health or quality outcomes was mentioned 35 times in the Bill? Accreditation, contracting, data collection and payment of service providers considered health outcomes. Where and how else would it prefer health outcomes considered in the Bill?

Mr Norman Tillema replied about negative pressure wound therapy that the tendency by payers was to put various suppliers in the same category – for example, saying an apple is an apple but then there were different types of apples. Systagenix believed that some products were superior to others, although the payers and procurement personnel bundled them all together. Systagenix believed that if an informed decision was not made about what the products could actually do, it might then only be a price consideration and the cheaper product would be procured. This was what concerned Systagenix. On similar NHI examples in other countries, to his knowledge there were not but he would find out.

On its perception that NHI would negatively impact innovation, Systagenix was concerned about the time it would take from when new technology became available in the market – to how quickly they could get it onto other formulary to make it accessible to the public. Systagenix was concerned about the time period from bringing it into country to it being used on patients.

Mr Mark Brand replied on the limitation of rights and asked to deliberate that with his colleagues and get back to the Committee. Systagenix read a lot about cost and lowest cost – he requested the opportunity to provide a more constructive response to that in writing, specifically how it could be made much clearer in the Bill. On considerations of cost and health outcomes, if one looked at the technology on the evidence that supported its performance effectiveness, how well it did compared to current standards of care, cost-effectiveness was different to cost. Cost-effectiveness looked at two components of the calculation. How much extra benefits were there for the extra cost. It was a lot more technical than could be explained in the meeting so explanation would be provided in writing.

One needed to understand the transitional component of the NHI from primary healthcare through to tertiary level care and this needed to included. There were examples of diabetic foot ulcers, which left untreated would become chronic, or could lead to amputations. Systagenix did not disagree about HTA in the context of transitional arrangements – particularly if there was a view to create an independent entity. If the short-term strategy was to implement internally and get through the work then it was difficult to argue with that. Having said that, there was a lot of work going on in the industry already on this. This possibly had a home in the Benefits Advisory Committee where it would take the outputs and recommendations of a HTA process, if internal or external, and make its determination based on that. He was not sure that making it internal or external made that much of a difference at the moment. Systagenix was aligned to the necessity to have some form of formal HTA and a structured approach to this. It would support the transitional arrangements for HTA. He could not see this making a difference if there was a sufficient amount of this work currently happening. He did mention building this internally only to relinquish it to an external body. He would respond to the questions about medical schemes formally in writing.

Mr Tillema explained that the suggestion about burns was that the knowledge gained on the treatment of burns at higher levels needed to filter down to the primary level, in terms of the calibre of care – depending on the size and severity of the wounds. The burn centres in South Africa were world class, they were superb.

Becton Dickinson (BD) Medical Device Company submission
Mr Ian Wakefield, BD General Manager, Ms Aadila Fakier, BD Public Affairs and Market Access and Ms Avanthi Bester, BD Regulatory Affairs Africa, presented to the Committee.
BD recognises the inequalities of current healthcare system and is keen to support the achievement of universal health coverage (UHC) in South Africa under NHI.

BD commented on the following aspects of the NHI Bill:
- The role of the private sector in the delivery of a quality healthcare system
- The MedTech sector and the role that it plays within the healthcare system
- Procurement of medical technology
- Health technology assessment and reimbursement of medical technology
- The accreditation process
- The benefits package & the rights of users
- Legal concerns.

Role of the private sector
Collaboration with the private healthcare sector for more rapid, innovative and constructive progress towards NHI objectives:
- Leverage existing current best practices amongst private healthcare stakeholders
- Resources, capabilities and systems can be provided
BD examples include: R&D to support Covid-19 response;         Collaboration with public sector to advance “Safety in Healthcare”; Training on brachytherapy technology for prostate cancer in the public sector; Surgical skills cadaver training – hernia repair; Labs for Life programme to capacitate healthcare and laboratories in Africa; Digital diabetes patient education programmes.

BD requests recognition and distinction of the medical technology industry:
- Medical devices and in vitro diagnostics (IVDs) play a vital role in patient care
- Consumes only a small percentage of healthcare expenditure:
- MedTech value: $20B vs Pharma Value $60B
- MedTech could play a significant role in healthcare for all South Africans under NHI
- It has distinct characteristics which impact procurement and practices compared to medicines and other health goods or services.

- Difference between medicines and medical devices/IVDs to be recognised in Bill definitions
- The terms “medical device” and “IVD” as defined in the Medicines and Related Substances Act should be used as opposed to         “health goods”
- Expertise in medical devices / diagnostics to be included in decision making bodies such as Benefits Advisory Committee, Healthcare Benefits Pricing        Committee, Stakeholder Advisory Committee (Chapter 7)
- An Essential Devices List be included on the formulary developed by the Office of Health Products Procurement in Clause 38(4).

The following are important considerations for equitable access to MedTech solutions under NHI and is our key focus: Procurement; HTA; Accreditation.

Procurement should support and recognise the value of innovation in medical technology:
- Medical technology often relates to integrated solutions: e.g. software with data management,
- Medical equipment plus consumables, after sales service, maintenance and training. capital equipment and consumables are not always interchangeable.
- Cycle of innovation is rapid (updates 6 to 24 months) – can be both evolutionary & incremental
- A centralised mechanism of procurement by the Office of Health Products Procurement will have practical implications for medical technology:
- Unmet patient needs –clinical variation amongst patients impact MedTech solutions required,
- Lack of innovation – fast pace of change in MedTech
- Exclusive contracts - - prevents multiple models and types required to meet specific needs
- Value added services is critical and cannot be separated from capital purchase
- Maintenance of equipment
- Servicing & technical support
- Education
- A value-based approach should take into account:
- Life-cycle cost of healthcare delivery
- Wider outcomes of care for the patient and society

Procurement of medical technology:
- NHI Procurement System should recognise the complexity of medical technology and review of international best practice on the procurement of medical technology encouraged .
- Decentralised procurement (where applicable) as opposed to a centralised system (Chapter 8(38)) - considering specific patient needs and full life cycle value, including servicing & maintenance requirements, training needs etc
- Agility in procurement process – cater for MedTech improvement cycles
- Tailored approach & multiple suppliers for specialised devices - clinical choice based on patient need
- Establishment of a substantive Essential Equipment and Diagnostics List( EEL) to support standardisation in access and standards of care – informed by HTA

Best Practice Example: Value Based Procurement in EU (MEAT):
- Value-based purchasing in accordance with “most economically advantageous tender” (MEAT)
- Adopts a broad definition of value benefits of a particular product/service/solution in terms of improved outcomes for patients
- Cost of care efficiencies
- Benefits for other stakeholders
- The sum of which is the most economically advantageous purchase

Health technology assessment and reimbursement of medical technology
- BD supports an independent Health Technology Assessment (HTA) agency:
- Ministerial Advisory Committee on HTA will serve as a precursor to the HTA agency
- HTA process based on principles of regularly reviewed, evidenced-based assessment of cost-effectiveness is a sound objective
- However, currently in SA there is a shortage of HTA skills.

- An HTA agency should be independent to the NHI: clause 58(3)(d)
- Information is required on composition and decision-making processes of the HTA agency
- HTA process should not become an administrative bottleneck that limits patient access (as evidenced by National Health Laboratory Services’ initial HTA process that led to discontinuation)
- We recommend the development of an independent agency to conduct an expert, efficient and uniform HTA process in SA that is patient-focused and seeks to achieve best value

Multiple accreditation steps could lead to administrative bureaucracy and duplication
The need to ensure quality goods, suppliers, service providers and the achievement of acceptable standards in the delivery of goods and services to the Fund are recognised.
- Registration, certification and accreditation must be supported by efficient processes
- Delays in the contracting of sufficient and appropriate providers and suppliers could impact negatively on patient access to appropriate and necessary care.

- SAHPRA remains only regulator for medical devices and in-vitro diagnostics
- Independence of SAHPRA maintained
- Adoption and inclusion of a quality management system operating on a clear set of SOPs and incorporating recognised standards (SABS / ISO  accreditation)
- Clear strengthening required in the assessment skills for medical devices.

Benefits package and Rights of Users
BD is supportive that all levels of care will be considered
- The Fund via the Benefits Advisory Committee will determine the healthcare services benefits due to users
- A significant number of details are outstanding such as the financing model, contents of the benefits package, details of the procurement process.
- Only complementary benefits can be purchased from medical schemes - greater clarification of complementary services
- The Medical Schemes Amendment Bill (MSAB) allows the Minister of Health and Registrar to prohibit schemes from providing NHI benefits.

- Freedoms of choice in access to healthcare services covered under NHI should be maintained as is international practice: Chapter 2, Chapter 8 clause 33
- Benefit design and services should be reviewed at least annually: Chapter 7 clause 25(5)
- BD supports the Bill on the emergence of new technologies – this must be considered in determining treatment guidelines: Chapter 7
- Decisions should be based on sound medical evidence
- Approach to drive cost-effectiveness should not mean cheapest: Chapter 7
- The governance processes in the selection and functioning of the Benefits Advisory Committee and Health Services Pricing Committee should be adequately defined: Chapter 7
- There should be adequate representation of MedTech expertise on these committees.

Legal Concerns
The constitutional impact of some clauses in the Bill is of concern for rights to freedom of association and access to healthcare services.
- Governance and decision-making to a large degree centralised in Office of Minister of Health
- Centralised decision-making poses a risk and does not accord with good governance principles
- The Minister appoints the BAC, HPC, SAC and all technical committees (Clauses 25 to 28).
- This creates concerns about the independence of the board.

- Any limitation of existing rights must meet criteria in Section 36 of the Constitution.
- The separation of legislative and executive power needs to be maintained
- Greater inclusivity in decision making
- Appropriate representatives with requisite expertise of MedTech should be included to provide input on the Stakeholder Advisory Committee.

Concluding remarks
BD looks forward to contributing positively to UHC attainment for all South Africans. We highlight the following concerns and recommendations for NHI as we move towards this goal:
- Phased implementation with milestones as opposed to being time-based
- Consideration given to time and investment required to improve existing health infra-structure especially in public sector through collaborative approach
- Access of all South African patients to “best” standard of care
- The continued existence of a private healthcare sector which provides for choice and creates a competitive landscape
- Procurement system allows for alignment with National Department of Health Strategic Plan
- Strong governance structures which are representative of all sectors
- Transparency and information on the financing of and flow of money within NHI

Mr Munyai referred to slide 10 – there seemed to be inherent assumptions that only the private sector could achieve rapid innovative and constructive progress to implement NHI. Although the public sector was meant to be the backbone of the NHI, it was also capable of coming up with innovative technologies or means to provide for cross-sectoral collaboration where necessary. Was it the assumption of BD that without making the private sector a core component of NHI, it should not be implemented? Why was it suggested that BD be represented on all key structures of the NHI – was it not a self-benefit suggestion meant to ensure expertise in this area could be used to influence decisions? If the structure included all stakeholders it is too big and unmanageable – adversely impacting decision-making and implementation of action plans. What forms of assessment should be in place to ensure effective and good-quality medical devices? Did clause 57(3)(d) and clause 38(2) in the Bill give comfort to MedTech who would be treated differently. BD should look at the Bill carefully to understand the certification and accreditation was very different – and who was responsible. His understanding was that this did not fall under SAHPRA responsibilities.

There was a concern about the Minister. In BD’s country of origin, USA, the governance system was federalism with decentralisation of its states. In South Africa there was a democratic unitary state where the party that won elections, implemented its own manifesto mandate. Did BD have a problem with the democratic structure and associated powers as provided in the Constitution?

Ms Ismail asked how BD viewed the effects of NHI on medical innovation and technology. Did BD believe it would improve or decrease the these? Would BD suggest that Parliament elect the committee overseeing the NHI Bill and the Fund when it came to expenditure? She was asking this in light of potential corruption.

Ms Chirwa suggested that BD made strong arguments, especially on evidenced based procurement. Medical intervention methods in the public and private sectors were not always the same. It created a problem in how medical evidence was deciphered and the response of the private sector to that of the public sector. This would influence the procurement process of medical goods and equipment. Which case specifics could be noted to support this argument? For example, surgical mesh was still widely used in South Africa, despite the problems it posed. Even after the Food and Drug Administration (FDA) had taken action on this – South Africa still used it. The private sector did not use this. Was it possible to reach a middle ground? How did they then assess evidence, as opposed to the response from the public and private sectors – if they were not fundamentally the same.

She heard the argument on the selection of the committees and the Minister’s power, this had been raised previously. The Portfolio Committee should perhaps be involved in the selection of the committee, as is the case with National Youth Development Agency (NYDA). ‘Absolute power’ was noted as an issue by the Committee when reading the Bill. What was BD’s proposal for this? It was not something that could just be ignored, noting the history of South Africa and the abuse of power and nepotism that had unraveled over the last 27 years.

Ms Gela said that BD made recommendations for the establishment of an independent HTA Agency. Were they not satisfied with the stipulations in clause 57 of the Bill? This outlined that the Ministerial Advisory Committee on HTA for the NHI must be established to advise the Minister on HTA. Did this not address BD’s recommendations?

Ms Havard noted BD’s comment about limiting choice and its request for clarity about the complementary benefits. Was clause 25 which spoke about the functions of the Benefits Advisory Committee, not adequate? Clause 25 should be read with clause 33(6)-(8).

Dr Jacobs noted BD highlighted legal concerns and stated that any limitations to existing rights must meet the requirements of Section 36 of the Constitution. The Constitutional Court had extensive jurisprudence on the limitation of rights. Therefore, did BD still think it was necessary for this to be included in legislation? BD should familiarise itself with those cases. Given BD’s experience internationally and in Africa in particular, what lessons could be incorporated in the South African setting to ensure the delivery of cost-effective healthcare. It was usually unclear how medical devices were priced in South Africa. What should the Committee look at introducing to ensure transparency in the sector?

Dr S Thembekwayo (EFF) referred to the approaches BD referred to as ‘tailored, substantive potential and value-based approaches.’ She asked that BD provide some local and international research references to support its argument for inclusion as an amendment, should there be an opportunity.

Dr Dhlomo noted that BD had made a comment that they would like to see greater inclusivity. Various institutions had made submissions and had emphasised ‘don’t forget us’ – specifically for consideration on the various committees. On the greater inclusivity approach, who was BD referring to? Was this a broad statement or was this a specific professional body or expertise that could be left out if not mentioned? What was BD proposing about medical schemes. Was BD suggesting that there should be a choice of service or possibly a payment by medical schemes right through – or at a particular transitional stage of the NHI?

Mr Ian Wakefield replied that the comment that BD perceived only the private sector could introduce innovation was incorrect. This was not the case, the public healthcare sector in South Africa had a history of innovation. The point made was that the private sector could contribute and could partner to both provide resources and expertise to accelerate innovation. BD was presenting itself as being open to doing that. BD had a history, not just in South Africa, but in other countries of doing that. That was a legacy BD was very proud of.

On the question about BD wanting to be represented – there was no suggestion that BD needed to be part of a Committee. What was critical, was that the expertise within particular subject areas be leaned on. There were various professional bodies within the medical device and technology space – it did not necessarily have to be corporate. There were specialties around procurement and technology, wherever possible that should be included going forward, to limit the size of committees or complexity thereof. There definitely needs to be the right expertise on the right committees. There were a number of questions about the role of Parliament and decision-making, as well as the role of the Minister of Health. Whatever the final approach was for NHI, in ensuring good governance, Parliament already had oversight of the statutory bodies. This was not coming from the perspective of the US being federal, and South Africa being democratic, it was really about ensuring there was correct oversight of government.

There was a question about centralised versus decentralised procurement. Within centralised procurement, if one was procuring something like a tongue depressor or syringes, the standards around those were fairly common and the adjudication process was fairly simple. Centralised procurement on large bulk tenders was fairly easy to do. Surgical meshes were much more specialised, and only used within specific specialties. The specificities around certain technologies required a more localised approach and needed to be evidenced based. The commentary with regard to the private sector currently making different choices to that of the public sector – BD suggested that there needed to be a common approach in how to utilise evidence to ensure best patient outcome. There was a methodology in the European Union (EU) called the Most Economically Advantageous Tender (MEAT), where they considered best procurement and right products, in terms of an evidence-based approach. The challenge in medicine was to have the right bodies making those decisions. The Committees that were framing the benefits structure – the necessary expertise needed to exist to support the decision-making. It was important to have a common mechanism to decide what the best approach was for a broad group of patients, while there needed to be a specialty decision around types of patients and certain disease management areas, because of where they fell within the treatment paradigm.

On complementary choice and the role of medical aid funders, the defined benefit package for NHI had not been completed, and was a work in progress. Therefore, complementary services would be an evolving space going forward. What may be deemed to be complementary at year x, may be included as part of the comprehensive package of care of NHI, five years down the line. The constant review of what fell within the different space was critical to ensure equitable quality care was delivered to patients on a broad basis. This would change as advancements were made and new technology came to the fore.

Ms Avanthi Bester replied that BD’s comment on procurement came from its experience with Personal Protective Equipment (PPE), over a year before. BD had been quite involved in the process of the PPE procurement. Only SAHPRA registered products as well as SAHPRA licensed suppliers should be considered in the procurement system. This was something that was already regulated, but what was seen the year before, did not happen. There were several questionable quality products on the market as well as suppliers who may not have been involved in that particular business before. SAHPRA should be the gate keeper and regulator for regulating medical devices. BD would like it to remain that way. SAHPRA was also responsible for accrediting or licensing companies that provided medical devices and IVD technology as they were able to assess the quality management system and performance and effectiveness of devices and IVD technology. BD would like this to remain the same. SAHPRA is an independent entity.

On HTA and if clause 57 covered BD’s concerns about independence. BD did not believe so. It did recommend that the Ministerial Advisory Committee as the precursor to an agency. The concern was that the agency should be independent and independent of the process. On lessons learnt across the continent, one area of learning was on localisation. Perhaps that had not been addressed enough throughout the NHI process. As BD worked with partners, they had tried to bring about a localisation of technologies, in that technologies could be manufactured in Africa for Africa. BD had tried on a number of fronts to ensure that there was some take-off, but there were many barriers that still existed for localisation. BD looked forward to working with government on removing those barriers. As long as they were importing more than 98% of medical technologies into South Africa, there would always be reliance and dependence on external sources. As a company they were very committed to assisting localisation. As an industry BD wanted to see this happen. Localisation affected transformation and it could only be a good thing. On how BD could help in that sector, BD had looked at first ensuring that technologies that could be produced in South Africa were supported. Their biggest lesson in Africa, where they had managed to produce locally, was that the dependence on importation of devices decreased and it did produce some level of stability in particular areas.

Mr Wakefield replied about the effects of NHI on innovation, innovation was an absolute requirement within the healthcare space because it led to increased patient care. One of the opportunities of competitive nations, was that if one had tenders where winners took all, one limited the number of spenders or suppliers within the space who could potentially limit innovation. There was limited innovation in the country , and limited innovation in terms of access to new products. It was critical to have access to innovative products to reduce patient care, and reduce hospital pressure. That needed to be going on unhindered. Therefore, the reference to an assessment of all medical devices, BD used MEAT. BD was looking at value-based innovation. There needed to be those systems and safeguards in place or methodology tools to assess if there was value to innovation. NHI would not limit access to innovation but it needed to be counter-balanced in assessing new technology and new innovation and ensuring there were the capabilities to do so within the necessary advisory committees going forward. The approach to who sat on those committees needed to be inclusive and diverse.

Dr Dhlomo encouraged BD to continue to engage with the Department in raising these issues.

In reply to Ms Ismail asking if SAHPRA will attend on 14 July, Dr Dhlomo said SAHPRA was given too short notice and would not be able to attend.

The meeting was adjourned.

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