SAMED is grateful for the guidance, support and participation by SAMED representatives and members, partner organisations SALDA and MDMSA, and other role players in healthcare for helping us make our first virtual annual conference a resounding success. We appreciate our plenary speakers – SAHPRA CEO, Dr Boitumelo Semete-Makoketlela, Western Cape Minister of Health, Dr Nomafrench Mbombo and head of NHI, Dr Nicholas Crisp and insights and time generously shared by all the presenters.
Looking back to the 2019 SAMED conference, we could not have foreseen this “new normal” of conferencing. SAMED 2020 featured high-quality, relevant content, expert speakers and a strong and engaged audience. We value the efforts that went into preparing and sharing with us thought-provoking and stimulating presentations.
The last day of the conference coincided with World Patient Safety Day, so it was fitting that the discussions gave much attention to regulatory compliance and personal protective equipment (PPE) as key factors in keeping our health workers and patients safe.
The conference highlighted key priorities which we will follow-up on with urgency. A few impressions and themes stand out.
Hot plenary topics: regulations, NHI, Western Cape COVID response
Dr Boitumelo Semete-Makoketlela, the CEO of the South African Health Products Regulatory Authority (SAHPRA) shared her vision for the agency and specifically medtech regulations. In an open and engaging manner, the CEO acknowledged bottlenecks and constraints highlighted by the COVID pandemic and related sudden entry of inexperienced new suppliers and untested products into the market. She outlined progress in moulding SAHPRA including the recently introduced changes to ensure effective, responsible and, as rapid as possible, regulatory processes related to COVID essentials. The CEO outlined what was in the pipeline, including greater collaborations and alignment with the not only SAMED and the Medical Device Forum but also the International Medical Devices Regulators Forum and other global and African medtech regulatory structures. SAHPRA has learned much from the COVID response on what needs to be done to effectively regulate medtech and IVDs in the future. Specific interventions to watch out for are: (i) the gazetting of updated medical device regulations – anticipated for the end of 2021, with a three-month comment period; (ii) publishing the medical device fees schedule – the finance committee is currently working on these; (iii) the call-up plan for registration of medical technologies; (iv) feedback on the application process of borderline products by December 2020; and (v) introduction of an electronic document management system. Although SAHPRA’s current regulations on advertising different classes of medical devices to HCPs and the public follow the World Health Organization and other international models, the regulator indicated that it will consider the merits of advertising certain class C and D devices to the public on an individual basis.
Monitoring of the safety and quality of medical technology including PPE and reporting on poor product quality, adverse events and recalls were shared responsibilities. Hence, SAMED supports – and amplifies – SAHPRA’s efforts to educate suppliers, stakeholders and the public. Anyone can report these matters to SAHPRA: email mlungisi.wondo@sahpra.org.za and momeena.omarjee@sahpra.org.za. Unlicensed companies trading medical technologies can be reported to SAHPRA at mokgadi.fafudi@sahpra.org.za.
As was highlighted by the SAHPRA CEO as well as Dr Andrea Julsing Keyter, the head of SAHPRA’s Medical Device Unit, ISO 13485 is the applicable standard for a medical technology establishment’s quality management system and is a requirement when applying to SAHPRA to renew a medical technology establishment license. How to conduct validation of processes related to the manufacture, supply, storage and delivery of medical technologies in accordance with ISO 13485 was further explained by Simone Rudolph Shortt from ISO Health SA.
Dr Nicholas Crisp, head of the National Health Insurance (NHI) programme, said that COVID had understandably delayed this process, with oral submissions and National Council of Provinces hearings still to happen. His emphasis was on the phased transition towards NHI as a funding (not service-providing) instrument – one that will centralise health funding through a single purchaser (the NHI Fund) and decentralise service provision to localised level. Dr Crisp noted the dangers of corruption, saying that the NHI team was working with the Special Investigating Unit on a risk management framework. Key implications for SAMED and the medtech industry were that the Office of Health Products Procurement will set up and consult on a formulary, and how to create effective and independent health technology assessment (HTA) capacity. Dr Crisp noted that his interactions with SAMED had shown the association’s efforts to manage the medtech environment in a responsible, self-regulated manner, and encouraged the industry, funders and other private sector role players to continue to contribute and engage with NHI policy makers.
Dr Nomafrench Mbombo, the Minister of Health in the Western Cape, presented on the province’s comprehensive, multifaceted and integrated COVID-19 response and drew lessons for the future of healthcare. She called the pandemic a “lifetime litmus test” for the health system as well as society. It required an agile, connected leadership across all provincial structures and departments; a holistic systemic response across primary and tertiary levels of care; honest, regular, epidemiology-informed and clear communication with the public to ensure trust and community buy-in; and working across the care continuum as the pandemic progressed, that is: suppression and containment, mitigation of outbreaks, managing adverse outcomes and co-morbidities, recovery and ongoing vigilance. The Minister spoke to the prioritisation of health worker safety and other needs and reflected on robust procurement approaches that will serve the province well going forward. This includes sufficient supply of quality PPE, public-private sector collaboration on patient load management and ongoing efforts to support local manufacture of medtech in the Western Cape.
Ethics, transformation, market access – and a glimpse of the digital future
SAMED and our industry work to establish a sustainable, ethical and transformed sector that ensures patient access to quality technologies and innovative solutions.
As a signatory to the President’s Health Sector Anti-Corruption Forum, SAMED is fully behind all efforts to root out corruption and advance governance. Anyone can report transgressions of the Medical Device Code to SAMED’s whistleblowing hotline, free-call 0800 000 468, email samed@tip-offs.com. Otherwise, healthcare fraud and corruption can be reported to Corruption Watch or to the SIU-led Health Sector Anti-Corruption Forum by calling 0800 037 774.
While all 24 conference sessions touched on corruption in healthcare as a true threat to health outcomes and an impediment to building a more robust, equitable and functional health system, three sessions were specifically dedicated to ethics.
- In her presentation, headlined “Cause of death: Corruption”, Kavisha Pillay from Corruption Watch looked at the devastating outcomes of corruption regardless of its various forms. These lead to serious consequences, such as insufficient and unusable medical equipment that demotivate experienced staff and prevent the realisation of the basic human right to health. Open Contracting for Health (OC4H) was proposed as a means to promote transparency and accountability as counters to malfeasance and fraud.
- Alwi Spearpoint, an active member of the SAMED Code Committee, led a consultation on the ethics of virtual and hybrid (part face-to-face and part virtual) events and meetings. These will eventually lead to updates of the Medical Device Code. Members and stakeholders can send their challenges and suggestions on how the industry can continue to ethically support HCPs and professional societies to compliance@samed.org.za.
- Candice Lee de Carvalho from Easy Ethics CPD challenged the delegates with thought experiments – how should we code morality, responsibility and empathy into AI-driven health technologies? How to weigh up kindness against truth during your interactions with patients? How to apply sometimes contradictory rules-based and virtue-based ethical theories to ensure beneficence, non-maleficence and justice within healthcare?
How medtech is at the epicentre of the 4IR (fourth industrial revolution) was highlighted by Deloitte’s Chief Digital and Innovation Officer Valter Adão. While the actual digital technology and its super-fast evolution and advancement were important, embracing the potential business value of digital, gig-based and AI-powered era depends on business leaders’ openness to its potential benefits and the behaviour change that has to happen even before new technologies are introduced to a business. It is a business conversation that leads to shifts in leadership and organisational behaviours – with the novel technology only acting as the enabler.
Transformation, B-BBEE and the role and development of small and medium sized enterprises (SMEs) were equally noted topics during the conference, with a number of dedicated and practical sessions addressing them as vital principles of a sustainable medtech industry in South Africa.
Advocate Lindiwe Madonsela from the B-BBEE Commission, the chairperson of the Employment Equity Commission Tabea Kabinde and Gary Joseph, the CEO from the SA Supplier Diversity Council gave practical insights into what SAMED members and medtech suppliers more broadly can do to understand the national transformation agenda – and avoid transgressions, like fronting. They gave advice on how medtech companies can comply with the legislation, realise meaningful management control and use supply-chain and skills development to not only gain B-BBEE points but lead to equitable participation in economic activity by Black people and other population segments, including youth and women.
Several speakers addressed topics related to market access – a critical and dynamic factor particularly during the COVID pandemic when the company representatives’ entry to health facilities was limited for infection control purposes. Similarly, seeking health services for reasons other than COVID was dramatically reduced during this time. Elna Steyn from a research agency IQVIA stated an estimated 146 000 elective surgeries were disrupted during a 12-week peak outbreak period. Combined implications of such disruptions would have short and longer-term impacts on health budgets, public health outcomes, cash-flow management, mental health of health workers, supply-chain management, accelerated innovations and HCP and patient engagement, among others.
With healthcare inflation – fuelled by lifestyle diseases, ageing membership bases of medical aid schemes and medical aid fraud – cited as a significant factor not just in South Africa but internationally, dealing with the financial impact of COVID is likely to further change funding models. Dr Noluthando Nematswerani, Discovery Health’s Head of the Centre for Clinical Excellence presented on the cost-per-event models and how this related to the new National Department of Health terminology to be applied to patient and diagnosis-related groups.
As Dr Zaheen Omar outlined, there is a serious need to contain healthcare costs, which is bringing global fees back into favour especially as the Competition Commission’s Health Market Inquiry recommended the phasing out of the fee-for-service model. In Dr Omar’s view, however, careful monitoring and granular understanding of the application and outcomes of global fees is most important in order to balance quality and cost of service. He suggested certain added features to the global fee model, such as risk transfer agreements, performance-based funding, quality assurance programmes and peer profiling.
In closing, SAMED Executive Officer, Tanya Vogt, expressed gratitude to all our members, colleagues and partners for a successful conference and a week during which we advanced many relationships and shared solutions and learnings on how to shape healthcare and grow medtech. Attendees concluded that participation was most worthwhile, that the speakers were great and the topics and content relevant.
A quote from a stakeholder from the post-conference survey illustrates our accomplishment: “Well done on your first virtual conference – you can be proud of yourselves and the team!”
