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EF: What is SAMED’s role in the industry?
TV: We are the voice of the medtech industry in South Africa, the key objective is to have a sustainable industry and to provide a credible platform for engagements between the med-tech industry and the key policymakers and other stakeholders that impact med-tech. We are also committed to transformation, we believe in driving meaningful and sustainable change which is an economic imperative and are focusing quite heavily on how to support and provide our members with the tools to enable meaningful transformation in our sector. The majority of SAMED members are small to medium companies with less than 50 employees and they are mainly distributors so we have a small local manufacturing industry and we have a number of multinationals but unlike the pharma industry where you have innovators and generics, we have primary distributors. Our president has recognized the med-tech sector is a key sector for strategic focus and growth and this ties in very nicely with our vision which is to have a sustainable industry and we will be participating in some very exciting initiatives aligned with the presidential social compact. We have just begun a Health Master Plan initiative led by the Department of Trade & Industry. I anticipate we will be doing some kind of landscape analysis of the sector identifying key areas and initiatives that are required to make the sector grow. One of the reasons we are primarily a distributor based market is because it is extremely expensive to do local manufacture so we need to find ways to bring in accreditation and auditors to audit companies to achieve the quality management system requirements for manufacturing med-tech – ISO 13485-2016- because currently, we have to import the auditors from either Europe or the US and pay in euros or dollars which makes it very expensive especially with our exchange rate. There is an exciting pathway ahead of us in terms of National Health Insurance and it won’t necessarily be business as usual. Apart from growing the local manufacturing industry, we have to upskill and we need to look at interventions at schools and university level in terms of regulatory affairs. There is definitely a need for med-tech regulatory requirements and we need to work at putting together some kind of regulatory competency framework.
EF: To what extent is harmonization created through the various local regulatory bodies?
TV: We are just starting on our journey in terms of regulating med-tech and I am planning another similar regulatory round table next year, bigger and better, where regulators can sit around a table and understand how to do post-market surveillance for instance, or how to manage product registration when there are 350 thousand products in the market and a thousand more coming in every month. From an industry perspective, we hold monthly regulatory forums for our members where we talk about all aspects of regulation, for example how to deal with recalls, what to do in terms of implementing and quality management systems, what to potentially expect in terms of product registration. At these regulatory forums, we tackle all the frequently asked questions as well as what is potentially coming to prepare our members because being distributors they don’t always have the regulatory skills, they don’t have a dedicated person for quality assurance or regulatory which is often found in a predominantly manufacturing-based sector.
EF: You represent more than 160 members, what is the economic spillover and current footprint you have?
TV: We have just done a market survey but the results haven’t been released yet, we are busy doing the draft report and hope to release the results sometime early next year. A number of studies have been done over the last 10 years but they are not totally conclusive because it is voluntary-as is our survey- so not every single member participates. There was a study done by Fitch Solutions and they reckon we registered a 9.1% compound annual growth rate between 2017 and 2018, a good growth even in comparison with some international markets. It is estimated to grow from 1.27 billion in 2018 to about 1.74 billion South African rand by 2022. The main product areas in terms of value is general consumables, then diagnostic imaging and then orthopedics and prosthetics which ties in quite nicely with our disease burden because diagnostics is needed for TB and HIV, more so now that in non-communicable diseases we are seeing a huge increase in diabetes, obesity, hypertension and cardiovascular. We also have quite a high rate of accidents, trauma, and crime-related violence which is why orthopedics and prosthetics are so high up. As our government wants to target areas for local manufacture, they are looking at orthopedic implants, at diagnostic test kits, gloves and wheelchairs as some of the items on the radar. Our industry is still growing and in the last 5 years we have seen a definite growth via South Africa into other African markets (Kenya, Ghana, Tanzania, Nigeria, Rwanda and Ethiopia).
EF: What are your top priorities today in terms of ranking, development, investing, partnerships, harmonization, etc., how do you balance all this?
TV: The priority is to build regulatory capacity and understanding, making sure we understand how the healthcare landscape is evolving. We just had the Health Market Enquiry Report released, we have the NHI bill coming and they will make for a transition into a different way of providing healthcare. The industry needs to be prepared; there has to be an upscale in health technology assessment and a gathering of data so that when we sell provide a value-based service not just a product on its own to bring about greater access and greater efficiencies in the system, reducing cost and bringing better health outcomes. There is a shift taking place and as an industry association we have to be at the forefront and help out members to enable this transition. We have a big role still to play in terms of creating awareness of the nuances of our industry when it comes to regulating we are different to medicines and when doing health technology assessments different types of evidence should be expected than with medicines. We can have alternate reimbursement models, make a space for innovation and the systems processes and timelines must support the growth of the sector and support innovation. A year is too long to wait for a decision on a HTA device because by that time there will be a new device out as our rate of innovation is much faster. The types of evidence we provide may be different, we come to market far quicker than medicines as clinical trial data shouldn’t be necessarily expected as we are a distributor based market we shouldn’t do clinical trials if it is not expected. We can take the data from elsewhere and use it because otherwise we might hamper access to innovative med-tech which has an important role in improving outcomes. This is the key message we need to work on showing the differences and nuances so that any model under NHII, the procurement model, for instance, is more centralized and could work for some med-tech products whereas local purchasing potentially might be better suited to others because demographics and the disease burdens are different, and because skills, human resources availability varies in different regions. A med-tech company might not have an international footprint because they are small distributor companies, so to be aware of the landscape and its nuances are fundamental. We must also go step by step, not try and do everything at once and as we move forward go learning from what we are doing and go correcting mistakes. We need very agile systems and processes because with the emergence of digital healthcare, artificial intelligence, interoperability, data informatics all coming the way we need to be ready for issues such as cybersecurity. In HWP they aren’t focusing on regulating artificial intelligence but on dealing with cybersecurity and digital healthcare.
EF: How do you see the HTA ( Health Technology Assessment ) evolving in South Africa?
TV: The funding industry does some kind of HTA to get a med-tech product reimbursed by the medical insurers doing an assessment and evaluation but it is not an HTA in the true sense. There is movement under the NHI bill to establish a HTA agency for HTA’s on med-tech and health products purchased under the NHI fund. I think it will be positive move in that only one agency will be doing this compared to now where insurers are doing their own form of HTA and hospitals have their own evaluation which is a duplication of effort and cost. The methodology sometimes is not totally transparent, the criteria used is unknown and there is uncertainty so I am hoping the HTA agency will play a pivotal role to bring about more transparency and certainty to industry. However I don’t think it will be possible to do HTA on every single med-tech product -no HTA agency in the world actually does- so we have to be more pragmatic about what we can and can’t do. We need some form of evaluation based on custom made clinical outcomes to know the person is buying the most appropriate cost-effective med-tech product. But it must not be a lengthy, bureaucratic and costly process and we would prefer the HTA agency should have complete autonomy.
EF: Do you see NHI as an opportunity or as a challenge?
TV: I think we have to achieve universal healthcare coverage in South Africa, there are gaps in both our private and public healthcare sectors which need to be improved and NHI is a tool to achieve universal healthcare coverage. The challenge lies in the implementation, in the governance thereof and really good leadership. I think it is a positive step forward. At the moment healthcare is quite fragmented in its delivery and in how it is procured, in some provinces with the buyout system, in others through tenders and in the private sector it is again different so we have all these different avenues that one must navigate and maybe under an NHI system there will be greater certainties, more streamlined, and more efficiencies. There is also a need to involve the med-tech users the doctors, nurses and technicians so that they can give input for innovative ideas because this is where most of the advancements happen in the industry. Doctors or nurses who have been using the product are the ones that can suggest improvements so we need to get them involved somehow in a feedback loop. We mustn’t forget the users or the patients especially when it comes to med-tech because they are key in innovation unlike with medicines that are developed in a lab. I even think we should be teaching doctors at university about med-tech and its value chain. With our new president there seems to be a greater impetus and focus on healthcare, he has just launched a healthcare anti-corruption forum and we are hoping to align with that ensuring that our industry continues to subscribe and implement a code of ethical marketing and business practices. We circulate a quarterly newsletter to all our members and stakeholders, to the doctors, societies and provincial departments of health and even to patient organizations where we share updates of our code, so they are aware of what to accept from the industry and in my opinion, this helps to create certainty. It also helps clinicians and procurement personnel to make independent decisions based on what is best for the patient or what is most cost-effective or appropriate to procure rather than follow the incentives or marketing campaigns.
EF: You have been SAMED’s leader for almost 10 years, what would you like to cheer for at the end of this year?
TV: I am very proud of bringing in and supporting regulatory systems for med-tech in South Africa. SAMED was actually established in 1985 to ensure safe, quality, effective med-tech products. I work with SAHPRA in this regard in the spirit of collaboration and we have managed to develop a positive relationship with our policymakers. The second achievement is probably showing the differences between med-tech and other health products. Bearing in mind the industry is a distributor based market some of the necessary skills are not always there, and when we are putting in place a regulatory system we need to take the suppliers along with us in a stepwise manner. We are getting a lot of smaller members to join us and I think that means they see us as a support, as the place to obtain information and guidance on the new regulatory requirements which is very positive as we will be seen to be more credible representing the voice of the sector. This is encouraging because it shows outsiders that we are quite a complex industry, not just big players but a whole mix and a varied group which is a great message to give. We have some amazing and wonderful innovators with some incredible ideas; recently a doctor and his team in Pretoria developed a titanium middle ear printed in 3D, the first of its kind in the world. They are not members but they could be distributors, as manufacturers sometimes have distributors and I don’t have the entire product base in my head. The value of data going forward is fundamental in order to make proper decisions and I think this is an area we need to focus on going forward. SAMED is a member of the Global Medical Technology Alliance (GMTA) and we engage and collaborate with our sister med-tech associations in the countries around the world, we gather business intelligence from them to make sure we are doing the right thing.