“The majority of the players in the SA medical devices industry are small to medium companies, most of which, like pharma, are importers. Covid-19 has shown us that we need to make sure we’re less dependent on imports and the rest of the world for our medical technologies,” said Tanya Vogt, COO of the South African Medical Device Industry Association (Samed), at the GIBS Healthcare Industry 2020 Conference. “We need to look at how we can support trade with our African counterparts and strengthen collaborations with the African Union, because apart from SA almost no local manufacturing of medical technology happens in other African countries.

The majority of the players in the SA medical devices industry are small to medium-sized enterprises [Image: teksomolika/Freepik].

BARRIERS TO PROCURING PPE

“What Covid-19 showed us was we really need to step up local manufacture because to get those Covid-19 essential products into the country there were a number of barriers.

“Because everyone was trying to keep as much product for their own use, many countries – particularly those in Europe and North America, and some in Asian – put trade embargoes in place. Air freight, the primary route for getting supplies into SA, was disrupted, and we had to tackle unfavourable exchange rates,” Vogt said.

GOVERNMENT RELAXED RULES

“Essentially there was panic, and our members were flabbergasted that suddenly there were non-medical technology companies that have never been in this sector, some of them not even licensed with the South African Health Products Regulatory Authority (SAHPRA), coming out of the woodwork and selling masks. We even saw some serological test kits, none of which had been approved by SAHPRA, advertised on websites. This was quite concerning.

“Unfortunately, this was because government relaxed some of the procurement rules that are written into legislation,” said Vogt. “They thought perhaps it was the best way. We needed alternatives and we needed to respond quickly, so perhaps we didn’t have to meet the rigorous requirements of the Public Finance Management Act (PFMA) and public procurement rules and legislation. I think that was quite dangerous because procuring masks and procuring PPE is not like procuring toilet paper. These products have certain standards and laws that apply. So, there wasn’t sufficient rigor and robustness applied to the procurement.”

REGULATOR RAISED REQUIREMENTS

“As a result, our regulator started to implement a number of more rigorous requirements. In fact, we saw over 40 guidance documents and communications come out to industry, and so in a very short space of time our members had to digest these guidance documents, they had to implement them, and they suddenly had to have products tested that had never required testing before,” said Vogt. “With SA not having a primary locally manufactured sector this was challenging. For example, there are not sufficient testing laboratories.”

THE ROAD AHEAD

“One of the things we can do differently, particularly our regulators and government, is before you implement regulations actually consult with key stakeholders, get their inputs, understand the potential impact of those regulations, are they actually able to be implemented, etc and then make fit-for-purpose regulations and guidance documents,” said Vogt.

“In terms of local manufacture there is a huge opportunity for us to focus on how we grow the local manufacturing industry. But again, it’s going to mean that we don’t operate in silos, we need to get all the ministries involved, to sit around a table together with industry and academic institutions and look at all the aspects of the value chain of manufacturing, distribution, marketing, etc, for medical devices, and then come up with a proper plan with everybody who needs to be involved at whatever particular juncture,” Vogt concluded.

 

AUTHOR: Nicky Belseck, medical writer