Pragmatism and speed are now essential
Today, politicians took a necessary and urgently needed decision in favour of sustainably supplying the Swiss population with quality-tested medical devices. The National Council’s final deliberation and acceptance of Councillor of States Damian Müller’s motion (20.3211) «For more room for manoeuvre in the procurement of medical devices to supply of the Swiss population» instructs the Federal Council to adapt national laws so that (in addition to medical devices with an EU certificate / CE mark) medical devices with U.S. Food & Drug Administration (FDA) approval will now also be recognised in Switzerland.
«Swiss Medtech very much welcomes the policymakers’ important and forward-thinking decision,» says Peter Biedermann, Managing Director of Swiss Medtech. «It is a response to circumstances that could no longer be ignored. Specifically, problems with the implementation of the new European medical device regulation and the negative consequences concerning availability, product range, and quality of medical devices throughout Europe. As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best,» says Biedermann. In Switzerland, the situation is further aggravated by the revised national medical device ordinance with its even tougher import hurdles. More than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products. They are not prepared to meet the additional requirements for the limited Swiss market – and patients in Switzerland are the ones to suffer.
No bureaucratic enforcement necessary: A streamlined system works
«It is important that the motion is implemented quickly and pragmatically. There is no need for an elaborate enforcement apparatus, as is often reported,» says Sandra Rickenbacher, member of Swiss Medtech's Management Board. Examples such as Australia and Israel show it can be achieved in an uncomplicated manner. In these countries, efficient procedures to recognise FDA approvals in parallel with CE marked medical devices have proven successful. The urgency to act is clear. «If patient safety suffers, waiting cannot be an option,» says the association lawyer responsible for the dossier.
Swiss Medtech represents more than 750 members in its role as industry association for Swiss medical technology. With 67,500 employees and a contribution of 11.5% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.