Yes, Europe’s regulatory system for medical devices is in need of an overhaul to improve patient safety and maintain timely access to innovative medical technology. No, the scrutiny procedure is not the best way to achieve that goal. That was—almost—the consensus at a meeting organised by the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee in Brussels on 26 February, according to a press release issued by Eucomed.
An array of stakeholders from the medtech ecosystem attended the hearing to register approval for greater transparency, traceability of devices and strict control of Notified Bodies while cautioning against an emotional but ill-considered move towards a US-style premarket authorisation system for high-risk devices. Eucomed claims that patients living under a US-type regulatory structure wait three to five years longer for access to the latest life-saving medical devices. The faster approvals in Europe, adds the association, do not compromise patient safety.
There was one discordant note at the hearing, when it was noted that a reimbursement lag may deprive European patients of the vaunted early access. Medical devices are approved for all of Europe, but reimbursement is managed by the national health systems. Existing special payment mechanisms in European countries are designed to accelerate access and bridge the period between product approval and new specific reimbursement for innovative technology, counters Eucomed. For association CEO Serge Bernasconi, there is no doubt that life-saving devices are available to European patients sooner than anywhere in the world. “A technology like renal denervation is already saving the lives of European hypertension patients, while an estimated seven million Americans with the condition are still waiting for this procedure to be approved,” he noted.
“We welcome the growing awareness of the benefits of the European device-specific approval system. We have made it very clear on various occasions that we want to significantly improve this decentralised system to guarantee the highest safety and avoid unnecessary delays of lifesaving medical technologies reaching patients,” added Bernasconi. “The European Commission’s proposal is a step in the right direction and we welcome many of the recommended measures. However, the proposed scrutiny mechanism is inappropriate because it does not contribute to patient safety and is essentially a duplication of reviews.”
Eucomed has proposed replacing the scrutiny mechanism with a systematic control procedure, and recently launched the Don’t Lose the 3 campaign to showcase the advantage that Europeans currently enjoy and explain the changes that need to be made.