Last week saw the European Parliament issuing its latest draft report on changes to the regulation of medical devices in Europe. So-called “Rapporteur” Mrs Roth-Behrendt calls for a shift towards a centralised pre-market authorisation system which Eucomed is warning us will confront patients in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety.
Having offered a guarded welcome to the original output from the European Commission last year, Eucomed has woken up to the idea that what we’re heading for is a PMA style system of approval for the higher risk devices. And it’s not difficult to see which elements of the proposals lead us there. The biggest single impact of the changes would be a significant increase in the amount of bureaucracy needed to drive it. This would require funding, which would come from Eucomed members. It would be slow. It would probably be no better at picking up important issues with new and existing devices than the current system.
But, importantly, it would allow the Eurocrats to show us just how brilliant they are at developing systems that protect their citizens from device-related problems.
So let’s get it straight. The current set-up, as we’ve discussed many times on this site, is flawed. It revolves around a notified body infrastructure that is nonsensical, often underqualified, inherently variable and vulnerable to abuse. Probably the biggest elephant in the room though is the fact that data used for regulatory submissions is unavailable to anyone, a single feature the correction of which would improve things enormously without adding any noticeable burden of time or cost.
So is Eucomed right when it says the draft report is a step backward for patients, healthcare systems and Europe?
Well, in a nutshell, probably. Adding bureaucracy rarely improves things and indeed, as the organisation states in its release on the subject, “multiple scientific reports and studies clearly indicate that a centralised pre-market authorisation system for medical devices, similar to the one in the US, will deliver no additional safety benefits for patients and will cause unnecessary delays of up to 3 years in lifesaving medical devices reaching patients.”
It goes on to highlight renal denervation, an innovative technology for the treatment of severe, uncontrolled hypertension in patients resistant to drug treatment. Regardless of whether you’re a believe in the technology or whether you have your doubts (which some do), it’s without question that this technology is already saving the lives of patients in Europe. In contrast, an estimated 7 million Americans with the condition are still waiting for this procedure to be approved and that’s not likely to happen this year.
So what happens next?
The Rapporteur will now enter discussions with her Parliamentary colleagues of the ENVI Committee on the content of the report. Members of the ENVI Committee will debate the report, table amendments and vote on the final version, after which it will be voted on in a plenary session of the European Parliament.
In the meantime Eucomed will continue to bang the drum with its “Don’t lose the 3” campaign, which references the average time delay between EU and US approval at the moment.