On 22 October, the Parliament will vote to decide the course of the EU's Medical Devices Regulation, but several of the amendments proposed by the ENVI Committee could endanger patients, in particular one that allows for the re-use of all medical devices, says Serge Bernasconi.
Serge Bernasconi is the chief executive officer of Eucomed, the European medical device industry association.
Members of the European Parliament’s ENVI Committee have made progress towards an improved regulation. They’ve introduced important changes to improve the transparency and traceability of medical devices and have toughened the needed competence of, and controls on, notified bodies (organisations that evaluate medical devices before they reach Europe’s patients).
Perhaps most importantly of all, the ENVI Committee has made stakeholder engagement a priority and given patients and doctors a greater voice when it comes to the medical devices they use. These measures all effectively improve the safety for patients. With a plenary vote by the full European Parliament only days away, Eucomed sees room for improvements to strengthen the approval system for medical devices and govern the reprocessing of devices created for single-use only.
We hope that the amendments for plenary currently being formulated by MEPs will provide a more sensible approach to the legislation.
In a recent EURACTIV editorial, I outlined a series of questions I believe MEPs should consider, but now it really boils down to one big question: should they accept the current ENVI Committee compromise amendments or should they aim to improve them by incorporating some of the alternative approaches on the table?
Those following the debate on the revision of the EU Medical Devices Directives (MDD) will be familiar with industry’s view that a centralised pre-marketing authorisation (PMA) system based on that of the US Food and Drug Administration (FDA), or the European legislation regulating pharmaceutical products, is neither in the interest of patients nor in the interest of the vibrant SME ecosystem in Europe.
Indeed, the ENVI Committee has voted against a full-blown centralised system as seen in the US, but as you may have noticed from our reaction on the ENVI vote, the Committee adopted a compromise amendment that would introduce a complex case-by-case centralised authorisation system that we believe does not effectively improve safety for patients. We fully agree that the regulation of medical devices must be improved, but a centralised PMA is not the answer.
Why don’t we want such a system? Europeans shouldn’t accept a system that will, as reported in the global media, lead to physicians being frustrated that they can’t get their hands on essential devices their patients desperately need. Europeans shouldn’t aim for a system that will delay millions of patients’ access to treatment that could drastically improve or even save their lives.
We should listen to those whose lives will be directly impacted by the new MDD, like sickle cell disease sufferers who fear that a centralised system as seen in the US will undo the work they’ve done over the past 20 years to get investors interested in creating better devices to treat their orphan condition.
We should be open to views from policymakers and leading health advocates like former UK health minister, MEP and ENVI Committee member John Bowis, who is worried that the current compromise “may ultimately harm patients, rather than protect them.”
We should pay heed to European doctors like Brussels-based orthopaedic surgeon Dr Thierry Scheerlinck, who in a European Parliament-produced video warns that overly strict regulation “will reduce our tendency to innovate”.
Indeed, we cannot simply ignore independent research that clearly indicates that a centralised (PMA) system for medical devices, similar to the one used in the US, will deliver no additional safety benefits for patients and will cause unnecessary delays of 3 to 5 years in life-saving medical devices reaching patients.
For what it’s worth I’d like to reiterate what’s at stake here. If the current ENVI compromise is carried to the final regulation, European patients will have to wait significantly longer for life-saving and life-enhancing medical devices and the many SMEs in this country will suffer greatly to bear the enormous cost of gaining approval.
We believe that the system could be clearer in its method. Scrutiny can be ‘built-in’ to the upgraded notified body approval system and not ‘added-on’ afterwards, doubling or even tripling systems on top of an already improved one. The scrutiny should follow a risk-based approach in line with the approach in the rest of the regulation, and should target high-risk implantable products as those are the ones of public health concern. Also, the ENVI compromise proposes a super-committee of up to 600 clinicians, a proposal that seems unworkable and needs to come to a reasonable size. The roles and responsibilities between authorities and clinicians should also be better defined. Authorities should be responsible for the scrutiny process with support from clinical where needed.
MEPs have recently taken great strides in efforts to simplify processes and remove layers of red tape in order to improve economic growth in Europe and enhance innovation for SMEs in many EU initiatives, such as Horizon 2020, the next research framework programme of the EU. We hope therefore that MEPs will in particular re-consider the negative impact of the ENVI Committee compromises that will be hugely cumbersome and detrimental for patient access to the latest medical technologies.
There is no doubt that MEPs and industry share the common goal of increased patient safety. We therefore hope that MEPs will reconsider the negative impact on patients of the ENVI Committee compromise on the re-processing of single-use medical devices. This amendment, 17 pages in length, would make all medical devices re-processable by default meaning that patients could be subjected to medical devices contaminated by blood and human tissue. We believe the Commission has a much more proportionate proposal, and most importantly, has considered carefully the impact on patient safety.
MEPs can now make a positive difference in the plenary vote by supporting the Commission’s balanced proposal and voting no to the ENVI Committee’s Compromise Amendment 3 on a cumbersome scrutiny procedure and make an informed decision about the other options on the table.
As industry, we understand that we are only one of many important stakeholders in the MDD debate and we understand that policymakers have a lot to take in when forming a position. In fact, EURACTIV has done a great job in providing a balanced overview of the various perspectives. In the end, MEPs will have to make their own decision on what is the best starting position for their discussions with Council on a new regulation for medical devices in Europe.