Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue to have timely access to the latest life-saving and life-enhancing medical technologies.
Members of the European Parliament’s ENVI Committee have made progress towards an improved regulation. They’ve introduced 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.
The approval system: still an open question
Still at the heart of the debate is the question of how medical devices will be approved in Europe, that is, how devices will make it from a device manufacturer to doctors and patients. Opinions differ on what this approval system should look like. With less than one week before a plenary vote by the full European Parliament, it is up to MEPs to review the facts and make up their own mind. In a recent editorial, I outlined a series of questions I believe they should ask themselves, but it really boils down to one big question: should they accept the current ENVI Committee compromise or should they aim to incorporate some of the alternatives that are 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 FDA or EU pharma regulation 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 firm reaction on the ENVI vote, the Committee did adopt a compromise amendment that would introduce a case-by-case PMA system. We strongly believe Europe should not want such a system.
Why don’t we want such a system?
Europeans shouldn’t accept a system that will 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 deny millions of patients access to treatment that drastically improves or even saves 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 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 this European Parliament-produced video warns against overly strict regulation “will reduce our tendency to innovate.”
Maintaining Europe’s 3-year advantage
Multiple scientific reports clearly indicate 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 lifesaving medical devices reaching patients (for examples of devices not available in the US but are saving lives in Europe, see this list prepared by Reuters). These facts serve as the basis of our “Don’t lose the 3” campaign.
Questions have been raised about the campaign and the facts behind it by pointing to an unpublished FDA-authored report that paints the EU system as unsafe and a FDA-authored article that suggests patient access to new devices is significantly slower in Europe due to cumbersome reimbursement practices. Both the report and article contain multiple factual errors and fail to grasp both the current regulatory reality in Europe and the nuances of how European patients receive access to the devices they need. It is also important to note that the report and article were created by the FDA in support of US political battles over the organisation’s future direction and funding. They were not aimed at accurately informing European policymakers in the very technical debate surrounding the revision of the MDD.
MEPs: It’s up to you
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 medical devices and Europe’s MedTech SMEs will suffer greatly to bear the enormous cost of gaining approval. In short, the untested approval system proposed by the ENVI Committee has the potential to inflict great damage to an already ailing European healthcare system without effectively improving patient safety.
Can the ENVI position, which is criticised as being bureaucratic and unworkable, be improved? The improvements may only emerge in the trilogue with Council and Commission. But there is still some time for MEPs to look at the ENVI position. We believe that the Member States’ authorities should be in charge through the Medical Devices Coordination Group (MDCG) and not a super-committee of over 600 clinicians. We believe that the system could be clearer in its method and not a random needle-in-the-haystack approach hoping to find something in the tens of thousands of products that fall within its scope. We believe that scrutiny can be ‘built-in’ to the normal upgraded notified body approval system and not ‘added-on’, doubling or even tripling systems on top of an already improved system. 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.
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 the new approval system for medical devices in Europe.
-Serge Bernasconi Chief Executive Officer, MedTech Europe, EDMA & Eucomed