Medical device industry group Eucomed has a message for EU legislators in the midst of considering changes that would subject medical device products-and particular higher-risk, implantable ones-to more rigorous regulation: Don't ruin a fundamentally sound system.
The group has launched a new regulatory campaign it's dubbing "Don't Lose the Three," so-named because of what it says is a three- to five-year advantage in advanced access to medical devices relative to "other parts of the world."
That advantage is outlined in a June 2012 report from the Boston Consulting Group, which found an average delay of 42.8 months between CE marking in the EU and approval in the US. It should be noted that other articles have found that this advantage is entirely wiped out, and even reversed, when the time to reimbursement is factored in.
At present, the EU uses a decentralized system of medical device regulation in which companies go through a CE-marking process run by notified bodies.
This means no one regulator is in charge of the system-a radical departure from the regulatory system for pharmaceuticals in the region, which is largely overseen by the European Medicines Agency (EMA). The system is also different in that it does not assess devices for efficacy, but simply rather that the device works as advertised and meets quality standards set by legislators.
That reduced burden, as well as the ability to seek out their own certifying notified body of choice, allows companies to get their devices approved more quickly.
Problems and Proposed Changes
But even as the system has in many ways benefited patients and manufacturers alike, it's also led to problems. A lack of coherent oversight has been blamed by some as being at fault for the failures of several implantable medical devices, including breast implants, metal-on-metal hips and others.
The most notable of those scandals, involving now-defunct French manufacturer Poly Implant Prothese (PIP), involved a breast implant product allegedly manufactured using deficient materials, resulting in a higher-than-average rupture rate and requiring thousands of revision surgeries in the EU.
Those scandals have left legislators looking to reform the system by more closely supervising the notified bodies, expanding requirements for implants and other devices, granting new authorities for notified bodies to carry out site inspections, expanding postmarketing surveillance systems and databases, tightening the requirements for clinical evidence, and better coordinating regional governments.
Those changes would have stopped the sorts of scandals that have been plaguing the EU from happening, said then-EC Commissioner John Dalli, who stepped down shortly thereafter due to an unrelated scandal of his own.
But even as the changes were getting accolades from those in government, device groups responded in alarm, saying the changes would cause the region to lose its competitive edge.
Case in point for Eucomed is renal denervation devices, which have been approved for use in the EU since 2010 for the treatment of hypertension. The device is still not on the market in the US, and a recent filing by Medtronic for the device indicates it could be another year before it reaches US consumers.
This "gap" is indicative of other devices as well, Eucomed said, pointing to transcatheter aortic valve implantations (TAVI) and blood processing machines for sickle cell anemia as other prominent examples.
"Many groups and experts in Europe, including doctors, patients and industry, agree that the current European system needs to be improved to cope with new medical technologies and innovations," the industry group wrote. "But let's keep what works and fix what needs to be improved instead of radically changing the system."
Eucomed Three-Point Proposal
Instead of the current proposal, Eucomed said legislators should adopt a three-principle plan for reform:
Get rid of the "bad apples," which it says are the exception to an otherwise fine system. This can be done through the use of more site inspections, including unannounced site inspections.
Notified bodies "should be subject to very strict requirements and frequent inspections by authorities to make sure that they are independent scientific centres of excellence and that only the best ones make the cut."
Patients should be given access to information about the medical devices they use, and a system should be in place to gather more information from patients to be distributed to the public.
"The PIP breast implant incident was a case of fraud," argued Eucomed. "The manufacturer secretly replaced medical grade silicone with industrial grade silicone to save money."
"No regulatory system, centralised or decentralised, can fully guard against fraud," it concluded.
Update: In response to this story, Eucomed has said it takes issue with the aforementioned study regarding device lag relative to reimbursement, saying it found numerous faults with the Public Library of Science study. In particular, they contend that patient access is not necessarily linked with reimbursement, that the study relied too heavily on anecdotal or questionable data, and used questionable starting points (submission time rather than the start of a dossier compilation.
"A concern was raised that European patients do not enjoy faster access than US counterparts because Europe's national health systems are slow in reimbursing new technologies. While the approval of a medical device is for the
whole of Europe, reimbursement is organised differently via national health systems. Early patient access in most European countries is ensured through special payment mechanisms and / or leveraging available reimbursement for innovative medical technologies. The existing special payment mechanisms accelerate access and bridge the period between product approval and new specific reimbursement for innovative technology. A recent study of the European Health Technology Institute (EHTI) conducted by the London School of Economics (LSE) reported that approximately 70% of countries surveyed use special payment mechanisms for innovative technologies and these are considered to be effective in integrating new technologies into the health system." - Eucomed statement.