As was widely reported in early 2012, the firm Poly Implant Prothèse (PIP) allegedly violated regulations by using unapproved industrial-grade silicone in some of its implantable products and by allegedly falsifying or withholding documents. Allegations, which if confirmed, can only be strongly condemned as disgraceful behaviour and an egregious breach of trust. Patient safety, public confidence, and ethical behaviour should always be the top priorities of any organisation active in the healthcare industry.
The PIP incident has made it crystal clear that healthcare actors must pull together to ensure that such a case of fraud never happens again. The medical device industry unanimously agrees that an overhaul of Europe’s regulatory framework is necessary to improve the system that has been the world’s fastest in providing life-saving technologies to patients without compromising safety.
Much of the media coverage and debate has focussed on the European regulatory system itself and how it must be improved. A review into the PIP incident led by UK Health Minister Lord Howe found that the country’s Medicine and Healthcare products Regulatory Agency (MHRA) handled the situation appropriately and followed scientific and clinical advice. The report did, however, stress the opportunity to learn from this experience and to improve MHRA processes.
The report also touched on the regulatory system at EU level, acknowledging the need to support Commission efforts towards improvement recommending that these be made "within the current legal framework". Lord Howe’s recommendations build on EU Health Commissioner John Dalli’s proposal for a joint plan of immediate measures to strengthen the European medical devices legislation which Eucomed strongly supports.
This attention is welcome given the importance of medical technology to Europe. Indeed, the value-based innovations of the medical device industry have proven to not only improve the lives of millions of patients but also play an important role in making European healthcare systems more efficient, which has become a priority for all European governments.
Towards an improved system
Eucomed welcomes most of the recommended measures in the Commission’s proposal for the revision of the European Medical Devices Directive but voices strong concern with regards to the ‘scrutiny procedure’ as it will ultimately harm patients and will negatively impact European governments and industry. The measure would address some political calls to move the system towards a centralised pre-market authorisation system as found in the United States but will ultimately result in harming European patients and negatively impact mostly European small and medium-sized enterprises (SMEs).
Recent reports from respected academics and researchers have shown that centralised pre-market authorisation systems deny patients receiving life-saving medical technologies as patients must wait on average three to five years longer for the same devices than those in Europe while delivering no additional safety. We are convinced that we can remain in this privileged situation with the support of a regulatory framework that successfully marries safety and the availability of new technologies.
Implementing a scrutiny procedure is not the right way to prevent another incident like the PIP breast implants. The procedure will fundamentally change the current system and will not lead to the desired outcome of increased safety for patients. Industry strongly supports stricter controls and monitoring of notified bodies – professional organisations that are authorized by national governments to assess the safety of medical devices before allowing them to be made available to patients (pre-market approval). Other recommendations such as increased coordination on vigilance and the establishment of a central registration database, that governments and patients can access, are welcomed as they will improve the overall safety and transparency for patients in Europe.
Similar suggestions have been made by industry and can be found in its position paper “A new EU regulatory framework for medical devices ”. Industry proposes a balanced six-step approach that would keep the positive aspects of the current European system while fixing the weaknesses and addressing important issues such as ageing populations and increasing pressure on national healthcare budgets.