April 29, 2013
My journey at the European industry association Eucomed started two and a half years ago. During my interviews for the communications role I was made aware that the medtech industry was facing new European legislation and that the process was underway. Never did I expect the need for a forceful modern communications campaign.
I’ve been trained professionally by a global communications consultancy firm which teaches you to be an honest devil’s advocate when advising clients. So during the last couple of years at Eucomed I’ve been able to ask many critical questions about industry’s suggestions for the new regulatory framework. I truly believe it is fair to say that industry has never opposed change and is willing to make the adjustments and investments that are necessary to improve the current approval system, which is decentralised. In essence, the industry asks for a system that improves patient safety and doesn’t unnecessarily tamper with the flourishing innovative ecosystem in Europe that is dominated by small and medium-sized enterprises. Many of these companies are developing innovative medical technologies that not only improve the lives of patients but also contribute to making healthcare systems more efficient, which is desperately needed in these times of economic hardship.
The European medical device manufacturers believe that the current decentralised approval system needs to be significantly improved but not radically transformed for the sake of change. Research reports show time over time that a centralised approval system for medical devices, as seen in the United States (FDA), does not improve safety and significantly delays life-saving medical technologies in reaching patients.
It was no surprise that there were calls for a better approval system after the PIP breast implant tragedy. It was however surprising that these calls were for a centralised approval system. The PIP incident was terrible but it was a case of fraud and a centralised approval system would not have prevented it either.
The public debates and media coverage that followed the PIP incident focused on improving safety for patients, which is without a doubt the paramount objective. But the discussions did lack another important element: the impact of delaying medical devices in reaching patients. There are medical devices that save lives and are available to Europeans three to five years earlier than Americans who have a centralised approval system. So besides achieving the most important objective of improving safety one should also take the impact of delayed treatment to patients into consideration.
When the calls for a centralised approval system in Europe became louder without taking the patient access element into consideration, industry decided to become more vocal about what really is at stake. Subsequently the “Don’t lose the 3”-campaign was launched in February this year.
The “Don’t lose the 3”-campaign is based on facts, consists of emotional ingredients and informs Europeans what could happen to them if a centralised system as seen in the US is copied into Europe. The campaign aims to grab attention by using thought-provoking videos and drive the viewers to a website that explains what is at stake in an easy-to-understand language. The medical technology examples and delay times used in the campaign are real and based on facts; the actors used in the short videos are a true reflection of real patients; the real patients tell their story in separate videos that are available and the opinions voiced in the campaign are based on research reports and real-life stories. The campaign does not exaggerate nor understate the merits of the current European decentralised approval system and clearly indicates which improvements need to be made.
When speaking to American journalists who cover the global medical device industry, I usually get the same response: they are astonished by the direction in which Europe is going. They do not understand why Europe wants to move towards a US-system of approving medical devices that has resulted in Americans waiting several years longer than Europeans for innovative medical technologies without any safety benefits. In addition they note that the American regulator (FDA) has some challenges of its own and has recently requested an 11% budget increase to speed up the approval times in its centralised pre-marketing authorisation process.
So when asked what I think is best for European patients and industry: keep the decentralised approval system and fix what needs to be improved instead of radically changing what we have today into something that won’t guarantee more safety. I believe that Europeans, including myself, want a safer system that doesn’t cause unnecessary delays in innovative medical technologies reaching us because they improve and save our lives. And when you take the time to look at how we can reach the desired outcome of improved safety and timely access, you realise that it can be achieved together through significantly improving what we have today. Europe doesn’t have to lose the 3.Author : MedTech Europe