Eucomed, the European medical technology industry association, expresses disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI). The Committee has voted in favour of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorization system. The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe’s 25,000 small and medium-sized device makers. The ENVI committee compromises patients and jobs in a what looks like a rushed through deal that seeks to satisfy the time pressure that Parliament feels ahead of the European elections, but not the needs of Europe’s patients and doctors. For several political groups, the outcome also represents a drastic shift away from their pro-innovation, pro-competitiveness platforms on which they are campaigning for re-election in 2014. It is now up to the political groups in light of the plenary vote in October to turn the “rushed deal” into a “right deal” for patients and jobs.
Brussels, 12 September 2013 – The results of a survey amongst medical device companies in Europe about the financial impact of the upcoming changes in the European medical device regulation show a significant increase in costs for bringing new devices to patients. In addition to the necessary € 7.5 billion investment to ensure the safety of patients, a shocking additional € 17.5 billion would be necessary to finance a centralised pre-marketing authorisation system as proposed by the European Parliament’s Rapporteur. Research shows that such an authorisation system does not improve patient safety and makes patients wait unnecessarily 3-5 years before receiving lifesaving medical devices. The result of such an enormous unnecessary increase in costs will most likely be a drain of innovation and leaving Europe with less SMEs, jobs and less R&D capabilities, ultimately leading to less treatment options for patients.
Demographic changes mean that Europe's population is growing increasingly older and in need of more and better care. Eye conditions like cataract are among the most frequently encountered by Europe's elders and healthcare stakeholders have realised that patients must have a choice in accessing the best available treatment options. A conference on 9 July in the European Parliament brought together doctors, Commission representatives and policymakers to raise awareness on the issue. Hosted by MEP Heinz K. Becker (EPP), the conferenced launched policy recommendations on Healthcare and Active Ageing: Patient Choice in Cataract Care and shed light on a growing consensus that patient awareness of and access to ground-breaking cataract treaments must be improved.
Eucomed, the European Medical Technology Industry Association, welcomes the update to class IIa with level of evidence A for device-based remote monitoring in the ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy (CRT). Class IIa therapies are treatments which are found to be useful and effective. The updated class not only reflects research findings which conclude that remote monitoring could help patients at high risk for stroke, but also follows a recent consensus between joint European and American experts on the benefits of remote monitoring for patients with a CRT device.
Today, the leading global medical technology industry associations AdvaMed, COCIR, MITA and MedTech Europe (the alliance of European medical technology industry associations EDMA and Eucomed) applaud the announcement to launch trade negotiations between the United States and European Union.