Regulatory process in Europe more efficient while not compromising patient safety
Brussels, 18 November 2010 – Dr. Josh Makower, one of America’s leading med-tech entrepreneurs, led a study that details how patients in Europe are getting access to new therapies an average of two years before patients in the United States due to regulatory challenges at the FDA.
Dr. Josh Makower compared the impact of the current regulatory environment on medical device innovation in the US versus the EU. The study, which was supported by Medical Device Manufacturers Association and the National Venture Capital Association, surveyed over 200 small and medium sized medical technology companies in the US to examine the impact FDA regulatory processes have on innovation, patient care and job-creation.
According to the study: “Data from the survey clearly indicate that European regulatory processes allow innovators to make new medical technologies available to patients more quickly and at a lower cost. The reasonable question has been raised whether greater regulatory efficiency in the EU has been achieved at the expense of patient safety. However, no information is currently available to suggest that patient safety in Europe has been compromised. If the same devices become available in U.S. following their European approval only after extensive delays and additional costs are accrued, we must evaluate whether U.S. premarket regulatory processes are truly contributing to the advancement and promotion of the public health, or if they are actually restraining it.”
In reaction to the study, John Wilkinson, Chief Executive of Eucomed, commented: “This study clearly indicates that the current EU regulatory system is efficient while ensuring safe products for patients and consumers. With regards to the Recast of the European Medical Device Directive we expect to take a step further forward that will strengthen the system’s safety elements, reduce redundant regulatory processes while sustaining the industry’s drive for research and innovation.”
Highlights of the survey include:
- Predictability: 85 % of respondents considered EU authorities to be highly or mostly predictable, while only 22 % gave the FDA the same ratings.
- Reasonableness: 91 % of respondents rated EU authorities as highly or mostly reasonable compared to just 25 % for the FDA.
- Transparency: 85 % found the processes and decisions of the EU authorities to be highly or mostly transparent compared to 27 percent for the FDA.
- Overall Experience: 75 % of respondents rated their regulatory experience in the EU excellent or very good. Only 16 % gave the same ratings to the FDA.
- FDA impact on U.S. Medical Technology Innovation, November 2010