Press release, /

21 February 2013 – Health First Europe considers that safety, transparency and access should form the basis of the new legislation on medical devices, but believes that the legislation in its current form would negatively impact the accessibility for patients to life-saving medical technologies. Launching today its statement on the new European legislation, HFE welcomes many of the provisions but voices concern that proposed additional new requirements for the the approval process will inevitably limit the timely access for patients to life-saving technologies.  Honorary President of Health First Europe John Bowis, stated:

“HFE has always been greatly concerned about the safety of patients and believes that the proposed legislation appropriately addresses safety issues.  However, reducing and limiting access for patients to medical technologies does not make patients safer.  In fact, it puts them at greater risk as they wait for technologies that can provide more reliable diagnoses, self-management capabilities and life-saving treatments.  The current proposal puts a new and disproportionate burden on patients.”

HFE’s members argue that the legislation must support both safety and access. The two are not mutually exclusive and we encourage policymakers and health stakeholders to seriously address the issue of access within the current proposal.  We must do all that we can to ensure that the ability of patients to receive safe, timely treatment is not unnecessarily jeopardised.

For more information, please contact:

Amanda Bogg

Health First Europe Secretariat

+32(0)2 626 1999