John Dalli, European commissioner for health and consumer policy, recently gave a speech at the Eucomed MedTech Forum 2011 in which he enumerated a number of points that sound similar to what’s been said about healthcare and the medical device industry in the United States. For instance: The medtech industry is a valuable source of employment. Medtech makes valuable contributions to R&D. And so forth.

 

It was somewhat more suprising that he acknowledged that, in Europe, healthcare expenditure “has risen steadily ever since governments took responsibility for the universal provision of healthcare.”

 

He also explained that his objective as commisioner was to continue to improve patients’ health and safety, which is, of course, something you might expect him to say. He added though: “I should say here that this [objective of improving healthcare in Europe] is not a response to comparisons which have been made between the EU and the U.S. systems. Actually, there is no evidence that one regulatory system is 'safer' than the other.”

 

That assertion, by the way, files in line with conclusions drawn by the AdvaMed-funded report titled “EU Medical Device Approval Safety Assessment.”

 

Quick question: If it is indeed the case that the regulatory systems in the United States and in Europe have similar safety ratings, than what is the motive (or the benefit) of the recent caution on the part of FDA—considering that some devices can be cleared in Europe in a fraction of the time?

 

Anyway, in his speech, Dalli went on to stress  that governments on both sides of the Atlantic should work to further improve safety and he also pointed out how the device industry, both in Europe and the United States, should continue to engage to shape the regulatory framework and that they should cooperate to make regulations more consistent internationally.

 

—Brian Buntz