Every year at this time, inquisitive U.S. eye surgeons, hard-working industry representatives—and those of us with an expense account and a burning need to exercise it—make our way to whichever European capital is hosting the ESCRS. Hard duty, it’s not.
Inevitably—to the point that you wonder if it’s a scheduled piece of the formal program—the discussion will ensue as to the speed of the European medical device approval process relative to our plodding FDA. There’s not much that can mollify a U.S. surgeon whose access to new treatment options is blocked by perceived bureaucracy. Two studies published this summer may offer new perspectives on this, but essentially highlight the lack of real data that would make a head-to-head comparison of the two systems legitimate.
In the first report, a systematic review, the authors assessed what data there is comparing the two systems and, unfortunately, found it to be very limited and of dubious quality.1 A scant nine studies were found that focused on pre-market approvals and timing, eight looked at device recalls, and three surveys collected opinions (most scathing) of U.S. device manufacturers. For a topic that engenders such high dudgeon, the overwhelming impression of this study’s conclusions is one of a serious lack of serious research.
The second report took a different tack. Its authors, both from the FDA, argue that compared to that of the four largest European markets, the U.S. approval process for devices of the highest risk level is actually faster when you consider not just the device approval but also the time needed to secure reimbursement. Factoring in patient access to new devices, particularly patients who are reliant on public insurance as are the majority of Europeans, is a critical aspect that is often overlooked, they say.
“Though a CE marking can be granted on the basis of fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those that the FDA imposes for device approval. European countries may require additional data on the device’s safety and effectiveness, as well as on cost-effectiveness,” the authors assert.
Until there is better, or even minimal, formal study of the differences in the device-approval systems, the charges of lost jobs and revenue, research and development withering on the vine, and poorer access to medical technology will continue. And there will always be something to talk about at ESCRS.
1. Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European union? A systematic review. PLoS Med. 2012 Jul;9(7):e1001276. Epub 2012 Jul 31.
2. Basu S, Hassenplug JC. Patient access to medical devices--a comparison of U.S. and European review processes. N Engl J Med 2012 Aug 9;367(6):485-8. Epub 2012 Aug 1.