After a headline-grabbing breast implant scandal rocked the continent, EU regulators are considering a more stringent approach to medical device regulation, a proposal industry leaders say would hamstring Europe's successful medical device sector.
As Reuters reports, a European Parliament committee is scheduled to vote July 10 on whether to adopt FDA-style pre-market approval for medical devices, mandating randomized clinical trials before doling out a CE mark. As it stands, the EU system is far faster than the U.S. regulatory process, and medical device companies from around the world typically turn first to Europe to pick up some ROI before embarking on the long and costly road to FDA approval.
That regulatory disparity has made Europe a breeding ground for innovative medical technology, industry group Eucomed told the news service, and mimicking the FDA would tack three to 5 years onto companies' path to market and stifling progress and profits.
"An FDA-like system would kill patients and kill innovative companies," Sofinnova's Antoine Papiernik told Reuters. "It would very likely kill VCs as well, who already have a hard time explaining to limited partners around the world that they should invest in Europe."
The concern first began in 2011, when authorities caught France's Poly Implant Prothèse selling breast implants made with silicone unfit for human use, leading to at least 4,000 breast implant ruptures in the EU and Latin America. After a long and colorful trial, PIP execs are headed for prison and a spooked continent of regulators is looking to avoid another international incident stemming from poorly vetted implants.
However, Eucomed said there's no evidence a pre-market approval process could have prevented the PIP problem, and trade group Chairman Guy Lebeau told Reuters that toughening regulations will only keep patients from novel therapies they need to survive.
Next month's vote will set the table for a final decision that'll require negotiations between EU nations. As it stands, France has has come out in favor of stronger medical device rules, while the U.K. stands in opposition, Reuters reports. Other countries are yet to weigh in.
- read the Reuters story