An increasingly vocal dustup between device companies and European lawmakers will reach a big milestone on Feb. 26, when both sides will meet during a European Parliament committee meeting and begin trying to hash out a way to strengthen medical device regulations. Their solution must protect patients but not hamper business and innovation, and all sides are fighting about the best way to get there.
If the argument sounds familiar as far as the European Union goes, it is. The conflict first gained major notice more than a year ago after regulators determined that breast implants made by the now-defunct French company Poly Implant Prothèse (PIP) were made with substandard silicone and ruptured more easily than standard implants and subsequently recommended their removal, causing anxiety among tens of thousands of women who worried their health was at risk. Faulty metal hips that have led to lawsuits and global recalls have heightened the debate.
As Reuters reports, the European Commission proposes tougher approval regulations. And some legislators want to go even further, replacing the premarket approval process with a new, more centralized system that would replace the series of private firms, or Notified Bodies, that handle CE marking across the continent. And while device companies are acknowledging the need for reform, they are fighting major changes, Reuters notes, that they say could delay a product launch over a period of years.
Right now, many companies pursue device approvals in Europe first. The process doesn't take as long. The story cites Boston Consulting Group data pointing to an approval process in Europe that brings products to market 43 months sooner on average for high-tech devices than in the U.S. And tougher regulations could go a long way toward closing the gap, even as FDA officials work to streamline their own approval process.
But Reuters explains that the Feb. 26 meeting is just another step in a very long process. Local EU governments will have their say, as will companies, parliament and the European Commission. So expect plenty of negotiations and new regulations as late as 2019.
- read the Reuters story