At AdvaMed, European regulations are on many CEOs' minds

After two delays, a European Parliament committee is scheduled to vote Sept. 25 on tougher new device regulations. Across the Atlantic, at the AdvaMed 2013 conference in Washington, D.C., at least one industry insider joked the vote could be delayed again. That's even before a full EU parliament vote predicted months from now.

"If there's a political process that makes ours look orderly, it is the EU political process," AdvaMed CEO Steve Ubl said during a press conference where the issue came up.

But there is worry behind the joking. Med tech CEOs and executives fear that any European regulatory changes could gum up what has been an otherwise efficient system, where notified bodies grant CE mark status to devices over a relatively quick time period. A tentative compromise would give the EU greater control over the notified bodies, and a proposal is in the mix to implement unannounced inspections. But others are still pushing for a U.S.-style centralized PMA approval process.

A CEO panel at AdvaMed focused on the European regulatory situation, where some said they were resigned to the pending regulatory changes and would work to adapt.

"It's safe to say that the regulation we have moving forward isn't going to be as easy as the one we have today," said panelist André-Michel Ballester. He's CEO of Sorin, an Italian maker of cardiac medical devices and surgical products. And he said that Sorin is moving ahead pragmatically.

There seems to be some consensus that any European regulatory changes will be set in stone by May 2014. With that in mind, Ballester told the overflow crowd that his company was reviewing its roster of products slated to enter the European market in the second half of 2014. The goal is to see if any can be safely brought to market and through the existing CE mark process before then.

"If there is something we can do to enter the process before a new directive, and we can do that safely," then Sorin will do that, Ballester said.

Karen Licitra, a panelist and worldwide chairman of Johnson & Johnson's global medical solutions group, noted the uncertainty about regulatory changes. She added, however, that a company the size of J&J ($JNJ) is positioned to help shape the discussions.

"No one knows exactly what is going to happen," she said. "But being as large as we are we have the benefit of having talent that can be close to this from the regulatory perspective."

"We stand for greater safety, and transparency, but we also want to be sure patients get access to new technology," Licitra added.

Panelist Nadim Yared is president and CEO of CVRx, a small Minnesota company developing an implantable device to treat high blood pressure and heart failure. He said he was worried that any European regulatory change could hurt the consistency that companies rely on to pursue clinical trials in the European Union.

And without that consistency, Yared said that European investors may start shying away from med tech startups with an EU focus, driving up the cost of funding as a result.

Ubl himself summed up the industry's position.

"At the end of the day, our strong view is that the EU system works very well. In many respects it is more timely and predictable than the U.S. System. We believe that the current, decentralized CE marking process, with modifications that would improve its consistency, is the right direction for the EU process moving forward."

-- Mark Hollmer (email | Twitter)

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