Industry Fears Investment Drain as EU Weighs New Medtech Rules

Europe will lose its leading position in the high-tech medical devices field if politicians pursue plans to tighten regulations and impose stringent pre-market clinical testing, industry leaders contend.

European politicians are proposing to make regulation far tougher after a breast implant scandal 18 months ago that shook confidence in Europe’s current approach, which is less strict than that of the United States.

“We are going to stop one of the last industries where the level of start-ups is one of the best in world,” Guy Lebeau, chairman of EU trade group Eucomed, representing some 22,500 medical device companies, told Reuters.

A European Parliament committee will vote on July 10 on a report calling for a new pre-market authorisation system for implantable devices, including randomised clinical trials.

Dagmar Roth-Behrendt, the German lawmaker chairing the committee, is convinced Europe needs a more stringent system. If her report is endorsed, it will go to a full plenary vote in parliament in the autumn and inform final discussions between governments.

Critics say Europe’s weak regulation is partly to blame for allowing France’s Poly Implant Prothese (PIP) to manufacture for up to a decade substandard silicone breast implants that were used by hundreds of thousands of women around the world.

But industry leaders argue no system could stop a fraud like PIP – and Lebeau said there was no evidence that moving to a pre-market approval system would improve patient safety.

Instead, Europe would simply suffer a three- to five-year delay in getting devices to market – destroying a key advantage that European companies currently enjoy over rivals in the United States, where extensive testing is required.

Coincidentally, the more conservative approach adopted by the U.S. Food and Drug Administration (FDA) is currently under fire from some doctors who argue it is denying patients access to beneficial therapies.

“An FDA-like system would kill patients and kill innovative companies,” said Antoine Papiernik, managing director of venture capital (VC) firm Sofinnova.

“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.”

Since 2007, venture firms have invested in more than 1,500 small and medium-sized medical device companies in Europe, creating medtech hot-spots in Britain, Germany, France and the Nordic countries.

Inventions from these start-ups have often gone on to be acquired by global companies, fuelling innovation in areas from hip implants to keyhole surgery to heart medicine.

Papiernik said investors had been putting their money in Europe because it offered a more predictable environment than the United States, but that comparative advantage would be lost if the new rules went through and investment would be slashed.

Under today’s system, European device makers must prove a product’s safety to the satisfaction of one of some 80 Notified Bodies – mainly private firms scattered across Europe – and show it functions as intended. Effectiveness is determined through post-approval surveillance as it is used in patients.

Roth-Behrendt contends that is not good enough for high-risk devices that are implanted in the body and she wants to transfer responsibility for a new pre-market authorisation process to the European Medicines Agency (EMA).

But companies question whether the EMA will have the capacity to evaluate the 400 to 600 so-called “Class III”, or high-risk, devices that currently reach the market each year in Europe.

Major makers of medical devices include Johnson & Johnson , Medtronic Inc., Boston Scientific Corp., Abbott , Allergan and Smith & Nephew plc.

The debate in parliament will be crucial in setting the scene for changes to Europe’s rules on devices, although the final decision depends on negotiations between governments.

So far, France – home to the PIP breast implant scandal – has come out in favour of pre-market approval while Britain is opposed. The position of other member states is still unclear.