* Europe revisits rules after breast, hip implant scandals
* Manufacturers fear new regulations will delay approvals
* Debate centres on overhauling decentralised EU system
By Ben Hirschler
LONDON, Feb 20 One year on from a breast implant
scandal that shook confidence in Europe's light-touch system for
regulating medical devices, lawmakers and manufacturers are at
loggerheads on ways to protect patients from shoddy products.
Companies that make implantable devices such as new hips and
heart stents accept the need for change to the current set-up
but oppose a radical overhaul, arguing that would delay the
launch of new devices by years and stifle innovation.
The European Commission, the bloc's executive arm, has
proposed a new level of scrutiny, and some members of the
European Parliament want a whole new system of pre-market
approval that would raise the bar still further.
National governments also take differing positions, with
France arguing EU laws must be "radically redrafted", while
Britain opposes big changes.
The issue will come to a head at a European Parliament
committee on Feb. 26, where officials, industry leaders and
doctors' representatives will argue over the way forward.
Dagmar Roth-Behrendt, the German lawmaker chairing the
panel, is convinced Europe needs a more rigorous system for
testing medical devices before they are approved.
"We absolutely need that," she told Reuters. "We don't need
it for every medical device, but for certain medical devices,
without any doubt, we need a more stringent prior authorisation
Like some top doctors, she believes the current system built
on around 80 Notified Bodies - mainly private firms scattered
across Europe - is simply not up to the job.
Panos Vardas, president of the European Society of
Cardiology, said there were "major deficiencies" in the current
system and a more coordinated approach was vital. Cardiologists
are big users of medical devices, ranging from stents that prop
open arteries to pacemakers and artificial heart valves.
The negotiation process between governments, parliament and
the Commission is likely to be lengthy, and new legislation may
not come into force across the EU until as late as 2019.
NEEDLE IN HAYSTACK
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 EU trade group Eucomed, representing some 22,500 device
companies, argues no system could stop a fraud like PIP. It also
questions whether a different regime would have stopped risky
metal-on-metal hip implants reaching the market, given such hips
were also approved under the more stringent U.S. system.
A key debate is whether Europe should shift to a centralised
system as in the United States, potentially by folding devices
regulation into the European Medicines Agency (EMA).
EMA boss Guido Rasi, who will address the Feb. 26 meeting,
said in an interview last year there was an "urgent need" to
regulate devices as tightly as drugs, although whether the EMA
should play a role was up to politicians.
That notion alarms Eucomed's CEO Serge Bernasconi.
"If Europe were to switch to a centralised system, we expect
that, once the new system is up and running, patients will
experience a 3-5 year unnecessary delay in receiving medical
devices compared to today's situation," he said.
And getting such a system up to speed could cause an
additional delay of one or two years, he added, undermining
Europe's leading position in devices innovation.
An analysis by Boston Consulting Group last year found
high-tech medical devices were, on average, made available in
Europe 43 months before reaching the U.S. market.
The European Commission's answer is to reform the current
decentralised system by allowing a new Medical Device
Coordination Group to request additional assessments - such as
longer or larger clinical trials - for some so-called "Class
III", or high-risk, devices.
Manufacturers, however, fear this approach will be random
and akin to looking for "a needle in a haystack", with little
chance of picking up problems.
Major makers of medical devices include Johnson & Johnson
, Medtronic, Boston Scientific, Abbott
, Allergan and Smith & Nephew.
The industry backs the Commission's goal of improving
standards at Notified Bodies, but would rather this was done by
selecting only the best ones to approve higher risk devices,
rather than introducing an extra layer of scrutiny.
More than 500,000 medical devices are sold in the EU,
ranging from bandages, dentures and wheelchairs to pacemakers.
They are regulated under the Conformite Europeenne system,
which is also used for gadgets like toasters, though getting a
"CE mark" for a medical device is tougher than for such