European Parliament could cripple medical innovation in Europe
25 September 2013
The European Parliament’s Committee for Environment, Public
Health and Food Safety (ENVI) has voted in favour of draft
legislation that trade body Eucomed says could cripple the medical
technology sector in Europe and delay patients' access to innovative
The Committee says that the draft legislation will better protect
patients from similar incidents to the PIP breast implant and the
"metal on metal" hip implant scandals. The proposals have been drawn
to iron out inconsistencies in the interpretation of current rules,
boost public health protection, remove obstacles faced by industry
in the EU internal market, improve transparency of information to
patients and strengthen traceability rules.
It also says that its amendments would boost public access to
clinical data, create a new approach to labelling medical devices,
and create a new advisory body of experts. Beefed-up conformity
assessment bodies (called “notified bodies”) will provide closer
scrutiny of manufacturers’ own product safety tests. The bodies must
have a permanent team of in house experts who meet new requirements
for minimum qualification requirements.
Eucomed, however, claims the proposed regulatory system will not
only unnecessarily delay by three years patient access to the latest
lifesaving medical technology, but also deliver a devastating
financial blow to Europe’s 25,000 small and medium-sized companies
making medical devices.
Eucomed says, "The ENVI committee compromises patients and jobs
in a what looks like a rushed through deal that seeks to satisfy the
time pressure that Parliament feels ahead of the European elections,
but not the needs of Europe’s patients and doctors. For several
political groups, the outcome also represents a drastic shift away
from their pro-innovation, pro-competitiveness platforms on which
they are campaigning for re-election in 2014. It is now up to the
political groups in light of the plenary vote in October to turn the
“rushed deal” into a “right deal” for patients and jobs.
"The ENVI Committee has voted for a scrutiny procedure that is
much more complex than the one proposed by the European Commission
in article 44, and introduces an extreme bureaucratic case-by-case
centralised pre-market authorisation system, as proposed by the
Rapporteur, that is managed by 21 groups of clinical experts as well
as the European Commission and the European Medicines Agency.
"Far from the initial committee of 28 experts foreseen by the
European Commission with a very focused mandate, the new committee
is almost Kafkaesque in its construction with over 600 medical
experts chosen from across Europe deciding across 21 sub-committees.
No assessment has been made of any kind as to what real safety gains
there would be, what delays it would cause for lifesaving devices
reaching patients and what the exact cost of the added bureaucracy
to European governments and industry will be.
"Industry has calculated that proposed system will result in a
bureaucratic behemoth costing anywhere between 10 and 25 billion
Euros and that in no way achieves the shared objective of improving
patient safety. Instead, the proposal represents an exercise in deal
making that capitalized on MEPs’ collective desire to conclude a
time-consuming, very technical dossier before campaign season.
"In addition, special notified bodies will be designated and
managed by the European Medicines Agency (EMA), while not answering
the question what qualifies an agency with limited medical device
expertise to do this job. Taxpayers will de facto pay twice for the
same procedure: once to equip special notified bodies with qualified
experts (which is in itself the right approach) and again for the
new conglomerate of up to 600 clinical experts who do a second
assessment of the product, which is an unnecessary duplication and
an inconsistency in the proposed system. If the proposal is carried
in the next plenary vote in the European Parliament it will throw a
blanket over European MedTech SMEs, innovation and inbound
Eucomed CEO Serge Bernasconi said, “This compromise proposal on
the table is said to be dramatically different than the heavy
centralised pre-market authorisation system as proposed in the draft
ENVI report. Let it be clear that this is a PMA in disguise carried
out on a case-by-case basis and will deal a blow to patient access
and medical device innovation in Europe.
"Also, no-one has shown how any part of the proposed new PMA
system would have changed the outcome of PIP or any other safety
issue. Bureaucracy will not prevent an alleged fraud like PIP.
Concrete actions do. The measures that the Commission adopted
yesterday do clearly help prevent incidents such as the PIP
happening again as they include unannounced visits of manufacturers
and are fully supported by industry.
"Our industry is also committed to invest €7.5 billion in
effective and necessary safety measures. But making us spend more
than our total R&D budget for a system without any proven benefits
for patients is beyond my comprehension. The political groups in the
parliament still have time to assess the impact of the system on
patients, innovation and resource implications and fix this rushed
deal into a right deal when the vote enters the plenary session in
This draft law and also one one concerning vitro medical devices
are due to be put to a vote by the full House during the 21 to 24
October European Parliament session in Strasbourg.
See the full Eucomed press release: