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 products.

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 investment."

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 October.”

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:


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