The Committee has voted in favour of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorization system. 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 device makers. 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 agreement adopted September, 25 has the characteristics of a deal cobbled together as it combines many elements of the Commission’s and Rapporteur’s proposal. 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: “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 Euro 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.”
The ENVI committee also showed another seemingly blind spot to reality and the needs of patients. Despite a growing European consensus against the re-processing of single-use medical devices including a full ban in France, the ENVI committee has voted in support of a measure that would make all devices re-processable by default. Eucomed believes the measure threatens patient safety by failing to require re-processors to meet the same safety and regulatory standards of original manufacturers.
Industry strongly believes that a move towards a system as proposed by the ENVI Committee is not the right way forward for the well-being of patients and the future of medical device innovation in Europe. Multiple scientific reports and studies clearly indicate that a centralised pre-market authorization (PMA) system for medical devices, similar to the one used by the FDA in the US, will deliver no additional safety benefits for patients and will cause unnecessary delays of 3 to 5 years in lifesaving medical devices reaching patients. A case in point is the example of an innovative medical technology like renal denervation for the treatment of severe, uncontrolled hypertension in patients whose condition cannot be treated solely by pharmaceuticals. This technology is already saving the lives of patients in Europe while an estimated 7 million Americans with the condition are still waiting for this procedure to be approved. Also US doctors have been extremely vocal about their frustration with such a system as it denies them and their patients access to the best available medical technology that saves lives. Leading European investors have also cautioned that an “FDA-like system would kill patients and kill innovative companies.”
A survey of medical technology companies to assess the financial impact from 2015 to 2020 indicated that it will cost a SME an additional € 17.5 million annually to bring a new Class III device to patients under the centralised premarket authorisation system as proposed by the Rapporteur. The European Commission’s original scrutiny procedure (article 44), the survey found, would cost an SME an additional € 2.5 million annually.
Medical device manufacturers recognise that the current system needs an overhaul and acknowledge that change is necessary to improve Europe’s medical device regulatory framework. Industry has provided clear suggestions for necessary and effective improvements to strengthen the system. Especially with regards to the approval process and Notified Bodies, professional organisations that are authorised by national governments to assess the safety of medical devices before allowing them to be made available to patients, industry has suggested to:
- Determine the appropriate competence that Notified Bodies must have in place to properly assess clinical evidence;
- Determine strict and harmonised measures that Competent Authorities must apply for the designation, monitoring and control of Notified Bodies.
Contrary to the Commission’s scrutiny procedure (article 44) and the Rapporteur’s centralised approval process, implementing both propositions would lead to an EU-wide consistent, high quality approval system that does not unnecessary delay lifesaving treatments reaching patients and does not lead to an enormous bureaucratic burden.