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EU MDR Transparency Not Enough: Time For A Big Debate?
Increased transparency is often highlighted as one of the major steps forward in the new EU Medical Device and IVD Regulations. But based on discussion at a Feb. 27 European Parliament committee meeting, some feel the changes do not go far enough. Is more debate needed?
During the hour-long debate on February 27 at the European Parliament in response to the global “Implant Files” investigation into medical device safety and oversight, the one topic that stood out most as being unresolved was transparency.
It emerged that there is a mismatch between the International Consortium of Investigative Journalists’ view of how much information should be made available in the best interests of patients, based on its research, and how much the European Commission believes is best. The ICIJ coordinated the Implant Files investigation, a collaboration of about 250 journalists in 36 countries that added a heavy dose of scrutiny to the medtech sector with articles beginning last November. (Also see “10 EU-Based Key Medtech Opinion Leaders React To The ‘Implant Files’” – Medtech Insight, 28 Nov, 2018.)
“Transparency could scare the public?” ICIJ’s Bowers repeated incredulously. “We were quite shocked when we heard that.”
Speaking at the European Parliament, Simon Bowers, ICIJ reporter and Europe partnership coordinator, was critical of the lack of clarity from the European Commission over how much information will be made transparent in the context of the EU Medical Device Regulation, which is scheduled to take full effect in May 2020.
Bowers was addressed a meeting of the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI), the committee that was involved in the drafting of the MDR and IVD Regulation (IVDR).
Commission Reluctance Won’t Cut It With Medical Community
The European Commission suggests does not want to make full information on medical device incidents public, Bowers said. He added that this is of great concern to many of the doctors and patient groups the ICIJ interviewed.
Similarly, Bowers said, the Commission does not want to make public full data from pre-approval clinical studies. There will be a summary, he noted, but the full data will not be made available.
“This is a sop,” he said. “The idea of only a summary being made available won’t cut it with medical community.”
‘Shocked’ At Commission Response
Bowers told the committee that the Commission had argued that publishing incidents reports could scare the public. “Transparency could scare the public?” he repeated incredulously. “We were quite shocked when we heard that.”
The Commission, Bowers said, had also expressed concern that industry would be more reluctant to report concerns about their devices if they knew the information was to be transparent.
“We felt that was a shocking answer,” Bowers challenged. The medical community is outraged and demands transparency, he told the meeting. “It is very hard to find an independent doctor who does not believe in transparency on these issues.”
“If things are not fixed enough, or moving sufficiently in the right direction, then we shouldn’t be afraid to say that we need to continue to improve what is being proposed,” MedTech Europe CEO Serge Bernasconi said.
He argued that the MDR simply does not go far enough, citing some member states as “having to supplement MDR by introducing compulsory implant registries in response to the implant files.”
This seems to be very much welcomed by the medical community, he said, “but it is curious it is detached from the EU process of regulation”.
Industry Calls For More Transparency
Bowers was one of three main speakers at the ENVI debate. MedTech Europe CEO Serge Bernasconi also took center stage, as did Antti Peltomäki, deputy director general at DG Grow (the Internal Market, Industry, Entrepreneurship and SMEs division of the European Commission). There was also time for four members of Parliament (MEP) to give their views – to an otherwise nearly empty European Parliament auditorium.
There is increased understanding from industry that we need to improve and be more transparent, Bernasconi told the meeting, emphasizing how positive industry is about the MDR changes it is implementing.
“We have to be transparent,” he said. “We shouldn’t be afraid to be transparent. … Anyway that is what is happening in other places around the world.”
Peltomäki, the Commission representative, spoke of how the MDR is raising medtech standards and considerably tightening the rules. And he cited transparency as one of the three most important improvements being introduced through the MDR.
In relation to transparency, he mentioned the revised Eudamed medical device database and the detailed information that it will contain.
“Important parts of the information in Eudamed will be publicly available,” he told the Parliament. This includes, for example, information about corrective actions taken by manufacturers.
In responding to Bower’s comments that Eudamed is not as open and transparency as it should be, Peltomäki said: “It is true we are still in discussing with EU member states the full extent of information that will be disclosed. It might well be that not all Eudamed information will be made public.”
He explained that decisions around disclosing information must be based on good reasoning. “Incidents require careful analysis of their nature and cause to determine whether they result from a malfunction of the device itself of whether they are due to any other factors that can be better controlled such as incorrect use or clinical environmental aspects?” he said.
“It is in the public’s interest,” Peltomäki said, “that we provide verified, accurate information when incidents occur, not potentially misleading automatic reporting.”
Peltomäki said many of the issues raised by the ICIJ reporters were in line with concerns that drove the Commission and co-legislators to reform the current EU directives into the new regulations in the first place. The MDR and IVDR, he said, “are an appropriate and balanced response to the identified weaknesses of the current system.”
Parliament “has to support an immediate modification of the regulation and perhaps a restructuring inside the European Medicines Agency” to create a new department responsible for assessing implants and other devices, said Nicola Caputo, MEP from the Italian Democratic Party.
MEP Views Diverge
At least one MEP, Christian Democrat Françoise Grossetête, a member of the MEP Heart Group and the European Society of Cardiology, agreed that the problems highlighted in the Implant Files reports have already been dealt with by the new regulations that are soon to be fully implemented.
The ICIJ’s revelations, she suggested, “showed up some real structural problems; these are the very problems that the Parliament has sought to resolve with the MDR.”
But the efforts taken by the European Parliament – in tightening up pre- and post-market monitoring rules, for example, has not been sufficiently stressed, she said.
“Certain broadcasts and newspapers have very much exaggerated the problems,” she argued. She added: “You can mention the problem without trying to alarm patients unnecessary or trying to sully the reputation of the whole sector. We need to ask journalists to take more care.”
Grossetête was the only MEP of the four to speak at the European Parliament on February 27 who squarely defended the new regulations. The other three MEPs said they have ongoing concerns and also highlighted issues with transparency.
This is clearly a topic that the medtech community needs to pay more attention to as the implementation forges ahead. Otherwise, there may be more calls for modifying the regulation. The position of Nicola Caputo from the Italian Democratic Party offered a stark warning for industry to ensure it answers its critics.
In light of the ICIJ investigation, Parliament “has to support an immediate modification of the regulation and perhaps a restructuring inside the European Medicines Agency” to create a new department responsible for assessing implants and other devices, Caputo said. “This would allow these products to be put to a more rigorous testing before they are approved.”
Implementation Above All
Bernasconi warned that now is not the time to start changing the regulation as this would cause delays in improving the safety of medical devices.
“If things are not fixed enough, or moving sufficiently in the right direction, then we shouldn’t be afraid to say that we need to continue to improve what is being proposed,” the MedTech Europe chief said.
But, in his view, the worst thing that could happen is to try and change everything now. The new regulations have “not even been put into motion,” he noted. “Do we want to go back to years of discussion before we go forward?” he challenged.
Bernasconi stressed the need to implement the new MDR and IVDR now for the sake of patients and urged that all players do everything possible to make the new rules implementable as soon as possible.