Regulatory experts speaking at the opening plenary of RAPS 2022 Euro Convergence on 10 May discussed the potential to improve patient outcomes by harnessing the power of registries and other large databases, including Eudamed and the recently proposed European Health Data Space (EHDS).
Data, sharing and outcomes
Alan Fraser, chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University Hospital of Wales, Cardiff, UK, said that all stakeholders in the medical field accept some level of risk; however, he added stakeholders also have a responsibility to balance that risk by conducting pragmatic high-quality clinical trials and shortening timeframes where possible.
“That means sharing data and using registries curated by professionals to high standard both for registry-based randomized trials and for postmarket surveillance,” Fraser added.
Fraser shared the stage with experts from industry, notified bodies, and the European Medicines Agency (EMA), who discussed how information from large databases, such as Eudamed, could revolutionize how devices get to market and improve the lives of patients.
“We will have access to some information from Eudamed in the field of medical devices but the clinical trials that will be summarized there are only those that are being done in Europe and approved and registered in Europe,” Fraser noted. “They’re not all clinical investigations, and clinicians will not have access to many of the modules even in the clinical part of Eudamed.”
“We will be given summaries of clinical investigations from those trials that have been registered and we will have the summary of safety and clinical performance, and to me, that’s clearly not enough,” he added. “What we need from a clinical perspective is to collect data that is of high standard in the way… that is done in routine practice, so we don’t have to spend time at computers instead of talking to patients and caring for them.”
Peter Schroeer, vice president of EMEA and Canada regulatory affairs at Johnson & Johnson, said that digital technologies have made the world more connected but some of that connectivity hasn’t been fully embraced by healthcare providers and regulators. He said that while there is a strong focus on high-risk medical devices, the field of digital health has produced new technology that can revolutionize healthcare delivery.
Schroeer added that Eudamed can play a critical role by helping collect and disseminate medical product data from real-world use to regulators and clinicians. He agreed that data collection and distribution should be more global and noted that the EHDS announced by the European Commission in early May is exactly what industry and other stakeholders have been waiting for.
While the EHDS may take years to implement, it will revolutionize how medical data is shared and used to improve patient care, Schroeer said.
“Here the patient is in the center, owns the data, and this data will now be made available to policymakers and regulators,” he said. “Under the rules, quality needs to be documented and it will also be available for researchers and innovators.”
Schroeer added that he thinks the EHDS could bring more medical device innovation to Europe because the new database will allow regulators to better understand how devices work in the real world.
“I think we’ll make it better world and I hope with this European Health Data Space we will share meaningful data, not the data which we have today,” he said.
The EHDS has been touted by the European regulators as a one-stop shop where patients will have immediate and easy access to their medical data in electronic format, free of charge. It will allow patients to share that data with their healthcare providers and across member states where governments are supposed to ensure access to patient summaries, ePrescriptions, images and image reports, laboratory results, discharge reports in a common European format.
An audience member asked about concerns surrounding patient privacy when medical data is widely available in databases such as Eudamed and through the European Health Data Space initiative.
Juan Garcia Burgos, head of public and stakeholders engagement at EMA, said that is an issue the agency gets asked a lot about, especially from patient organizations.
“Patient organizations in general support the use of the data,” he added. “Sometimes its health systems who have the misconception that there is some concern from patients to share the data when actually there is no such concern.”
Burgos also noted that these kinds of public debate are necessary to ensure that all stakeholders are aligned on the safeguards in place to mitigate potential risks to patients.
Speed of innovation
The plenary speakers also discussed the tradeoffs between speeding access to new treatments and the risk of rushing products to market.
Governments should not be competing over who gets to approve new devices in their regulatory regime first, Fraser said, adding that the practice tends to put patients at risk as regulators often speed new products to market. He also cautioned against a culture of European and American regulators competing to be the first to authorize products.
“I also personally think that it’s almost unethical for regulators and governments to compete with each other to produce the environment that is most favorable to innovation because … that means extra risk,” he said, noting that research has shown that getting medical devices on the market faster in Europe has led to increased risk that those devices will be recalled or subject to field safety notices.
In recent years, the US Food and Drug Administration has made a major push to get breakthrough products to market before Europe. Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), has repeatedly stated he wants to ensure the US takes the lead on medical device innovation by streamlining the premarket review process.
Fraser cautioned that type of thinking may put patients at risk.
“It does seem to me that our approach to regulation has historically been reactive rather than proactive,” he said. “If I can make one main comment in this discussion, it is that whatever any of us do, whether we’re clinical or regulatory or with notified bodies or industry. [Our work] needs to be guided by science and setting the appropriate level for regulatory supervision needs to be guided by the risks and the insights from clinical research.”
Fraser noted recent research on breakthrough devices that concluded that FDA should collaborate with the European Union to pool data that can be used to better understand the effectiveness and safety profile of new medical devices. He also cautioned that while there is a plethora of data out there, not all of it is of good quality.
Separately, Burgos addressed Fraser’s concerns that regulators may be compromising patient safety for the sake of innovation.
“I think regulation is not contrary to innovation and I think the pandemic has given us a very good example on how regulation can be totally aligned with innovation,” said Burgos.
Fraser responded noting that much of the useful data used to spur innovation to help in the fight against COVID-19 was from very large, pragmatic, and well-conducted clinical trials.
“I would also point out that everyone who claims they’re doing innovation is not necessarily doing it, and we don’t need all the things that are labeled as innovation,” he added. “There’s a view that I see from a clinical perspective that if you criticize innovation, you’re against progress, but it’s not innovation, it’s proper evidence-based innovation we need.”
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