LONDON, December 19 (Portal) – Nicola Osypka’s German company has been selling medical equipment used in neonatal surgery in Europe for decades, but new European Union regulations have forced it to make tough choices.
To prevent another healthcare scandal like the one in 2010 with ruptured Poly Implant Prothese breast implants, companies must apply for new certificates for their medical devices.
But Osypka says the small company, founded by her father Peter in 1977, can’t afford the process and has withdrawn five product lines sold in the EU, some for more than 30 years.
“A law created 10 years ago to stop the actions of a criminal enterprise is now endangering the lives of patients, including children, and European manufacturing plants,” Osypka said.
“Is that what the EU wants for its citizens?”
Osypka AG is one of eight companies Portal spoke to, including Swedish medical device maker Getinge (GETIb.ST), who are withdrawing devices from the EU market or have stopped manufacturing them due to the costs needed to comply with the regulations .
While some companies say the products they’re cutting aren’t impacting patients or profits, others say some of the withdrawn devices are essential, and doctors agree.
According to the EU Medical Devices Regulation (MDR), which came into force in May 2021, all medical devices, from implants and prostheses to blood glucose meters and catheters, must meet stricter safety criteria, some with new clinical studies.
The eight manufacturers all said the requirements extend the time it takes to get a product line certified to up to two and a half years, compared with a few months under the old system.
Costs have also increased by three to 10 times, the companies said. As a result, some are simply letting their product certifications lapse, meaning hospitals in the EU can no longer use their devices.
When asked by Portal, the European Commission said it was concerned about the pace of implementation of the new rules and would do everything in its power to ensure patients have access to the medical devices they need.
INTERRUPTION FOR DOCTORS
Portal also spoke to two medical associations, three physicians and two regulation experts, and like the companies, they said the new rules are causing widespread disruption and shortages of essential equipment.
Doctors in Austria, Belgium and Germany indicated that in some cases they were no longer able to provide their standard care because equipment for routine procedures was no longer available.
The Standing Committee of European Doctors (CPME), a group of national medical associations, told Portal that hospitals in Austria and Denmark have reported shortages of critical equipment.
France’s national medical regulator (ANSM) told Portal that the country’s healthcare system has been hit by a shortage of different types of equipment, partly due to the new law.
Nicola Osypka, a molecular biologist, said she sat down with collaborators to get numbers on their niche products, such as B. a tiny catheter used to keep newborns with malfunctioning heart valves alive until surgery can be performed.
“These types of products are of great benefit to these patients, but we can’t afford the half a million euros it takes to conduct a clinical trial even though these products have been on the market for 30 or 40 years,” he said you.
Equally painful is the fact that Osypka cannot afford the estimated cost of one million euros to prepare the application for an innovative product that has already undergone clinical trials.
The company’s new stent for babies took eight years to develop and doctors successfully used it on 19 babies during the study in Germany, according to Portal findings.
John O’Dea, CEO of Paliare, a small Irish medical equipment manufacturer, is so keen to market his company’s new laparoscopic device for abdominal or pelvic surgery that he has swallowed the expense.
The process has taken a year and a half so far, and O’Dea estimates the total cost at about €100,000 for devices approved by the US Food and Drug Administration two years ago.
Under the old system, it took around €15,000 and a few months to get a similar device approved, he said.
SYSTEM OVERLOAD
The costly approval process is the latest blow to the world’s second-largest medical device market, worth more than $150 billion, which is already suffering from soaring energy bills and unpredictable supply chains following pandemic lockdowns.
A spokesman for the EU Commission said in an emailed statement that there are currently not enough agencies, known as notified bodies, to do the work of recertifying products, although device makers are also not doing enough to prepare for the change had.
Brussels has approved 36 agencies and is considering 20 more applications, the spokesman said.
Tom Melvin, Associate Professor of Regulatory Affairs for Medical Devices at Trinity College Dublin, said there were nearly 100 such agencies under the old system a decade ago.
In a major concession, the EU Health Commissioner on December 9 proposed pushing back the May 2024 deadline for companies to comply with the new law to 2028 to avoid bottlenecks.
The extension requires an amendment to the law, which must be approved by the European Council and Parliament, which would not happen until next year.
While a delay would mean that some equipment would not be shut down in the short term, it would not resolve the deadlocks and high costs that are preventing companies from going through the process, according to executives like Frank Matzek, Biotronik’s vice president of regulatory and government affairs. a heart device manufacturer in Berlin, said.
Data released this month by the European Commission shows the extent of the problem.
Under the old system, there are about 25,000 certificates. To date, manufacturers have submitted around 8,000 applications under the new system, but fewer than 2,000 have been approved.
Certificates cover multiple devices and in some cases entire product lines, making it difficult to estimate the number of potentially affected products. Industry experts say around 500,000 different devices are sold in the EU.
WALKING BACKWARDS
Even large companies with deeper pockets and more experience dealing with stringent global regulations were amazed at the complexity and cost of the new system.
Getinge, which makes products for surgery, critical care and sterilization, has new certificates for about 20% of its portfolio and feels on track to meet the deadline, said Mikael Johansson, an executive overseeing implementation of the MDR.
But that work began in 2018, required a full review of the company’s portfolio and resulted in about a third of Getinge’s products being removed from the range of hundreds of devices.
He said the culling was “healthy” in that it removed low-impact products, but recertifying the rest was more demanding and took much longer than expected.
But while some companies move forward, others let certifications lapse.
Andreas Kohl, who runs stent and catheter maker AndraTec in Germany, said he plans to discontinue two or three devices because he can’t afford to apply for all six of its products currently sold in the EU.
Balton in Poland told customers in October that it was abandoning a dozen products, including coronary angioplasty catheters and stents and pacing leads, due to costs and other difficulties in complying with the new law, according to a Portal email.
The company did not respond to requests for comment.
Doctors say the most glaring example of the impact of the company’s decisions was devices for rare diseases, such as B. Catheters used in newborns with heart problems.
Marc Gewill, director of pediatric cardiology at University Hospital Leuven, a teaching hospital in Belgium, said he lost access to nearly a dozen machines needed for procedures, which forced him to improvise with three babies.
One procedure required him to use a catheter to access the atrial septum in the heart through the groin rather than through the umbilical cord with a balloon catheter.
The procedure is usually performed within five minutes of birth, but without the preferred device, he has to move the baby to another part of the hospital, delaying him by 30 minutes.
“These are minutes in a child when little oxygen is getting to their brain,” he said. “We’re going back 20 to 30 years in medicine.”
($1 = 0.9405 euros)
Reporting by Maggie Fick; Additional reporting by Tassilo Hummel in Paris; Edited by Josephine Mason and David Clarke
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