LONDON, Dec 19 (Reuters) – Nicola Osypka’s German company has been selling medical devices used in newborn surgeries in Europe for decades, but new European Union rules have forced it to make tough decisions.
Under regulations designed to prevent another health scandal, such as the 2010 rupture of breast implants made by Poly Implant Prothese, companies must apply for new certificates for their medical equipment.
But Osypka says the small company founded in 1977 by his father Peter can’t afford the process and has recalled five lines of devices sold in the EU, some dating back more than 30 years.
“A law created to stop the actions of a criminal enterprise 10 years ago now endangers 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 Reuters has spoken to, including Swedish medical equipment maker Getinge. (GETIb.ST)that are withdrawing devices from the EU market, or have stopped manufacturing them due to the cost of complying with the standards.
While some companies say the cut products have no impact on patients or profits, others say some of the recalled devices are essential, and doctors agree.
Under the EU’s Medical Device Regulation (MDR), which came into force in May 2021, all medical devices, from implants and prosthetics to blood glucose meters and catheters, must meet stricter safety criteria, sometimes with new clinical trials.
All eight manufacturers said the requirements were stretching the time it takes to obtain a certificate for a product line to two and a half years, compared with a few months under the previous system.
Costs have also risen, between three and 10 times, the companies said. As a result, some simply allow their product certifications to lapse, meaning EU hospitals can no longer use their devices.
The EU Commission, in response to questions from Reuters, said it was concerned about the pace of implementation of the new rules and would do everything possible to ensure patients have access to the medical devices they need.
DISRUPTION FOR DOCTORS
Reuters also spoke to two medical associations, three doctors and two regulatory experts, and like the companies, they said the new rules were causing widespread outages and shortages of crucial equipment.
The doctors, in Austria, Belgium and Germany, said that in some cases they were unable to provide standard quality of care because devices for routine procedures were no longer available.
The Standing Committee of European Doctors (CPME), a group of national medical associations, told Reuters that hospitals in Austria and Denmark have reported shortages of critical devices.
France’s national medical regulator (ANSM) told Reuters the country’s healthcare system was being hit by shortages of various types of devices, partly due to the new law.
Nicola Osypka, a molecular biologist, said she sat down with staff to run the numbers for its niche products, such as a tiny catheter used to keep newborns with nonfunctioning heart valves alive until surgery can be performed. .
“These types of products are totally beneficial for these patients, but we cannot afford the half a million euros that it costs to carry out a clinical study, despite the fact that these products have been on the market for 30 or 40 years,” he said.
Just as painful is the fact that Osypka cannot afford the estimated costs of one million euros ($1.1 million) to prepare the application of an innovative product that has already gone through clinical trials.
The company’s new stent for babies took eight years to develop and was successfully used by doctors on 19 babies during a trial in Germany, according to results seen by Reuters.
John O’Dea, chief executive of Palliare, a small Irish medical equipment manufacturer, is so interested in bringing his company’s new laparoscopic device for surgery on the abdomen or pelvis to market that he has picked up the costs.
The process has lasted a year and a half so far and O’Dea estimates that the total cost will be around 100,000 euros, in equipment approved two years ago by the US FDA.
Under the old system, it took about 15,000 euros and a few months for a similar device to be approved, he said.
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 reeling from skyrocketing energy bills and unpredictable supply chains afterward. of pandemic lockdowns.
A spokesperson for the EU Commission said in an emailed statement that there were currently not enough agencies, known as notified bodies, to do the job of recertifying products, although device manufacturers had not prepared enough for the process either. change.
Brussels has authorized 36 agencies and is considering 20 more applications, the spokesperson said.
Tom Melvin, associate professor of medical device regulatory affairs at Trinity College Dublin, said that a decade ago there were almost 100 such agencies under the old system.
In a major concession, the EU health commissioner proposed on December 9 to push back the May 2024 deadline for companies to comply with the new law until 2028 to avoid shortages.
The extension will require an amendment to the law to be approved by the European Council and Parliament, which would not happen until next year.
While a delay would mean some devices won’t be cut anytime soon, it wouldn’t address the bottlenecks and high costs that prevent companies from going through the process, executives like Frank Matzek, vice president of regulatory and government affairs at Biotronik, a maker of cardiac devices in Berlin, he said.
Data from the EU Commission published this month shows the magnitude of the problem.
Under the old system, there are around 25,000 certificates. So far, manufacturers have filed applications under the new system for about 8,000, but fewer than 2,000 have been approved.
The certificates cover multiple devices and, in some cases, entire product lines, making it difficult to estimate the number of products potentially affected. Industry experts say around 500,000 different devices are sold in the EU.
Even big companies with bigger pockets and more experience in dealing with strict global regulations say they have been astounded by the complexity and cost of the new system.
Getinge, which makes surgical, intensive care and sterilization products, has new certificates for about 20% of its portfolio and feels it is on track to meet the deadline, said Mikael Johansson, an executive overseeing MDR implementation.
But that work began in 2018, required a complete overhaul of the company’s portfolio, and resulted in the removal of about a third of Getinge’s products from its range of hundreds of devices.
He said the cull was “healthy” in the sense that it removed products with little effect on earnings, but recertifying the rest has been more demanding and took much longer than expected.
But as some companies move forward, others let certifications lapse.
Andreas Kohl, who runs the stent and catheter maker AndraTec in Germany, said he plans to abandon two or three devices because he cannot afford to order the six products he currently sells in the EU.
Balton in Poland told customers in October that it would drop more than a dozen products, including catheters and stents used for coronary angioplasties and pacemaker leads, due to cost and other difficulties in complying with the new law, according to an email seen. by Reuters.
The company did not respond to requests for comment.
Doctors say the clearest example of the impact of the company’s decisions has been devices for rare conditions, such as catheters used in newborns with heart problems.
Marc Gewillig, director of pediatric cardiology at University Hospital Leuven, a teaching hospital in Belgium, said he lost access to nearly a dozen devices needed for the procedures, forcing him to improvise with three babies.
For one procedure, he said he had 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 done within five minutes of birth, but without the preferred device, you have to move the baby to another part of the hospital, delaying it by 30 minutes.
“That’s minutes in a child with little oxygen to the brain,” he said. “We’re going to take medicine back 20 to 30 years.”
($1 = 0.9405 euros)
Information from Maggie Fick; Additional reporting by Tassilo Hummel in Paris; Edited by Josephine Mason and David Clarke
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