Nicola Osypka’s German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make tough decisions.
Under the regulations designed to prevent another health scandal, such as the one in 2010 involving ruptured breast implants made by Poly Implant Prothese, companies must apply for new certificates for their medical equipment.
But Osypka says the small firm founded in 1977 by her father Peter cannot afford the process and it has withdrawn five lines of devices sold in the EU, some for more than 30 years.
“A law created to stop one criminal company’s actions 10 years ago now endangers patients’ lives, including children, and European manufacturing sites,” said Osypka.
“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 making them due to the cost it takes to comply with the rules.
While some companies say the products they have cut have no impact on patients or profits, others say some of withdrawn devices are essential, and doctors agree.
Under the EU’s Medical Devices Regulation (MDR), which came into effect 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.
The eight manufacturers all said the requirements were stretching the time it takes to get a certificate for a product line to as much as two-and-a-half years, compared with a few months under the old system.
Costs have also surged, by anywhere from three to 10 times, the companies said. As a result, some are simply allowing their product certifications to lapse, which means hospitals in the EU can no longer use their devices.
The EU Commission, in response to Reuters’ questions, said it was concerned about the pace of the implementation of the new rules and would do all it could 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 disruption and shortages of crucial equipment.
The doctors, in Austria, Belgium and Germany, said in some cases they were unable to provide their 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 that the country’s health system was being affected by shortages of various types of devices, partly because of the new law.
Nicola Osypka, a molecular biologist, said she sat down with staff to run the numbers on their niche products, such as a miniscule catheter used to keep newborns with non-functioning 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 it takes to conduct a clinical study, even though these products have been on the market for 30 or 40 years,” she said.
Just as painful is the fact Osypka cannot afford costs estimated at one million euros ($1.1 million) to prepare the application for an innovative product that has already been through clinical trials.
The company’s new stent for babies was developed over eight years and doctors successfully used it on 19 babies during the trial in Germany, according to the results seen by Reuters.
John O’Dea, chief executive of Palliare, a small Irish medical equipment manufacturer, is so keen to get his firm’s new laparoscopic device for surgery in the abdomen or pelvis onto the market, he has swallowed the costs.
The process has taken a year and a half so far and O’Dea estimates the total cost will come to about 100,000 euros, for equipment approved two years ago by the US Food and Drug Administration.
Under the old system, it took about 15,000 euros and a few months to get a similar device approved, he said.
The costly approval process is the latest blow to the world’s second-biggest medical device market, worth more than $150 billion, which is already reeling from soaring energy bills and unpredictable supply chains following pandemic lockdowns.
An EU Commission spokesperson said in an emailed statement that there were currently not enough agencies, known as notified bodies, to do the work of recertifying products, though device makers had also not prepared sufficiently for the change.
Brussels has authorised 36 agencies and is considering 20 more applications, the spokesperson said.
Tom Melvin, an associate professor of medical device regulatory affairs at Trinity College Dublin, said there were nearly 100 such agencies a decade ago under the old system.
In a major concession, the EU Health Commissioner proposed on Dec. 9 to delay the May 2024 deadline for companies to comply with the new law to 2028 to prevent 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 will not be cut in the short term, it would not address the logjams and high costs putting firms off going through the process, executives such as Frank Matzek, vice president of regulatory and governmental affairs at Biotronik, a cardiac devices maker in Berlin, said.
EU Commission data released this month shows the scale of the problem.
Under the old system, there are about 25,000 certificates. So far, manufacturers have submitted applications under the new system for about 8,000, but less than 2,000 have been approved.
Certificates cover multiple devices, and in some cases whole product lines, making it hard to estimate the number of products potentially affected. Industry experts say about 500,000 different devices are sold in the EU.
Even large companies with deeper pockets and more experience of handling tough global regulations say they have been astonished by the new system’s complexity and expense.
Getinge, which makes products for surgery, intensive care and sterilization, has new certificates for about 20 per cent of its portfolio and feels it is on track to meet the deadline, said Mikael Johansson, an executive overseeing MDR implementation.
But that work started in 2018, required a full review 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 that it removed products with little effect on profit, but recertification of the rest has been more demanding and taken much longer than expected.
But as some companies press ahead, others are letting certifications lapse.
Andreas Kohl, who runs stent and catheter manufacturer AndraTec in Germany, said he plans to drop two or three devices because he cannot afford to apply for all six of his products currently sold in the EU.
Balton in Poland told customers in October it would ditch over a dozen products, including catheters and stents used for coronary angioplasties and pacing electrodes, due to the costs and other difficulties of complying with the new law, according to an email seen by Reuters.
The company did not respond to requests for comment.
Doctors say the starkest example of the impact of the company decisions has been on devices for rare conditions, such as catheters used on newborns with heart problems.
Marc Gewillig, director of paediatric cardiology at the University Hospital Leuven, a teaching hospital in Belgium, said he has lost access to nearly a dozen devices needed for procedures, forcing him to improvise on three babies.
For one procedure, he said he had to use a catheter to access the atrial septum in the heart through the groin, instead of through the umbilical cord with a balloon catheter.
The procedure is usually carried out within five minutes of birth, but without the preferred device, he must transfer the baby to another part of the hospital, delaying it by 30 minutes.
“Those are minutes in a child with little oxygen going to its brain,” he said. “We’re going back in medicine by 20 to 30 years.”
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