Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Advises Against Use of Paclitaxel Devices Amid Mortality Fears
The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has said not to use devices featuring paclitaxel in the routine treatment of patients with intermittent claudication. MHRA took the action after finding the potential mortality risk outweighs the benefits in this patient group.
The safety of drug-coated balloons (DCB) and drug-eluting stents (DES) that use paclitaxel has been in the spotlight since late last year, when a meta-analysis linked the products to a significant increase in death over non-coated balloons and bare metal stents. Subsequent analyses, including research funded by Medtronic, have questioned the findings, leaving regulators with the task of figuring out if DCB and DES remain a suitable treatment option.
MHRA formed an expert advisory group in March to analyze that question. The group reported its findings this week, stating that the statistical analysis used in the paper that identified the mortality risk is robust. As such, while there is no scientific or clinical explanation for the increase in deaths, the expert group advised MHRA to restrict use of DCB and DES in some patient populations.
The agency has followed those recommendations. Until additional high-quality evidence is available, physicians are not to use DCB or DES in the routine treatment of intermittent claudication, a condition characterized by leg pain as a result of muscle ischaemia associated with arterial stenosis or occlusion. Prior to the restriction, physicians restored blood flow to the leg muscles by inflating a balloon inside the artery and using a stent to keep it open.
While the expert group thinks the risks outweigh the benefits in these patients, they remain open to the use of DCB and DES in other indications. MHRA, at the advice of the experts, thinks paclitaxel DCB and DES remain an appropriate treatment option for patients with critical limb ischaemia. That position reflects these patients’ risk of irreversible ischemic damage and lower life expectancy.
When physicians want to use DCB and DES, MHRA expects them to discuss the current evidence of an increased risk of death with the patient and ensure they receive enhanced life-long follow-up. The enhanced follow-up may include telephone consultations and reviews in the community.
The expert group’s assessment of the risks and benefits of paclitaxel devices has implications for some clinical trials. In the wake of the meta-analysis, sponsors of studies including BASIL-3, a UK trial that is comparing ballooning to stenting, stopped enrolling new patients. The expert group thinks the sponsors of trials in critical limb ischaemia should consider resuming enrollment.
To increase understanding of the longer-term risks of DCB and DES, the expert group is also asking sponsors of ongoing and completed trials that gathered one to two years of data to continue tracking patients. The expert group wants these trials to gather at least five years of follow-up data to help establish the longer-term mortality risks associated with paclitaxel devices.
, Expert Recommendations
HPRA Seeks More New Recruits for Medical Device Team
Ireland’s Health Products Regulatory Authority (HPRA) is hiring more medical device staff. The new job listings come weeks after HPRA began recruiting people to help it implement incoming medical device regulations.
With the European Union (EU) medical device regulations set to come into effect next year—and in vitro
diagnostic (IVD) changes to follow—Ireland began last month by posting adverts two jobs: A medical devices regulatory and policy assessor and an IVD operations manager. Now, HPRA has released adverts for other medical device roles.
HPRA is seeking “a number” of scientific officers to work in the assessment and surveillance section of its medical device group. The officers will manage vigilance issues related to devices and IVDs and ensure compliance with relevant legislation. Other tasks assigned to the officers include designation and ongoing oversight of notified bodies for medical devices and IVDs, and development of technical guidance at a national and EU level.
Irish officials are also seeking a medical devices inspector, compliance. The new hire will execute audits related to the designation of medical device notified bodies in Ireland and as part of joint EU assessment activities. HPRA will also look to the inspector to perform audits arising from its ongoing surveillance and monitoring program for notified bodies.
HPRA published the new job adverts alongside the reposting of the listing for a medical devices regulatory and policy assessor. The agency originally planned to stop accepting applications in mid May and hold interviews toward the end of the same month. However, HPRA has since re-published the job advert, minus the lines about the application deadline and interview date.
The new closing date for applications for the regulatory and policy assessor post is the end of August. HPRA will stop accepting applications for the two new posts advertised this week later in June.
, Devices Inspector
Spain Introduces Portal for Electronic Reporting of Medical Device Adverse Events
The Spanish Agency of Medicines and Medical Devices (AEMPS) has introduced an electronic portal to facilitate the reporting of incidents involving medical devices. AEMPS’ portal features two forms for reporting incidents, one for health care professionals, another for patients.
Visitors to the portal are asked to state the region of Spain where the incident took place and share other information about themselves, the medical device and the adverse event. AEMPS has included links to explanatory texts to help users inform it of incidents.
Once a report is submitted, the information is automatically sent to the relevant contact in the region of Spain where the incident happened. In this way, AEMPS thinks the portal will improve access to medical device reports for the 17 autonomous communities that make up Spain.
The regional recipient of the information will validate the report and refer it to the surveillance unit at AEMPS. Further down the line, the manufacturer may conduct an investigation into the incident. Users of the portal can opt to permit manufacturers to contact them in the course of investigations or choose to remain anonymous.
AEMPS wants people to use the portal to submit details of any incidents involving medical device failures or other problems arising from their use that could have consequences for human health. If the availability of the online portal encourages more people to report incidents, AEMPS could gain a fuller picture of the safety of medical devices, enabling it to respond quicker and more effectively to emerging concerns.
Switzerland to Publish Pharmacopoeia for Free Online for the First Time
Switzerland is set to publish the Pharmacopoeia Helvetica online for free. The move follows a change in Swiss law regarding the publication of official documents.
Currently, the Pharmacopoeia Helvetica is only available to people who buy the paper version. An electronic version is available but is only accessible to people who have a code that comes with the physical pharmacopoeia.
That is set to change. As of 1 July, Switzerland will make the pharmacopoeia available online for free. All subscriptions to the print version of the document will be terminated, although people will still be able to pay to buy physical copies.
The chair of the Dutch Medicines Evaluation Board
(MEB) has said there is “still some way to go” before real-world data can be used “in a meaningful way.” MEB Notice