Report Confirms Falsification of Medical Devices in EU

A new report based on survey findings among Council of Europe member states has confirmed the existence of falsified medical devices in the EU.

The report explains that medical devices comprise over 500,000 different varieties of products, with the field currently experiencing significant developments in terms of new technologies and new product types. Due to the complexity of this domain, work to establish effective legal frameworks and monitoring systems remains ongoing.

Additionally, given that implementation of the latest EU regulations applicable to medical devices (2017/745 and 2017/746) is ‘still in its early stages’, there is little information on the impact of these regulations in addressing falsified medical devices. Compared to medicines, the regulation of medical devices is relatively new, and this is reflected in the systems and processes in place to handle irregularities, and the resources to deal with them.

21 of the 46 member states participating in the survey reported insufficient data-sharing among themselves with regard to falsified medical devices, as well as differences in their individual application of EU regulations.

While awareness of the falsification of medical devices was considered high among some authorities, it was relatively low among others. Only seven countries said they were aware of criminal investigations having taken place with regard to falsified medical devices, and only five were aware of any prosecutions arising from such investigations.

Furthermore, most countries experienced difficulty identifying whether a medical device was falsified or genuine, and said they would benefit from better access to tools for detection.

Regarding the reporting of suspect cases, most countries said they usually submitted reports to relevant health regulatory authorities, but only a minority sent reports to the police, customs, or other stakeholders.

Ongoing problem

While the problem of falsified medical devices is ongoing, criminals never miss a chance to cash in on pandemics and other abnormal incidents. During the COVID-19 pandemic, the falsification of medical devices was at an all-time high as cases of substandard and counterfeit facemasks, hand sanitisers, syringes, COVID test kits, antibiotics, blood pressure monitoring machines, and many other devices were detected globally.

The gravity of counterfeit medicine is made clearly apparent in the annual seizure data released by Interpol from its Operation Pangea effort to disrupt the online sale of counterfeit and illicit health products. Pangea has been in operation for 15 years and is now coordinated by Interpol, the Medicines and Healthcare Products Regulatory Agency (MHRA), the Criminal Enforcement Unit (CEU) and more than 89 countries.

In the UK, for example, the MHRA said that, over those 15 years, it had seized over 25 million illegally traded medicines and devices, valued at more than $100 million.

The falsification of medical devices remains a severe international matter, with an absence of quality data hindering the ability of authorities to properly assess the current state of affairs.

The Council of Europe survey was conducted by the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED), which is part of the European Directorate on the Quality of Medicines & Healthcare (EDQM). The full survey results are available at www.edqm.eu/en/-/falsification-of-medical-devices-results-of-european-survey.