I explained last month that the difference between a legal COVID-19 testing kit and an illegal one is the CE marking. If a medical device carries a CE mark, it has been considered safe for use by the EU.
In response to my blog, Charles Russell Speechlys tweeted that the GPhC had written to a client of theirs, telling them to stop supplying COVID-19 testing kits because they were said to be illegal, even though the kits were CE-marked and were legal.
Dave Rushton, the founder of Paradigm Shift consultancy, commented under my C+D blog on the topic, saying: “Just a gentle reminder to people that where there is money there are organised crime groups, scammers and falsified or counterfeit products. Please do your due diligence, do not buy from ‘randoms.’”
Conor Daly, partner of Rushport pharmacy consultancy, commented on a link to my blog on LinkedIn saying that “the big problem comes if you try to check to see if the CE mark is real or has been faked. There is no central database despite a plan for one some time ago.”
These comments hit the nail on the head. Selling a medical device that doesn’t have a CE mark is a criminal offence under the Consumer Protection Act 1987. It is a strict liability offence, which means that a person selling a device with fake CE marking is guilty of an offence even if they didn’t know that the marking was fake.
But help may be at hand. Launched as part of Brexit planning, the Medicines and Medical Devices Bill 2019-21 is progressing through parliament.
If the Bill becomes law in its current form, it will introduce a “defence of due diligence” into the Medical Devices Regulations 2002. It will be a defence for a person charged with an offence to show that they “took all reasonable steps and exercised all due diligence” to avoid committing the offence.
An accused person will not be able to rely on the new defence if they relied on information supplied by another person – for example, that the CE marking is genuine – unless the defendant shows it was reasonable in all the circumstances to rely on the information, having regard in particular to:
- “the steps which the defendant took…to verify the information
- “whether the defendant had any reason to disbelieve the information”
The Bill is awaiting a date for its second reading in the House of Lords. Healthcare professionals should not be exposed to the risk of a criminal record if they break the law through inadvertence, so the introduction of a due diligence defence will be a welcome change in the law.
In response to this blog, GPhC chief executive Duncan Rudkin said: “We are aware that there are manufacturers selling and supplying COVID-19 rapid antibody testing kits and that these tests are being offered privately in several community pharmacies across Great Britain.
“Although the GPhC does not have jurisdiction over the legality, safety or efficacy of particular types of tests or kits, we do have responsibility as the regulator of pharmacy professionals...
“Although it may be legal to sell or supply a product, for example it may have a CE mark, this does not necessarily mean that it is appropriate for a health professional to supply it to a patient or member of the public. We would expect all pharmacy professionals and pharmacy owners to consider the wider public health impact. During this ongoing national public health crisis, any activity that may contribute to false results or assurances that then impact on public behaviour should not be supported.
“We are aware that this is a fluid landscape and so we will continue to work closely with other regulators with leading roles in relation to testing.”
David Reissner is chair of the Pharmacy Law and Ethics Association