By Les Rose and Mandy Payne
At HealthWatch we have for some time been concerned that the marketers of so-called "bioresonance devices" persist in making therapeutic and diagnostic claims in the absence of any robust evidence. A recent ruling by the Advertising Standards Authority reported a device marketed as "the Resonator" claiming to cure infections including Covid-19, treat long Covid, and even replace vaccines. The ASA quoted text from its website including: “viruses are not alive, so they cannot be killed. They have to be destroyed, and the only safe way to destroy a virus is to shake it to pieces, which is what the Resonator does … Yes, it can replace vaccines as it will – if used, destroys any virus, parasite, or bad bacteria that invade the body.”
Les Rose, HealthWatch trustee who has worked doggedly to highlight and fight misleading claims by marketers of such devices, was surprised to see that one of the complaints had been brought by the Medicines & Healthcare products Regulatory Authority (MHRA). In fact, the MHRA is itself the statutory regulator for medical devices, so why was matter referred to the ASA, an independent body whose code is voluntary, instead of using its own regulatory powers? In this case, the ASA upheld the complaints and asked for the claims to be removed. But at the time of writing, six weeks after the ruling, they remain on the company's website.
So, what is going on, when a government regulator's action is to refer to an independent regulator which has no enforcement powers? HealthWatch asked the MHRA directly. In the following text we adapt their written answers in the form of a Q&A.
HealthWatch asked: Can you provide a statement please, answering these questions?
- Why was the ASA asked to deal with this matter?
- What constrains the MHRA from taking regulatory action?
- The ASA says that medical claims are not permitted for devices which are unregistered or not CE marked. Can you explain please why the MHRA did not take action on this basis?
- What is the regulatory status of so-called `bioresonance' devices, of which there are many on the UK market? To our knowledge all make unsubstantiated claims.
- Does the MHRA propose to take any further action on this case, in view of the advertiser's refusal to comply?
MHRA replied: "There is not a defined regulatory status of bio resonance products. The regulatory status is defined by the intended purpose and usage claims assigned to the product by its legal manufacturer when first placed onto the market. If a bio resonance machine placed on the market is making specific medical claims that bring it within the definition of a medical device (as defined in the Medical Device Regulations 2002), that device would fall under the remit of the MHRA for our review and investigation. Each product is reviewed on a case by case basis.
"The MHRA does not directly regulate the advertising of medical devices, as there are no specific provisions in the Medical Device Regulations 2002 (as amended) in relation to the advertising or promotion of medical devices. As such, referrals received by MHRA which specifically relate to advertising are passed to the ASA, as the body responsible for regulating advertising in the UK.
We are not able to comment on individual cases due to confidentiality restrictions however we continue to monitor allegations of non-compliance."
We were grateful for the MHRA's prompt response to our questions, but their statement raised new ones. So we pressed for clarification, and the answers are reported below.
HealthWatch's request for clarification
- You say: "There is not a defined regulatory status of bio resonance products. The regulatory status is defined by the intended purpose and usage claims assigned to the product by its legal manufacturer when first placed onto the market." So, if a manufacturer placed a product on the market with non-medical intended purpose, and then started promoting it and selling it using medical claims that bring it within the definition of a medical device (as per MDR2002), they could thereby escape coming within MHRA regulation. Is that a correct interpretation? If so, does MHRA agree that this presents a danger to the public? How might it be addressed? Note that provision 2(1) of the MDRs 2002 state that intended purpose includes labelling, the instructions for use and/or the promotional materials. It is not confined to when the product was first placed on the market. We also pointed out that the Medical Device Regulations (MDRs) state that the intended purpose is defined by what the manufacturer says about the product. If the purpose is medical diagnosis and/or treatment, the product is therefore a medical device. The MDRs then say that a medical device must have a CE marking. What action can the MHRA take against devices that make medical claims but do not have a CE marking?
- You say: "If a bio resonance machine placed on the market is making specific medical claims that bring it within the definition of a medical device (as defined in the Medical Device Regulations 2002), that device would fall under the remit of the MHRA for our review and investigation. Each product is reviewed on a case by case basis." What are the possible outcomes of "review and investigation"? If the device is found to be unlawful, how is non-compliance penalised? Is there a publicly available online source that lists findings of these investigations and whether a penalty was enforced (as there is for the ASA - which acts as a deterrent for the non-compliant behaviour)? If there is no such source, what is the reason for this?
- You say: "We are not able to comment on individual cases due to confidentiality restrictions however we continue to monitor allegations of non-compliance." Please could you expand on the nature of the confidentiality restrictions - what information does this apply to, and why are they not lifted on conclusion of investigation (as they would be for ASA or a legal case)? We understand that confidentiality might apply during an investigation, but once concluded there is a clear public interest to know the outcome. What does "continue to monitor allegations of non-compliance" mean? What are the possible outcomes from such monitoring?
"It would not be correct to state that a manufacturer could avoid regulation by making medical claims only once they’ve placed their product on the market. If a manufacturer subsequently makes medical claims for a product which has already been placed on the market and those claims bring the product within the definition of a medical device then it will be regulated as such. If the manufacturer wishes to continue making such claims, they will have to undergo the relevant conformity assessment.
"Unless exempt, medical devices which do not display the appropriate conformity marking (CE / UKCA / CE UKNI) may be subject to enforcement action. For example, we may issue a Compliance Notice under the Medicines and Medical Devices Act 2021 requiring a manufacturer to cease sale and supply until such time that they have undergone the relevant conformity assessment and their device meets the requirements of the Medical Device Regulations.
"Every allegation of non-compliance is reviewed by the Devices Compliance team and is subject to a risk assessment. This helps us identify and prioritise referrals, ensuring any enforcement action is proportionate to the level of risk posed by the non-compliance and balanced by the resources we have available. Where referrals are prioritised, they are assigned to a member of the team for further investigation and enforcement action, where necessary.
"We have a range of enforcement powers at our disposal which are set out in the Medicines and Medical Devices Act 2021. A person commits an offence if they breach an enforcement notice and may be liable to imprisonment, to a fine or to both.
"We also work with a range of stakeholders including Border Force, Trading Standards, online trading platforms such as eBay and Amazon and other UK and international regulators to help us monitor the market and to take the necessary enforcement action to ensure medical devices in the UK are safe and perform as intended. As well as the enforcement notices referred to above, we can take other action such as seizing consignments of non-compliant devices and removing websites or product listings.
"The confidentiality restrictions refer to Section 237 of the Enterprise Act 2002 which prevents the disclosure of information about the affairs of an individual or business if that information comes to the MHRA in connection with the exercise of any function it has or by virtue of the Devices Regulations. We do not currently publish the outcomes of Compliance investigations, however, this is something we are looking to do in the future.
"We continue to monitor allegations of non-compliance by regularly reviewing the information we receive to help us identify any trends or emerging issues. This might lead to wider market surveillance work or targeted action within a particular sector or device-type. We can re-visit risk assessments and consider whether there has been any change to the risk profile that might warrant further investigation."
Given that the confidentiality restrictions deny us access to decisions made on individual devices or even device categories, and that the devices continue their non-compliant activities unabated, we would speculate that the outcome of risk assessments of bioresonance machines place them at a low priority for enforcement given budgetary limitations. Should these risk assessments be re-visited? We also have concerns that there is no transparency in a process that is publicly funded and run in the public interest.
Les Rose, HealthWatch trustee and Clinical Science Consultant (retired)
Mandy Payne, HealthWatch Newsletter Editor