As the pandemic progressed, we saw a substantial growth in both inaccurate information about COVID-19 as well as new market entrants launching products to address COVID-19 without really understanding the regulatory background or rules for doing so, challenging when similar items can be regulated very differently. The ASA has worked hard to combat ads which make misleading claims.. In this review, we look at some of the ads which blurred or crossed the line between general consumer products and medicines and medical devices.
The pandemic prompted the ASA to implement a fast track reporting system for raising concerns about ads that make "misleading, harmful or irresponsible claims around the current 'COVID-19' situation". Misleading claims and confused product presentation were particularly prevalent in the medicines and medical devices spaces.
Medicines and medical devices are distinct categories of regulated products which have specific requirements to be placed on the market and other products should not mislead as to their status. There are specific rules for each which must be respected, including advertising. Depending on the product, other categories like general products and PPE may be relevant.
Medicines may only be marketed if they are licensed and even then it has to be in accordance with their marketing authorisation. Prescription only medicines ("POMs") cannot be marketed to the public. Products which are not licensed medicines cannot make medicinal claims i.e. they cannot be presented as having properties of preventing or treating disease, or imply that their use restores/corrects/modifies a physiological function by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis. Realising that the "presentation" limb of the definition is broad is vital. Merely presenting the substance as treating or preventing disease is enough for it to be a medicine. So the words chosen to describe use and efficacy are key. It is very easy for a product to inadvertently present itself as a medicine, disease is a broad category including any 'injury, ailment or adverse condition, whether of body or mind'.
Medical devices are any instrument, apparatus, appliance, software, material or other article, alone or in combination, for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, investigation, replacement, modification and does not achieve its principal intended action by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means. Claims for medical devices, like all products which do not have an authorisation scheme, must be capable of substantiation and the status of the product as a medical device is separate to the question of efficacy.
Unfortunately, the pandemic saw a number of businesses blurring, and crossing these defined lines leading inevitably to complaints and upheld rulings from the ASA. Examples included:
- A trio of rulings against different advertisers claiming their unlicensed IV drips could prevent coronavirus lead to joint action from the ASA and Medicine and Healthcare products Agency (MHRA).
- APOM Vitamin B12 injection being advertised to the public (for indications that were unauthorised even in ads to healthcare professionals).
- Food making prohibited claims to treat human disease, including vitamin C shots claiming to cure COVID-19 and other food products claiming to boost immunity.
- Claims in an ad for in vitro diagnostic medical device that an positive antibody test would show that consumers were immune to COVID-19 being found misleading.
- A device which was not a CE-marked medical device but was making medical claims to “destroy... Covid-19 in the body” and replace vaccines.
The final example is particularly interesting because the MHRA, (the designated authority that administers and enforces the law on medical devices in the UK) chose to complain to the ASA rather than launch its own action. This is understandable in the circumstances - no one can deny the MHRA has had a busy couple of years.
Top Tips from DWF
The above showcases how not to approach to advertising and product compliance. To get off on the right foot our top tips are:
- Classification is key, be clear about what your product is and how you can describe it to stay within the rules.
- Take care with how you describe the product, a poor choice of words can change a food or cosmetic to a medicine for instance.
- Review the ad as a whole to ensure the product is presented according to its category.
- Assess what you want to say versus how it might be interpreted.
- Hold evidence for all claims made.
- Be clear on regulatory requirements.
If you require advice or support on any of the issues covered in this article please contact Katharine Mason.
Introducing the Life Sciences team:
The Global Life Sciences team at DWF offer the scope to 'pick and mix' legal advice ranging from Brexit to Venture Capital, across 9 different countries.
For the full details of our range of services and locations click here to access our capabilities document.
In the UK, investment in life sciences is a government priority and part of the 'future proofing' plans that the pandemic has stimulated.
There is, however, also a need to 'look back' and learn and our experience is that many clients in life sciences are also having to prepare for the pending UK National Inquiry into the COVID-19 inquiry (an investigation that is likely to be mirrored in every continent) over the coming months.
That support service is also available from DWF via our Regulatory Teams capabilities, so, whatever your legal need for expert support contact Vicki Swanton who can put you in touch with your relevant local advisor.