On 17 March 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published its 2021 annual report on the regulation of medicines advertising within its remit for 2021. The MHRA also discussed its findings and various ‘hot topics’ in medicines advertising in a webinar on the same day (alongside other stakeholders such as the Prescription Medicines Code of Practice Authority (PMCPA)).
In this review we reflect on seven key themes in medicines advertising emerging from the annual report.
1. Numbers of complaints received significantly down on previous year
Complaints received by the MHRA were down overall by over a third compared to 2020 (144 complaints in 2021 versus 277 in 2020). This is likely because complaints are increasingly being dealt with by other regulatory bodies, especially the UK Advertising Standards Authority (ASA), with the MHRA focusing only on cases that it considers especially serious and referring less serious complaints to other bodies.
2. Very little enforcement activity under the MHRA’s statutory powers
No corrective statements were required in respect of complaints made in 2021 and the MHRA had no recourse to statutory procedures.
The number of investigations started by the MHRA during 2021 was also down (53 investigations started versus 207 in 2019).
The vast majority (89 per cent) of advertisements where a complaint was upheld were voluntarily withdrawn, and the companies behind a smaller number of advertisements (for which no potential risk to public health was identified) were provided with advice on changes required.
3. Continued emphasis on industry self-regulation
While the MHRA reiterates that it is prepared to take robust action pursuant to its statutory powers when required, particularly where a potential risk to public health and safety is identified, it continues to support self-regulation by the industry.
The MHRA has worked closely with other organisations such as the ASA, the Association of the British Pharmaceutical Industry (ABPI) and the PMCPA, with the latter being responsible for administering the ABPI Code of Practice which governs interactions between pharmaceutical companies and healthcare representatives, including promotional activities.
4. Significant cooperation with (and reliance on) other regulatory bodies such as the ASA or PMCPA
The MHRA has also collaborated with other bodies to resolve complaints, in particular the ASA and PMCPA. Of the 144 complaints received by the MHRA in 2021, 55 were investigated directly by the MHRA or one of its units, while 89 were referred to another body.
5. Commentary on complaints received by MHRA
- The majority of complaints concerned the advertising of prescription only medicines to the public (consistent with previous years).
- The number of complaints relating to social media campaigns continues to rise.
- Very few of the MHRA’s complaints which were upheld involved a Marketing Authorisation Holder (five of the total 49 upheld).
- Of the cases investigated by the MHRA, there was a roughly even split between consumer and competitor complaints (26 to 22, respectively), with one investigation initiated by the MHRA itself.
6. Increased pre-vetting
There was an increase in the MHRA’s pre-vetting of product advertisements in 2021, with 60 products pre-vetted (versus 46 in 2020), and with COVID-related products unsurprisingly featuring prominently.
7. Some points of best practice for advertising medicines
The MHRA’s report identifies six key themes from its medicines advertisement vetting experiences in 2021, which it considers to demonstrate best practice:
- Appropriate (and authorised) indications should be clearly and prominently stated to ensure claims are properly contextualised.
- Claims must not be misleading - in particular:
- claims should be supported by accurate, evidence-based data, with limitations clearly stated;
- clinical data must not be presented in a way that implies a clinical benefit in the absence of ‘a sound statistical basis or a clinically important effect’. Non-clinical data must not imply a clinical benefit unless data are available to demonstrate clinical relevance;
- where a claim relates to risk reduction, absolute risk should also be stated to enable better assessment of clinical impact;
- graphics should not exaggerate the benefits of use of the product; and
- claims must be substantiated – particular caution should be exercised with quality-of-life claims.
- Important information should not be hidden in footnotes: claims must be able to stand alone: ‘footnotes are unlikely to be an appropriate way to caveat or explain important information that may affect the prescribing or dispensing choice of a busy healthcare professional.’
- Key safety messages should be included, including key contraindications, warnings, side effects and any follow up/monitoring required.
- Use of expert advisory boards should be given careful consideration and must be strictly non-promotional. For example, expert advisory meetings should not cover topics such as promotional activity or corporate strategy (see also the PCMPA’s helpful guidance on the use of advisory boards).
- Public-facing materials must be factual, balanced and non-promotional in content. For example, any press releases announcing the launch of a new product must be given particular consideration (e.g. avoid emotive language; not raise unreasonably patient expectations about the benefits or safety of the product).
Please get in touch if you would like to discuss in more detail or for related queries.
Complaints received by the MHRA were down overall by over a third [with]complaints ...increasingly being dealt with by other regulatory bodies, especially the UK Advertising Standards Authority (ASA), with the MHRA focusing only on cases that it considers especially serious and referring less serious complaints to other bodies.