2021 Annual Report on Medicines Advertising

The MHRA recently published its annual report on Delivering High Standards in Medicines Advertising Regulation. This 16th edition of the annual report covers the 2021 calendar year and includes information on how the MHRA acts in relation to complaints, vetting of advertising and collaboration with industry self-regulatory bodies.

The introduction of the report acknowledges that the MHRA is currently undergoing significant structural changes. These changes must not be understated as the MHRA’s budget was slashed last year, partly as a result of Brexit, and we also understand that the dedicated devices and medicines divisions have been rolled into one as part of an ongoing “streamlining” exercise.

Complaints

There was a 37% decrease in the number of complaints the MHRA received about medicines advertising. This was attributed to the success of the joint working initiative with the ASA in relation to advertising of botox, which has been in place for the last two years. The proportion of complaints upheld also increased by 40%, reflecting the lower number of investigations initiated by the MHRA. The MHRA noted that all cases were concluded through voluntary agreements with the companies involved, no statutory procedures were necessary. The most common complaints were for the promotion of prescription only medicines (POMs) to the public, promotion of unlicensed medicines and those promotions that didn’t make it clear the product was an over-the-counter (OTC) product.

Vetting

The MHRA’s Advertising Standards team vetted material for 60 medicines last year, a big increase on past years. This was primarily because advertising for all new active substances is reviewed prior to launch and there was a bump in the number of new products authorised in 2021. Based on their experience over the last year, the MHRA reiterated some key recommendations for best practice, including the following:

• Clearly state appropriate authorised indications for each product;
• Make data limitations clear, and include sufficient objective information to allow readers to judge the importance of a claim for themselves;
• Safety information should be included as appropriate;
• Company advisory boards should be kept to a minimum and must be strictly non-promotional; and
• Where a press release is used to announce a POM, the material must be factual, balanced and non-promotional (note that advertising a POM to the public is prohibited).