The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its annual report on drug advertising. The agency says complaints are down versus previous years, but notes it received more complaints about advertisements made on websites and social media.
In addition to adhering to the general advertising rules in the UK, companies are expected to voluntarily comply with the standards for drug advertising and promotion contained in The Blue Guide, MHRA’s primary guidance document on medicines advertising.
Because companies operating in the UK self-regulate their advertising and promotion, MHRA does not vet every advertisement for medicinal products. Instead, companies can request advice from either MHRA on specific requirements or consult with one of the trade associations that offer services related to drug advertising and promotion.
In general, only drugs approved by MHRA or the European Commission (EC) may be advertised in the UK. Companies may advertise over the counter (OTC) medicines to the general public; however, prescription-only medicines (POMs) may only be promoted to healthcare professionals. In addition, special provisions are made for traditional herbal medicines and homeopathic medicines.
For the legal basis for medicines advertising and promotion in the UK see The Human Medicines Regulations 2012, Part 14.
To facilitate the system of self-regulation, companies and individuals can file a formal complaint about any drug advertisement they feel does not comply with the law. MHRA will then conduct an investigation of the advertisement. In response to a complaint, MHRA will typically try to reach an informal agreement with a company. If an agreement cannot be reached, MHRA may take legal action against the advertiser.
Highlights for 2014
For the past nine years, MRHA has published an annual report on drug advertising, Delivering High Standards in Medicines Advertising Regulation.
The ninth edition of the report finds complaints are down significantly from previous years, and notes that complaints for homeopathic medicines were also lower than previous years. In total, there were 193 complaints to MHRA in 2014, down from 237 in 2013.
More than three-quarters of complaints came from industry, with only 14 complaints to MHRA originating from members of the public or healthcare professionals in 2014. MHRA notes that members of the public are more likely to notify the Advertising Standards Authority (ASA) if they feel an advertisement is improper. Almost two-thirds of the complaints resulted in companies voluntarily withdrawing the advertisement in question, and none of the complaints required corrective action by MHRA.
Enforcement on the Web and Social Media
Like other regulators, MHRA is concerned with online advertising and the use of social media. In 2012, the agency updated The Blue Guide to include a section detailing its position on POMs advertising over social media.
In its 2014 report, MHRA said that the majority of complaints received were related to advertisements for POMs to the public. These complaints were primarily about material found on the web, including Facebook, Twitter and other social media websites. The report also mentions that the Medicines Advertising Liaison Group (MALG) included social media as a topic of discussion at both of its meetings in 2014.
Additionally, MHRA’s Enforcement Group, which is responsible for carrying out enforcement actions, said it shut down more than “1600 illicit websites and nearly 19,000 YouTube videos” and worked with companies such as Amazon and eBay to root out counterfeit and unlicensed drug sellers.
MHRA says it will continue many of its operations to ensure companies meet its standards for drug advertising and promotion. The agency says it will work with industry groups to ensure new products such as a newly approved emergency contraceptive are advertised responsibly.
The agency says it will also continue its work with the European Forum on Advertising Medicines “to share expertise and information” with other regulators.