Advice for media and social media outlets: advertising and promotion of prescription-only medicines
Reports in the media sometimes refer to medicines, including prescription-only medicines or clinical trial results on new products still in development. It is important to note that the Irish advertising regulations for medicines prohibit the advertising of prescription-only medicines to the public. These regulations apply to anyone who advertises a medicine in Ireland, not just pharmaceutical companies.
Media and social media outlets can ensure compliance with the law when discussing medicines by:
- Reporting on them fairly and accurately
- Avoiding any promotional language and phrases
- Ensuring that a balanced view of the medicine is represented which means that the risks associated with the medicine are presented alongside any benefits it may have
The benefits discussed can only relate to what is listed in the approved product information. The approved product information for any medicine can be found in its Summary of Product Characteristics (SmPC). This information is publicly available and can be found on the HPRA website or alternatively the European Medicines Agency (EMA) website.
What is medicines advertising?
Advertising is defined as any material or activity that is ‘designed to promote the prescription, supply, sale or consumption’ of a medicine. The HPRA regulates the advertising of human medicines in Ireland.
Advertisements for human medicines in Ireland must comply with the Medicinal Products (Control of Advertising) Regulations of 2007 (S.I. No. 541 of 2007). These regulations apply to any material or activity that falls within the definition of ‘advertising’ in relation to medicines for human use.
The regulations include a prohibition on advertising medicines which have not been granted a licence and a prohibition on advertising prescription-only medicines to the public. The regulations state that advertisements must present the medicine objectively, without exaggerating its properties, and they must not be misleading.
Who do the advertising regulations apply to?
The regulations apply to any person who promotes (i.e. advertises) a medicine in Ireland, not just pharmaceutical companies. Proof of a commercial link to the sale of the product is not required. This can include newspaper or magazine articles, radio or tv shows, social media and blog posts.
How to comply with the advertising regulations
- Media articles and reports that inform the public about a medicine, rather than encouraging its prescription, supply, sale and/or consumption, do not fall within the scope of the Irish advertising regulations.
- Information provided on the medicine in such reports should be factual and in line with the approved information for the product.
- Media articles and reports about medicines should present the medicine in an objective manner, by ensuring that a balanced view is given. A balanced view means that the benefits and uses of the medicines are not exaggerated and that the risks and precautions associated with the medicine are not overlooked.
- Tone and content of the material should be factual and not sensationalised.
- Language used to describe a medicine should not be promotional.
- Care should be taken not to move into what is called ‘off-label’ discussion about a medicine. The ‘off-label’ use of a medicine means using a medicine for anything other than what it is licensed and intended for.
- Target audience of the media piece should not be encouraged to seek a particular medicine from their healthcare provider because of that media piece.
You can find more information on the regulations on our advertising human medicines in Ireland webpage.