Every country has their own legal requirements when it comes to writing health promotional materials. Do you know yours?
In this guest post, freelance medical writer Gemma Williams summarises the key requirements from the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.
This checklist is a timely reminder that you should always remember to double check that your promotional writing is credible and compliant – as well as high-quality content that readers will understand.
The Association of the British Pharmaceutical Industry (ABPI) Code of Practice has many requirements regarding the content of health promotional materials.
As a freelance medical writer or health copywriter you need to be up to speed on the mandatory information required in your content and what is and isn’t permitted when it comes to claims and comparisons.
To ensure compliance with the ABPI Code, all promotional materials must be certified by two pharmaceutical company representatives (one of whom must be a registered medical practitioner or a pharmacist registered in the UK – Clause 14.1).
Any material that does not fully comply will be picked up during the review stage and subsequently will not be approved.
Ensure that all of your promotional material meets the ABPI requirements from the outset by following the checklist below.
Writing health promotional materials: Mandatory information
- Drug’s generic name – this should be immediately adjacent to the most prominent display of the brand name, in bold type, of a size such that a lower case ‘x’ is no less than 2 mm in height, or in type of such a size that the generic name occupies a total area no less than that taken up by the brand name
- Adverse event (AE) statement
- If required, a black triangle to denote that additional monitoring is required in relation to AEs – this should be next to the most prominent mention of the brand name, inverted, black, equilateral and sized 5 mm for A4, 3 mm for A5, and 7 mm for A3
- Prescribing information – the type size should be such that a lower case letter ‘x’ is no less than 1 mm in height, lines should be no more than 100 characters in length (including spaces), and text should be easy to read (eg. sufficient space between lines, a clear style of type, and adequate contrast between text colour and background)
- Job bag number
- Date of preparation
- Legal symbols (e.g. copyright)
- Company details
Health claims in promotional materials
- All statements and claims in health promotional materials about a product must be accurate, up to date and consistent with the Summary of Product Characteristics (SPC), particularly in terms of dosage, patient population, use with other medications, contraindications and AEs
- The benefit/risk profile of a drug should always be clear
- The word ‘safe’ (and related words such as ‘safety’) must not be used without qualification; ‘well tolerated’ may be used instead
- Labelling a drug as ‘new’ is allowed only for 12 months from its first marketing in the UK
Comparisons
A comparison is permitted in promotional material if it is accurate, balanced and not misleading. This means:
- Comparisons must only be made between the same features of each drug
- Comparisons must only be made between drugs intended for the same purpose (i.e. indication)
- Comparisons must be balanced e.g. if you present the results of a study in which your product was superior to a competitor product, you must also mention four similar studies which demonstrated superiority of the competitor product
- No hanging comparisons where it is not clear what is being compared (e.g. “Drug X is easier to administer” – compared to what?)
- Statements must not be disparaging to competitor products – i.e. no ‘knocking’ copy
Supporting data in health promotional materials
- All statements must be supported by data which is relevant, up to date and available (not copyright or privileged)
- Unpublished data, referred to as ‘Data on File’, is allowed but it must be provided to anyone who requests it – including employees of other companies
- If non-clinical studies such as in vitro or human volunteer studies are used in health promotional materials, data must be clinically relevant and the non-clinical nature must be made clear
Graphs, figures and artwork
- All of the requirements above apply to graphs, figures and artwork
Websites
All of the requirements above apply to health promotional materials on the web. However, there are some additional factors to consider:
- Access to online promotional materials should generally be restricted to HCPs, e.g. by password protection
- However, if access is not restricted, information must also be provided for the general public (the intent is so that it is not necessary for the public to enter the HCP site)
- The intended audience should be clearly identified on all areas of a website
References
Association of the British Pharmaceutical Industry. Code of practice for the pharmaceutical industry. London: ABPI, 2014. Available at: http://www.abpi.org.uk/our-work/library/guidelines/Pages/The-Code-of-Practice-for-the-Pharmaceutical-Industry-2014.aspx
Gemma Williams is a freelance medical writer with over 7 years’ in-house experience in medical publishing and communications. She specialises in educational medical writing and has a highly creative flare for projects. Having worked in-house as a medical editor for various medical journals and medical communications agencies, she also has a strong background in medical editing.
