Key Topic 6: Obligatory Information in Promotional Material
Remember that you need to establish the purpose of the asset, its target audience etc before you can decide which obligatory information is required.
Requirements in terms of obligatory information vary between countries so it is very important to establish which regulations and codes apply to each asset.
You will be familiar with this list of items which may be obligatory for certain materials:
- Prescribing information
- Unique identifying number for each asset
- Date of preparation and for global materials an expiry date (usually 12 months)
- Adverse event reporting information
- Declaration of AZ involvement
In addition some digital assets will require additional obligatory information – for example websites require cookie notices and legal information.
Consider the following examples related to obligatory information:
GSK
GSK sponsored a supplement entitled “ProState of the Nation Report. A call to action: delivering more effective care for BPH [benign prostatic hyperplasia] patients in the UK” which was delivered to health professionals along with the journal ‘Health Service’. GlaxoSmithKline’s corporate logo appeared on the bottom left hand corner of the front page above the statement:
‘GSK has sponsored the production of this supplement; for details please see the back cover page of the report’.
The corporate logo also appeared on the lower left hand corner of the back outside cover alongside the statement ‘GSK sponsorship has included payment for a medical writer, honoraria to the editorial board and payment to a public relations agency in respect of project management support’.
Would you approve this as an appropriate declaration of sponsorship?
Ruling
This was the subject of a complaint in the UK and was found not to be in breach. The Panel considered that GlaxoSmithKline’s role in the production of the supplement had been made clear. Sufficient details appeared prominently on the front page with further explanation on the outside back cover.
Article
An article entitled ‘Best practice in childhood fever – the comfort cycle’ was the subject of a complaint in the UK. The article referred to Nurofen for children (ibuprofen suspension) which was marketed by Reckitt Benckiser Healthcare.
Reckitt Benckiser Healthcare had commissioned the article and provided relevant information for inclusion. The company was able to comment on the final article and had paid for it to be included as a bound insert in the journal ‘The Practitioner’
The declaration ‘Supported with an unrestricted educational grant from Reckitt Benckiser Healthcare’ appeared on the front of the article.
Would you approve this?
Ruling
This was ruled to be in breach because the declaration of sponsorship misleadingly implied that it was an independently written educational piece. It was also deemed to be disguised promotion.
