Clause 8: Advertising and Promotion of Products
What are The Code’s requirements where claims are made in an Advertisement?
All claims made in Advertisements directed at HCPs must be substantiated. Companies are required to hold appropriate, balanced, comprehensive and credible evidence to substantiate Advertising/Promotional claims. It is fundamental that any therapeutic claim made must be consistent with the registered intended purpose of the technology and conform to current standards for clinical evidence.
The source of a claim should be cited (e.g. by footnote) where the claim is likely to mislead or deceive if the source is not cited. Care should be taken to ensure the correct reference for the particular claim is provided in the footnote and that it fully supports that claim.
In determining whether sufficient evidence is available to support a claim, Companies should have regard to issues such as the study design, the number of patients, the location of the trial or study, its primary purpose and endpoints, the results, its consistency with the current body of evidence and whether or where the study has been published.
Advertising/Promotional claims should not rely solely on evidence from sources such as poster presentations or abstracts that do not provide sufficient evidence to assess the veracity of the claim. Companies should not selectively use evidence to support their claims. Inserting selected abstracts into an Advertisement, which do not accurately reflect the results of the study, has the potential to mislead by omission or implication.
Who may request to see supporting evidence of a claim?
Any third party may request substantiation (i.e. supporting evidence) of a claim which must be made available within 10 working days of the request. Such evidence may comprise published studies, reports etc. It should be accessible so that the time frame can be met. Where a claim is referenced by ‘data on file’ (in the case of unpublished data) or ‘in press’ material, the advertiser is committed to honouring the request from any third party for production of the supporting data. A statement that the data is ‘confidential’ will not be accepted.
What is Comparative Advertising?
In The Code “Comparative Advertising” refers to advertising which compares one product with another product which has the same intended purpose.
The intent of any comparison should be to provide valuable and accurate information comparing products for the benefit of HCPs and their patients. Graphical or visual comparisons should be accurate and appropriate.
Can an advertisement report on the outcomes of comparative testing?
It is permissible in an Advertisement to report on outcomes of comparative testing of Medical Technologies, provided the Medical Technologies have been subject to the same and appropriate testing; the outcomes are reported in a fair and balanced manner; and each outcome is referenced and consistent with the body of evidence.
Best practice would require, for example, that inclusion and exclusion criteria were of a similar patient population, demographic or risk profile. A comparison of pivotal trials may not necessarily be a basis for similarity.
Where a comparative claim is made, there must be strong evidence to support the claim and must be referenced in the body of the advertisement. Claims should be current, accurate and balanced and must not mislead by implication or omission.
Subject to the above requirements being met, if the relevant data used arises from separate studies then there must be a qualifying statement to that effect.