PMCPA Advice - The provision of Adverse Event Reporting statements in relation to digital materials
The PMCPA has become aware of some confusion regarding the provision of the adverse event reporting statement as set out in Clause 12.9 of the 2021 Code in relation to digital materials, particularly banner advertisements and has drafted this advice to clarify its position.
Please note that the PMCPA cannot approve any activities or materials, it can only give informal advice based on its interpretation of the Code. In the event of a complaint being received about a matter upon which advice had been given, it would be considered in the usual way. The Code of Practice Appeal Board has the final word on such matters. It is important to note that each case is considered upon its own merits and based upon the allegations raised by the complainant.
Clause 12.9 of the 2021 Code states that all promotional material must include the prominent statement 'Adverse events should be reported. Reporting forms and information can be found at [website address which links directly to the MHRA Yellow Card site]. Adverse events should also be reported to [relevant pharmaceutical company]'. The supplementary information to Clause 12.9 states, inter alia, that a telephone number or email address for the relevant department of the company may be included.
It follows therefore that all promotional material, including digital material which includes banner advertisements, requires the inclusion of the prominent adverse event reporting statement as part of the material itself.
The PMCPA is aware that the adverse event reporting statement is sometimes included by companies within the prescribing information which must be provided in a clear and legible manner in all promotional material as set out in Clause 12.1. The adverse event reporting statement, however, is a separate requirement; it is neither listed in the elements which make up the prescribing information in Clause 12.2 nor otherwise considered to be part of the prescribing information. Any arrangements for the prescribing information as set out in Clause 12 do not automatically apply to the adverse event reporting statement requirements. Unlike Clause 12.4 which permits prescribing information to be provided by way of a clear, and prominent, direct single click link in digital materials such as advertisements in electronic journals, emails, electronic detail aids and suchlike, there is no such allowance within the Code to provide the adverse event reporting statement in this way.
The supplementary information to Clause 12.1 Advertisements in Electronic Journals states, inter alia, that ‘the first part of an advertisement in an electronic journal, such as the banner, is often the only part of the advertisement that is seen by readers. It must therefore include a clear, prominent statement as to where the prescribing information can be found. This should be in the form of a prominent, direct, single click link’. This applies to the prescribing information as defined in Clause 12.2. As no reference is made in Clauses 12.1 and 12.2 or the associated supplementary information to the adverse event reporting statement, the reference to a ‘prominent, direct, single click link’ does not appear to apply to the adverse event reporting statement.
The supplementary information to Clause 12.1 Advertisements in Electronic Journals further states, inter alia, that the first part [of such an advertisement] is often linked to other parts and in such circumstances, the linked parts will be considered as one advertisement. It is the PMCPA’s view that there is a difference between the linked parts of an advertisement eg frames of a banner advertisement which form one advertisement and links within that advertisement to a separate webpage or document.
According to the requirements of the Code as set out above, the adverse event reporting statement should appear as an integral part of the banner advertisement as required by Clause 12.9; there is no exemption for it to be provided via an external link in the banner to a separate webpage or document. The adverse event reporting statement concerns the safety of medicines, and it is important that readers of materials are provided with information about reporting adverse events as easily as possible.
Clause 12.9 requires the adverse event reporting statement to be prominent and it is the PMCPA’s view that it must be included within digital materials including banner advertisements in a way where it is unlikely to be missed. As banner advertisements vary in style and layout, it is for the company to decide how best to meet this requirement.
The PMCPA appreciates that there is a published case (Case AUTH/3367/7/20) whereby a Code of Practice Panel ruling of no breach of Clause 4.9 of the 2019 Code was made in relation to the adverse event statement appearing within the prescribing information linked from a banner advertisement. It is important to note that each case is considered upon its own merits based upon the allegations raised by the complainant. The allegation in Case AUTH/3367/7/20 was on a very narrow basis. There is more recent and relevant case precedent that supports the interpretation as set out above. (Case AUTH/3432/12/20; Case AUTH/3451/1/21; CASE AUTH/3552/8/21 and Case AUTH/3563/9/21 and Case AUTH/3564/9/21).
This point will be considered when the Code is next amended.