PAGB published its updated Professional Code for Medicines (the Code) on 12 February 2025.
PAGB is the UK trade association that represents manufacturers of branded over the counter (OTC) medicines, self-care medical devices and food supplements. PAGB publishes two codes: the Code, which concerns advertising of OTC medicines to persons qualified to prescribe or supply (and people working for them) (PQPS), and a code regarding advertising of OTC medicines to consumers. Together, the two codes are intended to ensure a high standard of conduct and provide a mechanism for industry self-regulation regarding the promotion of OTC medicines in the UK.
The purpose of the updates to the Code was to remove outdated references and streamline content. The key points that have been updated are set out below.
Product Information
The Code has adopted the term ‘product information’, replacing ‘essential information’, to align with the terminology most often used by industry.
As previously, the Code provides that product information must be provided in all advertising materials directed at PQPS, except where specifically exempt. Long form product information may be used in any advertisement to fulfil this requirement but must be used for: (i) training materials for pharmacy-only (P) medicines; and (ii) advertisements for innovative P medicines exceeding 420cm2, all loose inserts for these medicines during the first two years after launch, and where mandated by the MHRA. Rule 1.4.14 of the Code sets out the content of long form and short form product information. Long form product information includes additional points not required by short form product information, such as the product licence number, dosage, method of use and cost. A welcome clarification in the Code is that a price range may be provided where the exact cost is not available.
The revised Code provides for the use of QR Codes to link to long form product information in advertisements in printed materials (including digital materials intended for downloading or printing). Clear instructions should be displayed to scan the QR code for the product information, and the QR Code should link to either a website which contains the long form information, or to the Summary of Product Characteristics (SmPC). If the QR code links to the SmPC, it must be ensured that any required information which is not included in the SmPC is within the advertisement itself. This would usually concern legal classification and cost.
In digital advertisements, the long form product information can be included by a direct single-click link to the SmPC, again ensuring that any required information not included in the SmPC is in the advertisement itself.
Long form product information need no longer be used for digital advertisements relating to General Sales List (GSL) and non-innovative P medicines. However, the short form product information must be included in full in the initial advertisement itself (ie, not by link). Long from product information is still required for innovative P medicines but can be provided by a single-click link.
Superiority claims
Under rule 1.4.5 of the Code, superiority claims should be supported by direct comparative tests. The revised Code has been updated to allow for an exception in the absence of such tests, whereby a “robust body of non-comparative data” may be acceptable.
Gifts and Prizes
Gifts and prizes offered to PQPS must be inexpensive. However, the Code has increased the previous thresholds. A gift, which could, for example, be pens, calendars or relevant books, should not cost more than £10 (excluding VAT) compared to £6 (excluding VAT) previously. The perceived value of the items must also be considered, which is the price at which the recipient could purchase the item themselves.
Prizes may now be up to £220 each (excluding VAT), compared to a previous maximum of £130 (excluding VAT). The number of prizes which may be awarded remains six in a national competition and three in smaller competitions. Acceptable prizes may include training courses, training software, work wear (eg white coats) and desk fans.
Conclusion
The new Code is in force and provides members with increased flexibility and clarity. It does not impose any new requirements on members and, therefore, materials produced following the previous Code remain compliant.
Arnold & Porter regularly advises on the promotion of prescription-only and OTC medicines and the associated regulatory landscape. Please do not hesitate to contact us with any questions.