Promotion of a Prescription-Only Medicine by Vertex Pharmaceuticals Incorporated - June 2024
Published 20 August 2024
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The Prescription Medicines Code of Practice Authority (PMCPA) referred a complaint from an anonymous, non-contactable UK healthcare professional about a social-media post issued on LinkedIn by Vertex Pharmaceuticals Incorporated that announced the grant of a new Marketing Authorisation in Great Britain.
In line with procedures outlined in the MHRA Blue Guide and in the PMCPA Constitution and Procedure, complaints are referred to the MHRA if a pharmaceutical company does not accept the jurisdiction of the PMCPA so that the complaint can be considered for potential breach of the Human Medicines Regulations 2012 (Part 14, Advertising).
The complainant alleged that the material highlighted information about a specific Prescription-Only Medicine (POM) and was concerned that the post was seen by patients, who had been asking for availability of treatment because the post said the POM had been approved by the MHRA. Regulation 284 of the above Regulations prohibits the issue of an advertisement to the general public that is likely to encourage them to request a particular POM.
MHRA upheld the complaint. In their response to the complaint, the company said that the material in question was posted on a corporate channel and was intended for global investors. We carefully reviewed the information they provided in their response against the social media post of concern. The MHRA took the view that the material was designed to promote the prescription, supply, sale, or use of a medicinal product and therefore fell within the scope of an advertisement for a medicinal product as defined by regulation 7 of the Human Medicines Regulations 2012.
It therefore followed that the material was in breach of regulation 284 of the Regulations because the specific medicinal product named in the material is a POM and because the information was both accessible to the general public without signposting safeguards as to the intended investor audience and was promotional in nature through the emotive language used in the post to announce the Marketing Authorisation. We considered that the information did not appear to be tailored to an investor audience and that the language could impact someone affected by the disease in question. The MHRA noted that the post also contained specific reference to Great Britain and the MHRA.
Vertex Pharmaceuticals Europe Ltd (a subsidiary of the company) confirmed that the company would review their social-media policies and activities impacting the UK to ensure that in future, announcements are targeted and signposted appropriately for the intended audience and do not use language that would be considered to be promotional in nature. Such guidance is outlined in the MHRA Blue Guide and in the industry-wide social media guidance from the PMCPA to support best practice for company activities for medicines that are prescribed.