Clause 28 - The Internet and other Digital Platforms
28.1 Promotional material about prescription only medicines directed to a UK audience which is provided on the Internet must comply with all relevant requirements of the Code.
Clause 28.1 Access
Unless access to promotional material about prescription only medicines is limited to health professionals and other relevant decision makers, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections for each target audience clearly separated and the intended audience identified. This is to avoid the public needing to access material for health professionals unless they choose to. The MHRA Blue Guide states that the public should not be encouraged to access material which is not intended for them.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
28.2 Information or promotional material about medicines covered by Clause 28.1 which is placed on the Internet outside the UK will be regarded as coming within the scope of the Code, if:
- it was placed there by a UK company/with a UK company’s authority, or
- it was placed there by an affiliate of a UK company, or with the authority of such a company and it makes specific reference to the availability or use of the medicine in the UK.
28.3 Information about medicines covered by Clauses 28.1 and 28.2 which is provided on the Internet and which is intended for members of the public must comply with Clause 26.2.
28.4 A medicine covered by Clause 28.1 may be advertised in a relevant independently produced electronic journal intended for health professionals or other relevant decision makers which can be accessed by members of the public.
Clause 28.4 Advertisements in Electronic Journals
It should be noted that the MHRA Blue Guide states that each page of an advertisement for a prescription only medicine should be clearly labelled as intended for health professionals.
28.5 Public assessment reports (European or UK), summaries of product characteristics, package leaflets and reference material for prescription only medicines may be included on the Internet and be accessible by members of the public provided that they are not presented in such a way as to be promotional in nature.
Clause 28.5 MHRA Guidance
The MHRA Blue Guide states that the public should not need to access non-UK websites or non-UK parts of websites to obtain basic information about a company’s products, such as package leaflets, summaries of product characteristics, public assessment reports and other non-promotional material. It is good practice for each page of a company website to include a statement identifying the intended audience.
Clause 28.5 Information on Clinical Trials
Information on clinical trials as agreed in the current Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the current Joint Position on the Publication of Clinical Trial Results in the Scientific Literature may be available at a UK or a non UK website.
Attention is drawn to Clause 13.1 and its supplementary information.
28.6 It should be made clear when a user is leaving any of the company’s sites, or sites sponsored by the company, or is being directed to a site which is not that of the company.