This clause allows for the provision of non-promotional information about prescription only medicines to the public either in response to a direct enquiry from an individual, including enquiries from journalists, or by dissemination of such information via press conferences, press announcements, television and radio reports, public relations activities etc. It also includes reference information made available by companies on their websites or otherwise as a resource for members of the public and information provided by means of posters distributed for display in surgery waiting rooms etc. Companies should take particular care if they use social media.
Any information so provided must observe the principles set out in this clause; that is, it should be factual, balanced and must not encourage members of the public to ask their doctors or other prescribers to prescribe a specific prescription only medicine. It must not constitute the advertising of prescription only medicines to the public prohibited under Clause 26.1. The provisions of Clause 26.5 must be observed if an enquiry is from an individual member of the public.
Information to the public falls into one of three categories depending on its purpose, how it is supplied and how the public is made aware of the information.
Proactive information is supplied to the public without a direct request. This includes booklets on diseases and/or medicines supplied directly or via a health professional, press releases, briefings, conferences, mailings to patient organisations and disease awareness information.
Reference information is intended to provide a comprehensive, up-to-date resource that companies should make available on their websites or by way of a link from their website or by some other means. The primary purpose of reference information is to be a library resource for members of the public giving information relating to prescription only medicines which have marketing authorisations. Such information must not be presented in such a way as to be promotional in nature. Pharmaceutical companies are not obliged to provide reference information but it is considered good practice to provide as a minimum the regulatory information comprising the:
• summary of product characteristics (SPC)
• the patient information leaflet which is included in the pack (PIL)
• and the public assessment report (PAR) (UK or European) where such a document exists.
Reference information may also include:
• registration studies used for marketing authorisation applications and variations and any other studies published or not including those referred to in the SPC, PIL, EPAR or UKPAR or available on clinical trial databases
• material supplied for health technology assessments to bodies such as the National Institute for Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC)
• medicine guides where available
• information about diseases
• information about specific medicines.
Where companies decide to make reference information available, this must represent fairly the current body of evidence relating to a medicine and its benefit/risk profile.
Reactive information is supplied to the public in response to a direct request and must be limited to that information necessary to respond to the request.
Public assessment reports (European or UK), summaries of product characteristics and package leaflets may be provided to members of the public on request.
The Media: It is good practice to reference the summary of product characteristics with a press release or press pack relating to a medicine. Companies should also consider including references to other credible sources of information about a condition or a medicine.
Particular care must be taken in responding to approaches from the media to ensure that the provisions of this clause are upheld.
Attention is drawn to the Blue Guide Appendix: Reporting to the public on medicines: Advice for journalists and patient organisations produced by the Medicines and Healthcare products Regulatory Agency (MHRA).
Individuals Prescribed Medicines: Information about medicines already prescribed for patients may be provided proactively, reactively or as reference information. It could also be supplied to health professionals to pass on to those patients to whom the medicine has already been prescribed. Such material must be factual and non-promotional and clearly state the intended audience.
Items for patients or for use by patients are covered in Clauses 19.2 and 26.3 and their supplementary information.
Disease Awareness or Public Health Campaigns can be conducted by a company provided that the purpose is to encourage members of the public to seek treatment for their symptoms while in no way promoting the use of a specific medicine. The use of brand or non-proprietary names and/or restricting the range of treatments described in the campaign might be likely to lead to the use of a specific medicine. Particular care must be taken where the company’s product, even though not named, is the only medicine relevant to the disease or symptoms in question.
Information on disease awareness campaigns may be proactive, reactive or reference information depending on the circumstances. Attention is drawn to the Blue Guide Appendix: Disease Awareness Campaign Guidelines produced by the MHRA.
Further information is available in Clauses 19.2 and 26.3 and its supplementary information.