Clause 26 Relations with the Public, Including Patients and Journalists

Attention is drawn to other relevant clauses of the Code, in particular, the quality standards Clauses 5 to 10, including meetings organised for or attended by members of the public, patients, journalists and patient organisations which must comply with Clause 10.

In the event of a complaint which relates to the provisions of this clause, companies will be asked to provide copies of any information supplied, including copies of any relevant press releases and the like. This information will be assessed to determine whether it fulfils the requirements of this clause.

Further information regarding temporary supply authorisations is given in the supplementary information to Clauses 3.1 and 3.2. Where the campaign for the public is approved by the health ministers all other relevant requirements of the Code will apply. In addition, such campaigns should include a general reference to the reporting of side effects as it is unlikely that the requirements of Clause 26.4 will apply as the relevant material is not intended for patients taking a particular medicine.

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.

A pharmaceutical company website or a company sponsored website providing information for the public as well as promotion to health professionals must have 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.

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.

Information made available in order to inform shareholders, the Stock Exchange and the like by way of annual reports and announcements etc may relate to both existing medicines and those not yet marketed. Such information must be non-promotional, accurate, presented in a factual and balanced way and not misleading, taking into account the information needs of the target audience. Business press releases should identify the business importance of the information and should only be aimed at the intended financial and investment audience.

Information about pharmaceutical companies provided to current or prospective employees may relate to both existing medicines and those not yet marketed. Such information must be factual and presented in a balanced way.

In general, information on medicines made available under this clause must be certified in advance as required by Clause 8.3. There are exceptions such as for responses from medical information departments or similar to unsolicited enquiries from the public, which should be examined as set out in the supplementary information to Clause 8.3.

Companies may supply information to relevant patient organisations, the public or patients in relation to forthcoming health technology assessments by public national organisations such as NICE, AWMSG or SMC, provided the information is accurate, not misleading, not promotional in nature and otherwise complies with Clause 26.2.

An ‘inexpensive’ item for patient support means one that has cost the donor company no more than £10, excluding VAT. The perceived value to the health professional and the patient must be similar. Such items may bear the name of a medicine and/or information about medicines only if such detail is essential for the proper use of the item by patients.

The obligatory wording required corresponds to that required for package leaflets by the European Quality Review of Documents Group which updated the requirements in The Human Medicines Regulations 2012. If the suggested wording is not used, the same meaning must be conveyed.

In the event that the website address given in Clause 26.4 is changed by the MHRA, companies must use the new address within one year of the change.

Details of the black triangle symbol can be found in the supplementary information to Clause 12.10.

This clause prohibits the provision of advice on personal medical matters to individual members of the public requesting it. This is to ensure that companies do not intervene in the patient/doctor or patient/prescriber relationship by offering advice or information which properly should be in the domain of the doctor or other prescriber.

Pharmaceutical companies can provide information appropriate to support the use of medicines and enhance patient welfare. Emergency advice, for example, action needed in the event of an overdose, can be provided. Other information may also be given, including information on medicines prescribed for the enquirer, provided that it complies with the requirements of Clauses 26.1 and 26.2 and does not impinge on the principle behind this clause. For example, answering requests from members of the public as to whether a particular medicine contains sucrose or some other ingredient, or whether the medicine should be taken before or after a meal, is acceptable. Particular care needs to be taken with regard to enquiries relating to adverse reactions, the indications for a medicine and suchlike.

Requests from members of the public must be handled carefully and a company should refer the enquirer to other sources where appropriate. These might include health professionals, NHS websites, NHS 111, their equivalents in the devolved nations and patient organisations etc.

A request from a patient for information may in some instances be more appropriately handled by passing the information to the patient’s doctor or other prescriber for discussion with them rather than providing the information direct to the patient concerned. This should not be done without the patient’s consent.