23.1 Prescription only medicines must not be advertised to the public. This prohibition does not apply to vaccination campaigns carried out by companies and approved by the health ministers.
23.2 Information about prescription only medicines which is made available to the public either directly or indirectly must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.
Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine.
23.3 Any material which relates to a medicine and which is intended for patients taking that medicine must include the statement below or a similar one:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.’
When the material relates to a medicine which is subject to additional monitoring an inverted black equilateral triangle must be included on it together with the statement below or a similar one:
23.4 Requests from individual members of the public for advice on personal medical matters must be refused and the enquirer recommended to consult his or her own doctor or other prescriber or other health professional.
23.5 The introduction of a new medicine must not be made known to the public until reasonable steps have been taken to inform the medical and pharmaceutical professions of its availability.
23.6 Companies are responsible for information about their products which is issued by their public relations agencies.
Clause 23.1 Advertising of Medicines to the Public
The advertising of prescription only medicines to the public is also prohibited by the relevant regulations relating to advertising.
The promotion of medicines to the public for self medication purposes is covered by the Consumer Code of the Proprietary Association of Great Britain (PAGB).
Clause 23.2 Information to the Public
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 and the like. It also includes information provided by means of posters distributed for display in surgery waiting rooms etc and reference information made available by companies on their websites or otherwise as a resource for members of the public.
Any information so provided must observe the principles set out in this clause; that is, it should be factual, balanced and must not be made for the purpose of encouraging 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 23.1. The provisions of Clause 23.4 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 advertising.
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 authorizations. 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 package leaflet (PIL) and the public assessment report (PAR) (UK or European) where such a document exists. Reference information may also include the registration studies used for marketing authorization 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. Reference information may also include 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).
Reference information may also include medicine guides where available, studies (published or not), information about diseases and information about specific medicines etc.
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.
It is good practice to include 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.
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.
Public assessment reports (European or UK), summaries of product characteristics and package leaflets may be provided to members of the public on request.
Companies may provide members of the health professions with leaflets concerning a medicine with a view to their provision to patients to whom the medicine has already been prescribed, provided that such a leaflet is factual and non- promotional in nature.
A company may conduct a disease awareness or public health campaign 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.
Attention is drawn to the Disease Awareness Campaigns Guidelines produced by the Medicines and Healthcare Products Regulatory Agency.
The requirements of Clause 7 relating to information (Clauses 7.2, 7.4, 7.5, 7.8, 7.9, 7.10 and 7.11) also apply to information to the public.
Meetings organised for or attended by members of the public, journalists and patient organisations must comply with Clause 19.
Items for patients or for use by patients are covered in Clause 18.2. and its supplementary information.
Clause 23.2 Financial Information
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 factual and presented in a balanced way. Business press releases should identify the business importance of the information.
Clause 23.2 Information to Current or Prospective Employees
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.
Clause 23.2 Approval of Information
Information on medicines made available under this clause other than responses from medical information departments or similar to unsolicited enquiries from the public must be certified in advance as required by Clause 14.3.
Clause 23.2 Health Technology Assessments
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 23.2.
Clause 23.3 Obligatory Wording
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.
Clause 23.3 Black Triangle Symbol
Details of the black triangle symbol can be found in the supplementary information to Clause 4.11.
Clause 23.4 Requests for Information or Advice on Personal Medical Matters
This clause prohibits the provision of advice on personal medical matters to individual members of the public requesting it. The intention behind this prohibition 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 23.1 and 23.2 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 inactive ingredient, or whether there would be problems associated with drinking alcohol whilst taking the medicine 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.
All requests from members of the public must be handled with great care and a company should refer the enquirer to other sources where appropriate. These might include health professionals, NHS Direct and patient organisations, etc.
A request from a patient for information may in some instances best be 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.