Clause 1 - Scope of the Code and Definition of Certain Terms
1.1 This Code applies to the promotion of medicines to members of the United Kingdom health professions and to other relevant decision makers.
The Code also applies to a number of areas which are non-promotional, including information made available to the public about prescription only medicines.
It does not apply to the promotion of over-the-counter medicines to members of the health professions when the object of that promotion is to encourage their purchase by members of the public.
For the purposes of the application of the Code, the United Kingdom includes the Channel Islands and the Isle of Man.
The Code applies to the promotion of medicines to members of the health professions and to other relevant decision makers as specified in Clause 1.1. This includes promotion at meetings for UK residents held outside the UK. It also applies to promotion to UK health professionals and other relevant decision makers at international meetings held outside the UK, except that the promotional material distributed at such meetings will need to comply with local requirements.
Some of the requirements of the Code are not necessarily related to promotion. Examples include declarations of sponsorship in Clause 9.10, clinical trials and non interventional studies in Clause 13, certain aspects of the provision of medicines and samples in Clause 17, donations, grants and fees for services in Clauses 19.2 and 21, the use of consultants in Clause 23, the provision of information to the public in Clause 26 and relations with patient organisations in Clause 27.
The Code does not apply to the promotion of over-the-counter medicines to members of the health professions when the object of that promotion is to encourage their purchase by members of the public as specified in Clause 1.1. Thus, for example, an advertisement to doctors for an over-the-counter medicine does not come within the scope of the Code if its purpose is to encourage doctors to recommend the purchase of the medicine by patients. Where the advertisement is designed to encourage doctors to prescribe the medicine, then it comes within the scope of the Code.
Advertisements for over-the-counter medicines to pharmacists are outside the scope of the Code. Advertisements to pharmacists for other medicines come within the scope of the Code.
- Clause 1.1 Market Extension
- Clause 1.1 Joint Working
- Clause 1.1 Journals with an International Distribution
- Clause 1.1 Advertising to the Public and Advertising Over-the-Counter Medicines to Health Professionals
- Clause 1.1 Promotion to Other Relevant Decision Makers
1.2 The term promotion means any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. It includes:
- journal and direct mail advertising
- the activities of representatives including any electronic or printed material used by them
- the supply of samples
- the provision of inducements to prescribe, supply, administer, recommend, buy or sell medicines by the gift, offer or promise of any benefit or bonus, whether in money or in kind
- the provision of hospitality for promotional purposes
- the sponsorship of promotional meetings
- the sponsorship of scientific meetings including payment of travelling and accommodation expenses in connection therewith
- all other sales promotion in whatever form.
It does not include:
- replies made in response to individual enquiries from members of the health professions or other relevant decision makers or in response to specific communications from them whether of enquiry or comment, including letters published in professional journals, but only if they relate solely to the subject matter of the letter or enquiry, are accurate and do not mislead and are not promotional in nature
- factual, accurate, informative announcements and reference material concerning licensed medicines and relating, for example, to pack changes, adverse reaction warnings, trade catalogues and price lists, provided they include no product claims
- price lists relating to unlicensed medicines, provided they include no product claims and they make clear that the products are unlicensed
- information supplied by pharmaceutical companies to national public organisations, such as the National Institute for Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) is exempt from the Code provided the information is factual, accurate and not misleading
- measures or trade practices relating to prices, margins or discounts which were in regular use by a significant proportion of the pharmaceutical industry on 1 January 1993
- summaries of product characteristics
- European public assessment reports
- Risk minimisation material
- UK public assessment reports
- the labelling on medicines and accompanying package leaflets insofar as they are not promotional for the medicines concerned; the contents of labels and package leaflets are covered by regulations
- information relating to human health or diseases provided there is no reference, either direct or indirect, to specific medicines.
- Supplementary information
- Clause 1.2 Replies Intended for Use in Response to Individual Enquiries
- Clause 1.2 Price Lists for Unlicensed Medicines
- Clause 1.2 Risk Minimisation Plans and Material
- Do risk minimisation materials need prescribing information?
- Do the requirements of the Code apply to third parties working on behalf of a pharmaceutical company?
- If a representative gained agreement to deliver approved risk minimisation materials to a health professional and then used this as an opportunity to promote medicines to the health professional would this be acceptable?
- What are examples of forms of sales promotion?
- What is promotion?
1.3 The term ‘medicine’ means any branded or unbranded medicine intended for use in humans which requires a marketing authorization.
1.4 The term ‘health professional’ includes members of the medical, dental, pharmacy and nursing professions and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
1.5 The term ‘other relevant decision makers’ particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.
1.6 The term ‘over-the-counter medicine’ means those medicines or particular packs of medicines which are primarily advertised to the public for use in self medication.
1.7 The term ‘representative’ means a representative calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines.
1.8 The term ‘promotional aid’ means a non-monetary gift made for a promotional purpose.
1.9 The term ‘healthcare organisation’ means either a healthcare, medical or scientific association or organisation such as a hospital, clinic, foundation, university or other teaching institution or learned society whose business address, place of incorporation or primary place of operation is in Europe or an organisation through which one or more health professionals or other relevant decision makers provide services.
1.10 The term ‘transfer of value’ means a direct or indirect transfer of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development or sale of medicines. A direct transfer of value is one made directly by a company for the benefit of a recipient. An indirect transfer of value is one made on behalf of a company for the benefit of a recipient or through an intermediate and where the company knows or can identify the recipent that will benefit from the transfer of value.
1.11 Pharmaceutical companies must comply with all applicable codes, laws and regulations to which they are subject.
1.12 Each company must appoint a senior employee to be responsible for ensuring that the company meets the requirements of the Code.