Clause 1 Scope of the Code and Definition of Certain Terms

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Clause 1
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1.1

This Code applies to the promotion of medicines to members of the United Kingdom (UK) health professions and to other relevant decision makers. For the purposes of the application of the Code, the UK includes the Channel Islands and the Isle of Man. 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 (OTC) medicines to members of the health professions when the object of that promotion is to encourage their purchase by members of the public.

  • Clause 1.1 Scope of the Code

    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 events/meetings for UK residents held outside the UK. It also applies to promotion to UK health professionals and other relevant decision makers at international events/meetings held outside the UK, except that the promotional material distributed at such events/meetings will need to comply with local requirements. Information on applicability of codes can be found in the supplementary information to Clause 3.4.

    The Code does not apply to the promotion of over-the-counter (OTC) 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 OTC 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 OTC medicines to pharmacists are outside the scope of the Code. Advertisements to pharmacists for other medicines come within the scope of the Code.

    Companies should be aware that if a non-promotional item is used for a promotional purpose, it would come within the definition of promotion. If an item which is covered by regulations such as the summary of product characteristics (SPC) or a patient information leaflet which is included in the pack (PIL) (excluded from the definition of promotion in Clause 1.17) is used for a promotional purpose, then it would come within the scope of the Code.

  • Clause 1.1 Journals with an International Distribution

    The Code applies to the advertising of medicines in professional journals which are produced in the UK and/or intended for a UK audience. The identification of the country in which a journal is ‘produced’ is based on factors such as where it is compiled and edited, and for printed journals, where it is typeset, printed and bound, rather than on factors such as the location of the head office of the publisher.

    International journals which are produced in English in the UK are subject to the Code even if only a small proportion of their circulation is to a UK audience. It is helpful in these circumstances to indicate that the information in the advertisement is consistent with the UK marketing authorisation.

    It should be noted that the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) guidance ‘Advertising and Promotion of Medicines in the UK’, The Blue Guide, differs from the above by advising that advertising material in professional journals intended primarily for circulation in the UK, whether or not in the English language, must comply with UK legislation and with the UK marketing authorisation for the product.

    In addition, where a journal is produced in the UK but intended for distribution solely to overseas countries, local requirements and/or the requirements of the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) Code of Practice should be borne in mind.

  • Clause 1.1 Advertising to the Public and Advertising OTC Medicines to Health Professionals

    The promotion of medicines to the public for self-medication is covered by the Consumer Code of the Proprietary Association of Great Britain (PAGB) (www.pagb.co.uk). The PAGB also has a Professional Code which applies to advertising involving OTC medicines aimed wholly or mainly at persons qualified to prescribe or supply and people working for them, where the object of the advertising is to influence sales and/or recommendations to the public.

  • Clause 1.1 Promotion to Other Relevant Decision Makers

    Particular attention is drawn to Clause 5.7.

1.2

Information or promotional material about medicines 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
• 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.

1.3

‘Collaborative working’ refers to pharmaceutical companies working with other organisations to deliver initiatives which either enhance patient care or are for the benefit of patients or alternatively benefit the National Health Service (NHS) and, as a minimum, maintain patient care. Further details are given in Clause 20.

1.4

‘Contribution to costs related to events’ in relation to the disclosure of transfers of value means providing or covering the costs of travel, accommodation and/or registration fees to support the attendance of an individual to an event organised or created by a company and/or independent organisation. When providing sponsorship of events/meetings to organisations, associations, etc. such contributions may include costs for subsistence (food and drink).

1.5

‘Donations and grants’ collectively mean providing funds, benefits-in-kind or services freely given for the purpose of supporting healthcare, scientific research or education, with no consequent obligation on the recipient organisation, institution and the like to provide goods or services to the benefit of the pharmaceutical company in return. Donations and grants to individuals are prohibited.

In general, donations are physical items, services or benefits-in-kind which may be offered or requested. Grants are the provision of funds.

1.6

‘Europe’ comprises those countries that are within the European Union and other countries with a trade association that is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

1.7

‘Events’ includes all professional, promotional, scientific and educational meetings, congresses, conferences, symposia, and other similar events (including, but not limited to, advisory board meetings, visits to research or manufacturing facilities, and planning, training or investigator meetings for clinical trials and non-interventional studies) organised or sponsored by or on behalf of a company (further examples can be found in the supplementary information to Clause 10.1).

1.8

‘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.

If a healthcare organisation consists of only one health professional or other relevant decision maker, then it would be subject to the requirements in the Code regarding individual health professionals.

1.9

‘Health professional’ includes any member of the medical, dental, pharmacy or nursing profession and any other person who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine. In relation to the annual disclosure of transfers of value (Clause 28), the term also includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional.

1.10

‘Hospitality’ is limited to travel, subsistence (food and drink), accommodation and genuine registration fees extended in connection with events/meetings.

1.11

‘Medicine’ means any branded or unbranded medicine intended for use in humans which requires a marketing authorisation.

1.12

‘Non-interventional study’ is defined as a study of a marketed medicine where the medicine is prescribed in the usual manner in accordance with the terms of its marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided by a study protocol but falls within current practice, and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collected data.

1.13

‘Other relevant decision maker’ particularly includes someone 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 is not a health professional.

1.14

‘Over-the-counter medicine’ (OTC) means a medicine or particular pack of medicine which is primarily advertised to the public for use in self-medication.

1.15

‘Patient organisation’ means an organisation mainly comprised of patients and/or caregivers or any user organisation such as a disability organisation, carer or relative organisation and consumer organisation that represents and/or supports the needs of patients and/or caregivers.

1.16

‘Individual representing a patient organisation’ means a person who is mandated to represent and express the views of a patient organisation.

1.17

‘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 events/meetings

• the sponsorship of scientific events/meetings, including payment of travelling and accommodation expenses in connection therewith

• all other promotion.

It does not include:

• replies made in response to unsolicited 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

• UK public assessment reports

• risk minimisation material approved by the Medicines and Healthcare products Regulatory Agency (MHRA)

• 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 direct or indirect reference to specific medicines.

  • Clause 1.17 Replies Intended for Use in Response to Individual Enquiries

    An unsolicited enquiry is one without any prompting from the company. In answering any unsolicited enquiry, a company can offer to provide further information. If the enquirer subsequently requests additional information, this can be provided and would be exempt from the Code as long as the additional information met the requirements of the exemption. A solicited enquiry would be one where a company invites or prompts a person to make a request. For example, material offering further information to readers would be soliciting a request for that information and placing documents on exhibition stands amounts to an invitation to take them; neither can take the benefit of this exemption.

    Replies intended for use in response to enquiries which are received on a regular basis may be drafted in advance provided that they are used only when they directly and solely relate to the particular enquiry. Documents must not look like promotional material.

  • Clause 1.17 Terms of Trade

    See supplementary information to Clause 19.1.

  • Clause 1.17 Price Lists for Unlicensed Medicines

    Price lists for unlicensed medicines which include no product claims and make clear that the products are unlicensed can be sent to health professionals and other relevant decision makers at reasonable intervals or in response to enquiries. They must not be used proactively in a manner which could be seen to be promoting unlicensed medicines, such as by displaying them on exhibition stands.

  • Clause 1.17 Risk Minimisation Plans and Material

    As part of the marketing authorisation process, companies can be required to have risk minimisation plans and material approved by the MHRA as part of the company’s pharmacovigilance obligations. Such approved documentation can be delivered by a representative or included on a company website without being considered to be promotion of the medicine to which it refers.

1.18

‘Promotional aid’ means a non-monetary item given for a promotional purpose. Promotional aids may be given to health professionals and other relevant decision makers only in accordance with Clause 10.5. Health professionals may, however, be provided with items which are to be passed on to patients in accordance with Clause 19.2.

1.19

‘Representative’ means a representative calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines.

1.20

‘Research and development transfers of value’ means, for the purposes of disclosure, transfers of value to health professionals or healthcare organisations related to the planning or conduct of:

i. non-clinical studies (as defined in the OECD Principles of Good Laboratory Practice)
ii. clinical trials (as defined in Regulation 536/2014)
iii. non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual or groups of health professionals specifically for the study.

1.21

‘Sample’ means a small supply of a medicine provided to health professionals so that they may familiarise themselves with it and acquire experience in dealing with it. A sample of a medicine may be provided only to a health professional qualified to prescribe that particular medicine.

1.22

A company can provide sponsorship for an activity to certain organisations. ‘Sponsorship’ means a contribution, financial or otherwise, in whole or in part provided by or on behalf of a company, towards an activity (including an event/meeting or material) performed, organised, created, etc. by a healthcare organisation, patient organisation or other independent organisation.

1.23

A company can provide support for individual health professionals or other relevant decision makers to attend events/meetings. ‘Support’ in this context is the provision of a financial contribution, in whole or in part, whether paid directly or indirectly to individual health professionals or other relevant decision makers to attend events/meetings.

1.24

‘Third party’ means a legal person/entity or individual that represents a company or interacts with other parties on behalf of a company or relating to a company’s medicine, such as distributors, wholesalers, consultants, contract research organisations, professional congress organisers, contracted sales forces, market research companies, advertising agencies, media buyers, providers of services related to events, public relations services, non-clinical services, non-interventional studies management services, etc.

Companies are responsible under the Code for the acts and omissions of their third parties which come within the scope of the Code, even if they act contrary to the instructions which they have been given.

1.25

‘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 recipient that will benefit from the transfer of value.

The following are not transfers of value for the purposes of the Code:

• transfers of value that are solely related to OTC medicines

• ordinary course purchases and sales of medicines by and between a company and a health professional or a healthcare organisation

• samples of medicines provided in accordance with Clause 21

• transfers of value provided in accordance with Clauses 10.5, 10.6 and 19.2

• subsistence provided to health professionals and other relevant decision makers in accordance with Clause 10.1.