Clause 1 - Scope of the Code and Definition of Certain Terms

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.

Activities which are designed to enlarge the market in a particular therapeutic area, such as disease awareness campaigns, are permitted, provided that these are carried out in a manner compatible with the Code.

Joint working with the NHS and others is permitted if carried out in a manner compatible with the Code. The Department of Health definition of joint working and other information including the conduct of joint working is covered in Clause 20 and its supplementary information.

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 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 authorization.

It should be noted that the Medicines and Healthcare products Regulatory Agency’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 authorization for the product.

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.

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 over-the-counter medicines aimed wholly or mainly at persons qualified to prescribe or supply and appropriate administrative staff, where the object of the advertising is to influence sales and/or recommendations to the public.

The provisions of the Code apply in their entirety to the promotion of medicines to other relevant decision makers except where the text indicates otherwise. This would include administrative staff where appropriate. For example, the prescribing information required under Clause 4 must be included in promotional material provided to other relevant decision makers but it is not permissible to provide samples of medicines to them as this is proscribed by Clause 17.1.

Particular attention is drawn to the provisions of Clause 11.1 and the supplementary information to that clause, which concern the appropriateness of promotional material to those to whom it is addressed.

The exemption for replies made in response to individual enquiries from members of the health professions or other relevant decision makers relates to unsolicited enquiries only. An unsolicited enquiry is one without any prompting from the company. In answering an 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 provided the additional information met the requirements of the exemption. A solicited enquiry would be one where a company invites a person to make a request. For example, material offering further information to readers would be soliciting a request for that information. 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 have the appearance of promotional material.

Price lists of 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.

As part of the marketing authorization 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 is exempt from the definition of promotion and 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.

‘Medical representatives’ and ‘generic sales representatives’ are distinguished in the supplementary information to Clause 16.3 relating to examinations for representatives.

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.

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

• transfers of value that are solely related to over-the-counter medicines
• ordinary course purchases and sales of medicines by and between a company and a health professional or a healthcare organisation including certain package deals as defined in the supplementary information to Clause 18.1 Package Deals
• samples of medicines provided in accordance with Clause 17
• transfers of value provided in accordance with Clauses 18.2 and 18.3
• subsistence provided to health professionals in accordance with Clause 22.1.

Pharmaceutical companies must ensure that they comply with all applicable codes, laws and regulations to which they are subject. This is particularly relevant when activities/materials involve more than one country or when a pharmaceutical company based in one country is involved in activities in another country.

Activities carried out and materials used by a pharmaceutical company located in a European country must comply with the national code of that European country as well as the national code of the country in which the activities take place or the materials are used.

Activities carried out and materials used in a European country by a pharmaceutical company located in a country other than a European country must comply with the EFPIA Code as well as the national code of the country in which the activities are carried out and materials are used.

For example a company located in the UK carrying out an activity outside the UK but within Europe, such as in France, must comply with the UK Code and the French Code regardless of whether or not UK health professionals or other relevant decision makers are involved. Conversely a company located in France carrying out an activity in the UK must comply with the ABPI Code regardless of whether or not UK health professionals or other relevant decision makers are involved. Details of the various codes can be found at www.efpia.eu or www.ifpma.org.

By ‘company’ is meant any legal entity that organises or sponsors promotion which takes place within Europe, whether such entity be a parent company (eg the headquarters, principal office, or controlling company of a commercial enterprise), subsidiary company or any other form of enterprise or organisation.

In the event of a conflict of requirements the more restrictive requirements would apply. There is a potential exception with regard to the limits for subsistence set in European countries where the national association is a member of EFPIA and thus covered by EFPIA Codes as referred to in the supplementary information to Clause 22.2.

All international events, that is to say events that take place outside the responsible pharmaceutical company’s home country, must be notified in advance to any relevant local subsidiary or local advice taken.

Companies must take reasonable steps to ensure that any other parties that they commission to design, implement or engage in activities covered by the Code but which do not act on behalf of the company, and are therefore not covered by Clause 1.2, for example joint ventures or licensees, comply with the Code.

There is an assumption that the responsible person is the managing director or chief executive or equivalent unless other formal arrangements have been made within the company.