1.1 This Code applies to the promotion of medicines to members of the United Kingdom health professions and to appropriate administrative staff.
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.
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 does not include:
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 ‘over-the-counter medicine’ means those medicines or particular packs of medicines which are primarily advertised to the public for use in self medication.
1.6 The term ‘representative’ means a representative calling on members of the health professions and administrative staff in relation to the promotion ofmedicines.
1.7 The term ‘promotional aid’ means a non-monetary gift made for a promotional purpose.
1.8 Pharmaceutical companies must comply with all applicable codes, laws and regulations to which they are subject.
1.9 Each company must appoint a senior employee to be responsible for ensuring that the company meets the requirements of the Code.
Clause 1.1 Scope of the Code
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 appropriate administrative staff 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 administrative staff 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, 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 18.6 and 18.7, the use of consultants in Clause 20, the provision of information to the public in Clause 22 and relations with patient organisations in Clause 23.
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
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.
Clause 1.1 Joint Working
Joint working with health authorities and trusts and the like is permitted if carried out in a manner compatible with the Code.
Joint working is where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery.
The Department of Health has issued to the NHS Best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations. A toolkit, Moving beyond sponsorship: joint working between the NHS and the pharmaceutical industry has been issued by the Department of Health and the ABPI. The ABPI has produced guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients.
The conduct of joint working is dealt with in Clause 18.5 and its supplementary information.
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 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.
Clause 1.1 Advertising to the Public and Advertising Over-the-Counter 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 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.
Clause 1.1 Promotion to Administrative Staff
The provisions of the Code apply in their entirety to the promotion of medicines to appropriate administrative staff except where the text indicates otherwise. For example, the prescribing information required under Clause 4 must be included in promotional material provided to administrative staff 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.
Clause 1.2 Replies Intended for Use in Response to Individual Enquiries
The exemption for replies made in response to individual enquiries from members of the health professions or appropriate administrative staff 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 appropriate administrative staff 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 1.6 Representatives
‘Medical representatives’ and ‘generic sales representatives’ are distinguished in Clause 16.4 relating to examinations for representatives.
Clause 1.8 Applicability of Codes
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 appropriate administrative staff 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 appropriate administrative staff are involved. Details of the various codes can be found at www.efpia.org 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.
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.
Clause 1.9 Responsible Person
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.