Clause 1 - Scope of the Code and Definition of Certain Terms
- How does the Code fit in with UK law?
- What are the relevant requirements for meetings when UK health professionals/other relevant decision makers attend a company organised meeting outside the UK as delegates?
- What does the Code cover?
- What is self regulation within the pharmaceutical industry?
- What is the aim of the Code?
- What is the definition of a sample?
- What is the difference between the ABPI and the PMCPA?
- What is the spirit of the Code?
- When referring to general research can companies link to ClinicalTrials.gov, eg provide the number of years of research in a stated therapeutic area and the number of patients involved in trials?
- Why are there requirements within the ABPI Code that go beyond UK law and the European Federation of Pharmaceutical Industries and Associations/ International Federation of Pharmaceutical Manufacturers and Associations Codes?
- Why is self-regulation important to the pharmaceutical industry?
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.
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 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
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 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.
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 Other Relevant Decision Makers
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.
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.
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 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.
Clause 1.2 Price Lists for Unlicensed Medicines
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.
Clause 1.2 Risk Minimisation Plans and Material
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.
- Are patient case studies promotional?
- 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?
- Provide some examples of Risk Minimisation Materials?
- What are examples of forms of sales promotion?
- What are risk minimisation measures?
- What is promotion?
- Why are regional public organisations not included in the exemptions for NICE, SMC, AWMSG?
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.
Clause 1.7 Representatives
‘Medical representatives’ and ‘generic sales representatives’ are distinguished in the supplementary information to Clause 16.3 relating to examinations for representatives.
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.
Clause 1.9 Healthcare Organisations
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.
1.10 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 recipient that will benefit from the transfer of value.
Clause 1.10 Excluded Disclosures
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.
1.11 Pharmaceutical companies must comply with all applicable codes, laws and regulations to which they are subject.
Clause 1.11 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 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.
- What are the requirements for materials and activities initiated and developed by teams with global or regional headquarters in the UK which are not directed at UK health professionals?
- When a conflict of requirements in different country codes happens the most stringent is always applied. Where is this set out in the ABPI Code and are there any situations where this is not so?
- Why does the Code not specifically mention other relevant laws such as the General Data Protection Requirement?
1.12 Each company must appoint a senior employee to be responsible for ensuring that the company meets the requirements of the Code.
Clause 1.12 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.