Clause 1

Question 1

1.1 What does the code apply to?

Answer 1

The code applies to the promotion of medicines to members of the UK HCP and other relevant decision makers. Also applies to a number of areas which are non-promotional inc. info made available to the public about prescription only medicines.

Question 2

1.1 What does the code not apply to?

Answer 2

It does not apply to the promotion of over-the-counter medicines to members of the health profession when the object of that promotion is to encourage their purchase by members of the public.

Question 3

1.2 What does the term promotion mean?

Answer 3

The term promotion means any activity undertaken by a pharma company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.

Question 4

1.2 What is included as promotions

Answer 4

• Journal and direct mail advertising
• Activities of reps inc any electronic printed material used by them
• Supply of samples
• Provision of inducements to prescribe, supply, administer, recommend, buy or sell medicines by the gift, offer or promise of any benefit or bonus, wether in money or in kind.
• The provision of hospitality for promotional purposes.
• The sponsorship of promotional meetings
• The sponsorship of scientific meeting inc payment of travelling and accommodation expenses in connection therewith.
• All other sales promotion in whatever form.

Question 5

1.2 What is not included as promotional?

Answer 5

• Replies made in response to individual enquiries from HCPs or relavent decision makers or in response to specific communications from them whether of enquiry or comment inc 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 catalogue 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 pharma companies to national public organisations is exempt from the code provided the info is factual, accurate and not misleading.
• Measures or trade practices relating to prices, margins or discounts which were in reg use by a significant proportion of the pharma industry on 1st Jan 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 covered , 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 medicine.

Question 6

1.3 What does the term medicine mean?

Answer 6

The term medicine means any branded or unbranded medicine intended for use in humans which required a marketing authorisation.

Question 7

1.4 What does the term health professional mean?

Answer 7

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.

Question 8

1.5 What does the term other relevant decision maker mean?

Answer 8

Particualry 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.

Question 9

1.6 What does the term over-the-counter medicine mean?

Answer 9

Those medicines for particular packs of medicines which are primarily advertised to the public for use in self medication.

Question 10

1.7 What does the term representative mean?

Answer 10

A representative calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines.

Question 11

1.8 What does the term promotional aid mean?

Answer 11

A non-monetary gift made for a promotional purpose.

Question 12

1.9 What does the term healthcare organisation mean?

Answer 12

Means either a healthcare, medical or scientific association or organisation such as a hospital, clinic, foundation, uni or other teaching institute 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.

Question 13

1.10 What does the term transfer if value mean?

Answer 13

Means a direct or indirect transfer of value, wether 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

Question 14

1.11 What should pharmaceutical companies comply with?

Answer 14

Must comply with all applicable codes, laws and regulations to which they are subject.

Question 15

1.12 What should each company appoint a senior employee to be responsible for?

Answer 15

To be responsible for ensuring that the company meets the requirements of the code.

Question 16

(1.1) 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. What does this include?

Answer 16

This includes promotion at meetings for UK residents held outside the UK. Also applies to promotion to UK HCPs and 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.

Question 17

(1.1) Some of the requirements of the code are not necessarily related to promotion, what are examples of these?

Answer 17

Declarations of sponsorship (9.10), clinical trials and non interventional studies (13) certain aspects of the provision of medicines and samples (17) donations, grants and fees for services (19.2, 21) use of consultants (23) provision of information to the public (26) relations with patient organisations (27)

Question 18

(1.1) 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.

Answer 18

For example, an advertisement to doctors for an over the counter medicine does not come within the scope of the code if its purées 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. for other medicines come within the scope of the code.

Question 19

(1.1 Market Extension) Activities which are designed to enlarge the market in a particular therapeutic care, such as disease awareness campaigns, provided these are carried out in a manner compatible with the code… is this permitted or not?

Answer 19

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.

Question 20

(1.1 Joint Working) Is joint working permitted with the NHS if carried out in a manner compatible with the Code?

Answer 20

Joint working with the NHS and others is permitted if carried out in a manner compatible with the Code.

Question 21

(1.1 Journals with an International Distribution) Does the code apply to the advertising of medicines in professional journals with are produced in the UK and/or intended for a UK audience.

Answer 21

The Code applies to the advertising of medicines in professional journals which are produced in the UK and/ or intended for a UK audience.

Question 22

(1.1 Journals with an International Distribution) What identifies the country which a journal is produced?

Answer 22

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 with as the location of the head office of the publisher.

Question 23

(1.1 Advertising to the Public and Advertising Over-the-Counter Medicines to Health Professionals) What code is the promotion of medicines to the public for self medication covered by?

Answer 23

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)

Question 24

(1.1 Advertising to the Public and Advertising Over-the-Counter Medicines to Health Professionals) Who is the PAGB Professional Code for?

Answer 24

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.

Question 25

(1.1 Promotion to Other Relevant Decision Makers) Do the provisions of the code apply to the promotion of medicines to other relevant decision makers?

Answer 25

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.

Question 26

(1.2 Replies Intended for Use in Response to Individual Enquiries) What is the exemption for replies made in response to individual enquires from members of the HPs or other relevant decision makes?

Answer 26

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.

Question 27

(1.2) What is an unsolicited enquiry?

Answer 27

An unsolicited enquiry is one without any promoting from the company. In answering an unsolicited enquiry a company can offer to provide further information. If the acquirer subsequently requests additional information this can be provided and would be exempt from the code provided the additional information met the requirements of the exemptions.

Question 28

(1.2) What is a solicited enquiry?

Answer 28

A solicited enquiry would be one 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.

Question 29

(1.2) What can be done in response to enquiries received on a regular basis?

Answer 29

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.

Question 30

(1.2 Price Lists for Unlicensed Medicines) When can price lists of unlicensed medicines be sent to HCPs or relevant decision makers?

Answer 30

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.

Question 31

(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. Is such approved documentation is exempt from the definition of promotion?

Answer 31

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.

Question 32

(1.9 Healthcare organisations) If a healthcare organisation consists of only one health professional or other relevant decision maker then is it subject to the requirements of the code?

Answer 32

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.

Question 33

(1.10 Excluded Disclosures) Which of the following are not transfer of value for the purposes of the code?

Answer 33

• 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.

Question 34

(1.11 Applicability of Codes) Pharmaceutical companies must ensure that they comply with all applicable codes, laws and regulations to which they are subject. When is this particularly relevant?

Answer 34

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.

Question 35

(1.11) The activities carried out and materials used by a pharmaceutical company located in a European country must comply with what?

Answer 35

They 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.
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.

Question 36

(1.11) The 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 what?

Answer 36

They 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.

Question 37

(1.11) What is meant by company?

Answer 37

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.

Question 38

(1.11) What requirement applies in the event of a conflict of requirements?

Answer 38

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.

Question 39

(1.11) What must all international events be notified of in advance?

Answer 39

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.

Question 40

(1.11) 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 with what?

Answer 40

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.

Question 41

(1.12 Responsible Person) Who is assumed to be the responsible person?

Answer 41

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.