Clause 9 - High Standards, Format, Suitability and Causing Offence, Sponsorship

Clause

9
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10

Advice

How can photographs of health professionals be used in promotion?
If a dialogue is established upon receipt of a promotional email, is there a requirement to provide both prescribing information and an unsubscribe option with each email response?

9.1 High standards must be maintained at all times.

Supplementary information
Cases

Clauses 9.1 and 9.2 Suitability and Taste
The special nature of medicines and the professional audience to which the material is directed require that the standards set for the promotion of medicines are higher than those which might be acceptable for general commodity advertising.

It follows therefore that certain types, styles and methods of promotion, even where they might be acceptable for the promotion of products other than medicines, are unacceptable. These include:
- the display of naked or partially naked people for the purpose of attracting attention to the material or the use of sexual imagery for that purpose
- ‘teaser’ advertising whereby promotional material is intended to ‘tease’ the recipient by eliciting an interest in something which will be following or will be available at a later date without providing any actual information about it
- the use of inappropriate language abbreviations or emoticons particularly in digital communications
- the provision of private prescription forms preprinted with the name of a medicine.

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9.2 All material and activities must recognise the special nature of medicines and the professional standing of the audience to which they are directed and must not be likely to cause offence.

Cases

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AUTH/3487/3/21 - NHS Commissioning Manager v Sanofi Breach: 2, 8.2, 9.1, 9.2, 15.2 No breach: 8.2, 9.2 Applicable Code: 2019 Received: 22 February 2021 Completed: 12 August 2021 AUTH/3503/4/21 - Complainant v Leo Breach: 2, 3.2, 4.10, 7.2, 7.3, 7.4, 7.9, 7.10, 9.1 No breach: 2, 3.2, 4.1, 4.6, 4.9, 4.10, 7.2, 7.4, 7.6, 7.9, 7.10, 9.1, 9.2, 9.6, 26.1, 26.2 Applicable Code: 2019 Received: 13 April 2021 Completed: 08 December 2022 AUTH/3315/3/20 – Anonymous v Novo Nordisk No breach: 9.1, 9.2, 26.1, 26.2 Applicable Code: 2019 Received: 05 March 2020 Completed: 17 September 2020

9.3 The name or photograph of a member of a health profession must not be used in any way that is contrary to the conventions of that profession.

Advice

What does the requirement that 'the name or photograph of a member of a health profession must not be used in any way that is contrary to the conventions of that profession’ mean? What activity(ies) are we trying to avoid?

9.4 Promotional material must not imitate the devices, copy, slogans or general layout adopted by other companies in a way that is likely to mislead or confuse.

9.5 Promotional material must not include any reference to the Commission on Human Medicines, the Medicines and Healthcare Products Regulatory Agency or the licensing authority, unless this is specifically required by the licensing authority.

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Cases
Advice

Clause 9.5 MHRA Drug Safety Update
Where factual safety information given in promotional material is based on advice in the MHRA Drug Safety Update, the information can be referenced to that publication.

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AUTH/3217/6/19 - Health professional v Otsuka No breach: 4.1, 9.5 Applicable Code: 2019 Received: 19 June 2019 Completed: 09 January 2020

Why can companies not mention the MHRA in materials for a medicine with a conditional licence?

9.6 Reproductions of official documents must not be used for promotional purposes unless permission has been given in writing by the appropriate body.

Cases

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AUTH/3503/4/21 - Complainant v Leo Breach: 2, 3.2, 4.10, 7.2, 7.3, 7.4, 7.9, 7.10, 9.1 No breach: 2, 3.2, 4.1, 4.6, 4.9, 4.10, 7.2, 7.4, 7.6, 7.9, 7.10, 9.1, 9.2, 9.6, 26.1, 26.2 Applicable Code: 2019 Received: 13 April 2021 Completed: 08 December 2022

9.7 Extremes of format, size or cost of material must be avoided.

Informational or educational materials must be inexpensive, directly relevant to the practice of medicine or pharmacy and directly beneficial to the care of patients.

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Cases
Advice

Clause 9.7 Extremes of Format, Size or Cost
Particular care needs to be taken in this regard in the first six months following the launch of a medicine to avoid criticism of the industry.

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AUTH/3488/3/21 - Complainant v AstraZeneca Breach: 4.1, 4.3, 4.4, 9.1, 14.1 No breach: 2, 4.3, 7.2, 7.4, 7.9, 7.10, 9.1, 9.7, 26.1, 26.2, 28.1 Applicable Code: 2019 Received: 10 March 2021 Completed: 29 September 2021

9.8 Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the public, contrary to Clause 26.1.

Supplementary information
Cases

Clause 9.8 Reply Paid Cards
Reply paid cards which are intended to be returned to companies through the post and which relate to a prescription only medicine should not bear both the name of the medicine and information as to its usage but may bear one or the other.

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AUTH/3389/9/20 - Voluntary admission by Sandoz Breach: 9.1, 9.8, 26.1 Applicable Code: 2019 Received: 30 September 2020 Completed: 12 March 2021 AUTH/3334/4/20 - Health professional v Rayner Breach: 2, 9.1, 9.8, 26.1 Applicable Code: 2019 Received: 21 April 2020 Completed: 03 July 2020

9.9 The telephone, text messages, email, telemessages, facsimile, automated calling systems and other electronic data communications must not be used for promotional purposes, except with the prior permission of the recipient.

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Cases
Advice

Clause 9.9 Unsubscribing to emails
Where permission to use emails for promotional purposes has been given by a recipient, each email sent should inform the recipient as to how to unsubscribe to them.
Clause 9.9 Responding to emails
An unsolicited enquiry received by email or an unsolicited enquiry received by post which includes an email address can be responded to by email without specific permission, consent to do so being implied in such circumstances. There is no need to inform recipients as to how to unsubscribe to an email response to an enquiry.
Clause 9.9 Remote Detailing
When promotion is carried out remotely, such as by telephone call, web chat or other online calls, prior permission from the recipient must be obtained in advance or at the start of the contact or call. In setting up the contact or call, full details must be given of the company the caller will represent, their role and the purpose of the call. Arrangements made to discuss a specific product should be adhered to.

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AUTH/3344/5/20 - Health Professional v Britannia Breach: 9.1, 9.9, 11.3, 15.2 No breach: 9.1 Applicable Code: 2019 Received: 04 May 2020 Completed: 02 December 2020 AUTH/3451/1/21 - Complainant v Teva Breach: 2, 3.2, 4.1, 4.6, 4.9, 9.1, 28.1 No breach: 2, 4.1, 4.2, 4.6, 4.9, 9.1, 9.9, 12.1, 14.1, 26.2, 26.3, 28.1, 28.3 Applicable Code: 2019 Received: 05 January 2021 Completed: 02 December 2021 AUTH/3275/10/19 - Britannia v Ever Pharma Breach: 3.2, 7.2, 7.3, 7.4, 7.10 No breach: 2, 4.3, 7.2, 7.4, 7.8, 8.1, 9.1, 9.9, 12.1, 14.1, 16.3, 18.1 Applicable Code: 2019 Received: 24 October 2019 Completed: 31 August 2021 AUTH/3471/2/21 - Complainant v Sanofi No breach: 1.11, 9.1, 9.9, 15.2 Applicable Code: 2019 Received: 05 February 2021 Completed: 09 August 2021 AUTH/3409/10/20 - Complainant v Daiichi Sankyo Breach: 2, 3.2, 4.1, 4.3, 4.4, 4.5, 4.8, 4.9, 7.2, 7.3, 7.4, 7.10, 9.1, 14.1 No breach: 9.1, 9.9, 9.10, 11.1, 11.3, 12.1, 14.5, 23.1 , 23.2, 24.1, 24.2, 26.1, 26.2 Applicable Code: 2019 Received: 29 October 2020 Completed: 01 April 2021 AUTH/3161/2/19 - Employee v Leo Pharma Breach: 15.9 No breach: 2, 9.1, 9.9, 14.1, 15.6, 15.9, 19.1, 19.2 Applicable Code: 2016 Received: 19 February 2019 Completed: 18 June 2019

9.10 Material relating to medicines and their uses, whether promotional or not, and information relating to human health or diseases which is sponsored by a pharmaceutical company must clearly indicate that it has been sponsored by that company.

The only exception to this is market research material which need not reveal the name of the company involved but must state that it is sponsored by a pharmaceutical company.

Supplementary information
Cases
Advice

Clause 9.10 Declaration of Sponsorship
The declaration of sponsorship must be sufficiently prominent to ensure that readers of sponsored material are aware of it at the outset. The wording of the declaration must be unambiguous so that readers will immediately understand the extent of the company’s involvement and influence over the material. This is particularly important when companies are involved in the production of material which is circulated by an otherwise wholly independent party, such as supplements to health professional journals.
Clause 9.10 Market Research
Where market research is carried out by an agency on behalf of a pharmaceutical company, the agency must reveal the name of its client to the Prescription Medicines Code of Practice Authority when the Authority requests it to do so. When commissioning market research, a company must take steps to ensure that its identity would be so made known to the Authority should a request for that information be made.

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Interactive 2019 Code

Download 2019 Code

Changes to the 2016 Code and Constitution and Procedures