Clause 23 Donations and Grants

Medical and educational goods and services (MEGS) provided under Clause 19 of the 2019 Code are likely to fall under donations in Clause 23 or collaborative working in Clause 20 of the 2021 Code. Companies wishing to continue with ongoing MEGS from 1 July 2021 can do so until 31 December 2021 under the 2021 Code without the need for them to be reclassified as either a donation or as collaborative working and comply with any new requirements as a result of this change. Thus there is a six month transition period for MEGS.

Clause 19.1 do not prevent the provision of donations and grants. They must not be provided to individuals.

The requirement in Clause 23.2 that donations must not bear the name of any medicine does not apply where the donation is an independently produced textbook or journal which includes as part of its texts the names of medicines.

Donations as a good or service may bear a corporate name. The involvement of a pharmaceutical company in such activities must be made clear to those receiving a service. In addition, the involvement of a pharmaceutical company in any services should be made clear to patients. Such involvement should also be clear in any associated materials for patients. Clause 5.5 would apply.

Companies should be clear regarding the role of staff in the provision of donations and grants, particularly the role of representatives. Companies should consider using staff other than representatives. If companies decide to use representatives in relation to donations and grants, then this should be in accordance with the principles set out below:

i. the acceptability of the role of representatives will depend on the nature of the donation or grant and the method of provision

ii. representatives may introduce a donation or no more than a call for grant applications by means of a brief description and/or delivering materials but may not instigate a detailed discussion about the donation or grant at the same time as a call or contact at which products are promoted

iii. if representatives provide, deliver or demonstrate a donation or grant, then this must not be linked in any way to the promotion of products. In order to comply with this, the representative must not carry out both activities at the same call or contact

iv. if, during a promotional call or contact by a representative, a change in medication to one of the company’s products is agreed, the representative may not then offer a donation or grant to facilitate the change in medication as this would be seen as a way for the company to ensure that the agreed change would in fact be made.

In addition, companies should consider the following in relation to donations in the form of a service:

v. the nature of the service provider and the person associated with the provision of the service is important, ie is the service provider a suitably qualified person, such as a health professional? If the service requires patient contact, for example, either directly or by identification of patients from patient records and the like, then representatives must not be involved. Only a suitably qualified person, such as a health professional, not employed as a representative, may undertake activities relating to patient contact and/or patient identification

vi. neither the company nor its representatives may be given access to data/records that could identify, or could be linked to, particular patients

vii. health professionals involved in the delivery of services are required to adhere to all relevant professional standards of conduct (see supplementary information to Clause 10.1). There should be no promotion of specific products by those health professionals

viii. the remuneration of those not employed as representatives but who are engaged to deliver a service as service providers must not be linked to sales in any particular territory or place or to sales of a specific product or products and, in particular, may not include a bonus scheme linked to such sales. Bonus schemes linked to a company’s overall national performance, or to the level of service provided, may be acceptable

ix. service providers must operate to detailed written instructions provided by the company. These should be similar to the briefing material for representatives as referred to in Clause 17.9. The written instructions should set out the role of the service provider and should cover patient confidentiality issues. Instructions on how the recipients are to be informed etc should be included. The written instructions must not advocate, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code

x. service providers must abide by the principle set out in Clause 17.5 that in an interview, or when seeking an appointment, reasonable steps must be taken to ensure that they do not mislead as to their identity or that of the sponsoring pharmaceutical company

xi. a recipient of a service must be provided with sufficient written information to avoid misunderstandings as to what the recipient has agreed. The identity of the sponsoring pharmaceutical company must be given

xii. any material designed for use in relation to the provision of a service must be non-promotional. It is not acceptable for such materials to promote the administration, consumption, prescription, purchase, recommendation, sale, supply or use of the sponsoring company’s medicines. Nor is it acceptable for materials to criticise competitor products as this might be seen as promotional

xiii. material relating to the provision of a service, such as internal instructions, external instructions, the written information for recipients and other material, must be certified as required by Clause 8.3

xiv. a copy of the materials must be made available to the PMCPA on request

xv. companies are recommended to inform relevant NHS or other organisations of their activities where appropriate. This is particularly recommended where companies are proposing to provide a service which would have budgetary implications for the parties involved.

Clauses 19.1 and 23.1 prohibit switch services paid for or facilitated directly or indirectly by a pharmaceutical company whereby a patient’s medicine is simply changed to another. For example, it would be unacceptable if patients on medicine A were changed to medicine B, without any clinical assessment, at the expense of a pharmaceutical company promoting either or both medicines. It would be acceptable for a company to promote a simple switch from one product to another but not to assist a health professional in implementing that switch even by means of a third party.

A therapeutic review is different to a switch service. A therapeutic review which aims to ensure that patients receive optimal treatment following a clinical assessment is a legitimate activity for a pharmaceutical company to support and/or assist. The result of such clinical assessments might require, among other things, possible changes of treatment including changes of dose or medicine or cessation of treatment. A genuine therapeutic review should include a comprehensive range of relevant treatment choices, including non-medicinal choices, for the health professional and should not be limited to the medicines of the sponsoring pharmaceutical company. The decision to change or commence treatment must be made for each individual patient by the prescriber and every decision to change an individual patient’s treatment must be documented with evidence that it was made on rational grounds.

Clause 27.2 sets out the arrangements for patient organisations. The written agreement for donations and grants to other organisations should include:

• description of the donation or grant

• objective of the donation or grant. How it will support healthcare, scientific research or education must also be included

• the names of the organisations/parties involved and their respective roles

• the type of activity and the nature of the company’s contribution

• the time frame

• the amount of funding and/or a description of indirect/non-financial, in-kind donation and the nature of that donation. Where possible a full breakdown of costs should be included

• a statement that all parties are fully aware that the donation or grant must be clearly acknowledged and apparent from the start

• the signatories to the agreement

• the date of the agreement.

Company support of individuals to attend events/meetings is covered by Clause 10.

Details of each donation or grant (transfer of value) must be publicly disclosed annually, giving in each case the financial amount or value and the name of the recipient institution, organisation or association. Companies are also encouraged to ask recipients to make such funding public. Where applicable, fees and expenses should be disclosed separately. Disclosure must be carried out in accordance with Clauses 28 and 29.