Should Transfers of Value to patient organisations be disclosed on Disclosure UK?

  • Clause 23 Medical and Educational Goods and Services which Comply with Clause 19 of the 2019 ABPI Code, Including their Transition under the 2021 ABPI Code

    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 23 (19.1) Donations and Grants

    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.

  • Clause 23 (19.1) Switch and Therapy Review Programmes

    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 23.2 Written Agreements

    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.

  • Clause 23.2 (19.2) Annual Disclosure of Donations and Grants

    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

  • Clause 24.1 Contracted Services with Members of the Public, Including Patients and Journalists

    Only certain services provided by members of the public, including patients and journalists, are covered by the Code; others are clearly outside the scope of the Code. The services covered by the Code generally relate to healthcare, disease or medicine. Providing advice with regard to the design of clinical trials would be an included contracted service whereas being a participant in a clinical trial would not.

    The transparency of contracted services with members of the public, including patients and journalists, is the next step in evolving disclosures made by pharmaceutical companies. The arrangements are similar to those used when disclosure for health professionals was introduced. The introduction of requirements for contracted services with the public, including patients and journalists, was thought necessary following publication of the EFPIA document ‘Working together with patients – principles for remunerating patients, patient organisation representatives and carers for work undertaken with the pharmaceutical industry’  in June 2019.

  • Clause 24.1 (23.1) Contracted Individuals

    The relevant provisions of Clause 10 apply to contracted individuals’ attendance at events/meetings.

  • Clause 24.5 (23.3) Annual Disclosure of Transfers of Value of Market Research

    Clause 24.5 relates only to market research using contracted individuals where the pharmaceutical company knows the identity of the contracted individuals. This is because the focus of the requirements concerning transparency is on areas where there are direct relationships between the parties and that is not so where the company does not know the identity of the participants.

  • Clause 24.6 (23.2) Annual Disclosure of Transfers of Value to UK Health Professionals and Other Relevant Decision Makers or their Employers on their Behalf

    Disclosure must be carried out in accordance with Clause 28.

    The information which must be disclosed is the total amount paid in a calendar year to each contracted individual who is a health professional or other relevant decision maker and has provided services. Companies may of course give greater detail, for example, by giving separate figures for different categories of service.

    The names of these contracted individuals must be disclosed except in relation to payments in relation to research and development work, including clinical trials, as defined below, where disclosure should be on an aggregate basis.

    Fees and expenses should be disclosed separately.

  • Clause 24.6 (23.2) Annual Disclosure of Transfers of Value in Relation to Contracted Services Provided by Patient Organisations or Individuals Representing Patient Organisations

    Disclosure must be carried out in accordance with Clause 29.

    A payment to an individual representing a patient organisation should be disclosed as a payment to that patient organisation. This means that the contract should also be with the patient organisation.

    The information which must be disclosed is the total amount paid per patient organisation over the reporting period and a description of the services provided that is sufficiently complete to enable the reader to understand the nature of the services provided without the necessity to divulge confidential information. This information should include contracted services provided by individuals representing patient organisations.

    Fees and expenses should be disclosed separately.

  • Clause 24.6 (23.2) Annual Disclosure of Transfers of Value in Relation to Contracted Services by Members of the Public, Including Patients and Journalists

    Disclosure must be carried out in accordance with Clauses 30 and 31.

    The information which must be disclosed is the total amount paid to members of the UK public over the reporting period, including the number of individuals contracted and a description of the types of services provided that is sufficiently complete to enable the reader to understand the nature of the services provided without the necessity to divulge confidential information.

    Companies should provide a breakdown of the total payments to each group of individuals, ie the public, patients and journalists, without the necessity to divulge confidential information.

    Fees and expenses should be disclosed separately.

  • Clause 24.6 (23.2) Annual Disclosure of Transfers of Value of Research and Development

    For the purpose of disclosure, research and development transfers of value are transfers of value to health professionals or healthcare organisations related to the planning or conduct of:

    i) non-clinical studies (as defined in the OECD Principles on Good Laboratory Practice)

    ii) clinical trials (as defined in Regulation 536/2014)

    iii) non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual or groups of health professionals specifically for the study.

    Costs that are subsidiary to these activities can be included in the aggregate amount.

  • Clause 27.3 (27.2) Purpose of Materials and Activities

    Companies should take into account the purpose of materials and/or activities. The purpose of information supplied to a patient organisation must be made clear. For example, there is a difference between providing information to be supplied to the members of a patient organisation and providing background information to enable a patient organisation to respond to a health technology assessment or similar.

  • Clause 27.4 (27.6) Contributing to Patient Organisation Material

    At the request of patient organisations, companies may contribute to the drafting of patient organisation materials from a fair and balanced and scientific perspective.

  • (24.1) Lawful Disclosure

    Companies must ensure that they have appropriate arrangements in place to lawfully disclose information about transfers of value and that recipients are aware of the process for disclosure.

  • (24.1) Transfers of Value

    Disclosure is required even if the payments etc are made by overseas affiliates, head offices in the UK or overseas and UK-based offices.

  • Clause 29.1 (27.7) Further Information

    An indication of the patient organisation’s total income and/or the company’s support as a percentage of the patient organisation’s total income may be given. Companies are encouraged to be prepared to make available up-to-date information about such activities at any time in response to enquiries.

    A template to disclose the information required in relation to patient organisations is available from the Prescription Medicines Code of Practice Authority (PMCPA) website www.pmcpa.org.uk. The use of this template is optional.

  • Clause 31.1 (New) Date of Implementation for Disclosure of Contracted Services Provided by the Public, Including Patients and Journalists

    The information required by Clause 30 must be publicly disclosed annually in respect of transfers of value made in 2022 and each calendar year thereafter.

A new function was launched in June 2021 on the Disclosure UK platform which provides a gateway for links to companies published patient organisation disclosure data.  This function is optional for companies. 

The disclosure requirements for patient organisations is set out in Clause 29.   This information must be disclosed on the company website either on a national or European level. Each reporting period shall cover a full calendar year.

Each company must include a note of methodologies used by it in preparing the disclosures and identifying support and contracted services provided.

 A template to disclose the information required in relation to patient organisations is available from the publications section of the PMCPA website www.pmcpa.org.uk. The use of this template is optional.