What is an expert patient, and how do companies interact with them?

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.

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

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.

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.

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.

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.

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.

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.

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

There is a central platform for disclosure in the UK which companies must use. The template to be used is available from the PMCPA website www.pmcpa.org.uk.

The clauses of the Code noted in Clause 28.2 should be consulted for further information about the requirements. In addition, the requirements of Clauses 10.1 and 10.10 should be borne in mind in relation to meetings.

If when providing sponsorship to a healthcare organisation, institution, other organisation etc in relation to their own event, a company contributes towards the overall cost of subsistence (food and drink), then this must be included in the disclosure of the cost of the sponsorship to the healthcare organisation, institution, other organisation etc. Where a company supports individual health professionals or other relevant decision makers (directly or indirectly) to attend events/meetings, there is no requirement to disclose subsistence (food and drink) as in Clause 10.1.

If an individual health professional or other relevant decision maker receives a number of transfers of value from a company and decides not to agree to disclosure of one or more of those transfers of value, then that company can disclose all of that individual’s transfers of value in its aggregate amount.

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.

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

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.

The arrangements for such services should meet the requirements of Clause 24.

Disclosure must be in the first six months in the calendar year following that in which the payments were made. The information which must be disclosed is the total amount paid in a calendar year to the public, including individual patients, journalists and members of the public who have provided services. The total number of individuals must be given. The names of the individuals need not be disclosed. Companies may, of course, give greater detail, for example, by giving separate figures for different categories of service or by providing details of the maximum and minimum payments etc.

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

All reasonable steps should be taken by companies to similarly disclose their best estimates of fees paid to UK individuals by overseas affiliates, head offices in the UK or overseas and UK-based European offices.

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.

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

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.