Clause 24 Contracted Services

Health professionals, other relevant decision makers or their employers on their behalf, healthcare organisations, patient organisations, individuals representing patient organisations, and members of the public, including patients and journalists, may be used as consultants and advisors, whether in groups or individually, for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, writing articles and/or publications, participation at advisory board meetings, and participation in market research where such participation may involve remuneration and/or hospitality.

(23.1 and 27.8) The arrangements which cover genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfil all the following criteria:

• a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services

• a legitimate need for the services must be clearly identified and documented in advance of requesting the services and entering into arrangements

• the criteria for selection must be directly related to the identified need and the persons responsible for selection must have the expertise necessary to evaluate whether the particular contracted individuals and/or organisations meet those criteria

• the number of contracted individuals and/or organisations retained and the extent of the service must not be greater than the number reasonably necessary to achieve the identified need

• the contracting company must maintain records concerning, and make appropriate use of, the services provided

• the hiring of the contracted party to provide the relevant service must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine

• the remuneration for the services must be reasonable and reflect the fair market value of the services provided. Token consultancy arrangements must not be used to justify compensating the contracted party

• in their written contracts or agreements, companies must include provisions regarding the obligation of the individual to:

• declare that they are a contracted individual to the company whenever they write or speak in public about a matter that is the subject of the agreement or any other issue relating to that company

• similarly, companies that employ, on a part-time basis, health professionals who are still practising their profession, must ensure that such persons are obliged to declare their employment arrangement with the company whenever they write or speak in public about a matter that is the subject of the employment or any other issue relating to that company.

(21) Contracts between companies and health professionals, other relevant decision makers or their employers on their behalf, healthcare organisations, patient organisations, individuals representing patient organisations, and members of the public, including patients and journalists under which they provide any type of service (not otherwise covered by the Code) to companies are allowed providing such services:

• are provided for the purpose of supporting healthcare, research or education; and

• do not constitute an inducement to recommend and/or, prescribe, purchase, supply, sell or administer a specific medicine.

(23.2) Pharmaceutical companies must publicly disclose annually details of the fees and expenses paid to UK individuals, organisations etc for contracted services such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. Such disclosure includes payments in relation to research and development work, including the conduct of clinical trials.

(23.3) In addition to the information required to be made public by Clause 24.4, companies must publicly disclose annually details of payments made to contracted individuals in relation to market research (unless the company concerned does not know the identities of those participating in the market research).

(23.4 and part of Clause 27.8) Fees, expenses and the like due to contracted individuals/organisations in relation to Clauses 24.3, 24.4 and 24.5 must be disclosed.

The relevant disclosure requirements are:

• fees and expenses paid for contracted services between companies and institutions, organisations or associations of health professionals

• fees and expenses paid for contracted services to health professionals and other relevant decision makers, or to their employers on their behalf

• the disclosure for contracted services provided by each patient organisation must include:

• the total amount paid per patient organisation per calendar year, including 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

• fees and expenses should be disclosed separately

• the disclosure for contracted services provided by members of the public, including patients and journalists, must include:

• the total number of members of the public contracted to perform services, the total amount paid to members of the public per calendar year 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

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

In addition, companies should disclose fees and expenses separately.

Contracts for UK individuals representing patient organisations should be made with the patient organisation and disclosed against the patient organisation as set out in Clause 29.