Clause 23 - The Use of Consultants
23 Use of Consultants
The term ‘consultant’ in Clause 23 covers any health professional or other relevant decision maker consulted for the purposes described in Clause 23 regardless of their normal roles.
Other relevant decision makers covered by Clause 23 are those who could influence in any way the prescription, supply, administration, recommendation, purchase or sale of any medicine.
Clause 23 Patient Organisations
The provision of services to pharmaceutical companies by patient organisations is covered by Clause 27.8.
23.1 Health professionals and other relevant decision makers 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, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The arrangements which cover these genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfill 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 in advance of requesting the services and entering into arrangements with the prospective consultants
- the criteria for selecting consultants must be directly related to the identified need and the persons responsible for selecting the consultants must have the expertise necessary to evaluate whether the particular consultants meet those criteria
- the number of consultants retained 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 by consultants
- the hiring of the consultant to provide the relevant service must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
- the compensation for the services must be reasonable and reflect the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating health professionals and other relevant decision makers
- in their written contracts or agreements with consultants, companies must include provisions regarding the obligation of the consultant to declare that he/she is a consultant to the company whenever he/she writes or speaks 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 that 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.
Clause 23.1 The Use of Consultants
The requirement that contracts or agreements with consultants must include provisions regarding their obligation to declare the arrangement whenever they write or speak in public applies to contracts entered into or renewed on or after 1 May 2011. If health professionals or other relevant decision makers attend events in a consultant or advisory capacity the relevant provisions of Clause 22 apply.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
23.2 Pharmaceutical companies must publicly disclose details of the fees paid to consultants in the UK, or to their employers on their behalf, for certain services rendered by them such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. It includes payments to consultants in relation to research and development work, including the conduct of clinical trials.
Clause 23.2 Disclosure
The information required by Clause 23.2 must be publicly disclosed in respect of the calendar year 2015 and each calendar year thereafter.
Disclosure must be carried out in accordance with Clause 24.
The information which must be disclosed is the total amount paid in a calendar year to each consultant who has provided services. Companies may, of course, give greater detail, for example by giving separate figures for different categories of service.
Fees and agreed expenses should be disclosed separately.
The names of the consultants 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.
Clause 23.2 Research and Development Transfers of Value
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:
- non-clinical studies (as defined in the OECD Principles of Good Laboratory Practice)
- clinical trials (as defined in Directive 2001/20/EC)
- non-interventional studies that are prospective in nature and involve the collection of 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.
23.3 In addition to the information required to be made public by Clause 23.2, companies must publicly disclose details of payments made to consultants in relation to market research (unless the company concerned is not aware of the identities of those participating in the market research).
Clause 23.3 Disclosure
Clause 23.3 relates only to market research using consultants where the pharmaceutical company knows the identity of the consultants. 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.
23.4 Fees, expenses and the like due to consultants in relation to Clauses 23.2 and 23.3 must be disclosed whether paid directly to them or to their employers or to healthcare organisations or to companies or charities etc.