Do the requirements for consultants apply when contracting with patients, journalists etc? If not why not?

  • 23

    Clause 23 - The Use of Consultants

    ​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, 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 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 Supplementary information
    • Guidance
    • 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

    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.

    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).

    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.

     

  • 23.1

    ​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, 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 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.
  • 27.8

    27.8 Contracts between companies and patient organisations under which they provide any type of services to companies are only allowed if such services are provided for the purpose of supporting healthcare or research.

    Patient organisations may be engaged as experts and advisors for services such as participation at advisory board meetings and speaker services. The arrangements that cover 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 the arrangements
    • the criteria for selecting services must be directly related to the identified need and the persons responsible for selecting the service must have the expertise necessary to evaluate whether the particular experts and advisors meet those criteria
    • the extent of the service must not be greater than is reasonably necessary to achieve the identified need
    • the contracting company must maintain records concerning, and make appropriate use of, the services
    • the engaging of patient organisations must not be an inducement to recommend a particular medicine
    • the compensation for the services must be reasonable and not exceed the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating patient organisations
    • in their written contracts with patient organisations, companies are strongly encouraged to include provisions regarding an obligation of the patient organisation to declare that they have provided paid services to the company whenever those concerned write or speak in public about a matter that is the subject of the agreement or any other issue relating to that company
    • each company must make publicly available, at a national or European level, a list of patient organisations that it has engaged to provide significant contracted services, which must include a description of the nature of the services provided that is sufficiently complete to enable the average reader to form an understanding of the arrangement without the necessity to divulge confidential information. Companies must also make publicly available the total amount paid per patient organisation over the reporting period. The list of organisations engaged must be updated at least once a year.

Clause 23 is limited to employing health professionals and other relevant decision makers as consultants. Companies would be well advised to apply the relevant principles in Clause 23.1 to contracting with patients, journalists etc. as they are not currently covered by this clause which is based on EFPIA requirements. Clause 27.8 covers contracts between companies and patient organisations under which they provide any type of services to companies.