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 Clause 20 - The Use of Consultants

20.1 Health professionals and appropriate administrative staff 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 appropriate administrative staff
  • 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.

20.2 Pharmaceutical companies must make publicly available 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 does not include payments to consultants in relation to research and development work, including the conduct of clinical trials. Nor does it include payment of UK travel costs or the cost of subsistence in relation to fees for services which are dealt with in Clause 20.3.

20.3 In addition to the information required to be made public by Clause 20.2, companies must make publicly available 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) and payments in respect of accommodation (both in and outside the UK) and travel outside the UK in relation to fees for services as defined in Clause 20.2.

20.4 Fees, expenses and the like due to consultants in relation to Clauses 20.2 and 20.3 must be declared whether paid directly to them or to their employers or to companies or charities etc.

​Clause 20 Supplementary Information

Clause 20 The Use of Consultants

The term ‘consultant’ in Clause 20 covers any health professional or administrative staff member consulted for the purposes described in Clause 20 regardless of their normal roles.

The administrative staff members covered by Clause 20 are those who could influence in any way the prescription, supply, administration, recommendation, purchase or sale of any medicine.

Clause 20 Patient Organisations

The provision of services to pharmaceutical companies by patient organisations is covered by Clause 23.8.

Clause 20.1 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. Companies are encouraged to renegotiate existing contracts to include such provisions at their earliest convenience.

Limited market research, such as one-off telephone interviews or mail/email/Internet questionnaires is excluded from the scope of Clause 20.1, provided that the consultant is not consulted in a recurring manner (either with respect to the frequency of the calls generally or of calls relating to the same research) and that the remuneration is minimal. Following implementation of Clause 20.3 payments made in relation to this limited market research must be made publicly available in accordance with that clause.

If health professionals or appropriate administrative staff attend events in a consultant or advisory capacity the relevant provisions of Clause 19 apply.

Clause 20.2 Disclosure

The information required by Clause 20.2 must be made publicly available in respect of payments made to UK consultants in 2012 and each calendar year thereafter. Disclosure must be in the calendar year following that in which the payments were made and the information must be made public within three calendar months of the end of the company’s financial year.

The information which must be disclosed is the total amount paid in a calendar year to all of the consultants who have provided services. The total number of consultants must be given. The names of the consultants 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.

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

Clause 20.3 Disclosure

Clause 20.3 relates only to market research using consultants whose identity is known to the pharmaceutical company. 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. The names of the consultants need not be disclosed.

The information required by Clause 20.3 in respect of payments made to UK consultants in 2013 and each calendar year thereafter must be made publicly available by including it in the fees for service declaration required by Clause 20.2 and its supplementary information.