Clause 24 - Relationships with Patient Organisations

Clause

24.1 Pharmaceutical companies can interact with patient organisations or any user organisation such as disability organisations, carer or relative organisations and consumer organisations to support their work, including assistance in the provision of appropriate information to the public, patients and carers.

Companies must respect the independence of patient organisations.

24.2 When working with patient organisations, companies must ensure that the involvement of the company is made clear and that all of the arrangements comply with the Code. This includes the need to declare sponsorship (Clause 24.9) and the prohibition on advertising prescription only medicines to the public (Clause 23.1). The requirements of Clause 19, which covers meetings for health professionals and appropriate administrative staff, also apply to pharmaceutical companies supporting patient organisation meetings.

  • Clause 24.2 Purpose of Materials and Activities

    Companies should take into account the purpose of materials and/or activities. The purpose of information supplied to a patient organisation must be made clear. For example, there is a difference between providing information to be supplied to the members of a patient organisation and providing background information to enable a patient organisation to respond to a health technology assessment or similar.

  • Clause 24.2 Hospitality for Carers

    Although the requirements in Clause 19 relating to the provision of hospitality at meetings apply where pharmaceutical companies support patient organisation meetings and their representatives, in exceptional circumstances, in the case of clear health needs such as disability, companies can pay for subsistence, accommodation, genuine registration fees and reasonable travel costs for an accompanying carer.

24.3 Companies working with patient organisations must have in place a written agreement setting out exactly what has been agreed, including funding, in relation to every significant activity or ongoing relationship.

  • Clause 24.3 Written Agreements

    The written agreement must include:

    • the name of the activity
    • the names of the organisations involved (pharmaceutical company, patient organisations and any third parties which will be brought in to help)
    • the type of activity (eg unrestricted grant, specific meeting or publication etc)
    • the objectives
    • the respective roles of the company and the patient organisation
    • the time-frame
    • the amount of funding
    • a description of significant indirect/non-financial support (eg the donation of public relations agency time or free training courses)
    • a statement that all parties are fully aware that sponsorship must be clearly acknowledged and apparent from the start
    • the code or codes of practice which will apply
    • the signatories to the agreement
    • the date of the agreement.

    Attention is drawn to the certification requirements as set out in Clause 14.3.

24.4 No company may require that it be the sole funderof a patient organisation or any of its programmes.

24.5 A company must not make public use of a patient organisation’s logo or proprietary material without the organisation’s written agreement. In seeking such permission, the specific purpose and the way in which the logo or material will be used must be clearly stated.

24.6 A company must not seek to influence the text of patient organisation material in a manner favourable to its own commercial interests. This does not preclude a company from correcting factual inaccuracies.

24.7 Each company must make publicly available, at a national or European level, a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support, which must include a description of the nature of the support that is sufficiently complete to enable the average reader to form an understanding of the significance of the support. The list of organisations being given support must be updated at least once a year.

The published information must include the monetary value of financial support and of invoiced costs. For significant non-financial support that cannot be assigned a meaningful monetary value, the published information must describe clearly the non-monetary value that the organisation receives.

  • Clause 24.7 Further Information

    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. Neither is obligatory.

    Companies are encouraged to be prepared to make available up-to-date information about such activities at any time in response to enquiries.

  • Clauses 24.7 and 24.8 Transfers of Value to Patient Organisations

    Transfers of value to patient organisations made in accordance with Clauses 24.7 and 24.8 are not subject to the requirements relating to transfers of value set out in Clause 21. Clause 21.3 excludes them from its scope.

24.8 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.

24.9 Companies must ensure that their sponsorship is always clearly acknowledged from the outset. The wording of the declaration of sponsorship must accurately reflect the nature of the company’s involvement.

Interactive 2014 Code