Clause 27 Relationships with Patient Organisations

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Clause 27
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27

  • Clause 27 Relationships with Patient Organisations

    Relationships between pharmaceutical companies and patient organisations are generally covered by the pharmaceutical company providing a donation, grant or sponsorship to the patient organisation or the patient organisation providing a contracted service to the company. In the event that arrangements with the patient organisation do not fall within these categories then the pharmaceutical company needs to satisfy itself that the activity complies with all of the requirements of the Code, including but not limited to Clauses 27 and 29.

27.1

When pharmaceutical companies interact with patient organisations or any user organisations such as disability organisations, carer or relative organisations and consumer organisations, companies must:

• respect the independence of the organisations

• assure the independence of the organisations, in terms of their political judgement, policies and activities

• ensure relationships are based on mutual respect, with the views and decisions of each partner having equal value

• not promote or request the promotion of a particular prescription only medicine

• ensure the objectives and scope are transparent and support provided by companies must always be clearly acknowledged.

27.2

When companies provide donations, grants or sponsorship (including in relation to events/meetings) to patient organisations as set out in Clauses 23.2 and 10, companies must have a written agreement in place for each donation, grant or sponsorship setting out exactly what has been provided.

The written agreement must include:

• a description of the donation, grant or sponsorship

• the objective of the donation, grant or sponsorship, including how it will support healthcare, scientific research or education

• the names of the organisations/parties involved (pharmaceutical company, patient organisations and any other parties) and their respective roles

• the type of activity and the nature of the company’s contribution (e.g. donation, grant, sponsorship of a specific meeting or publication, etc.)

• the time frame

• the amount of funding and/or a description of indirect/non-financial, in-kind donation and the nature of that donation (e.g. the donation of agency time or free training courses). Where possible, a full breakdown of costs should be included

• a statement that all parties are fully aware that the donation, grant or sponsorship must be clearly acknowledged and apparent from the start

• the signatories to the agreement

• the date of the agreement.

This written agreement must be certified as set out in Clause 8.3. A company must ensure that any materials, activities, etc. resulting from working with patient organisations are also certified where these are covered in Clause 8.3.

Donations, grants and sponsorships (including in relation to events/meetings) must be publicly disclosed annually as set out in Clause 29.

27.3

When providing donations, grants or sponsorship (including in relation to events/meetings) to patient organisations, companies must ensure:

• they comply with the prohibition on advertising prescription only medicines to the public

• 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 the provision, and the wording of the declaration must accurately reflect the nature of the company’s involvement.

  • Clause 27.3 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.

27.4

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.

27.5

Companies can contract with patient organisations or individuals representing patient organisations under which they provide any type of service to companies providing these comply with Clause 24. Companies must publicly disclose annually fees and expenses paid to patient organisations as set out in Clause 29. In their written contracts with patient organisations, companies are strongly encouraged to include provisions regarding an obligation of the patient organisations 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.

Where companies contract with individuals representing patient organisations to provide services, such contracts should be made with the patient organisation, and payment should be disclosed as a payment to the patient organisation.