ABPI Website
Partnerships
Working with patient organisations
Working with patients and patient organisations - 2022 sourcebook for industry
Principles and agreements

Principles and agreements

Principles for working together

The ABPI/National Voices guide, “ Working Together, Delivering For Patients” sets out four guiding principles that should underpin all collaborative working between industry and patient organisations:

Clarity of purpose: each party should be clear about the reason for and the planned outcome of the collaboration – and the ultimate benefit for patients

Integrity: each party should act, and be seen to act, honestly and with integrity at all times

Independence: each party should maintain their independence

Transparency: each party should be open and honest about the purpose of the collaboration and be able to account publicly for the associated activities and any exchanges of funding

When thinking about setting up a new industry-patient partnership, it is helpful to test your thinking against these four interlocking principles. Asking questions like the ones below can assist the development of your plans:

Why do we want to work together?
How will patients and the health system ultimately benefit?
How will we agree the desired outcomes and evaluate them?
Why, how and when will we involve patients?
How will this project benefit my organisation?
How will we retain independence whilst working together and making decisions, e.g. on the scope of work?
What money or benefit transfers are involved?
What will being transparent involve?

What the ABPI Code says

The 2021 ABPI Code has been set out in an updated format with information applicable to interactions and relationships with patient organisations and individuals representing patient organisations now incorporated in the grey, yellow, pink and teal sections of the Code. The grey section of the code covers ‘Overarching Requirements’. This section provides standards which apply broadly to interactions and relationships with definitions key to understanding the code set out in Clause 1, including for Patient Organisations and Individuals representing patient organisations :-

Clause 1.15 ‘Patient organisation’ means an organisation mainly comprising of patients and/ or caregivers or any user organisation such as a disability organisation, carer or relative organisation and consumer organisation that represents and/or supports the needs of patients and/or caregivers.

Clause 1.16 ‘Individuals representing patient organisations’ means a person who is mandated to represent and express the views of a patient organisation.

Clause 27 sets out some requirements which are specific to working with patient organisations. It states that 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.

Clause 27.2 sets out the requirements for a written agreement to be in place for each donation, grant, or sponsorship setting out exactly what must be included as captured in the table 1 below.

Clause 27.3 states 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.

27.4 states that 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.

Clause 27.2 Requirements for the written agreement for each donation, grant or sponsorship must include:

✔ A description of the donation, grant or sponsorship

✔ The objective including how it will support healthcare, scientific research or education

✔ The names of the organisations/parties involved and their respective roles

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

✔ Time Frame

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

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

✔ Signatories to the agreement

✔ Date of the agreement

In addition to Clause 27 requirements, the 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.

Working together with one or more companies

Pharma companies can work with patient organisations in other areas beyond grants, donations and sponsorship e.g., fee for service, contracted activities and ‘collaborative working’

The ABPI Code states ‘Collaborative working’ refers to pharmaceutical companies working with other organisations to deliver initiatives which either enhance patient care or are for the benefit of patients or alternatively benefit the National Health Service (NHS) and, as a minimum, maintain patient care.

The ABPI Code sets out that Collaborative working between the pharmaceutical industry and healthcare organisations with the goal of enhancing patient care, benefiting patients and/or benefiting the NHS is acceptable, providing it is carried out in a manner compatible with the Code.

Collaborative working projects may involve working with a patient organisation and in such circumstances, the arrangements for the patient organisation involvement must comply with Clause 27 and is likely to be a contracted service (Clause 24), as set out in Clause 27.5. Therefore, a patient organisation must not be a party of the collaborative working agreement. This is to ensure patient organisation involvement is separate and the transfer of value is disclosed as a clear and separate interaction. Further, as a collaborative working project may explicitly reference and/or use a company’s medicinal product it would not be appropriate for a patient organisation to be involved as part of the overall project, including the contract.

When working with a patient organisation a company cannot insist that it is the sole funder or sponsor of a patient organisation, nor make its support conditional on it being the sole funder. However, it may find itself the only company wishing to support a particular patient organisation or its activities.

Many patient organisations are supported by a number of pharmaceutical companies. However, a patient organisation may choose to work with just one commercial organisation, for example in a project focused on a rare disease. The IFPMA Code of Practice covers this issue in its Q&A section (page 55).

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.

Clarity in written agreements

Whilst large patient organisations may be familiar with agreements and have the resources to draft and review them, individuals or small organisations may not. Use plain English and take care not to exclude people or groups inadvertently by developing an over-complex document. The Plain English Campaign is a good source of writing guides, including one on medical information.

Patient Focused Medicines Development, the Workgroup of European Patient Advocacy Networks (WECAN) and Myeloma Patients Europe have developed a guide: Reasonable Agreements between Patient Advocates and Pharmaceutical Companies. Their work addresses the concern that agreements are often too long or complex and can put patient organisations or advocates in a vulnerable position. Note: This guide has not been assessed in relation to the 2021 ABPI Code of Practice.

Single point of contact

It is very helpful if a company can provide a consistent and single point of contact for the patient organisations it plans to work with, and takes time to support them through the process: commercial structures can be complicated for others to navigate, and representatives of patient organisations often have very limited time or resources to devote to administration.

The Association of Medical Research Charities (AMRC) recommends that “charities should aim to have an established point of contact in their partner company and a specific member of staff who leads on managing the relationship.”(AMRC (2014) An Essential Partnership: A guide for charities working with industry. London: AMRC.)