How is the independence of patient representatives ensured?

Patient involvement Participation in Therapy Development
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I’m curious about how the independence of patient representatives is safeguarded, especially when they are involved in discussions with healthcare providers, policymakers, or pharmaceutical companies.

  • From whom do patient representatives typically receive compensation?
  • Are there any guidelines to prevent conflicts of interest?
  • And who is responsible for ensuring that they can truly operate independently?
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In general, rules and guidelines that apply to patients and the organisations they represent should be no different than those that apply to other stakeholders. Basic principles to consider:

All participants declare their (potential) conflicts of interest, someone else assesses the validity, as well as the consequences for the process

All participants should be transparent and open about their interests; it is better to declare more, than not enough

Fair compensation of all experts (including patient representatives!) at the table should never be subject to debate

Internationally, several institutions and authorities have published guidelines and instructions for handling (potential) conflicts of interests, see for example the information on the EMA website for the experts they consult and members of EMA committees. Also patient (umbrella) organisations, such as EURORDIS and WECAN, provide support and guidelines to their members on good governance. For pharmaceutical companies, the EFPIA Code is important to consider when engaging with patient organisations. Specifically on the topic of fair compensation national regulations apply. These also include potential (fiscal) consequences for disability benefits, when the payment of patient representatives that work as volunteers is concerned.

In the Netherlands, patient organisations may be eligible for funding from the government. Specific requirements apply, see the DUS-I website (in Dutch) for details. Most national patient organizations publish an annual financial overview on their website, as a matter of transparency and good governance. The umbrella organization Patient Federation (Patientenfederatie Nederland) published a code of conduct for its members on sponsorship and fundraising. Specific financial transactions between a pharmaceutical company and a patient organization should be registered via Transparantieregister Zorg.

Finally, although conflicts of interest in general are more or less automatically narrowed to financial matters, they should be interpreted in a broader context. François Houÿez (EURORDIS) gave an interesting presentation at a CIOMS conference, in preparation of the CIOMS publication on patient involvement in medicine development and regulation. Chapter 3 of this publication is dedicated to the guiding principles for patient engagement and may contain some useful references.

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