Recommendations

Recommendations for a greater institutionalisation of patient organisations’ involvement

Recommendation on the institutional framework include: 

• Institutionalisation is essential to embed the role of patient organisations in health policy-making; while the absence of a legal basis is not, in itself, a barrier to meaningful participation, it risks making engagement ad hoc rather than structural and fails to recognise the legitimacy of patient organisations’ contributions.
• A clear definition of patient organisations is needed to distinguish organisations that genuinely represent patients and their interests from other types of organisations.

Recommendation on patient involvement include:

• Early and consistent involvement of patient organisations across the policy process, from ideation to monitoring and evaluation, is essential to ensure that decisions truly meet patients’ needs.

Recommendations on transparency include:

• Establish clear and transparent criteria for the involvement of patient organisations in policy-making. These eligibility criteria should be publicly available and consistently applied, and should include:
  • Governance criteria, including composition of the membership and governing bodies, not-for-profit status, representativeness, existence of accountability and consultation mechanisms
    o Relevance to the policy area and demonstrated expertise
    o Transparency of funding sources
• Put in place robust conflict of interest (CoI) frameworks and disclosure requirements, as well as proportionate mitigation measures that ensure the integrity of policy processes without discarding relevant input;
  Establish transparent and publicly accessible registries of patient organisations and representatives involved in policy processes;
  Introduce regular, well-publicised and transparent calls for applications for patient organisations to participate in consultative or decision-making bodies. These should be accompanied by clear evaluation criteria, transparent selection procedures, and feedback mechanisms.

Recommendations on HTA include:

• Establish a predictable framework for patient involvement: A clear and public framework should define how patients and their representatives engage in HTA, including their roles, timelines, methods, and governance structures
• Patients should be involved as early as possible in the process and until the appraisal phase. Their contributions should not be limited to “late-stage consultation”.

Recommendations on funding and capacity building include:

• Provide dedicated, predictable, and sustainable funding mechanisms for patient organisations, including public funding.
  Ensure the available of multi-annual core grants, not only project-based funding, to support long-term strategic involvement and organisational stability, based on fair and transparent eligibility criteria.
•  Invest in capacity building for patient organisations across all countries, including training on health policy and regulatory processes, but also skills development, governance, and knowledge-sharing.