Understanding ethical principles and recommendations for decision-making is crucial, but applying them in practice requires clear processes. 

When conducting an appraisal of a technology, where societal values and ethical principles are considered in a recommendation, the best health systems aspire to use an approach that embraces these to the greatest extent possible. Rules that govern proceedings that may have far-reaching implications for society are therefore necessary if not an absolute requirement.

These rules include procedural rights such as:

Right to Participate – Stakeholder Involvement

Involving stakeholders (anyone affected by or interested in the decision) enhances decision-making by:

  • To improve the quality of information concerning the population’s values, needs, and preferences.
  • To encourage public debate over the fundamental direction of the health system
  • To ensure public accountability for processes and outcomes.
  • To protect the public interest.

To ensure legitimacy, decision-making processes should allow for broad stakeholder involvement. Committees overseeing these decisions often include diverse members, such as

  • Patients
  • Citizens
  • Medical experts
  • Technology analysts
  • Company representatives

However, participation must be carefully managed to avoid undue influence, with transparent rules on who participates, how they are chosen, and the duration of their involvement.

Right to a fair and accountable process

A fair process reflects procedural justice, underpinned by three key principles:

  • Transparency: Clearly explaining the grounds for decisions (e.g., publishing summary documents).
  • Rational Justifications: Using rationales that are relevant and acceptable for meeting health needs fairly (e.g., providing draft recommendations for stakeholder comments).
  • Revision Procedures: Allowing challenges to decisions and revising them based on valid concerns.

Right to Information

Best practices include ensuring that information is accessible, even to those not actively participating. Many health technology assessment (HTA) bodies now publish reports and explain their recommendations online, though this is not yet standard everywhere. Transparency promotes trust and fairness in decision-making.


For more information on the EU HTA process please access the course Course: EU Health Technology Assessment Regulation (HTAR) | EUPATI Open Classroom