Centralized drug review processes: are they fair?

Numerous countries have implemented centralized drug review processes to assist in making drug coverage decisions. In addition to examining the final recommendations of these bodies, it is also important to ensure fairness in decision making. Accountability for reasonableness is an ethics-based framework for examining the fairness of priority setting processes. The objective of this study was to assess the fairness of four internationally established centralized drug review processes using accountability for reasonableness. Semi-structured telephone interviews were conducted with stakeholders in Canada, New Zealand, Australia and the UK (n=16). Participants were asked to evaluate their country's centralized drug review process against the four conditions of accountability for reasonableness. Each centralized drug review process satisfied at least one of the four ethical conditions, but none satisfied all four conditions. All participants viewed transparency as critical to both the legitimacy and fairness of centralized drug review processes. Additional strides need to be made in each of the four countries under study to improve the fairness of their centralized drug review processes. Ideally, a fair priority setting process should foster constructive stakeholder engagement and enhance the legitimacy of decisions made in assessing pharmaceutical products for funding. As policy makers are under increasing scrutiny in allocating limited resources, fair process should be seen as a critical component of such activity. This study represents the first attempt to conduct an international comparison of the fairness of centralized drug review agencies in the eyes of participating stakeholders.