Background: The formulation of pharmaceutical national policies has increased the role of evidence over the years. However, a standardised mechanism for use of evidence in pharmaceutical policy that can be used as a guide for policy makers, does not exist

Objectives: To present an evidence-based novelty model for the incorporation of evidence in the formulation of pharmaceutical policy.

Methods: A realist review was developed in order to identify the domains and subdomains of the process of formulation of pharmaceutical policy. A series of iterative searches and posterior analysis were developed in order to generate a model about the utilisation, the contextual factors and main points of use into the process of developing the policy. A conceptual map was created in order to present the relationship among the domains and subdomains. A framework was developed and validated with pharmaceutical policy makers, evidence providers, decision makers and stakeholders.

Results: The model identified 6 domains: evidence generation, evidence translation, evidence use, formulation of the pharmaceutical policy, publication of pharmaceutical policy and evaluation. Each domain has several subdomains which specify the interrelations and dynamics of each domain. 40 subdomains were identified in total. The model focuses on the main points of the process of pharmaceutical policy that need evidence, the requirements of its generation, synthesis and translation in order to present the evidence in a usable way for policy makers with high methodological rigour. The model also presents the decision process that uses evidence and how this can be more consistent and transparent. Other relevant aspect of the model is the interrelation among stakeholders, policy makers, evidence providers and pressure groups and their relationship with evidence use and the development of the pharmaceutical policy. Barriers and facilitators of evidence uptake were identified.

Conclusions: The model can guide policy makers and stakeholders in the process of evidence-based pharmaceutical policy formulation and to understand the role of evidence in decision making.