Is pharmaceutical policy evidence-informed? A case of the deregulation process of nicotine replacement therapy products in Finland

Objective: This qualitative study aims to identify the key dimensions of the political argumentation in the debate leading up to the deregulation of nicotine replacement therapy products (NRT) in Finland in 2006. The deregulation was introduced by the Amendment of larger package of changes in medical legislation prepared in 2005. Methods: All publicly available documents of the legislative process introducing NRT deregulation and interviews of 12 Members of Finnish Parliament conducted in spring 2006 were analyzed by inductive content analysis. Results: NRT deregulation was introduced to decision-makers as a safe intervention to increase smoking cessation and thus provide public health benefits. However, a whole variety of other features were brought into debate: NRT characteristics, principle change in prevailing medical legislation, use of evidence and the political process. Finally, the expected public health benefits of the decision were not directly informed by any evidence. Conclusions: This study provides an example of the use of public health benefits as justification for decision-making. However, the decision can include other aspects, less brought up in its preparation stage. Our study addresses the need for policymakers to critically evaluate the evidence, its suitability in decision-making context and raise awareness of the principles of evidence-informed policy-making. (C) 2012 Elsevier Ireland Ltd. All rights reserved.