Study on the economic impact of the Paediatric Regulation, including its rewards and incentives : final report (redacted version)

The current study is aimed at providing a review of the economic impacts of the Regulation since it entered into force until the end of 2015. This study thus covers the following dimensions: (i) Analysis of the regulatory costs to the pharmaceutical industry for meeting legal obligations; (ii) Analysis of the economic value of the rewards/ incentives to the pharmaceutical industry; (iii) Overall assessment of the rewards/ incentives to the pharmaceutical industry; (iv) Analysis of the direct and indirect social and economic benefits; and (v) Exploratory high-level cost-benefit assessment providing estimates of the broad economic impacts. The regulatory costs analysis is based on data provided by PIP and waiver applicants by means of a survey questionnaire and follow-up interviews. The analysis of the economic value of the rewards and incentives is based on data available from IMS Health. A consultation on the societal benefits of the Regulation was conducted through a two-stage survey to expert stakeholders. The economic model developed here explores the cost-benefit profile for eight medicinal products in detail, while extrapolates in relation to 108 additional PIPs that have already received a positive statement of compliance. Spillover effects of the R&D investment are also considered.