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HomeStudy on the economic impact of the Paediatric Regulation, including its rewards and incentives
Final report (redacted version)
Publication metadata
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.
- Published:
- Corporate author(s): Directorate-General for Health and Food Safety (European Commission) , ECORYS , Empirica , Technopolis
- Personal author(s): Schiffers, Krijn ; Varnai, Peter ; Birov, Strahil ; Thiel, Rainer ; Oortwijn, Wija ; Meindert, Lars ; Simmonds, Paul ; Schothorst, Marien van ; Farla, Kristine ; Stroetmann, Karl
- Themes: Health policy
- Subject: cost analysis , economic consequence , health policy , medical research , medicinal product , paediatrics , regulation (EU) , report , tax incentive
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| ISSN | ISBN 978-92-79-77284-9 | DOI 10.2875/662696 | Catalogue number EW-07-17-191-EN-N |
- Released on EU publications website:
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