Pharmaceutical regulation in 15 European countries: review

Dimitra Panteli, Reinhard Busse, Francis Arickx, Irina Cleemput, Guillaume Dedet, Helene Eckhardt, Emer Fogarty, Sophie Gerkens, Cornelia Henschke, Jenni Hislop, Claudio Jommi, Daphne Kaitelidou, Paweł Kawalec, Ilmo Keskimäki, Madelon Kroneman, Julio Lopez Bastida, Pedro Pita Barros, Joakim Ramsberg, Peter Schneider, Susan SpillaneSabine Vogler, Lauri Vuorenkoski, Helle Wallach Kildemoes, Olivier Wouters

Research output: Contribution to journalSpecial issue

40 Citations (Scopus)

Abstract

In the context of pharmaceutical care, policy-makers repeatedly face
the challenge of balancing patient access to effective medicines with
affordability and rising costs. With the aim of guiding the health policy
discourse towards questions that are important to actual and potential patients,
this study investigates a broad range of regulatory measures, spanning
marketing authorization to generic substitution and resulting price levels in a
sample of 16 European health systems (Austria, Belgium, Denmark, England,
Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland,
Portugal, Scotland, Spain and Sweden).

All countries employ a mix of regulatory mechanisms to contain
pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical
care, albeit with varying configurations and rigour. This variation also
influences the extent of publicly financed pharmaceutical costs. Overall,
observed differences in pharmaceutical expenditure should be interpreted in
conjunction with the differing volume and composition of consumption and
price levels, as well as dispensation practices and their impact on measurement
of pharmaceutical costs.

No definitive evidence has yet been produced on the effects of different
cost-containment measures on patient outcomes. Depending on the foremost
policy concerns in each country, different levers will have to be used to enable
the delivery of appropriate care at affordable prices.
Original languageEnglish
Number of pages143
JournalHealth systems in transition
Volume18
Issue number5
Publication statusPublished - 2016

Keywords

  • DELIVERY OF HEALTH CARE
  • EVALUATION STUDIES
  • HEALTH FINANCING
  • HEALTH CARE REFORM
  • HEALTH SYSTEM PLANS
  • PHARMACEUTICALS

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