title: Pharmaceutical regulation in 15 European countries review.
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.
authors.affiliation: European Observatory on Health Systems and Policies.
authors.forename: Dimitra
authors.initials: D
authors.lastname: Panteli
authors.forename: Francis
authors.initials: F
authors.lastname: Arickx
authors.forename: Irina
authors.initials: I
authors.lastname: Cleemput
authors.forename: Guillaume
authors.initials: G
authors.lastname: Dedet
authors.forename: Helen
authors.initials: H
authors.lastname: Eckhardt
authors.forename: Emer
authors.initials: E
authors.lastname: Fogarty
authors.forename: Sophie
authors.initials: S
authors.lastname: Gerkens
authors.forename: Cornelia
authors.initials: C
authors.lastname: Henschke
authors.forename: Jennifer
authors.initials: J
authors.lastname: Hislop
authors.forename: Claudio
authors.initials: C
authors.lastname: Jommi
authors.forename: Daphne
authors.initials: D
authors.lastname: Kaitelidou
authors.forename: Pawel
authors.initials: P
authors.lastname: Kawalec
authors.forename: Ilmo
authors.initials: I
authors.lastname: Keskimaki
authors.forename: Madelon
authors.initials: M
authors.lastname: Kroneman
authors.forename: Julio
authors.initials: J
authors.lastname: Lopez Bastida
authors.forename: Pedro
authors.initials: P
authors.lastname: Pita Barros
authors.forename: Joakim
authors.initials: J
authors.lastname: Ramsberg
authors.forename: Peter
authors.initials: P
authors.lastname: Schneider
authors.forename: Susan
authors.initials: S
authors.lastname: Spillane
authors.forename: Sabine
authors.initials: S
authors.lastname: Vogler
authors.forename: Lauri
authors.initials: L
authors.lastname: Vuorenkoski
authors.forename: Helle
authors.initials: H
authors.lastname: Wallach Kildemoes
authors.forename: Olivier
authors.initials: O
authors.lastname: Wouters
authors.affiliation: European Observatory on Health Systems and Policies and Department of Health Care Management, Berlin University of Technology.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Busse
mesh_terms: D005060:Europe; D006801:Humans; D007885:Legislation, Pharmacy