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Pharmaceutical regulation in 15 European countries - Review

Panteli D, Arickx F, Cleemput I, Dedet G, Eckhardt H, Fogarty E, Gerkens S, Henschke C, Hislop J, Jommi C, Kaitelidou D, Kawalec P, Keskimäki I, Kroneman M, Lopez Bastida J, Pita Barros P, Ramsberg J, Schneider P, Spillane S, Vogeler S, Vuorenkoski L, Wallach Kildemoes H, Wouters O, Busse R
Health Systems in Transition Vol 18(5); pp. 1 - 143




In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. The main goal of this study is to illustrate direct and indirect regulatory strategies shaping pharmaceutical care in different European countries in a systematic, comparative manner in the hopes of guiding the health policy discourse towards questions that are important to those covered in publicly financed (statutory) systems - and thus to actual and potential patients - particularly regarding quality of care. 

The investigation spans measures related to marketing authorization; pricing and price updates; post-marketing evaluations guiding coverage decisions (health technology assesment); patient cost-sharing; specific cost and quality control measures targeting individual stakeholder groups;generic substitution; and resulting price levels. 

A sample of 16 European health systems was selected (Austria, Belgium, Denmark, England, Finland, France, Grmany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). Quantitative data from the OECD and country-specific regulatory documents, as well as published and grey literature, were combined to form an initial evidence base in the form of health system profiles, which were then sent to relevant experts for review and validation. 

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