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Health Systems in Transition. Pharmaceutical regulation in 15 European countries: review 2016.

Panteli, D., Arickx, F., Cleemput, I., Dedet, G., Eckhardt, H., Fogarty, E., Gerkens, S., Henschke, C., Hislop, J., Jommi, C., Kaitelidou, D., Kawalek, P., Keskimäki, I., Kroneman, M., Lopez Bastida, J., Pita Barros, P., Ramsberg, J., Schneider, P., Spillane S., Vogler, S., Vuorenkoski, L., Wallach Kildemoes, H., Wouters, O., Busse, R. Health Systems in Transition. Pharmaceutical regulation in 15 European countries: review 2016. Kopenhagen: WHO Regional Office for Europe, 2016. 146 p.
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This publication is available at Euro Health Observatory.

Pharmaceutical care accounts for a very significant proportion of health expenditures and policy-makers repeatedly face the challenge of balancing patient access to effective medicines against affordability, particularly as costs rise.

This review by the European Observatory on Health Systems and Policies investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution to understand their impact on price and utilization and to guide the health policy debate towards those questions that are important to actual and potential patients.

It examines the situation in 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden) as a way of understanding the range of practice