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 Spillane; Sabine Vogler; Lauri Vuorenkoski; Helle Wallach Kildemoes; Olivier Wouters

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

NOVA School of Business and Economics (NOVA SBE)

Research output: Contribution to journal › Special issue › peer-review

95 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 language	English
Number of pages	143
Journal	Health systems in transition
Volume	18
Issue number	5
Publication status	Published - 2016

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Panteli, D., Busse, R., 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., Bastida, J. L., Barros, P. P., Ramsberg, J., Schneider, P., ... Wouters, O. (2016). Pharmaceutical regulation in 15 European countries: review. Health systems in transition, 18(5).

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abstract = "In the context of pharmaceutical care, policy-makers repeatedly facethe challenge of balancing patient access to effective medicines withaffordability and rising costs. With the aim of guiding the health policydiscourse towards questions that are important to actual and potential patients,this study investigates a broad range of regulatory measures, spanningmarketing authorization to generic substitution and resulting price levels in asample 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 containpharmaceutical expenditure and ensure quality and efficiency in pharmaceuticalcare, albeit with varying configurations and rigour. This variation alsoinfluences the extent of publicly financed pharmaceutical costs. Overall,observed differences in pharmaceutical expenditure should be interpreted inconjunction with the differing volume and composition of consumption andprice levels, as well as dispensation practices and their impact on measurementof pharmaceutical costs.No definitive evidence has yet been produced on the effects of differentcost-containment measures on patient outcomes. Depending on the foremostpolicy concerns in each country, different levers will have to be used to enablethe delivery of appropriate care at affordable prices.",

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Panteli, D, Busse, R, 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, Bastida, JL, Barros, PP, Ramsberg, J, Schneider, P, Spillane, S, Vogler, S, Lauri Vuorenkoski, Kildemoes, HW & Wouters, O 2016, 'Pharmaceutical regulation in 15 European countries: review', Health systems in transition, vol. 18, no. 5.

TY - JOUR

T1 - Pharmaceutical regulation in 15 European countries

T2 - review

AU - Panteli, Dimitra

AU - Busse, Reinhard

AU - Arickx, Francis

AU - Cleemput, Irina

AU - Dedet, Guillaume

AU - Eckhardt, Helene

AU - Fogarty, Emer

AU - Gerkens, Sophie

AU - Henschke, Cornelia

AU - Hislop, Jenni

AU - Jommi, Claudio

AU - Kaitelidou, Daphne

AU - Kawalec, Paweł

AU - Keskimäki, Ilmo

AU - Kroneman, Madelon

AU - Bastida, Julio Lopez

AU - Barros, Pedro Pita

AU - Ramsberg, Joakim

AU - Schneider, Peter

AU - Spillane, Susan

AU - Vogler, Sabine

AU - Lauri Vuorenkoski,

AU - Kildemoes, Helle Wallach

AU - Wouters, Olivier

PY - 2016

Y1 - 2016

N2 - In the context of pharmaceutical care, policy-makers repeatedly facethe challenge of balancing patient access to effective medicines withaffordability and rising costs. With the aim of guiding the health policydiscourse towards questions that are important to actual and potential patients,this study investigates a broad range of regulatory measures, spanningmarketing authorization to generic substitution and resulting price levels in asample 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 containpharmaceutical expenditure and ensure quality and efficiency in pharmaceuticalcare, albeit with varying configurations and rigour. This variation alsoinfluences the extent of publicly financed pharmaceutical costs. Overall,observed differences in pharmaceutical expenditure should be interpreted inconjunction with the differing volume and composition of consumption andprice levels, as well as dispensation practices and their impact on measurementof pharmaceutical costs.No definitive evidence has yet been produced on the effects of differentcost-containment measures on patient outcomes. Depending on the foremostpolicy concerns in each country, different levers will have to be used to enablethe delivery of appropriate care at affordable prices.

AB - In the context of pharmaceutical care, policy-makers repeatedly facethe challenge of balancing patient access to effective medicines withaffordability and rising costs. With the aim of guiding the health policydiscourse towards questions that are important to actual and potential patients,this study investigates a broad range of regulatory measures, spanningmarketing authorization to generic substitution and resulting price levels in asample 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 containpharmaceutical expenditure and ensure quality and efficiency in pharmaceuticalcare, albeit with varying configurations and rigour. This variation alsoinfluences the extent of publicly financed pharmaceutical costs. Overall,observed differences in pharmaceutical expenditure should be interpreted inconjunction with the differing volume and composition of consumption andprice levels, as well as dispensation practices and their impact on measurementof pharmaceutical costs.No definitive evidence has yet been produced on the effects of differentcost-containment measures on patient outcomes. Depending on the foremostpolicy concerns in each country, different levers will have to be used to enablethe delivery of appropriate care at affordable prices.

KW - DELIVERY OF HEALTH CARE

KW - EVALUATION STUDIES

KW - HEALTH FINANCING

KW - HEALTH CARE REFORM

KW - HEALTH SYSTEM PLANS

KW - PHARMACEUTICALS

M3 - Special issue

SN - 1817-6127

VL - 18

JO - Health systems in transition

JF - Health systems in transition

IS - 5

ER -

Pharmaceutical regulation in 15 European countries: review

Abstract

Keywords

UN SDGs

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