Special edition - Pharmaceutical regulation in 15 European countries (2016)

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 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 and finds that:

• All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency, but with widely varying configurations and rigour.
• Pharmaceutical prices are more or less directly controlled across the sample but, despite their widespread use, current pricing policies have real limitations.
• Prices in Europe have not converged as could be expected, at least for originator products, although the comparative studies that show this should be interpreted with caution as they are plagued by a number of inherent, methodological limitations (outlined in the review).
• There are very substantial differences between countries in terms of what their priorities are and the challenges they face. While for some timely and/or equitable access to new medicines may be the main issue, others may be primarily concerned with quality of care or containing public pharmaceutical expenditure. 
• There is as yet no definitive evidence on the effects of different cost-containment measures on patient outcomes. However, it is clear that different levers will have to be used to enable the delivery of appropriate care at affordable prices in different settings and in line with countries’ specific policy concerns.