Pharmaceutical regulation in 15 European countries: review

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

Routinely collected data for randomized trials: promises, barriers, and implications

This work was supported by Stiftung Institut für klinische Epidemiologie. The Meta-Research Innovation Center at Stanford University is funded by a grant from the Laura and John Arnold Foundation. The funders had no role in design and conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript or its submission for publication.Peer reviewedPublisher PD

Nordic responses to Covid-19: governance and policy measures in the early phases of the pandemic

This paper explores and compares health system responses to the COVID-19 pandemic in Denmark, Finland, Iceland, Norway and Sweden, in the context of existing governance features. Content compiled in the Covid-19 Health System Response Monitor combined with other publicly available country information serve as the foundation for this analysis. The analysis mainly covers early response until August 2020, but includes some key policy and epidemiological developments up until December 2020. Our findings suggest that despite the many similarities in adopted policy measures, the five countries display differences in implementation as well as outcomes. Declaration of state of emergency has differed in the Nordic region, whereas the emphasis on specialist advisory agencies in the decision-making process is a common feature. There may be differences in how respective populations complied with the recommended measures, and we suggest that other structural and circumstantial factors may have an important role in variations in outcomes across the Nordic countries. The high incidence rates among migrant populations and temporary migrant workers, as well as differences in working conditions are important factors to explore further. An important question for future research is how the COVID-19 epidemic will influence legislation and key principles of governance in the Nordic countries