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

Absence of evidence or evidence of absence - a review of the evidence for hydroxychloroquine as a potential candidate for prophylaxis against COVID-19

Clinical trials are investigating several agents as potential options for pre-exposure prophylaxis and post-exposure prophylaxis to prevent infection with COVID-19. A particular focus has been high risk groups including healthcare workers. Chloroquine (CQ) and hydroxychloroquine (HCQ) are the predominant agents in terms of numbers of clinical trials listed on Clinicaltrials.gov. However, CQ/HCQ have not been proven as an effective treatment option for COVID-19, and it is currently unclear what benefit, if any, is available to support their use in a prophylactic role. Four randomised control trials have been published so far which have examined the effect of HCQ as pre-exposure (PrEP) and post-exposure prophylaxis (PEP). This study summarises the evidence to date for HCQ as a potential prophylactic option for PEP and PrEP, presents both the aggregated and disaggregated data and details the gaps in the evidence base. The absolute risk differences for the pre-exposure prophylaxis studies were -0.3% to -2% and for the post prophylaxis studies were -0.6% and -2.4%. There were more adverse events noted in the hydroxychloroquine arms across all four studie