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Pharmaceutical regulation in 15 European countries / Dimitra Panteli / Brussels [Belgium] : European Observatory on Health Systems and Policies (2016)  

Pharmaceutical regulation in 15 European countries = Reveiw 2016 [printed text] / Dimitra Panteli, Author ; Francis Arickx, Author ; Irina Cleemput , Author ; Guillaume Dedet, Author ; Helen Eckhardt, Author ; Emer Fogarty, Author ; Sophie Gerkens, Author . - Brussels (Rue de l'Autonomie, 4, 1070, Belgium) : European Observatory on Health Systems and Policies : Geneva (Switzerland) : World Health Organisation (WHO), 2016 . - 143 pp.. - (Health Care Systems in Transition, ISSN 1020-9077; 18(5)) . Languages : English (eng) Descriptors: Indexation Delivery of Health Care ; Evaluation Studies [Publication Type] ; Health Care Reform ; Health System Plans ; Healthcare Financing ; Pharmaceutical Preparations Classification W 84.4 Quality of health care (General) 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. Contents note: 1. Introduction -- 2. The context of pharmaceutical care –expenditure and consumption data -- 2.1 Expenditure -- 2.2 Consumption -- 3. The link between marketing authorization, reimbursement and pricing -- 4. Pricing mechanisms in publicly financed (statutory) health systems -- 5. Reimbursement -- 6. Patient cost sharing -- 7. Targeted measures of cost containment -- 7.1 Industry -- 7.2 Pharmacists and wholesalers -- 7.3 Physicians/prescribers -- 8. Generics -- 9. International comparisons of pharmaceutical prices -- 9.1 Methodological elements in international comparisons of pharmaceutical prices -- 9.2 Comparison of price levels amongst studied countries -- 10. Conclusions -- References -- Annex I: Additional visualizations of health expenditure -- Annex II: Key information and reimbursement/pricing systems in 15 European countries Link for e-copy: http://www.euro.who.int/__data/assets/pdf_file/0019/322444/HiT-pharmaceutical-re [...] Format of e-copy: Open Access Record link: http://kce.docressources.info/index.php?lvl=notice_display&id=4128