European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children

Several high-risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU-funded CORE-MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow-up meeting took place in March 2023. We developed recommendations for investigation of high-risk medical devices for children building on participants' expertise and results of a scoping review of clinical trials on high-risk medical devices in children. Approaches for evaluating and certifying high-risk medical devices for market introduction are proposed

European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.

Several high-risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU-funded CORE-MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow-up meeting took place in March 2023. We developed recommendations for investigation of high-risk medical devices for children building on participants' expertise and results of a scoping review of clinical trials on high-risk medical devices in children. Approaches for evaluating and certifying high-risk medical devices for market introduction are proposed

The Implementation of External Reference Pricing within and across Country Borders

An assessment of the way that 29 countries implement external reference pricing (ERP), which aims to contain medicine costs, using a systematic literature review-based process

Evaluating the impact of liberalisation on public services: a critique of the European Commission 2004 report "Horizontal Evaluation Of The Performance Of Network Industries Providing Services Of General Economic Interest" EC SEC(2004) 866

A critique of the European Commission's 2004 Horizontal Evaluation Report's conclusions and analysis, and a set of proposals for a better way of evaluating Services of General Economic Interest across Europe

Religion and healthcare in the European Union : policy issues and trends

92 p. ; 24 cm.Libro ElectrónicoThe impact of religious doctrine on the law, policy and practice of healthcare is becoming increasingly significant for a whole range of issues – from euthanasia to fertility treatment; from belief-based exemption from performing abortion for doctors to the medication and dietary needs of religious patients; from organ donation to contraception; from circumcision to suicide. The relationship between religion and healthcare has a long history of evoking tension and debate in Europe. While developments in medical technologies and techniques question the religious beliefs of policy-makers, practitioners and patients across the European Union, research into the legal and policy responses by EU member states on such issues remains underdeveloped. The challenge of health policy, which is common across the European Union, is to balance fundamental human rights such as the right to equality, the right to health and the right to freedom of religion while adhering to secular principles. This report aims to map out the major issues at stake and to initiate a broader discussion on how the religious needs of the community, religious doctrine and religious practices across the European Union affect public health policy.Preface: The ‘Religion and Democracy in Europe’ initiative 7 About the authors 8 Introduction 9 Background 9 Purpose and conceptual framework 10 Terms, scope, methodology and structure 13 Summary of recommended main policy questions for further development 16 1 The legal and policy context in the European Union 17 1.1 European Union law 17 1.2 National law and policy 18 2 The influence of religion on national healthcare policy development 21 2.1 Conflict of duty in health‑service provision 22 2.1.1 Does national healthcare policy permit belief‑based exemption? 23 2.1.2 Scope and limits of belief‑based exemption in healthcare 23 2.1.3 Safeguards 27 2.2 Euthanasia 27 2.2.1 Active euthanasia 29 2.2.2 Passive euthanasia 30 2.2.3 Conflict of duty and safeguards related to euthanasia 32 2.3 Belief‑based patient decisions 34 2.3.1 Organ transplant and donation 34 2.3.2 Refusal of medical treatment 36 2.4 Emerging policy trends and outstanding policy questions 413 Healthcare policy and religious diversity 43 3.1 Healthcare policy and accommodating religious needs in hospitals 45 3.1.1 Religious assistance and faith space 45 3.1.2 Medication and dietary needs 47 3.1.3 The sex of the health practitioner and hospital clothing 48 3.1.4 After‑death issues: post‑mortem and burial 49 3.2 Healthcare policy and accommodating religion outside hospitals 50 3.2.1 Training of healthcare professionals 50 3.2.2 Substance abuse 52 3.3 Emerging policy trends and outstanding policy questions 53 4 Religion and sexual and reproductive healthcare 56 4.1 Contraception, HIV/AIDS and other sexually transmitted diseases 56 4.1.1 The influence of religion on contraception policy 57 4.1.2 The influence of religion on HIV/AIDS education and prevention policies 58 4.1.3 The4.1.3 The influence of religion on other STD policy 60 4.2 Abortion and sterilization 61 4.2.1 Some religious positions on abortion 61 4.2.2 National policy positions 62 4.2.3 Safeguards when abortion is denied 63 4.2.4 Sterilization 65 4.3 Fertility treatment and reproductive techniques 65 4.4 Circumcision 68 4.5 Female genital mutilation 70 4.6 Emerging policy trends and outstanding policy questions 71 5 Religion and mental healthcare 73 5.1 The European policy context and the influence of religious institutions 74 5.2 The influence of religion on mental illness 77 5.2.1 Diagnosis of mental illness 77 5.2.2 Treatment of mental illness 78 5.3 Emerging policy trends and outstanding policy questions 82 Conclusion 84 Appendix A Roundtable participants 86 Appendix B Belief‑based exemption from healthcare provision 87 Appendix C National policy on euthanasia in some EU states 88 Appendix D National policy on abortion in some EU states 8

Trade unions and reform of public utilities: international perspective

An overview of international and EU experience with privatisation of relevance to Russia and other eastern European countries

Primary Care and Prescription Drugs: Coverage, Cost-Sharing, and Financial Protection in Six European Countries

Examines health coverage, innovations in cost-sharing design, and affordability of primary care and prescription drugs in Denmark, France, Germany, the Netherlands, Sweden, and the United Kingdom. Explores lessons for U.S. reforms and insurance design

Survey of the pine wood nematode (PWN) Bursaphelenchus xylophilus in Norway 2003

In this survey of 2003, 600 samples were collected from 96 forest blocks in the counties of Aust-Agder and Vest-Agder in southern Norway. The sampling activity involved 19 municipalities situated mainly within the two zone sites D and E close to Kristiansand and Arendal. Samples from Scots pine (Pinus sylvestris) formed 92%, while samples of Norway spruce (Picea abies) made up 8% of the total sample volume. Timber and forest debris was the most common objects sampled. Ninety-eight percent of the samples, regardless of tree species, showed signs of Monochamus activity. Nematodes were common and occurred in 90% of the samples analysed. Eight samples of pinewood were positive for the genus Bursaphelenchus. This genus did not occur in spruce. Bursaphelenchus mucronatus was detected in 6 samples of forest debris of pine attacked by Monochamus and collected in the county of Aust-Agder. In the municipality of Evje and Hornes B. mucronatus was detected at Skjerkelia and Sutestad. In the municipality of Froland the nematode was found in two samples from Budalsfjellet, and in one sample from Mjålandsvatn. In the municipality of Birkenes one sample from Vågsdalen contained B. mucronatus. This is the fourth report on the occurrence of B. mucronatus in Norway. The pine wood nematode Bursaphelenchus xylophilus was not detected.Survey of the pine wood nematode (PWN) Bursaphelenchus xylophilus in Norway 2003publishedVersio