{"title":"Safety of scientific medical research is a State obligation.","authors":"Marjolein Timmers, Mária Éva Földes","doi":"10.1017/S174413312500009X","DOIUrl":"https://doi.org/10.1017/S174413312500009X","url":null,"abstract":"<p><p>Conducting scientific medical research with human subjects presents risks that raise both ethical and human rights concerns. We argue in this article that applying a human rights framework to the problems that arise in the context of scientific medical research can contribute to a better understanding of the impact on individuals, the related obligations of the State, and the avenues to make the State accountable when things go wrong. We start our analysis with a case brought to the European Court of Human Rights, which we use as an illustration throughout the article. We then discuss the relevance of human rights to the field of scientific medical research with a focus on the right to life and the right to health. The article draws on international human rights jurisprudence that deals with concrete disputes arising from the clinical reality. We use case law to highlight the role of human rights law in tackling the real-life problems that may occur during scientific medical research. Our analysis contends that human rights law can provide valuable guidance for healthcare professionals and equip them to handle concrete situations in the clinical reality when the safety of research subjects is at stake.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Karel C F Stolper, Izel Yildirim, Lieke H H M Boonen, Frederik T Schut, Marco Varkevisser
{"title":"Do consumers perceive and trust health insurers within a system of managed competition as prudent buyers of care?","authors":"Karel C F Stolper, Izel Yildirim, Lieke H H M Boonen, Frederik T Schut, Marco Varkevisser","doi":"10.1017/S1744133124000185","DOIUrl":"https://doi.org/10.1017/S1744133124000185","url":null,"abstract":"<p><p>In health care systems based upon the principles of managed competition, health insurers are expected to act as prudent buyers of care. Consumers are expected to switch between insurers based upon the performance of insurers in this role. Yet, the Dutch experience shows that trust of consumers in health insurers is low and that switching consumers focus primarily on price. The question arises if consumers do in fact perceive and trust insurers as prudent buyers of care. We addressed this question by using a mixed-method approach. The results show that most people know that insurers buy health care and feel that the purchasing tasks suit their role. They even have reasonable, though fragile, trust in the purchasing competencies of the insurer. However, the results also revealed that consumers have insufficient information to cast a judgement about insurers as purchasers and incorrectly think that insurers are commercial organisations. Hence, improving the public information about insurers and their purchasing role seems to be crucial. Given the inherent complexity in the system, it remains to be seen if this objective can be reached in the (near) future. For that reason, policymakers should also consider additional measures to encourage that insurers will take integral purchasing responsibility.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"1-26"},"PeriodicalIF":3.0,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143598125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices.","authors":"Stefania Manetti, Elisa Guidotti, Federico Vola, Milena Vainieri","doi":"10.1017/S1744133124000148","DOIUrl":"https://doi.org/10.1017/S1744133124000148","url":null,"abstract":"<p><p>The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.A systematic review was undertaken until February 2024 following the PRISMA guidelines. Original peer-reviewed articles in English and incorporating RWE/RWD into any sort of post-market assessment strategy for an MD were included and their reference lists manually checked. A narrative synthesis was employed to describe evidence retrieved.Totally, 145 research articles were identified. Administrative databases were mostly utilised; clinical and/or economic evidence gathered in a short/medium time horizon the most frequently reported; other evidence types (e.g., organisational) underreported; patient perspectives rarely incorporated; the innovation complexity of MDs relatively low.To our knowledge, this study is the first in its kind to provide a comprehensive picture of how non-randomised evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help health policy scholars in addressing the avenues for research in RWE for MDs and policy-makers to better understand the risks and benefits of medium and long-term use of MDs alongside clinical practice and make more informed decisions about adoption and use.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"1-33"},"PeriodicalIF":3.0,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Procedural fairness to recalibrate the power imbalance in health decision-making: comment on the report: 'Open and inclusive: Fair processes for financing universal health coverage'.","authors":"Dheepa Rajan, Benjamin Rouffy-Ly","doi":"10.1017/S1744133124000197","DOIUrl":"10.1017/S1744133124000197","url":null,"abstract":"<p><p>The policy-making process for health financing in most places lacks equity, failing to adequately consider the voices of ordinary citizens, residents, and especially those facing significant disadvantage. Procedural fairness is about addressing this imbalance, which requires a recalibration of power dynamics, ensuring that decision-making incorporates a more diverse range of perspectives. In this comment, we highlight the important contributions made by the report 'Open and inclusive: Fair processes for financing universal health coverage' in furthering the understanding and importance of procedural fairness in health financing decision-making especially as it relates to the three sub-functions of financing - revenue raising, pooling, and purchasing. We also argue for the importance of conceptual clarity - especially as to the added value of procedural fairness vis-à-vis accountability - and critically review the proposed framework for procedural fairness, emphasising the role of voice as the linchpin to advancing equity in influence.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"19-25"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why procedural fairness is essential to financing universal health coverage.","authors":"Rocco Friebel, Iris Wallenburg","doi":"10.1017/S1744133125000064","DOIUrl":"https://doi.org/10.1017/S1744133125000064","url":null,"abstract":"","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":"20 1","pages":"1-3"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhancing procedural fairness: a critique of the open and inclusive approach to health financing decisions.","authors":"John Kinuthia","doi":"10.1017/S1744133125000027","DOIUrl":"10.1017/S1744133125000027","url":null,"abstract":"<p><p>This article is a critique of a report, Open and Inclusive: Fair Processes for Financing Universal Health Coverage. The report proposes a framework that is meant to improve procedural fairness and how decisions in financing of health care can be fairer. The author of this article argues that while procedural fairness and the proposed framework are an important step in improving equity in health sector financing, the report falls short on several aspects of achieving the set objectives. First, the report does not place emphasis on the role of civic education as an important component of public education building on access to information. Therefore, there should be caution in assuming that improved dissemination of information will lead to increased civic action. Secondly, the author proposes that the report include principles that should guide how decisions are made in public deliberations when consensus cannot be achieved. Lastly, the framework in the report does not speak to the complexity of the trade-offs that have to be made between health and other sectors. The author argues that a key area of deliberations in health financing is understanding how practitioners in the sector can argue for better funding against other competing sector such as education and agriculture while still finding complementarities.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"13-18"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fair processes for financing universal health coverage?","authors":"Daniel M Hausman","doi":"10.1017/S1744133124000227","DOIUrl":"10.1017/S1744133124000227","url":null,"abstract":"<p><p>Although the fair financing report, 'Open and Inclusive: Fair Processes for Financing Universal Health Coverage', has many sage things to say about democratic deliberative processes, its title belies its content: the report does not offer any assessment of processes for financing universal health coverage. What it does instead is scrutinise processes for deciding how to finance universal health coverage without any linkage to substantive questions concerning financing, and, moreover, the discussion is not narrowly focused on fairness.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"9-12"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142773503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Olena Levenets, Tetiana Stepurko, Abel Polese, Milena Pavlova, Wim Groot
{"title":"Just informal patient payments are not enough, 'personal connections' and knowledge of the 'rules' are also required: a logistic regression analysis of informal practices in health care in Ukraine.","authors":"Olena Levenets, Tetiana Stepurko, Abel Polese, Milena Pavlova, Wim Groot","doi":"10.1017/S1744133124000215","DOIUrl":"https://doi.org/10.1017/S1744133124000215","url":null,"abstract":"<p><p>In Ukraine, patients and their family members face numerous barriers to health care services. In response, they use coping strategies, that are manifold and complex activities aimed at overcoming these barriers, the financial burden of the treatment, and the poor quality of health care services. These activities include formal and informal practices. Based on representative survey data from 2015 (<i>N</i> = 2,022), we identify patterns in the use of coping strategies, specific coping strategies used to secure good quality consultation and treatment, and analyse opinions and actions towards coping practices. We further analyse the factors associated with the last experience of coping and look at patterns of connection building. We find that the chances of using both money and connection as a coping strategy are higher for people with incomplete higher and highest levels of education. The size of this effect increases with the level of education. Older people, people with better health, and people with a higher opinion of the state use informal practices less, while women are more active in developing connections. The closer the relationship is with a medical doctor, the higher is the chance that such connection will be used in case of health service consumption.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":"20 1","pages":"64-84"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144051998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Success and failure in establishing national physician databases: a comparison between Canada and Israel.","authors":"Baruch Levi, Nadav Davidovitch, Sara Allin","doi":"10.1017/S1744133124000318","DOIUrl":"10.1017/S1744133124000318","url":null,"abstract":"<p><p>Physician databases constitute an essential component of health workforce planning. However, while some countries have established functioning national physician databases, others have failed to do so. We compared the healthcare systems of two technologically and economically developed countries, Canada and Israel, which represent cases of respective success and failure in establishing physician databases. A comparative analysis was conducted using a historical-institutionalist approach to examine contemporary health policy outcomes. White papers, studies on healthcare human resources, and reports by professional committees were examined to explore the aims, interests, positions, and actions of stakeholders. In Canada, state-medical profession cooperation, deep-rooted in a longstanding regulatory bargain between the two parties, has facilitated the creation and management of physician databases, albeit limited and in need of urgent improvement, on national and jurisdictional levels. The lack of such regulatory arrangement coupled with enduring conflicted relations between stakeholders due to particular historical developments have hindered the development of an Israeli equivalent database so far. Finally, health policy outcomes may be explained against the backdrop of broader political, governance, and organisational contexts. How medical organisations respond to governmental healthcare initiatives is heavily influenced by their institutional position vis-à-vis the state, shaped by historical processes and regulatory arrangements.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":" ","pages":"47-63"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Précis of <i>Open and Inclusive: Fair Processes for Financing Universal Health Coverage</i>.","authors":"Alex Voorhoeve, Elina Dale, Unni Gopinathan","doi":"10.1017/S1744133124000331","DOIUrl":"https://doi.org/10.1017/S1744133124000331","url":null,"abstract":"<p><p>We summarise key messages from the World Bank Report <i>Open and Inclusive: Fair Processes for Financing Universal Health Coverage</i>. A central lesson of the Report is that in decision-making on the path to Universal Health Coverage (UHC), procedural fairness matters alongside substantive fairness. Decision systems should be assessed using a complete conception of procedural fairness that embodies core commitments to impartial and equal consideration of interests and perspectives. These commitments demand that comprehensive information is gathered and disclosed and that justifications for policies are publicly debated; that participation in decision-making is enabled; and that these characteristics of the decision system are institutionalised rather than up to the good will of decision-makers. Procedural fairness can improve equity in outcomes, raise legitimacy and trust, and can help make reforms last. While improving procedural fairness can be costly and there are barriers to achieving it, the range of instruments that countries at varying levels of income and institutional capacity have used with some success shows that, in many contexts, advances in procedural fairness in health financing are possible and worthwhile.</p>","PeriodicalId":46836,"journal":{"name":"Health Economics Policy and Law","volume":"20 1","pages":"4-8"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144045838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}