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Objective Data Sources and Study Setting Study Design Principal Findings Conclusion What is known on this topic What this study adds To explore variation in rates of acute care utilization for mental health conditions, including hospitalizations and emergency department (ED) visits, across high‐income countries before and during the COVID‐19 pandemic.Administrative patient‐level data between 2017 and 2020 of eight high‐income countries: Canada, England, Finland, France, New Zealand, Spain, Switzerland, and the United States (US).Multi‐country retrospective observational study using a federated data approach that evaluated age‐sex standardized rates of hospitalizations and ED visits for mental health conditions.There was significant variation in rates of acute mental health care utilization across countries. Among the subset of four countries with both hospitalization and ED data, the US had the highest pre‐COVID‐19 combined average annual acute care rate of 1613 episodes/100,000 people (95% CI: 1428, 1797). Finland had the lowest rate of 776 (686, 866). When examining hospitalization rates only, France had the highest rate of inpatient hospitalizations of 988/100,000 (95% CI 858, 1118) while Spain had the lowest at 87/100,000 (95% CI 76, 99). For ED rates for mental health conditions, the US had the highest rate of 958/100,000 (95% CI 861, 1055) while France had the lowest rate with 241/100,000 (95% CI 216, 265). Notable shifts coinciding with the onset of the COVID‐19 pandemic were observed including a substitution of care setting in the US from ED to inpatient care, and overall declines in acute care utilization in Canada and France.The study underscores the importance of understanding and addressing variation in acute care utilization for mental health conditions, including the differential effect of COVID‐19, across different health care systems. Further research is needed to elucidate the extent to which factors such as workforce capacity, access barriers, financial incentives, COVID‐19 preparedness, and community‐based care may contribute to these variations. Approximately one billion people globally live with a mental health condition, with significant consequences for individuals and societies. Rates of mental health diagnoses vary across high‐income countries, with substantial differences in access to effective care. The COVID‐19 pandemic has exacerbated mental health challenges globally, with varying impacts across countries. This study provides a comprehensive international comparison of hospitalization and emergency department visit rates for mental health conditions across eight high‐income countries. It highlights significant variations in acute care utilization patterns, particularly in countries that are more likely to care for people with mental health conditions in emergency departments rather than inpatient facilities The study identifies temporal and cross‐country differences in acute care management of mental health conditions coinciding with the onset of the COVID‐19 pandemic. [ABSTRACT FROM AUTHOR]

Ageism in healthcare has received increased attention in recent years, but literature focusing on how it affects individuals living with rare diseases remains scant. The rare disease population already faces obstacles when navigating health systems, and ageism has the potential to exacerbate existing health inequities. We conducted a systematic review of peer-reviewed and gray literature on health inequities in rare disease populations, seeking to identify publications that reported primary or secondary data on the equitable or inequitable treatment of these populations, or that discussed related regulatory, moral, or philosophical issues. Our aims were to understand how health inequities in these populations arise, how they are justified from societal points of view, how they manifest themselves in laws and regulations, and what effects they have on health care access and health outcomes. We retrieved information from 63 publications, which we inductively synthesized into five categories: ethical discussions, societal preferences, regulations, access to care, and health outcomes. Integrating insights from these categories, we developed an Ethical Spectrum and Resource Allocation Framework, which explains the emergence of equity issues and how they are manifested in health systems. By providing a better understanding of the root causes of health inequities, particularly among older adults, the framework can inform health policymaking, improving access to care and health outcomes for rare disease patients., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Newborn screening is a public health measure to diagnose rare diseases at birth, thereby minimising negative effects of late treatment. Genomic technologies promise an unprecedented expansion of screened diseases at low cost and with transformative potential for newborn screening programmes. However, barriers to the public funding of genomic newborn screening are poorly understood, particularly in light of the heterogenous European newborn screening landscape. This study therefore aims to understand whether international newborn screening experts share a common understanding of the barriers to fund genomic newborn screening. For this purpose, we convened 21 European newborn screening experts across a range of professions and national backgrounds in a Delphi study. Stable consensus, determined via the Wilcoxon matched-pairs signed-ranks test, was found via three consecutive survey rounds for all presented barriers. Experts generally judged the scenario of genomic newborn screening being available to every newborn in seven years to be unlikely, identifying treatability and the absence of counselling and a skilled workforce as the most significant barriers to public funding. We identify value re-definition for rare disease treatments, centralisation of genomic expertise, and international research consortia as avenues for pan-European actions which build on the consensus achieved by our Delphi panel., Competing Interests: Declaration of competing interest Anne-Sophie Chalandon and Alicia Granados are employed by Sanofi S.A. The views presented here are those of the authors and not necessarily those of Sanofi S.A., its directors, officers, or staff. Julian Nam is employed by F. Hoffmann-La Roche Ltd. The views presented here are those of the authors and not necessarily those of F. Hoffmann-La Roche Ltd., its directors, officers, or staff. Andreas Clemens is employed by Novartis AG. The views presented here are those of the authors and not necessarily those of Novartis AG, its directors, officers, or staff. All other authors declare that they have no conflict of interest., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Countries with small and/or less-resourced regulatory authorities that operate outside of a larger medical product regulatory system face a regulatory strategy dilemma. These countries may rely on foreign well-resourced regulators by recognising the regulatory decisions of large systems and following suit (regulatory reliance); alternatively, such countries may extend formal decision recognition to regulators in multiple other jurisdictions with similar oversight and public health goals, following a system which we call regulatory pluralism. In this policy comment, we discuss three potential limitations to regulatory pluralism: (i) regulatory escape, in which manufacturers exploit regulatory variation and choose the lowest regulatory threshold for their product; (ii) increased fragmentation and complexity for countries adopting this approach, which may, in turn, lead to inconsistent processes; and (iii) loss of international bargaining power in developing regulatory policies. We argue that regulatory pluralism has important long-term implications, which may not be readily apparent to policy makers opting for such an approach. We advocate for the long-term value of an alternative approach relying on greater collaboration between regulatory authorities, which may relieve administrative pressures on countries with small or less-resourced regulatory authorities, regardless of whether countries pursue a strategy of domestic regulation or regulatory pluralism., Competing Interests: Conflict of interest None., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)