Health Technology Assessment (HTA) in Europe has undergone significant evolution, culminating in the adoption of Regulation (EU) 2021/2282 on HTA (HTAR) aimed at fostering sustainable collaboration in HTA at the European Union (EU) level. The EUnetHTA 21 project, a 2-year initiative, was commissioned to address key methodological issues and prepare for the implementation of the HTAR. This commentary documents the outcomes of the EUnetHTA 21 project, focusing on Joint Clinical Assessments (JCAs), while analyzing challenges encountered and lessons learned for future collaboration under the HTAR. The EUnetHTA 21 consortium, comprising thirteen European HTA bodies, developed twenty guidance documents and thirteen templates, refining methods and procedures for joint work in HTA at EU level. Pilot JCAs and Joint Scientific Consultations were conducted to test these materials. Lessons learned from this experience emphasize the importance of inclusive consensus building, effective time and resource management, capacity building, and continuous quality improvement. The project’s realization underscores a collective commitment among HTA bodies to continue to collaborate, now under a legal framework. Recommendations from the project, along with experiences gained from previous European Network for HTA (EUnetHTA) Joint Actions, provide a foundation for developing guidance for EU-HTA under the HTAR. Further proactive efforts at national and central levels are essential to coordinate and ensure a sustainable cooperation. The EUnetHTA 21 experience provides valuable insights for advancing cooperation in HTA under the HTAR, aiming to improve the quality of HTA, avoid duplication, and ultimately enhance patient access to safe and effective health technologies in the EU.

Innovative health technologies offer much to patients, clinicians, and health systems. Policy makers can, however, be slow to embrace innovation for many reasons, including a less robust body of evidence, perceived high costs, and a fear that once technologies enter the health system, they will be difficult to remove. Health technology funding decisions are usually made after a rigorous health technology assessment (HTA) process, including a cost analysis. However, by focusing on therapeutic value and cost-savings, the traditional HTA framework often fails to capture innovation in the assessment process. How HTA defines, evaluates, and values innovation is currently inconsistent, and it is generally agreed that by explicitly defining innovation would recognize and reward and, in turn, stimulate, encourage, and incentivize future innovation in the system. To foster innovation in health technology, policy needs to be innovative and utilize other HTA tools to inform decision making including horizon scanning, multicriteria decision analysis, and funding mechanisms such as managed agreements and coverage with evidence development. When properly supported and incentivized, and by shifting the focus from cost to investment, innovation in health technology such as genomics, point-of-care testing, and digital health may deliver better patient outcomes. Industry and agency members of the Health Technology Assessment International Asia Policy Forum (APF) met in Taiwan in November 2023 to discuss the potential of HTA to foster innovation, especially in the Asia region. Discussions and presentations during the 2023 APF were informed by a background paper, which forms the basis of this paper.

Contact tracing for COVID-19 in England operated from May 2020 to February 2022. The clinical, demographic and exposure information collected on cases and their contacts offered a unique opportunity to study secondary transmission. We aimed to quantify the relative impact of host factors and exposure settings on secondary COVID-19 transmission risk using 550,000 sampled transmission links between cases and their contacts. Links, or ‘contact episodes’, were established where a contact subsequently became a case, using an algorithm accounting for incubation period, setting, and contact date. A mixed-effects logistic regression model was used to estimate adjusted odds of transmission. Of sampled episodes, 8.7% resulted in secondary cases. Living with a case (71% episodes) was the most significant risk factor (aOR = 2.6, CI = 1.9–3.6). Other risk factors included unvaccinated status (aOR = 1.2, CI = 1.2–1.3), symptoms, and older age (66–79 years; aOR = 1.4, CI = 1.4–1.5). Whilst global COVID-19 strategies emphasized protection outside the home, including education, travel, and gathering restrictions, this study evidences the relative importance of household transmission. There is a need to reconsider the contribution of household transmission to future control strategies and the requirement for effective infection control within households.

Avoidable disasters are both saddening and baffling. In 2022, 159 people, mostly in their 20s, and 30s were crushed to death in Itaewon’s narrow alleyway amid South Korea’s first pandemic-restrictions-free Halloween celebration. What is particularly sobering about this tragedy is that although many people called police hotlines as crowds became cramped and static, their calls went unheeded for hours. Rather than order independent investigations into the catastrophe (as of January 2024), the President of South Korea at the time focused on superficial issues such as asking the public to refer to the disaster as an “accident” (which it was not, it was an avoidable disaster) and the casualties as “the dead” (who are casualties indeed, instead of victims of a preventable tragedy). In this paper, we examine how officials’ complacency about public health and safety dangers, ineffective disaster prevention, and preparedness systems, as well as the government’s chronic lack of prioritization of public health and safety may have contributed to the disaster. Furthermore, we discuss the importance of creating integrated public health and safety protection systems to prevent similar tragedies from happening.

A substantial international body of evidence links housing to health outcomes. In 2021, the World Health Organisation (WHO) evaluated a small selection of policies from its six geographic regions and found that, in Australia as in the rest of the world, existing healthy housing measures fall short of the systemic response required to address health impacts and inequities. This paper takes the novel step of applying Bacchi’s (2009) ‘What is the Problem Represented to Be?’ approach to a wide-ranging thematic analysis of over 300 Australian policies across the domains of health and housing and related policy areas. In so doing, it offers an overview of existing healthy housing policy as well as illuminating the conceptual understandings and priorities of policy makers, shedding light on the policy paradigms that see housing under-utilised as a preventive health and health equity measure.

This column describes the history, mission, and work of Saint Louis University School of Law’s service-learning course Health Law, Policy and Advocacy: Grassroots Advocacy. Grassroots Advocacy allows law students to work with advocacy organizations on state and federal health policy initiatives, engaging in legislative and administrative advocacy and public education. The course uses community collaboration, community-led advocacy, and collaborative learning to train the next generation of health policy advocates for Missouri and the nation.

Neither the individualistic regulatory health paradigm nor the vulnerable populations approach of public health can provide the legal structure necessary to address the most pressing problems in health care today. These approaches fail to address conflicts between individuals and populations as well as challenges to qualifying for care and are in inherent conflict with each other, sometimes within the same statute. As health concerns become more global, it is necessary to move past a vulnerable populations approach to a broader population approach that respects individual choice but does not sacrifice community health for liberty interests.

Women are the fastest-growing population of people who use drugs in the US. As a group, they are more likely than men to experience stigma, poverty, and negative mental health outcomes. This article discusses the unique needs of women drug users in the US and provides suggestions on how to leverage national attention — and federal funding — to make harm reduction services in the US more gender sensitive, and, as a result, more effective in reducing harm for women who use drugs in this country.

Australia’s mandatory vaccination policies have historically allowed for non-medical exemptions (NMEs), but this changed in 2016 when the Federal Government discontinued NMEs for childhood vaccination requirements. Australian states introduced further mandatory vaccination policies during the COVID-19 pandemic for a range of occupations including healthcare workers (HCWs). There is global evidence to suggest that medical exemptions (MEs) increase following the discontinuation of NMEs; the new swathe of COVID-19 mandatory vaccination policies likely also placed further pressure on ME systems in many jurisdictions. This paper examines the state of play of mandatory vaccination and ME policies in Australia by outlining the structure and operation of these policies for childhood vaccines, then for COVID-19, with a case study of HCW mandates. Next, the paper explores HCWs’ experiences in providing vaccine exemptions to patients (and MEs in particular). Finally, the paper synthesizes existing literature and reflects on the challenges of MEs as a pressure point for people who do not want to vaccinate and for the clinicians who care for them, proposing areas for future research and action.

This prospective study examines the immune response to SARS-CoV-2 vaccination in patients with psychotic disorders compared with healthy volunteers. Participants were recruited naturalistically as part of the UK's COVID-19 vaccination programme. Prior to receiving their first COVID-19 vaccine, blood samples were provided by participants to examine anti-SARS-CoV-2 immunoglobulins (IgG) at baseline, followed by a repeat assay 1 month after receiving their first vaccine to assess vaccine response. The increase of IgG levels from baseline to 1 month post-vaccination was significantly lower in patients compared with controls, supporting evidence of impaired vaccine response in people with psychotic disorders. When excluding patients treated with clozapine from the analysis, this difference was no longer significant, suggesting that effects may be particularly marked in people taking clozapine.

This paper considers whether and how managed competition arrangements could be introduced into the Aotearoa health and disability system. The paper describes the key features of the system, including new organisational arrangements established from 1 July 2022. It discusses major reforms and managed competition plans that were developed in the 1990s, with the managed competition plans abandoned fairly early on, as a result of major issues with the reforms that had been implemented and with problems in designing a fair payment system for competing health plans. The paper goes on to argue that the development of capitated, risk-bearing and competing Primary Health Organisations set up in the 2000s should be considered in terms of managed competition, and the paper points to the issues that have arisen in Aotearoa due to a lack of regulations that would have better supported the better achievement of effectiveness, efficiency, and equity goals over the past 20 years. Finally, the paper also looks ahead to whether and how managed competition might again be considered in Aotearoa and the extent to which the system currently includes key pre-conditions to support such arrangements.

Antimicrobial resistance (AMR) remains a critical public health problem that pervades hospitals and health systems worldwide. The ongoing AMR crisis is not only concerning for patient care but also healthcare delivery and quality. This article outlines key components of the origins of AMR in the United States and how it presents across the American healthcare system. Numerous factors contributed to the crisis, including agricultural antibiotic use, wasteful prescribing practices in health care, conflicting behaviours among patients and clinicians, patient demand and satisfaction, and payment and reimbursement models that incentivize inappropriate antibiotic use. To combat AMR, clinicians, healthcare professionals, and legislators must continue to promote and implement innovative solutions, including antibiotic stewardship programmes (ASPs), hand hygiene protocols, ample supply of personal protective equipment (PPE), standardized treatment guidelines for antibiotic prescribing, clinician and patient educational programmes, and health policy initiatives. With the rising prevalence of multi-drug resistant bacterial infections, AMR must become a greater priority to policymakers and healthcare stakeholders.

The Australian health system is characterised by high quality care by international standards, produced by a mix of public and private provision and funding of healthcare services. Despite good overall results, three issues are of concern. The first issue relates to the public procurement of healthcare, whose flaws have impacted individuals' access to care, and the high out-of-pocket spending. The second issue concerns the sustainability of the private health insurance market, given the government's goal of relieving cost and capacity from the public scheme, incentivising participation. Third, there are existing inefficiencies and inequities related to the duplication resulting from the interaction between public and private schemes. To ensure a sustainable, efficient and equitable health system, structural reforms are necessary to achieve long-term performance improvements. Using a framework for mixed public–private health systems, we assess the extent to which the Australian healthcare system achieves preconditions for efficiency and affordability in competitive healthcare markets.