Mattia Andreoletti

The increasing number of expensive cell- and gene-based therapies (CGT) on the market have raised concerns regarding equal patient access, regarding both affordability and timely access. Health Technology Assessments (HTA) and Managed Entry Agreements (MEA) play a pivotal role in pricing and reimbursement (P&R) decisions for expensive drugs in Europe, aiming to ensure patient access while optimizing resource allocation. However, discrepancies in HTA and P&R processes lead to delayed, unequal or lack of access in different countries, exacerbating health inequalities across Europe. Though they facilitate access, MEAs introduce additional delays in pricing and reimbursement discussions, and their lack of transparency increases administrative burden and encourages pricing inequity, negatively affecting healthcare system sustainability. Recent legislative changes under Regulation (EU) 2021/2282 have established the Health Technology Assessment Coordination Group (HTACG), which will oversee mandatory joint clinical assessments in the coming years. This new legislation aims to streamline HTA processes across the EU. To address the ethical imperative of improving access equality for CGT in Europe, we propose further policy reforms including concurrent HTA, early benefit assessment, and incorporation of additional elements of value in HTA evaluations, alongside current initiatives to increase cross-border collaboration.

Dementia prevention has become a priority in medical research and public health. Various medical, social and environmental risk factors have been identified; however, medical studies, media discourses and health policies predominantly centre on individual‐level prevention and promote personal responsibility for maintaining cognitive health. This emphasis on individual preventive efforts faces increasing criticism for being ethically problematic, medically insufficient and reflective of a neoliberal responsibilisation of (cognitive) ageing. Our study, based on 64 semi‐structured qualitative interviews with stakeholders involved in dementia research, care and health policy from Canada, Germany and Switzerland, situates the preventive turn within contemporary ageing cultures and welfare policies. By examining the epistemic and normative arguments underlying current debates on dementia prevention, we illustrate how stakeholders justify both personal and governmental responsibilities in preventing dementia. Although managing and mitigating various risk factors throughout life is often framed as a matter of personal responsibility, many stakeholders advocate combining individual‐level prevention with population‐level efforts to address social inequalities that affect the risk of developing dementia. Drawing on the interview study, we highlight the importance of recognising the political and normative foundations and implications of dementia prevention strategies.

This paper addresses the relatively overlooked field of rehabilitation and physical medicine, offering an epistemological perspective on clinical reasoning in these disciplines, focusing on three different domains: diagnosis, prognosis, and treatment. Rehabilitation sciences, often overshadowed by medicine and nursing, present unique challenges in terms of clinical reasoning. We explore these challenges, highlighting the distinctive features that set rehabilitation apart from clinical medicine. Notably, rehabilitation focuses on functions, aiming to improve an individual’s quality of life, setting it apart from disease-centered medicine. Drawing also from philosophical insights in nursing literature, we offer a multidisciplinary perspective on the epistemological dimensions of rehabilitation and physical medicine, shedding light on their placement within healthcare disciplines.

As a relatively new tool, the use of artificial intelligence (AI) in medicine and dentistry has the potential to significantly transform the healthcare sector. AI has already demonstrated efficacy in medical diagnosis across several specialties, used successfully to detect breast, lung and skin cancer. In Oral Medicine, AI may be applied in a similar fashion, used in the detection and diagnosis of oral cancers and oral potentially malignant diseases. Despite its promise as a transformative diagnostic aid, the use of AI in healthcare presents significant safety, reliability and ethical concerns. There is no formal consensus on the safe and ethical implementation of AI systems in healthcare settings, but the literature converges on several key principles of ethical AI use including transparency, justice and fairness, non‐maleficence, responsibility and privacy. This article provides a narrative review of the key ethical issues surrounding AI use in medicine, and reflects on these, providing view‐points of a bioethicist and Oral Medicine clinicians from several units.

The aim of this paper is to shed light on and critically evaluate the potential impact of evidential pluralism in the realm of pharmaceutical regulation. In the complex landscape of drug evaluation and approval, the role of evidence is pivotal. Firstly, we delve into the role of evidence of mechanisms within drug regulation, with a particular focus on the Accelerated Approval pathway administered by the US Food and Drug Administration. Our analysis reveals that this program, in practice, closely resembles a pluralistic approach to evidence. Secondly, we undertake a thorough examination of the reliability of evidential pluralism within the context of drug regulation. We dissect and discuss the open-cases approach recently put forth by Sung and Holman. While acknowledging its potential merits, we also identify and articulate significant limitations inherent in this approach. Finally, we propose an alternative empirical approach that centres on the real-world outcomes of regulatory programs.

The integration of Artificial Intelligence (AI) technologies into clinical practice holds significant promise for revolutionizing healthcare. However, the realization of this potential requires rigorous evaluation and validation of AI applications to ensure their safety, efficacy, and clinical significance. Despite increasing awareness of the need for robust testing, the majority of AI-related Randomized Controlled Trials (RCTs) so far have exhibited notable limitations, impeding the generalizability and proper integration of their findings into clinical settings. To understand whether the field is progressing towards more robust testing, we conducted an analysis of the registration data of ongoing and planned RCTs of AI in medicine available in the Clinicaltrials.gov database. Our analysis highlights several key trends and challenges. Effectively addressing these challenges is essential for advancing the field of medical AI and ensuring its successful integration into clinical practice.

In the evolving landscape of digital medicine, digital biomarkers have emerged as a transformative source of health data, positioning them as an indispensable element for the future of the discipline. This necessitates a comprehensive exploration of the ethical complexities and challenges intrinsic to this cutting-edge technology. To address this imperative, we conducted a scoping review, seeking to distill the scientific literature exploring the ethical dimensions of the use of digital biomarkers. By closely scrutinizing the literature, this review aims to bring to light the underlying ethical issues associated with the development and integration of digital biomarkers into medical practice.

Recent research has challenged the notion that dementia is an inevitable outcome of age-related cognitive decline, highlighting the possibility of preventing or delaying onset by addressing specific risk factors. This paradigm shift suggests that prevention through lifestyle modifications and early interventions is possible, potentially averting millions of cases worldwide. This study explores the translation of scientific evidence on dementia prevention into public health policy in Switzerland. Combining the analysis of official policy documents and qualitative interviews with stakeholders, the study explores potential barriers and challenges to implementing preventive intervenions or programs, as well as opportunities for improvement. Results indicate a significant gap in incorporating emerging scientific evidence on dementia prevention into health policies and disseminating information to the public in Switzerland. This study underscores the need for a collaborative and coordinated approach to address these barriers and effectively translate scientific findings into preventive policies and campaigns. These insights can inform policy and targeted programs in Switzerland both at the federal and the cantonal level, eventually serving as a model for other countries seeking to translate evidence-based dementia prevention strategies into public health policies. By bridging the gap between research and policy, significant progress can be made in preventing or delaying the onset of dementia, providing significant benefits to individuals, families, and society.

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and efficacy of the drug. While considerable scholarly attention has been devoted to this case, the ethical aspects of the AA regulatory pathway have so far remained relatively unexplored. In this paper, we set out to fill this gap. We illustrate six conditions that should be met for AA to be ethically acceptable: moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency. We discuss such conditions and suggest practical steps to implement them in regulatory and oversight processes. Taken together, our six conditions represent a benchmark for assessing the ethical validity of AA processes and decisions.