Suchergebnisse

The sufficiency view : a primer / Carina Fourie -- Sufficiency, health and health care justice : the state of the debate / Annette Rid -- Axiological sufficientarianism / Iwao Hirose -- Sufficiency, priority, and aggregation / Robert Huseby -- Some questions (and answers) for sufficientarians / Liam Shields -- Essentially enough : elements of a plausible account of sufficientarianism / David V. Axelsen and Lasse Nielsen -- Intergenerational justice, sufficiency, and health / Axel Gosseries -- Basic human functional capabilities as the currency of sufficientarian distribution in healthcare / Efrat Ram-Tiktin -- Disability, disease, and health sufficiency / Sean Aas and David Wasserman -- Sufficiency of capabilities, social equality, and two-tiered health care systems / Carina Fourie -- Determining a basic minimum of accessible health care : a comparative assessment of the well-being sufficiency approach / Paul T. Menzel -- Just caring : the insufficiency of the sufficiency principle in health care / Leonard M. Fleck -- Defining health care benefit packages : how sufficientarian is current practice? / Dimitra Panteli and Ewout van Ginneken -- Sufficiency, comprehensiveness of healthcare coverage, and cost-sharing arrangements in the realpolitik of health policy / Govind Persad and Harald Schmidt -- Applying the capability approach in health economic evaluations : a sufficient solution / Paul Mark Mitchell, Tracy E. Roberts, Pelham M. Barton, and Joanna Coast

ABSTRACTAs hospitals have experienced a surge of Covid‐19 patients, investigators of Covid‐19 treatment trials face a difficult problem: when an institution has more eligible and interested patients than trial slots, who should be enrolled? Defining a clear strategy for selecting participants for "high‐demand" Covid‐19 treatment trials is important to avoid ad hoc and potentially biased decision‐making by local investigators, which could inadvertently compromise a trial's social value, participants' interests, or fairness. In this article, we propose a set of ethical criteria for evaluating participant‐selection strategies for such trials. We argue that the pandemic context—in particular, great urgency to develop safe and effective treatments, uncertainty surrounding Covid‐19, and strain on the health care system that limits the time and effort available for trial enrollment—favors participant‐selection strategies that optimize the ease of enrollment and, ideally, social value. A lottery and, where possible, a weighted lottery have important advantages in these respects.

There are millions of individuals living in North America and the European Union who lack access to healthcare services. When these individuals participate in research, they are at increased risk of being exposed to the risks and burdens of clinical trials without realizing the benefits that result from them. The mechanisms that have been proposed to ensure that research participants in low‐ and middle‐income countries are not exploited are unlikely to protect participants in high‐income countries. The present manuscript argues that one way to address concerns about exploitation in high‐income countries would be to require sponsors to provide targeted benefits such as medical treatment during the trial, or the study drug after the trial. The latter could be achieved through extension studies, expanded access programs, or named‐patient programs. Sponsors also might provide non‐medical benefits, such as education or social support. Ethical and regulatory guidance should be revised to ensure that research participants in high‐income countries who lack access to healthcare services receive sufficient benefits.

New "budget impact test" is an unpopular and flawed attempt to solve a fundamentally political problemWith hospital wards overflowing and trusts in deficit, the introduction of cost effective but expensive new technologies places increasing strain on NHS finances. The National Institute for Health and Care Excellence (NICE) and NHS England plan to tackle this problem by delaying the introduction of interventions with a "high budget impact."1 The change may deliver short term savings but is flawed.What prompted the new policy? In 2015 NICE recommended the use of several new drugs for hepatitis C.2 Although they were judged clinically useful and cost effective, NHS England considered them unaffordable, with annual costs of between £700m and £1bn, and delayed adoption.34From 1 April 2017, the current requirement to fund NICE recommended technologies within 90 days will not apply for those with annual costs that exceed £20m (€23m; $24m).1 Instead, NHS England will be granted up to three years—longer in exceptional circumstances—to conduct commercial negotiations.1 As a result, patient access to some new technologies will be substantially slowed.Views expressed during the consultation on this policy were far from supportive. Respondents recognised the …

AbstractIntroductionWhile pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co‐infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy‐specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next‐generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co‐infections research.DiscussionThe 26‐member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics‐centred guidance for advancing timely, responsible HIV/co‐infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug‐related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post‐approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co‐infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups.ConclusionsThere are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for – and the promise of – advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.