ELSI Implications of Prioritizing Biological Therapies in Times of COVID-19

Druedahl, Louise C.; Lebret, Audrey; Minssen, Timo

doi:10.1177/1073110520958884

Cited by 5 publications

(4 citation statements)

References 12 publications

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“…Thus, that the interviews were conducted via telephone did not influence the quality of the interviews. A main limitation is that this study was conducted prior to the COVID-19 pandemic and therefore opinions between now and then could have occurred [ 51 ]: this may be of interest to investigate in a future study. Another limitation is that we did not interview HTA bodies or physicians and that the interviews were conducted pre-Brexit and thus do not capture any possible differences in opinions between the UK and current EU regulators.…”

Section: Discussionmentioning

confidence: 99%

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

et al. 2022

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Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018–August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

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Section: Discussionmentioning

confidence: 99%

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

et al. 2022

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“…From its Danish context, one might wonder why this study was not structured by the European ethical principles presented by Rendtorff and Kemp ( 2000 ) on autonomy, dignity, integrity, and vulnerability (Druedahl, Lebret, and Minssen 2020 ). Specifically, Druedahl, Lebret, and Minssen argue that choosing Beauchamp and Childress’s theory ( 2019 ) overlooks the principle of solidarity, even though this principle is important in a Danish context (Druedahl, Lebret, and Minssen 2020 ). Nevertheless, we selected Beauchamp and Childress’s ( 2019 ) theory because it is one of the most influential theories in biomedical ethics and has been used worldwide for ethical assessments for more than four decades.…”

Section: Theorymentioning

confidence: 99%

“…Regarding Rendtorff and Kemp’s criticism that Beauchamp and Childress’s ( 2019 ) theory focuses narrowly on respect for autonomy and the claim by Druedahl, Lebret, and Minssen ( 2020 ) that Beauchamp and Childress’s account ignores the principle of solidarity, Beauchamp writes: This truly basic principle [respect for autonomy] 6 has been misrepresented in some of the bioethics literature as a principle of individualism, sometimes uncannily characterized as an “American individualism” that emphasizes a liberal political philosophy of individual rights, while neglecting solidarity, social responsibility, social justice, health policy priorities, and the like. But this principle has nothing to do with either individualism or American values.…”

Section: Theorymentioning

confidence: 99%

Principles for Just Prioritization of Expensive Biological Therapies in the Danish Healthcare System

Bladt,

Vorup-Jensen,

Ebbesen

2023

Bioethical Inquiry

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The Danish healthcare system must meet the need for easy and equal access to healthcare for every citizen. However, investigations have shown unfair prioritization of cancer patients and unfair prioritization of resources for expensive medicines over care. What is needed are principles for proper prioritization. This article investigates whether American ethicists Tom Beauchamp and James Childress’s principle of justice may be helpful as a conceptual framework for reflections on prioritization of expensive biological therapies in the Danish healthcare system. We present an empirical study exploring the principles for prioritizing new expensive biological therapies. This study includes qualitative interviews with key Danish stakeholders experienced in antibody therapy and prioritizing resources for expensive medicines. Beauchamp and Childress’s model only covers government-funded primary and acute healthcare. Based on the interviews, this study indicates that to be helpful in a Danish context this model should include equal access for citizens to government-funded primary and acute healthcare, costly medicine, and other scarce treatments. We conclude that slightly modified, Beauchamp and Childress’s principle of justice might be useful as a conceptual framework for reflections on the prioritization of expensive biological therapies in the Danish healthcare system.

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“…Some legal aspects have been discussed elsewhere 9–14 , and both the European General Data Protection Regulation (GDPR) 15 and US Health Insurance Portability and Accountability Act (HIPAA) 16 provide legal frameworks to protect citizen privacy, but ethical considerations have been less formally addressed (although of course ethics and law are often intertwined, such as with regard to privacy and ownership issues). There are methods, however, such as the framework of the principles of biomedical ethics of Beauchamp and Childress 17 (namely respect for beneficence, non-maleficence, autonomy, and justice 8–11 , 18 ), which can help to identify, address, and ultimately solve ethical medical dilemmas.…”

Section: Introductionmentioning

confidence: 99%

Ethical perspectives on surgical video recording for patients, surgeons and society: systematic review

et al. 2023

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Background Operating-room audiovisual recording is increasingly proposed, although its ethical implications need elucidation. The aim of this systematic review was to examine the published literature on ethical aspects regarding operating-room recording. Methods MEDLINE (via PubMed), Embase, and Cochrane databases were systematically searched for articles describing ethical aspects regarding surgical (both intracorporeal and operating room) recording from database inception to the present (the last search was undertaken in July 2022). Medical subject headings used in the search included ‘operating room’, ‘surgery’, ‘video recording’, ‘black box’, ‘ethics’, ‘consent’, ‘confidentiality’, ‘privacy’, and more. Title, abstract, and full-text screening determined relevance. The quality of studies was assessed using Centre for Evidence-Based Medicine grading and no formal assessment of risk of bias was attempted given the theoretical nature of the data collected. Results From 1048 citations, 22 publications met the inclusion criteria, with three more added from their references. There was evident geographical (21 were from North America/Europe) and recency (all published since 2010) bias and an exclusive patient/clinician perspective (25 of 25). The varied methodology (including ten descriptive reviews, seven opinion pieces, five surveys, two case reports, and one RCT) and evidence level (14 level V and 10 level III/IV) prevented meaningful systematic grading/meta-analysis. Publications were narratively analysed for ethical thematic content (mainly education, performance, privacy, consent, and ownership) that was then grouped by the four principles of biomedical ethics of Beauchamp and Childress, accounting for 63 distinct considerations concerning beneficence (22 of 63; 35 per cent), non-maleficence (17 of 63; 27 per cent), justice (14 of 63; 22 per cent), and autonomy (10 of 63; 16 per cent). From this, a set of proposed guidelines on the use of operative data is presented. Conclusion For a surgical video to be a truly valuable resource, its potential benefits must be more fully weighed against its potential disadvantages, so that any derived instruments have a solid ethical foundation. Universal, ethical, best-practice guidelines are needed to protect clinicians, patients, and society.

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ELSI Implications of Prioritizing Biological Therapies in Times of COVID-19

Cited by 5 publications

References 12 publications

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

Principles for Just Prioritization of Expensive Biological Therapies in the Danish Healthcare System

Ethical perspectives on surgical video recording for patients, surgeons and society: systematic review

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