Papers by Felicitas S Holzer
Revista de Bioética y Derecho, 2020
Propuesta para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID-19... more Propuesta para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID-19 Proposal for the elaboration of a triage guideline in the context of the COVID-19 pandemic Proposta per a l'elaboració d'un protocol de prova en el context de la pandèmia de COVID-19
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Swiss Medical Weekly, 2021
Over past months, several effective COVID-19 vaccine
candidates have been developed in different ... more Over past months, several effective COVID-19 vaccine
candidates have been developed in different countries
around the world, with some of them still being in the approval phase. At the same time, the impossibility of having enough vaccines for everyone in the near future has
opened the floor for a debate about the priority of values
and ethical principles that should guide vaccine allocation.
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Revista Latinoamericana de Filosofia Politica , 2020
Health research enterprises in low-and middle-income countries have frequently been associated wi... more Health research enterprises in low-and middle-income countries have frequently been associated with the moral wrong of exploitation. Accounts that predominate in the current research ethics literature frame exploitation as a transaction-specific concept irrespective of its structural context. This has led to the common notion among applied philosophers that sponsors,-usually pharmaceutical companies and national research agencies from wealthy countries-and other agents are not responsible to remedy structural injustice. This paper addresses the conceptual connection between exploitation and structural injustice in the context of off-shored international health research. I offer a new account that conceptually links structural injustice to a subset of exploitative transactions I will call "systemic exploitation". To advance my position, I will juxtapose structural theories and transactional approaches to exploitation and seek a new account that gives credit to the structural concerns without animating the transactional critique. This has considerable implications for the moral vindication to remedy background injustice.
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Ethical Theory and Moral Practice, 2021
Jeremy Snyder’s book “Exploiting Hope – How the Promise of New Medical Interventions Sustains Us ... more Jeremy Snyder’s book “Exploiting Hope – How the Promise of New Medical Interventions Sustains Us and Makes Us Vulnerable” offers a new angle on exploitation by introducing the concept of hope. The eight chapters in which he develops his main argument add to a vast companion of theories from Marxist exploitation to fairness-based accounts and accounts of respect-based exploitation.
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International Journal of Public Health, 2021
Objectives: We face the impossibility of having enough COVID-19 vaccines for everyone in the near... more Objectives: We face the impossibility of having enough COVID-19 vaccines for everyone in the near future. This study aims to contribute to the debate on equitable global access to COVID-19 vaccines, tackling key ethical discussions and policy challenges regarding early phases of COVAX, the global cooperation mechanism for supporting fair vaccine allocation. Methods: We conducted in-depth interviews with twelve experts and a literature research on academic articles, media sources and public statements. We built a data analysis matrix and conducted a thematic analysis. Results: Our findings show, first, that interviewed experts who hold different views on vaccine allocation, including moderate nationalist perspectives, agree on joining a global cooperation mechanism. Second, incentives to join COVAX vary greatly among countries. Third, specific barriers to COVAX emerged in the early implementation phase. And fourth, countries might be trapped in a zero-sum game regarding the global vaccine supply. Conclusion: We present findings that enrich analyses of early phases of COVAX (April 2020-21), we introduce three ethical discussions that provide a common ground for equitable access to COVID-19 vaccines, and we highlight policy challenges.
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Developing World Bioethics, 2022
What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and mid... more What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the
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Therapeutische Umschau, 2022
Shared Decision Making (SDM) is a normative model of decision-making in the clinical context, in ... more Shared Decision Making (SDM) is a normative model of decision-making in the clinical context, in which physicians and patients assess alternative treatment options and jointly take value-based decisions based on the preferences of patients. It is important that the exchange of information is free and uncoerced and that the advantages and disadvantages of different treatment options are carefully considered. The aim of this article is to reconstruct SDM historically and conceptually and to embed the model in a normative theory of patient autonomy. Furthermore, we define the scope of SDM in clinical practice by pointing to the limits of the SDM model. Our aim is to determine under what conditions patients and doctors take decisions together, what role doctors shall play, and when patients potentially participate too much or too little in the decision-making process.
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Journal of Medical Ethics Blog, 2022
Equal access to vaccines has been one of the key ethical challenges during the COVID-19 pandemic.... more Equal access to vaccines has been one of the key ethical challenges during the COVID-19 pandemic. Most scholars consider the massive purchase and hoarding of vaccines by high-income countries, especially at the beginning of the pandemic, to be unjust towards vulnerable people living in low-and middle-income countries.
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Journal of Medical Ethics , 2022
Equal access to vaccines has been one of the key ethical challenges during the COVID-19 pandemic.... more Equal access to vaccines has been one of the key ethical challenges during the COVID-19 pandemic. Most scholars consider the massive purchase and hoarding of vaccines by high-income countries, especially at the beginning of the pandemic, to be unjust towards the vulnerable living in low-income countries. A recent proposal by Andreas Albertsen of a vaccine tax has been put forward to remedy this problem. Under such a scheme, high-income countries would pay a contribution, conceptualised as a vaccine tax, dedicated to buying vaccines and distributing them to low and middle-income countries. Proceeding from this proposal, we critically assess the feasibility of a vaccine tax and suggest how to conceptualise and implement a vaccine tax in practice. We present our 'VaxTax model' and explore its comparative advantages and disadvantages while considering other possible measures to address the global vaccine access problem, also in view of future pandemics and disease outbreaks.
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Cadernos Ibero-Americanos de Direito Sanitário, 2021
The world witnessed one of the fasted responses in history to a new disease in terms of drug and ... more The world witnessed one of the fasted responses in history to a new disease in terms of drug and vaccine development. However, despite the fact that safe and effective vaccines for COVID-19 were developed at a remarkable pace, international cooperation seems to have failed regarding the global equitable allocation of vaccines. This article explores challenges to international cooperation in global health and specifically to the fair allocation of vaccines at a global scale. We will present major obstacles to cooperative efforts and an interesting answer such as the COVAX facility, a cooperative redistribution scheme that has recently been launched by WHO, CEPI and Gavi. Considering COVAX a laudable and necessary first step to improve international cooperation in health, we nevertheless argue that the facility needs to identify key areas of potential improvement.
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Law, Innovation and Technology , 2019
A significant part of the literature on innovative practice in medicine relates to seizing opport... more A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term innovation with the more literal of new non-validated practice. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonization of regulations and legislation (e.g. right-to-try laws).
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American Journal of Bioethics, Open Peer Commentary, 2019
In an insightful article, Jacob Earl (2019) outlines the concept of innovative practice, addresse... more In an insightful article, Jacob Earl (2019) outlines the concept of innovative practice, addresses ethical problems and presents a permissive oversight proposal to deal with the ethical concerns identified. We agree to a large extent with Earl's approach and, therefore, decided to develop his comprehensive analysis further. In particular, we want to extend it from national to global contexts. In this regard we argue that innovative practice in countries with poor regulation of the sale and marketing of new drugs carries a higher risk of crowding out research. In turn, this entails the potential harm to global public health caused by a significant reduction or exclusion of sound and socially valuable research. We think that analyzing innovative practices performed in a global landscape of poor regulation, like the one we find in many Latin American countries, can provide us with useful insights into Earl's approach.
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Hastings Center Report, 2019
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Ordnung der Wissenschaft ISSN 2197-9197, 2016
Der Zugang der Entwicklungsländer zu den Errungen
schaften des medizinischen Fortschritts i... more Der Zugang der Entwicklungsländer zu den Errungen
schaften des medizinischen Fortschritts ist vielfach defizitär. Besondere Probleme bereitet dabei der Zugang zu patentgeschützten Arzneimitteln. Das Spannungsverhältnis zwischen den internationalen Regeln des Patent
schutzes einerseits und den pharmazeutischen Bedürfnissen der Entwicklungsländer andererseits ist das Thema des Beitrags von Holzer. Schwerpunkt ist die Auseinandersetzung mit den rechtspolitischen Vorschlägen zur Lösung der Problematik. OdW ist für Diskussionsbeiträge zu diesem wichtigen wissenschaftspolitischen Thema offen.
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Bioethics , 2017
The " socially valuable knowledge " (SVK) principle has been widely acknowledged as one of the mo... more The " socially valuable knowledge " (SVK) principle has been widely acknowledged as one of the most important guiding principles for biomedical research involving human subjects. The principle states that the potential of producing socially valuable knowledge is a necessary requirement, although not sufficient, for the ethical conduct of research projects. This is due to the assumption that the social value of knowledge avoids exploitation of research subjects and justifies the use of health resources. However, more recently, several authors have started interrogating the validity of SVK in research and offered various lines of argument against the SVK principle as a necessary constraint to research. In this paper, I will reconstruct the main arguments of this discussion between defenders and debunkers of the SVK principle and offer a third way to consider the social value of knowledge in research studies. I will argue the social value of knowledge can be supported by an independent justification. This justification of the SVK principle addresses the rationality and common interest of researchers. Thus, I will introduce the SVK principle as a safeguarding principle
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Journal of Medical Ethics , 2014
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The Hastings Center Report , 2015
AbstractA commentary on “Models of Consent to Return of Incidental Findings in Genomic Research,”... more AbstractA commentary on “Models of Consent to Return of Incidental Findings in Genomic Research,” by Paul S. Appelbaum, Erik Parens, Cameron R. Waldman, Robert Klitzman, Abby Fyer, Josue Martinez, W. Nicholson Price II, and Wendy K. Chung, in the July-August 2014 issue.
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Books by Felicitas S Holzer
Book: "Praxisbuch Medizintourismus" ed. by M. Asefi; MWV Germany; ISBN: 978-3-95466-733-8, 2022
Ethik im Medizintourismus bezieht sich auf internationale Patienten, die sich-meist auf Eigenkost... more Ethik im Medizintourismus bezieht sich auf internationale Patienten, die sich-meist auf Eigenkosten-Behandlungen im Ausland unterziehen. Manchmal übernehmen allerdings auch Versicherungen oder andere Kostenträger in den Herkunftsländern die Therapiekosten. Anhand der Vielzahl rechtlicher Normen und Regulierungen des Medizinwesens in verschiedenen Ländern können diverse ethische Konflikte auftreten, was sowohl ausländische Patienten im Inland sowie einheimische Patienten im Ausland betreffen kann. Ethische Fragestellungen im Medizintourismus können insbesondere die individuellen Rechte von Patienten und Dienstleistenden, die Verteilungsgerechtigkeit von Ressourcen im Gesundheitswesen, die Regulierung von Behandlungen und Einrichtungen sowie die Beziehung von Patient und Gesundheitsversorgenden betreffen. Im Folgenden werden diese vier Themenfelder anhand von Beispielen besprochen, wobei dargelegt werden soll, welche ethischen Konflikte für Patienten, Dienstleistende sowie für Politik und Gesellschaft auftreten. 1.1. Individuelle Rechte von Patienten und Dienstleistenden Um die Problematik individueller Rechte und Pflichten zu beleuchten, werden zwei gängige Praktiken aus der Reproduktionsmedizin diskutiert, die besondere Anwendung im Medizintourismus erlangen: die künstliche Befruchtung und die Leihmutterschaft im Ausland.
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Book: M. Hevia & E. Rivera López (Eds.), Controversies in Latin American Bioethics. Springer. Zenodo Preprint, https://doi.org/10.5281/zenodo.2577257, 2019
The term "innovation" or what we call "new non-validated practice" has recently gained attention ... more The term "innovation" or what we call "new non-validated practice" has recently gained attention in the context of clinical research and practice regarding the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities that fall into this category, such as stem cell treatments, genome sequencing for diagnostic purposes, or novel and yet non-validated reproductive technologies. Latin American countries are among the places where new and non-validated medical activities take place, notably due to a lack of clear regulations and the poor support of authorities of existent legal and ethical guidelines, which is driven by "hidden battles" on the moral status of certain interventions. The increasing importance of new and non-validated interventions underlines the importance of developing a general framework for these practices. Therefore, the present chapter scrutinizes this nascent line of research in Latin America and offers a framework for innovation understood as "new non-validated practice" as well as its ethical justification. We will argue that "responsible innovation" understood as "responsible new non-validated practice" is ethically permissible and poses an acceptable medical option in exceptional circumstances where no reasonable alternatives can be provided to an individual patient. Finally, we focus on the peculiarities and specific difficulties the category of new non-validated practice poses to the Latin American context. We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America.
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Book: Precision Medicine eds. Hans-Peter Deigner and Matthias Kohl eBook ISBN: 9780128054338 Paperback ISBN: 9780128053645
This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in ... more This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical innovation applies to reasonable, but yet unproven novel health interventions, it does not aim to generate generalizable knowledge under a sound research design. We will characterize clinical innovation as “new and insufficiently validated practice” because it resembles medical practice in terms of the aim to directly benefit individual patients. However, clinical innovation departs in a significant way from validated medical practice because innovative medical procedures go along with unknown safety and efficacy features. We will argue that innovation understood as new and non-validated practice is ethically justified as an acceptable medical option when no reasonable alternatives can be provided to an individual patient. Thus, we show that clinical innovation is an ethically required category that falls under the category of clinical practice, which should be distinguished from clinical research.
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Papers by Felicitas S Holzer
candidates have been developed in different countries
around the world, with some of them still being in the approval phase. At the same time, the impossibility of having enough vaccines for everyone in the near future has
opened the floor for a debate about the priority of values
and ethical principles that should guide vaccine allocation.
schaften des medizinischen Fortschritts ist vielfach defizitär. Besondere Probleme bereitet dabei der Zugang zu patentgeschützten Arzneimitteln. Das Spannungsverhältnis zwischen den internationalen Regeln des Patent
schutzes einerseits und den pharmazeutischen Bedürfnissen der Entwicklungsländer andererseits ist das Thema des Beitrags von Holzer. Schwerpunkt ist die Auseinandersetzung mit den rechtspolitischen Vorschlägen zur Lösung der Problematik. OdW ist für Diskussionsbeiträge zu diesem wichtigen wissenschaftspolitischen Thema offen.
Books by Felicitas S Holzer
candidates have been developed in different countries
around the world, with some of them still being in the approval phase. At the same time, the impossibility of having enough vaccines for everyone in the near future has
opened the floor for a debate about the priority of values
and ethical principles that should guide vaccine allocation.
schaften des medizinischen Fortschritts ist vielfach defizitär. Besondere Probleme bereitet dabei der Zugang zu patentgeschützten Arzneimitteln. Das Spannungsverhältnis zwischen den internationalen Regeln des Patent
schutzes einerseits und den pharmazeutischen Bedürfnissen der Entwicklungsländer andererseits ist das Thema des Beitrags von Holzer. Schwerpunkt ist die Auseinandersetzung mit den rechtspolitischen Vorschlägen zur Lösung der Problematik. OdW ist für Diskussionsbeiträge zu diesem wichtigen wissenschaftspolitischen Thema offen.