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Published in: Journal of Bioethical Inquiry 3/2023

Open Access 21-09-2023 | Original Research

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

Authors: Tara Bladt, Thomas Vorup-Jensen, Mette Ebbesen

Published in: Journal of Bioethical Inquiry | Issue 3/2023

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Abstract

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.
Footnotes
1
Since resources of societies are limited, priorities need to be set for healthcare. Beauchamp and Childress therefore consider the right to a decent minimum of health care an attractive goal “… and, realistically, probably the only goal that can be achieved in most societies seeking to implement a right to health care” (Beauchamp and Childress 2019, 292–293).
 
2
In this article, our purpose is to explore principles for just prioritization of expensive biological therapies in the Danish healthcare system. This aim includes exploring the use of data gained from analytic techniques in general in the light of distributive justice (Beauchamp and Childress 2019, 253). These analytic techniques are briefly exemplified by cost-effective and cost-benefit analyses. Strictly speaking, however, cost-effective analyses and cost-benefit analyses are two different approaches (Ubel 2000; Lippert-Rasmussen and Lauridsen 2010).
 
3
Cost-benefit analysis (CBA) (Beauchamp and Childress 2019, 253).
 
4
In this article, MS patients are considered a minor patient group suffering from a rare disease. In Denmark approximately 17,200 patients, or approx. 3:1000, suffer from MS (Danish Sclerosis Association 2022), which would not qualify MS as a rare disease according to the European Union definition with a threshold at 1:2000 (European Commission 2021). However, in the public debate, the concept of rare disease seems to follow a more relational understanding, where it is noted that the prevalence of MS is dwarfed by cancer, type II diabetes, and heart diseases. This is also evident from our interviews and discussed in the present paper with this understanding.
 
5
The issue of what equal access requires in the context of rare diseases is thoroughly discussed in the literature (Albertsen 2022; Juth 2017; Juth et al. 2021; Magalhaes 2022; Sandman and Gustavsson 2017).
 
6
Inserted by the authors.
 
7
Hermeneutics is the study of the interpretation of texts. The aim of hermeneutics is to gain a valid and common understanding of a text (Kvale 1983).
 
Literature
go back to reference Albertsen, A. 2022. Rare diseases in healthcare priority setting: Should rarity matter? Journal of Medical Ethics 48(9): 624–628.CrossRefPubMed Albertsen, A. 2022. Rare diseases in healthcare priority setting: Should rarity matter? Journal of Medical Ethics 48(9): 624–628.CrossRefPubMed
go back to reference Beauchamp, T. 2019. A defence of universal principles in biomedical ethics. In Biolaw and policy in the twenty-first century, edited by E. Valdés and J. Lecaros, 3–17. International Library of Ethics, Law, and the New Medicine. Vol. 78. Cambridge: Springer. Beauchamp, T. 2019. A defence of universal principles in biomedical ethics. In Biolaw and policy in the twenty-first century, edited by E. Valdés and J. Lecaros, 3–17. International Library of Ethics, Law, and the New Medicine. Vol. 78. Cambridge: Springer.
go back to reference Beauchamp, T. and J. Childress. 2019. Principles of biomedical ethics. 8th edition. New York: Oxford University Press. Beauchamp, T. and J. Childress. 2019. Principles of biomedical ethics. 8th edition. New York: Oxford University Press.
go back to reference Bladt, T., T. Vorup-Jensen, E. Sædder, and M. Ebbesen. 2020. Empirical investigation of ethical challenges related to the use of biological therapies. Journal of Law, Medicine and Ethics 48(3): 567–578.CrossRef Bladt, T., T. Vorup-Jensen, E. Sædder, and M. Ebbesen. 2020. Empirical investigation of ethical challenges related to the use of biological therapies. Journal of Law, Medicine and Ethics 48(3): 567–578.CrossRef
go back to reference Druedahl, L., A. Lebret, and T. Minssen. 2020. ELSI implications of prioritizing biological therapies in times of COVID-19. Journal of Law, Medicine and Ethics 48(3): 579–582.CrossRef Druedahl, L., A. Lebret, and T. Minssen. 2020. ELSI implications of prioritizing biological therapies in times of COVID-19. Journal of Law, Medicine and Ethics 48(3): 579–582.CrossRef
go back to reference Ebbesen M. 2011. Cross cultural principles for bioethics. In Advanced biomedical engineering, edited by G. Gargiulo and A. McEwan, 207–215. Croatia: IntechOpen. Ebbesen M. 2011. Cross cultural principles for bioethics. In Advanced biomedical engineering, edited by G. Gargiulo and A. McEwan, 207–215. Croatia: IntechOpen.
go back to reference ———. 2010. Two different approaches to principles of biomedical ethics: A philosophical analysis and discussion of the theories of the American ethicists Tom L. Beauchamp and James F. Childress and the Danish philosophers Jakob Rendtorff and Peter Kemp. In Bioethics: Issues and dilemmas, edited by T. Pace, 95–111. USA: Nova Science Publishers. ———. 2010. Two different approaches to principles of biomedical ethics: A philosophical analysis and discussion of the theories of the American ethicists Tom L. Beauchamp and James F. Childress and the Danish philosophers Jakob Rendtorff and Peter Kemp. In Bioethics: Issues and dilemmas, edited by T. Pace, 95–111. USA: Nova Science Publishers.
go back to reference Ebbesen M., and B. Pedersen. 2007a. Empirical investigation of the ethical reasoning of physicians and molecular biologists – The importance of the four principles of biomedical ethics. Philosophy, Ethics, and Humanities in Medicine 2: article 23. Ebbesen M., and B. Pedersen. 2007a. Empirical investigation of the ethical reasoning of physicians and molecular biologists – The importance of the four principles of biomedical ethics. Philosophy, Ethics, and Humanities in Medicine 2: article 23.
go back to reference ———. 2007b. Using empirical research to formulate normative ethical principles in biomedicine. Journal of Medicine, Healthcare and Philosophy 10(1): 33–48.CrossRef ———. 2007b. Using empirical research to formulate normative ethical principles in biomedicine. Journal of Medicine, Healthcare and Philosophy 10(1): 33–48.CrossRef
go back to reference European Commission. 2021. Directorate-General for Research and Innovation, Collaboration: A key to unlock the challenges of rare diseases research. Publications Office. https://data.europa.eu/doi/https://doi.org/10.2777/249334. Accessed December 1, 2022. European Commission. 2021. Directorate-General for Research and Innovation, Collaboration: A key to unlock the challenges of rare diseases research. Publications Office. https://​data.​europa.​eu/​doi/​https://​doi.​org/​10.​2777/​249334. Accessed December 1, 2022.
go back to reference Furst, D., F. Breedveld, G. Burmester, et al. 1999. Access to disease modifying treatments for rheumatoid arthritis patients. Annals of Rheumatic Diseases 58(1): 1129–1130. Furst, D., F. Breedveld, G. Burmester, et al. 1999. Access to disease modifying treatments for rheumatoid arthritis patients. Annals of Rheumatic Diseases 58(1): 1129–1130.
go back to reference Gadamer, H-G. 2003. Truth and method. Originally published 1960. 2nd revised edition. Translation revised by J. Weubsheimer and D.G. Marshall. New York: Continuum. Gadamer, H-G. 2003. Truth and method. Originally published 1960. 2nd revised edition. Translation revised by J. Weubsheimer and D.G. Marshall. New York: Continuum.
go back to reference Higginbottom, G., J. Pillay, and N. Boadu. 2013. Guidance on performing focused ethnographies with an emphasis on healthcare research. The Qualitative Report 18(9): 1–6. Higginbottom, G., J. Pillay, and N. Boadu. 2013. Guidance on performing focused ethnographies with an emphasis on healthcare research. The Qualitative Report 18(9): 1–6.
go back to reference Juth, N. 2017. For the sake of justice: Should we prioritize rare diseases? Healthcare Analysis 25(1): 1–20.CrossRef Juth, N. 2017. For the sake of justice: Should we prioritize rare diseases? Healthcare Analysis 25(1): 1–20.CrossRef
go back to reference Juth, N., M. Henriksson, E. Gustavsson, and L. Sandman. 2021. Should we accept a higher cost per health improvement for orphan drugs? A review and analysis of egalitarian arguments. Bioethics 35(4): 307–314.CrossRefPubMed Juth, N., M. Henriksson, E. Gustavsson, and L. Sandman. 2021. Should we accept a higher cost per health improvement for orphan drugs? A review and analysis of egalitarian arguments. Bioethics 35(4): 307–314.CrossRefPubMed
go back to reference Kvale, S. 1983. The qualitative research interview: A phenomenological and hermeneutical mode of understanding. Journal of Phenomenological Psychology 14(2): 171–196.CrossRef Kvale, S. 1983. The qualitative research interview: A phenomenological and hermeneutical mode of understanding. Journal of Phenomenological Psychology 14(2): 171–196.CrossRef
go back to reference Lindseth, A. and A. Norberg. 2004. A phenomenological hermeneutical method for researching lived experience. Scandinavian Journal of Caring Sciences 18(2): 145–153.CrossRefPubMed Lindseth, A. and A. Norberg. 2004. A phenomenological hermeneutical method for researching lived experience. Scandinavian Journal of Caring Sciences 18(2): 145–153.CrossRefPubMed
go back to reference Lippert-Rasmussen, K., and S. Lauridsen. 2010. Justice and the allocation of healthcare resources: Should indirect, non-health effects count? Medicine, Healthcare and Philosophy 13(3): 237–246.CrossRef Lippert-Rasmussen, K., and S. Lauridsen. 2010. Justice and the allocation of healthcare resources: Should indirect, non-health effects count? Medicine, Healthcare and Philosophy 13(3): 237–246.CrossRef
go back to reference Lu, R-M., Y-C. Hwang, I-J. Liu, et al. 2020. Development of therapeutic antibodies for the treatment of diseases. Journal of Biomedical Science 27(1). Lu, R-M., Y-C. Hwang, I-J. Liu, et al. 2020. Development of therapeutic antibodies for the treatment of diseases. Journal of Biomedical Science 27(1).
go back to reference Magalhaes, M. 2022. Should rare diseases get special treatment? Journal of Medical Ethics 48(2): 86–92.CrossRefPubMed Magalhaes, M. 2022. Should rare diseases get special treatment? Journal of Medical Ethics 48(2): 86–92.CrossRefPubMed
go back to reference Mariottini, A., P. Muraro, and J. Lünemann. 2022. Antibody-mediated cell depletion therapies in multiple sclerosis. Frontiers in Immunology 13: 953649.CrossRefPubMedPubMedCentral Mariottini, A., P. Muraro, and J. Lünemann. 2022. Antibody-mediated cell depletion therapies in multiple sclerosis. Frontiers in Immunology 13: 953649.CrossRefPubMedPubMedCentral
go back to reference Murphy, K., C. Weaver, and L. Berg. 2022. Janeway’s immunobiology, 10th edition. New York: W.W. Norton & Company, Inc. Murphy, K., C. Weaver, and L. Berg. 2022. Janeway’s immunobiology, 10th edition. New York: W.W. Norton & Company, Inc.
go back to reference Parker-Lue, S., M. Santoro, and G. Koski. 2015. The ethics and economics of pharmaceutical pricing. Annual Review of Pharmacology and Toxicology 55: 191–206.CrossRefPubMed Parker-Lue, S., M. Santoro, and G. Koski. 2015. The ethics and economics of pharmaceutical pricing. Annual Review of Pharmacology and Toxicology 55: 191–206.CrossRefPubMed
go back to reference Pedersen, B. 1999. Nursing practice, language and cognition. 3rd revised edition 2005. PhD thesis. Aarhus University, Denmark. Pedersen, B. 1999. Nursing practice, language and cognition. 3rd revised edition 2005. PhD thesis. Aarhus University, Denmark.
go back to reference Rendtorff, J. 2002. Basic ethical principles in European bioethics and biolaw: Autonomy, dignity, integrity and vulnerability – Towards a foundation of bioethics and biolaw. Journal of Medicine, Healthcare and Philosophy 5: 235–244.CrossRef Rendtorff, J. 2002. Basic ethical principles in European bioethics and biolaw: Autonomy, dignity, integrity and vulnerability – Towards a foundation of bioethics and biolaw. Journal of Medicine, Healthcare and Philosophy 5: 235–244.CrossRef
go back to reference Rendtorff, J., and P. Kemp. 2000. Basic ethical principles in European bioethics and biolaw. Vol. 1: Autonomy, dignity, integrity and vulnerability. Copenhagen: Centre for Ethics and Law and Barcelona: Institut Borja de Bioètica. Rendtorff, J., and P. Kemp. 2000. Basic ethical principles in European bioethics and biolaw. Vol. 1: Autonomy, dignity, integrity and vulnerability. Copenhagen: Centre for Ethics and Law and Barcelona: Institut Borja de Bioètica.
go back to reference Ricoeur, P. 1976. Interpretation theory: Discourse and the surplus of meaning. Texas: Texas Christian University Press. Ricoeur, P. 1976. Interpretation theory: Discourse and the surplus of meaning. Texas: Texas Christian University Press.
go back to reference Sandman, L., and E. Gustavsson. 2017. The (ir)relevance of group size in health care priority setting: A reply to Juth. Healthcare Analysis 25(1): 21–33.CrossRef Sandman, L., and E. Gustavsson. 2017. The (ir)relevance of group size in health care priority setting: A reply to Juth. Healthcare Analysis 25(1): 21–33.CrossRef
go back to reference Sharma, P., and J. Allison. 2020. Dissecting the mechanisms of immune checkpoint therapy. Nature Reviews in Immunology 20: 75–76.CrossRefPubMed Sharma, P., and J. Allison. 2020. Dissecting the mechanisms of immune checkpoint therapy. Nature Reviews in Immunology 20: 75–76.CrossRefPubMed
go back to reference Troein, P., M. Newton, K. Scott, and C. Mulligan. 2021. The impact of biosimilar competition in Europe. Durham: IQVIA. Troein, P., M. Newton, K. Scott, and C. Mulligan. 2021. The impact of biosimilar competition in Europe. Durham: IQVIA.
go back to reference Ubel, P.A. 2000. Pricing life: Why it's time for health care rationing. Basic bioethics series. Cambridge, MA: MIT Press. Ubel, P.A. 2000. Pricing life: Why it's time for health care rationing. Basic bioethics series. Cambridge, MA: MIT Press.
Metadata
Title
Principles for Just Prioritization of Expensive Biological Therapies in the Danish Healthcare System
Authors
Tara Bladt
Thomas Vorup-Jensen
Mette Ebbesen
Publication date
21-09-2023
Publisher
Springer Nature Singapore
Published in
Journal of Bioethical Inquiry / Issue 3/2023
Print ISSN: 1176-7529
Electronic ISSN: 1872-4353
DOI
https://doi.org/10.1007/s11673-023-10283-2

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