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

T.M. Bladt , T. Vorup-Jensen , E. A. Sædder , and M. Ebbesen “Empirical Investigation of Ethical Challenges Related to the Use of Biological Therapies,” Journal of Law, Medicine & Ethics 48, no. 3 (2020): 567-568.

These are respect for autonomy, nonmaleficence, beneficence, nonmaleficence, respect for autonomy, and justice. See T. L. Beauchamp and J. F. Childress , Principles of Biomedical Ethics 7th ed., (New York: Oxford University Press, 2013), part II.

J.I. Diaz , “How Will COVID-19 Impact Biosimilar Trends In The Top 5 European Markets?” Biosimilar Development (May 5, 2020), available at <https://www.biosimilardevelopment.com/doc/how-will-covid-impact-biosimilar-trends-in-thetop-european-markets-0001> (last visited August 17, 2020).

G. Curigliano , M.J. Cardoso , P. Poortmans , et al., “Recommendations for Triage, Prioritization and Treatment of Breast Cancer Patients During the COVID-19 Pandemic,” Breast 52, no. 8 (2020), doi: 10.1016/j.breast.2020.04.00.

G. Persad , A. Wertheimer and E. J. Emanuel , “Principles for Allocation of Scare Medical Interventions,” Lancet 373, no. 9661 (2009): 423-431, at 423, doi: 10.1016/S0140-6736(09)60137-9.

M. Ebbesen and B.D. Pedersen , “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, no. 23 (2007): 1-16, doi: 10.1186/1747-5341-2-23.

See in particular J.D. Rendtorff and P. Kemp , Basic Ethical Principles in European Bioethics and Biolaw—Volume 1: Autonomy, Dignity, Integrity and Vulnerability, Report to the European Commission of the BIOMED-II Project, (Etik & Ret, 2000).

CESCR General Comment No. 14: “The Right to the Highest Attainable Standard of Health,” 11 August 2000 (in Document E/C.12/2000/4).

See the Convention on Human Rights and Biomedicine, 4 April 1997, ratified by Denmark in 1999. See also the International Covenant on Economic, Social and Cultural Rights (ICESCR), 16 December 1966, ratified by Denmark in 1972 (Art. 12 on the right to health etc). Among treaties related to vulnerable persons, see Convention on the Rights of the Child, 20 November 1989, ratified by Denmark in 1991 or Convention on the Rights of Persons with Disabilities, 13 December 2006, ratified by Denmark in 2009.

See CESCR General Comment No. 14: “The Right to the Highest Attainable Standard of Health,” 11 August 2000, Id. See also the case Pentiacova from the European Court of Human Rights, in which the Court found inadmissible the applications of several persons who claimed that the absence of reimbursement of hemodialysis breached their right to life and their right to private life. Pentiaova and others v. Moldada, App. N°14462/03 (2005).

Charles Gard and others v. UK, App n° 39793/17 (2017), at the core of this case, the interpretation of the “best interest of the child”. Prior decisions of the Court: see Hristozov and others v. Bulgaria, App. Nos. 47039/11 and 358/12 (2012) and Durisotto v. Italy, App. n° 62804/13 (2014). The applications were found inadmissible.

R.D. Truog , “The United Kingdom Sets Limits on Experimental Treatments: The Case of Charlie Gard,” JAMA 318, no. 11 (2017): 1001-1002, doi: 10.1001/jama.2017.10410.

A.S. Tsiftsoglou , S. Ruiz , and C.K. Schneider . “Development and Regulation of Biosimilars: Current Status and Future Challenges,” BioDrugs 27, no. 3 (2013): 203–211, doi: 10.1007/s40259-013-0020-y.

IQVIA. “The Impact of Biosimilar Competition in Europe,” (Oct, 2019), available at <https://ec.europa.eu/docsroom/documents/31642/attachments/1/translations/en/renditions/native> (last visited August 17, 2020).

IQVIA, D. Long , Vice President, Industry Relations, “Global / US Generics and Biosimilars: Trends, Issues and Outlook,” (February 5, 2019), available at <https://www.accessiblemeds.org/sites/default/files/2019-02/Doug-Long-Access2019.pdf> (last visited August 17, 2020)

K. Sarnola , M. Merikoski , J. Jyrkkä , and K. Hämeen-Anttila , “Physicians’ Perceptions of the Uptake of Biosimilars: A Systematic Review,” British Medical Journal Open 10 (2020): e034183, doi: 10.1136/bmjopen-2019-034183.

C. Gastieger , A.S.K. Jones , M. Kleinstäuber , et al., “The Effects of Message Framing on Patients’ Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch,” Arthritis Care Research (2019), doi: 10.1002/acr.24012.

L. Peyrin-Birouleta , S. Lönnforsb , X. Roblinc , et al. “Patient Perspectives on Biosimilars: A Survey by the European Federation of Crohn’s and Ulcerative Colitis Associations,” Journal of Crohn’s and Colitis 11, no. 1 (2017): 128-133, doi: 10.1093/ecco-jcc/jjw138.

A. Azevedo , A. Bettencourt , M. Selores , et al. “Bio-similar Agents for Psoriasis Treatment: The Perspective of Portuguese Patients,” Acta Médica Portuguesa 31, no. 3 (2018): 496-500, doi: 10.20344/amp.10127.

K. Davio , “Regulator Explains How Denmark Has Achieved Its Biosimilar Success” interview of Nikolai C. Brun, Chief Medical Officer and Director of the Division of Medical Evaluation and Biostatistics at the Danish Medicines Agency, AJMC The Center for Biosimilars, (March 19, 2020), available at <https://www.centerforbiosimilars.com/conferences/biotech-pharma-summit-biosimilars/regulator-explains-how-denmark-has-achieved-its-biosimilar-success> (last visited August 17, 2020).

For an overview of the Danish legal framework cf. C.C. Collet and J. Ørndrup , “Biosimilars and Biologics,” (January 23, 2020), available at <https://pharmaboardroom.com/legal-articles/biosimilars-biologics-denmark/> (last visited August 17, 2020).

Diaz, supra note 3; Azevedo et al., supra note 20.