Ethics of Phage Therapy

  • Jan Borysowski
  • Andrzej Górski


Phage therapy is an experimental method of treatment of antibiotic-resistant bacterial infections. Patients can get access to phages either by enrolling in a clinical trial or during compassionate treatment. Very few clinical trials of phages have been conducted to date. Therefore, so far most patients have got access to phage therapy on a compassionate use basis. The main objective of this chapter is to discuss main issues relevant to ethics of clinical trials and compassionate use of phage therapy. Discussion of compassionate use focuses on whether phage therapy is compliant with the four main principles of medical ethics including non-maleficence, beneficence, justice, and respect for the patient’s autonomy. Moreover, we discuss ethical guidelines which might be helpful for doctors who consider performing phage therapy on a compassionate use basis.


Ethics Phage Phage therapy Clinical trial Compassionate use 


  1. Abdelkader K, Gerstmans H, Saafan A, Dishisha T, Briers Y (2019) The preclinical and clinical progress of bacteriophages and their lytic enzymes: the parts are easier than the whole. Viruses 11(2):E96. CrossRefPubMedGoogle Scholar
  2. Balasubramanian G, Morampudi S, Chhabra P, Gowda A, Zomorodi B (2016) An overview of compassionate use programs in the European Union member states. Intractable Rare Dis Res 5:244–254. CrossRefPubMedPubMedCentralGoogle Scholar
  3. Beauchamp TL, Childress JF (2012) Principles of biomedical ethics. Oxford University Press, New YorkGoogle Scholar
  4. Borysowski J, Ehni HJ, Górski A (2017) Ethics review in compassionate use. BMC Med 15:136. CrossRefPubMedPubMedCentralGoogle Scholar
  5. Borysowski J, Ehni HJ, Górski A (2019) Ethics codes and use of new and innovative drugs. Br J Clin Pharmacol 85(3):501–507. CrossRefPubMedGoogle Scholar
  6. Caplan AL, Bateman-House A (2015) Should patients in need be given access to experimental drugs? Expert Opin Pharmacother 16(9):1275–1279. CrossRefPubMedGoogle Scholar
  7. Caplan AL, Teagarden JR, Kearns L, Bateman-House AS, Mitchell E, Arawi T, Upshur R, Singh I, Rozynska J, Cwik V, Gardner SL (2018) Fair, just and compassionate: a pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials. J Med Ethics 44(11):761–767. CrossRefPubMedGoogle Scholar
  8. Ehni HJ, Wiesing U (2019) Illegitimate authorship and flawed procedures: fundamental, formal criticisms of the declaration of Helsinki. Bioethics. CrossRefGoogle Scholar
  9. Electronic Code of Federal Regulations (2009) Expanded access to investigational drugs for treatment use. Accessed 12 Mar 2019
  10. Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283(20):2701–2711. CrossRefPubMedGoogle Scholar
  11. European Parliament (2004a) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
  12. European Parliament (2004b) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the community code relating to medicinal products for human use.
  13. Górski A, Bollyky PL, Przybylski M, Borysowski J, Międzybrodzki R, Jończyk-Matysiak E, Weber-Dąbrowska B (2019) Perspectives of phage therapy in non-bacterial infections. Front Microbiol 9:3306. CrossRefPubMedPubMedCentralGoogle Scholar
  14. Henein A (2013) What are the limitations on the wider therapeutic use of phage? Bacteriophage 3(2):e24872. CrossRefPubMedPubMedCentralGoogle Scholar
  15. Jarow JP, Lemery S, Bugin K, Khozin S, Moscicki R (2016) Expanded access of investigational drugs: the experience of the center of drug evaluation and research over a 10-year period. Ther Innov Regul Sci 50:705–709. CrossRefPubMedPubMedCentralGoogle Scholar
  16. Kortright KE, Chan BK, Koff JL, Turner PE (2019) Phage therapy: a renewed approach to combat antibiotic-resistant bacteria. Cell Host Microbe 25(2):219–232. CrossRefPubMedGoogle Scholar
  17. Littmann J, Buyx A, Cars O (2015) Antibiotic resistance: an ethical challenge. Int J Antimicrob Agents 46(4):359–361. CrossRefPubMedGoogle Scholar
  18. Miedzybrodzki R, Fortuna W, Weber-Dabrowska B, Górski A (2009) A retrospective analysis of changes in inflammatory markers in patients treated with bacterial viruses. Clin Exp Med 9(4):303–312. CrossRefPubMedGoogle Scholar
  19. Międzybrodzki R, Borysowski J, Weber-Dąbrowska B, Fortuna W, Letkiewicz S, Szufnarowski K, Pawełczyk Z, Rogóż P, Kłak M, Wojtasik E, Górski A (2012) Clinical aspects of phage therapy. Adv Virus Res 83:73–121. CrossRefPubMedPubMedCentralGoogle Scholar
  20. Moye ZD, Woolston J, Sulakvelidze A (2018) Bacteriophage applications for food production and processing. Viruses 10(4):E205. CrossRefPubMedGoogle Scholar
  21. Nardini C (2014) The ethics of clinical trials. Ecancermedicalscience 8:387. CrossRefPubMedPubMedCentralGoogle Scholar
  22. Sawchik J, Hamdani J, Vanhaeverbeek M (2018) Randomized clinical trials and observational studies in the assessment of drug safety. Rev Epidemiol Sante Publique 66(3):217–225. CrossRefPubMedGoogle Scholar
  23. Vandenheuvel D, Lavigne R, Brüssow H (2015) Bacteriophage therapy: advances in formulation strategies and human clinical trials. Annu Rev Virol 2(1):599–618. CrossRefPubMedGoogle Scholar
  24. World Medical Association (2006) WMA international code of medical ethics.

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© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Jan Borysowski
    • 1
  • Andrzej Górski
    • 1
    • 2
  1. 1.Department of Clinical ImmunologyMedical University of WarsawWarsawPoland
  2. 2.Laboratory of Bacteriophages, Ludwik Hirszfeld Institute of Immunology and Experimental TherapyPolish Academy of SciencesWrocławPoland

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