International Journal of Clinical Pharmacy

, Volume 40, Issue 3, pp 509–512 | Cite as

Off-label and unlicensed prescribing in Europe: implications for patients’ informed consent and liability

  • Lise AagaardEmail author
  • Kent Kristensen


This article reviews the implications of off-label (OL) and unlicensed (UL) medicine use with respect to the legal duty to inform patients and the liability for failure to provide the patient with adequate information on benefits and risks. Informed consent is a legal prerequisite to any medical treatment and requires the physician to inform the patient about benefits and risks important for the patient’s decision. Since OL/UL medicine use is common in all fields of medical practice, physicians must be aware of the stricter requirements for information of the patient. The UK High Supreme Court ruled in the case Montgomery v. Lanarkshire Health Board that physicians’ information duty is not limited to the level of information that the physician finds important, but to what the patient deems important. In general, violations of the rule of informed consent does not constitute a physical injury, and patients can only claim compensation for damages, if adequate disclosure had been given, and its likely, that patients would have either rejected or opted for an alternative treatment.


Informed consent Liability Medicine use Off-label prescribing Patient information Unlicensed prescribing 




Conflicts of interest

The authors declare that they have no conflict of interest.


  1. 1.
    Lenk C, Duttge G. Ethical and legal framework and regulation for off-label use: European perspective. Ther Clin Risk Manag. 2014;10:537–46.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ. 2000;8(320):79–82.CrossRefGoogle Scholar
  3. 3.
    Spatz ES, Krumholz HM, Moulton BW. The new era of informed consent. Getting to a reasonable-patient standard through shared decision making. JAMA. 2016;315:2063–4.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    European Medicines Agency. Evidence of harm from off-label or unlicensed medicines in children. 2004.…/Other/…/WC500004021.pdf. Accessed 14 March 2018.
  5. 5.
    Aagaard L. Off-label and unlicensed prescribing of medicines in paediatric populations: occurrence and safety aspects. Basic Clin Pharmacol Toxicol. 2015;117:215–8.CrossRefPubMedGoogle Scholar
  6. 6.
    Eguale T, Buckeridge DL, Verma A, Winslade NE, Hanley JA, Tamblyn R. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med. 2016;176:55–63.CrossRefPubMedGoogle Scholar
  7. 7.
    Birkeland SB. Informed consent obtainment, malpractice, litigation, and the potential role of shared decision-making approaches. Eur J Health Law. 2016;24:1–21.Google Scholar
  8. 8.
    Danish Ministry of Health. Health Act. Consolidated Act no. 1188 of 24 September 2016. Accessed 14 March 2018.
  9. 9.
    House of Lords. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118. Accessed 14 March 2018.
  10. 10.
    United Kingdom High Supreme Court. Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland), [2015] UKSC 11, on appeal from [2013] CSIH 3; [2010] CSIH 104 (2015). Accessed 14 March 2018.
  11. 11.
    Fremgen BF. Medical law and ethics. 5th ed. Pearson; 2015.Google Scholar
  12. 12.
    Council of Europe. Convention for the Protection of Human Rights and Fundamental Freedoms. Accessed 14 March 2017.
  13. 13.
    European Court for Human Rights. Csoma v Romania. = 001-115862. Accessed 14 March 2018.
  14. 14.
    European Court for Human Rights. V.C. v. Slovakia. = 001-107364. Accessed 14 March 2018.
  15. 15.
    House of Lords. Sidaway v. Board of Governors of the Bethlehem Royal Hospital [1985] UKHL 1 (21 February 1985). Accessed 14 March 2018.
  16. 16.
    Beckmann HB, Markakis KM, Suchmann AL, Frankel RM. The doctor–patient relationship and malpractice. Lessons from plaintiff depositions. Arch Int Med. 1994;154:1365–70.CrossRefGoogle Scholar
  17. 17.
    Chan SW, Tulloch E, Cooper SE, Smith A, Wojcik W, Norman JE. Montgomery and informed consent: where are we now? BMJ. 2017;357:j2224.CrossRefPubMedGoogle Scholar
  18. 18.
    High Court of Australia. Wallace v Kam [2013]. HCA 19. 87 ALJR 648; 297 ALR 383. Accessed 14 March 2018.
  19. 19.
    Waddington L, McSherry B. Exceptions and exclusions: the right to informed consent for medical treatment of people with psychosocial disabilities in Europe. Eur J Health Law. 2016;23:279–304.CrossRefPubMedGoogle Scholar
  20. 20.
    Clark T, Nolan D. A critique of Chester v Afshar. Oxf J Leg Stud. 2014;34:659–92.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Havemann Law FirmCopenhagenDenmark
  2. 2.Institute of Law, University of Southern DenmarkOdenseDenmark

Personalised recommendations