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


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.

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  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.

    Article  PubMed  PubMed Central  Google 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.

    Article  Google 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.

    Article  PubMed  PubMed Central  CAS  Google 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.

    Article  PubMed  CAS  Google 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.

    Article  PubMed  Google 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.

  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.

    Article  Google 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.

    Article  PubMed  Google 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.

    Article  PubMed  Google Scholar 

  20. 20.

    Clark T, Nolan D. A critique of Chester v Afshar. Oxf J Leg Stud. 2014;34:659–92.

    Article  Google Scholar 

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Correspondence to Lise Aagaard.

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Aagaard, L., Kristensen, K. Off-label and unlicensed prescribing in Europe: implications for patients’ informed consent and liability. Int J Clin Pharm 40, 509–512 (2018).

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