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Off-Label or Unauthorised Use of Drugs – Is It (I)Legal?

14 Pages Posted: 20 Mar 2012  

Borut Strazisar

ERUDIO - European Institute for enterpreneurship research

Strazisar Branka

affiliation not provided to SSRN

Date Written: March 16, 2012

Abstract

Objective: To clear terms off-label, unlicensed use, unauthorized use of drug and use of drug for unathorised indication, method or route of administration. To expose some medical and legal problems, connected with of drug for unathorised indication, method or route of administration.

Study methods: Review of medical and legal literature dealing with the problem of drug use for unathorised indication, method or route of administration.

Conclusion: EU legislative environment is flexible enough also for so called orphan drugs. So there is no need that in cancer treatment still exist so high percentage of drug usage for unathorised indication, method or route of administration. In the case that there is a need of such treatment, all actors should be included before drug use for unathorised indication, method or route of administration. Special attention should be given to the patient involvement. Proposed procedure could reduce the possibility for the lawsuits. It should be noted that with drug use for unathorised indication, method or route of administration the doctor could be easily found in the court.

Keywords: off label use of drug, unathorised use of drug

JEL Classification: I18, K42

Suggested Citation

Strazisar, Borut and Branka, Strazisar, Off-Label or Unauthorised Use of Drugs – Is It (I)Legal? (March 16, 2012). Available at SSRN: https://ssrn.com/abstract=2025915 or http://dx.doi.org/10.2139/ssrn.2025915

Borut Strazisar (Contact Author)

ERUDIO - European Institute for enterpreneurship research ( email )

Litostrojska c. 40B
LJUBLJANA, SI -1000
Slovenia

Strazisar Branka

affiliation not provided to SSRN ( email )

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