Pharmacy World & Science

, Volume 32, Issue 6, pp 691–695 | Cite as

Generic and therapeutic substitutions: are they always ethical in their own terms?

  • Mubarak AlAmeriEmail author
  • Miran Epstein
  • Atholl Johnston


Cost containment-driven drug substitution, whether generic or therapeutic, is defined as switching to another drug because it is cheaper. So far, such substitutions have drawn their public legitimacy from the general belief that they would not compromise the clinical interests of patients and certainly not violate their right to decline them if they did. This article does not enter the debate on whether or not such substitutions must give exclusive priority to the patient’s interests and choices in order to be ethical. Indeed, it acknowledges the plurality of views on this matter. It simply argues that when such substitutions involve a cheaper drug that is known to have different effects and side effects, or even a drug whose effects and side effects are unknown, they are potentially deleterious to the patient, and that no competent and well-informed patient would ever consent to them. Such substitutions are thus unethical in their very own terms.


Bioequivalence trials Ethics Generic substitution Non-inferiority trials Therapeutic substitution 



William Harvey Research Institute, Queen Mary University of London.

Conflicts of interest

The authors have no financial or proprietary interest in the subject matter or material discussed. We declare that we have no conflict of interest.


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Copyright information

© Springer Science+Business Media B.V. 2010

Authors and Affiliations

  • Mubarak AlAmeri
    • 1
    Email author
  • Miran Epstein
    • 2
  • Atholl Johnston
    • 1
  1. 1.Clinical Pharmacology, William Harvey Research InstituteBarts and The London, School of Medicine and DentistryLondonUK
  2. 2.Institute of Health Sciences EducationBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonLondonUK

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