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