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

Abstract

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.

A survey to determine the views of renal transplant patients on generic substitution in the UK

“…But some authors and general practitioners are now questioning the quality of some cheaper medicines [11][12][13][14][15][16][17][18][19]. Without consulting patients, and thus obtaining their consent to treatment, many healthcare providers including the British NHS have been promoting drug substitution in an attempt to contain their costs [20,21].…”

“…Random switching among generic versions of the same drug is also not suggested [17,18]. A study reported that indiscriminate switching among generic versions of branded drug could potentially result in 40-60% differences in rate or extent of absorption [34].…”

Generic and therapeutic substitution: ethics meets health economics

“…In their commentary on the ethical aspects of generic and therapeutic substitution, AlAmeri et al [1] argued that the health economic rationale for promoting substitution, i.e. the creation of cost savings to the health care system, may be harmful to patients and, thus, that substitution is unethical.…”

Generic and therapeutic substitution: a response to our critic

“…In his response to our paper [1], Simoens complains that we ''focus on the individual patient's perspective to the detriment of the societal perspective''. He goes further to explicate what health economics, his field, perceives to be the 'societal perspective'.…”