Generic and therapeutic substitutions: are they always ethical in their own terms?
- 320 Downloads
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.
- 1.Johnston A. Challenges of therapeutic substitution of drugs for economic reasons: focus on CVD prevention. Curr Med Res Opin. 2010;26(4):871–8Google Scholar
- 4.National Health Service. Prescriptions dispensed in the community statistics for 1998 to 2008: England. http://tinyurl.com/2423uov. Accessed 3 Feb 2010.
- 5.Department of Health. Consultation on the proposals to implement ‘Generic Substitution’ in primary care. http://tinyurl.com/2f2wlrt. Accessed 26 Jan 2010.
- 6.Department of Health. The NHS Constitution for England. http://tinyurl.com/8gplsm. Accessed 26 Feb 2009.
- 7.Andersson K, Sonesson C, Petzold M, Carlsten A, Lonnroth K. What are the obstacles to generic substitution? An assessment of the behaviour of prescribers, patients and pharmacies during the first year of generic substitution in Sweden. Pharmacoepidemiol Drug Saf. 2005;14(5):341–8.CrossRefPubMedGoogle Scholar
- 9.Dombrowski C. U.K. drug pricing scheme to allow generic substitution, promote innovation. EuroPharma Today. www.europharmatoday.com. Accessed 17 June 2009.
- 10.Johnston A, Stafylas P, Stergiou GS. Effectiveness, safety and cost of drug substitution in hypertension. Br J Clin Pharmacol. 2010 (accepted). http://tinyurl.com/2v6tkaq.
- 11.Lister S. Plan to switch to cheaper medicines will harm patients, say experts. timesonline. http://tinyurl.com/2wlhr4p. Accessed 4 March 2010.
- 12.Phillips B, Roberts C, Rudolph AE, Morant S, Aziz F, O’Regan CP. Switching Statins: the impact on patient outcomes. Br J Cardiol. 2007;14(5):280–5.Google Scholar
- 15.European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. http://tinyurl.com/2c8fsrw. 5 July 2010.
- 21.The Association of the British Pharmaceutical Industry. Facts & statistics from the pharmaceutical industry medicines and the NHS, 2007. http://tinyurl.com/34vm2nd. Accessed 10 July 2010.
- 22.Bandolier. Switching Statins. 2007. http://tinyurl.com/2wdgxu3. Accessed 27 July 2010.
- 35.Food and Drug Administration (FDA). Approved drug products with therapeutic equivalence evaluations. 2009. http://tinyurl.com/y92ahby. Accessed 1 Feb 2010.