During the open session, a number of participants commented on the criteria used to select medicines for inclusion in the Model List, in particular, with regard to fixed-dose combination products. It was noted that fixed-dose combinations offer certain advantages; they facilitate adherence to treatment regimens and they can delay the emergence of antimicrobial resistance. It was also noted that many illogical and ad hoc combinations of various medicines are currently being marketed in a number of countries. Any proposal to include fixed-dose combinations in the Model List should be backed by adequate proof of pharmaceutical compatibility and bioavailability.
In light of these comments, the Committee recognized that its selection criteria with regard to fixed-dose combination products were in need of review and recommended that they be modified as follows:
Most essential medicines should be formulated as single compounds. Fixed-dose combination products should be selected only when the combination has a proven advantage in therapeutic effect, safety, adherence or in decreasing the emergence of drug resistance in malaria, tuberculosis and HIV/AIDS.