Alternativas Terapéuticas Equivalentes

In recent times, the debate about when and how two or even more medicines may be declared therapeutically equivalent has become more and more important in Spain. Many Spanish regions and hospitals are taking the view that they may rule that some products are equivalent and then direct prescribers to use the one with the lowest price at least in most common situations.

The Spanish parliament is currently working on an amendment of Law 29/2006 aiming to state, in a clear manner, that only the Spanish Medicines Agency is competent to decide on whether two products are therapeutically equivalent.

In this conference, Faus & Moliner partner Juan Suarez shared the table with Emilio Vargas and Juan Tamargo, Professors at the Universidad Complutense de Madrid, and with Francisco Javier Bautista, Head of the Pharmacy Service of the Hospital Virgen del Rocio in Sevilla, one of those who has more strongly advocated for establishing therapeutic equivalence between products as a tool to improve purchasing terms.

In his presentation, Juan Suarez has stressed that neither the regions nor the pharmacy services of hospitals should individually declare that two products are therapeutically equivalent before the Spanish Medicines Agency has studied each case individually. Juan Suarez also referred to the legal limits that would apply for any declaration of this sort, in particular in the event that this declaration restricts the access of patients to products that have been admitted for reimbursement at the Spanish National Health System.