Equivalencia terapéutica – Marco legal

Therapeutic equivalence is one of the hottest topics in Spanish pharmaceutical law and practice. In some regions, the purchasing authorities have decided to trigger public procurement procedures which may lead to the selection of one product and make it very difficult for prescribers to use a different one.

In this event, the Spanish Rheumatology Society has asked Faus & Moliner to speak about how Spanish law may impact on these issues.

Our partners Juan Suarez and Jordi Faus have worked extensively on this matter and have represented many companies in various procedures. At the course, Juan Suarez focuses on the new rules approved in July 2013, when Law 29/2006 was amended, and which foresee that only the Spanish Medicines Agency is competent to issue reports implying a comparison exercise between two medicines.

In some other European countries such as Italy, some Courts have already ruled that regional authorities should not carry out this selection of medicines unless the regulatory authorities have previously ruled that two products are therapeutically equivalent. The judgement of the Umbria Regional Court of 16 April 2013 is one of these cases.

In Spain, the Central Court for Administrative Contractual Appeals ruled, on 27 March 2013 that when approving an invitation to tender dividing the object of the contract in various lots, different active ingredients should not be included in the same group because therapeutic equivalence should not be taken for granted.