Medicamentos biosimilares – Aspectos a considerar en una regulación específica

Jordi Faus intervenes in a round table on the need of a specific regulation for biosimilar products.

CEFI, Centro de Estudios para el Fomento de la Investigación, has organized this Seminar with the aim of dealing with various matters in connection with the legal regime applicable to biologics in Spain.

The event has been opened by Maria Alonso Burgaz, President of CEFI; and by Regina Revilla Pedreira, President of Asebio.

In his speech, Jordi Faus has expressed his sympathy for the preparation of a new Royal Decree which could deal, specifically, with various aspects related to biological products. He has recalled that Article 45 of Law 29/2006 already contemplates this possibility in view of the special characteristics of these medicines.

This new regulation, in the opinion of Jordi Faus, should rely on a rigorous analysis of scientific and medical aspects; and take into account the position of the patients, of healthcare professionals, of those in charge of managing the healthcare system in general, and also of suppliers of these products. The new regulation should also address issues which are currently dispersed in various texts that have been adopted over time, and it should do so rigorously and with finesse, without forgetting that the issues at stake are rather complex and that legal certainty benefits all those whose position has to be taken into account.