Faus & Moliner participates at the 19th National Hospitals and Health Management Congress

In recent times, the development of biological and biosimilar drugs has resulted in new legal challenges. Once the issues on the assessment and approval of these drugs were tackled at European level, rules at national level have had to deal with matters related to prescription, substitution and pharmacovigilance of these products.

The relevance of these issues has justified its treatment in the 19th National Hospitals and Health Management Congress organized by SEDISA.

In the debate that took place, participants agreed that it is convenient that biological drugs be identified with their tradename when prescribed. This is supported also by current Spanish legislation, given that Royal Decree 81/2014 states that prescriptions for biological products identify them through their tradename. The audience also agreed as regards the need of adapting pharmacovigilance procedures to the special characteristics of these products. Because of this, Royal Decree 577/2013 require that adverse reactions related to these products be notified by reference to the tradename and also to the batch number of the product that caused the event.

As regards substitution of biological products, Jordi Faus explained that under Spanish law these products may not be substituted by the pharmacists when dispensing them unless the prescribing physician expressly agrees.