Rare diseases: Kedrion hoping for temporary authorisation for use of drugs (ATU) in Italy

«It is essential to insist on how important the ATU, i.e. Autorizzazione Temporanea di Utilizzo or Temporary Authorisation for use of orphan or life saving drugs, is for patients, so that quick access is given to such class of drugs while guaranteeing the products’ safety».

This was stated by Rodolfo de Dominicis, Deputy President of Kedrion, a biopharmaceutical company specialising in the development and manufacture of plasma-derived products, during the conference on “Temporary Authorisation for Use: legal deficiency and protection of the right to health”, organised in Rome a few days ago by the association “Giuseppe Dossetti: i Valori”.
In particular, the French legal framework about Temporary Authorisation for Use was described during the conference. The current French legislation enables patients to have drugs intended for the treatment of rare, orphan or serious conditions much earlier than it would take to wait for them to be awarded a Marketing Authorisation, lacking an effective therapeutic alternative, provided such products are safe.
In order to lay down rules in this respect in our country, a Bill was issued to such purpose, i.e. DDL 2153 dated 3 May 2010. Under such Bill, the Temporary Authorisation for Use framework takes inspiration from the French one and applies to drugs intended for the treatment of rare, orphan or serious conditions.
«We hope attention to such issue will remain high in Italy – Rodolfo de Dominicis went on – and we also hope a Bill will be passed that will have force per se and will not be conditional on a budget Bill». «In this way – he concluded –, there would be no extra costs for the National Health System, and the primary goal, that is to guarantee the patients’ needs, would be protected».

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