EuropaBio welcomes the European Commission’s intentions to improve the Regulation on advanced therapy medicinal products

03.04.2014

Statement

Brussels, 03 April 2014

 

EuropaBio welcomes the European Commission’s publication of the report on the application of the Regulation 1394/2007 on advanced therapy medicinal products (ATMPs). This report outlines the situation of ATMPs in the EU and assesses the impact of the Regulation on the development of advanced therapies.

EuropaBio members are pleased that the Commission acknowledges the current concerns and difficulties faced by ATMP developers, as was outlined in EuropaBio’s comments to the public consultation in early 2013. As only 4 ATMPs have been granted marketing authorisations since the application of the ATMP Regulation in December 2008, the Commission’s intention to improve various aspects of the ATMP Regulation is a positive sign towards the industry and patients.

EuropaBio members areglad that the Commission is committed to revitalising the EU market for ATMPs while ensuring high level of public health and patient safety.In particular, we welcome the Commission’s intention to harmonise the implementation of the ATMP Regulation when it comes to the so-called Hospital Exemption, and to streamline the marketing authorisation procedure. We believe that these improvements will further stimulate the industry, and more specifically SMEs, to invest in ATMPs and address patients’ unmet medical needs.

EuropaBio looks forward to concrete legislative steps that would make these considerations a reality. We stand ready to cooperate with the European Commission, co-legislators and stakeholders to find a balanced approach that would exploit the full potential of this promising medical technology in an enabling policy framework.