Brussels, 16 February 2017 - The European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) today express their support for key aspects of the “Position on Hospital Exemption” for Advanced Therapy Medicinal Products (ATMPs), developed by the Alliance for Regenerative Medicines (ARM). ARM, EBE and EFPIA call for greater transparency on all ATMPs available to patients, whether through EU authorisation or national exemptions issued in accordance with Article 28 (2) of the Advanced Therapy Medicinal Product Regulation.
On the occasion of the 5th annual conference on the regulation of ATMPs on 16 December 2016 in London, some presenters spoke to us on their work and their thoughts on how to improve access for patients to these potentially curative medicines.
Recently, compromise texts were agreed by the European Commission, Council and Parliament on new legislation on Medical Devices (MD) and on In Vitro Diagnostic (IVD) Medical Devices (MD). A key issue that remains to be dealt with is the reimbursement of diagnostic tests that are necessary to personalised medicines.