Press Releases
EBE and EFPIA Welcome European Commission's Initiative on Advanced Therapies
EFPIA AND EBE WELCOME EUROPEAN COMMISSION’S INITIATIVE
ON ADVANCED THERAPIES
Brussels, 16 November 2005 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Emerging Biopharmaceutical Enterprises (EBE) broadly welcome the European Commission’s proposal for a new integrated EU legal framework in support of gene, cell and tissue-based therapies as an important step for patients in the key area of biotechnology.
“Advanced therapies are at the cutting edge of the biopharmaceutical sector”, stressed EFPIA Director General, Brian Ager. “The Commission's proposal aims at providing regulatory clarity and predictability that R&D-based companies need to have in order to develop and deliver new products to the patients who need them”.
So-called advanced therapy products, at the forefront of life sciences and medical innovation, are expected to have a significant positive impact on public health. They should open up new prospects for the treatment of previously untreatable conditions. Regenerative medicine for example is due to reduce the need for organ transplantation.
For EFPIA and EBE, the proposed set of new rules is likely to help highly innovative enterprises, many of them of small and medium size, that are active in these research activities. The proposal provides overall legal clarity, and includes some provisions that are clearly aimed at avoiding inappropriate bureaucracy. It allows sufficient flexibility for enterprises and regulators to keep up with the evolution of science and technology while ensuring that the primary objective of patient safety is guaranteed.
In addition to its clear public health benefits for patients, the setting up of a harmonized and adequately tailored EU framework for advanced therapy products should also contribute towards the EU goal of better health, growth and jobs.
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