European Parliament opens door for advanced therapies

For the European Association for Bioindustries (EuropaBio) the decision of the European Parliament is a big step towards advanced therapies regulations. Johan Vanhemelrijck, EuropaBio Secretary General: “The regulation will put an end to the bewildering patchwork of guidelines, regulations and procedures that exist today, where some countries have no specific framework at all”. The European Parliament pointed out, that the new regulation does not interfere with decisions made by Member States on whether to allow the use of specific types of cells such as embryonic stem cells in accordance with their ethical choices. The aim of the regulation is to provide a compulsory centralized procedure to authorise the marketing of these innovative products and also for post-authorisation monitoring of patients and products to enhance product safety and make life easier for small firms.

 

Beside the benefits for the patients, advanced therapies have a great potential for the European economy. Due to a report of EuropaBio, Biotechnology is the job machine of the coming decade, the share in sales of biotechnology in the pharma industry for example will grow from 11-18 percent to 18-40 percent. Furthermore the number of biopharmaceutical companies rose from 37 in 1996 to 143 in 2005 and in 30% of all in vitro diagnostics in the EU were biotech.

 

Further information: European Parliament