European Advanced Therapies framework for biotech products approved

EU Health Ministers have decided to go ahead with a new system for the centralised review and approval of all gene, cell- and tissue-based therapies in the region.

On 31 May, Ministers voted in favour of the proposed "EU Regulation on Advanced Therapies" regulation, which accepts the compromise package proposed by the EU Parliament. The approval means that the EU will now have a harmonised legal framework in place for innovative treatments which could start as early as January 2008.

Andrea Rappagliosi, chair of the Healthcare Council at EuropaBio - the EU Association for Bioindustries - said: "The Advanced Therapies Regulation provides Europe with a great advantage to attract the leading companies researching and developing these innovative therapies and providing the scientific community, patients and industry with a predictable and clear legal framework."

The regulation means that all advanced therapies can receive a single EU Marketing Authorisation, valid throughout the EU, following a scientific evaluation by a new eCommittee of Advanced Therapy (CAT) experts at the EMEA.

The single, centralised authorisation will give patients the opportunity to benefit from new generation and novel treatments, while ensuring they meet EU-wide common safety and efficacy standards. The single system will replace the 27 differing standards.

The regulation text remains to be translated and also must have standard legal and linguistic checks applied to it before being formally published in the EU Official Journal.

Wills Hughes Wilson, chair of EuropaBio's Advanced Therapies Working Group, said: "Europe has been waiting a long time for this regulation and decision by the EU Health Ministers represents a great leap forward for all those who can benefit from this new generation of truly innovative treatments. For the first time, people will be able to benefit from the fruits of research, which have the potential to revolutionise treatment in a variety of serious and life-threatening conditions. The council decision is great news for everyone."

The next stage will see the development of the secondary-level implementing legislation and the Technical Guidelines. EuropaBio members have said they are looking forward to the timely setting in place of the required technical guidance and add that they are continuing to work with the EU Commission and the EMEA on these issues, together with all other stakeholders.

Members added that the implementing rules along with continued adequate funding for the EMEA are vital to ensure that the EU can develop a world-class science-based system for biotechnology products.