Europe's biotech industry has given a warm welcome to proposals put forward by the European Commission last week for new regulations governing the way that tissue engineered products are approved and marketed in the EU.
The Commission's proposal on "advanced therapies", published on November 16, covers gene therapy, cell therapy and tissue engineering treatments under a single regulatory framework. Primarily, it envisages the establishment of a central marketing authorization procedure that would allow companies working in those fields direct access to the EU market.
"The basic motivation for the regulation is very simple," Gregor Kreuzhuber, the European Commission's spokesman for enterprise and industry, told
The lack of a clear EU-wide structure has meant that individual countries have taken diverging views on the classification and authorization of products in this field. This causes a headache for companies developing tissue engineered products "which have huge potential," Kreuzhuber said. "We believe there is a clear cut case for the EU to set a straightforward framework."
The EU's biotech industry couldn't agree more, and has been calling for a regulation such as this one for years. "We're very pleased about this proposal, that's for sure," said Heidi de Wit, director of corporate affairs, Europe, for Genzyme. "If you look at all the points that have come into place, the Commission has really done a major job."
One particularly positive note is the Commission's proposal to have the regulatory process centralized through the European Medicines Agency (EMEA), said de Wit, who also heads the Advanced Therapies Working Group at EuropaBio, the biotech industry group. "Because there's so little expertise around in this area, that really is the only way to go."
The biotech industry also likes the fact that the Commission decided to propose the rules as a regulation rather than a directive, de Wit said. While directives need to be implemented into national law country by country, regulations, once passed by EU lawmakers, are immediately applicable in all EU countries.
The proposals would also create a new expert committee within the EMEA to assess advanced therapy products and follow scientific developments in the field, and create tailor-made technical requirements, adapted to the particular characteristics of these products.
Furthermore, the Commission's plan also involves strengthening requirements for risk management and traceability of gene, cell and tissue-based therapies, and offers special incentives for small and medium-sized enterprises working in the field. "Definitely it is going to encourage innovation," said de Wit.
The Commission's proposals cannot come into force until they have been passed by ministers in the Council of the European Union, and by the European Parliament. As far as the industry is concerned, that approval can't come fast enough.
"Europe is already late in this field," said Johan Vanhemelrijck, secretary general of EuropaBio, in a statement. "The US has had rules in place for these products for some time [and] US companies have benefited from a more predictable legislative environment and clarity."
Eucomed, a group that represents medical technology companies, added that the tissue engineering market has been evaluated at 400 billion euros worldwide. "A large share of this market will become accessible to the EU, if an appropriate harmonized framework is put into place," the group said in a statement.
Early indications are that the proposal "has gone down very well" among representatives of EU member countries, said Gregor Kreuzhuber. "This is largely because we have made it very clear that the proposal doesn't take away from countries' right to apply these technologies or not according to their own ethical principles."
Nevertheless, there's every chance that the proposals will be amended during the approval process, he conceded. And given the complexities of passing new rules in the EU, it is unlikely that adoption of the regulation will happen before 2007.