Brussels, 06 Jul 2005
Contribution of the European biotechnology industry to the Proposal for a Community Regulatory Framework on Advanced Therapies of 4 May 2005, following the public consultation and the stakeholder meeting organised by DG Enterprise 7 June 2005.
In 2002, the European Commission launched a first public consultation to assess the need for a legislative framework for human tissue-engineered products (hTEPs). This consultation highlighted a fairly broad consensus, in particular amongst industry and governments, in favour of a specific and uniform EU regulatory framework covering hTEPs.
Participants in the consultation acknowledged that any new initiative should comprehensively address existing and future hTEPs. In particular, this should include products which currently do not fall clearly or entirely within the scope of existing legislation (such as Directive 93/42/EEC on medical devices or Directive 2001/83/EC on medicinal products).
The main driver behind the industry's proposal is to establish an effective internal market for tissue engineered products, while ensuring the highest level of protection for patients.
This is an innovative and fast-moving healthcare sector, which promises to offer a variety of new treatment opportunities for patients with often currently unmet medical needs. According to the IPTS report on this subject, published in October 2003, about 113 tissue engineering companies were identified in Europe, most of them small and medium size companies, in particular medical device and biotech companies. Also, both during and since the Lisbon and Stockholm summits, biotechnology has been clearly identified as the backbone of a knowledge-based economy, a vital driver of Europe's competitiveness.