BioWorld International Correspondent
BRUSSELS, Belgium - The European Parliament's key environment committee has at last adopted a view on proposed new European Union rules for advanced therapies - cell therapy, gene therapy and tissue engineering. That opens the way for a vote by the full Parliament in March, and for the finalization of legislation that the European biotech industry has long been calling for.
The environment committee agreed on its position by a large majority - four months after the it threw out a previous draft opinion, when its members disagreed sharply over integrating ethical controls into the new rules. Crucially, the adopted text omits an earlier clause which rejected any commercialization of the human body, of products that modify the human germ line, or of products derived from human-animal hybrids. Instead, it merely calls for the exclusion of medicines containing or deriving from human embryonic and foetal cells or human germ cells.
This neatly sidesteps the problem created by divergent national views, particularly on embryonic stem cell research, which is banned in Italy, Poland and Ireland, but allowed in the UK and Ireland. The new version leaves responsibility for ethics largely in the hands of member states.
That approach has been welcomed by industry groupings. "This is a huge positive step," said Wills Hughes-Wilson of Genzyme. The UK BioIndustry Association also saw it as positive: "The decision today is a step toward the introduction of a regulatory framework for the development and approval of safe and effective therapies for patients," said Aisling Burnand, its chief executive.
The European biotechnology industry association, EuropaBio, hailed the "overwhelming endorsement" of the concept of centralized regulation of advanced therapies, which industry sees as a way to provide a predictable framework for research and development.
The committee has backed a single assessment procedure covering the safety, efficacy and quality of all advanced therapies in the EU, including combined advanced therapies that contain a medical device and bio-material. The system would be run by the European Medicines Agency in London, so that alongside the existing single marketing authorization procedure for cell- and gene-therapy products, tissue-engineered products would also be incorporated into the system.
"A centralized procedure through the EMEA is the best way to ensure that patients have access to high-quality, safe and effective products, and will help companies by providing them with universal access to the European market," said Andrea Rappagliosi of Serono, who chairs EuropaBio's health care council. But he insisted that the London agency will have to be adequately funded to carry out its new duties.
The committee's opinion also emphasizes the need for guarantees about the safety of the products and techniques used, and urges more support for smaller companies working in this field. It excludes advanced therapies prepared in full in a hospital, but in line with industry wishes, only when they are produced "on a one-off basis according to a specific, nonstandardized and nonpatented process."
Any industrial-level production in a hospital would be covered by the requirements of the new rules, which industry feels is vital to ensure a level playing field.