MEPs approve regulation for innovative therapies
A proposed regulation on marketing innovative therapies and on monitoring patients and products post-authorisation, was approved by the European Parliament on 25 April. The regulation provides for a compulsory centralised procedure to authorise the marketing of innovative products, and also for post-authorisation monitoring of patients and products. In the compromise package reached between MEPs and the Council, amendments were included to enhance product safety and make the process easier for small and medium-sized enterprises (SMEs). Innovative therapies have the potential to cure diseases such as Parkinson's, Alzheimer's and degenerative conditions such as cancer and heart disease. They involve the use of gene therapy, cell therapy and tissue engineering, and it is this aspect of the proposal that led to long discussions on ethics in the run-up to the Parliament vote. The new regulation will not affect decisions made by the Member States on whether to allow the use of certain types of cells, such as embryonic stem cells. Some MEPs had wanted to include amendments prohibiting the use of these cells, but this position was rejected first by the Environment Committee, and then by the Parliament as a whole. The general ethical principles included in the original Commission proposal therefore remain unchanged: the donation of cells and tissues must be voluntary and unpaid, and the anonymity of donors and recipients guaranteed. Patients must have the right to know the origin of any cells or tissues used, subject to respect for donor anonymity. Member States remain free to allow or forbid some therapies on their territory. MEPs voted to exclude any products containing or consisting of non-viable human or animal cells or tissues from the scope of the legislation. Hoping to encourage the development of innovative therapies, which also offer great benefits to Europe's economy, the Commission has also proposed reducing by 90% the fee payable to the European Medicines Agency (EMEA) for a scientific opinion. The Parliament voted to increase this reduction to 95% for SMEs, but to limit the reduction to 65% for other companies. MEPs also voted to reduce by 50% the marketing authorisation fee that SMEs pay. Products using cells and genes that are already on the market in accordance with existing rules will be granted a three-year transitional period. Tissue-engineered products will have four years. The regulation should come into force by mid-2008, and the Commission will have to report on how it has functioned after five years.