EU parliament adopts rules on new medical treatments
Medical research
(STRASBOURG) - The European parliament on Monday adopted new rules on the authorisation of cutting-edge medical treatments, overcoming considerable misgivings from some MEPs over ethical questions.
The EU regulation on techniques such as gene therapy, cell therapy and tissue engineering "offers new hope to thousands of patients and researchers", the Strasbourg-based parliament said in a statement.
British MEP Giles Chichester, a member of the parliament's Industry, Research and Energy Committee, strongly supported the measure.
"I regularly see reports in the press of exciting new therapies and developments in this field. But usually they are in the USA and not in Europe, which is to our loss," he said.
Such "innovative therapies", which have huge potential for curing diseases such as Parkinson's, Alzheimer's and other degenerative conditions including cancer and heart disease "also have great potential for the European economy", the parliament said.
The new regulation provides for a compulsory centralised procedure to authorise the marketing of innovative medical products and also for the subsequent monitoring of patients and products.
But the parliament assured it "does not interfere with decisions made by member states on whether to allow the use of specific types of cells such as embryonic stem cells in accordance with their ethical choices".
Some MEPs had tabled ethical amendments but these were mainly rejected.
The opposition came mostly from Italian and German members and those from eastern Europe, who wanted to exclude from the regulations those treatments deemed to be ethically questionable.
Polish MEP Konrad Szymanski warned that the new rules "may have serious shortcomings" as "there may not be enough guarantees for human dignities".
If Europe rightly wanted to set human rights standards in the world, he continued, it could not afford to adopt a "passive position" when it comes to advanced therapies.
An amendment that proposed the exclusion of embryonic or foetal cell tissue products from the regulation was defeated by 357 votes to 269.
The parliament did vote to exclude any products containing non-viable human or animal cells or tissues.
The regulation states that the donation of cells and tissues must be voluntary and unpaid and the anonymity of donors and recipients guaranteed.
Patients must also have the right to know the origin of any cells or tissues used, subject to respect for donor anonymity.
Three of the main political groupings in the parliament had agreed a compromise package to allow the regulation to enter into force speedily, probably around mid-2008.
It already has the approval of representatives of the 27 EU member states, despite opposition from the official parliamentary rapporteur, Slovak Miroslav Mikolasic.
The package is aimed at enhancing product safety, harmonising authorisation procedures and making life easier for small firms.
To boost the development of innovative therapies, MEPs agreed to grant smaller companies a reduction of 95 percent of the fee payable to the European Medicines Agency (EMEA) for a scientific opinion, and up to 65 percent for larger firms.
After five years the European Commission must report on the way the regulation has functioned and review its scope.
Text and Picture Copyright 2007 AFP. All other Copyright 2007 EUbusiness Ltd. All rights reserved. This material is intended solely for personal use. Any other reproduction, publication or redistribution of this material without the written agreement of the copyright owner is strictly forbidden and any breach of copyright will be considered actionable.
Webfeed
