Medical Research
April 29, 2007
Earlier this week, the European parliament overcame considerable misgivings from some MEPs over ethical questions, and adopted new rules to help authorize cutting-edge medical treatments,
The new EU regulation on so-called “advanced therapies” covers gene therapy, adult stem-cell therapy and tissue engineering. All three treatments are based on replacing human genes, cells or tissues affected by various diseases with healthy ones.
The regulation provides for a compulsory centralized procedure to authorize the marketing of innovative medical products and also for the subsequent monitoring of patients and products.
'Great economic potential'
It also 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 ailments such as Parkinson's, Alzheimer's, blindness, spinal cord injury, cancer and heart disease, "have great potential for the European economy," the parliament said.
Ethical debate on stem-cell research
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."
Stem-cell therapy is the most controversial emerging medical treatment as it can involve cells extracted from human embryos. The practice is illegal in some EU countries, including Poland and Italy.
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 fetal-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.
Regulation offers guarantees to donors, patients
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.
Current rules on the authorization of the so-called 'advanced
therapies' differ widely across the EU's 27 member states.