Stem-cell approval leaves ethical doubts

By Karen Carstens

Date: 18/12/03

MEPs have given their seal of approval to a proposal on the handling of human tissues and cells, including stem cells, where member states permit.

But human embryos for stem-cell research are not covered, leaving controversial ethical questions surrounding EU funding for this type of research, vehemently opposed by some member states, mired in a grey zone of legal uncertainty.

The human cells and tissues directive was adopted (503 votes for to 42 against) in a second reading vote on Tuesday (16 December).

In a previous vote last April, MEPs stirred controversy by supporting a ban on creating human embryos for stem-cell research, although they failed to agree on a definition of "embryo". But, because ethical questions are considered the legal domain of member states under the subsidiarity principle, they have since been dropped from the directive.

Laura Gilbert, public affairs manager for the British Bioindustry Association, said the Parliament had now sent "a more positive" message to Europe's fledgling biotech firms.

The directive sets minimum standards for the donation, procurement, storage and processing of human tissues and cells.

Following a compromise reached with EU governments, it now states that donors can be paid for cells and tissues - but only for loss of earnings and expenses.

Some countries, including Italy and Spain, were concerned that payment would encourage a trade in body parts. The UK, by contrast, has no qualms about paying donors. It would also not mind receiving EU funds for this research.

But a blocking minority of five member states - Germany, Austria, Italy, Portugal and Luxembourg - prevented two consecutive meetings (26 November and 3 December) of EU governments from reaching agreement on unlocking frozen EU funds for stem-cell research.

The trouble is that a self-imposed moratorium on the funds is due to expire at the end of this month.

Research Commissioner Philippe Busquin has said he will start the approvals' process for less controversial projects - such as creating an EU-wide stem-cell bank - on a case-by-case basis after 1 January. But legal challenges could, in a worst-case scenario, be mounted against the EU executive by some member states.

German MEP Peter Liese, rapporteur for the cells and tissues directive, warned that the Commission "is skating on very thin ice - legally, this is very unclear".

The upcoming Irish presidency, meanwhile, has said it will not pursue the stem cells question.

Stem cells are coveted by medical researchers because these unspecialized "master" cells have a unique capacity to multiply and change into many types of cells and tissues.

Research is designed to repair damaged tissues and find cures for serious diseases and conditions including neurodegenerative disorders such as Parkinson's disease, Alzheimer's and spinal cord injuries, as well as diabetes, stroke, burns, heart disease and genetic disorders.

Stem cells can also be obtained from adults, but many researchers claim their embryonic counterparts are more promising. According to industry association EuropaBio, embryonic stem cells are "pluripotent", meaning "they have a unique capacity to develop into almost all cell lineages".

Adult stem cells, by contrast, are "multipotent" and "can only give rise to a limited number of differentiated cell lineages". Laura Gilbert said the jury was still out on whether both could serve the same purpose. "At the moment it's too early to block off either one," she said. "The research is at a fairly early stage and we should not be blocking off one of those two avenues."

The European Parliament voted on 16 December 2003 in favour of a range of strict standards on quality and safety for human tissues and cells. However, human embryos for stem-cell research are not covered, leaving controversial ethical questions surrounding EU funding for this type of research.