The Union's remit in this area is limited, writes Denis Staunton, European Correspondent
The recommendations of the Commission on Assisted Human Reproduction, published this week, go far beyond what is required of the Government under EU law, it has emerged.
Ireland has until April 2006 to comply with an EU directive on human tissues and cells that was approved by EU governments and the European Parliament last year.
The directive, which was conceived by Ireland's former commissioner, David Byrne, aims to create high standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, including reproductive tissue.
It requires each EU member state to set up a competent authority to inspect and accredit tissue-banking establishments, both public and private, and to ensure that staff engaged in procuring donor tissues and other tissue-banking activities are properly trained.
The directive does not, however, oblige governments to change national rules on the use of any human tissues or cells, including those involved in assisted reproduction.
"This directive does not affect the decisions of the member states prohibiting the donation, procurement, testing, processing, preservation, storage, distribution or use of any specific type of human tissues or cells or cells from any specified source, including where those decisions also concern imports of the same type of human tissues or cells," it says.
The EU has no authority to dictate to member states on ethical issues surrounding human tissue and cells, a fact acknowledged explicitly in the directive.
"This directive should not interfere with decisions made by member states concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells . . . Moreover, this directive should not interfere with provisions of member states defining the legal term 'person' or 'individual'," it adds.
Proposing the directive three years ago, Mr Byrne said that its purpose was to protect patients who received treatment that used human tissues.
"The proposed directive will increase public confidence in the use of human tissues and cells for application in the human body," he said.
The EU has two main legal instruments, regulations and directives. Regulations are binding and directly applicable in all member states, while directives are binding as to the result to be achieved but leave the member state to decide on the method of achieving that result.
In the case of the directive on human tissues and cells, the member states were given two years to implement it.
After that, the European Commission will evaluate whether it is being implemented properly in each member state.