New European regulations covering assisted reproduction have been criticised by experts.
The EU Tissues and Cells Directive applies to donation of all tissues and cells except blood. It aims to prevent threats to human health, such as infection. Assisted Reproduction Technologies (ART) are covered by the directive.
But the European Society of Human Reproduction and Embryology is warning that compliance could prove extremely costly and problematic.
The Directive calls for a mandatory quality management system, requiring "adequately trained and certified staff, full documentation and formulation of standard operating procedures, quality control and quality assurance at all units performing assisted reproduction".
Under the Directive, all patients must be tested for HIV, hepatitis, Human T-lymphotropic virus, and syphilis prior to each treatment, and "this is not open for national interpretation".
About 900,000 assisted reproduction treatments such as IVF and intrauterine inseminations are carried out annually. The overwhelming majority of all patients will be non-infected, says the Society.
However, the proposal could cost over 140m Euros per year, plus extra hospital administration, personnel and documentation costs.
Dr Soren Ziebe from the University Hospital of Copenhagen, Denmark, said: "In the history of ART and the area covered by the Directive there has been no single documented report of viral transmission. How can we document something that never happened?"
The Society explains that most national authorities agree that the Directive is not relevant to the ART sector.
"The ART field should have a separate specific Directive, given that ART is so different in its specifications compared to tissue or organ donations," said Professor Jean Francois Guerin of the University of Lyon, France.
Leave a Reply