All patients undergoing assisted reproductive treatments may be screened for diseases between each cycle, potentially leading to massive cost implications, under a new interpretation of European Union rules on tissue and cell donation proposed by the European Commission.
Currently couples are screened for diseases like HIV (human immunodeficiency virus) and hepatitis before their first treatment cycle and, once completed, are considered virus-free for the remainder of the course of their treatment. However, in a meeting on 19-20 October, the Commission stated that, under the European Union Tissues and Cells Directive (EUTCD; EC/2004/23), all patients must be tested for HIV, hepatitis, Human T-lymphotropic virus (HTLV), and syphilis prior to each treatment and that this is not open for national interpretation.
At present, an estimated 500,000 IVF treatments are performed in Europe, as well as 400,000 intrauterine inseminations (IUI). The costs of this new proposal throughout Europe could be 140 million Euros annually, according to the European Society for Human Reproduction and Embryology (ESHRE). However, this figure is exclusive of additional burdens such as administration, personnel and the documentation that the hospitals would have to carry.
Professor Peter Braude, head of the Department of Women's Health at King's College, London, said: 'This new interpretation of the EU directive is of extreme concern to fertility practitioners, as it will have substantial implications for the costs of fertility treatment to individual patients and for the NHS'. He added: 'Whilst we already comply with the bizarre EU idea that sperm samples from couples who have been married or cohabiting for many years are treated as 'partner donation', and men have to have infection screens done at least annually, this interpretation would mean that both partners in the relationship would now have to be tested for HIV, hepatitis, HTLV and syphilis every time they underwent an IVF or even an IUI procedure, which could be two or three times a year or even more often'.
Dr Luca Gianaroli, chairman of ESHRE, urged members to take action over 'quite alarming signals' from the EU Commission over its interpretation of the Directive. He said that, after 30 years of IVF, 15 million treatments and around three million children born, there had been no examples of viruses being transmitted in the areas covered by the Directive.