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Rules and regulations in reproductive medicine: sensible requirements that should start with evidence.

Over the last decade, reproductive medicine in Western countries has seen a vast increase in rules and regulations, promoting or mandating the responsible application of available medical technologies. These regulations are meant to improve the quality and safety of the provided services and, in the case of the European Union (EU), to bring about harmonization over national borders (Pennings, 2004; Tatarenko, 2006; Johnson and Petersen, 2008). The issues considered relate to ethical, organizational and legal issues and set technical standards. In Europe, one of the most influential recent documents concerned with artificial reproductive technology (ART) is the EU Tissues and Cells Directive from 2004 (EUTCD; 2004/23/EC), with its supplementary Technical Directives (2006/17/EC, 2006/86/EC). The EUTCD and Technical Directives cover all transplanted tissues and cells, with the exception of blood and blood products. As a result, this also encompasses gametes, zygotes and embryos when processed outside the human body, irrespective of the relations between the people involved in the treatment. The EUTCD and Technical Directives provide minimum standards that ought to be taken up in the legislation of EU member states within 2 years after the adoption of 2004/23/EC. In this issue, Wingfield and Cottell present a critical appraisal of the regulatory aspects in the context of tissue and cell donation that they have been working with in Ireland since the recent introduction of mandatory testing regimes. They evaluate and question the regulations mandated by the European Directives and the national rules that these Directives have translated into in their homeland, focusing on the requirements relating to viral screening in ‘partner donation’ (the donation of cells between a man and woman who have an intimate physical relationship, according to the EU definition) (Wingfield and Cottell, 2010). The authors have scrutinized the medical and scientific evidence for the mandated procedures, complementing their literature search with a survey of the experiences in seven Irish ART clinics over the last few years. They come to the conclusion that there is no medical or scientific evidence for requiring virology screening in each treatment cycle of partner donation, and assert that it is both discriminatory and distressing. This is in line with ESHRE’s statement (2009) on the very same topic; both the statement and the overview make an appeal for reconsideration of the requirements concerned and, in general, call on professionals, politicians and others involved in making ART regulations to think about the fundamental reasons for various requirements in directives, laws, protocols etc. Are these requirements sensible and do they derive from evidence, or is ART approached as an exceptional branch of medicine for which the approach to rules may differ (Johnson and Petersen, 2008)? Wingfield and Cottell’s contribution presents a good illustration of cases that may deviate from reasonableness. It may be useful to distinguish the two basic types of reasons for questioning the regulations applied in the context of partner donation of gametes. Both are touched upon, directly and indirectly, by Wingfield and Cottell (2010) and have been dealt with in other contributions (Mortimer, 2005; ESHRE position paper, 2007; ESHRE statement, 2009):