Regulating ART: The Rise of a (Common?) 'Procedure-Oriented' Approach Within EU

The paper aims to suggest different regulatory models emerging from the comparative analysis of some national regulations on assisted reproduction technologies (ART), such as Spain, the UK, France and Italy. The aim is to identify common trends when approaching the decision-making process regarding ART, in order to answer the following questions: Is a set of common procedural principles (standards) detectable? What is their impact on the content of statutory law? The proposal is to shift from statutory content to the method of law-making process, in order to verify if it might be possible to identify a connection between the concrete characters of that process and its outcome. Therefore, the following indexes have been considered: a) the regulative space that is recognized by each jurisdiction for regulatory sources other than the statutory one, considering particularly the role of science and scientific knowledge as regulative means; b) the role of both expertise and society in the decision-making process and their impact on the content of regulation (in terms of both participation in and exclusion from that process); c) the existence of regulatory mechanisms open to expertise involvement in the law-enforcement process; d) law-making and law-evaluation mechanisms; e) the adequacy of scientific content of legislation, evaluated also on the grounds of its performance; f) the impact of expertise involvement on the degree of discretion exercised by the legislature. The comparative analysis has led to the identification of two general (and competing) models: 'procedure-oriented' and 'value-oriented' systems. The distinction is based on the degree of fulfillment of each classification index: the more they are accomplished, the more the regulative model will move towards a procedural approach. In order to describe the main characteristics of both models, it can be said that while within the ‘procedure-oriented’ the integration of different regulative tools prevails (albeit with different levels and mechanisms of implementation), on the contrary the ‘value-oriented’ model is characterized by a statutory-centered approach that excludes (or prevents) any contribution from different regulative sources. By analyzing different national legal systems (Spain, France and Italy), an attempt will be made to understand what the effects of each approach are, in terms of constitutional legitimacy, scientific adequateness and effective implementation.