Abstract
This paper looks at the recent EU public consultations on the proposed Substances of Human Origin (SoHO) Regulation and compares them with the prior consultations on the ATMP Regulation. Information on each contributor to the three most recent consultations on SoHO and the two available consultations on the ATMP was collected, analysed, and used to develop a novel typology of entities participating in the consultations. This data set included the country of origin of each entity making a contribution and the type of entity involved (academic/research Institutions, National Bodies, companies, business organizations, patient and consumer organizations, learned societies, individual citizens, networks/Innovation organizations, and other Non-Governmental Organizations). The results show that the SoHO consultations attracted a far greater total volume of participants and displayed a greater variety of organizations from more distinct countries compared to the ATMP consultations. The most significant finding is the very low overlap in organisations making a contribution to both a SoHO and an ATMP consultations. This strongly suggests that there is significant institutional fragmentation between organisations collecting human biomaterials and organisations developing ATMP for market. Given that collection of biomaterials is a necessary first step in the development of most ATMP, European policy makers wishing to support 'homegrown' innovation with ATMP should give greater consideration to building better links between organisations collecting biomaterials and ATMP developers. guarantee a high level of protection of human health, but to create a shared space of definitions, standards and practices of BI that can be considered 'European'. The creation of EU regulations on BI are a site at which visions of 'Europe' itself as a political entity are articulated, contested and ultimately enacted (Callon, 2004; Mahalatchimy et al 2021). Under the tripartite 'co-decision' ordinary system of the EU, the European Commission proposes new legislation, the European Parliament (representing EU citizens), and the Council of the European Union (representing the political positions of Member States) debate and finally vote on it. Most of the time, proposals of the Commission are based on previous works including a process of public consultation. As Faulkner (2012a) has observed the 'public' in EU public consultations on BI is primarily constituted in terms of 'stakeholders' such as national and European regulators, biotechnology, pharmaceutical and medical device companies, scientists engaged in research and development, clinicians, hospital managers, industry bodies, patient organisations, tissue and blood banks, and business consultants offering advice to smaller companies. As such the consultation is a process where "a great deal of lobbying by interest groups occurs" (Faulkner 2012a, p393). This makes the EU public consultations on regulations an important, but largely under-explored, site for studying the coproduction of law and BI in Europe.