The mutual constitution of legal environments and practices : A case of assisted reproductive technology

Purpose – Institutional theorists treat law and regulations as external factors that is part of the organization’s environment. While institutional theory has been criticized for its inability to recognize the role of agents and to theorize agency, the growing literature on institutional work and institutional entrepreneurship, partially informed by and co-produced with practice theory, advances a more dynamic view of processes of institutionalization. In order to cope with legal and regulatory frameworks, constituting the legal environment of the organization, there are evidence of organizational responses in the form of bargaining, political negotiations, and decoupling of organizational units and processes. The purpose of this paper is to report how legal and regulatory frameworks both shape clinical practices while at the same time they are also informed by the activities and interests of professional communities and commercial clinics. Design/methodology/approach – This paper reports an empirical study of the Swedish-assisted conception industry and is based on a case study methodology including the use of interviews and formal documents and reports issues by governmental agencies. Findings – The empirical material demonstrates how scientists in reproductive medicine and clinicians regard the legal and regulatory framework as what ensures and reinforces the quality of the therapies. At the same time, they actively engage to modify the legal and regulatory framework in the case when they believe it would benefit the patients. The data reported presents one successful case of how PGD/PGS can be used to develop the efficacy of the therapy, and one unsuccessful case of regulatory change in the case of patient interest groups advocating a legalization of commercial gestational surrogacy. In the former case, scientific know-how and medicinal benefits served to “push” the new clinical practice, while in the latter case, the “demand-pull” of patient interest groups fails to get recognition in regulatory and policy-making quarters. Originality/value – The study contributes to the literature on agency in institutional theory (e.g. the emerging literature on institutional work) by emphasizing how legal and regulatory frameworks are in a constant process of being modified and negotiated in the face of novel technoscientific practices and social demands. More specifically, this process include many scientific, technological, economic, political and social relations and resources, making the legal environment of organizations what is the outcome from joint negotiations and agreements across organizational and professional boundaries.