Consultants in Regulatory Expansion

Regulatory expansion has created a range of new actors involved in regulation’s increased activities, notably “regulatory intermediaries” – actors beyond the traditional regulator-industry dyad, such as credit ratings agencies, NGOs, or supragovernmental agency networks. One example of regulatory intermediaries, largely overlooked by the emerging literature, are expert consultants dealing with specific areas of regulation requiring highly specialised, often scientific knowledge. This paper examines the role of expert regulatory consultants as intermediaries in the process of regulatory expansion. We focus on the case of consultants in statutory regulation of in vitro diagnostics in the European Union. With the new In Vitro Diagnostics Regulation (2017/ 746), the EU has significantly tightened regulatory requirements for granting marketing authorisation of new diagnostics. The implementation of the Regulation has been fraught with resistance from the medical device and diagnostics (MD&D) industry, which has repeatedly called for a delay in its application, foreseen for 2022. The industry has notably argued a delay is warranted due to the lack of experts available in public regulators (notified bodies) across Europe. In parallel, there has been an increased demand for regulatory experts from among MD&D industry and a proliferation of freelance and small consultancy firms focused on statutory regulation of diagnostics. We examine whether and how these consultants contribute to the shaping of the new policy, whose implementation is at present still ongoing, and what the transparency and legitimacy of their input is. Based on a set of semi-structured interviews with diagnostics regulatory consultants in the UK, France, Germany, the Netherlands and Brussels, we find that the consultants’ legitimacy depends predominantly on their scientific expertise. Their influence on policy is indirect, mitigated via their provision of specific knowledge to the industry. Their interests, however, align also with those of the regulators, as their business model depends on expanding and increasingly complex regulation that is difficult to navigate for small diagnostics companies. We conclude that when regulatory expansion occurs, consultants emerge as a new category of stakeholders with specific interests and potentially opaque influence on policy.