Resumo

This work proposes that the performative approach based on the actor-network theory can significantly contribute to a new signification of regulation, conceived here as a performative socio-material artefact. Regulation is a broad term with an epistemological weakness which claims for new concepts. Because of it, the notion of regulation, stabilising and controlling bias, can be revisited under a new paradigm. The construct will be seen as a dynamic artefact under a performative influence. A performative mentality for studying regulation takes place from the actor-network theory perspective.

Our problem question is: “How to understand the regulation of the clinical trial segment in Brazil from a performative perspective?" We do so through a case study of Brazilian clinical trial regulation involving a debate within a bill of law in progress in the Brazilian National Congress, which aims to create a regulatory framework for clinical trial with the promise of profound changes in the relations of the actors in the system.

The heterogeneous use of “regulation” shows the gap for its review in a new paradigm. It has been criticised as a construct that lacks a theorisation to help establish an optimality criterion about what should be regulated, the extent of regulation, and who controls the regulator. However, regulation can be viewed as ontologically fluid and relational. A new concept is proposed on a performative approach based on the micro foundation of actor-network theory.

When researching based on ANT, Latour (2007, p. 208) reminds us that a painter does not create his art by starting with the frame. It means that the methodological path of mapping controversies requires more than the adoption of known techniques but the creativity of elaborating the very instruments of data collection and analysis that led to the work of following the actors and describing the performative dynamics of the regulatory artefact. In this work, we conducted a documental analysis using the cartography of controversies technique.

From the multiple ramifications and different traceable paths, we structured the reassembly of the controversy based on three narrative themes that helped us to understand the clinical trial regulatory dynamics: (a) clinical trial, (b) the CEP/CONEP system, and (c) the Bill of Law (PLS 200/2015 – PL 7082/2017) which generated fifteen controversies were mapped.

A new concept of regulation is proposed: ‘The socio-material notion derived from ANT allows us to move regulation away from the idea of an institute resulting from deliberate human will and be understood as a negotiated process of heterogeneous interests whose agency is symmetrically distributed. It is also the effect of an agreement (socio-technical arrangement) whose network actors claim power over the other actants who participate in the network.

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