On Tuesday (April 23), after almost 10 years of bicameral procedures, the Brazilian Senate approved the bill of law No. 6.007/2023 (“PL No. 6.007/2023”), which establishes the new legal framework for conducting clinical research in Brazil. This project originates from PLS 200/2015, presented in April 2015 by the then senators Ana Amélia de Lemos (PP/RS), Waldemir Moka (MDB/MS) and Walter Pinheiro (PT/BA), and its approval ends a long sectoral struggle led by Aliança Pesquisa Clínica (a coalition made up of researchers, representatives of medical-scientific societies and institutions connected to the pharmaceutical innovation industry).
The approved bill of law establishes, within the scope of federal legislation, rules that seek to harmonize the Brazilian regulatory environment with international good practices in clinical research and includes, among its main guidelines, the following:
- Ethical and scientific requirements for conducting research involving human beings;
- Ethical review bodies (represented by Research Ethics Committees – CEPs);
- Protective standards for research participants;
- Responsibility of researchers and sponsors;
- Rules for the manufacture, use, import and export of goods or products for this type of research;
- Rules for the storage and use of data and human biological material;
- Change in the rules for the post-study supply of medicines, establishing that supply may be terminated, among other hypotheses, after five years of commercial availability of the experimental medicine in Brazil.
The main objectives of the PL No. 6,007/2023 are to accelerate the approval of clinical research in Brazil and provide greater legal security to all agents involved. The aim is to provide more incentives for the sector and allow Brazil to receive research that currently is no longer carried out in the country due to challenges imposed by regulation (or lack of regulation).
As per the bill rapporteur, Senator Hiran Gonçalves, the approval of the text has the ultimate purpose of benefiting people suffering from serious illnesses, such as cancer and rare diseases. According to him, the version approved by the Senate’s Commission of Constitution and Justice (CCJ) represents the possible consensus among all actors interested in the matter.
The version approved by the Senate imposes important changes in relation to the proposal from the Brazilian House of Representatives, such as:
- The maintenance of the National Ethics System in Clinical Research with Human Beings,
- The elimination of the role of the researcher-sponsor, and
- Deletion of the Commitment and Exemption Document, which could exempt research sponsors from liability.
Furthermore, the version approved by Senates’ Plenary implemented editorial adjustments in relation to the text approved by the Commission (such as replacing the expression “study center” by “research center”, which aimed to expand the scope of the Law, to reach any research with human beings conducted in the country).
PL 6,007/2023 was analyzed under an urgency regime and now proceed to presidential sanction.
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