Federal Law No. 14,874/2024 is published – Research with human beings

Summary

After significant discussion about Bill No. 6.007/2023, Federal Law No. 14.874/2024 was published today to provide for research with human beings and establish the National System of Ethics in Research with Human Beings. There were two vetoes:

1) Paragraph 3 of Article 24 of the Bill, which provided that the participation of a member of an indigenous group in research would be communicated to the Public Prosecutor’s Office; and,
2) Item VI of art. 33 of the Bill, which provided for the possibility of interrupting the free supply of the experimental drug after a period of 5 (five) years has elapsed, counting from the commercial availability of the experimental drug in Brazil.

In more detailThe Ministry of Health and the Ministry of Education were consulted and expressed their support for the veto on the grounds that interrupting the supply of the drug in the post-study period would infringe on the rights of research participants and compromise the development of ethical research based on principles of dignity, beneficence and justice. Therefore, the experimental drug should continue to be supplied to research participants regardless of its commercial availability by the private sector.

The other hypotheses for interrupting the supply of the experimental drug (for example, the impossibility of obtaining or manufacturing the experimental drug for technical or safety reasons with the provision of a therapeutic alternative and the availability of the experimental drug in the public health system) have been fully maintained.

The definition of a post-study supply plan (a document drawn up by the sponsor and submitted for ethical analysis, with the justification for supplying or not supplying the experimental drug after the end of the clinical trial) has also been maintained and will allow some discussion on the subject, observing the characteristics of each study.

The reasons for the veto will be forwarded to the National Congress and deputies and senators will deliberate in a joint session. In order to reject a veto, an absolute majority of the votes cast by deputies and senators is required, i.e. 257 votes by deputies and 41 votes by senators, counted separately. If there are fewer votes for rejection in one of the Houses, the veto is upheld.

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