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In brief

On 23 April 2024, the Federal Senate approved Bill 6,007/2023, which originated as Bill 200/2015, and which generated intense debate among all those involved in the clinical research ecosystem. 

While the bill was supported by the economic sectors and part of academia due to the stability and security it brings to clinical research in Brazil, various social segments, part of academia and government authorities who are members of the system raised concerns about the possibility of weakening national ethical guidelines and dismantling the CEP/CONEP system. 

Having returned to the Senate and under the report of Senator Dr. Hiran, the substitute was analyzed in detail.


Some highlights:

  • The bill fills a gap in the national legal system involving research with human beings, which is currently regulated by infra-legal rules.
  • The proposal now covers all research with human beings in all areas of knowledge, not just clinical research. Specific research in the humanities and social sciences will be regulated in the future.
  • The Senate rejected the Chamber of Deputies’ proposal to abolish the National System of Ethics in Clinical Research and maintain the CEPs as the only body for ethical review. The two-tiered system (CEPs and the “national research ethics body”) was re-established.
  • The Senate maintained the obligation for CEPs to have an interdisciplinary composition.
  • The Senate rejected the possibility of the CEP waiving the signing of an Informed Consent Form (ICF) for the future use of data and biological material in new research.
  • The use of placebo was regulated.
  • There are rules on the manufacture, use, import and export of goods and products for clinical research purposes.
  • The Data Protection Law must be observed in relation to the disposal of human biological material, its data and the protection of research participant data.
  • The need for prior approval of clinical trials by ANVISA is maintained when the research involves health-related products. The sanitary analysis related to primary petitions for clinical trials with human beings cannot exceed ninety working days.
  • There are rules on post-trial supply and the preparation of a post-study access plan. The post-study plan must ensure the continuity of the participant’s safety follow-up, in order to guarantee that they receive the experimental treatment after the end of the clinical trial for a fixed period of time.
  • The free supply may be interrupted, with justification from the CEP, in seven defined situations, such as, for example, the impossibility of obtaining or manufacturing the experimental drug for technical or safety reasons, and provided that the sponsor provides an equivalent or superior therapeutic alternative on the market; the expiry of a period of 5 (five) years, counting from the commercial availability of the experimental drug in Brazil or the availability of the experimental drug in the SUS.
  • Conducting research with human beings in breach of the provisions of the Law constitutes an ethical infraction and subjects the offender to the disciplinary sanctions provided for in the legislation of the professional council to which they are linked, without prejudice to civil and criminal sanctions. There is express provision for situations that constitute health infractions, as well as the subsidiary application of Data Protection Law.

More details

We recommend a detailed analysis of the final wording of Bill 6,007/2023, as there are other important changes. This bill will now be sent for presidential approval.

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Author

Henrique Kruger Frizzo joined the firm in 2004 and became a partner in 2014. He is the leader of the Life Sciences group and also integrates the Public and Regulatory Law group. He acts in the preparation of legal opinions and consultations on topics of his expertise, including tenders and contracts with the government, public service concession contracts and public-private partnerships. He has experience in complex negotiations with the government and assists clients in structuring effective government relationships. He also acts in the identification of irregularities and illicit acts in contracts and relationships with the government and in the area of sales to defense and public security agencies, including in the structuring of technological compensation agreements.
In the Healthcare sector, he advises pharmaceutical, medical device and other companies in the sector on a wide range of matters, including transactions involving commercial agreements and complex negotiations with the government and health technology transfer agreements. He also advises clients on market access strategies, including procedures for the incorporation of new health technologies into SUS and ANS, and represents companies in CMED administrative proceedings. Henrique prepares consultations involving clinical research and regulatory issues, reviews promotional materials, and acts in administrative litigation involving local health authorities and ANVISA. Additionally, he provides support in compliance issues, digital health and analysis of the constitutionality/legality of legislation. Due to his expertise, he participates in the drafting of bills of law and regulations for the industry.
In Public Law, Government Affairs, Regulatory and Compliance, he has extensive experience in corporate investigations, with a focus on government procurement and corruption, and their respective consequences in the civil and administrative areas. We assist clients in defining strategic decisions regarding the results of the investigation and participate in the defense before or during the negotiation with the civil and administrative police authorities responsible for the cases.

Author

Carla Bacchin Fernandes de Moraes Cox associou-se ao escritório em 2012. Sua área de especialização é em Direito Público e Direito Regulatório, com foco em consultivo e contencioso administrativo. Auxilia clientes na área regulatória, especialmente na área de saúde/sanitária, com atuação perante a Agência Nacional de Vigilância Sanitária – ANVISA , Comissão Nacional de Ética em Pesquisa – Conep, Câmara de Regulação do Mercado de Medicamentos – CMED, Ministério da Agricultura, Secretarias Estaduais de Saúde e vigilâncias sanitárias municipais. Atua na elaboração de pareceres e consultas sobre os temas de sua especialização, incluindo licitações e contratos com o governo. Além disso, Carla é membro da Comissão de Bioética e Biodireito da OAB.

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