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Publications
Brazil enacts a law to regulate clinical trials
Brazil has enacted Law No 14,874/2024, which is the first law regulating human subjects research in the country. The law modifies regulatory oversight, introduces clear timelines and redefines sponsor responsibilities, including with relation to post trial obligations, positioning Brazil as a potential global hub for clinical research and promising increasing of investments.
Released on Feb 20, 2025
The right to be forgotten in Portugal: health and insurance law considerations
The right to be forgotten plays a crucial role in both insurance law and health law, particularly when addressing sensitive health-related information. This article discusses how health data intersects with insurance law, and the recent developments in Portugal in relation to the right to be forgotten for people who have overcome or mitigated situations of aggravated risk of health or disability.
Released on Feb 11, 2025
The legal framework for partnerships for productive development: PDPs and PDILs
This article analyses recent regulatory changes in Brazil’s health economic-industrial complex, including the transition from Decree 9,245/2017 to Decree 11,715/2023 and the impact of Ordinances 4,472/2024 and 4,473/2024. While these changes aim to enhance oversight, foster innovation and stimulate local production, they have also introduced regulatory uncertainty.
Released on Feb 11, 2025
Conflicts of interest in the relationship between medical professionals and the pharmaceutical industry
This article explores the regulatory gaps in Brazil concerning the relationship between medical professionals and the pharmaceutical industry, focusing on ethical and conflict of interest concerns. It analyses national and state-level measures, including the Minas Gerais ‘Sunshine Act’ and CFM Resolution No 2,386/2024 – discussing their implications, challenges and alignment with global transparency initiatives to safeguard patient care and uphold healthcare integrity.
Released on Feb 11, 2025
Projects
IBA Healthcare and Life Sciences Law Committee annual global surveys
Each year the Healthcare and Life Sciences Law Committee has produced a new comparative legal guide covering a highly relevant topic in over 50 countries. This guide is intended to offer practitioners and industry users easy access to the relevant applicable rules. In 2023, the Committee addressed questions related to telemedicine. In 2024, the Committee summarised the requirements for promoting pharmaceutical and medical devices in these countries.
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If you are a member of the Healthcare and Life Sciences Law Committee, for additional networking opportunities, programs, interviews with fellow members and tips all exclusive to members, join our LinkedIn page at: https://www.linkedin.com/groups/9166617/.