Open African Innovation Research (Open AIR)’s Post

Delighted to read that Emma Law, Head of Clinical Quality Assurance, and Isabel Smith, Senior Research Officer at Protas, have been published in a special issue of Sage Journal's Research Ethics.    The issue, "Preparing for the Next Global Crisis: Research Ethics and Integrity in Crisis Situations," explores critical global health challenges, including the COVID-19 pandemic, and reinforces the key role that ethics and integrity play in conducting high-quality, informative clinical trials.   Read their article here: https://lnkd.in/e9VQ4W7d   The principles outlined are deeply embedded in our work at Protas. Find out more: www.protas.co.uk #researchethics #clinicaltrials #covid19 #globalhealth

Brazil:  Senate approves controversial bill on clinical research involving human biological material: 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. The post Brazil:  Senate approves controversial bill on clinical research involving human biological material appeared first on Global Compliance News. -via @bakermckenzie

Come and join our virtual event to discuss empirical bioethics.

The Australasian Association of Bioethics and Health Law (AABHL)'s Empirical Bioethics Stream is under new leadership: Supriya Subramani, Yves Saint James Aquino, MD, PhD, Hilary Bowman-Smart, Nina Roxburgh and myself. We have grand plans for a variety of online events throughout the year to complement academic and social activities that we will host at the annual AABHL conferences. This will include i) critical dialogues probing contemporary developments and innovations in empirical bioethics, ii) a journal club, and iii) on-the-ground, personal insights from scholars pursuing empirical bioethics research in a new 'Stories from the Field' seminar series. We are kicking things off next month with a Critical Dialogue that aims at interrogating some of the foundational questions about the value, nature and purpose of empirical bioethics. We hope you will join us if you work in this area. Moderated by Nina, the other stream leads will each make a short pitch about their own views on what empirical bioethics is, or how they understand its place in their own work, followed by audience discussion. Key points that emerge from this discussion will then inform future activities and priorities for the stream moving forward. May 13th 2024, 3pm - 4.30pm (AEST) on Zoom. Please register here: https://lnkd.in/eDQpbusF

evista de Direito Sanitário – new book review published: HOW THE COVID-19 PANDEMIC RAISED NEW ETHICAL AND LEGAL QUESTIONS REGARDING INTELLECTUAL PROPERTY By: Fernando Hellmann ABSTRACT: The book “Saúde & propriedade intelectual”, edited by Marcos Wachowicz and Ângela Kretschmann, provides a comprehensive view of the complex ethical and legal issues related to the COVID-19 pandemic and intellectual property in the context of global health. It is a work that explores the critical intersection of intellectual property and public health, with a focus on the COVID-19 pandemic. The book examines ethical issues arising from the pandemic, particularly the conflict between private economic interests and the preservation of people’s lives. It emphasizes the need to rethink intellectual property in biotechnology, considering its social function and pointing to the necessity of balancing public and private interests within the patent system. The work also delves into the Brazilian National Public Health System and international negotiations regarding the intellectual protection of genetic resources, along with the challenges of patenting medicines in resource-constrained countries. Due to its wide coverage, this publication is essential reading for academics, public health experts, legal professionals, and anyone interested in the intersection of intellectual property and public health. Available at: https://lnkd.in/dVR5inXf

Revista de Direito Sanitário – new book review published: HOW THE COVID-19 PANDEMIC RAISED NEW ETHICAL AND LEGAL QUESTIONS REGARDING INTELLECTUAL PROPERTY By: Fernando Hellmann ABSTRACT: The book “Saúde & propriedade intelectual”, edited by Marcos Wachowicz and Ângela Kretschmann, provides a comprehensive view of the complex ethical and legal issues related to the COVID-19 pandemic and intellectual property in the context of global health. It is a work that explores the critical intersection of intellectual property and public health, with a focus on the COVID-19 pandemic. The book examines ethical issues arising from the pandemic, particularly the conflict between private economic interests and the preservation of people’s lives. It emphasizes the need to rethink intellectual property in biotechnology, considering its social function and pointing to the necessity of balancing public and private interests within the patent system. The work also delves into the Brazilian National Public Health System and international negotiations regarding the intellectual protection of genetic resources, along with the challenges of patenting medicines in resource-constrained countries. Due to its wide coverage, this publication is essential reading for academics, public health experts, legal professionals, and anyone interested in the intersection of intellectual property and public health. Available at: https://lnkd.in/dKf-SQFX

I joint Lawrence Gostin and Sam Halabi in writing for The Hindu today on the ongoing pandemic treaty negotiations, that failed to reach a consensus at the 77th World Health Assembly.  We discuss three key contentious issues in the latest draft of the Pandemic Agreement that remain significant  obstacles to its adoption:  i) a pathogen access and benefit sharing (PABS) mechanism;  ii) technology transfer, local production, and intellectual property; and  iii) the One Health approach which emphasizes coordinated public health measures based on animal, human, and environmental health. A core aim of the Pandemic Agreement—beyond ensuring the immediate availability of medical products during emergencies—should be to promote long-term and sustainable access to these products by diversifying production and enhancing regional manufacturing capabilities. Issues of pathogen access and technology transfer are not mere technicalities; they are essential to the success of the pandemic agreement once it is adopted. The coming months of negotiations are crucial; this treaty is not just for the next pandemic but serves as a blueprint for a more equitable and resilient global health system. O'Neill Institute for National and Global Health Law #healthlaw #pandemictreaty #healthsecurity Georgetown University Law Center Georgetown Law Centers & Institutes

The Head of our Pharma and Life Sciences Practice , Partner Julia Pournara and the Head of our Privacy and Digital Practice , Senior Manager Antonios Broumas , will participate as Panelist and Speaker respectively, to the 3rd Health Law and Policies Conference organized by NOMIKI BIBLIOTHIKI , on November 12th. They will raise key regulatory issues on the pricing and reimbursement of medicines and big data. During the conference, many distinguished academics and practitioners will address the critical challenges of the ever changing life sciences sector. For more information and registration: https://lnkd.in/dkARV-tz   #EYLaw #PlatisAnastassiadis #healthcarelaw #lifesciences #digitallaw

Nyrada Inc. (ASX:NYR) has submitted its Phase Ia first-in-human clinical trial regulatory package to the Human Research Ethics Committee (HREC). HREC review is expected in January 2025, subject to which, volunteer recruitment will commence. More information at https://bit.ly/3VZiO5e John Moore James Bonnar

🗣️"This law has been an important step forward in the regulation of assisted reproduction in Italy, but there are still many challenges to be solved"   Sara Dalla Costa, specialist in health law at the Instituto Bernabeu, has participated in the 30th International Congress on Law and Human Genome held in Bilbao.   In her talk, entitled "20 years of Law 40/2004 in Italy: Emerging challenges and unresolved issues in assisted reproduction", she spoke about Italian legislation on assisted reproduction, which is much more restrictive than the Spanish one.   🔗More information can be found in the first comment of this post.