Aug 2026· Trends in Biotechnology· 0 citations· 9 references
Medicine
Abstract
Mexico's General Health Law regulates certain transfers abroad of human tissues used in population genomic studies. We clarify how this framework may apply to oriGen, why the nature of the material transferred is legally decisive, and why publicly verifiable clarification of the applicable permit and registry requirements is essential for regulatory accountability, participant trust, lawful national stewardship, and responsible, equitable international genomic collaboration.
This article is devoted to the legal regulation of the use of genomic editing technology in individual states. In general, it can
be stated that in most legal systems there are restrictions on genomic editing in relation to hereditary genes, however, in rare cases
exceptions are allowed, which must be recognized as justified in view of the reality of threats to human life and health. Using the method
of comparative legal analysis, the author identifies the most optimal experience that can be useful to the domestic system of law-making
on the way to forming legislation in the field of public health protection.
Anastasia E. Kraynyukova· Civil society in Russia and...· 0 citations
The current legal framework is analyzed, the existing need for legislative action is identified, the existing need for legislative action is identified and a practice-oriented regulatory proposal is developed.
Cancer mortality in sub-Saharan Africa is projected to double by 2030. African populations exhibit the highest genetic diversity worldwide, impacting cancer susceptibility, tumor biology, and therapeutic response, yet remain critically underrepresented in biomedical research. This narrative review examines biobanking and genomic research infrastructure in sub-Saharan Africa and its implications for precision oncology, highlighting that locally governed, sustainable biobanks and equitable international partnerships are fundamental prerequisites for Precision Oncology Without Borders.
This paper examines Indonesia’s legal framework for cross-border transfer of genomic data and evaluates how it balances the rights of data subjects, state sovereignty, and national security. Using a normative juridical method supported by comparative analysis, it reviews the Personal Data Protection Law 2022 and the Health Law 2023, along with their derivative ministerial regulations, in relation to international standards such as the General Data Protection Regulation (GDPR), the California Consumer Privacy Act (CCPA), the World Health Organization (WHO) 2024 Guidelines, and China’s Regulation on Human Genetic Resources (HGR Regulation) 2019. The findings reveal three regulatory weaknesses: the limited recognition and protection of genomic data as sensitive data; the absence of benefit sharing and informed consent as fundamental rights of data subjects; and the lack of binding interstate treaty obligations to protect genomic data outside Indonesia. The paper proposes a ‘treaty-first’ approach in the Material Transfer Agreement (MTA), benefiting data subjects as a right, and a binding international framework designed explicitly for the cross-border protection of genomic data. This article is also included in The Business & Management Collection which can be accessed at https://hstalks.com/business/.
Tri Andika, Zainul Daulay, Ferdi et al.· Journal of Data Protection &...· 0 citations
Genomic datasets exist in Canada; however, many are inaccessible because they are held by individual researchers on institutional servers or by third-party sequencing companies abroad.
As a result, the genomic evidence needed to evaluate new therapies is often difficult to find.
Genome Canada is working to improve data accessibility through the Canadian Precision Health Initiative and the Pan-Canadian Genome Library.
The Atlantic Cancer Consortium and Atlantic PATH have also built federated models with formal access processes.
Naveed Aziz, Chief Data Officer, Genome Canada· Canadian Journal of Health T...· 0 citations
Wil Rich, Editor, Cell & Gene Therapy Insights, speaks with Eddie Tan Han Pin, Assistant Professor, Centre of Regulatory Excellence, Duke‑NUS Medical School, about his career journey from molecular cancer biology through GMP manufacturing and regulatory science into health policy, the evolving regulatory landscape for cell and gene therapies in Singapore and the Asia‑Pacific region, the role of regulatory reliance frameworks in broadening equitable patient access, and the transformative potential of AI across the cell and gene therapy development value chain.
Eddie Tan Han Pin· Cell and Gene Therapy Insigh...· 0 citations