UAE GENETIC RESOURCE ACCESS: AN IN-DEPTH LOOK AT CABINET DECISION NO. 15/2023
18 January 2024
The United Arab Emirates (UAE) has enacted a pioneering law to govern the use of the human genome, the complete genetic material of living organisms. The legislation, geared towards ensuring the ethical and secure utilization of genomic data, covers diverse applications, including healthcare, research, and legal considerations.
Dubai: The law sets up a national genomic database and a genome program with the aim of leveraging the genomic data of UAE citizens and developing the Emirati genome reference.
In the ever-evolving landscape of legal regulations, one area gaining significant attention is the access to genetic resources and their derivatives. The United Arab Emirates has taken a decisive step in this arena with the issuance of Cabinet Decision No. 15/2023, detailing the implementing regulations of Federal Law No. 8/2021 on Access to Genetic Resources and their Derivatives, and Equal Sharing of Benefits Arising from their Use.
Key Changes Introduced by the Law:
The law delves into the types and validity periods of authorizations and approvals, outlining a structured approach. The Competent Authority is empowered to issue authorizations for various purposes, ranging from scientific research to commercial and industrial applications. Importantly, the decision emphasizes a nine-month validity period for authorizations, promoting a dynamic yet controlled approach. The Ministry plays a pivotal role by issuing approvals for the import and export of genetic resources. These approvals, valid for six months and single-use, are contingent on adherence to stringent criteria, safeguarding against any adverse impact on the environment and human health.
2.Procedural Rigor and Ethical Considerations
Article 3 meticulously outlines the procedures and controls for obtaining genetic resources. Applicants must navigate a comprehensive set of requirements, including specifying characteristics, purpose, location, quantity, and time limits for resource collection. Moreover, the inclusion of traditional knowledge and ethical considerations ensures a responsible and sustainable approach to genetic resource access.
3.Informed Consent for Genomic Screening:
The law mandates obtaining explicit consent or the approval of a legal representative for genomic or genetic screening on any individual.
4.Controls for Biological Samples:
Stringent controls are outlined for the collection, analysis, use, preservation, and transportation of biological samples for genomic or genetic analysis or DNA profiling.
5.Individual Rights and Withdrawal:
Every person is granted the right to withdraw from voluntary genomic or genetic screening at any stage without the need for justification. Individuals also have the right to access the results of their own analyses.
6.Health-focused Genomic Screening:
The law permits genomic or genetic screening for pre-symptomatic prevention, diagnosis, and treatment of diseases within the framework of public health.
7.Reproductive and Mandatory Genomic Screening:
Genetic screening is allowed at medical support centers for reproduction and for pregnant women to identify and prevent hereditary diseases. Mandatory genomic screening is imposed on umbilical cord blood, newborns, and couples for various health-related purposes.
8.International Trade Controls
The law addresses the complexities of international trade in genetic resources through detailed procedures and controls for both export and import. Notably, the Ministry mandates the submission of authorizations, import approvals, and Benefit-Sharing Agreements, underscoring the commitment to equitable sharing of benefits arising from the use of genetic resources.
9.Employment and Insurance Restrictions:
Employers are prohibited from subjecting job candidates or workers to genomic screening outside voluntary health programs. Insurance corporations are barred from enforcing genomic screening for insurance seekers or using results from prior screenings.
10.Legal Constraints on Genomic Screening:
Genomic screening or genetic screening for specific disease diagnosis and damage estimation is prohibited unless authorized by a judicial order. DNA profiling for proving lineage and kinship is only permitted based on a court order.
11.Establishment of National Genomic Database and Genome Program:
The law establishes a national genomic database for storing genomic and genetic data in the UAE. A genome program aims to utilize this data to enhance the public health of Emiratis and create a genome reference, a digital DNA sequence.
12.Regulation of Genomic Services:
Facilities offering services related to human genomes and genes must obtain a license from competent authorities. Advertising these services is also regulated and requires the necessary license.
The implications and future outlook of this law makes it clear that the UAE is embracing the new age with all required legislative advancements. While acknowledging the immense potential of genomic technology, the UAE's new law underscores the importance of effective governance and legal frameworks to maximize benefits and minimize risks. This comprehensive and forward-thinking legislation, aligned with the UAE's vision, is expected to drive innovation in the health sector. As implementing resolutions take effect in 2024, heightened protection of individual rights and advancements in the UAE's health landscape are anticipated. Cabinet Decision No. 15/2023 establishes a robust legal framework for the access to genetic resources in the UAE. Its meticulous approach, combining procedural rigor, ethical considerations, and international trade controls, reflects a commitment to responsible and sustainable use. As legal professionals, we stand ready to assist businesses, researchers, and entities navigating the intricacies of this landmark decision, ensuring compliance and fostering responsible innovation in genetic resource utilization.
ALKETBI team is highly skilled and frequently provides legal assistance specializing in new areas of the laws. If you would like to know more or request further guidance with relation to the new genome law. Let us know!