Legislation Details
- Full Title: Federal Law by Decree Regulating the Use of the Human Genome
- Law Type: Federal Law by Decree
- Law Number: [no number] of 2023
- Issued Date: 02 Oct 2023
- Effective Date: 01 Dec 2023
- Official Gazette: No. 762
- Sector: Healthcare
- Status: Active
- Number of Articles: 120
- Chapters/Parts: 0
- Amendments: 0
Summary
The Federal Law by Decree Regulating the Use of the Human Genome establishes a comprehensive legal framework for the safe and ethical use of genomic and genetic data in the United Arab Emirates. The law aims to ensure the protection of human rights, dignity, and privacy while promoting the use of genomic information for public health, disease prevention, and scientific research. It covers a wide range of applications, including genetic screening, genome scanning, gene therapy, and the establishment of a national genomic database. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1-3)
This legislation is crucial for businesses, healthcare providers, and individuals in the UAE, as it sets clear guidelines and requirements for the handling of sensitive genomic data. It also establishes penalties for non-compliance, empowers regulatory authorities, and outlines the rights and obligations of various stakeholders. The practical impact of this law is to foster the responsible development of personalized medicine, enhance disease prevention efforts, and strengthen the UAE's position as a hub for genomic research and innovation. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1-3)
What is the scope and purpose of this law?
The Federal Law by Decree Regulating the Use of the Human Genome applies to all uses related to the human genome in the United Arab Emirates, including in free zones. The law's primary objectives are to: (1) ensure the safe use of the human genome and prevent its use for purposes inconsistent with human rights and dignity; (2) promote the protection of public health through the diagnosis, prevention, and treatment of genetic diseases; (3) protect the confidentiality of genetic and genomic data; and (4) utilize the genomic data of UAE citizens to develop the Emirati Genome Reference and other permitted areas. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 2-3)
What are the key definitions under this law?
- DNA (Deoxyribonucleic acid): A biochemical molecular compound found in the nucleus of all cells that stores the basic data for cell construction and human development. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1)
- Chromosomes: Bundles of tightly coiled DNA located in the nucleus of almost every cell, carrying genes that transmit genetic data. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1)
- Genome: All the genetic material in a living organism, including genes that contain the biological data needed to build and sustain another organism. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1)
- Gene: The basic unit for the transmission of genetic traits from parents to children, consisting of a DNA sequence that occupies a specific position in a chromosome. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1)
- Genetic Screening: Medical examination to analyze a person's gene or genes and examine specific genetic areas of their DNA. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1)
- Genomic Screening: Medical examination to analyze a person's gene and examine specific genetic areas of their DNA. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1)
What are the main obligations and requirements?
The law imposes several key obligations and requirements, including:
- Obtaining informed consent before conducting any voluntary genomic or genetic screening or scanning, except in certain cases such as when required by law or ordered by a competent judicial authority. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 4, 6)
- Ensuring that genomic or genetic screening and scanning are only conducted by health authorities or authorized bodies, in accordance with approved mechanisms and controls. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 5)
- Complying with specific controls for taking, analyzing, using, preserving, and transporting biological samples, including providing genetic counseling, coding samples to maintain confidentiality, and using accredited laboratories. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 7)
- Prohibiting the use of the human genome for purposes inconsistent with the principle of respecting basic human rights and protecting human dignity and privacy. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 3, 16)
What licensing, registration, or approval requirements exist?
The law does not specify any licensing, registration, or approval requirements for individuals or companies. However, it does require that genomic or genetic screening and scanning be conducted by health authorities or authorized bodies in accordance with approved mechanisms and controls. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 5)
What rights and protections does this law provide?
The law provides several key rights and protections, including:
- The right to withdraw from a genomic or genetic screening or scanning at any time. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 8)
- The right to know the results of a genomic or genetic screening or scanning. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 9)
- The protection of the confidentiality of genetic and genomic data and information. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 3, 25-27)
- The prohibition of using the human genome for purposes inconsistent with the principle of respecting basic human rights and protecting human dignity and privacy. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 3, 16)
Which authorities or bodies are responsible for enforcement?
The law empowers several authorities and bodies for the enforcement and implementation of its provisions:
- The Ministry of Health & Prevention is responsible for issuing executive resolutions, coordinating with other health authorities, and making recommendations to the Cabinet. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 46)
- Health authorities, which include the Ministry of Health & Prevention and any other federal or local government authority concerned with regulating health affairs in the UAE, are responsible for various regulatory and enforcement functions. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 1, 5, 28, 44)
- The Cabinet is empowered to determine certain obligatory genomic or genetic screening and scanning cases based on the Minister's recommendation. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 4, 5)
What are the penalties for non-compliance?
The law specifies the following penalties for non-compliance:
- For legal persons (companies, organizations, etc.):
- Fines ranging from AED 100,000 to AED 1,000,000. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 40)
- Temporary or permanent closure of the facility. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 40)
- Revocation of licenses or permits. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 40)
- For individuals:
- Imprisonment for a period not exceeding 5 years. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 29)
- Fines ranging from AED 50,000 to AED 500,000. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 29)
- Deportation for non-UAE nationals. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 29)
What fees, charges, or financial provisions are specified?
The law does not specify any fees, charges, or other financial provisions related to the use of the human genome. (Federal Law by Decree Regulating the Use of the Human Genome, 2023)
What exemptions or exceptions apply?
The law provides the following exemptions and exceptions:
- Approval is not required for obligatory genomic or genetic screening mentioned in the law, screening requested by a competent judicial authority, or screening determined by the Minister or head of a health authority in the event of a threat to public health or to diagnose the effects of environmental factors on the human genome. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 4, 5)
- The Cabinet may determine other obligatory genomic or genetic screening cases based on the Minister's recommendation and in coordination with the heads of health authorities. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Art. 4, 5)
How are disputes resolved under this law?
The law does not specify any dispute resolution mechanisms or procedures. (Federal Law by Decree Regulating the Use of the Human Genome, 2023)
What are the key deadlines and time limits?
The law does not specify any deadlines or time limits. (Federal Law by Decree Regulating the Use of the Human Genome, 2023)
How does this law interact with other UAE legislation?
The law references the following related legislation:
- Federal Law No. (1) of 1972 concerning the Competences of Ministries and the Powers of Ministers, as amended. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Preamble)
- Federal Law by Decree No. (28) of 2023 Establishing the UAE Drug Corporation. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Preamble)
- Federal Law by Decree No. (39) of 2023 Regulating the Federal DNA Profiling Database. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Preamble)
When did this law come into effect?
The Federal Law by Decree Regulating the Use of the Human Genome was issued on 02 October 2023 and came into effect on 01 December 2023. (Federal Law by Decree Regulating the Use of the Human Genome, 2023, Issued Date, Effective Date)
Source Documents
This article analyses Federal Law by Decree Regulating the Use of the Human Genome for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.