The UAE issues ground-breaking law on the use of the human genome
Healthcare & Life Sciences Focus
In this article, we summarise the law and provide recommendations to operators of projects involving the human genome in the UAE.
Law Update: Issue 364 - Healthcare & Life Sciences Focus
Andrea TithecottPartner, Head of Regulatory,Head of Healthcare & Life Sciences
The United Arab Emirates (‘UAE’) has recently issued a new law to regulate the use of the human genome, which is the complete genetic material of a living organism. In this article, we summarise the law and provide recommendations to operators of projects involving the human genome in the UAE.The law aims to ensure the safe and ethical use of the human genome for various purposes, such as health, research, and legal matters, while protecting the rights and dignity of individuals and the public interest. The law also establishes a national genomic database and a genome programme to utilise the genomic data of the UAE citizens and develop the Emirati genome reference. The law imposes several obligations and restrictions on the entities and individuals involved in the use of the human genome, and sets out the penalties for violations. This article summarises the main provisions of the law and provides some recommendations for operators of projects involving the human genome.
The law applies to all uses related to the human genome in the UAE, including free zones. The law defines the human genome as all the genetic material in a living organism, including genes that contain all the biological data it needs to build and sustain another organism similar to it and distinct from its type. The law also defines other related terms, such as deoxyribonucleic acid (DNA), chromosomes, gene, genetic screening, genomic screening, genetic scanning, genomic scanning, genetic counselling, gene therapy, biological sample, genetic areas, DNA profiling, genomic data, genetic data, pharmacogenomics, amniotic fluid, genome programme, genome reference, and biobank.
The primary provisions of the law are summarized below:
stipulates that no person may be subject to genomic screening or genetic screening, which are medical examinations that analyse a gene or several genes of a person or persons identified by name, except after obtaining consent or the consent of their legal representative, if the person is incapacitated or incompetent, and on the condition that the purpose of the screening and the areas of its use are specified. The law also stipulates that no person may be subject to genomic scanning or genetic scanning, which are genetic analyses that are carried out on a large scale that include a group of individuals identified on the basis of one or more traits they have in common, and not on the basis of prior knowledge of their names, except after obtaining consent or the consent of their legal representative, if the person is incapacitated or incompetent. The law provides some exceptions to the requirement of consent, such as obligatory screening or scanning determined by the competent authorities in the event of a threat to public health, or to diagnose the effects of environmental factors on human genes or genome, or cases in which the screening or scanning is conducted at the request of the competent judicial authority, or other obligatory cases determined by the cabinet.
sets out the controls for taking, analysing, using, preserving and transporting the biological sample, which is a part of the human body or its biological secretions, which is used for performing genomic or genetic analysis or determining the DNA profiling. These controls include providing genetic counselling and conducting a general explanation by the specialist physician or any specialist in genomics, taking the sample in accordance with the scientific standards and principles, analysing the sample in accredited or licensed laboratories, coding the sample to maintain the confidentiality of its owner identity, destroying the sample in accordance with the controls determined by the competent authorities, and not transferring or storing the sample outside the UAE, except in cases determined by the competent authorities or after their approval.
grants every person the right to withdraw from a voluntary genomic or genetic screening or scanning at any stage of the screening or scanning without providing justification for doing so. The law also grants every person or their legal representative, if he is incapacitated or incompetent, the right to request the results of their own analyses, which are obtained within the framework of the targeted genetic or genomic screening or scanning, whether participation in that screening or scanning is voluntary or obligatory. However, the law also obliges the person or their legal representative to express in writing their unwillingness to know the results, and obliges the competent authorities to inform the person or their legal representative of the results if they show a risk that threatens the life of the person examined, or the life of the foetus of a pregnant woman. The law also prohibits the disclosure of results related to racial origins or lineage, except to the owner of the biological sample or to their legal representative, or upon their request, and prohibits the disclosure of any other additional results that are not targeted by the screening or scanning, except after taking the consent of the person or their legal representative of their desire to know them.
allows genomic screening or genetic screening to be performed within the public health framework, provided that the screening is based on the approval of a specialist physician licensed by the competent authorities, and after the approval of the concerned person to provide the biological sample or their legal representative if he is incapacitated or incompetent, and for the following purposes: pre-symptomatic prevention, which aims to detect and predict susceptibility to disease, even if the person does not show symptoms; diagnose and treat diseases and health conditions; and select the appropriate treatment, medication, and dose for the person within the framework of pharmacogenomics, which is the study of how genes affect the body response to certain medications.
allows genetic screening of gametes and embryos at centres for medical support in reproduction based on the approval of a specialist physician licensed by the competent authorities, and after the consent of the person from whom the sperm or unfertilised eggs are extracted, provided that the screening is for identifying and preventing hereditary diseases in accordance with the legislation in force. The law also allows genetic screening of pregnant women based on the approval of a specialist physician licensed by the competent authorities, and after the approval of the pregnant woman, provided that the screening is for detecting traits that directly affect the health of the foetus, and discovering any deformities or genetic diseases that it may suffer from. The law also provides that if the screening proves that the pregnancy poses a threat to the life of the pregnant woman, or that the foetus has a serious deformity that affects its health and life after birth, or there is a risk of contracting a serious hereditary disease that threatens the life of the newborn during its lifetime, the pregnant woman shall be informed of their and all medical options shall be available to deal with it, including abortion and safe procedures for that in accordance with the legislation in force.
imposes obligatory genomic screening of umbilical cord blood in cases of requesting to store umbilical cord blood in umbilical cord blood preservation centres, provided that the screening is for detecting hereditary traits and diseases, and for examining matching for future cases of blood stem cell transplantation in a parent or sibling. The law also allows voluntary genomic screening of the umbilical cord of a child immediately after its birth, based on the approval of a specialist physician licensed by the competent authorities, with the approval of one of the parents, provided that the screening is for evaluating the health of the newborn, in accordance with the requirements of the competent authorities.
imposes obligatory genomic screening of newborns, provided that the screening is based on the approval of a specialist physician licensed by the competent authorities, and for diagnosing injuries and diseases in newborns, and early intervention to treat them, reduce them, or prevent their complications, in accordance with the legislation in force. The law also imposes obligatory genomic screening for couples, provided that the screening is based on the approval of a specialist physician licensed by the competent authorities, and for planning a healthy family, detecting genetic diseases and the possibility of transmitting them to children in accordance with the legislation in force. The law also provides that procedures for concluding a marriage contract may not be completed except after submitting evidence of the conduct of their examination, and informing the couple getting married its results, pursuant to the form approved by the competent authorities.
The law prohibits the use of human genes and genomes in any way with the intention of altering the genomic structure of people, whether to improve their lineage, purify the human race, or other uses that conflict with the law.
prohibits the use of human genes and genomes in any way with the intention of altering the genomic structure of people, whether to improve their lineage, purify the human race, or other uses that conflict with the law. The law provides an exception to the prohibition if the purpose of altering the genomic structure is to treat or prevent diseases, in accordance with the controls set by the law. These controls include obtaining the approval of a specialist physician licensed by the competent authorities, obtaining the consent of the person or their legal representative, ensuring that the treatment does not cause more damage than the damage that already exists, ensuring that the treatment achieves the benefit of recovery or pain relief, ensuring that the treatment does not lead to the acquisition of certain traits that are not related to the therapeutic purpose, and ensuring that the treatment is carried out by licensed specialists, in licensed health facilities, and using licensed gene therapy products.
permits scientific or clinical research or study related to the human genes and genome or any of its applications on any person for scientific research, in accordance with the controls set by the law. These controls include fulfilling the requirements and controls contained in the legislation regulating scientific and clinical study in the UAE, and for scientific objectives related to reviewing and understanding the structure and function of the human body, reviewing and understanding diseases that affect humans, and promoting public health. The law also prohibits human cloning or modifying the human traits of persons and embryos for purposes that violate the law, or that involve the risk of generating genetically modified biological organisms that pose a threat to humans and the environment. The law also obliges the entities and individuals involved in scientific or clinical research or study to keep all diagnoses, results, data and information related to human genomes and genes completely confidential, and not to disclose them except in cases permitted by the legislation in force in the UAE.
prohibits entities and employers from enforcing job seekers or workers to any genomic screening or genetic screening for purposes that do not fall within the framework of a voluntary health programme aimed at enhancing their protection from diseases, and requires obtaining their consent in accordance with the law. The law also prohibits entities and employers from requesting or using the results of any previous genetic screening or genomic screening for job seekers or workers. The law provides an exception to the prohibition in cases where there is scientific proof of the causal relationship between a person specific genetic predisposition and occupational diseases, or exposure to work accidents or injuries resulting from the exercise of the specific job, within the framework of preserving the person health and safety. The law also provides that a committee shall be formed by a resolution issued by the minister to determine the appointed positions that are subject to genomic screening or genetic screening and the diseases targeted on the basis of their susceptibility to infection.
prohibits insurance corporations from enforcing those seeking insurance coverage to any genomic screening or genetic screening aimed at detecting and predicting their susceptibility to diseases and considering it as a basic requirement for providing insurance services to them. The law also prohibits insurance corporations from requesting or using the results of any previous genetic screening or genomic screening for those seeking insurance coverage.
prohibits genomic screening or genetic screening to be requested to detect symptoms or diagnose a specific disease for estimating damage and calculating and claiming compensation for it, except by a judicial order or ruling. The law also prohibits DNA profiling, which is a fixed genetic trait or pattern that distinguishes each person from another, to be performed to prove lineage and kinship,except based on an order or ruling from the competent court in accordance with the legislation in force. The law also allows DNA profiling for investigating crimes and identifying their perpetrators, identifying victims of crises, disasters and accidents, identifying bodies or unknown human remains and body parts, and identifying unidentified and missing persons in accordance with the legislation regulating their matter. The law also allows a person, at their request or their legal representative, if he is incapacitated or incompetent, to conduct genetic screening to identify their lineage or ethnic origins, provided that the results are disclosed in accordance with the law.
establishes a national genomic database in which genomic and genetic data and information shall be stored in the State. The law provides that the cabinet shall determine the entity that shall establish the database, the sources of the data and information, the controls and procedures for registering and preserving it, managing it, using it, circulating and exchanging it, and the mechanisms for linking it to the relevant databases in all health, research and private bodies. The law also obliges all parties organising or implementing a genomic screening or genetic screening or scanning for any purpose to provide the entity that shall establish the database with all genomic or genetic data to be stored in the national genomic database. The law also grants the ministry of interior or local police general commands the authority to view and exchange the data of the DNA profiling of victims of crises and disasters or other unknown persons with the national genomic database in accordance with the controls issued by the cabinet.
establishes a genome programme that aims to use the genomic data of the UAE citizens, analyse it and benefit from it to improve the public health of Emiratis, enhance the prevention of hereditary and chronic diseases, and reach personalised treatment for each patient pursuant to genetic factors. The law also establishes a genome reference, which is the digital DNA sequence, which is collected as an example of the gene sequence of Emirati individual. The law provides that the cabinet shall determine the responsibilities and controls for the use and dissemination of the Emirati genome reference, as well as the mechanism and periodicity of updating it.
requires that no facility may provide services related to human genomes and genes for any of the uses mentioned in the law or otherwise, whether within the framework of genomic or genetic research, analysis of biological samples, or storage, preservation and transfer of biological samples or genomic or genetic data, except with a licence from the competent authorities. The law also requires that the facility may not advertise its services in the visual, written or audio media or on social media, except with a licence from the competent authorities, each within their jurisdiction in accordance with the legislations.
The law sets out the penalties for violations of its provisions, which include imprisonment and fines ranging from AED 10,000 to AED 10,000,000, depending on the type and severity of the violation. The law also provides for the confiscation of the tools of the crime, the funds and proceeds arising from it, the deportation of the foreigner who is convicted of one of the crimes, the closure of the place in which the offence is committed, and the dissolution of the legal person involved in the violation. The law also provides for the punishment of the attempt to commit the crimes of altering the genomic structure of people or gene therapy.
The law is a comprehensive and advanced legislation that regulates the use of the human genome in the UAE, and reflects the UAE vision and leadership in promoting the development and innovation of the health sector, as well as the protection and enhancement of the rights and interests of the individuals and the society. The law also contributes to the achievement of the UAE national agenda and the UAE Centennial 2071, which aim to make the UAE the best country in the world in various fields, including health, education, and economy.
The law imposes several obligations and restrictions on the operators of projects involving the human genome, and requires them to obtain the necessary licences and approvals from the competent authorities, to comply with the ethical and scientific standards and principles, to respect the consent and confidentiality of the individuals, to avoid any misuse or abuse of the human genome, and to report any breach or violation of the law to the competent authorities. The law also grants the operators of projects involving the human genome several opportunities and benefits, such as accessing and utilising the national genomic database and the Emirati genome reference, conducting scientific or clinical research or study related to the human genome, and providing various services related to the human genome for health, legal, or other purposes.
Therefore, the operators of projects involving the human genome are recommended to:
Review and update policies and procedures to ensure compliance with the law and the resolutions issued in implementation thereof, and to seek legal advice if needed;
Apply for the required licences and approvals from the competent authorities before engaging in any activity related to the human genome, and to renew them periodically;
Provide adequate training and awareness to staff and stakeholders on the provisions and objectives of the law and the best practices in the field of the human genome;
Establish effective mechanisms for obtaining and documenting the consent and the results of the individuals who are subject to genomic or genetic screening or scanning, and to provide them with genetic counselling and support;
Ensure the security and confidentiality of the biological samples and the genomic or genetic data and information, and to use them only for the specified purposes and in accordance with the law;
Cooperate and coordinate with the competent authorities and other operators of projects involving the human genome, and to share and exchange the genomic or genetic data and information in the national genomic database and the Emirati genome reference, in accordance with the controls set by the law; and
Monitor and evaluate the performance and outcomes of projects involving the human genome, and to report any challenges or risks or violations to the competent authorities.
For further information,please contact Andrea Tithecott.
Published in January 2024
