UAE Healthcare / Pharma LawFederal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome

Article (1) Definitions In application of the provisions of this Law by Decree, the following words and phrases shall have the meanings stated to each of them, unless the context otherwise requires: State : United Arab Emirates The Ministry : Ministry of Health & Prevention The Minister : Minister of Health & Prevention Health Authority : The Ministry or any other Federal or Local Government Authority concerned with regulating health affairs in the State, each within their jurisdiction. Deoxyribonucleic acid: (DNA) : Deoxyribonucleic acid (DNA), a biochemical molecular, is a vital compound found in the nucleus of all cells that make up the human body (except red blood cells). A person inherits it from his parents, and stores all the basic data for cell

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 2 construction and the formation and development of the human being in specific form and traits. Chromosomes: (Chromosomes) : Bundles of tightly coiled DNA located in the nucleus of almost every cell in the human body, and carry genes that transmit Genetic Data. Genome (Genome) : 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 human Genetic balance is composed of (46) compact molecules of DNA called Chromosomes, in addition to mitochondrial genes. Gene (Gene) : Basic unit for the transmission of Genetic traits from parents to children. It consists of a DNA Sequence that occupies a specific position in the chromosome. Genetic Screening : Medical examination through which a gene or several genes of a person or persons identified by name is analysed, and Genetic Areas of the DNA determined by the purpose of the test are examined. Genomic Screening : Medical examination through which a gene of a person or persons identified by name is analysed, and Genetic Areas of the DNA determined by the purpose of the test are examined. Genetic Scanning : Process by which Genetic analysis is carried out on a large scale that includes 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, in accordance with what is decided by the body organising or implementing the Genetic Scanning. Genomic Scanning : Process by which Genetic analysis is carried out on a large scale that includes a group of individuals identified on the

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 3 basis of one or more traits they have in common, and not on the basis of prior knowledge of their names, in accordance with what is decided by the body organising or implementing the Genomic Scanning. Genetic Counselling : A health service that provides data and support to people with or at risk of Genetic diseases. Gene Therapy : Therapeutic procedure based on gene modification with the aim of treating the disease, suspend the progression of the disease, or prevent it through medical techniques that work to: - Replace the disease-causing gene with a healthy copy of the gene. - Disable a gene that causes a disease that is not working properly. - Introduce a new or modified gene into the body to help treat or prevent disease. Biological Sample : A part of the human body or its biological secretions, which is used for performing Genomic or Genetic analysis or determining the DNA Profiling. Genetic Areas : Areas in the DNA complex, some of which are coded, so they contain instructions for building a specific protein in the body, while others are non-coding, so they do not contain instructions for building a specific protein in the body. DNA Profiling : Fixed Genetic trait or pattern that distinguishes each person from another. It is repeated only in rare cases such as identical twins. The DNA Profiling is produced after examining the Biological Sample and analysing the DNA in specific and highly variable locations. Genomic Data : Data related to complete Genetic material, obtained as part of Genomic Screening or Scanning and after analysis of a Biological Sample.

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 4 Genetic Data : Data related to a portion of a person Genetic material, which may include DNA Profiling, which is obtained as part of Genetic Screening, Scanning, or DNA Profiling, and after analysing the Biological Sample. Pharmacogenomics : Study of how genes affect the body response to certain medications, through Genetic Screening that enables the Health Care Provider to choose the appropriate medication and dose for the patient, or to predict that he shall suffer serious side effects from the medication. Amniotic Fluid: : Amniotic Fluid is the fluid that surrounds the foetus during pregnancy, inside the pregnant woman uterus. Genome Programme The Emirati : A national project that aims to use the Genomic Data of the State 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. Genome Reference: The Emirati : The digital DNA Sequence, which is collected as example of the gene sequence of Emirati individual. Accordingly, the Genomic Sequence of the Emirati Community is linked to it, for use in personalised medicine and disease prevention. Biobank : The facility through which Biological Samples are collected, preserved, stored and distributed, such as: blood, tissues, cells, etc, and associated data for future use. Examples of these include blood banks, umbilical cord blood banks, facility cells, and others.

Article (3) Objectives This Law by Decree aims to: 1. Ensure the safe use of the Human Genome, and prevent its use for purposes inconsistent with the principle of respecting basic human rights and protect his dignity and the sanctity of his private life. 2. Promote the protection of public health in community through diagnosis, prevention, and treatment of Genetic diseases spread among some members of community, and promote scientific research related to the Human Genome. 3. Protect the confidentiality of Genetic and Genomic Data and Information. 4. Utilise the Genomic Data of the State citizens and analyse it to develop the Emirati Genome Reference and any other areas permitted by the legislation in force in the State.

Article (5) Genome Scanning and Genetic Scanning 1. No Genomic or Genetic Scanning may be carried out in the State except by Health Authorities or a body authorised by them, and in accordance with their approved mechanisms and means. 2. No person may be subject to Genomic Screening or Genetic Screening except after obtaining his consent or the consent of his legal representative, if the person is incapacitated or incompetent, in accordance with the provisions of Article (6) of this Law by Decree. 3. By resolution of the Minister, after coordination with the Relevant Authorities, the controls for conducting the Scanning shall be issued, as well as the controls for the work of the agencies and facilities charged with implementing it, including the mechanism for disposing of the Biological Samples collected and destroyed within this framework. 4. The following cases shall be excluded from the requirement to obtain approval referred to in Clause (2) of this Article: a. Any obligatory Genomic Scanning or Genetic Scanning shall be determined by resolution of the Minister or the Head of the Health Authority, as the case may be, in the event of a threat to public health, or to diagnose the effects of environmental factors on Human Genes or Genome. b. Other obligatory Genomic Scanning or Genetic Scanning cases determined by the Cabinet based on the Minister recommendation in coordination with the Heads of Health Authorities.

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 7

Article (6) of this Law by Decree, and on the condition that the purpose of that Screening be specified. and areas of its use. 2. As an exception to Clause (1) of this Article, approval is not required in the following cases: a. Obligatory Genomic Screening or Genetic Screening mentioned in this Law by Decree. b. Cases in which the Screening is conducted at the request of the Competent Judicial Authority. c. Any obligatory Genomic Screening or Genetic Screening shall be determined by resolution of the Minister or the Head of the Health Authority, as the case may be, in the event of a threat to public health, or to diagnose the effects of environmental

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 6 factors on Human Genes or Genome. d. Other obligatory Genomic Screening or Genetic Screening cases determined by the Cabinet based on the Minister recommendation in coordination with the Heads of Health Authorities.

Article (6) of this Law by Decree. b. 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. c. Relationship referred to in Paragraph (b) of this Clause shall be established with the list of jobs subject to Genomic Screening or Genetic Screening and the diseases targeted on the basis of their susceptibility to infection. d. By resolution of the Minister, a Committee shall be formed whose membership includes the Relevant Authorities to determine the appointed positions, provided that the list referred to in Paragraph (C) of this Clause shall be issued by resolution of the Minister based on the recommendation of the Committee.

Article (7) Controls for taking, analysing, using, preserving and transporting the Biological Sample Biological Sample is taken from the person, analysed, used, preserved and transported, in accordance with the following controls: 1. Provide Genetic Counselling and conduct a general explanation by the Specialist Physician or any specialist in Genomics, concerning Genomic Screening or Genetic Screening within the health framework, on the following matters for the person from whom the Biological Sample is to be taken or his legal representative if he is incapacitated or incompetent, before taking the Biological Sample: A. Purpose of the Screening and areas of its use. B. Potential negative physical and psychological effects of the results. C. Potential risks of the Screening and its periodicity. D. Any other matters necessary for Screening. 2. The sample shall be taken in accordance with the scientific standards and principles in force in this regard. In the event that the sample is insufficient or unsuitable for any reason, another sample shall be taken. The sample taken shall be destroyed in accordance with the provisions of Clause (8) of this Article. The person from whom it is taken, or from whom it is taken, shall be informed. He shall be legally represented if he is

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 8 incapacitated or incompetent to do so, and shall re-obtain his consent thereto in accordance with the provisions of Article (6) of this Law by Decree. 3. Taking a Biological Sample in facilities, public places, and sites designated for collecting samples determined by the Health Authority. Samples shall be coded to maintain the confidentiality of their owner identity in accordance with the applicable laws to maintain data confidentiality. 4. Analysis shall be carried out on the Genetic Areas targeted by the Screening or Scanning pursuant to its purpose in accordance with medical principles and standards. It may not perform the analysis for purposes or on Genetic Areas other than those targeted by the Screening or Scanning. 5. Analysis shall be carried out in laboratories accredited or licensed by the Health Authority, which have the necessary qualifications and equipment to carry out this work, in accordance the Health Authority rules. 6. If a person Genomic Data is already available in the National Genomic Database, he or she shall not be subjected to the Sampling Procedure again. 7. In the event of a desire to use the collected Biological Samples and benefit from them for other additional purposes, the written consent of the concerned person, or his legal representative if he is incapacitated or incompetent, shall be re-obtained in accordance with the provisions of Article (6) of this Law by Decree, and he has the right of rejection. 8. Complete the transfer, circulation, preservation, and destruction of the Biological Sample and what remains of it after analysis within the State, in accordance with the controls determined by the Minister or the Head of the Health Authority, as the case may be, and taking into account the controls and conditions for preserving samples in the Biobanks used by Health Authorities. 9. Biological Sample may not be transferred or stored outside the State, except in cases determined by the Health Authority, or after its approval of the justifications for doing so.

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 9

Article (8) Withdrawing from a Genomic or Genetic Scanning or Screening 1. Every person has the right to withdraw from a voluntary Genomic or Genetic Scanning or Screening at any stage of the Screening or Scanning without providing justification for doing so. 2. If the person withdraws after submitting Biological Samples, the entity organising or implementing the Screening or Scanning shall not retain or analyse the samples that are taken from him or analyse them, or keep the data and information resulting from their analysis, except after obtaining the written consent of the concerned person, or his legal representative if he is incapacitated or incompetent, pursuant to the provisions of Article (6) of this Law by Decree, and he has the right of rejection.

Article (9) The right to know the results of the analysis within the framework of a Genomic or Genetic Scanning or Screening 1. Every person or his legal representative, if he is incapacitated or incompetent, has the right to request the results of his 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. 2. The person or his legal representative shall express in writing his unwillingness to know the results referred to in Clause (1) of this Article, pursuant to the form referred to in Clause (2) of Article (6) of this Law by Decree. 3. Inform the person or his legal representative of the results referred to in Clause (1) of this Article is obligatory if the results show risk that threatens the life of the person examined, or threatens the life of the foetus of the pregnant woman. 4. The Specialist Physician or any specialist in this field shall provide Genetic Counselling to the person or his legal representative, after the results of his tests are issued, in order to inform him clearly and accurately of those results, and of the possible effects that may result from them, or preventive or therapeutic interventions or additional Screening or

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 10 refer it to Specialist Physicians in this regard to deal with these effects. 5. It may not disclose results related to racial origins or lineage, except to the owner of the Biological Sample or to his legal representative if he is incapacitated or incompetent, or upon their request. 6. Without prejudice to Clauses (3) and (4) of this Article, it may to disclose any other additional results that are not targeted by the Screening or Scanning, whether they are known as a result of the Screening or Scanning, or are available in the National Genomic Database, except after taking the consent of the person or his legal representative of his desire to know it.

Article (10) General Health Genomic or Genetic Screening Areas and Purposes of Use Genomic Screening or Genetic Screening may be performed within the public health framework, provided that the Screening shall be based on the approval of a Specialist Physician licensed by the Health Authority, and after the approval of the concerned person to provide the Biological Sample or his legal representative if he is incapacitated or incompetent, and for the following purposes: 1. Pre-symptomatic prevention, which aims to detect and predict susceptibility to disease, even if the person does not show symptoms. 2. Diagnose and treat diseases and health conditions. 3. Select the appropriate treatment, medication, and dose for the person within the framework of Pharmacogenomics.

Article (12) Genetic Screening of Pregnant Women 1. Genetic Screening may be performed on a pregnant woman in accordance with the following controls: a. Conduct Genetic Screening of the foetus or Amniotic Fluid based on the approval of a Specialist Physician licensed by the Health Authority, and after the approval of the pregnant woman. b. Screening shall be for detecting traits that directly affect the health of the foetus, and discovering any deformities or Genetic diseases that it may suffer from. 2. If it is proven from the Screening that if the pregnancy continues it would pose a threat to the life of the pregnant woman, or it is proven 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 this. All medical options shall be available to deal with it, including Abortion and safe procedures for that in accordance with the legislation in force.

Article (13) Genomic Screening of Umbilical Cord Blood 1. In cases of requesting to store umbilical cord blood in umbilical cord blood preservation Centres, obligatory Genomic Screening of the umbilical cord blood is required, 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. 2. It may conduct voluntary Genomic Screening of the umbilical cord of a child immediately after his birth, based on the approval of a Specialist Physician licensed by the Health Authority, with the approval of one of his parents. The Screening shall be for evaluating the health of the newborn, in accordance with the requirements of the Health

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 12 Authority.

Article (15) Examination of Couple getting married 1. Obligatory Genomic Screening shall be conducted for Couple, provided that the Screening is based on the approval of a Specialist Physician licensed by the Health Authority, and for planning a healthy family, detecting Genetic diseases and the possibility of transmitting them to children in accordance with the legislation in force. 2. Procedures for concluding a marriage contract may not be completed except after submitting evidence of the conduct of this examination, and inform the couple getting married its results, pursuant to the form approved by the Health Authority. 3. By resolution of the Minister, in coordination with Health Authorities, a list of Genetic Diseases required to be examined for the couple getting married shall be issued.

Article (17) Use for Gene Therapy Human Genes or Genomes may be used for Gene Therapy, in accordance with the following controls: 1. Treatment shall be based on the approval of a Specialist Physician licensed by the Health Authority, and for diseases that are determined by a Specialist Committee formed by a resolution issued by the Minister or the Head of the Health Authority, each within the limits of their jurisdiction. 2. This type of treatment is not causing more damage than the damage that already exists. 3. The treatment shall achieve the benefit of recovery or pain relief, and shall not lead to immediate or future harm to the concerned person. 4. The goal of treatment shall be to combat a specific disease or prevent it in the future, whether for the person or his family. 5. Therapeutic alternative that achieves the same targeted result is hard to fined with the same efficiency and effectiveness. 6. Use for therapeutic purpose shall not lead to the acquisition of certain traits that are not related to the therapeutic purpose to be achieved. 7. Consent of the person or his legal representative shall be obtained pursuant to a form prepared by the Health Authority. 8. Treatment shall be carried out by licensed specialists, in accordance with the legislation in force. 9. Gene Therapy shall be provided at health facilities that have a licensed laboratory that meets the requirements for performing Genetic analyses, as determined by the Health Authority. 10. Use licensed Gene Therapy products, in accordance with applicable legislation. 11. Any other controls set by the Health Authority.

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Article (18) Scientific Research Purposes Scientific or clinical research or study related to the Human Genes and Genome may be carried or any of its applications on any person for scientific research, in accordance with the following controls: 1. Fulfil the requirements and controls contained in the legislation regulating scientific and clinical study in the State, and for scientific objectives related to the following: A. Review and understand the structure and function of the human body. B. Review and understand diseases that affect humans. C. Promote public health. 2. Human cloning or modifying the human traits of persons and embryos for purposes that violate the provisions of this Law by Decree, or that involve the risk of generating genetically modified biological organisms that pose a threat to humans and the environment. 3. All diagnoses, results, data and information related to Human Genomes and Genes, which were carried out or arrived at within the framework of scientific or clinical research or study, shall be kept completely confidential, and shall not be disclosed except in cases permitted by the legislation in force in the State.

Article (19) Use in Functional Framework 1. Entities and Employers may not: a. Enforce job seekers to a Genomic Screening or Genetic Screening aiming at discovering or predicting their susceptibility to diseases, in order to make the decision to employ them or not based on that. b. Enforce 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 provisions of Article (6) of this Law by Decree.

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 15 c. Request or use the results of any previous Genetic Screening or Genomic Screening for job seekers or workers. 2. As an exception to Clause (1) of this Article, employers and entities may subject job seekers or employees to voluntary Genomic Screening or Genetic Screening aiming at detecting and predicting their susceptibility to diseases in accordance with the following controls: a. Approval from the job seeker or employee, in accordance with the provisions of

Article (25) Genomic and Genetic Data 1. All Genomic or Genetic Data in the State shall be completely maintained confidential and shall not be circulated or disclosed except in cases permitted by the legislation in force in the State. 2. No Genomic or Genetic Data may be used in a way that leads to discrimination between members of community because of their Genetic traits or because of their ethnic origins or lineage which results in limiting their rights assigned to them under the legislation in force in the State. 3. No research or studies that include data, information, or statistics related to the UAE Genome Programme may be published, except after the approval of the Minister or the Head of the Health Authority in accordance with the controls determined by the Cabinet.

Article (26) National Genomic Database 1. A National Genomic Database shall be established in which Genomic and Genetic Data and Information shall be stored in the State. The entity that shall establish it, the sources of this 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 shall be determined by a resolution of the Cabinet. The concerned parties and the obligations of these parties to provide the party that shall be determined by the Cabinet with any Genomic or Genetic Data and Information available to them or to their affiliated facilities. 2. All parties organising or implementing a Genomic Screening or Genetic Screening or Scanning for any purpose shall provide the party referred to in Clause (1) of this Article with all Genomic or Genetic Data to be stored in the National Genomic Database. 3. In the event that there are victims of crises and disasters or other unknown persons

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 18 whose DNA Profiling do not match any other DNA Profiling in the Federal DNA Profiling Database at the Ministry of Interior. The Ministry of Interior or local police general commands may be granted the authority to view and exchange the data of those DNA Profiling with the National Genomic Database in accordance with the controls issued by the Cabinet Resolution mentioned in Clause (1) of this Article.

Article (38) Anyone who does the following shall be punished by imprisonment and a fine of no less than AED (100,000) one hundred thousand and no more than AED (300,000) three hundred thousand, or one of these two penalties. 1. Conduct any research or clinical study related to Human Genomes and Genes or any of their applications to humans, with the aim of human cloning or modifying the human traits of people and foetuses, or involving the risk of generating Genetically modified biological organisms that pose a threat to humans and the environment. 2. Publish any research or studies containing data, information or statistics related to the UAE Genome Programme in violation of the provisions of Clause (3) of Article (25) of this Law by Decree.

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Article (42) Without prejudice to the rights of bona fide third parties, the following shall be ruled in all cases: 1. Confiscate tools of the crime, funds and proceeds arising therefrom. Where it is not possible to rule on confiscation because it relates to the rights of bona fide third parties, the Court shall decide a fine equivalent to the value thereof at the time of committing the

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Federal Law by Decree No. (49) of 2023 Regulating the Use of the Human Genome 22 crime; 2. Deport the foreigner who is convicted of one of the crimes stipulated herein 3. Close the place in which the offence is committed. It shall not be opened unless it is prepared for a legal purpose, and after the approval of the Public Prosecution.