Gene therapy. A New Era of Hopes, Dreams and Fears (3-3)
UAE legislation regulates "gene technology"
«Lavin». One of the first cases to undergo gene therapy was recovery from spinal muscular atrophy.
The UAE provided Munira with gene therapy, which is the most expensive in the world.
With advances in genomics. We got a different healthcare landscape, where we can practically participate in understanding and shaping our personal health profiles.
However, we need to balance the prospects of this science with the challenges posed by the technological, financial, ethical, and cultural constraints to which it is subject.
"Emirates Today" opens the file of development in understanding this event, and understanding public views on the editing of the human genome and foreseeing the future in it by surveying the opinions of experts and specialists from the UAE and Arab countries, in addition to polling parents with children of determination, by relying on an electronic survey to explore people's attitudes towards the impact of gene technology on them and their communities.
The UAE has made great strides in the modern genomics project applications and associated gene therapy.
It has successfully treated more than one person with genetic traits that have caused them rare genetic diseases.
Currently, gene technology in the UAE is regulated through a number of laws and practices, including:
First: The prohibition of human cloning operations in accordance with Federal Law No. 10 of 2008 on Medical Liability, which was replaced by Federal Law No. (4) of 2016.
Second: Legislation on human tissues, such as authorizing the transfer and transplantation of human organs and tissues in accordance with the provisions of Federal Decree Law No. (5) of 2016 regarding the regulation of the transfer and transplantation of human organs and tissues, and this law applies to operations that take place inside the country or in its free zones.
Third: Prohibition of trafficking in human organs in accordance with Federal Law No. 51 of 2006 on combating human trafficking, as amended by Federal Law No. 1 of 2015.
The legal regulation of genetic interventions on gametes and embryos in the UAE is characteristically strict, under the ongoing regulation of the Emirates Genome Project, and various decisions and policies related to the country's compliance with universally accepted values (such as respect for nature, protection of biodiversity, or even protection of human dignity found in the National Constitution and Charter of Human Rights), along with similar concepts.
The European Convention on Human Rights and Biomedicine (widely known as the Oviedo Convention) is currently the only instrument of international law regulating the field of modern medicine.
Member of the Federal National Council, Aisha Al-Mulla, pointed out that the editing of the genome of somatic cells is currently subject to regulation in various countries of the world and is placed within the framework of gene therapies, as an advanced therapeutic medical product.
She stressed that proactive policymaking is a demonstration of the governance framework, and that the establishment of a national genome healthcare strategy is an excellent opportunity to consider how to better utilize the great potential to improve public health, clinical and smart care.
Lawyer Nadia Abdul Razzaq said that "modern technologies and the applications of artificial intelligence they include pose a contemporary legal challenge with their breakthroughs."
She added that «any activity that has an impact on man and his life needs a legislative framework that regulates his work, and governs the resulting effects, so the law in all its branches is currently facing many challenges created by modern technology, whether in the field of contracts that regulate the work of its applications or in the field of civil and criminal liability», noting that «technology applications have produced new areas that require legal intervention to protect them».
UAE laws have witnessed a major qualitative leap in the recent period, in the digital space, the ease of reproducing, modifying and publishing intellectual works leads to a deep imbalance in the right to intellectual property, and accordingly, Decree-Law No. 38 of 2021 was issued regarding copyright and related rights, as well as the legislator issued many laws to regulate all legal problems resulting from technological development. For example, Federal Decree-Law No. 45 of 2022 on the protection of personal data and others.
The Emirati experience has produced many stories of Emirati and resident families who tried gene therapies to get rid of incurable diseases, and found new hope in them.
The father of a baby girl who had muscle atrophy said: "Gene therapy to help my daughter heal was a last option for us, after suffering a long time trying treatments and drugs to no avail.
"Sometimes decision-making is necessary in the best interest of health, although there are concerns about the side effects of this type of modern treatment, and ethical caveats." "Any medical option that leads to positive results and improves the quality of life of our children, is a positive choice," he said.
The Iraqi child, Lavigne, was one of the first cases to undergo gene therapy for spinal muscular atrophy, as she began her treatment journey in March 2020.
Her family said that the treatment she received with the generosity of His Highness Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, put an end to her pain, especially as those infected with this disease usually deteriorate their health condition and deepen their suffering.
The father said Lavigne received gene therapy at the age of 19 months after he and her mother almost lost hope of being cured or her condition improved, and considered this therapeutic breakthrough as a hope for humanity to cure diseases that had never been treated before.
In a third human story, Ahmed al-Ibrahim, a father of two girls with spinal spondylic muscular atrophy, recounts that he never imagined the dream would become a reality.
He explained that «the UAE provided my daughter Munira with gene therapy, which is the most expensive in the world to treat her, from the disease that threatens her life».
He continued: «It was not my daughter's first experience in dealing with this disease, as her older sister Shaza contracted it, and he was able to do it».
He stated that Munira suffered from spinal muscular atrophy, since her birth, which caused her to be unable to move at all, difficulty breathing, and an acceleration in her heartbeat, but after receiving the gene therapy represented in the injection «Zolgensma», which costs about eight million dirhams, she began to move parts of her body, stressing that the remarkable development began after the first physiotherapy sessions that she underwent in one of the specialized centers in Abu Dhabi, hoping that the process of development will continue in Gradient until complete recovery.
Citizens and residents of the country (Salem Al-Ameri, Mahmoud Abdel Rahman, Ahmed Abdel Azim, Zahra Fathy, Laila Jabbar) called on the health authorities to subject genetic diseases to health insurance coverage, as they constitute a large financial burden.
They stated that these diseases are not covered by insurance and the prices of their medicines range from thousands to millions of dirhams.
Khadija Al-Tunaiji, a community trainer, said, "It is important to educate and involve the public in discussions about gene therapy and testing, gene editing, as well as the ethics and governance of inherited human genome editing, so that community members acquire the necessary information about the risks and benefits related to these technologies."
She requested that such information be included in discussions on acceptable standards.
"We must recognize that gene editing has the potential to influence the genetic heritage that is shared by all human beings."
"Scientists should not be solely responsible for making decisions about whether or not to allow these technologies," she said.
Al Tunaiji stressed the need to provide the opportunity to put a regulatory framework for genetic editing on the political agenda by engaging people in the debate on this topic through various means such as the media, panel discussions and workshops. She called for a public referendum to gather opinions and learn about interests and ideas about how human genome editing technology can improve their quality of life. In sum, the human genome belongs to all of us morally, and so we should all have a voice in deciding whether or not to proceed with genome editing.
Mohammed Ahmed Al Louz, Director of the Excellence and Leadership Department at Dubai Municipality, stressed that this can be adopted as long as it has a positive impact and contributes to improving human health and overcoming the quality of complex diseases.
"An important point is that participatory technology assessment methods generally aim to integrate public vision into governance and decision-making processes, which may contribute to finding socially acceptable solutions in areas where technological development increases complexity and uncertainty of future consequences," he said.
Nadia Alshaya, an expert in government excellence, explained that "for public participation to be effective, it must be linked in some way, even if informal, to decision-making processes. Every five years, or whenever amendments are proposed to the 1994 Bioethics Act, which regulates ethically relevant science and technology issues, hundreds of activities are organized across the country to obtain public views on ethically charged issues in science and technology, and then the National Ethics Advisory Committee (National Ethics Advisory Committee) prepares a report summarizing the results of the public consultation. It recommends, when needed, legislation to address public concerns, and this report is sent directly to the French Parliamentary Office for Scientific and Technological Assessment for parliamentary debate."
"This model ensures that regulatory provisions around controversial and ever-evolving technologies remain temporary, subject to public scrutiny, adaptable, and responsive to citizens' concerns." "Collective governance helps respond to the growing demand for public participation and decision-making on issues of importance to the future of humanity," she said, noting the importance of helping to spur strong dialogue and debate about the future of genome editing and the synergistic roles that law, science and public policy can play in promoting or hindering specific uses of technology.
"The establishment of a national healthcare strategy enabled by genomics represents an opportunity to harness its great potential."
• "The UAE legislator has issued many laws to regulate the legal problems resulting from technological development."
• "Technology applications have spawned new areas that require legal intervention to protect them."
"Genetic editing has the potential to influence the genetic heritage shared by all humans."
Poll for «Emirates Today»
Emirates Today conducted a survey from May 21 to 27 by publishing a questionnaire on its website on the impact of genome editing technology in improving human health with the participation of a random sample of 82 participants to investigate their attitude towards the genome project and human genetic modification. The survey questions aimed to explore the extent to which people know about this science and its tools and applications, and how willing they are to participate in experimenting with gene therapies related to genome editing, as well as their vision of the overall impact that such revolutionary therapies reflect. The results showed that few members of the population (22%) did not know about human genome editing, while the majority of respondents (78%) said they had read or heard about human genome editing.
They attributed this to the social media environment, and the technological progress in the UAE in particular, which facilitated the exchange of information between members of society.
The study showed that 73 per cent of respondents knew that the UAE had a human genome program, compared to 26 per cent who did not know.
91.5% of those who approve of the contribution of editing the human genome to saving the lives of children with genetic and rare diseases was <>.<>%, attributing this to the great services provided to such groups suffering from complex diseases.
In contrast, the percentage of rejections was 8.5%.
They attributed their position primarily to fear of future effects for subsequent generations, concerns about morality in the second place, and religious reasons in the third place.
Regarding the impact of human genetic modification, the majority of respondents (52.4%) view the modification as a double-edged sword, sometimes with a "positive effect" on improving the quality of life, and at other times seeing it as "having the opposite effect" on the quality of life.
Those who believe that the technology will have a positive impact on improving the quality of life are 45.1%.
• Develop necessary and practical laws, regulations and guidelines for genomic medicine, its tools and applications.
• Carry out the editing of the human genome, like any other medical intervention, according to appropriate and ethically approved evidence and research studies.
• Advocating for the development of appropriate laws, regulations, national policies and strong and enforceable regulatory frameworks for genome editing in accordance with international and national rules and standards.
• Educate community members on the international and local ethical frameworks that regulate the genome.
• Establish a supervisory and monitoring body under the umbrella of the United Nations for everything related to genomic science research, especially genetic modification and human genetic engineering, and that this body has specific and well-known international powers to monitor any violations in this very sensitive area.
• Develop a joint Arab cooperation framework whose main task is to focus on our most important and various needs in this field.
• Establishing a local or Arab coordinating center to discuss controversial topics in the field of science, biomedicine and technology.
• Insurance companies should not require genetic testing.
• Increase the establishment of major institutes for genetic research.
• Establishment of specialties in biomedicine and its fields.
• Providing an Arabic database for genome projects.