Legal consultants Christina Sochacki and Andrea Tithecott at Al Tamimi and Company discuss biotechnology and genomics strategies across the GCC
Earlier this year, 2024, the Kingdom of Saudi Arabia (KSA) unveiled its ambitious National Biotech Strategy, aiming to become a regional leader and global player in the biotechnology sector. This strategy is complimentary to Vision 2030 goals and the Saudi Genome Program.
KSA is not alone in its pursuit of biotechnology excellence in the region. Specifically in relation to genomics, several other countries in the Gulf Cooperation Council (GCC) have launched their own national genome programs, with the aim of using genomic data to improve health and well-being, understand and treat rare genetic diseases, and develop personalised and preventive healthcare. For example, the United Arab Emirates (UAE) has developed the Emirati Genome Program to establish a national genomic database, and recently issued a new law to regulate the use of the human genome database. The Kingdom of Bahrain (Bahrain) developed its National Genome Program and set up the National Genome Center and the Regenerative Medicine Center, which offer a range of innovative therapies, including stem cell therapy, tissue engineering, and gene therapy.
This particular current focus on genomics, as well as cell and gene therapy, aligns with the region’s high incidence of genetic diseases. We expect to see a marked increase in demand – and development of legal and regulatory pathways for – CRISPR, stem cell therapies, and similar technologies.
KSA – National Biotech Strategy
KSA’s National Biotech Strategy’s goals include prioritising its preparedness and active involvement in vaccine development and distribution; reducing dependence on imported drugs through localising bio-manufacturing, increasing biologic and biosimilar exports; expanding the national genomic database and analytics platform, and developing a supportive regulatory environment; and establishing and securing a sustainable food supply in KSA, supporting the Saudi Green Initiative.
The Kingdom sees the advancement of a biotechnology agenda as contributing towards high quality job opportunities, boosting financial reserves, and cultivating a knowledge economy. Biotechnology is one of the industries targeted for localisation, through bio-manufacturing of vaccines and biosimilars, feeding into the Kingdom’s drug security aims. The strategy focuses on supporting research and development, fostering local biomanufacturing capabilities, and forging strategic partnerships with global leaders in the biotechnology field.
Regional genomics programs
We see across the region a focus on creating country specific genome programs amongst a rising awareness of the study of genomics and development of personalised medicine.
Kingdom of Saudi Arabia
In KSA, the Saudi Genome Program (SGP) started in the King Abdul Aziz City for Science and Technology (KACST), which aimed to sequence the genome of Saudi Arabians and study the underlying basis for rare genetic diseases. In 2022, the first phase of strategy development was set in motion for SGP, unveiling the roadmap for SGP 2.0. Amongst its goals are: establishing the Kingdom as a global hub for worldclass collaborations on prevalent genetic diseases, becoming a leader in genetics and genomics within the MENA region, and ensuring genomics plays a vital role in delivering high-quality healthcare to all Saudi citizens.
In addition, the Saudi Biobank, a national medical research project, supports genetic and epidemiological research of rare diseases. A variety of other medical genetics programmes have been established in the Kingdom, including through several institutions focused on science and technology, such as King Abdullah University of Science and Technology (KAUST), King Saud University (KSU), King Abdulaziz City of Science and Technology (KACST), King Abdullah Institute of Medical Research (KAIMRC) and King Faisal Specialist Hospital and Research Center. (KFSH&RC). Many of these institutions have made substantial investments in state-of-the art infrastructure, including a batch-size manufacturing line in KACST.
Complimentary to these initiatives, in August 2023, the Saudi Cabinet announced the approval of the Saudi National Institute of Health (SNIH). The institute will focus on supervising and promoting the value of translational research – turning basic research into practical results – and clinical trials. Earlier this year, the SNIH posted for public comment a draft regulation concerning the issuing of grants by the SNIH.
Furthermore, we have seen the Saudi Food and Drug Authority create a regulatory framework for biosimilars, and Dammam Valley launched a biotech startup program in 2022. It also announced the development of a Saudi-German Genomic Center in Riyadh to establish this state-of-the-art genomic center which stems from the Kingdom’s goal to accelerate the implementation of genetic testing for the early diagnosis of diseases, particularly cancer and rare genetic disorders, but also address the preventive element in personalised medicine.
United Arab Emirates
The UAE recently issued a new law to regulate the use of the human genome. 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 program to utilise the genomic data of the UAE citizens and develop the Emirati genome reference.
This compliments the national genome program, the Emirati Genome Program, launched in 2019, which aims to use large-scale genomic data to improve health and well-being, and is overseen by the UAE Genomics Council. The goals for the resulting reference genome are to develop personalised and preventive healthcare for the UAE’s citizens and a comprehensive understanding of rare genetic disorders and develop new treatments.
G42 Healthcare aims to boost its clinical genomics capabilities and has built the region’s largest Omics Centre of Excellence, which leverages advanced sequencing technologies for short and long reads and includes a somalogic proteomics laboratory and the Middle East’s largest third generation sequencing platform.
Kingdom of Bahrain
In Bahrain, the National Genome Program was launched in 2019, with the goal of drawing Bahrain’s genetic map and creating a comprehensive database. Another significant development towards revolutionising healthcare in Bahrain entails the establishment of the National Genome Center, an institution dedicated to studying the human genome and its impact on health and disease. One of the primary goals of the National Genome Center is to create a comprehensive database of genomic information from the Bahraini population.
With the recent establishment of the Regenerative Medicine Center, Bahrain is seeking to be at the forefront of innovative healthcare solutions. The center offers a wide range of regenerative therapies, including stem cell therapy, tissue engineering, and gene therapy. The Regenerative Medicine Center in Bahrain is actively involved in research and clinical trials to develop effective gene therapies for a range of conditions.
Conclusion
These initiatives demonstrate the growing awareness and interest in biotechnology and genomics in the GCC, as well as the potential for collaboration and innovation in this field. Biotechnology and genomics offer tremendous opportunities for advancing healthcare, agriculture, and environmental sustainability in the region and beyond. By harnessing the power of biotechnology and genomics, the GCC countries can enhance their competitiveness, resilience, and quality of life in the face of global challenges and opportunities.
Al Tamimi & Company’s Healthcare & Life Sciences sector group regularly advises on all legal and regulatory matters pertaining to the healthcare and life sciences industries.
For further information please contact: www.tamimi.com