Healthcare and Life Sciences Trends and Developments Across MENA | Latham & Watkins LLP
The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification.
The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are advancing initiatives to nurture a thriving life sciences ecosystem in the Middle East and North Africa (MENA). In January 2024, Saudi Arabia launched its National Biotechnology Strategy, which aims to position itself as a biotech leader in MENA by 2030 and an international biotech hub by 2040. Abu Dhabi Vision 2030 has also identified the biotechnology industry as one of the main sub-sectors to develop. In this blog post, we outline key trends including investments, licensing and collaboration, and legislative developments.
Investments, Licensing, and Collaborations
The UAE and Saudi Arabia are developing a healthcare and life sciences ecosystem in MENA and starting to focus on manufacturing, clinical trial infrastructure, and research and development (R&D). Advances in genomics and precision medicine are further opening up new opportunities for personalized medicine, while the development of targeted therapies aims to help improve patient outcomes and reduce healthcare costs.
In the last few years, regulators and investors have been building public-private partnerships with biopharmaceuticals and life sciences companies. While government initiatives are prioritizing research into diseases, increasing life span, and developing drugs, the biopharmaceutical industry has made progress with developing manufacturing capabilities.
Regional startups and multinationals are being drawn to the GCC’s favorable business environment, availability of financing options, and the potential for R&D. Initiatives include tax incentives, research grants, and the establishment of research and innovation hubs. Examples of the UAE and KSA incentivizing multinationals to operate in the region include:
UAE
- The Abu Dhabi Economic Vision 2030 and the UAE Vision 2071 include the objective of making the UAE a world-class healthcare system.
- The “UAE National Strategy for Artificial Intelligence 2031” demonstrates its commitment to innovation-driven healthcare transformation, with the UAE spearheading various initiatives to promote artificial intelligence adoption in healthcare.
- The UAE cabinet has established the Emirates Drug Corporation (EDC) in September 2023, which will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices and aims to strengthen the country’s position as a global hub for pharmaceutical and medical industries.
- The UAE has launched the Emirati Genome Programme, a national strategy to map the DNA of every Emirati to provide personalized medical care for every citizen, which in the future aims to produce, design, and manufacture ground-breaking treatments on a local basis. This project utilizes large-scale genomic data to empower healthcare practitioners for personalized treatments.
- High-profile collaborations between the UAE and US in relation to hospitals and medical facilities, including technology transfer, have attracted experts and researchers to the UAE. Further, the rise of biosimilars and biologics manufacturing demonstrates the UAE’s growing capabilities in the pharmaceutical industry.
KSA
- The National Biotechnology Strategy aims to advance Saudi Arabia’s self-sufficiency in vaccines, biomanufacturing, and genomics, unlocking a high-growth sector, fostering innovation, and improving health and wellbeing. The strategy aims to provide a flexible regulatory environment and advanced infrastructure, as well as integration and collaboration between the public and private sectors.
- Saudi Arabia has also launched the National Transformation Program, which includes a range of initiatives focused on improving healthcare services, including establishing new medical cities.
- Investments in bioinformatics and digital health continue to drive the region’s healthcare agenda. KSA’s Vision 2030 framework promotes the use of artificial intelligence to facilitate innovative digital health solutions. In particular, the National Strategy for Data and Artificial Intelligence includes healthcare as a priority sector that is being implemented through local gigaprojects.
Legislative Developments
UAE
The UAE is laying the groundwork for the use of innovative digital health technologies by developing a regulatory framework for such technologies. It has issued a regulation which 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 of individuals), as well as a comprehensive national AI strategy, in November 2023.
Guidelines and policies have been put in place to safeguard patient data privacy and address security concerns. For example, in February 2019, the UAE issued Federal Law No. 2 of 2019 (the Health Data Law) on the use of Information and Communications Technology (ICT) in health fields, which is supplemented by Implementing Regulations. The Health Data Law, which took effect in May 2019, impacts businesses in the UAE that use ICT to process health information, such as healthcare service providers, life sciences companies, cloud service providers, healthcare IT systems suppliers, and medical insurance providers. For more information on the Health Data Law, see this Latham Client Alert.
Other key federal laws include Data Protection Law No. 45 of 2021, under which health data is considered sensitive personal data and is subject to additional controls; Law No. 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions; as well as other emirate and free zone laws and policies.
KSA
Regulatory bodies in KSA are collaborating to address digital healthcare trends. In addition to the regulatory framework that governs healthcare and life sciences in KSA, a new Personal Data Protection Law (PDPL) was amended and adopted in April 2023, under which health data is considered sensitive personal data and subject to additional controls. For more information on the PDPL, see this Latham blog post.
Other relevant laws include the Law of Practicing Health Professionals (Royal Decree No. M/59) and its Implementing Regulations, the Law of Private Health Institutions (Royal Decree No. M/40) and its Implementing Regulations, and Ministry of Health (MOH) Legal Regulations for Telehealth Services.
In addition, the MOH has published several policies in respect of the Saudi Health Information Exchange initiative, which is aimed at the use of health information and covers topics such as identity management, authentication, patient consent and access, breach notification, and secondary use.
Outlook
The Middle East market is transforming itself into a global player in the life sciences industry; however, it may still face legal, commercial, and operational challenges, for example, the development of the intellectual property regime, mature regulatory frameworks, and need for continued investment including in tertiary education for scientific endeavour. Opportunities include the region’s commitment to R&D, coupled with infrastructure projects, which provides a robust environment to foster innovation.
With the support of government initiatives, the growing academic and research ecosystem, and significant investments in infrastructure, the region is poised for continued growth in biotechnology, pharmaceuticals, and digital health, including through the use of emerging technologies such as artificial intelligence. Latham & Watkins will continue to monitor developments in this area.
