Regenerative Medicine Regulations in the UAE

Healthcare and Medical Tourism in the UAE

The United Arab Emirates (UAE) is nestled in the Middle East and is part of the Gulf Cooperation Council (GCC), which is the regional, intergovernmental, political, and economic union comprising Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates¹. The UAE is an elective monarchy formed from a federation of seven emirates, consisting of Abu Dhabi (the capital), Ajman, Dubai, Fujairah, Ras Al Khaimah, Sharjah and Umm Al Quwain.       

The Emirates have a comprehensive government-funded health service and a rapidly developing private health sector that delivers a high standard of health care to the population^2,3. Healthcare in the UAE is so good that there were 337,011 medical tourists to Dubai in the year 2018². Post the Coronavirus pandemic, it is anticipated that this will rise to 500,000 medical tourists per year. Already there are several medical cities in the UAE that are dedicated to serving healthcare needs⁴.

The UAE has taken numerous steps in recent years to ensure they can provide world-class healthcare and encourage innovations in the medical field. Most of the infectious diseases such as malaria, measles, and poliomyelitis that were once prevalent in the UAE have been eradicated. The prenatal and the postnatal care is on par with the world's most developed countries, as demonstrated by childbirth mortality rates; the newborn mortality rate has been reduced to 5.54 per 1000, the infant mortality rate to 6.4 per 1000, and the maternal mortality rate has dropped to 3 for every 100,000⁴. The current life expectancy in the UAE is 77.8 years, similar to Europe and North America⁴.

All UAE nationals have access to subsidized healthcare, but guest workers and visitors must pay more to access healthcare. Expatriates (expats) living and working in the UAE are entitled by law to have health insurance provided by their sponsor or employer. Expats may apply for the national public health card through the Ministry of Health and Prevention, affording them the same 50% discount on healthcare services as UAE nationals, but this only allows treatment at a small number of facilities. Otherwise, private healthcare can be costly and prices have been rising about 13% per year⁴. The UAE has set up charitable funds that help underinsured expats to finance more serious medical conditions, such as cancer, dialysis, polytrauma and disability.

Healthcare in UAE is regulated by both the federal and the emirate level governments. These authorities include the Ministry of Health and Prevention (MOHAP), Health Authority-Abu Dhabi (HAAD), the Dubai Health Authority (DHA) and the Emirates Health Authority (EHA)³. In 2018, healthcare expenditure was AED 50.3 billion (3.4% of GDP). This expenditure is funded through taxes collected (although there is no income tax in the UAE)⁵.

Regenerative Medicine in the UAE

The process of rejuvenating, replacing, regenerating, and restoring cells and establishing healthy function is called Regenerative Medicine (RM)⁶. There is already a strong RM market in the UAE and further growth is expected. Healthcare cities and healthcare clinics offer a variety of RM options, especially for musculoskeletal ailments, cardiovascular diseases, and aesthetic or cosmetic dermatology. Stem cell therapy has growing popularity in the UAE.

Certain trends in the healthcare sector of UAE favor the growth of the RM industry. One is that the UAE is shifting from importing drugs and therapeutic products towards allocating funds for the local manufacture of pharmaceutical and therapeutic products. Another trend is greater government investment in biomedical research and development. This encompasses advanced biotherapies such as cell therapy, immunomodulation therapy, gene therapies, and tissue engineering. These emerging medical technologies will further drive the future growth of the RM market in UAE.

The downside of the massive growth in the healthcare sector of UAE has been chronic staffing inadequacies such as availability of trained healthcare professionals.  Expats have a high turnover and attrition in the Middle East, returning to their respective countries once their contracts terminate. The leadership of the UAE has recently addressed this problem by facilitating “Golden visas” which enable highly skilled foreign talents to stay for 10 years⁷.

Biobanking in the UAE

Most of the biobanks in the UAE are either cord blood banks or adipose stromal cell banks. Cord blood banking has a long history in the UAE. The Dubai Cord Blood Research Center (DCRC) began in 2006 as the first public bank accepting cord blood donations in the UAE, although since 2018 they only offer private services. The first family cord blood bank to open a laboratory in the UAE was Cryo-Save Arabia, also launched in 2006, and now known as CellSave Arabia. Until this year, the majority of the cord blood banks marketing to parents in the UAE have been shipping their cord blood collections to laboratories in the United Kingdom or India for processing and storage.

A 2020 law from the UAE Ministry of Health which became effective in January 2022 requires banks that collect cord blood units in the UAE to set up a laboratory and storage facility inside the UAE⁸. Compliance with this law is not visible to consumers yet, because cord blood banks have been given extensions to operate if they can demonstrate that they are taking steps to establish a laboratory. The law requires that applicants for a license to bank cord blood in UAE must put up a guarantee bond of AED 10 million. The law further specifies that within two years of commencing operations, the laboratory facility must be accredited by AABB or FACT or JACIE.

Clinics that use adipose stromal cells (ADSC) or stromal vascular fraction cells (SVFC) from autologous sources are allowed in the UAE. The prevalence of these clinics has driven the creation of biobanks for adipose cells. A 2020 law from the Government of Dubai spells out the regulations on autologous adipose cellular therapies⁹. The regulations allow a variety of techniques for isolation of adipose cells, provided that the cells are minimally manipulated and are not combined with other therapeutic products. Specifically, isolation methods can include mechanical dissociation by liposuction, the use of enzymes (i.e., GMP collagenase is approved for use in the UAE), rapid sonication  (sonication-mediated cavitation), and possibly other “FDA techniques” being developed⁹.

Regulations on the Practice of Regenerative Medicine in the UAE

Biotherapies can be approved for use in the UAE if they are approved by recognized regulatory bodies elsewhere, such as the United States FDA or an equivalent in another country, and also including international medical associations and professional bodies. The level of previous approval that will be considered is flexible, covering both biotherapies that are considered a standard care for that indication, as well as biotherapies that are in officially registered clinical trials for that indication. Applications for approval of a biotherapy in the UAE must include all the  processes and protocols governing the production or manufacturing of the cells or their derivatives and their therapeutic uses. 

Regenerative medicine therapies can only be provided in the UAE by licensed and authorized healthcare facilities. In order to be licensed to provide therapies with cells or cell derivatives, the healthcare facility must show evidence of Good Laboratory Practice (GLP), Good Medical Practice  (GMP), Good Tissue Practice (GTP) and Good Clinical Practice (GCP) when applicable.  The facility should be able to comply with and provide evidence of accreditation and international approvals applicable for the scope of services offered.

The UAE also has training requirements for the physician or surgeon that administers the biotherapy. The provider must present evidence of recognized training in RM with a clear description of the amount and the nature of the hands-on training received. This should include: donor selection, patient eligibility and suitability, selection of procedures, preparation of patients, screening for infectious diseases, intraoperative and post-operative care, and follow-up. The provider should also be able to furnish records of demonstrated competency such as the number of cases treated and their outcomes, evidence of Continuing Medical Education credits, and the provider must hold an Advanced Cardiac Life Support (ACLS) or Advanced Life Support (ALS) certification where required.

Review of product advertising and promotional labeling is mandatory in the UAE. Advertising of stem cell therapies is strictly frowned upon and can be punishable by law, where the UAE may impose sanctions on the facility and the healthcare practitioner in relation to any breach of requirements. The regulations on autologous adipose therapies state that “Healthcare providers are required to … avoid the use of exaggerated, alarming expressions and/or unfounded claims for such therapies”⁹. In the case of compassionate use or off-label prescribing of a cell/cellular therapy, an application for approval of the intended use of stem cells/stem cell derivatives must  be submitted prior to initiation of the therapy. Note too that the UAE cord blood banking law explicitly prohibits the import and export of cord blood stem cells without prior formal permission⁸.

There is now a renewed focus in the UAE healthcare sector to look ahead and embrace innovation. Regenerative medicine with stem cell therapy has growing popularity in the UAE, and a massive expansion is expected in the next few years.

Dr. Bapat is originally from India, where she earned her medical degree with specialization in clinical pathology. For over a decade she has lived in Dubai, while consulting for medical organizations around the world. Dr. Bapat is an expert in the operational management and regulatory compliance of stem cell facilities. Her expertise ranges across the complete spectrum from setting up laboratory SOP, to achieving accreditation, to submitting documentation for clinical trials of cellular therapy products. She has executed projects on behalf of diagnostic laboratories, hospitals, biobanks, apheresis and transfusion facilities, and biotherapy providers. Dr. Bapat has worked with numerous international Quality Management Systems, including AABB, FACT, SCB, JCI, CAP, USFDA, and the Ministry of Health for various nationalities. Dr. Bapat held a chair on the committee that developed the cord blood banking regulations adopted by the Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI). She has worked for multiple cord blood banks as well as companies producing therapy products based on perinatal cells and tissues. Dr. Bapat has developed training materials for professionals as a subject matter expert on the topics of biotherapies and blood components. Dr. Bapat is the 2022 recipient of the AABB President's Award. She is a member of the Advisory Panel to Parent’s Guide to Cord Blood Foundation. Dr. Bapat is a co-founder and Vice President of Infohealth FZE and of Questar Enterprises, both in Dubai, UAE. She is also a Director for MEMP (Middle East Medical Portal) of London, UK, and Regenerative Outcomes LLC, of Nashville USA. She has working proficiency in eight languages.

References

1. Haglund, David G. Gulf Cooperation Council | History, Member Countries, Purpose, & Summits. Encyclopedia Britannica, https://www.britannica.com/topic/Gulf-Cooperation-Council, Accessed 25 July 2022.
2. Arnold, Sarah. The healthcare system in the UAE. Expatica, 21 June 2022, https://www.expatica.com/ae/healthcare/healthcare-basics/the-healthcare-system-in-the-united-arab-emirates-71767/, Accessed 8 August 2022.
3. The United Arab Emirates’ Government portal. Home - The Official Portal of the UAE Government, https://u.ae/en/#/, Accessed 25 July 2022.
4. Embassy of the United Arab Emirates, Washington DC. Healthcare. https://www.uae-embassy.org/discover-uae/society/healthcare, Accessed 26 July 2022.
5. Arnold, Sarah. A guide to the tax system in the United Arab Emirates. Expatica, 21 June 2022, https://www.expatica.com/ae/finance/taxes/the-tax-system-in-the-united-arab-emirates-71746/, Accessed 8 August 2022.
6. AABB. Regenerative Medicine. https://www.aabb.org/news-resources/resources/cellular-therapies/facts-about-cellular-therapies/regenerative-medicine, Accessed 5 August 2022.
7. The United Arab Emirates’ Government portal. Getting the Golden visa. https://u.ae/en/information-and-services/visa-and-emirates-id/residence-visa/getting-the-golden-visa, Accessed 8 August 2022.
8. UAE Ministry of Health. Endorsement of the Regulations of Cord Blood and Stem Cells Storage Centers. Council of Ministers Decision No.6 of year 2020 https://mohap.gov.ae/app_content/legislations/php-law-en-97/mobile/index.html, Accessed 8 August 2022.
9. Government of Dubai. Standards for Autologous Adipose-Tissue Derived Stem Cells/Stromal Vascular Fraction Cells (ADSCs/SVFCs) Therapy. https://www.dha.gov.ae/uploads/112021/11ef0e41-d096-404e-9c8f-bf14ec990548.pdf, Accessed 8 August 2022.