Life Sciences Horizons Brochure 2025 - Flipbook - Page 80
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2025 Horizons Life Sciences and Health Care
Key reforms in the United Arab Emirates
The United Arab Emirates (UAE) recently introduced a
number of significant reforms at both the federal and
Emirate level. These changes highlight the UAE's
commitment to the continuous improvement of its
regulatory framework to keep pace with the rapid
growth of the health care sector:
New Pharmacy Law: Federal Decree-Law No. 38 of 2024
(the “New Pharmacy Law”) came into force, repealing
its predecessor and reforming the regulation of medical
products and pharmaceutical practices in the UAE. Notably,
the New Pharmacy Law highlights the movement of regulatory
responsibilities from the Ministry of Health and Prevention
(MoHAP) to the newly established Emirates Drug Establishment
(EDE), marking a significant evolution in the federal UAE
health care framework. The EDE will regulate pharmacological
research, register medical products, and manage
marketing approvals.
New Federal Genomics Law: Effective 1 December 2023,
Federal Law No. 49 of 2023 established a comprehensive
framework to regulate genomic data use across the UAE.
Among other things, it regulates consent requirements
and bans genome alteration and human cloning.
New Mental Health Law: Coming into force in 2024, Federal
Law No. 10 of 2023 regulates the relationship between
psychiatric patients and health care providers, and outlines
licensing requirements for mental health services.
National Standards for Home Health care Services:
MOHAP Resolution No. 40 of 2024 established national
standards for home health care services and regulates
registration requirements, staffing, safety and rights, and
the use of remote monitoring equipment.
New and Updated Department of Health Abu Dhabi (DOH)
Policies and Standards: Including version 2 of the DOH
Standard for Provision of Home Health Care Services, version 2
of Abu Dhabi Health Care Information and Cyber Security
Standard (ADHICS), new Accreditation Standards for Health
Care Facilities (Hospitals), new Policy on Biobanking, new
Guidelines for Clinical & Translational Research in Genomics,
new Guidelines for Clinical & Translational Research in Stem
Cells, and a new Standard for Continuing Professional
Development for Health Care Workforce.
New and Updated Dubai Health Authority (DHA) Policies
and Standards: Including a new Policy on Do Not Resuscitate,
and a new Policy for Health Data and Information Sharing.
Looking to 2025 and beyond, we expect continued rapid
growth in the health care sector, with a particular focus on the
growth of digital health supported by regulatory frameworks that
encourage telehealth and the expansion of electronic health
records. We also expect the EDE, which is currently transitioning
responsibilities from MOHAP, to become fully operational as
the primary regulator of pharmaceuticals, medical devices,
and clinical trials in the UAE, with new guidelines expected
to be published soon.
Imtiaz Shah
Partner
Dubai
Janelle Moussa
Associate
Dubai