On Wednesday, 31 January 2024, the U.S.-U.A.E. Business Council hosted a discussion with Dr. Fatima Al Kaabi, Director General of the newly created Emirates Drug Establishment. Dr. Al Kaabi discussed the new entity’s mandate and expected role in the U.A.E.’s healthcare and life sciences ecosystem. She spoke to an audience of executives representing U.S. and U.A.E. healthcare providers, pharmaceutical companies, medical product developers, healthcare technology companies, and legal and professional services firms. 

Dr. Al Kaabi outlined the scope and mandate of the new Emirates Drug Establishment (EDE), which will manage and regulate the production and distribution of pharmaceutical products, medical devices and technology, animal and agricultural goods, and stem cell or blood matter products. She emphasized that the EDE’s aim is to serve as a public-private partnership with the primary goal of increasing the U.A.E.’s self-sufficiency in healthcare. She explained that public safety was at the core of EDE’s mandate, with four main objectives: 1) to work with the healthcare industry to create an attractive environment for investment in this sector; 2) to stimulate a research and development ecosystem in the U.A.E.; 3) to enhance drug safety through a protective model that incorporates all private and public stakeholders; and 4) to adopt international best practices and standards for regulations and to maintain an agile and evolving regulatory environment that keeps up with industry. She highlighted research and development in medical devices, new medicines and generics, genomics and gene therapy, and, in healthcare technology, AI and pharmacovigilance, as key priorities for the entity.

Dr. Al Kaabi cited the creation of EDE as a significant evolution of the U.A.E.’s healthcare regulation framework, moving regulatory responsibilities from the U.A.E. Ministry of Health and Prevention (MoHAP) – and some elements from the Ministry of Climate Change and Environment (MOCCAE) – into an establishment that aims to shape the regulatory environment through public-private cooperation. She encouraged companies in the audience to contact the EDE with best practices and ideas regarding application and enforcement of standards that ensure an attractive environment for knowledge sharing and innovation. She anticipates numerous opportunities for industry to partner with the EDE and called on companies with innovative health, security, and technology solutions to connect with the EDE in the early stages of its development. She mentioned that several RFPs related to branding and formation of the entity have already been published with many more to follow. As a new establishment, EDE will have the opportunity to adopt in its regulation “proper language for private partners” in order to facilitate and strengthen R&D, intellectual property rights protection, and drug safety throughout the U.A.E.

Dr. Al Kaabi stressed that the EDE aims to have the private sector engaged in every aspect of its mandate to ensure the regulatory environment remains attractive to the best companies, scientists, and innovators that might utilize the U.A.E. for development of new healthcare products. In this regard, she noted that the U.A.E. government at the highest levels has allocated funding to the EDE to attract and foster research and development in the country. Harmonizing standards and policies across the federal and emirate-level governments, as well as developing a mechanism for harmonizing pharmaceutical product pricing, remain important priorities for the entity. The EDE plans to offer extensive opportunities for industry to consult and provide feedback on policies and regulations.

Dr. Al Kaabi expects that the core of the entity will be operational within the next three months including its online site, workforce and staff, and office location in Masdar City, Abu Dhabi. She encouraged companies in the audience to monitor developments in the space to capitalize on opportunities to collaborate with the EDE in its early stages. 

For questions about this event or the Business Council’s work in the healthcare sector, please contact Alyssa Kristeller at akristeller@usuaebusiness.org.