Our first edition of 2022 focuses on Healthcare and Life Sciences. It is a sector that will once again have the spotlight on it this year as we continue to tackle COVID-19 and its subsequent variants. While the pandemic continues to challenge the sector, governments across the region forge ahead with their plans to expand and upgrade healthcare systems and develop robust world-class healthcare infrastructure.
For the region, healthcare is a vital pillar in diversifying its economies, both locally and as medical tourism hubs. To underpin this, healthcare authorities across the region continue to implement frameworks and regulations that provide structure and accountability.
In this edition, you have unique access to great insights and expert commentary on a number of pertinent healthcare regulatory developments. You will find a topical mix of articles; for example, our lawyers discuss vaccines and returning to work during the pandemic. They take you through several other areas, including stem cell research in Bahrain, clinical research laws in Egypt, and Saudi medical device and pharmaceutical laws.Take a read of the edition
Shaden El Shibiny
Setting Up and Licensing
Setting up and operating research institutions requires substantial investment in human and financial capital and, as such, it is important that their operations are compliant with the applicable laws and regulations in order to effectively exploit research and avoid any disruption of their research activities.
The UAE laws and regulations applicable to research institutions are diverse and include both federal and emirate level legislation, depending on the location of the institution and the nature of research activities conducted. At the federal level, the Ministry of Higher Education and Scientific Research (‘MOHESR’) was established by Federal Law No. 4 of 1992 and became responsible for a number of things, including coordination with research institutions regarding approvals to licence such institutions.
At the incorporation level, research institutions in the UAE should be licensed to conduct research activities under their corporate licence (issued by the relevant authority of the jurisdiction where they are incorporated). Certain public institutions are established by decree, which will set out the authorised activities that can be conducted by them. Private institutions wishing to engage in education and research activities in the UAE must apply for a number of permits, including the MOHESR approval. If, for example, a private intuition wishes to set up their operations in the Dubai Healthcare City (‘DHCC’), they will require the necessary approvals from the MOHESR and a DHCC Education Permit to be able to provide education or training programmes in the DHCC. Furthermore, to conduct research activities, a DHCC Research Permit is needed, which is obtained by submitting details of the clinical research to be undertaken at the facility. Not all research is permitted in the DHCC, thus, for example, research involving animal studies and human embryonic stem cell research is not permitted.
Besides the corporate licensing requirements, depending on the nature of the research activities, research institutions may also be required to obtain specific research licences from the specialised governmental bodies regulating the relevant research activities.
Scientific research projects on the physical and biological environment, including research on air, soil, water, and wild organisms must obtain permits from the environment agency in the emirate where the research is conducted. Thus, for example, in Abu Dhabi, a scientific research no objection certificate is required from the Environment Agency – Abu Dhabi, in addition to specific authorisations for research that involves activities such as import or export of live animals.
Some other notable regulated research activities include nuclear related research activities, the use of drones such as for survey or other purposes, the use of certain marine or coastal areas, the use of private islands or lands, and research activities in culturally and archaeologically significant sites.
Further, the devices used for conducting research activities may require special approvals. In the case of medical devices, the Ministry of Health and Prevention (‘Ministry’) requires such devices to be registered with the Ministry prior to their importation and should be in compliance with the UAE requirements. On the other hand, telecommunication devices may require type approvals issued by the Telecommunication Regulation Authority (‘TRA’) in the UAE.
When research activities involve the capture and use of personal information of individuals, these institutions should comply with the relevant data protection laws, consumer protection laws and other general information protection elements of the UAE laws, depending on the jurisdiction where the research is being undertaken.
It is important to note that scientific research may, in certain cases, relate to new and unregulated activities or fields. In these cases, it is prudent to carefully determine and consult with the relevant regulatory bodies that oversee such activities and obtain their guidance in relation to these.
On and Off Campus
Research institutions are not always fully aware of research activities conducted by their faculty and staff. It is therefore important for research institutions to have clear protocols and guidance in place to ensure compliance with the research activities as approved on their licence permits, and the applicable laws and regulations. In addition, research institutions should put in place awareness seminars and training for their faculty and staff to ensure that they follow the processes and procedures in place to protect the institution from being exposed to heavy civil or penal sanctions, including monetary fines, delayed release of shipments of materials or equipment from customs, and the suspension of research activities permits and licences. There are also potential reputational damages to consider.
The number of permits and approvals required by research institutions to be able to undertake scientific research can appear daunting; however, with proper guidance and use of an approvals matrix, the task can be accomplished in a methodical and efficient way.
For more information, please contact Ahmad Saleh, Partner & Head of Patents & Designs (R&D and Innovations) at Al Tamimi & Co at A.Saleh@tamimi.com or by phone at +971 55 362 8282.