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
The main principle according to the above Law is to implement the registration of all medicines with the Ministry of Health (MOH) in order to be legally circulated in the UAE market. Article 65 of the Federal Law No. 4 of 1983 concerning the Profession of Pharmacy and Pharmaceutical institutions, states the following:
“No imported medicine, pharmaceutical preparation or children’s food should be put for circulation before being registered in the Ministry. Any medical company, which plans the marketing of its production in the country, should be registered in the Ministry”.
Based on the above article, it is clear that the general rule is not to allow the import of any medicine unless it is registered in the UAE. However, the question arises as to whether there are any exceptions and does the above rule apply in all situations? According to the Law there are no exceptions, as imported drugs are only permitted if they have been registered with the MOH.
However, practices by pharmaceutical companies have proven that there are indeed exceptions and in some cases, they have been able to import unregistered drugs. The MOH has enabled a process to import unregistered medicines in exceptional circumstances, namely:
Accordingly, some hospitals which are affiliated with Abu Dhabi Health Authority or Dubai Health Authority are allowed to import unregistered drugs into the UAE subject to approval from the MOH. The application to import unregistered drugs in such circumstances must be detailed and specific in order to gain approval. As such, the quantity of the imported medicines shall be limited to the hospital capacity and the number of existing and/or expected patients and under no circumstances are they able to supply non-registered medication outside the hospital. The MOH has the full authority to refuse an application to import unregistered drugs, amend the quantities, or issue a conditional or unconditional acceptance to such request and quantities.
The MOH have set a number of conditions with regards to the import of unregistered drugs:
Any hospital/entity which imports unregistered medicine is liable for such import and use of that medicine. This legal obligation is referenced by the condition above requiring a Letter of Undertaking from the hospital to use the product and bear all responsibility of such use. The sanctions stated in Law No. 4 of 1983 concerning the Profession of Pharmacy and Pharmaceutical Institutions shall be applied in case of any violation of the terms.
As with the general rule applying to all medicines, the law also prohibits importers of unregistered drugs from promoting any medicine in any way as per Article 92 of the Pharmacy Law which states: “Publication of pamphlets or books and advertising through newspapers, radio and TV for any medicine, pharmaceutical preparation or children’s food to be determined by the Minister shall not be permitted”. Conversely, the MOH welcomes medicine and disease awareness programs subject to their approval regardless of whether the drug is registered.
As with most rules, the above shows that whilst the law prohibits the importation of unregistered drugs, there are instances in which exceptions can be made.