The regulatory regime
To be supplied in the UAE, therapeutic goods must be vetted by the Registration and Control Department (RCD) of the Ministry of Health and Prevention (MOHP). The importer, exporter, manufacturer or seller of medicine or medical devices must satisfy the requirements of the RCD before they can be disseminated for public consumption within the UAE.i Classification
The RCD regulates medication and medical devices (which includes a delineation for devices that include a pharmaceutical component). The RCD further oversees the examination and registration of dietary supplements (including vitamins and herbal extracts), medicated cosmetics, antiseptics and disinfectants, and all other products that contain a pharmaceutical component or medical claim that cannot otherwise be appropriately classified as a medication. Foodstuffs and general consumer products are not regulated by the RCD provided they assert no medical or therapeutic value or claims.
The RCD and the MOHP have the unilateral right to pull or ban any products that they may later deem to be unsafe for public consumption based on studies or recent cases within the UAE.ii Non-clinical studiesUse of animals
UAE Federal Law No. 16 of 2007 (on animal protection) states, at Article 12, that the use of animals for scientific purposes must be approved by the applicable governmental authority. Further, animals are protected from neglect, abuse and cruel treatment by applicable UAE law.
The law specifically states 'scientific purposes', which seems to implicate medical or pharmaceutical testing and does not directly address or contemplate the use of animals for the testing of (non-medicated) cosmetics or household products. The governmental approval process is always at the discretion of the concerned director, who may reject any request deemed excessive, unnecessary or generally harmful.Embryos
UAE Federal Law No. 11 of 2008 (on the licensing of fertilisation centres) contained several provisions that allowed for the freezing of embryos, which were overturned a few years later by a directive of the UAE government and, as a result, hospitals and clinics were ordered to destroy or otherwise dispose of any frozen embryos in their custody. Now, only unfertilised eggs may be stored at appropriately accredited and licensed facilities.
The UAE Federal National Council is currently reviewing draft regulations relating to embryo freezing, with a particular focus on keeping pace with the other regions of the world that allow for this protocol. Although no firm deadlines have been published, these regulations are likely to be promulgated in 2019.IVF regulation
IVF clinics are regulated pursuant to UAE Federal Law No. 11 of 2008 (on the licensing of fertilisation centres). Governmental approvals are contingent upon satisfaction of numerous requirements, including facilities, equipment and staffing with appropriate professional personnel. There are numerous IVF clinics throughout the UAE.Stem cells
There are no specific regulations (and, therefore, no restrictions) with respect to stem cell therapies in the United Arab Emirates. In 2010, the MOHP licensed its first stem cell practitioner, a specialist in spinal cord and brain injuries, and a facility to perform stem cell therapies within the UAE. There have been reports of autologous stem cell treatment on two patients with degenerative diseases. However, general stem cell transplants have been permitted on a restricted, alternative basis, although the storage of stem cells has been permitted. The Dubai Health Authority (DHA) approved the first stem cell and regenerative medical centre in Dubai in 2018.
The UAE has further announced the intent to inaugurate a new cancer treatment and research centre by 2020, which will also have a state-of-the-art bone marrow transplant division.Organ transplants
The UAE federal law permitting organ transplantation became effective in March 2017. The law allows the transplant of tissue or organs from either live or deceased patients for the care of patients in need of the same. However, the law prohibits the sale of human tissue or organs, the funding of transplantation if this results from such sale, and the unlicensed advertising of transplantation services.
Currently, there are four duly licensed organ transplant clinics in the UAE. The DHA announced in November 2018 that a local committee will be formed to regulate the transport and transplantation of organs and tissues in Dubai.iii Clinical trials
All clinical and research trials within the UAE require human subject consent, as well as the written approval of the MOHP, or other concerned governmental authorities, after a review of an application for such trials.
The Guidance of the Drug Control Department (DCD) of the MOHP states that the sponsor of a specific clinical trial or experimental protocol is required to secure all the necessary agreements between the concerned parties.
Designated clinical trial centres should establish independent institutional ethics committees (IECs), which are then tasked with reviewing the relevant proposals of the sponsors. These IECs will review the proposals for clinical trials and experimental protocols, taking into consideration the soundness of the objectives and the medical protocols and practices.
The IECs will render recommendations as whether or not to commence a clinical trial based upon the information provided. The findings and recommendation will then be provided to the applicable governmental authorities for their final, official approvals.
In the respective proposal, the sponsor is to set forth the compensation (if any) for the investigators and the subjects of a clinical trial in its proposal to the IEC. Furthermore, the IEC is to review and approve the proposal of the sponsor with respect to insurance coverage, indemnities or other forms of compensation in case of subject injury.
The investigator may also be the sponsor of a clinical trial, provided it independently plans, conducts and assumes full responsibility for the clinical trial.
All amendments to protocols and all unexpected or serious adverse reactions to drugs administered during the clinical trial are to be reported immediately to the Ethics Committee.
While the clear letter of the law states that no unregistered drugs may be used within the UAE, there are certain circumstances where the MOHP or other governmental departments have approved the use of unregistered drugs (discussed in further detail in subsection iv, below).
The Guidance further states that all clinical trials should follow the Helsinki Declaration to safeguard the rights of individuals subject to a clinical trial.iv Named-patient and compassionate use procedures
In exceptional circumstances, governmental authorities in the UAE have permitted the importation and use of unregistered medicine into the country. The MOHP has recently put forth an approval process that allows such importation, under any of the following circumstances:
- to extend the life of a patient in an emergency situation;
- certain heart or cancer treatment medication that is not available in the UAE and cannot be dispensed in hospitals;
- other medication that has not yet been regulated by the MOHP, but which the MOHP has determined may be of benefit in emergency or other circumstances;
- medications that have been previously registered but have been cancelled by the local agent as a result of lack of market demand; or
- unregistered narcotic or psychotropic drugs for use in specialised hospitals with specific protocols.
Because of the nature of the UAE's regulated market, applications to obtain or use unregistered medication or devices must be tailored for specific patients, trials or protocols, and exigent circumstances. As a result, the quantity of unregistered medication should be limited to a specific hospital or clinic capacity, and for existing or anticipated patients per the application. The MOHP has the discretion to reject, approve, or approve with modifications any application for unregistered medication.
Furthermore, the application to the MOHP must include the following documents or information: (1) a signed undertaking letter from the concerned hospital or clinic that it shall bear all liability for the use of the unregistered medicine; (2) a certification that the medicine is registered in the country of origin or an approved jurisdiction, such as the United States, the European Union or the Gulf Cooperation Council; and (3) a registration certificate from the manufacturer listing the chemical components of the medication.v Pre-market clearance
To be supplied in the UAE, medication, pharmaceuticals and medical devices must be vetted and cleared by the MOHP. A foreign manufacturer of medication, pharmaceuticals and medical devices must appoint a local representative and a local agent (which may be the same person) for the sale and distribution of these products within the UAE.
Unless there are exigent circumstances (as described in subsection iv, above), there are virtually no exceptions to expedite or accelerate the approvals process. The approval of a new medication, for example, would take, on average, no less than two years from submission of an application to the relevant authorities.Medicines and biologicals
The UAE is a signatory to international conventions on narcotics and psychotropic substances. When a medication is approved and registered for use in the UAE, the method of dispensation is also agreed. This is based on the level of control in the source country, as well as the level of control of the active ingredient pursuant to UAE law.
Pricing for medications are fixed by UAE law, and the MOHP provides an updated pricing list for these periodically. Attempts by manufacturers and agents to circumvent the fixed pricing may be subject to fines, bans or other legal recourse by the UAE government.Devices
Medical devices must also be approved by the MOHP before they can be sold or distributed in the UAE. The law defines a medical device as any such device that is used to diagnose, monitor or treat an illness. UAE laws and regulations make a distinction between devices that provide therapeutic benefit through purely mechanical or non-pharmaceutical means and those devices that have a pharmaceutical component (i.e., devices that dispense a drug therapy). The latter may be subject to pricing controls similar to those of medication.
Currently the UAE is largely dependant on import of sophisticated medical equipment. However, recently, there has been development in the nascent medical products industry. In the near future, the UAE may play a leading role in 3D printing in the medical products sector, which could involve developing 3D-printed teeth, bones, artificial organs, medical and surgical devices, and hearing aids.vi Regulatory incentives
Patents are registerable for pharmaceuticals for a period of up to 20 years, with no extension period allowed.
However, unlike other jurisdictions in the region, the UAE recognises the patentability of second-use medical inventions under the law, and has registered a number of these.
There are no remarkable regulatory incentives within the UAE with respect to the marketing, developing or production of pharmaceuticals at this time.vii Post-approval controls
Under UAE law, the foreign manufacturer of a drug must appoint a local authorised representative within the UAE. The representative may also be the distributor of the medication within the UAE. The representative will be tasked with handling all complaints or recalls relating to the medication, as well as fulfilling all requirements with respect to placing the product in the market. The post-market obligations include the obligation to maintain distribution records, complaint-handling procedures and incident-reporting processes, and implement processes to execute investigations and recalls in respect of defective or potentially defective products promptly.
The RCD or MOHP have the discretion to recall any medication based on any information or incident reports directed to them.viii Manufacturing controls
The relevant governmental authorities must approve a pharmaceutical manufacturing plant within the UAE. A foreign shareholder cannot own more than 49 per cent of the shares of a pharmaceutical manufacturing company within the UAE.
The proposed facility must be approved as far as its layout, infrastructure, manufacturing capacities, and its storage and handling of chemicals. The government reserves the right for site inspections and for assessing penalties upon non-compliant facilities.
The UAE Federal Law No. 19 of 2018 introduces the framework under which the UAE Cabinet will exercise its powers in respect of permitting increased levels of foreign ownership in companies operating in certain sectors of the economy but specifically excludes medical retail (including pharmacies) and blood banks, quarantines, and venom and poison banks.ix Advertising and promotion
Healthcare and medical advertising are strictly regulated by governmental authorities and there are stringent guidelines to ensure transparency and honesty, and to stamp out misleading marketing practices. All forms of medical and pharmaceutical advertising require governmental pre-approval before publication. Comparative advertising is usually not permitted and, given other considerations (mainly relating to potential criminal liability for libel or harm to business reputation), most companies steer clear of any advertising pitting themselves against their competitors. Even advertisements on discount websites for businesses such as laser hair removal or dermal fillers require Ministry of Health approval and carry a requisite warning to customers relating to efficacy or potential risks of such procedures.
Additionally, advertisements must not violate public morals, decency, UAE customs or Islamic values and traditions. Medical advertising cannot be false, deceptive or misrepresent the quality or type of medical treatment or product presented. Further, it cannot mislead potential patients regarding the efficacy of certain medication treatment, therapy or protocol, or that the aforementioned will have no potential side effects.
Advertising for telemedicine companies should clearly state what services they are and not authorised or licensed to provide. Advertisements geared towards children are prohibited.
Incentives to healthcare workers for the sale of specified medications, procedures or devices are not permitted by any medical or healthcare advertisement.x Distributors and wholesalers
The UAE has a number of provisions within its Agency Law, Civil Code and Commercial Code that provide a number of protections to local agents and distributors. Some pharmaceuticals or medical equipment may, in certain circumstances, require a registered 'commercial agent' be the importer on record. Such registered commercial agents enjoy wide protections under the UAE's Agency Law, including exclusivity within the UAE market.
A registered agency under the Agency Law makes it difficult for a foreign principal to terminate. Often, a registered agency will only agree to deregister a registered agency (and, hence, allow the principal to distribute products through other agents or resellers) upon an agreed and substantial financial settlement.xi Classification of products
In addition to the basic definition of 'prescription' medication, the MOHP recognises the following three classifications: narcotics, CDA and CDB.
Narcotics are defined based upon their active ingredients and composition. Additionally, CDA medications are defined by their active ingredients, as well as their potential for abuse or diversion for illegal use. CDB medications are defined as those that are used for psychiatric conditions, avoid narcotic controls and restrictions owing to their chemical formulation, or require stricter control than simply those medications that are designated as 'prescription'.
Medical devices are classified in order of risk:
- Class I medical devices are considered to be of low risk to patients. A declaration of conformity is usually accepted from the manufacturer.
- Class II medical devices are considered of medium risk because of the invasive nature of the device; however, these devices are only applied to the body's natural orifices.
- Class III medical devices are considered to be of medium risk to patients and are partially or wholly implantable within the human body, and may modify the biological or chemical composition of body fluids.
- Class IV medical devices are considered to be of high risk to patients. They involve clinical trials and product certification. These devices affect the functioning of vital organs or life-support systems. These devices are usually life-sustaining, life-supporting and invasive.
That being said, the vast majority of medication or medical devices that fall outside the categories of stricter scrutiny are available for sale and distribution over the counter.xii Imports and exports
To import medicine or medical devices into the UAE, a UAE company must obtain a medical warehouse licence or a UAE national must obtain a medical importer licence with the relevant government authorities. The law was amended to permit companies with mixed UAE and foreign shareholding to obtain a medical import licence.
Re-exportation of imported goods can occur within six months of importation – provided the goods are in unused and otherwise exportable condition and the applicable documentation relating to the goods is current.
The UAE's Boycott of Israel Law prevents the direct importation of any goods from Israel (referred to as the 'primary boycott'). The law also prohibits the importation of goods that may have even relatively minor components manufactured in Israel ('the secondary boycott'). Currently, however, the UAE usually enforces the primary boycott alone.xiii Controlled substances
Controlled substances are heavily regulated and monitored in the UAE. In most circumstances, narcotics or psychotropic substances can only be administered within the confines of a hospital or clinic, or dispensed exclusively from a government hospital upon submission of a valid prescription.
The MOHP has a list of controlled substances that cannot be brought into the UAE by people visiting or entering the country, regardless of whether the person has a valid prescription for the medication in the country of origin. Following changes in October 2018, the MOHP announced that all tourists and residents entering the UAE will be required to complete an electronic form to obtain prior online approval to carry narcotic, psychotropic and controlled medication in to the UAE for personal use.xiv Enforcement
The UAE governmental authorities have broad powers of regulation and sanction for the violation of any laws or regulations relating to medication and medical devices. These include: warning, fining, banning of distribution of certain products, blacklisting of manufacturers or medication, suspension or deregistration of local representatives or agents, and closing operations of pharmaceutical plants. The fines may be substantial, and imprisonment may be warranted in cases of intentional criminal activity.