The UAE life sciences industries are subject to stringent regulation, primarily by rules and regulations at federal level and, to a lesser degree, at individual emirate level. Abu Dhabi and Dubai have the most developed rules and regulations of the seven emirates and the other emirates usually follow their lead on policy and legislation.

As the UAE has evolved as a member of the global economy, it has endeavoured to make itself a global destination for health care. Accordingly, much of its new legislation reflects the influence and direction of jurisdictional trends of international market players in the pharmaceutical and medical industries. There has been a growth phase in the health care sector in the past few years, which has helped the UAE move to becoming a hub for medical tourism. The national strategy also aims to guide and support the industry by building sustainable public-private partnership models in the health care sector.

See Question 3.

The national health care system is divided between public and private hospitals and clinics.

Public hospitals and clinics are operated, maintained, and regulated by various government health care entities, including the Ministry of Health (MOH), Abu Dhabi Department of Health, Dubai Health Authority, and the Abu Dhabi Health Services Company (SEHA).

The UAE is a mandatory health insurance jurisdiction. Employers and sponsors, for example, must cover the costs of health insurance for their employees. Residents who are not employed (for example, minors and the elderly) must have their health care covered by a sponsor (who may be a parent or adult child of a non-working parent). The employer must cover the health insurance costs of an employee's dependent children.

Individuals not otherwise covered by employers or sponsors must pay health insurance premiums and other expenses.

UAE nationals have single-payer health insurance funded by the government and managed through the national health insurance company, regulated by the MOH.

The pricing of medication and pharmaceutical products is strictly fixed and enforced by the MOH, in accordance with Ministerial Resolution No. 834 of 2008. The Pharmaceutical Law also discusses price fixing for medication and regulates the payment process from the authorised distributor or representative to the clinic or pharmacy and finally to the patient.

Ministerial Resolution No. 171 of 2011 regulates the profit margins of pharmaceutical distributors and pharmacies and prohibits offering bonuses or discounts outside these strict margins. All other bonus schemes, commissions, or incentives are strictly prohibited.

The UAE Government can reimburse private health care providers for government-funded or government-insured patients.

Pharmacies and insurance providers often enter into agreements with a discount percentage of 5% to 10%, to deal with claims more effectively.

The UAE (under the direction of Abu Dhabi) has moved towards a diagnostic rate group (DRG) system for insurance billing and reimbursement. One purpose of this is to lower medical costs in the UAE (where nearly 80% of medication is imported).

The DRG system requires new billing systems in hospitals and clinics and staff training to document and code applicable medical services. A potential benefit across the UAE is to combat fraudulent practices and abuse.

The UAE government has also entered into public-private partnerships to try to address issues of efficiency and cost-effectiveness in insurance billing and reimbursement.

See above, Reimbursement.

The various regulatory authorities stipulate that medicine can only be dispensed in accordance with an applicable medical prescription by a licensed and registered doctor or pharmacist.

The Pharmaceutical Law distinguishes prescription medical products from non-prescription medical products. Non-pharmaceutical institutions cannot trade in prescription medical products.

An applicant can seek authorisation from the MOH and the relevant Emirate-level authority to sell medication online. Mail order medication may be regulated by both UAE Customs (under the GCC Common Customs Law, effective 2002) as well as the MOH.

The MOH, through its Registration and Control Department, is responsible for the overall regulation of medicines and medical products in the UAE. No medical product can be imported or exported without prior authorisation from the MOH.

Under the Pharmaceutical Law, all pharmaceuticals must be registered by the MOH before they can be imported into the UAE for sale and distribution. Applications are made to the MOH Licensing Committee (see Question 4, Life Sciences Regulation in the United Arab Emirates: Overview).

The government (through the MOH and other government departments) can carry out site inspections and impose penalties for a non-compliant facility (see Question 3, Life Sciences Regulation in the United Arab Emirates: Overview).

The penalties for non-compliance with the Pharmaceutical Law range from fines between AED50,000 to AED1 million and/or periods of imprisonment of up to five years.

See Question 6.

Parallel imports are not allowed into the UAE.

The main laws on the advertising and promotion of medical products in the UAE are:

The MOH, the Abu Dhabi Department of Health, and the Dubai Health Authority all regulate medical product advertising in the UAE.

There is no specific definition of advertising or advertisement in relation to pharmaceuticals. The Pharmaceutical Law generally prohibits the advertisement of a medicinal product by any means but allows the following subject to MOH approval (see Question 12):

No specific internal regulations have to be set up but companies must comply with the Pharmaceutical Law.

The Pharmaceutical Law requires all information and data about a medical product (including on the inner and outer label and the relevant leaflet) to be disclosed to and approved by the MOH before its advertisement, importation, distribution, or use in the UAE.

All medical and pharmaceutical advertising must obtain governmental pre-approval before publication. Comparative-product advertising is not usually permitted and can result in criminal liability for defamation/harm to reputation under UAE laws).

In a marketing authorisation application, information to be submitted to the MOH includes the following:

Any failure to obtain the necessary authorisations for new uses or prior approvals/marketing authorisations from the MOH is punishable by imprisonment for at least six months and up to one year and/or a fine of between AED50,000 and AED 200,000.

Comparative-product advertising is not usually permitted and can result in criminal liability for defamation/harm to reputation under UAE laws.

A medical/pharmaceutical product cannot be marketed in the UAE without receiving prior approval from MOH. However, the MOH has great discretion and can, on an exceptional basis, authorise the import of unregistered medical products and equipment required by health institutions and in emergency situations.

See Question 17.

See Question 12 and Question 13. The MOH, the Abu Dhabi Department of Health, and the Dubai Health Authority all regulate medical product advertising in the UAE.

The Pharmaceutical Law generally prohibits the advertisement of a medicinal product by any means but allows the following subject to MOH approval:

All medical and pharmaceutical advertising must obtain governmental pre-approval before publication. Comparative-product advertising is not usually permitted and can result in criminal liability for defamation/harm to reputation under UAE laws).

In general, advertisements cannot violate public morals, decency, UAE customs, or Islamic values and traditions.

Medical advertising cannot be false, deceptive, or intentionally misrepresent the quality or type of medical treatment or product presented.

Additionally, advertising cannot:

Sales incentives to health care workers are not permitted in any medical or health care advertisement.

The Code of Practice states that samples can only be provided free of charge and in moderate quantities to health care professionals in order to prescribe the product and be introduced to it.

The Code of Practice also states that companies that sell medical products and their local agents can provide pharmacies with a quantity of free goods (bonus) up to 15% of the quantity of pharmaceuticals sold/recorded in the invoice. Otherwise, no cash or cash equivalent can be offered such as additional bonuses, discounts, or any other forms of financial benefit to pharmacies or health care establishments.

There is nothing in the Patent Law that deals with patient organisations or free samples of patented goods. The authors would suggest that free samples (currently under patent) cannot be sold to or used by patients.

The Pharmaceutical Law defines a health care practitioner as a person scientifically and technically qualified and licensed to practise any of the health care professions in the UAE, as set out by the Pharmaceutical Law Implementing Regulation.

The Pharmaceutical Law generally prohibits the advertisement of a medicinal product by any means but allows announcing, advertising, or promoting a medical product in magazines and scientific resources intended for health care practitioners (subject to MOH approval).

The Code of Practice does not distinguish between advertising to health care professionals/health care organisations and to the general public. Marketing authorisation is required to market/promote medical products to health care professionals and health care organisations.

There are no anti-bribery or anti-corruption laws specific to the UAE life sciences industry. However, the relevant part of Federal Decree-Law No. 31/2021 (Criminal Code) prohibits gifts or things of value to both public and non-public officials.

Under Federal Decree-Law No. 4/2016 on Medical Liability (Medical Liability Law), insurance companies, third-party administrators, and health care providers are banned from paying or receiving commissions, financial or other incentives, or profiting from referring patients to medical testing.

The Code of Practice has restrictions on financial benefits to pharmacies or health care establishments (see Question 18).

Pharmaceutical companies must disclose/follow the details of transfers of value to health care professionals or health care organisations which may be specified by the MOH, Abu Dhabi Department of Health, Dubai Health Authority, and SEHA.

See Question 12 and Question 13.

Patents in the UAE are governed by Federal Law No. 11 of 2021) (Patent Law).

The UAE is a signatory to a number of international treaties on patent protection (see Question 28).

In general, a patent can be granted for an invention that:

(Article 5, Patent Law.)

Types of patent available in the UAE are:

Patents can be obtained through letters patent or utility certificates. Utility certificates (under Articles 6 of the Patent Law) are issued for inventions that cannot show the intellectual effort or innovative character required for letters patent but still meet the industrial application requirement in Article 5 of the Patent Law.

The following among others cannot be granted patent protection:

(Article 7, Patent Law.)

See above, Main Categories Excluded from Patent Protection.

Typically, claims for patents of new uses of known substances (second medical uses) are not accepted. A claim can be made provided the claim is directed to a compound X for use in a treatment of condition Y (under the EPC 2000).

The UAE Ministry of Economy, International Center for Patent Registration (ICPR), registers patents. Guidance with details of patent fees is available on its website.

The process involves filing an application form, including a brief description and protected element of the invention. Within 90 days from submission of the application form, the applicant must submit:

A priority term of 12 months is given for an application filed in a country that is in a treaty with the UAE (Article 11, Patent Law).

The review of the patent application takes two to three months, which includes a report on whether it is accepted, partially accepted, or rejected.

The patent is published in the Industrial Property Journal or the Official Gazette of the UAE. Oppositions to patent registrations can be made within 60 days of publication.

Under Article 14 of the Patent Law, patent protection lasts for 20 years from the application filing date. Utility certificates are valid for ten years from the filing date.

The Patent Law does not provide for extensions of patent protection beyond this term.

The Patent Law does not contemplate supplementary protection certificates (SPCs) or any other forms of extended protection.

Under Article 19(1) of the Patent Law, a patent owner has the exclusive right to exploit the patent (manufacture, use, offer for sale, sell, or import a protected product for these purposes) and prevent anyone else from enjoying this right without the owner's express consent.

If the patent is for a method or industrial process, the owner has the same right relating to the direct result of using such a process or method.

A patent is infringed where there is unauthorised manufacture, sale, use, retention, or importation of the invention.

All essential elements of at least one claim must be present in the infringing product for infringement to take place.

Research exemption. Under Article 22(1) of the Patent Law, rights granted by a patent or a utility certificate do not apply to use for education and scientific research purposes.

The Patent law does not expressly mention an exemption for commercial use/research required to obtain marketing authorisation (Bolar-style exemption). In terms of marketing authorisation, however, generic companies cannot use clinic data of innovative companies for marketing approval until eight years after the innovator company obtaining its marketing authorisation (Decision No. 321 of 2020 On the Usage of Data and Information of Innovative Pharmaceutical Products).

IP exhaustion. Under Article 19(3) of the Patent Law, patent rights are confined to works performed for industrial or commercial purposes and do not extend to activities relating to the patented product after an authorised sale of the product.

Other exemptions. Other exemptions from patent infringement include:

The UAE is a party to the following key international IP treaties, among others.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The Gulf Cooperation Council.

The Patent Cooperation Treaty 1970 (PCT).

Paris Convention for the Protection of Industrial Property 1883.

The legislation governing trade marks in the UAE is the Trade Mark Law (Federal Law No (36) of 2021 on Trade Marks). The UAE has not yet implemented the GCC Trade Mark Law.

A trade mark is any distinctive combination of words, letters, figures, graphics, logos, patterns, or other marks used or intended to be used to distinguish the goods, products, or services of their owner based on their provision, manufacturing, selection, or trading (Article 2, Trade Mark Law). A voice accompanying such a mark is considered part of the overall mark.

If a trade mark is registered, its owner becomes the exclusive rights holder in that mark for the goods or services claimed. The owner has the exclusive rights to use that mark in the UAE, and the right to prevent third parties from using it (or a mark that is confusingly similar) in relation to identical or similar goods/services.

Except for well-known marks, unregistered rights are not recognised in the UAE.

The following cannot be registered as a trade mark:

An application for registration is made to the Trade Mark Registration Section of the Ministry of Economy. Its website provides guidance on the application procedure. There is no separate review by pharmaceutical regulators for trade mark registration.

Details of trade mark fees are on the Ministry of Economy website.

An application is reviewed by the Registrar to ensure that it complies with the required formalities (including submission of any documents to support a priority claim).

An assessment on absolute and relative grounds is then made by the examiners. Acceptance or rejection of the application must be made within 30 days.

After publication in the Trade Mark Journal or Official Gazette, objections to the registration must be made within 30 days by any interested party. If an opposition is filed, the registration procedures are suspended until a final decision. If no oppositions are filed, the Trade Mark Registration Section issues a trade mark registration certificate within 30 days of the end of the publication period.

Federal Law No. 4 of 2012 (Competition Law) is the key legislation on competition in the UAE.

The production, sale, and distribution of pharmaceuticals are specifically exempted from the Competition Law (Article 4(1) and the Appendix, Competition Law), primarily for reasons of public policy.

The Ministry of Economy enforces competition law in the UAE.

There are no competition issues associated with the entry of generic pharmaceuticals in the UAE.

Because of other legislative protections in place, there are no abuse of dominance issues in the UAE pharmaceutical sector.

Parallel imports are not dealt with under the Trade Mark Law and so do not necessarily trigger IP (or competition law) issues in the UAE. However, to import medication into the UAE, a foreign manufacturer must enter into an agreement with a representative or agent registered with the MOH. As a result, Federal Law No. 3/2022 on the Regulation of Commercial Agencies (Commercial Agency Law) or Federal Decree-Law No. 50/2022 on the Promulgation of the Commercial Transactions Law (Commercial Code) may apply, particularly if the agency agreement is registered with the Ministry of Economy. If the agreement is registered, the agent can prevent third parties from bringing parallel products into the country and selling them. Without registration of this agreement (which requires careful consideration), trade mark owners or agents cannot prevent parallel imports.

The production, sale, and distribution of pharmaceuticals are specifically exempted from the Competition Law (Article 4(1) and the Appendix, Competition Law), primarily for reasons of public policy.

The Pharmacy Law sets prices for medication and pharmaceutical products.

The MOH reviews the price of generic drugs to ensure affordability to the general public.

There are no restrictions on licensing or assigning patents to foreign parties. The authors are not aware of any restriction on licensing or assigning patents that are fully or partially funded by public investment.

UAE law does not require governmental approval to grant a licence, nor to pay royalties to a foreign licensor.

Recordal of a trade mark licence is not mandatory but it has no legal effect unless it is published in the Trade Mark Register, the Trade Mark Journal or the Official Gazette, and further published in two daily UAE newspapers. The official fee to record a trade mark licence with the Trade Mark Office is about AED2,000, plus local newspaper publishing fees (depending on the size of the published mark/licence). Recordal of a licence can take between four and six months.

A patent licence must be recorded with the Patent Office to have effect against third parties and cannot exceed the patent protection period. The official fee to record a patent licence with the Patent Office is about AED600 for natural persons and AED800 for entities. Recordal of a licence can take between one and two months.

Under the Pharmaceutical Law, a medical control and review committee must be formed within the MOH. Based on recommendations by this committee to the Minister of Health and Prevention, the Minister can prohibit the distribution of medication found harmful to the public. The medication must then be deregistered with the MOH, confiscated, and destroyed with no compensation to its owners or manufacturers.

In addition to the protections set out in Question 35, patients are protected by the Consumer Protection Law (Federal Law No. 15/2020). This protects consumers from harm caused by defects in products sold to the public, as well as by incomplete or deceptive labelling or advertising relating to them.

A product liability suit must be brought in tort as envisaged under UAE Federal Law No. 5 for 1985 (Civil Code).

Licensed pharmacists, doctors, manufacturers, suppliers, and distributors can all be liable for defective medicinal products. This depends on a variety of circumstances including, for example, failure to report adverse circumstances appropriately, failure to update information, or labelling relating to adverse reactions or contraindications.

Possible defences include making an appropriate report and liaising with the governmental authorities, and unilateral recall as soon as the product is discovered to be causing harm.

A product liability claim must be brought in tort as envisaged under UAE Federal Law No. 5 for 1985 (Civil Code). Under the Civil Code, the claimant must bring its cause of action within three years of discovering the harm and the tortfeasor.

A product liability claim can also be brought under the Consumer Protection Law.

There are also criminal implications under the Commercial Fraud Law in relation to product liability with distinct limitation periods.

Class actions are not recognised in the UAE. Individual claimants must file separate lawsuits.

Under the Civil Code, direct monetary damages are the most likely compensation to be awarded to a claimant in a UAE court. Consequential damages may be available for medical treatment resulting from the defective product.

Punitive damages are generally not recognised by UAE law.