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Overview

Healthcare funding

In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.

Historically, healthcare in the United Arab Emirates (UAE) has been funded by the UAE government - particularly for UAE nationals. Public hospitals, by and large, cater to UAE nationals - whereas the expatriate population is more likely to be serviced by private hospitals.

In the past several years, the UAE government has been focusing on public-private partnerships. Additionally, private investment funds have recently begun investing in healthcare.

Health insurance is now mandatory for employees and/or their dependants within the Emirates of Abu Dhabi and Dubai. The funding for healthcare can, therefore, be broken down as follows:

  • insurance premiums paid by employers on behalf of their employees and/or their dependants (an employee may need to pay the premiums on behalf of some of his family members who are dependants and are not otherwise employed);
  • insurance premiums paid by individuals who do not otherwise qualify as employees or dependants (eg, sole proprietors and business owners); and
  • government funding for the single-payer health insurance scheme of UAE nationals, as managed by the national health insurance company (Daman), and regulated by the Ministry of Health (MOH).

The UAE government may reimburse private healthcare providers for the dispensation of medication or treatment of patients who are under the national healthcare scheme. Medical devices or products may likewise be funded or reimbursed by the UAE government in a similar fashion.

It is important to note that, while the UAE government, under the auspices of the MOH, does fund healthcare, there is no law or regulation which compels it to do so, nor any that require a certain budgetary allocation be made on an annual basis. The annual budget is based on perceived needs or trends in the healthcare market every year.

Delivery

In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.

Public healthcare facilities provide medical care and treatment for UAE nationals, whereas private hospitals do so for expatriates living the UAE. It should be noted that UAE nationals may avail themselves of healthcare in private hospitals should they choose to do so. There is an increasing perception among UAE citizens that private healthcare facilities provide superior technology and the latest in medical procedures and protocols.

Key legislation

Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.

As the UAE is a fairly young nation, its legislation is constantly developing. Taking that into account, the following represent key pieces of healthcare legislation in the UAE are:

  • UAE Federal Law No. 7 of 1975 (Medical Profession Law);
  • UAE Federal Law No. 4 of 1983 (Pharmacy Law);
  • UAE Federal Law No. 5 of 1984 (Non-Physician Medical Profession Law);
  • UAE Federal Laws No. 2 of 1996 and No. 4 of 2015 (Private Medical Establishments Law);
  • UAE Federal Law No. 10 of 2008 (Medical Liability Law), and
  • UAE Federal Law by Decree No. 4 of 2016 (New Medical Liability Law).

The MOH regulates healthcare throughout the UAE. The following authorities, however, provide further supervision and regulation on the Emirate-level:

  • the Department of Health of Abu Dhabi (DOH), previously known as the Healthcare Authority of Abu Dhabi (HAAD);
  • the Dubai Health Authority; and
  • the Sharjah Health Authority.

The other Emirates (Ajman, Ras Al Khaimah, Umm Al Quwain, and Fujairah) have healthcare departments or authorities that are effectively governed by the MOH.

Responsible agencies

Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?

The MOH and its various departments have enforcement authority on the federal level. The various healthcare authorities throughout the Emirates have enforcement capabilities on the local level. Furthermore, the Dubai Healthcare City Authority (DHCA), which regulates the Dubai Healthcare City free zone (DHCC), also has enforcement powers within its jurisdiction.

Scope of enforcement

What is the scope of their enforcement and regulatory responsibilities?

The MOH, Emirate-level entities, and DHCA have very broad enforcement powers, including the right to inspect healthcare facilities, clinics, pharmacies and manufacturing plants, and to fine or shut down nonconforming facilities. They have the power to remove or recall medications that do not conform to regulations, and to remove or fine physicians and other healthcare professionals who do not meet licensing standards or requirements.

The governmental entities’ regulatory responsibilities include the licensing of medical and healthcare facilities, the approval, regulation and pricing of medication and medical devices, and the licensing of physicians and other healthcare professionals.

Regulation of pharmaceutical products and medical devices

Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?

The MOH and its departments and sub-committees are responsible for the registration and regulation of pharmaceutical products and medical devices in the UAE, including the Licensing Committee, the Drug Control Department, and the Supreme Committee on Drug Registration.

These enforcement departments are funded through the government’s budgetary allocations. They also generate revenue through licensing and renewal fees as well as various enforcement activities. Budgetary allocations are usually made based on the current needs or requirements of the UAE.

Scope of enforcement

What is the scope of their enforcement and regulatory responsibilities?

Generally speaking, the enforcement and regulatory responsibilities revolve around licensing pharmaceutical products and medical devices, and fining, confiscating or removing products which violate regulations or guidelines (eg, medicines which are sold in excess of the pricing fixed by MOH).

Other agencies

Which other agencies have jurisdiction over healthcare, pharmaceutical and medical device cases?

In addition to the above-mentioned authorities, UAE Customs may also become involved in the importation of pharmaceuticals or medical devices, and, to the extent that there is any wilful misconduct, the Public Prosecution within the various Emirates’ Judicial Departments may file a criminal complaint against violating parties.

Simultaneous investigations

Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?

As a matter of practice, different government departments do not conduct simultaneous investigations of the same subject matter. A governmental department conducting an investigation may rely on evidence or information of another governmental department. A report or finding made by such governmental department will normally be relied upon by other governmental departments.

Regulation of pharmaceutical products and medical devices

Monitoring powers

What powers do the authorities have to monitor compliance with the rules on drugs and devices?

The authorities have the right to conduct site inspections and visits, as well as temporarily or permanently closing facilities (depending on number and severity of violations and the capability of infractions to be remedied), as well as issuing fines, or confiscating or recalling violating pharmaceuticals and medical devices.

Investigation time frames

How long do investigations typically take from initiation to completion? How are investigations started?

There are no guidelines or requirements as to the initiation and completion of an investigation related to licensing, registration, or other regulatory violations or infractions. The investigation may be initiated by the MOH itself through site inspections or through a review of customer complaints collected from its offices or online portal.

Access to investigation materials

What rights or access does the subject of an investigation have to the government investigation files and materials?

Investigations in general are addressed in the New Medical Liability Law of 2016. The Law implies that the subject of an investigation may not have direct access to government investigation files or materials, but has a right to receive a report generated by the Medical Liability Committee as formed by the MOH.

With respect to investigations into pharmaceuticals and medical devices, the MOH and/or Medical Liability Committee often relies on fact-finding papers or studies prepared by healthcare bodies throughout the world, as well as complaints which may be lodged by patients or other concerned persons. To the extent that these papers form the basis of a report by the Medical Liability Committee, a subject would have the right to review these, and rebut them in an appeal as contemplated by the law.

Investigations abroad

If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?

While the MOH does have a number of agreements with foreign pharmaceutical and medical companies, and the UAE does seek to become a leader in pharmaceutical manufacturing, in part, through these relationships, visits to foreign manufacturing plants for purposes of investigation are not common. Rather, the authorities in the UAE rely on the patents, market authorisations, certifications, or accreditations of conformity from such countries. Inspections of foreign pharmaceutical products or devices that are imported into the UAE are conducted by qualified pharmacists, scientists, engineers and other technicians, many of whom received their credentials from Western jurisdictions.

Enforcement proceedings

Through what proceedings do agencies enforce the rules?

Under the New Medical Liability Law, concerned parties may file complaints relating to medical malpractice or negligence with the Public Prosecution within the respective Judicial Department. The Public Prosecution is to refer these complaints to the concerned healthcare authority, which should then cooperate with the Medical Liability Committee relating to an investigation or report. Once a report is generated (and is ratified), this may be disseminated to the various governmental departments for enforcement.

These proceedings are civil in nature, unless there is evidence of criminal activity by a practitioner. In such circumstances, allegations of criminal conduct will likely be referred to the Public Prosecution for review and action.

It should be noted that, in the context of pharmaceuticals and medical devices, particularly those manufactured abroad, the MOH, in tandem with other governmental agencies, is likely to recall violating medications or devices.

Sanctions

What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?

The authorities may impose a variety of sanctions against drug and device manufacturers and distributors, including fines, confiscation, recalls, the temporary or permanent closing of facilities, and the temporary or permanent revocation of licensing for the respective facilities or healthcare professionals.

Actions against employees

Can the authorities pursue actions against employees as well as the company itself?

Unless there is evidence of wilful or criminal actions or misconduct, or professional malpractice, the authorities do not generally pursue actions against employees.

Defences and appeals

What defences and appeals are available to drug and device company defendants in an enforcement action?

Depending on the circumstances, a potential violator may petition the authorities for additional time to ensure that their products or devices are brought into line with licensing or regulatory requirements. The authorities are generally more lenient in granting such a request to first-time offenders.

Minimising exposure

What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

Companies under investigation should cooperate fully and transparently with authorities, including cooperating with any order or settlement or offering reasonable settlements to remedy nonconforming products.

Recent enforcement activities

What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?

With marked rates of obesity, diabetes and cardiovascular disease, the UAE has focused on monitoring medication related to these issues.

Recently, the MOH has recalled several medications for hyper­tension out of concern that a key active ingredient - valsartan - contained impurities in recent medical formulations and may, therefore, be carcinogenic. The MOH also recently suspended the registration of Lipodar, a cholesterol-lowering drug, claiming the drug did not conform to specifications for the original product. Additionally, the MOH issued a decree publicising the recalls.

Self-governing bodies

Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?

The Emirates Medical Association (EMA) is a non-profit organisation consisting of healthcare professionals and practitioners. There are numerous medical societies functioning under the auspices of the EMA - including the Emirates Pharmacy Society. The EMA and its various societies are focused on scientific training, education, and collaborating with various governmental bodies or entities. They have no effective independent regulatory authority on their members.

Relationships between healthcare professionals and suppliers

Relationship rules

What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?

The pricing of medication and pharmaceutical products is fixed and strictly enforced by the MOH, in accordance with Ministerial Resolution No. 834 of 2008. Furthermore, the Pharmacy Law discusses the fixing of prices for medication, as well as regulating 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 proscribes the offering of bonuses or discounts outside of these strict margins. All other bonus schemes, commissions, or incentives, are strictly prohibited.

With respect to medical devices, UAE medical regulation draws a distinction between devices which provide a therapeutic benefit or effect through non-pharmacological or mechanical means and devices which have a pharmacological component (ie, dispensation of a drug). The latter devices may be governed by pricing controls and margins parallel to those for medication described above.

Enforcement

How are the rules enforced?

The rules are enforced through site inspections, and where applicable, the auditing of accounts. Depending on the severity or repetition of the violations, the authorities may do the following:

  • assess fines;
  • temporarily or permanently close entities; and/or
  • temporarily or permanently revoke licences of pharmacies, clinics, pharmacists or other healthcare professionals.

Reporting requirements

What are the reporting requirements on such financial relationships? Is the reported information publicly available?

The default position under UAE law and regulation is that the parties will comply with the price controls put in place by the MOH. Generally speaking, non-compliance is uncovered through site inspections or auditing of accounts.

Regulation of healthcare delivery

Authority powers

What powers do the authorities have to monitor compliance with the rules on delivery of healthcare?

The authorities have broad powers to monitor compliance with the rules on the delivery of healthcare - including conducting investigations on potential medical malpractice or negligence claims.

The New Medical Liability Law calls for the formation of the Medical Liability Committee by the Minister of Health. The Committee is to be composed of medical professionals of various specialisations. It has exclusive jurisdiction to review medical malpractice or negligence claims as submitted by the various health authorities, the Public Prosecution or the courts. The Committee shall determine causality, severity of harm (including consequential harm), assessment of liability and, where applicable, apportionment of liability where multiple parties may be involved.

Investigation time frames

How long do investigations of healthcare providers typically take from initiation to completion? How are investigations started?

There are no time requirements stipulated in the New Medical Liability Law. However, depending on the complexity of the issues involved, and any underlying investigations of the concerned healthcare authority, it is possible that an investigation may take several months to upwards of a year.

Access to investigation materials

What rights or access does the subject of an investigation have to the government investigation files and materials?

The New Medical Liability Law states, at Article 20, that the complainant or defendant healthcare practitioner may appeal a report prepared by the Medical Liability Committee (as discussed in response to question 24 above) within 30 days of legal notification of such report.

The implicit conclusion of the Law and other healthcare regulations, such as the Healthcare Regulator Manual of the DOH (2017), is that a subject does not have the independent right to investigate files, materials, or information used in the preparation of the report but can rebut such documents or information which form the basis or conclusions of the report once issued.

The complainant and defendant in a medical investigation of the Medical Liability Committee have 30 days from official notification of the Committee’s report to lodge an appeal. The appeal will be forwarded, along with a copy of the report and supporting documents, to the Medical Liability Supreme Committee for final review and adjudication. The Supreme Committee may affirm, deny, or modify the findings of the report of the Medical Liability Committee. The decision of the Supreme Committee is final, binding, and is not subject to any further appeal.

While the New Medical Liability Law was enacted in 2016 (and amends the previous law of 2008), a UAE Supreme Court Case from 2013 may still be relevant in the assessing the application of reports from the Medical Liability Committee and the Medical Liability Supreme Committee during litigation in civil cases (and, potentially criminal cases).

In this case, the UAE Supreme Court ruled that reports of these respective Committees are to be treated like any other expert reports, and reports concluded by health authorities or other experts should not necessarily be set aside as a result. The Supreme Court stated that all reports and evidence should be weighed for their probative value.

However, it appears to be clear that under the New Medical Liability Law that no claim for compensation may be made until a report is issued by the Medical Liability Committee or the Medical Liability Supreme Committee.

Enforcement agencies

Through what proceedings do agencies enforce the rules?

The courts will rely on the findings of the Medical Liability Committee, or, where applicable, the Medical Liability Supreme Committee. As cited above, the courts, at their absolute discretion, may rely on the reports of various health authorities or other healthcare experts.

In addition to civil liability for medical malpractice and negligence, the New Medical Liability Law assesses criminal liability for a number of violations, including:

  • human cloning;
  • unauthorised or unlicensed medical experiments without the consent of the patient;
  • assisted suicide;
  • intentional abortion or sterilisation where the life of the mother is not in danger; and
  • gross medical negligence.

For these acts, the Medical Liability Law allows for the assessment of substantial fines, imprisonment or a combination of both penalties.

Sanctions

What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare providers?

During an investigation, the concerned health authority may suspend the licence of a healthcare practitioner for upwards of 30 days while the Medical Committee adjudicates on liability or while the authority conducts the initial investigation of a potential violation of the Medical Liability Law. These periods of suspension may be renewed as required.

Additionally, healthcare practitioners may not be investigated, arrested, or placed in preventive detention until the final medical report of the concerned healthcare authority is issued with a determination of gross medical negligence, or malpractice has been committed by the subject.

Defences and appeals

What defences and appeals are available to healthcare providers in an enforcement action?

In addition to the appeals process outlined above, the New Medical Liability Law offers the following defences for a healthcare practitioner in refuting an investigation or enforcement action:

  • demonstration that the harm was caused by the actions or omissions of the patient in following the instructions of the healthcare professional;
  • demonstration that the harm was caused by an external action (beyond the reasonable control or diligence of the healthcare professional);
  • proof that the healthcare professional used a medical protocol or methods which conform to generally accepted medical practices or principles (even if these are not used by a majority of practitioners sharing the defendant’s specialisation); and
  • the consequences or complications were unforeseeable.

Minimising exposure

What strategies should healthcare providers adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

Healthcare providers should establish relationships with governmental authorities, and cooperate fully and transparently with any investigation or enforcement action.

Recent enforcement activities

What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?

Recently, the authorities have focused on issues relating to healthcare fraud, including persons using fake degrees to practice medicine, and doctors forging medical reports and prescribing medication based on fraudulent reports or diagnoses. Because these issues have involved wilful misconduct, they have resulted in criminal actions, with the assessment of terms of imprisonment.

Self-governing bodies

Are there self-governing bodies for healthcare providers? How do those organisations police members’ conduct?

The EMA is a non-profit organisation dedicated to scientific training, education, and conferences with its member healthcare professionals and practitioners. The EMA and the various specialist societies that operate under its auspices are focused on support activities, raising awareness of evolving issues in current medical practice and protocols, and liaising with governmental authorities. The EMA and its societies do not have independent policing or regulatory powers.

Remedies for poor performance

What remedies for poor performance does the government typically include in its contracts with healthcare providers?

The government can include a broad array of remedies in its contracts, including suspensions of licensing, mandatory training or certification courses, and dismissal if the performance of the healthcare practitioner does not improve.

Private enforcement

Causes of action

What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?

The New Medical Liability Law states that it applies to all concerned persons, which would include any patient or other person directly affected by a violation of a healthcare regulation or law. Therefore, setting aside the powers of the Medical Liability Committee, a person or private body may be in a position to bring a civil claim relating to a violation of a relevant healthcare regulation or law, or to contact the Public Prosecution relating to a potential criminal claim.

Framework for claims

What is the framework for claims of clinical negligence against healthcare providers?

According to the New Medical Liability Law, in order to demonstrate a breach of a standard of care, the claimant must demonstrate one of the following relating to his or her healthcare practitioner:

  • ignorance of technical matters which should be known by a practitioner with the same degree and specialisation;
  • non-compliance with generally accepted professional medical principles; or
  • failure to exercise due diligence or reasonable care.

The Law further states that the criteria of gross medical error shall be set forth in its implementing regulations.

A civil court in the UAE would generally assess monetary damages for a claimant. The concept of compensation being equivalent to the harm caused is enshrined in the UAE Civil Code (Federal Law No. 5 for 1985). In the medical liability context, UAE courts have taken into consideration personal injuries, loss of income, and moral damages, effectively assessing direct and consequential damages. In addition, a complainant may be entitled to punitive damages by a UAE court for gross medical negligence.

Seeking recourse

How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?

Purchasers or users of pharmaceuticals and medical devices have the right under applicable law to seek redress for regulatory or legal infringements; grounds for which would include harm incurred from the use of the pharmaceutical or device as intended and failure of pharmaceutical to conform with specifications as approved by the MOH.

Compensation

Are there any compensation schemes in place?

In addition to the other medical laws cited herein, the UAE Consumer Protection Law (Federal Law No. 24 of 2006, as amended) provides for categories of fines for violations relating to mislabelling of goods, misleading advertising, advertising and/or sale of counterfeit products, and harmful products.

That being said, under UAE law, a complainant harmed by the use of pharmaceuticals or a medical device may be entitled to damages for physical harm, permanent disability, loss of income and moral damages.

Class and collective actions

Are class actions or other collective claims available in cases related to drugs, devices and provision of care?

The UAE law and court procedure do not currently recognise class or collective actions. Any claim must be made be a claimant on an individual basis.

Review

Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?

Under the New Medical Liability Law, any concerned person is in a position to bring forth a claim relating to a violation of the standard of medical care. This should include any party affected by the acts or decisions of the healthcare institutions. An individual should be in a position to petition the healthcare authority, the UAE courts, the Public Prosecution, or the Medical Liability Committee.

According to the UAE Civil Code, claims for tortious conduct - which includes harm caused by medical malpractice or negligence - must be brought within three years of the harm being inflicted or discovered. The complainant will have to demonstrate a lack of requisite skill, a lack of practice due or reasonable care, or non-compliance with generally accepted medical standards.

While the right to file a complaint is asserted in the Law, the vast majority of the clauses devoted to review of liability revolve around individual practitioners. The Law does mandate that healthcare facilities must maintain adequate medical liability insurance.

The Law calls for the issuance of fines, which may be applied to institutions. Penalties against individual practitioners may include temporary or permanent revocation of licences, as well as fines and imprisonment.

Whistleblowers

Are there any legal protections for whistleblowers?

While the UAE has recently enacted legislation for whistleblower protection in the contexts of financial corruption, no such corollary exists in the framework of medical liability.

However, the New Medical Liability Law is broadly worded, and any concerned person may be in a position to file a complaint or initiate an investigation with respect to a violation of applicable healthcare laws or regulations.

Does the country have a reward mechanism for whistleblowers?

As the UAE does not have a whistleblowing scheme in the medical context, there is likewise no reward mechanism in place.

Are mechanisms allowing whistleblowers to report infringements required?

There are currently no such mechanisms in place within the UAE.

Cross-border enforcement and extraterritoriality

Cooperation with foreign counterparts

Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?

There is no indication that UAE law enforcement authorities cooperate with foreign counterparts. That being said, UAE healthcare authorities do rely heavily on medical certifications, as well as studies and reports, originating abroad (particularly those from the United States, the European Union and Japan) with respect to enforcement and compliance within the UAE (especially for pharmaceuticals and medical devices).

Triggering investigations

In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?

A foreign enforcement activity is likely to only trigger an investigation within the UAE to the extent that a drug, medical therapy or protocol, or device is being implemented both abroad and within the UAE. The UAE is likely to become concerned if there is a potential for harm to patients within the country.

Otherwise a foreign enforcement order would have to be in its final stage (ie, not subject to appeal) before parties could attempt to domesticate the action or judgement within the UAE. Foreign court judgments are difficult to enforce within the UAE, particularly since the UAE does not have reciprocal enforcement treaties with jurisdictions outside the Gulf Cooperation Council.

Pursuing foreign entities for infringement

In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?

Generally speaking, foreign companies will only be pursued to the extent that they have an established corporate presence within the UAE. More often than not, the healthcare authorities will pursue a cause of action against the local agent or representative rather than direct their attention towards the foreign company.

Foreign nationals are only usually pursued to the extent that they are resident within the UAE. Given the lack of reciprocal extradition treaties with most jurisdictions, it is difficult to compel a foreign national to appear in the UAE based on a petition lodged by a complainant.

Update and trends

Current developments

What are the authorities’ enforcement priorities likely to be in the coming year? Are there any noteworthy cases pending? Are there any current developments or emerging policy or enforcement trends that should be noted?

No updates at this time.