In case you missed it: Key UAE Federal Healthcare Law Updates 2023
Healthcare & Life Sciences Focus
Raesa AfzalSenior Counsel,Corporate Commercial
Clive D'souzaAssociate,Corporate Commercial
In 2023, we have witnessed significant changes in the healthcare legislative landscape in the UAE and as the new year begins, we would like to provide you with a recap of all the newly issued legislation and amendments across key areas, such as: healthcare professional licensing; healthcare facility licensing; medical liability; pharmaceutical and medical product regulations that have occurred over the past year.
One of the significant developments in the UAE healthcare sector over the past year is the Allied HCPs Law. This new law introduced stricter licensing requirements for all allied healthcare professionals (being healthcare practitioners other than physicians or pharmacists) working in professions such as: nursing; medical physics; functional therapy; physiotherapy; aesthetics; anaesthesia; audiology; and radiology, among others (‘Allied HCPs’).
Article 4 of the law expressly states that no person may practice as an Allied HCP unless they are licensed by a UAE health authority. Allied HCPs are also now mandated to meet certain minimum requirements (similar to physicians and pharmacists), as outlined in Article 5 of the Allied HCPs Law, which include: holding an academic certificate or a degree recognized in the UAE; maintaining a record of good conduct with no prior convictions for felonies or misdemeanours; and proving their medical fitness to perform their duties.
Article 8 of the Allied HCPs Law establishes a new code of ethics and professional conduct for Allied HCPs, which includes: adhering to regulations and responsibilities within their practice areas; working within the scope of their license; maintaining accuracy and honesty in patient care; upholding professional dignity and ethics of their profession; informing the attending physician of all relevant information relating to a patient, and maintaining the confidentiality of patient information. They must also ensure patient dignity, provide assistance without discrimination, keep their skills up-to-date, and be prepared to train others in their field.
In addition to this, the Allied HCPs Law introduces prohibitions applicable to Allied HCPs, as set out in Article 12, such as: practicing their profession in an unlicensed place (except in certain cases to be defined by the Executive Regulations to this law); submitting forged documents or incorrect data; selling medicines or samples to patients or promoting specific medicines; directing patients to purchase exclusively from a particular pharmacy; engaging in conflicting practices; marketing themselves without adhering to defined regulations; or disclosing patient secrets in violation of relevant laws.
Further, the Allied HCPs Law establishes a 'National Medical Register' that mandates registration for all licensed Allied HCPs. This register will be maintained by the UAE Ministry of Health and Prevention (‘MOHAP’) in coordination with local emirate-level health authorities (such as the Dubai Health Authority), containing all details related to the registration and licensing of Allied HCPs.
The relevant health authority may impose disciplinary sanctions on any Allied HCPs in violation of the Allied HCPs Law; disciplinary sanctions include: warnings; notices; fines ranging from AED 1,000 to AED 50,000; temporary license suspension for up to 6 months; partial revocation of the license, or complete license revocation with removal from the register.
The UAE Courts may also impose criminal penalties on Allied HCPs for breaching the Allied HCPs Law, which include: an imprisonment sentence and/or a fine ranging between AED 50,000 and AED 100,000 for practicing without a licence; submitting invalid documents/ data during the Allied HCPs licensing process; not fulfilling their licensing conditions; and using any literature or publicity to mislead the public to incorrectly give the impression that the Allied HCP's are licensed to practice in the UAE. Furthermore, the Courts may at their discretion decide to close down a facility where the actual violation has taken place.
One of the major highlights of 2023 were the PHFL Amendments, which eased the foreign ownership restrictions and altered the requirement for UAE national partners in the ownership of private health facilities.
Under the previous Article 6 of Cabinet Resolution No. 29 of 2020, issuing the Executive Regulations of the Private Health Facilities Law (‘PHFL’), the ownership of private health facilities was restricted to UAE nationals, and foreigners could only co-own a private health facility if it had more than 50 beds, if it carried out a rare specialty, or if it was a clinic within a hotel, foreign community school, or a large construction company.
The PHFL Amendments completely overhauled this prior requirement in Article 6 of the PHFL by allowing complete foreign ownership of health facilities ‘without any legal impediments’, permitting any legal person to completely own a private health facility, thereby removing the requirement for a UAE national partner.
Furthermore, the PHFL Amendments introduced monetary penalties, in addition to the disciplinary penalties previously prescribed for violations of the PHFL. Managers, individuals in charge, and employees of private health facilities may now face fines ranging from AED 1,000 to AED 500,000, in addition to warnings or temporary or permanent work suspension.
Private health facilities themselves are now subject to monetary penalties for breaching the PHFL, ranging from AED 1,000 to AED 1,000,000, and/or either full or partial temporary closure of the facility or permanent closure, depending on the nature of the violation.
Federal Law No. 8 off 2019, concerning Medical Products, Pharmacy Profession, and Pharmaceutical Establishments (the ‘PL’) is a key law that governs the import, manufacture, sale, and distribution of medical and pharmaceutical products in the UAE, as well as the regulation of pharmacists and pharmacies. This year the PL has undergone key changes, through the PL Amendments, where the definition of 'Marketing Authorization Holder' (‘MAH’) has now been revised. Previously, it was defined as 'the legal person authorized to market a specific product within the country.' The new definition allows an MAH to obtain a license to market one or more medical products in the country, simplifying the process for obtaining authorizations for multiple products.
A new defined term, 'Exclusive Marketing', has been included, permitting the approval to market specific medical products for specific entities within the state, without requiring additional marketing approval.
Article 7 of the PL regarding a licensees’ obligations (with respect to the marketing of a medical product) has now been amended to include a new requirement to have “two or more pharmaceutical establishments to carry out all activities related to the import and marketing of licensed medical products”.
Article 27 regarding the appointment of a pharmaceutical establishment has also been updated; where previously only a single establishment was required to be the licensee, the minimum mandated requirement is that a MAH must appoint at least two pharmaceutical establishments with licenses to import into the UAE and one or more pharmaceutical establishments with licenses to distribute the relevant product in the UAE.
MOHAP have yet to issue any supporting executive regulations to determine how these new changes will be applied in practice, and whether it will impact on existing registered medical products/existing distribution agreements or only on new medical product registrations/ new distribution agreements.
The Amendment to the Medical Liability Law introduced changes to the provisions governing the conditions for Assisted Reproductive Technology ('ART'). Previously, ART procedures were only expressly permitted through the provisions of the Federal Decree Law No. 4 of 2016 concerning Medical Liability (‘MLL’). However, the Amendment to the Medical Liability Law amended Article 14 of the MLL, which now simply suggests that all ART procedures must comply with existing legislation. This change was made to align with the requirements under which ART can be conducted in accordance with Federal Law No. 7 of 2019 concerning Medically Assisted Reproduction, which was published after the issuance of the MLL.
Amendments have also been made to Article 16 of the MLL, which details the conditions under which doctors can perform abortion procedures or prescribe drugs that induce abortions. Under the Amendment to the Medical Liability Law, abortion procedures can only be conducted by specialist gynaecologists/obstetricians at public or private health institutions authorized by the local emirate-level health authority, introducing an additional layer of approval, previously there was no requirement for the health institution at which the abortion is being performed to be authorized by the emirate level health authorities.
The conditions for abortion in cases of fetal impairment have changed significantly under the Amendment to the Medical Liability Law. Consent from both spouses is no longer required; only the consent of the pregnant woman is necessary, following approval by a medical committee formed by the local emirate-level health authority. The husband's or custodian's consent is now only required if the pregnant woman is unable to provide consent.
Previously, only the MOHAP was authorized to permit advertisements or promotions relating to the sale of medical products, under Article 3 of Cabinet Resolution No. 7 of 2007 Concerning Health Advertisements (the ‘Health Advertisement Law’). Local emirate-level health authorities (such as the Dubai Health Authority) were prohibited from granting such authorizations. However, the Amendment to the Health Advertisements Law now allows the MOHAP to authorize local emirate-level health authorities to grant approvals for health advertisements, pursuant to a resolution to be issued soon by the UAE Minister of Health.
This new law establishes the UAE Drug Corporation, which is a new federal authority that will be responsible for the regulation and licensing of medical products in the UAE (including free zones). Its responsibility covers: pharmaceutical products; medical equipment; healthcare items; and nutritional supplements, amongst other categories of products including but not limited to veterinary products, cosmetics, fertilisers, and pesticides.
The UAE Drug Corporation will work in coordination with MOHAP and other emirate-level health authorities with respect to policy development, legislation, and strategy. The UAE Drug Corporation aims to promote public health and strengthen the position of the UAE as a global hub for pharmaceutical and medical industries, enhancing research and development in the pharmaceutical and medical products sector, in addition to attracting investments in the research and pharmaceutical industries.
Amongst some of the functions of the UAE Drug Corporation, they will prepare a national framework for pharmacological research and clinical and non-clinical trials, test and trace medical products across the UAE, establish a national system for tracking and monitoring medical products from the manufacturer to the consumer, and develop a national pharmacovigilance system to ensure the quality and safety of medical products.
The year 2023 has ushered in significant transformations in the healthcare legislative landscape of the UAE. The amendments and additions made to the healthcare laws and regulations demonstrate the UAE's continuing commitment to ensuring the highest standards of healthcare, patient safety, and medical ethics, in addition to a commitment to improve the ease of doing business in the UAE for healthcare sector investors.
As we enter a new year, these changes will undoubtedly have a profound impact on the healthcare sector, further enhancing the quality of healthcare services provided to the people of the UAE and contribute to the nation's ongoing development. Stay tuned for more updates and insights as we continue to keep you informed on key developments throughout the course of 2024.
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For further information,please contact Raesa Afzal and Clive D'souza.
Published in January 2024
