Stringent new compliance obligations for handlers of health data in Abu Dhabi
Following the issuance of its New IVF Law last year, the UAE recently published Executive Regulations to update and clarify certain rules around medically assisted reproduction in the UAE. This article looks at some of the key changes for healthcare professionals to consider.
On 19 December 2019, His Highness Sheikh Khalifa Bin Zayed Al Nahyan, President of the United Arab Emirates (UAE), announced the New IVF Law. The New IVF Law officially came into force on 1 January 2020, repealing the Old IVF Law. Towards the end of last year, the Executive Regulations which sit alongside the New IVF Law were published in the Official Federal Gazette.
One of the most fundamental changes introduced by the New IVF Law for fertility patients relates to the freezing of human embryos as well as unfertilized eggs and sperm.
The New IVF Law also introduces a framework for intra-governmental consultation and decision making, and allows limited scientific research, in the field of fertility treatments. These changes are in line with the UAE's National Agenda 2021 and the UAE Centennial 2071 project, which aim to elevate the UAE's position in the global community and are especially important as the UAE positions itself as the go-to medical hub in the region.
According to Colliers, it is expected that the New IVF Law will provide more options to couples looking to conceive. Additionally, the new law will also further establish the UAE as a key destination for IVF treatments regionally and internationally.
The New IVF Law has brought a significant change in respect of the freezing of human embryos. Fertility centres are now permitted to freeze human embryos for a period of 5 years (extendable upon request).
Under the Old IVF Law it was not possible to freeze human embryos but only unfertilised eggs. This change is a substantial milestone for the UAE and is expected to drastically decrease the costs of undergoing IVF.
According to Colliers, by allowing individuals to freeze extra embryos for future use, the UAE is moving in line with western IVF practices. The move will not only significantly reduce the cost of future IVF cycles for couples who have extra embryos, but also increase the chances of a successful pregnancy and assist with decreasing the stress and uncertainty associated with IVF.
The New IVF Law has also created strides for fertility preservation in the UAE by allowing unmarried individuals to freeze their eggs or sperm for a period of 5 years (extendable upon request). This should provide relief for individuals who are undergoing medical treatments which affect fertility and those who choose to get married at an older age.
Under the New IVF Law, the position remains that sperm and egg donations and surrogacy are illegal (and subsequently, so are embryonic banks), as only a married man and woman may conceive a child together.
Under the New IVF Law, subject to compliance with certain controls and procedures, samples of frozen unfertilised or fertilised eggs or sperm may be taken abroad, if prepared in the UAE, or brought into the UAE, if prepared abroad.
Additionally, research is now permitted on fertilised and unfertilised eggs and sperm cells subject to receiving consent from the concerned parties and their spouses and the relevant regulatory health authority.
Scientific research can be carried out for the following purposes only: (i) increase knowledge concerning severe cases or diseases; (ii) develop treatments for severe cases or diseases; (iii) develop treatments for fertility problems; (iv) increase knowledge concerning issues leading to abortion; (v) develop methods of detection of abnormal chromosomes or genes or mitochondrial embryo before its implantation in the uterus; (vi) increase knowledge about embryonic development; (vii) increase knowledge concerning the process of freezing gametes or foetuses; or (viii) develop methods to detect any abnormal chromosomes or genes or epigenetic disorder concerning the eggs and sperm.
The Executive Regulations make it clear that research cannot be carried out for: (i) reproductive cloning; (ii) selecting genetic traits for reproduction purposes; (iii) commercial purposes; or (iv) the purposes of changing the human genetic structure.
The loosening of restrictions on research serves to stimulate medical research and innovation in the UAE. This is especially significant as the country continues to expand its global influence in the fields of technology and medicine and seeks to establish itself as a destination of choice for medical tourism.
The New IVF Law explicitly refers to the protection of patient data and maintaining patient confidentiality. This is in line with the UAE's increasing focus on protecting data and cybersecurity; which coincides with a world-wide focus on the same issue.
It is worth mentioning that in February 2019, UAE Federal Law No 2 of 2019 Concerning the Use of Information and Communication Technology in the Field of Health was promulgated to introduce a number of high level obligations relating to the protection, storage and use of patient data and devolved responsibility for detailed implementing standards to the local health authorities. In September 2020, Abu Dhabi issued its own standards and we expect that health authorities in other Emirates will follow suit. See article linked here for further information.
The New IVF Law has brought a significant change in respect of the freezing of human embryos.Fertility centres are now permitted to freeze human embryos for a period of 5 years (extendable upon request).
Under the Old IVF Law it was not possible to freeze human embryos but only unfertilized eggs.
Under the Old IVF Law, a technical committee, which operated under the Ministry of Health, was responsible for the oversight and control of fertility centres in the UAE.
The New IVF Law creates a new legal framework that distributes regulatory oversight of fertility centres in the UAE between federal and local authorities.The new framework aims to streamline regulatory processes, including audits, investigations and decision-making.
In addition, the New IVF Law makes provision for the establishment of a national advisory committee that submits recommendations and proposals in relation to medically assisted reproduction and coordinates between the relevant regulatory authorities in the UAE. We believe that this committee will equip the regulatory authorities to deal with the rapid developments in the field of medicine, specifically genetics and medically assisted reproduction.
For fertility centres engaging in medically assisted reproduction, the Old IVF Law did not make any provision for disciplinary sanctions, and instead resorted to criminal penalties for any breaches.
The New IVF Law introduces disciplinary sanctions, including written reprimands, written notices, fines not exceeding AED 1 million (minimum of AED 1,000), temporary suspension of the fertility centre's licence (which cannot exceed 6 months) and cancellation of the licence.
Disciplinary sanctions on the fertility centre's staff for breaches have similarly changed and now includewritten reprimands, written notices, fines not exceeding AED 500,000 (minimum of AED 1,000), temporary suspension of the employee's licence (which cannot exceed 1 year), and cancellation of the employee's licence.
Certain criminal penalties remain under the New IVF Law, showing the seriousness with which the New IVF Law will be governed. This change is a substantial milestone for the UAE and is expected to drastically decrease the costs of undergoing IVF.
Medically assisted reproduction and genetic research in the UAE continues to be a leading topic. It is highly encouraging, that the New IVF Law and Executive Regulations take many positive steps to advance healthcare laws to benefit patients, which will ultimately lead to better outcomes and increased fertility rates in the UAE. The developments in the New IVF Law showcase the UAE's desire to progress and innovate and its commitment to becoming a leader in global healthcare.
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This article was originally published by Colliers in Research & Forecast Report, Q2 2021, IVF & Fertility in the MENA Region with a Focus on the UAE, KSA & Egypt, available at www.colliers.com/en-ae/research/dubai/ivf-in-the-mena-region.