UAE Healthcare / Pharma LawCabinet’s Resolution No. (15) of 2020 On the Regulation of Medical Examination for Newborns

Article (1) Definitions For the purpose of this Resolution, the following words and expressions shall bear the meanings assigned thereto respectively, unless the context requires otherwise: The State : The United Arab Emirates. The Ministry : The Ministry of Health and Prevention. The Minister : The Minister of Health and Prevention. The Health Authority : The Ministry or any government authority in charge of health affairs in the State. The Health Facility : Any place equipped and licensed for conducting medical examination on patients, providing them with medical

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Cabinet Resolution of 2020 on the Regulation of Medical Examination for Newborns 2 counselling, assisting in diagnosing their diseases, providing them with treatment, nursing or hospitalization services for the purpose of medication, or carrying out any activity related to prevention, treatment or rehabilitation, whether such facility is owned or managed by natural or legal persons. Such definition includes health facilities affiliated to colleges of medicine operating in the State if they provide any of the above health services or clinical testing on patients. The Newborn : A baby from the time of birth up to 28 days of age. The Preterm Baby : A baby who is born before the thirty seventh week of pregnancy. Newborn Examination Regulation : The procedures, controls and rules regulating the medical examination of newborns, including following up and ascertaining tests in order to ensure the accuracy of the examination results and the clinical and biochemical evaluation of test results. Health Threats : Any condition causing mental or physical disability, or leading to death. Newborn Examination : All procedures that include taking a blood sample from the Newborn to carry out the necessary biochemical testing at the reference laboratory of Newborn examination, in order to detect Health Threats in newborns specially threats related to genetic conditions, as well as examining hearing to detect hearing disorders, heart to detect heart defects or any other relevant examinations to be subsequently added to the protocols.

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Cabinet Resolution of 2020 on the Regulation of Medical Examination for Newborns 3 The Reference Laboratory : The Reference Laboratory designated by the Ministry which will, within the scope of this Resolution, analyze blood samples taken from Newborns.

Article (7) Obligations of the Health Facility in which Delivery is Carried out 1. The Health Facility in which the delivery is carried out shall deliver to one of the persons mentioned in above Article (6), as the case may be, a pamphlet including all information on the Newborn examination during the pregnancy follow-up or immediately after the delivery, as per the form designated by the Minister’s resolution in coordination with all Health Authorities. 2. The Health Facility referred to in Clause (1) above shall carry out the medical examination for each Newborn that is born therein, pursuant to the provisions of this Resolution, unless one of the Newborn’s relatives mentioned in Article (6) above, as the case may be, rejects such examination. Such rejection shall be recorded in writing under a declaration signed by the person who abstained from having the Newborn undergo the medical examination. If such person refuses to sign the aforesaid declaration, a report to that effect shall be drawn and signed by the Health Facility’s manager or his representative, along with the signature of the person supervising such examination in the Health Facility.

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Cabinet Resolution of 2020 on the Regulation of Medical Examination for Newborns 5 3. Any Health Facility in which the delivery is carried out shall notify the competent Health Authority of such delivery and provide it with a document stating whether or not the medical examination of Newborn has been made and, in absence thereof, the reason. If the reason is attributable to the abstention of the Newborn’s relatives, referred to in Article (6) above, a document stating such abstention in writing shall be submitted.

Article (10) Violations and Administrative Penalties 1. A fine of (AED 5000) five thousand dirhams shall be imposed on a private Health Facility per case if it is proved that it has not carried out the medical examination of Newborns or failed to take the procedures necessary for conducting such examination, unless it is proved that the examination is not made due to the abstention of Newborn’s relatives mentioned in Article (6) above.

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Cabinet Resolution of 2020 on the Regulation of Medical Examination for Newborns 6 2. A fine of (AED 2000) two thousand dirhams shall be imposed on any of the persons mentioned in Article (6) above who are proved to have abstained from having the Newborn undergo the medical examination provided herein. 3. When the violations set forth in Clauses (1) and (2) above, the relevant penalty shall be imposed by a resolution of the Minister or head of the Health Facility or his delegate, as the case may, each within his respective area of competence.

Article (11) Appeal Against Administrative Penalties 1. A decision issued on the imposition of the penalties set forth in Article (10) above may be appealed to the Minister or head of the Health Facility. The appeal must be submitted within a period not exceeding (15) fifteenth days from the date of notifying the violator against whom the penalty is issued. The appeal must also be reasoned and accompanied by all supporting documents, as per the procedures defined by the Ministry or the Health Authority, as the case may be. 2. The Minister or the head of the Health Authority shall decide on the appeal within a period not exceeding (15) fifteenth days from the date of its submission. The decision issued on the appeal shall be final. The appeal shall be deemed rejected upon the expiry of such period without responding to the appellant.