New Oman Public Health Law: Key Compliance Requirements for the Healthcare Sector

Royal Decree No. 43/2025 introduces a new Public Health Law (‘Law’) in Oman, representing a significant overhaul of the country’s public health regulatory framework. The Law imposes wide-ranging compliance obligations on healthcare providers, including hospitals, clinics, and pharmacies. It addresses critical areas such as licensing and accreditation, data confidentiality, emergency powers, pharmaceutical regulation, blood services, maternal and mental health, occupational safety, prohibited practices, and enforcement measures.

Key Provisions

1. Accreditation and Enforcement Powers (Articles 4 & 5)
   Healthcare institutions must obtain and maintain accreditation through a system to be developed and updated by the Ministry of Health (‘MoH’), in coordination with the competent accreditation authority. Institutions are required to comply with prescribed standards and procedures. The MoH is empowered to suspend operations or order closures—either temporarily or permanently—where institutions pose a threat to public health or fail to meet regulatory requirements.
2. Emergency Use of Healthcare Facilities (Article 5)
   The Minister of Health may direct the full or partial use of healthcare facilities during public health emergencies or disasters and may order closures where necessary to protect public health.
3. Data Confidentiality and Information Controls (Articles 7 & 8)
   Healthcare providers must safeguard the confidentiality of identifiable patient data, and disclosure is restricted to circumstances permitted under applicable law. The Law also prohibits the dissemination of rumours or unauthorised health-related information.
4. Pharmaceutical Dispensing and Oversight (Article 18)
   Only licensed pharmacists are permitted to dispense medications. The Ministry is responsible for regulating the registration, manufacture, importation, and circulation of pharmaceuticals and issuing the necessary licences.
5. Regulation of Blood Services (Article 19)
   Facilities providing blood services must comply with Ministry requirements relating to blood donation, processing, storage, transport, and use. The Ministry also regulates blood banks and related services.
6. Maternal and Child Health Services (Article 20)
   Maternal and child health is designated as a public health priority. The Ministry in coordination with the competent authorities, must provide prenatal and postnatal care, ensuring immunisation coverage, and generally promoting family health awareness.
7. Mental Health Regulation (Article 23)
   Mental health services are subject to specific regulatory requirements, including protocols for involuntary admissions and discharges, as well as obligations to uphold the rights and responsibilities of psychiatric patients.
8. Occupational Health and Safety (Article 35)
   Healthcare employers must provide safe working environments, occupational health services, and appropriate personal protective equipment. The Ministry and competent authorities may conduct inspections to ensure workplace health standards are maintained.
9. Prohibited Medical Practices (Articles 11, 14, 15 & 16)
   The Law now introduces express prohibitions on human cloning and related preparatory activities, restricts the use of stem cells to specific ethical and medical conditions, and limits access to abortion and sex reassignment procedures to legally and medically permitted cases.
10. Penalties and Administrative Sanctions (Articles 46 & 47)
    Non-compliance with the Law may result in administrative fines of up to OMR 5,000, which may be doubled in repeat cases. Authorities may also impose warnings, suspend activities, revoke licences, or order temporary or permanent closures.

Conclusion

Royal Decree No. 43/2025 establishes a more comprehensive new regulatory framework for the delivery of public health services in Oman. All stakeholders within the sector must take proactive steps to align their operations, policies, and compliance functions with the new requirements.