Minister of Health: Regulations to govern the prescription, dispensing, and follow-up of biological treatments
Abdulkarim Al-Abdullah: Minister of Health Dr. Ahmed Al-Awadi issued a ministerial decision regarding the regulation of prescribing, dispensing, and monitoring biological therapies within the Ministry of Health. This step represents a strategic milestone in the journey of developing national pharmaceutical policies, establishing the first comprehensive regulatory framework that governs all stages of prescribing, dispensing, and monitoring biological therapies within the Ministry. The framework spans from the approval of treatment protocols and patient selection, through dispensing mechanisms, monitoring, and pharmacovigilance, to the clinical and economic evaluation of outcomes, in accordance with global best practices and scientific standards.
This decision responds to the rapid developments in modern medicine in the field of biological therapies, which include monoclonal antibodies, biosimilars, and advanced therapy medicinal products (ATMPs), including gene and cell therapies, genetically modified cells, and CAR-T therapies. These promising therapeutic technologies have brought about a global transformation in the treatment of many diseases; however, they simultaneously require a precise regulatory system to ensure their safe use, optimize their benefits, and enhance the efficiency of their management within the health system.
The decision reflects the Ministry of Health’s direction toward building a modern pharmaceutical system based on scientific evidence and good governance. The Ministry’s role extends beyond merely providing the latest treatments to ensuring they are prescribed, dispensed, and monitored according to approved protocols, for the appropriate patient, at the right time, and under the supervision of qualified medical professionals. This approach aims to achieve the highest standards of quality, patient safety, and resource efficiency.
The decision establishes comprehensive regulatory controls, starting from patient selection criteria and mechanisms for prescribing and dispensing biological therapies, and regulating their use according to approved protocols. It continues through requirements for clinical monitoring, tracking treatment safety, and reporting adverse effects, ending with the evaluation of clinical and economic outcomes. This ensures that treatment decisions are based on scientific evidence, transparency, and continuous measurement of results.
Furthermore, the decision solidifies the organized scientific use of biosimilars, recognizing them as an effective and safe therapeutic option when they meet scientific and regulatory requirements. It sets precise controls for switching from reference therapies to biosimilars according to approved protocols based on international best practices. This enhances the confidence of patients and healthcare practitioners and contributes to achieving financial sustainability and improving spending efficiency without compromising the quality of healthcare.
The decision also keeps pace with the new generation of advanced biological therapies by restricting their use to approved hospitals and specialized centers that possess the necessary infrastructure and clinical expertise. These facilities are mandated to apply precise systems for treatment tracking, obtain informed consent, and establish records for monitoring clinical outcomes and short- and long-term safety indicators, thereby ensuring the highest levels of patient protection.
A key feature of the decision is its adoption of the Value-Based Healthcare concept. This approach links treatment decisions not only to the provision of treatment but also to measuring its actual therapeutic value, the extent of patient benefit, its impact on quality of life, and the efficiency of healthcare resource utilization.
Additionally, the decision strengthens the oversight and pharmacovigilance system by obliging healthcare practitioners to report adverse drug interactions and developing national programs to monitor the safety of biological therapies. It ensures continuous monitoring of safety and efficacy indicators, thereby reinforcing a culture of continuous improvement and healthcare quality.
