Minister of Health Issues a Decision to Regulate the Prescription, Dispensing, and Follow-up of Biological Treatments - Sarmad
(KUNA) – Kuwait’s Minister of Health, Dr. Ahmed Al-Awadi, issued a ministerial decision today, Thursday, to regulate the prescription, dispensing, and follow-up of biological treatments within the Ministry, in response to the rapid developments in modern medicine in the field of biological therapies.
The Ministry stated in a press release that the decision establishes the first comprehensive regulatory framework for biological treatments, starting from the approval of treatment protocols and patient selection, through dispensing and follow-up mechanisms and pharmacovigilance, to clinical and economic evaluation of outcomes, in accordance with best practices and global scientific standards.
It clarified that the decision responds to advancements in modern medicine regarding biological treatments, which include monoclonal antibodies, biosimilar biological treatments, and advanced therapies of biological origin.
It added that this also encompasses “gene and cell therapies, including genetically modified cells, which are promising therapeutic technologies that 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 aligns with the new generation of advanced biological therapies by restricting their use to accredited hospitals and specialized centers that possess the necessary infrastructure and clinical expertise, while mandating them to implement precise systems for treatment tracking, obtaining informed consent, and establishing records to monitor short- and long-term clinical outcomes and safety indicators, thereby ensuring the highest levels of patient protection.
Among the key features of the decision is its adoption of the value-based healthcare concept, linking 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 health resource utilization.
The decision strengthens the surveillance and pharmacovigilance system by obligating healthcare practitioners to report adverse drug interactions and by developing national programs to monitor the safety of biological treatments and continuously track safety and efficacy indicators, thereby reinforcing a culture of continuous improvement and healthcare quality.
The Ministry emphasized that the decision demonstrates its commitment to continuously updating the national pharmaceutical system and preparing the health system to accommodate future therapeutic technologies within a comprehensive regulatory framework that combines innovation and responsibility, enhancing Kuwait’s position as a health system based on scientific evidence, good governance, sustainability, and responsible innovation in delivering healthcare.
