Minister of Health Issues Decision to Regulate the Prescription, Dispensing, and Follow-up of Biological Treatments
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 added that this also includes “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 framework that ensures their safe use, optimizes their benefits, and enhances the efficiency of their management within the health system.”
It was noted that the decision keeps pace with the new generation of advanced biological-origin therapies by restricting their use to accredited hospitals and specialized centers that possess the necessary infrastructure and clinical expertise, while mandating them to implement strict systems for treatment tracking, obtaining informed consent, and establishing records to monitor clinical outcomes and short- and long-term safety indicators, thereby ensuring the highest levels of patient protection.
The Ministry highlighted that a key feature of the decision is its adoption of the value-based healthcare concept, linking treatment decisions not only to the provision of therapy 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.
It pointed out that the decision strengthens the pharmacovigilance and drug safety monitoring system by obligating healthcare practitioners to report adverse drug interactions and by developing national programs to monitor the safety of biological therapies and continuously track safety and efficacy indicators, thereby reinforcing a culture of continuous improvement and healthcare quality.
The Ministry affirmed that the decision demonstrates the Ministry’s commitment to continuing the modernization of the national pharmaceutical system and preparing the health system to accommodate future therapeutic technologies within an integrated regulatory framework that combines innovation with responsibility, enhancing the position of the State of Kuwait as a health system grounded in scientific evidence, good governance, sustainability, and responsible innovation in healthcare delivery.
