Al-Awadi issues a decision to regulate the prescription, dispensing, and follow-up of biological treatments
Minister of Health Dr. Ahmed Al-Awadi issued a ministerial decision to regulate the prescription, dispensing, and follow-up of biological therapies within the Ministry, in response to the rapid developments witnessed by modern medicine in the field of biological treatments.
The Ministry stated in a statement on Thursday that the decision establishes the first comprehensive regulatory framework for biological therapies, starting from the approval of treatment protocols and patient selection, through dispensing and follow-up mechanisms and pharmacovigilance, to the clinical and economic evaluation of outcomes, in accordance with best practices and global scientific standards.
It added that this also includes genetic, cellular, and genetically modified cell therapies, which are promising therapeutic technologies that have brought about a global transformation in the treatment of many diseases, but at the same time require a precise regulatory system that ensures their safe use, optimizes their benefits, and enhances the efficiency of their management within the health system.
The Ministry 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 apply precise 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.
It highlighted that a key feature of the decision is its adoption of the value-based healthcare concept, by 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 Ministry pointed out that the decision strengthens the surveillance and pharmacovigilance system by obligating healthcare practitioners to report adverse drug interactions and developing national programs to monitor the safety of biological therapies and continuously track safety and efficacy indicators, thereby cementing a culture of continuous improvement and healthcare quality.
It 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 a comprehensive regulatory framework that combines innovation and responsibility, enhancing the position of the State of Kuwait as a health system based on scientific evidence, good governance, sustainability, and responsible innovation in delivering healthcare.
