Kuwait has introduced a new framework regulating the prescription, dispensing and monitoring of 231 biological treatments across Ministry of Health hospitals, specialized centers and primary healthcare facilities. The mechanism was approved by Health Minister Dr. Ahmed Al-Awadhi.
Biological treatments are advanced medicines made using living cells or biological processes. They target specific cells, immune responses or disease pathways and are used to treat conditions including cancer, rheumatoid arthritis, Crohn’s disease, psoriasis, multiple sclerosis, blood disorders and some rare genetic diseases. They include monoclonal antibodies, certain insulin products, vaccines, and advanced gene and cell therapies.
Under the new rules, the listed treatments will generally be restricted to Kuwaiti citizens, with exceptions possible for cases covered under the approved mechanism. Only specialist physicians or doctors of higher rank in the relevant field may prescribe them, following approved treatment protocols.
Biological medicines must be prescribed using their trade name and international nonproprietary name (INN), and should normally be used after conventional treatments have proved inadequate, unless protocols allow earlier use. Continued treatment depends on documented clinical improvement and regular evaluation.
The framework gives priority to biosimilars for patients starting biological treatment, unless a doctor documents a medical reason to use the original reference medicine. Stable patients may also be switched to approved biosimilars under monitoring protocols.
Pharmacies cannot automatically substitute one biological medicine for another. Any switch between reference medicines and biosimilars, or between biosimilars, requires approval from the treating physician and must follow ministry procedures.
Stricter safeguards apply to advanced therapies, including gene, cell, genetically modified cell and chimeric T-cell therapies. These may only be administered at approved specialized facilities with the necessary expertise and infrastructure. Patients or legal representatives must provide informed consent.
Hospitals must maintain detailed records tracking advanced treatments, including product identification, manufacturing, transportation, storage and administration. Pharmacy departments must verify the treatment’s identity and suitability before dispensing.
The ministry will also identify emergency conditions where delaying biological treatment could seriously threaten a patient’s life or safety, allowing such cases to be handled through specific procedures.
Doctors, pharmacists and nurses must educate patients about the nature of biological treatments, available alternatives, expected benefits and any proposed switch to a biosimilar or advanced therapy. The overall framework aims to ensure biological medicines are used safely, effectively and cost-efficiently across Kuwait’s public healthcare system.
