Inquiries regarding the operational status of the center were directed to the Ministry of Health, seeking clarification on the reasons for the delay and the facility’s potential contributions to the field. Responses to these questions are currently pending. In the interim, the Association of Lymphoma and Leukemia Patients has formally petitioned the Minister of Health to convene all relevant stakeholders promptly.
The association emphasized that necessary procedural guidelines should not be viewed merely as administrative hurdles. They argued that for seriously ill patients undergoing demanding therapies, these procedures constitute a critical safeguard. These safeguards are essential for ensuring drug quality, guaranteeing safety, maintaining traceability, monitoring treatment efficacy, and providing a professionally justified assessment confirming that the anticipated benefits of treatment outweigh the associated risks.
Furthermore, the association highlighted the technical nature of CAR-T therapy, clarifying that it is more than just a cell therapy. From both a scientific and regulatory perspective, CAR-T drugs fall under the category of advanced treatment, specifically qualifying as advanced therapy medicinal products. The ongoing delay means that patients are currently waiting for these advanced treatments, underscoring the immediate need for action within the health sector.
Topics: #patients #waiting #health
