An unprecedented drug shortage is looming due to a global scarcity of raw materials, inflation, and rising labor costs. The eight major pharmaceutical associations in Taiwan have jointly recommended relaxing the requirement for drug procurement regarding the remaining shelf-life, reducing it from one year to 5-8 months. The Ministry of Health and Welfare (MOHW) emphasized that patient welfare should be the primary consideration, stating that drugs can be used as long as they remain within their validity period. The Taiwan Food and Drug Administration (TFDA) respects the agreements between individual pharmaceutical companies and hospitals.
Since last October, TPADA, TPMA, IRPMA, TGPA, CAPA, TRPMA, NPCA, and TPMMA have been issuing official letters to the operators of joint drug tenders, recommending a review of the joint supply contract terms for the 2024-2025 drug procurement.
A representative of the pharmaceutical industry proposed reducing the required remaining shelf-life for drugs supplied in joint procurement tenders from 8 months to 5 months to help drug companies increase stock levels and ensure a stable supply. He also called for the removal of high penalties imposed on companies for not meeting the minimum shelf-life requirements, arguing that drugs remain effective until their expiry date. Additionally, pharmaceutical companies expressed willingness to exchange products with less than 3 months of shelf-life for those with a longer shelf-life, ensuring hospitals face no losses.
Since 2023, patients in Taiwan have been affected by drug shortages. In addition to the ongoing shortage of saline solution, they are facing uncertainty following the withdrawal of Aprovel and Prozac from the Taiwanese market.
An industry insider, speaking anonymously, expressed his hope that public hospitals would consider making such an adjustment. Most drugs have a shelf-life of about two years. After accounting for the time needed for post-manufacturing testing, the remaining validity period is just slightly over one year. Many hospitals refuse to accept products that do not meet their minimum shelf-life requirements, contributing to drug shortages.
Hospitals have stated that the minimum shelf-life requirement is intended to ensure the availability of medications for repeated prescriptions for chronic conditions. However, the pharmaceutical industry argues that since repeated prescriptions are typically valid for three months, drugs with a remaining shelf-life of five months should still be accepted. Some military hospitals have already reduced their requirement from one year to eight months, and the industry suggests it could be further lowered.
Dr. Chiang Chih-Kang, Director-General of the TFDA, stated that the TFDA does not intervene in contracts between individual drug companies and hospitals. However, he emphasized the importance of making all decisions with patients' well-being in mind. From the TFDA's perspective, drugs are safe to use as long as they remain within their validity period, provided they have been stored under appropriate conditions.
【2025-03-26 / United Daily】
