Our latest article “Strict Procedures vs Urgent Needs: Is it possible to be equal to the occasion?” by Nihan Bacanak, Can Aksoy ve Bengüsu Güvendi is published on Lexology.

As known, pharmaceutical products for human use can in principle only be placed on the market upon obtaining a licence for the specified indications for which the product is allowed to be used. On the other hand, as experienced during the COVID-19 pandemic, not being able to access pharmaceutical products particularly in cases of emergency where a licensed product is unavailable can lead to aggrievements and the lengthiness of the process of obtaining a licence for a pharmaceutical product can cause additional problems. Hence it is of utmost importance to properly set a balance between satisfying the urgent needs of patients in an efficient manner and safely placing the products on the market. Various methods enabling patients to access unlicensed products are available under Turkish law. Amongst these methods which are briefly described below, named patient programme and off-label use have enabled rapid actions to be taken in particular during the COVID-19 pandemic.

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