Amendment Adopted To Czech Pharmaceuticals Act To Address Drug Shortages

• Published date: 15 January 2024
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Law Firm: Kinstellar
• Author: Tom' Čihula and Simona Semanov'

January 2024 - An amendment to the Pharmaceuticals Act has been adopted by the Czech parliament and officially published.

As already reported in our previous newsletter, the aim of the amendment is to improve the availability of medicines on the market and to mitigate the potential negative impacts of recent and ongoing medicine supply shortages.

The amendment creates new obligations for operators in the medicines market, in particular (i) additional obligations following the interruption or discontinuation of the supply of a given medicinal product; and (ii) a mandatory system of reserve stocks. Following a number of additional changes made by Czech legislators, the national pharma regulator, the State Institute for Drug Control (SUKL), has been granted certain powers to address potential drug shortages.

The key elements of the new law are summarised below:

Obligations after a supply interruption or termination

Under the proposed plan, marketing authorisation holders (MAHs) will be obliged to continue to make available certain medicinal products after an interruption or discontinuation of supplies, with a statutory minimum quantity of either up to twice the given medicinal product's average monthly usage, or the average monthly supply of the given medicinal product, provided that the given product has been supplied either without interruption or with an interruption not exceeding 20 days in total during the previous two years. This obligation may be also fulfilled by foreign-language-labelled batches of the given medicinal product. However, the Ministry of Health (MoH) will be able to issue exemptions via a special list of medicinal products to which this obligation will not apply. Medicinal products will also generally be exempted for the first 12 months after being placed on the market in the Czech Republic.

In addition, the State Institute for Drug Control (SUKL) will be able to designate certain medicinal products as being "restricted availability" where the MAH has notified an interruption or termination of supplies in the Czech Republic - if the SUKL assesses that the current available quantity of the given medicinal product does not meet the current needs of patients in the Czech Republic. The SUKL will also designate as "restricted availability" substitute medicinal products for which the MAH has notified an interruption in marketing.

Within 30 days of the designation of a medicinal product as "restricted availability", the MAH must make public...