NewsCzech health ministry drafts pharmaceuticals act amendment and sets up working group to respond to drug shortages

Like the rest of Europe, the Czech Republic has faced shortages of certain pharmaceuticals, including antibiotics and drugs for fever reduction for children, in the final months of 2022. As a result, the Ministry of Health, together with the State Institute for Drug Control, recently took steps to ensure the supply of scarce pharmaceuticals. Although the situation is improving, the Czech pharmaceutical market has still not recovered fully.

There are several reasons for the lack of pharmaceuticals on the European market, such as issues with the manufacture and logistics of the drugs. The European Medicine Agency is aware of this problem and is closely monitoring the situation.

Given that the lack of pharmaceuticals is a broader issue, which needs to be addressed on the European (or even global) level, the Czech Republic has only a limited ability to “effectively” regulate the availability of pharmaceuticals in its market. Nevertheless, the Ministry of Health has set up a formal working group, which will focus on the availability of medicines in the Czech market. The Ministry has also prepared a Draft Amendment to the Pharmaceuticals Act, which is currently in the early stages of the legislative process.

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This article was written by CMS partner Tomáš Matĕjovský and senior associate Pavel Dřímal, and was first published on CMS Law-Now on January 9, 2023, available here.