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

Czech Republic

Like the rest of the 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 of 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.

In principle, according to the Draft Amendment, in the event of an interruption in the supply of a pharmaceutical that is reimbursed from the public healthcare system or has a set maximum price in the market, marketing authorisation holders will be required to inform the Institute for Drug Control of the reasons for the shortage and the corrective measures being taken, together with information on the current stocks of the product. At the same time, marketing authorisation holders will have to ensure the supply of the product for two months after the date of interruption or termination of supply.

The Draft Amendment should also supersede the current unclear (and in practice unenforceable) requirements laid down by the Pharmaceuticals Act, which sets out that marketing authorisation holders should supply products to distributors under certain conditions.

The Ministry of Health's efforts, in cooperation with the Institute and other stakeholders, to ensure the availability of pharmaceuticals in the Czech Republic are welcome. Given, however, that the legislative process has just begun, it is still not possible to evaluate whether the Draft will achieve its goals.

There is no doubt that measures must also be adopted at the European level in order to effectively deal with drug shortages. Another question is whether the private sector will respond. In short, will pharma companies take steps to decentralise the manufacture of products (creating manufacturing sites around the world) to minimise risks connected with the manufacture of drug products (including compliance with the rules on the good manufacturing practices), the availability of active substances and other auxiliary substances, and pandemic restrictions?

For more information on steps being taken in the Czech Republic and EU to remedy pharmaceutical shortages, contact your CMS client partner or local CMS experts.