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Czech Republic: Proposed new medicinal product supply obligations and mandatory stock requirements

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Draft amendment to the Act on Medicinal Products and the Act on Public Health Insurance

In brief

Draft amendment to the Act on Medicinal Products and the Act on Public Health Insurance

In depth

As many other countries in the EU, the Czech Republic has repeatedly experienced shortages in the supply of medicinal products for human use (“Medicinal Products“). In response to this unfavorable situation, the Government of the Czech Republic prepared and submitted for discussion to the Parliament of the Czech Republic a draft amendment to Act No. 378/2007 Sb. on Medicinal Products and on Changes to Some Related Acts, as amended (“Act on Medicinal Products“). This draft aims to implement new tools and obligations meant to improve the availability of Medicinal Products for patients in the Czech Republic, which will affect practically all links of the distribution chain. During the consideration process before the Chamber of Deputies of the Parliament of the Czech Republic, a number of legislative riders were introduced (such as the widely discussed comprehensive legislative rider originating with the Ministry of Health of the Czech Republic (“Ministry“)), including the proposed amendments to Act No. 48/1997 Sb., on Public Health Insurance on Changes and Supplements to Some Related Acts, as amended (“Act on Public Health Insurance“).

On 15 November 2023, the respective draft amendment to the Act on Medicinal Products and the Act on Public Health Insurance (including some of these legislative riders) (“Amendment“) was approved by the Chamber of Deputies of the Parliament of the Czech Republic and will now be submitted to the Senate of the Parliament of the Czech Republic for discussion.

Although the legislative process for the Amendment has not been completed yet, and the Amendment wording cannot, therefore, be considered final, we would like to provide an overview of the proposed legislative changes most relevant for Medicinal Product distributors and marketing authorization holders (MAH).

Click here to access the full alert.

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Author

Milena Hoffmanová heads the Prague office Pharmaceuticals & Healthcare group. Her practice covers pharmaceuticals and healthcare matters, compliance, general commercial law, administrative law, as well as data protection and privacy law matters. She studied law at the University of Limerick in Ireland prior to graduating from the Law Faculty of Charles University in Prague in 2008. Ms. Hoffmanová’s practice focuses mainly on ensuring compliance with legal regulations as well as ethical standards relating to medicinal products and medical devices, including assisting with drafting of internal company guidelines and policies and labeling/packaging requirements. She also advises on anti-corruption compliance matters, including the extraterritorial application of US law, such as application of the Foreign Corrupt Practices Act and foreign bribery laws. She has experience in a broad range of compliance matters, including corporate and regulatory investigations, FCPA and global anti-corruption compliance, compliance program development and anti-corruption due diligence, including data privacy issues such as cross-border data flows, data security, whistle-blower hotlines, e-monitoring and other privacy-related issues. Admission Czech Republic (2008)

Author

Kateřina Šejdová is a member of the Pharmaceutical & Healthcare Practice Group in Prague. She focuses on pharmaceutical and healthcare law, commercial law and data protection.

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