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The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines. This platform is a direct result of Regulation (EU) 2022/123, which aims to improve preparedness for and mitigation of medicine shortages across EU member states.

Key Points:

• Platform Availability: The European Shortages Monitoring Platform (ESMP) is now accessible online.
• Mandatory Usage: Starting from February 2, 2025, all Marketing Authorization Holders (MAHs) with centrally authorized products will be required to use the ESMP.
• Early Familiarity: EMA encourages MAHs to familiarize themselves with the platform before the mandatory deadline.
• Data Submission: Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can submit data on supply, demand, and availability of both centrally and nationally authorized medicines to the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
• Medicine Monitoring: The platform will be used for routine monitoring of all centrally authorized medicines and may also be used for monitoring nationally authorized medicines under special circumstances.

Additional Resources:

• Frequently Asked Questions

From January 1, 2025, Slovakia will include medicines and medical devices in the reduced VAT rate of 5%. This move is part of a broader tax reform aimed at improving access to essential goods for the population while reducing the financial burden on patients. The changes are likely a response to the European Commission’s assessment of public finances and an effort to reduce the budget deficit.

This change contrasts with developments in the Czech Republic, where, as of January 1, 2024, the VAT rate on medicines increased from the original 10% to 12%, as we mentioned in our previous article Changes in VAT Rate for Pharmaceuticals.

What Impact Will the Reduced VAT Rate Have in Slovakia?

The lower VAT rate is expected to significantly reduce costs for patients in Slovakia for medical devices and medicines, both in outpatient and hospital care. The direct financial impact on individuals will depend on specific measures and pricing policies. For comparison, Slovakia’s VAT on medicines has dropped from 10% to 5%, which could lead to a more noticeable impact on final prices than in the Czech Republic, where the rate was increased.

Impact on External Price Referencing for Medicines

The reduced VAT rate in Slovakia, however, will not affect the external price referencing (EPR) of medicines, used by some countries to set maximum prices and reimbursement levels in their markets. The VAT change does not reflect in EPR because the reference price is almost universally based on the manufacturer’s price.

At the same time, this change offers an opportunity to compare tax policies across the EU, where VAT rates on medicines and medical devices vary significantly. For example, according to data from EFPIA (European Federation of Pharmaceutical Industries and Associations) as of January 1, 2024, Spain applies a 4% VAT rate on medicines, while Denmark has a standard rate of 25%.

Stay tuned to our website for more updates on legislative changes and their impact on healthcare in the EU.

The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.

EU residents will have more control over their health data, being able to access it electronically and share it across borders. This is particularly beneficial for cross-border healthcare, allowing individuals to access medical records and receive care seamlessly throughout the EU.

The EHDS promotes the secondary use of health data for research, innovation, and policy-making. Researchers and innovators will be able to access health data more easily and securely, which could drive the development of new treatments, medical devices, and AI applications.

The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):  

EHDS - main points:

• 3 May 2022 – European Commission launched the EHDS regulation proposal to easier exchange and access health data at EU level.
• 6 December 2023 – The EU Council approved the regulation proposal.
• 15 March 2024 – After five tripartite meetings between Parliament, the Council and the Commission, so called “trialogue”, an agreement on provisional proposal was reached between the European Parliament and the EU Council. The compromised text contains e.g. a right to opt-out of the system, an electronic health records system assessment, a data localisation and some specific timelines of implementation.
• 24 April 2024 - The European Parliament formally approved EHDS regulation proposal. After the end of the legislative process, the European Parliament and the Council will adopt the final text of the new Regulation. 
• The proposal is currently in its first reading procedure, document identifier COM(2022)0197. The European Parliament is expected to decide on the proposed amendments by the end of December 2024. 

EHDS general information:

One key feature of the EHDS is the introduction of common standards for electronic health record (EHR) systems across the EU, fostering interoperability and creating a single market for these systems. This includes a mandatory self-assessment for systems to ensure secure data storage and transfer.

The regulation also establishes an opt-out system where individuals can choose to restrict access to their data for secondary purposes, such as research, while still allowing essential data sharing for healthcare delivery. Member States will manage access requests for health data and may implement stricter rules for sensitive information like genetic data.

The EHDS framework is expected to enhance patient care by reducing unnecessary testing and improving evidence-based decision-making. It also strengthens privacy protections while enabling the reuse of health data for public health and research purposes.

CTIS byl zřízen farmaceutickým zákonem v rámci Nařízení o klinických studiích (Nařízení (EU) č. 536/2014) a po 30. lednu 2025 kompletně nahradí původní systém pro klinické studie EudraCT (Databáze klinických studií orgánů pro regulaci léčiv Evropské unie).

Evropská léková agentura (EMA) průběžně publikuje zprávy, jak proces přechodu na nový systém pokračuje.

V předchozím článku jsme ukazovali, jaká byla situace v únoru 2024, v tomto článku jsme informace o počtu podání a rozhodnutí o přechodu aktualizovali ke konci srpna 2024.

Obr. č. 1 – Změny v počtu podaných žádostí, resp. v počtu podání, kde již bylo rozhodnuto, v porovnání s předchozím měsícem

V průběhu léta aktivita podávání žádostí poklesla, ale ve srovnání se stavem v únoru je celkový počet podaných žádostí vice než dvojnásobný a počet studií s rozhodnutím je také skoro dvojnásobný.

Nicméně stále jsou klinické studie, pro které je třeba podat žádost.

EMA publikuje novinky v této oblasti každé dva týdny, kde mj. uvádí, jaké změny v systému CTIS provedla.

Také připravila Information Day for CTIS 17. října 2024 pro všechny zainteresované subjekty.

Uložte si datum do kalendáře a nepolevujte v přechodu vašich studií na nový systém.

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Důležité milníky pro klinické studie:

• Klinické studie zahájené po 30. lednu 2023 – všechny žádosti o počáteční klinické studie v Evropské unii (EU)/Evropském hospodářském prostoru (EHP) musí být podány prostřednictvím CTIS
• Klinické studie ukončené před 30. lednem 2025 – Klinická studie je spravována v systému EudraCT nebo národních systémech
• Klinické studie, u kterých se očekává, že budou pokračovat po 30. lednu 2025 – je nutný přechod z EudraCT nebo národních systémů na CTIS.

Obr. č. 2 – schéma přechodu na nový informační systém pro klinická hodnocení