Articles

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

As with many healthcare systems worldwide, the Czech Republic faces challenges regarding sustainable funding and escalating healthcare costs, particularly concerning chronic and rare diseases.

Aiming to address emerging needs in public healthcare, on 12 April 2024, the Ministry of Health of the Czech Republic introduced a draft amendment to the Act on Public Health Insurance and other related laws, which is proposed to take effect on 1 January 2026. In this article, we provide an overview of the key areas affected by the legislative proposal, namely (i) price and reimbursement regulation of medicinal products and medical devices, (ii) preventive care support, (iii) reimbursement of cross-border healthcare services, and (iv) dental care reimbursement.

At the heart of the global economy and public health, the life sciences industry is a driving force for progress in an ever-evolving web of laws and regulations.

Recent legislative initiatives in the EU illustrate some of the regulatory challenges – and opportunities – for the life sciences industry on a pan-European level.

Dive into our article below where we highlight some of the legal topics that we consider key for the life sciences industry in 2024 and how they might impact the industry.

Read further, download the article: Key EU Legislative Initiatives Shaping the Life Sciences Landscape in 2024

The Belgian Constitutional Court (“CC”), on 6 November 2025, annulled some provisions of the Law of 18 May 2024 containing various provisions on health and finance, striking down the pharma industry ‘unavailability contribution’.

Food company Mowi Poland successfully challenged the European Commission’s new hygiene rules governing ‘stiffening’—a specialised fish processing technique—on the grounds that the Commission failed to obtain mandatory scientific consultation. While the Commission defended its approach by characterising the measures as mere “clarification” of existing law and citing industry guidelines as support, the EU General Court rejected this argument in its judgment of 24 September 2025 (T-354/24). Siding with the food business operator, the Court determined that the regulation imposed substantive new obligations requiring a scientific basis and consequently annulled the contested fish stiffening rules.

As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies—are becoming increasingly vital, especially in treating complex diseases like cancer. These therapies promise improved clinical outcomes through synergistic mechanisms of action. However, the reimbursement process for such therapies presents significant regulatory and legal challenges, particularly in the area of information sharing between pharmaceutical companies. Recognising this issue, the Belgian Competition Authority (the “BCA”) has issued on 10 September 2025 a communication clarifying how companies can cooperate without breaching competition law.

The European Commission often relies on scientific evidence for its regulatory decisions. But when challenged, how much deference is owed to the regulator’s interpretation of the underlying science? This question came up in Joined Cases C‑71/23 P and C‑82/23 P concerning the classification of titanium dioxide – a chemical used in products like cosmetics and medicinal products – as a suspected human carcinogen. The Commission’s decision was based on technical input from the European Chemicals Agency (ECHA). After the General Court (GC) struck down the classification, criticizing the technical input, the Commission and France appealed. They argued that the General Court had overstepped its judicial role. The Court of Justice (ECJ) upheld the annulment, confirming the Court’s power to review the technical reasoning behind a regulatory decision.