Belgium: Healthcare

The European Union has struck a provisional deal to streamline its AI Act, delaying high-risk AI obligations until late 2027 and 2028 whilst introducing new prohibitions on AI-generated sexual content.

The European Parliament and Council have reached a provisional agreement on reforms to the EU AI Act, introducing extended compliance deadlines and clarifications for high-risk AI systems.

The access conditionality under Article 56a has shifted from an incentive (“carrot”) to a penalty (“stick”) — Member States can request marketing authorization holders (MAH) to launch and supply products...

This update (No. 122 | 31 August 2025) covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia's war against Ukraine, health threats, and cyber threats. It does not purport to provide an exhaustive overview of developments.

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations ("MA") for medicinal products) ("Variations Guidelines").

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation.

The intersection of pharmaceutical advertising, consumer protection, and internal market freedoms remains a complex legal battleground within the EU. In Apothekerkammer Nordrhein v. DocMorris NV (C-517/23)...

The 2025 HIMSS Global Health Conference is an annual event that attracts thousands of digital health professionals chasing cutting-edge health solutions.

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia's war against Ukraine, health threats, and cyber threats.