Articles for the ‘Pharma law’ Category

Over the Christmas break, the Belgian Parliament adopted an urgent law with several measures linked to the approved 2026 healthcare budget, with effect from 1 January 2026. The law is intentionally limited to provisions that must enter into force immediately to ensure that the required savings and revenues are available from the start of the budget year. Several measures are directly relevant for pharma companies. This blog post highlights the key takeaways and briefly examines the central budgetary provisions affecting the sector.

On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here). The reform seeks to update the EU’s pharmaceutical rulebook to facilitate access to safe and affordable treatments and bolster the life sciences sector’s competitiveness. While more detailed information is still trickling out, including the official text of the provisional agreement, we summarise below the main axes of the package available at this time.

In the dynamic world of medical technology, it is essential to always be aware of the latest regulatory requirements. The introduction of the AI Act poses new legal challenges for medtech companies when using AI.

In addition, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?

Using practical examples we will answer this question and would like to invite you to our free webinar (in German language):

“The interplay of the Medical Device Regulation, AI and data protection in medical technology”
on Thursday, June 13, 2024
from 12:30 – 13:30
via MS Teams

Register for free today and benefit from our in-depth knowledge and expertise in the field of digital health: to the registration

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.

The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains.This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies.