News
16 April 2026: AIFMD II Finally Takes Effect
After years of legislative process, the local transposition deadline of 16 April 2026 for AIFMD II (Directive 2024/927/EU) has finally arrived. This marks a significant milestone for the investment fund industry across the European Union, bringing with it a range of important changes for both fund managers and the vehicles they manage.
EU General Court bars patient association from challenging medicine authorisation refusal
In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.
Despite EU harmonisation, Member States may impose authorisation requirements on pharmacy-prepared medicines, rules EU Court of Justice
Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use). This includes “magistral formulae” (prepared in a pharmacy for an individual patient on prescription) and “officinal formulae” (prepared in a pharmacy in accordance with a pharmacopoeia and supplied directly to that pharmacy’s […]
EU General Court: technical vaccine data does not have to be disclosed on request
The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies’ commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).
Belgium’s healthcare plans for 2026 – and where pharma fits in
Every year, Belgium’s federal ministers publish their policy notes for discussion in Parliament. They give a high-level snapshot of what each minister plans to focus on in the coming year. For the pharmaceutical industry, the healthcare policy noteis usually the one to watch. Interestingly, the economic policy notealso weighs in on pharma this year. In this blog post, we unpack the key policy signals for the pharmaceutical sector and group them around three main pillars: budget, accessibility, andpricing.
New EU De-minimis Registration Obligation: What Businesses Receiving Public Subsidies Need to Know
As of 1 January 2026, the administrative landscape for de-minimis aid in the EU has changed significantly. Businesses that receive public subsidies should understand how this new system works – and what it means in practice.
A Protocol for IP Disputes at the Brussels Enterprise Court
The Dutch-speaking Enterprise Court of Brussels has long been a central forum for intellectual property litigation in Belgium. On 2 March 2026, a protocol entered into force setting out best practices for interactions between lawyers and the court in IP matters. Its aim is straightforward: to improve cooperation and ensure efficient, professional case management. Three points stand out.
Game-changing rules for managing sick leave: What every employer must know now
The landscape of employee incapacity has fundamentally shifted. Are you prepared? On 1 January 2026, new legal rules entered into force aimed at accelerating the reintegration of incapacitated employees. They include important changes to the reintegration track and the force majeure track, as well as the obligation for employers to include a procedure for maintaining […]
The new Product Liability Directive
The new Product Liability Directive (“PLD”) replaced the old Product Liability Directive (Directive 85/375/EEC) and aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global supply chains. It also focuses on improving the harmonisation of the common rules on liability for defective products and tackling the difficulties faced by victims when gathering evidence to prove product liability. This blog focuses on the main changes the PLD brings. Entry into force The […]
Be ready for the long-awaited Flemish duty of care obligation in the construction sector: update your agreements and compliance procedures now
From 1 January 2026, a duty of care obligation applies to clients [1] and (sub)contractors active in the construction sector [2]. Some years ago, the Flemish government launched the idea of optimising contractor chain responsibility schemes in case of illegal employment, but actual implementation has taken some time. In the meantime, the obligations have been […]
BCA publishes draft guidance on the application of competition rules to public procurement — join us to discuss what it means in practice
The Belgian Competition Authority (BCA) has published a draft guidance document for public buyers on the application of competition rules to public procurement — a clear signal that competition compliance in tenders is a priority, not only for bidders but also for public buyers. The draft guidance is currently subject to a public consultation until […]
Belgian Parliament has adopted urgent 2026 healthcare budget measures: what’s the impact on the pharma industry?
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 […]