Articles for the ‘’ Category

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 patients). As a result, they are not subject to the Directive’s requirements, including marketing and manufacturing authorisations. This raises the question to what extent Member States may regulate these exemptions in national law. In particular, can they impose additional conditions – such as requiring authorisation in certain circumstances – not foreseen by EU law? That issue arose before the EU Court of Justice (“CJEU”), in Case C-589/24, following a reference from the Dutch Supreme Court concerning national rules limiting the officinal formula exemption based on the quantity supplied to patients by pharmacies per month.

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.

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).

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 note is usually the one to watch. Interestingly, the economic policy note also 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, and pricing.