Tags: Life Sciences
Belgian Constitutional Court strikes down pharma industry ‘unavailability contribution’
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’. Background Parts of the above Law sought to protect patients from bearing additional costs when reimbursable medicines become unavailable and must be […]
Food Hygiene for Fish: EU General Court Requires Scientific Basis to “Clarify” the Law
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 […]
Combination therapies in Belgium: how to collaborate without breaching competition law
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 […]
LSS: Challenging Government Decisions: Legal Strategies in Agri-food & Life Sciences
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?
Titanium dioxide: General Court strikes down classification as human carcinogen and ECJ now confirms
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?
REACH obligation to register imported chemicals may be assumed by a person other than the buyer
Under the EU’s REACH Regulation 1907/2006, substances must be registered with the European Chemicals Agency before being imported. The duty to register lies with the importer. In practice, the act of ‘importing’ often involves multiples actors, including the seller, the buyer and various intermediaries who move the goods across borders. So, who then should register […]
Two kiwis a day to chase constipation away – European Commission approves fruit health claim
The European Commission has authorised a new food health claim recognising the digestive health benefits of green kiwifruit. The claim—“Consumption of green kiwifruit contributes to normal bowel function by increasing stool frequency”—has recently been added to the Union list of permitted claims under Regulation (EU) No 432/2012, following a five-year authorisation process. Food-related health claims […]
Procurement of medical devices: New measures between the EU and China
Measures imposed by the EU On 30 June 2025, several measures entered into force that were imposed by the European Commission regarding the purchase of medical equipment originating from China. The following two measures apply: Bidders must therefore ensure that goods and services of Chinese origin do not exceed 50% of the total contract value […]
Category Captains beware!: Belgian competition authority fines Category Management of OTC medicines
On 24 April 2025, the Belgian Competition Authority (BCA) announced a landmark decision imposing fines totaling over €11.2 million on three major pharmaceutical companies for their involvement in a long-running anti-competitive arrangement concerning the placement of over-the-counter (OTC) medicines in Belgian pharmacies..
The new Belgian government’s public health policy: 10 key take-aways for pharma policy
The new Belgian federal government has outlined its vision for public health in a policy paper under the slogan “More money for health, more health for our money”. Public health is a high-priority sector with a significant budget, and the policy paper introduces several key measures that will shape the pharmaceutical industry in the coming years. For pharma companies operating in Belgium, these developments bring both new regulatory challenges and strategic opportunities. Here is a focused analysis of ten key changes and their potential impact on the pharma industry.
CJEU’s DocMorris Ruling: where is the line for pharmaceutical advertising?
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 Court of Justice of the European Union (CJEU) revisited the meaning of ‘advertising of medicinal products’, clarifying how far national restrictions on pharmaceutical advertisements can go under EU pharmaceutical law and internal market principles.
New year, new policy: CPVO updates its public access to documents policy
The Community Plant Variety Office (CPVO) recently revised its public access to documents policy to align with the European Union (EU)’s evolving transparency standards. Effective since 15 January 2025, the new policy seeks to ensure broad access to all documents that the CPVO holds, while protecting private parties’ commercial interests. In particular, a system of prior confidentiality requests has been put in place for applicants of Community plant variety rights (CPVR).