Articles for the ‘Life Sciences’ Category

CJEU’s DocMorris Ruling: where is the line for pharmaceutical advertising?

Published 13 May 2025 by Kirian Claeyé ALTIUS Lawyers, Belgium

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.

... Read more

Compliance with the SmPC and the Presentation of Non-Registration Studies in Advertising

Published 12 May 2025 by Kateřina Slavíková HAVEL & PARTNERS | Czech Republic, Czech Republic

Informing healthcare professionals about the latest findings from studies related to medicinal products is crucial for ensuring effective and safe patient care. Access to the most recent scientific knowledge allows physicians to better understand the effects and potential side effects of medications, leading to more informed prescribing decisions.

... Read more

The new Belgian government’s public health policy: 10 key take-aways for pharma policy

Published 17 March 2025 by Kirian Claeyé ALTIUS Lawyers, Belgium

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.

... Read more

New year, new policy: CPVO updates its public access to documents policy

Published 12 February 2025 by Philippe de Jong ALTIUS Lawyers, Belgium

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).

... Read more

European Commission proposes new PPP labelling requirements

Published 05 February 2025 by Philippe de Jong ALTIUS Lawyers, Belgium

On 6 January 2025, the European Commission published a draft proposal aimed at further harmonising labelling requirements for plant protection products (PPPs) in the European Union (EU). The proposal intends to repeal the existing labelling rules and introduce certain new requirements, including mandatory digital labelling. Since the draft proposal has not yet been formally adopted, some changes to the final version remain possible.

... Read more