Tags: Life Sciences
Can parallel importers (re)brand generic medicines? The CJEU limits the ‘room for manoeuvre’
If a branded medicine and its generic version are put on the EEA market by economically-linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? After the Brussels Court of Appeal had referred questions on this issue for a preliminary ruling two years ago, the CJEU has now clarified the limits.
New rules on medical force majeure and the medical certificate
A new Act, which includes various provisions on incapacity for work, was published in the Belgian State Gazette on 18 November 2022.
Invisible life to the rescue: European Commission facilitates approval of micro-organisms in plant protection products from 21 November 2022
Micro-organisms or microbes (e.g. bacteria, fungi or protozoa) are invisible to us but play a significant ecological role as they help to break down organic matter and produce oxygen. Some of them protect crops from pests and diseases, making them a suitable alternative to chemical-based plant protection. Given its ambition […]
Life Sciences Session #9: Hot topics in healthcare tendering
Our Life Sciences team is taking the initiative to offer you short, digestible and regular online Life Sciences Sessions.
European Commission Unveils Measures to Unleash the Potential of Health Data
The European Commission has presented its Proposal for a Regulation on the European Health Data Space (the “Proposal”). While it aims to strengthen the rights of individuals and unlock data’s potential for research purposes, it also adds complexity to an already extensive legal framework.
Brussels and Brussels South Charleroi Airports fined for use of thermal cameras
The Belgian Data Protection Authority has fined Brussels Airport and Brussels South Charleroi Airport 200,000 and 100,000 EUR respectively for their use of thermal cameras during the Covid-19 pandemic.
Webinar video | Life Sciences Session #8: Global MAs and regulatory data protection a substantive and procedural challenge
Our speakers Philippe de Jong and Kirian Claeyé discuss the interesting judgment of the General Court in Polpharma v. EMA.
Belgian competition authority hits pharmaceutical wholesalers with cartel fine
Belgian companies active in the pharmaceutical sector at different levels should beware of competition law.
Webinar Video | Life Sciences Session #4: How to optimise your regulatory exclusivity rights for pharmaceutical products?
In the fourth online Life Sciences Session our experts, Kirian Claeyé and Laura Traest, will be focusing on regulatory exclusivity rights for pharmaceutical products, which will include data exclusivity, orphan exclusivity, SPCs and paediatric rewards.
“100g of mealworm please!” – First insect approved under the Novel Foods Regulation
On 3 May 2021, the EU Member states approved “dried yellow mealworms” as a novel food under EU Regulation 2015/2283. According to the applicant, mealworms can be used in a broad range of food products, such as bread, cookies, or pasta.
Webinar video | Life Sciences Session #3: ‘Trop is te veel’: what not to do in case of pricing of medicines?
The COVID-19 pandemic challenges companies and firms worldwide, and requires us all to adopt new proactive approaches. While COVID-19 prevents us from being together, our Life Sciences team takes the initiative to give you short, digestible and regular online Life Sciences Sessions.
Is AstraZeneca obliged to supply the EU with sufficient covid-19 vaccines?
The EU-AstraZeneca agreement imposes a “best reasonable efforts” obligation on AstraZeneca to manufacture and deliver its Covid-19 vaccine doses to the EU. This obligation applies to AstraZeneca’s manufacturing sites not only in the EU, but also in the UK. Although the production issues of the Anglo-Swedish pharma company at its Belgian plant may not necessarily violate its “best reasonable efforts” obligation, it remains highly questionable whether AstraZeneca is allowed under the agreement to prioritise supply of the UK over the EU with its vaccines produced in the UK.