Tags: Life & Health

December 2, 2022

Are parallel importers necessarily allowed to rebox medicines in case of visible traces from ATDs? The CJEU says NO

Pharmaceutical companies are obliged to affix an anti-tampering device (‘ATD’) on prescription-only medicines to enable verification of whether a medicine’s packaging has been tampered with. Parallel importers argue that this results in an overarching objective necessity to ‘rebox’ such medicines.

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November 24, 2022

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.

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November 16, 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 […]

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November 8, 2022

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.

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July 7, 2022

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.

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May 6, 2022

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.

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March 31, 2022

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.

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February 22, 2022

Belgian competition authority hits pharmaceutical wholesalers with cartel fine

Belgian companies active in the pharmaceutical sector at different levels should beware of competition law.

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May 25, 2021

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.

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May 11, 2021

“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.

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March 23, 2021

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.

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February 2, 2021

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.

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