Tags: Life & Health
New Mdeon rules applicable as from 1 January 2023
Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023.
The Belgian Competition Authority fines Novartis for abuse of collective dominance regarding eye disease medicines
The Belgian Competition Authority fines Novartis for abuse of collective dominance regarding eye disease medicines
On 23 January 2018, the European Court of Justice (“ECJ”) handed down its judgment (C-179/16) in relation to Novartis’ Lucentis® and Roche’s Avastin® eye disease medicines, and ruled that disseminating misleading information on the off-label use of a medicine could constitute a restriction of competition ‘by object’. Exactly 5 years later, on 23 January 2023, the Belgian Competition Authority (“BCA”) imposed a fine on Novartis Pharma SA and Novartis AG (together “Novartis”) for abuse of collective dominance resulting from disseminating misleading information regarding risks in relation to the off label use of Roche’s Avastin®.
When are IP holders liable for enforcing a later invalidated IP right?
At this IP Update, our IP specialists, Christophe Ronse and Kirian Claeyé, will discuss under what circumstances IP holders may be held liable for enforcing a later invalidated IP right.
EU harmonizes THC limits in hemp seed (food) as from 1 January 2023
Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework.
WEBINAR VIDEO | What do the CJEU’s decisions on parallel trade of medicines mean for your company?
At this additional Christmas edition, the IP specialists in our Life Sciences team discuss the CJEU’s latest decisions on the parallel trade of medicines, and what these decisions mean in practice for your company. On 17 November 2022, the CJEU delivered essentially two decisions on the parallel trade of medicines. The first concerned the rebranding […]
What do the CJEU’s decisions on parallel trade of medicines mean for your company?
At this additional Christmas edition, the IP specialists in our Life Sciences team will discuss the CJEU’s latest decisions on the parallel trade of medicines, and what these decisions mean in practice for your company.
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.
WEBINAR VIDEO | Life Sciences Session #9: Hot topics in healthcare tendering
Please join us on 28 November 2022 from 13:30 to 14:30 for our ninth online Life Sciences Session, where Caroline De Mulder and Kirian Claeyé will discuss the latest evolutions in the field of healthcare public procurement and will answer questions such as:
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.