Tags: Life Sciences
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.
Webinar Video | Life Sciences Session #2: Vaccine liability: what if vaccination goes wrong?
The ongoing vaccination campaign against Covid-19 raises the question of possible side effects and of the potential liability for damages arising from the use of vaccines used against this disease.
Precaution is not enough – CJEU finds that Cannabidiol (CBD) is not a narcotic drug
The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. The Court has ruled that CBD is not a narcotic drug and that the principles of free movement apply.
Webinar Video | Life Sciences Session #1: What’s new in the parallel world of parallel trade?
In our first Life Sciences Session, our experts Philippe de Jong and Kirian Claeyé talk you through a number of recent decisions and developments in the field of parallel trade of pharmaceuticals, medical devices and plant protection products.
TRIS procedure further clarified by the Court of Justice in two recent rulings of 8 October 2020
The Court of Justice of the EU has shed light on Directive 2015/1535 (TRIS) in two recent rulings of 8 October 2020. They explain when a national law triggers the notification procedure and clarify the interrelationship with a notification under another piece of EU law.
Can a parallel importer rebrand generic medicines?
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?
Food labelling – National rules on mandatory indication of the country of origin
This is the third decision of the CJEU on the concept of “country of origin” in a (bit more than a) year.
Webinar Video | Lunch & Learn: Life Sciences : Morceaux choisis
Ce webinar porte sur les sciences du vivant et est composé de deux parties: ‘Ecueils et dangers pour la protection de la recherche & du développement dans le secteur du vivant: préceptes de bonne hygiène juridique’ et Vente de produits de produits de santé et de médicaments aux hôpitaux : les points d’attention en droit des marchés publics”.
The Belgian Competition Authority confirms that Belgian merger control rules apply to the creation of loco-regional hospital networks pursuant to the Act of 28 February 2019
Following the recent legislative amendment obliging hospitals to establish and be part of a loco-regional hospital network, the Belgian Competition Authority published on 22 July 2020 a note setting out the principles that will guide it when assessing the establishment of hospital networks and their possible qualification as a concentration under competition law.