Tags: Life Sciences
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.
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.
Belgian federal government restricts the sale of personal protective equipment and medical devices that can be used in the fight against Covid-19 – Updated
On 23 March 2020, a Ministerial Decree on special measures in the context of the SARS-CoV-2 pandemic on the basis of Book XVIII of the Code of Economic Law was adopted by the Belgian Minister of Economic Affairs, which restricts both the retail and wholesale distribution of certain types of personal protective equipment, as well as of medical devices used for treating Covid-19 patients.
EC has adopted temporary derogations from certain EU competition rules
On 30 April 2020, the European Commission adopted three implementing regulations allowing temporary derogations from the strict cartel prohibition provided for by EU competition law in three specific agricultural sectors: dairy, potato and live plants and flowers.
Belgium takes measures to avoid medicine shortages during the COVID-19 pandemic
On 8 April 2020, the Belgian federal agency for medicines and health products adopted a consolidated version of its decision taking the following urgent measures for certain listed medicines to avoid medicine shortages during the SARS-CoV-2 pandemic.
Reimbursement of medicinal products in times of pandemics and budgetary constraints: why quick fixes do not work
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent.
CJEU clarifies when reverse payment patent settlements can be anticompetitive
In its ruling of 30 January 2020, the Court of Justice of the European Union (‘CJEU’) has clarified for the first time the criteria governing whether a reverse payment settlement agreement concerning a dispute between the holder of a pharmaceutical patent and a manufacturer of generic medicines is contrary to EU competition law.
The DPA approves a draft Act prohibiting life and health insurers from processing health sensor data
The Belgian data protection authority has approved a draft Act that prohibits life and health insurers from processing the health sensor data of their insurance holders.
CJEU sheds light on the “Country of Origin” concept
In the run-up to the entry into force of specific rules on country of origin labelling for primary ingredients, the CJEU has recently clarified both the concept of the “country of origin” under the FIC Regulation and its interplay with other regulations such as the Regulation on the common organisation of the agricultural products markets and the Union Customs Code.
New Belgian Act on medicinal product shortages
On 3 February 2020, the Belgian Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Belgian State Gazette.
The new Plant Health Regulation is ready to take off as of 14 December 2019
Pests threaten plant health. To fight the increased risks owing to the further globalisation of trade and climate change, the European legislature has adopted measures concerning the determination and reduction of risks imposed by pests: Regulation 2016/2031.