Corporate, Commercial & Regulatory

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    • 21/09/2021
    • News

    European Commission Announces Interim Measures to Avert Possibly Irreversible Consequences of Grail's Acquisition by Illumina

    Less than a month ago, the European Commission (the Commission) announced that it would open an investigation to determine whether Illumina’s decision to acquire Grail pending its review of that transaction under Regulation 139/2004 on the control of concentrations between undertakings (the Merger Regulation) is in breach of the “standstill obligation” provided for by Article 7, Merger Regulation (see, Van Bael & Bellis Life Sciences News & Insights of 24 August 2021). The Commission has now raised the stakes by issuing a Statement of Objections against Illumina in which it threatens to adopt interim measures designed, in the Commission’s words, to “prevent the potentially irreparable detrimental impact of the transaction on competition, as well as [the] possible irreversible integration of the merging parties, pending the outcome of the Commission's merger investigation” (see, attached press release of 20 September 2021). The Commission took pains to point out that Illumina’s autonomous decision to keep Grail separate following its acquisition (and thus avoid the possibly irreversible consequences which the Commission professes to avert) was not sufficient and presented several “serious shortcomings”. It also insisted that any adoption of interim measures would not preclude a possible later finding on the merits that Illumina’s conduct was in violation of the standstill obligation. The new hostilities come against the background of the Commission’s controversial assertion of merger control jurisdiction over the Illumina-Grail transaction which Illumina challenged before the European General Court.

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  • Van Bael & Bellis has ‘impressive knowledge of dispute resolution, including mediation’. The firm is notable for its strong regulatory and administrative law contentious practice as well as its impressive life sciences sector presence.

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Recent publications

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    • 20/09/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 8

    The August 2021 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

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    • 17/09/2021
    • Articles

    European Commission Launches European Health Emergency Preparedness and Response Authority

    On 16 September 2021, the European Commission (the Commission) decided to establish the European Health Emergency Preparedness and Response Authority (HERA) which will seek to prevent, detect, and respond to health emergencies and will complement the work carried out by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). However, unlike these autonomous agencies, HERA will be created as a Commission service, headed by a Director-General, and will therefore remain under its control. As such, it will form an important part of the emerging European Health Union (see, Van Bael & Bellis Life Sciences News & Insights of 30 June 2021, 19 February 2021, and 12 November 2020). According to Article 2 of the Commission Decision establishing HERA, the new service will be given a range of tasks, including assessing health threats and ensuring directly or indirectly the research, development, production, procurement, distribution, stockpiling and knowledge building in relation to what are referred to as “medical countermeasures” (MCM). MCM are products used to face serious health threats and include antibiotics, chemical antidotes, diagnostic tests, medical equipment, personal protective equipment, therapeutics and vaccines. In addition to the decision establishing HERA, the Commission also tabled a proposed Regulation “on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level”. While HERA will be a Commission service, its board will consist of one representative of each Member State. In a move unlikely to meet with a warm welcome, the European Parliament will only be invited to designate an observer to the HERA board and will thus be placed on an equal footing with several specialised EU agencies and bodies. HERA will rely on a budget of EUR 6 billion from the current Multiannual Financial Framework for the period covering 2022-2027, but other EU programmes will also make contributions, thus causing the total European support to reach an estimated EUR 30 billion. The Commission points out that the project’s firing power will even be larger as a result of additional Member State initiatives and private sector ventures. The attached extensive documentation includes a (i) Commission press release; (ii) Commission questions and answers file; (iii) Commission Communication on the subject; (iv) annex to the Communication; (v) Commission decision establishing HERA; and (vi) proposed Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.

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    • 10/09/2021
    • Articles

    Belgium Prepares to Implement Regulation (EU) 2019/6 on Veterinary Medicinal Products

    Earlier this week, Belgian plans for implementing Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC (the Vet Reg) were made partially publicly available pursuant to the notification procedure governing possible technical barriers to trade provided for by Directive (EU) 2015/1535. This Technical Regulation Information System or “TRIS” procedure allows both the European Commission and the EU Member States to review before their adoption technical regulations which Member States intend to introduce for products and Information Society services. The TRIS procedure thus created a mechanism to increase the likelihood that the proposed texts are compatible with EU law, including the Internal Market principles. The European Commission’s TRIS platform now displays the text of a draft Law governing veterinary medicinal products (“Voorontwerp van Wet betreffende diergeneesmiddelen”/“Avant-projet de loi sur les médicaments vétérinaires” – the Draft Vet Law – see, attached Dutch and French versions) which will be submitted to Parliament and is intended to apply on 28 January 2022, the date of application of the Vet Reg. As a Regulation the Vet Reg is directly applicable in EU Member States and, theoretically, does not require national implementation. However, as was the case for many Regulations across diverse fields of law, implementing measures also proved necessary for the Vet Reg. Accordingly, the Draft Vet Law contains an extensive set of detailed rules and provides for the prospect of even more elaborate implementing rules that will be enacted by Royal Decree. The Draft Vet Law regulates a set of important issues, including clinical trials with veterinary medicinal products; marketing authorisations; post marketing authorisation measures; pharmacovigilance; the manufacturing, preparation, importation and exportation of veterinary medicinal products; wholesale and retail trade, including sales at a distance; parallel trade; publicity; inspection, supervision and criminal penalties; administrative settlements; and the processing of inspection data. As a result of the Draft Vet Law, the Law of 25 March 1964 governing medicines will no longer apply to veterinary medicinal products and is for that reason made subject to a lot of modifications.

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