News & Insights

  • 11/10/2021
  • News

Van Bael & Bellis’ Open Office Day 2021

Van Bael & Bellis is holding its “Open Office Day” for law students on Wednesday, 27 October 2021.

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    • 19/10/2021
    • Books

    Van Bael & Bellis’ Competition Law of the European Union, Sixth edition, receives high praise from Professor Nicolas Petit

    The Sixth Edition of “Competition Law of the European Union”, authored by Van Bael & Bellis and published by Kluwer, has just been released. This book provides a comprehensive and up-to-date analysis of the EU competition rules as developed primarily by the Commission, the General Court and the Court of Justice. The new Sixth Edition of this major work by the well-known competition law team at Van Bael & Bellis in Brussels reflects the many developments in the case law and relevant legislation that have occurred since the Fifth Edition was published in 2010 (as “Competition Law of the European Community”). On the launch of the Sixth Edition of the book, Head of Competition at Van Bael & Bellis Andrzej Kmiecik commented: “The publication of the Sixth Edition is a significant achievement for the firm’s competition team. The practice of competition law at the highest level requires leading technical expertise in this continuously evolving field of the law, and we believe the appearance of this new edition is an important illustration of our expertise. We trust it will contribute to the better understanding and further development of the law.” This edition continues to follow the successful format of previous editions in covering all substantive and procedural aspects of the EU antitrust rules and merger control, as well as including a much-extended chapter on private enforcement and – for the first time – a dedicated section on competition law in the pharmaceutical sector. In this comprehensive new edition, the authors examine such notable developments as: – important rulings concerning the concept of a restriction by object under Article 101; – the extensive case law in the field of cartels, including in relation to cartel facilitation and price signalling; – important Article 102 rulings concerning pricing and exclusivity, including the Post Danmark and Intel judgments, as well as standard essential patents; – the current block exemption and guidelines applicable to vertical agreements, including those applicable to the motor vehicle sector; – developments concerning online distribution, including the Pierre Fabre and Coty rulings; – the current guidelines and block exemptions in the field of horizontal cooperation, including the treatment of information exchange; – the evolution of EU merger control, including court defeats suffered by the Commission and the case law on procedural infringements; – the burgeoning case law related to pharmaceuticals, including in respect of reverse payment settlements; – the current technology transfer guidelines and block exemption; – procedural developments, including in relation to the right to privacy, access to file, parental liability, fining methodology, inability to pay and hybrid settlements; – the implementation of the Damages Directive and the first interpretative rulings. With an attempt to cut through the theoretical underpinnings of EU competition law to expose its actual impact on business, this book combines a critical commentary on the rules with practical guidance on their application. One of its kind, this book is an authoritative new edition of a classic work that – time and again – proves to be of immeasurable value to both business persons and their legal advisers. Van Bael & Bellis’ previous Fifth Edition of “Competition Law of the European Community” received a glowing book review from Valentine Korah, Emeritus Professor at University College London (UCL): “Any new edition of Van Bael & Bellis, a “must stock” brand if ever there was one, is a major event. Its appearance is warmly welcome.” Click here to order the book.

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    • 18/10/2021
    • Books

    Philippe De Baere authors WTO chapter of The International Trade Law Review, 7th edition

    The International Trade Law Review, the 7th edition of which was recently published by Law Business Research, includes a chapter on the World Trade Organization authored by Philippe De Baere. The chapter examines significant legal developments in the area of WTO dispute settlement proceedings during the past year and addresses the impact of covid-19 on those proceedings as well as the Appellate Body impasse, the Multi-party Interim Appeal-Arbitration Arrangement and the use of alternative means of dispute resolution. Van Bael & Bellis associates Tetyana Payosova, Joanna Redelbach and Victor Crochet assisted in the drafting of the chapter.  Please click on the PDF below to access the chapter.

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    • 14/10/2021
    • Articles

    European Commission Proposes to Delay Application of Regulation on In Vitro Diagnostic Medical Devices

    The European Commission (the Commission) published today a proposal for a Regulation delaying the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) by three to five years, depending on the risk involved in the devices concerned (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices – the Proposal; see, attached copy). The IVDR was set to take effect on 26 May 2022. Referring to the extraordinary circumstances created by the COVID-19 pandemic and the resulting delay in the designation and work of notified bodies under the IVDR, the Proposal stresses that immediate action is necessary to avert a “significant disruption in the supply of in vitro diagnostic medical devices on the market both for health institutions and for the public” (p. 2). To date, only six notified bodies have been designated under the IVDR. Moreover, these six notified bodies are established in only three countries (France, Germany and the Netherlands). Extending the existing transitional period for devices covered by a valid certificate issued under the current in vitro diagnostic medical devices Directive (Directive 98/79/EC) by one year, the Proposal provides that these devices can continue to be placed on the market or put into service until 26 May 2025. Furthermore, the Proposal introduces tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVDR. For these devices, the length of the transitional period will depend on the risk class of the device concerned. Lower risk devices such as class B and class A sterile devices will benefit from a transition period until 26 May 2027, whereas higher risk devices (class D and class C devices) will only have a transition period until, respectively, 26 May 2025 and 26 May 2026. The Proposal responds to a widespread call for delayed application of the IVDR. This call is not new though. As early as in April 2020, the European trade association for the medical devices sector, MedTech Europe, warned that “even before the COVID-19 pandemic, very little progress had been achieved yet, to get the new IVDR regulatory system ready” and that “since the present COVID-19 outbreak, the IVDR implementation progress has come to a total halt” (see, Van Bael & Bellis Life Sciences News and Insights of 24 April 2020).

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    • 11/10/2021
    • Articles

    EU Clinical Trials Regulation - EMA Publishes Clinical Trial Information System Go-live Plan

    On 8 October 2021, the European Medicines Agency (EMA) provided an update on the progress in the development and preparations for the ‘go-live’ of the Clinical Trial Information System (CTIS) on 31 January 2022. EMA also published a 12-page CTIS go-live plan summarising the key steps remaining before the launch of CTIS (the Plan; see, attached copy). According to EMA and the Plan, CTIS is currently being extensively tested to identify any potential remaining stability issues. A key priority in preparing CTIS for launch is ensuring that the sponsor workspace is fully functional. Once this has happened, the workspace for health authorities will be finished, followed by the public portal. Other priorities are to set up a dedicated helpdesk for CTIS users and to prepare materials for “extended stakeholder training”. These materials will complement the existing training materials already issued by EMA, including online training modules and a sponsor handbook (see, Van Bael & Bellis Life Sciences News and Insights of 9 August 2021). Further preparations are also necessary to allow for clinical trial safety reporting and monitoring as included in the initial scope of CTIS activities. The Plan provides for all of the outstanding matters a chart with a timeline for their implementation. In the first quarter of 2022, EMA will publish a follow-up plan focusing on the activities post 31 January 2022 which will cover post go-live releases, CTIS operation and maintenance, continued training offerings and stakeholder support and interaction. CTIS is the cornerstone for the application of the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014). Comprising an EU Portal and EU Database, CTIS will ensure a single-entry point for the submission of data and information relating to clinical trials by sponsors, evaluation and supervision by Member State health authorities, and access to publicly available data and information relating to clinical trials by the public (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021 and Van Bael & Bellis Life Sciences News and Insights of 9 August 2021).

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    • 11/10/2021
    • Articles

    Belgium, Ireland, and The Netherlands Jointly Agree under Aegis of Beneluxa Initiative to Reimburse Zolgensma®

    On 8 October 2021, Belgium, Ireland, and The Netherlands announced that they had reached an agreement with Novartis Gene Therapies (Novartis) regarding the reimbursement of Zolgensma® (onasemnogene abeparvovec), a gene therapy medicinal product that was designated as an orphan medicine and is indicated for the treatment of two specific types of Spinal Muscular Atrophy (SMA) (see, attached press release). SMA is the most common genetic cause of mortality in infants and affects nerve cells that cause general muscle weakness. Infants with SMA typically do not survive more than two years. For its part, Zolgensma® is known as the world’s priciest medicine, but the press release does not address the price reductions which Novartis is understood to have consented to in order to secure reimbursement in the three countries. The agreement was reached under the aegis of the Beneluxa initiative, a collaborative effort of Austria, Belgium, Ireland, Luxemburg, and The Netherlands designed to expand patient access to high quality and affordable medicines. Under the Beneluxa initiative member governments pursue joint activities in the areas of (i) horizon scanning; (ii) Health Technology Assessment; (iii) the sharing of information; and (iv) pricing and reimbursement. The arrangement with regard to Zolgensma® is the first agreement governing the price and reimbursement of a medicine involving 3 countries. The previous one only applied to two countries, Belgium and The Netherlands, but, interestingly, related to Biogen’s Spinraza® (nusinersen), a medicine also indicated for the treatment of specific SMA conditions (see, Van Bael & Bellis Life Sciences News & Insights of 12 July 2018). Zolgensma® will qualify for reimbursement in Ireland with immediate effect. In The Netherlands, the medicine will be reimbursable on 1 November 2021, while Belgium will reportedly follow suit on 1 December 2021.

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    • 08/10/2021
    • News

    Jean-François Bellis participates in panel on the revision of the rules on vertical agreements at the Autumn Conference of the European University Institute in Florence

    Jean-François Bellis participated in a panel on the revision of the rules on vertical agreements at the Autumn Conference of the European University Institute in Florence on 8 October 2021. The conference, which is part of the Florence Competition Programme of the Institute, is entitled “Classics Revisited: Market Definition, Horizontal and Vertical Agreements”. The full programme can be found here: http://fcp.eui.eu/event/florence-competition-autumn-conference/.

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    • 07/10/2021
    • Newsletters

    VBB on Competition Law, Volume 2021, No. 9

    The September 2021 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at the European Union, UK and Member State levels.

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    • 06/10/2021
    • News

    Alex Stratakis to speak in a panel discussion on Brexit and UK Competition Law

    On 7 October Van Bael & Bellis partner and head of our UK Competition Practice will participate in a panel discussion on "Brexit & Competition law: What Greek/EU lawyers and businesses need to know about the new era of UK competition law". https://lnkd.in/dvyibqgD Other panellists are Dr. Andriani Kalintiri, Lecturer in Competition Law at King's College London. The panel will be moderated by Kyriakos Fountoukakos, Managing Partner, Herbert Smith Freehills in Brussels.

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    • 04/10/2021
    • News

    Katharina Bongs is shortlisted as one of the top women competition law practitioners by [email protected]

    Van Bael & Bellis counsel Katharina Bongs has been shortlisted by [email protected] in the ‘Five Star Women Competition Professionals’ Survey which celebrates notable women competition professionals. Katharina focuses on EU and German competition law and on EU trade law. You are invited to vote for Katharina and other competition law professionals in the fields of Private Practice, Economics, Enforcement, In-house, Policy, Advocacy & Media, using the following link: https://womenat.com/w-comp-5-stars-brussels-private-practice

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