Overview

Koen T'Syen specialises in commercial and competition law as well as in Belgian and EU life sciences regulatory matters (medicines and medical devices).

He advises clients on a wide range of commercial matters including contract law, distribution law, public procurement law and unfair market practices. Further, he assists clients in competition law matters including cartel damages claims and merger control.

Koen’s expertise is often put to use in the life sciences sector, of which he has a thorough knowledge. He has substantial experience in advising life sciences clients on commercial and regulatory matters including, for instance, advertising and promotion issues, clinical trials, marketing authorisations and pricing and reimbursement issues.

Koen represents clients before Belgian civil and administrative courts and has also represented clients before the Court of Justice of the European Union. Koen was appointed as the National Reporter for Belgium at the 2016 Congress of the International League of Competition Law (LIDC) in Geneva in view of his expertise in life sciences and competition law.

He regularly speaks and writes on matters falling within his area of expertise.

Languages 

Dutch, English, French

Recommendations

  • Euromoney Legal Media Group – Rising Star: Belgium
  • Expert Guides – Life Sciences (Rising Star)
  • Legal 500 for Competition Law (Belgium)
  • Legal 500 for Healthcare and Life Sciences

Education

  • College of Europe, Bruges, LL.M. in European Legal Studies, 2007
  • University of Leuven, Master of Laws, 2006
  • University of Namur, Bachelor of Law, 2003

Publications

Chambers & Partners Life Sciences Guide - EU Chapter, co-author with Peter L’Ecluse Catherine Longeval and Thibaut D’hulst, Chambers and Partners, 2019.
 
“Taxis, Limousines and Information Society Services – Court of Justice of European Union Confirms Uber’s Status as a Transport Services Company”, co-author with Charlotte Woolfson, IHT 2019, issue 2, pp. 263-269.
 
Chambers & Partners Life Sciences Guide - EU Chapter, co-author with Peter L’Ecluse Catherine Longeval and Melody Moodley, Chambers and Partners, 2018.
 

Belgium chapter on antitrust in pharmaceutical markets in P. KOBEL ET AL. (eds.), Antitrust in Pharmaceutical Markets & Geographical Rules of Origin, LIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition, Springer, 2017.

Pharma.be’s Commented Codex Pharma – Public Health in Belgium, Knops Publishing, 2013.
“Off-label use of medicinal products and product liability”, co-author with Peter L’Ecluse and Catherine Longeval, Life Sciences Cross-border Handbook, Practical Law Company, 2013.

“Patent settlement agreements: the state of play in the EU and the US”, co-author with Peter L’Ecluse, Catherine Longeval and Steven Corcoran, Life Sciences Cross-border Handbook, Practical Law Company, 2012.

“De bescherming van zakengeheimen in het Belgisch en Europees mededingingsrecht: Wat geheim is blijft geheim…of toch niet?”, co-author with Peter L’Ecluse, Cah. Jur. 2011, issue 1, pp. 20-30.

Contributor to Van Bael & Bellis, Competition Law of the European Community (fifth edition, Kluwer, 2010), the standard work of reference in the field of EU competition law.

“Market Power in Bidding Markets: An Economic Overview”, World Competition 31(1):37-62, 2008 (this publication is a slightly amended version of Koen’s thesis at the College of Europe, Bruges, Belgium, for which Koen was awarded the Rafael Sanz Rodriguez Memorial Prize for best thesis in the College of Europe’s law department).

Professional Memberships

Member of the Association for the Study of Competition Law (Vereniging voor de Studie van het Mededingingsrecht/Association pour l'Etude du Droit de la Concurrence)

Member of TOPRA (The Organisation for Professionals in Regulatory Affairs)

Member of AIJA (International Association of Young Lawyers)

Bar Admission

Brussels

Notable assignments

  • Assisting and representing a global provider of integrated supply chain solutions to, amongst others, clients in the defence industry, in litigation against an international organisation with a view to recovering a claim of more than $ 200 million.

  • Assisting and representing a joint venture of two global engineering and construction companies in litigation against a subcontractor in a dispute relating to a large construction project.

Publications and insights

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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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