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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    • 19/02/2021
    • Articles

    European Commission Presents Hera Incubator to Bolster Fight against Coronavirus

    On 17 February 2021, the European Commission (the Commission) presented an updated version of the Vaccine Strategy which it had adopted in June 2020 to tackle the coronavirus (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020). The update was prompted by the need to address the increased threat of Covid-19 variants and is called somewhat bombastically the Hera Incubator because it foreshadows the future European Health Emergency Preparedness and Response Authority (HERA), whose advent was announced in November 2020 as part of the incipient European Health Union (see, Van Bael & Bellis Life Sciences News Alert of 12 November 2020). The Hera Incubator has 3 main components that, in turn, cover a range of detailed action points: • To detect, analyse and assess variants – The EU will support the development of specialised tests to detect new variants and support with at least EUR 75 million the associated genomic sequencing. The research and data exchange on variants will be bolstered with separate funding of EUR 150 million. The Commission also plans to launch the VACCELERATE COVID-19 clinical trial network which brings together 16 EU Member States and five associated countries, including Switzerland and Israel, to exchange data and include children and young adults as trial participants. • To speed up regulatory approval of adapted vaccines – The new rules will be modelled on the annual influenza vaccine model. The EU will also facilitate the certification of new or repurposed manufacturing sites by involving the regulatory authorities early. • To increase the production of COVID-19 vaccines – The Commission plans to adapt existing Advance Purchase Agreements and conclude new such agreements to support the development of new and adapted vaccines through EU funding. On 17 February 2021, the Commission already approved a second contract with Moderna that provides for an additional purchase of 300 million doses. Furthermore, the Commission also promises to establish “a detailed and credible plan showing capability to produce vaccines in the EU”. The overall EU manufacturing capacity will be expanded by the “EU FAB” project, a network of emergency response production facilities for vaccine and medicine manufacturing at EU level. Separately, the Commission will develop a voluntary dedicated licensing mechanism to facilitate technology transfer. This is probably a signal that the Commission will not follow the path of compulsory patent licences. The attached documents contain detailed information on the Commission’s plans.

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    • 19/02/2021
    • Articles

    European Commission | Assessment of Member State Rules on Health Data in Light of GDPR

    On 12 February 2021, the European Commission’s DG Health and Food Safety published an assessment of the EU Member State rules governing health data in the light of the General Data Protection Regulation (EU) 2016/679 (GDPR). The study’s objective was to examine possible differences between Member States and identify elements that might affect the cross-border exchange of health data in the EU for the purposes of healthcare, research, innovation and policy-making. The European Commission concluded that the existing fragmented approach of national rules governing health data between Member States hampers cross-border co-operation in the provision of healthcare, the administration of healthcare systems and research carried out so as to further public health objectives. The study discusses the use of health data for primary purposes (patient care), for secondary use in public health and for scientific or historical purposes. For each of these uses, the study analyses the legal bases for processing the data under the GDPR and inquires whether local legislation provides for alternatives to the use of consent as a legal basis. In response to the challenges identified, the study suggests actions at EU level to support the European Health Data Space and ensure the best possible use of health data. Furthermore, the study shows that co-operation between the EU Member States is crucial as it should draw on the work of national data protection authorities that come together as the European Data Protection Board, as well as on the numerous national and EU level bodies. Please click on the link below for a short article on the Commission’s assessment.

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    • 15/02/2021
    • Articles

    Belgium Creates Exceptional Regime for Temporary Reimbursement of Medicines

    The Royal Decree of 26 January 2021, which entered into force on 13 February 2021, establishes a regime for the temporary reimbursement of medicines “under exceptional circumstances or in situations of force majeure” that must be defined by the Council of Ministers (the Royal Decree). The temporary reimbursement will be achieved following a short procedure that only involves a proposal by the Service Medical Treatment of the National Institute for the Insurance of Disease and Invalidity (Dienst voor geneeskundige verzorging van het Rijksinstituut voor Ziekte-en Invaliditeitsverzekering/Service des soins de santé de l'Institut national d'assurance maladie-invalidité), an opinion by the Commission for the Reimbursement of Medicines (Commissie Tegemoetkoming Geneesmiddelen/Commission de remboursement des médicaments) (CRM) and a final reasoned decision by the Minister for Social Affairs and Public Health (Minister van Sociale Zaken en Volksgezondheid/Ministre des Affaires sociales et de la Santé publique). Crucially, the marketing authorisation holder (MAH) of the medicine at issue will not be heard. This is a dramatic departure from the regular reimbursement procedure governed by the Royal Decree of 1 February 2018 which can only be initiated by an application of the MAH and which provides for a repeated back and forth between the MAH and the CRM. The temporary reimbursement is designed to ensure that patients will not be deprived of “proper therapeutical means” (deugdelijke therapeutische middelen/moyens thérapeutiques valables) for financial reasons or otherwise. The new regime came into being because of the Covid-19 pandemic, but its application clearly transcends this crisis. The temporary reimbursement of a given medicine will apply during a stated period, during the time of the specific crisis that prompted the reimbursement or until the medicine becomes reimbursable as a result of a reimbursement decision which is based on a regular reimbursement application.

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