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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    • 14/01/2020
    • Articles

    OECD Makes Recommendations for Improvement of Performance-Based Managed Entry Agreements for Medicines

    The Organisation for Economic Co-operation and Development (“OECD”) published a health working paper (the “Paper”) authored by Martin Wenzl and Suzannah Chapman that offers recommendations for the use of performance-based managed entry agreements in OECD countries and EU Member States (see, attached). The Paper reflects the results of a review of managed entry agreements (“MEAs”) carried out in 2018 and 2019. MEAs are arrangements between healthcare payers and pharmaceutical firms that provide for the reimbursement of generally new health technologies, including medicines, while controlling the financial impact of that reimbursement and keeping price concessions confidential. These financial agreements are thus tools for achieving patient access to medicines while managing uncertainty. A further group of MEA’s, far less common than these purely financial agreements, are performance-based contracts. Both financial MEA’s and performance-based MEA’s can be assessed either at the level of individual patients or at that of a given population. The Paper indicates that the experience with performance-based MEA’s is both limited and mixed. This is in large part due to the dearth of available information as few countries have formally assessed their experience with performance-based MEA’s. The Paper therefore relies on limited public sources and a number of expert interviews. Only Belgium and Sweden had independent evaluations conducted by third parties. The tentative conclusion of the Paper is that performance-based MEA’s have made only a limited contribution towards reducing uncertainty regarding product performance. This is why the Paper makes recommendations for good practices that make it more likely for performance-based MEA’s to reach their objectives. These are: i. to use performance-based MEA’s strategically and in the wider context of information derived from the use of other instruments such as horizon-scanning; ii. to identify uncertainties and design the performance-based MEA’s to address such uncertainties; iii. to create a governance framework that ensures transparency of process and guarantees that results are actually acted upon; iv. to ensure an appropriate level of transparency of content, even though some parts of the MEA’s, such as prices, may have to remain confidential. The Paper points out that countries could benefit from sharing information but very little information is at present published or shared. Still, the Paper cites approvingly a number of collaborative initiatives of the European Medicines Agency such as the EU-wide framework on patient registries or the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

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    • 13/01/2020
    • News

    Brussels Court of Appeal Confirms Infringement of Competition Rules by Professional Organisation of Pharmacists but Directs BCA to Recalculate Fine

    On 8 January 2020 the Market Court of the Brussels Court of Appeal confirmed a finding of the Belgian Competition Authority (“BCA”) that the professional organisation of pharmacists had infringed the competition rules. However, it also directed the BCA to recalculate the fine which is now expected to turn out significantly lower. Please find attached a note on the judgment as well as its text.

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    • 10/01/2020
    • Articles

    MEP Cindy Franssen Raises Important Questions Regarding Medicine Shortages in European Union

    Member of the European Parliament Cindy Franssen submitted to the European Commission (the “Commission”) a series of interesting questions regarding medicine shortages (see, attachment). Broadly, the questions probe for (i) possible violations of Directive 2001/83/EC if pharmaceutical firms “caus[e] shortages [of medicines] on the basis of commercial decisions”; (ii) the measures which the Commission plans to take to tackle shortages; and (iii) the proposals which the Commission intends to put forward in order to enhance local production of medicines. While some of these questions exhibit bias against the pharmaceutical industry, they are likely to prompt important answers from the Commission in relation to (i) the public service obligation associated with supplying medicines as contained in Article 81 of Directive 2001/83/EC; (ii) the initiatives which the Commission will take to address medicine shortages (see, Van Bael & Bellis Life Sciences Newsflash of 26 November 2019 and Van Bael & Bellis Life Sciences Newsflash of 11 September 2019); and (iii) calls made in various circles to make sure that the production of key pharmaceutical ingredients is moved to Europe (see for example, Van Bael & Bellis Life Sciences Newsflash of 9 July 2019).

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