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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    • 16/09/2020
    • Articles

    US President Signs Another Executive Order Implementing International Pricing Index Model

    On 13 September 2020, the US President signed another executive order (the New Order) implementing an international pricing index model (see, attachment). At the same time, he revoked an earlier such order signed at the end of July 2020 (see, Van Bael & Bellis Life Sciences News Alert of 28 July 2020). The New Order is more a political manifesto than a set of technical rules. It once more bemoans the allegedly unfair price differences for many prescription medicines between the US and other developed nations and posits that US citizens are thus “subsidizing innovation and lower-cost drugs for the rest of the world”. Additionally, the New Order expresses concern about access to medicines in that “high drug prices in the United States also have serious economic and health consequences for patients in need of treatment”. The New Order seeks to remedy these problems in similar fashion to what the July order tried to achieve and dictates that the price of qualifying medicines should not exceed that of the most-favoured nation price (MFNP) for these medicines. The MFNP is defined as the “lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the Organisation for Economic Co-operation and Development (OECD) that has a comparable per-capita gross domestic product.” On that basis, the Secretary of Health and Human Services is directed to develop and test a payment model which implements the MFNP for two categories of medicines. Critics were quick to point out that the elaboration of a payment model does nothing more than signaling the start of a potentially lengthy administrative process. Still, developed nations are again at the receiving end of a strong message that prices for medicines in overseas markets that were developed in the US are likely to go up rather than down, regardless of their actual development costs.

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    • 10/09/2020
    • Articles

    Court of Justice of European Union Is Asked to Rule on Rebranding of Parallel Imported Generic Medicines as Branded Medicines

    Attached is a note discussing two Belgian references for a preliminary ruling seeking clarification from the Court of Justice of the European Union regarding the rebranding of parallel imported generic medicines with the name of the originator reference product. A judgment is due in 2021.

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    • 09/09/2020
    • Articles

    French Competition Authority - Genentech, Novartis and Roche Fined EUR 444 million in Saga Involving Wet Age-Related Macular Degeneration

    The French Competition Authority (Autorité de la concurrence or AdC) imposed this morning a fine of EUR 444 million on Genentech, Novartis and Roche on account of the abuse of a collective dominant position in relation to the treatment of wet age-related macular degeneration (AMD) (see, attached French and English versions of press release as well as decision). The AdC thus took an unusual and audacious approach to tackle conduct which the Italian competition authority and courts, with the blessing of the Court of Justice of the European Union (CJEU), had penalised earlier under anti-collusion rules (see, Van Bael & Bellis Life Sciences News Alert of 24 January 2018). Genentech, a Roche subsidiary, developed two medicines from related active substances. The first, Avastin® (bevacizumab), was granted a marketing authorisation (MA) for oncological indications. The second, Lucentis® (ranibizumab), was developed later and was granted an MA specifically for the treatment of ophthalmological conditions such as macular degeneration and glaucoma. However, physicians gradually started to prescribe Avastin® for the treatment of eye conditions. Many health authorities permitted, and later encouraged, this “off-label” use, even after Lucentis® had received its own MA and obtained reimbursement for an ophthalmological indication. In Europe, Genentech licensed out commercialisation rights in Avastin® to Roche, while it granted similar rights in Lucentis® to Novartis. Lucentis® was priced many times higher than Avastin®. Collective dominant position According to the AdC, Genentech, Novartis and Roche had to be considered as a single entity (“une entité collective”) for purposes of applying the competition rules. AdC based its findings on the licensing agreements existing between the parties and the shareholdings between some of them. This is because Novartis holds a non-controlling 33,33% stake in Roche which, in turn, controls Genentech (Roche had 60% of Genentech’s shares until 2009 when it acquired all of that company’s shares) (see, chart at p. 5 of the press release and p. 43 of the decision). The finding of collective dominance by the AdC allowed it to dispense with the search for evidence of collusive conduct among the parties, a path which the Italian authorities had pursued. The three defendants were now regarded as a monolithic entity which the AdC found to be dominant on the French market for the treatment of AMD. The next step was for the AdC to demonstrate abuses of that dominant position by this entity. Abusive conduct The defendants were collectively found guilty of two sets of abusive conduct. First, Novartis mounted a communication campaign targeting ophthalmologists, including key opinion leaders, to explain that Avastin® should not be used for treating eye diseases at the expense of Lucentis®. According to the AdC, this campaign did not amount to a bona fide presentation of Avastin® in the interest of public health, but was rather a self-serving tactic discrediting Avastin® and stoking fears over its use in the ophthalmological field. AdC maintains that the campaign of Novartis was successful and reduced the off-label prescriptions of the product. Second, the three defendants were also found to have directed a series of misleading and “alarmist” messages at various public authorities, thus delaying a critical head-to-head trial comparing Avastin® and Lucentis® and at one point securing the prohibition of the off-label use of Avastin®. Regulatory angle Separately and earlier, the reimbursement of Avastin® for an ophthalmological application not covered by that product’s MA formed the subject of a distinct strand of litigation and also culminated in a judgment of the CJEU which held that under EU law national healthcare insurance systems are allowed to reimburse a medicine for off-label use (see, Van Bael & Bellis Life Sciences News Alert of 21 November 2018).

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