Overview

Catherine Longeval specialises in dispute resolution, both before the Belgian courts and before arbitral tribunals (mainly CEPANI). She advises clients on a wide range of issues, including life sciences law. Her expertise in this area covers laws governing medicines, biotech products, medical devices, cosmetics and food supplements, among other aspects.

She also specialises in unfair market practices, distribution law, product liability, public procurement, employment law and general commercial law.

Catherine began her professional career in October 1989. Prior to joining Van Bael & Bellis in 1994, she worked as an associate with a leading Brussels law firm. 

She regularly lectures and writes on life sciences regulatory matters and procedural law matters. She often speaks at conferences.

Languages

Dutch, English, French, German (passive knowledge)

Recommendations

  • Chambers Global and Chambers Europe for Dispute Resolution
  • Chambers Europe – ‘Leaders In Their Field’ (Dispute Resolution) 
  • Expert Guides – Guide to the World’s Leading Litigation Lawyers
  • PLC for EU Life Sciences – Regulatory
  • PLC for EU Life Sciences – Competition/Anti-trust
  • PLC for Dispute Resolution 
  • PLC for Belgium Life Sciences – Regulatory
  • Legal 500 for Employment law
  • Legal 500 for Dispute Resolution
  • European Legal Experts for Litigation
  • Who’s Who Legal for Life Sciences
  • LMG Life Sciences (Europe) – Life Sciences Star
  • Best Lawyers – Litigation  

Education

  • University of Brussels (ULB), Master of Laws, 1989 
  • University of Leuven, Master of Laws, 1987

Publications

Contributor to Van Bael & Bellis' Business Law Guide to Belgium (Kluwer Law International/Bruylant, 2003).

Co-author of PLC's Life Sciences Handbook, Chambers' Pharmaceutical Advertising Guide, and dispute resolution section of Chambers' Litigation guide. 

Professional Memberships

Member of CEPINA (Belgian Centre for Mediation and Arbitration)
Member of the Brussels Pharma Law Group
Member of the European Employment Lawyers Association
Member of the International Bar Association

Bar Admission

Brussels

Notable assignments

  • Representing a global pharmaceutical company in the context of “extreme urgency” suspension proceedings before the Council of State, aimed at the suspension and annulment of a tender decision of the Office de la Naissance et de l’Enfance (ONE) granted in favour of a competitor of our client.

  • Representing a global logistics company in proceedings initiated by an international organisation and the Belgian State following our client’s attachment of assets in a case which raises complex issues under international and procedural law.

Publications and insights

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    • 16/05/2022
    • Articles

    Belgium - In Enforcement Priority Note for 2022, Pharmaceutical Industry is Again Target of Belgian Competition Authority

    The Belgian Competition Authority (BCA) has just published its enforcement priority note for 2022 (see, attachments). In keeping with its list of priorities in previous years and in tandem with the approach taken by fellow competition authorities, including the Dutch "Autoriteit Consument & Markt", the BCA will continue to have the pharmaceutical industry in the crosshairs and makes it clear that its vigilance and efforts apply to the entire value chain. As if to remind stakeholders that it means business, the BCA refers to recent enforcement action against pharmaceutical wholesalers (see, Van Bael & Bellis Life Sciences News and Insights of 18 February 2022). While this “hybrid” settlement case resulted in a fine of EUR 29.8 million for pharmaceutical wholesaler Pharma Belgium-Belmedis, the BCA continues to pursue proceedings against another wholesaler, CERP, which refused to settle. The BCA is also understood to handle cases involving excessive pricing and access to the hospital market. Of broader interest than the pharmaceutical industry is the BCA’s announcement that its budget will benefit from an increase of EUR 1.4 million (20%). The additional funds are earmarked for staff expansion, IT, knowledge management, and enforcement tools such as e-discovery and whistle blowers.

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    • 04/05/2022
    • Articles

    European Commission Launches European Health Data Space

    On 3 May 2022, the European Commission (the Commission) launched the European Health Data Space (EHDS), the European Union’s first sector-specific set of rules pursuant to its 2020 European data strategy. The EHDS, as expressed in the proposed Regulation on the European Health Data Space (COM(2022) 197 final) and in an associated Commission Communication (COM(2022) 196 final), has two principal components: • primary use of electronic health data, i.e., rules to improve access to and control by natural persons over their personal electronic health data in healthcare; and • secondary use of electronic health data, i.e., rules to broaden the use of health data for the benefit of society at large in areas as diverse as research, innovation, policy-making, patient safety, personalised medicine, statistics and regulatory activities. Under the primary use of electronic health data individuals will have easy and free of charge access to their own health data for purposes of data management and sharing the data with healthcare professionals (HCP) in and across Member States in the language of the HCP. Files such as ePrescriptions, images, and laboratory results will be created and accepted in a common European format and will be stored and transferred in a safe environment. The rights of the individuals will be guaranteed by a new digital health authority in each Member State and each such authority will participate in [email protected], a central platform for digital health that will support and facilitate the exchange of electronic health data between Member State contact points for digital health. The secondary use of electronic health data will boost the access to and utilisation of health data for research and other purposes of benefit to society. Access will be subject to a permit to be delivered by a newly created health data access body which will ensure that the data is used only for defined purposes in a close and secure environment. The identity of individuals will not be revealed, and specific types of data usage will be prohibited. Examples include taking decisions to exclude individuals or groups of natural persons from insurance coverage and engaging in advertising activities that target HCPs, health organisations or individuals. The health data access bodies will be connected to [email protected], a new European facility that creates a link between national contact points and the central platform specifically for the secondary use of electronic health data. The principal documents that embody the EHDS are attached and include the proposed Regulation, the Commission Communication, a Commission press release and a set of questions and answers.

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    • 14/04/2022
    • Articles

    European Commission Updates Q&A on EU Clinical Trials Regulation

    On 13 April 2022, the European Commission published an updated version of its Q&A on the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR) (see, attached copy). The updated Q&A forms part of Volume 10 (“Clinical trials guidelines”) of EudraLex and includes the following changes: • an updated answer to question 1.4: What document/data shall be submitted with an application? • an updated answer to question 1.5: How to proceed in case of discrepancies between the CTR and ICH Good clinical practice guidance? • an answer to new question 1.22: What are the legal warranties for the validity of decisions by tacit approval? • an answer to new question 1.23: Appeal and implementation of change of decision due to an appeal • an updated answer to question 5.8: What should be included in the protocol synopsis described in Annex I, D.24? • an answer to new question 6.5: What is the recommended strategy for the publication of trial documents with proprietary information? • an updated answer to question 11.10: What are the consequences of switching the regulatory framework applicable to a clinical trial? • an updated decision tree in Annex I to the Q&A to establish whether a study is a “clinical trial”. The CTR repealed and replaced the Clinical Trials Directive (i.e., Directive 2001/20/EC; the CTD) as from 31 January 2022. However, the CTD will continue to apply until 31 January 2025 to (i) clinical trial applications submitted before 31 January 2022; and (ii) clinical trial applications submitted between 31 January 2022 and 31 January 2023 in which the sponsor opts for the CTD system (see, Van Bael & Bellis Life Sciences News and Insights of 9 August 2021). Ensuring a greater level of harmonisation of the rules for conducting clinical trials throughout the EU, the CTR introduces an authorisation procedure based on a single submission and an assessment procedure leading to a single decision. At the heart of the CTR system is the Clinical Trial Information System (CTIS). Comprising an EU Portal and EU Database, CTIS ensures 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 data and information relating to clinical trials by the public (see, Van Bael & Bellis Life Sciences News and Insights of 11 October 2021).

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