Overview

Catherine Longeval specialises in litigation before the Belgian courts and 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, 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

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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    • 20/05/2019
    • Articles

    Medicine Shortages - Growing Pressure on European Commission To Take Action in Next Legislative Cycle

    On 17 May 2019, a broad group of organisations representing patients, consumers, healthcare professionals and public health advocates called on the European Commission to investigate medicine shortages and take appropriate action that complements the work undertaken by a joint task force of the heads of national medicine agencies and the European Medicines Agency (“EMA”) (see annex 1 - letter addressed to European Commissioner responsible for Health and Food safety Vytenis Andriukaitis and the Director General for Health and Food Safety, Anne Bucher). The initiative comes ahead of the European elections at the end of May 2019 which will create a new European Parliament but will also trigger the designation of a freshly composed European Commission. The letter advocates action “during the next legislative period”. The letter reflects the position of heavyweight organisations such as the European Association of Hospital Pharmacists which, in November 2018, published the results of a pan-European survey (1,666 responses from 38 countries) on medicine shortages in the hospital sector and listed the major challenges to be tackled (annex 2). It is the latest voice in a growing chorus of calls from various sectors in favour of action at the European level. For example, in early April 2019, the European Society for Medical Oncology, published its own set of “recommendations for the 2019-2024 legislative cycle”, including the adoption of legislation for early notification requirements for medicine shortages and the creation of catalogues of shortages (annex 3). Earlier, in February 2019, France’s pharmaceutical trade association Leem came out in favour of increased cooperation between national and European regulators to tackle what it described as a sharp increase in the number of medicines at risk of shortages (annex 4). According to Leem, in 2008 companies reported to the French medicines regulator ANSM 44 medicines of major therapeutic interest at risk of or experiencing shortages. That number grew to 538 in 2017. Leem attributes the shortages to an expanding global demand coupled with insufficient production capacity, as well as changes in production chains, controls and regulatory obligations. It supports an EU-wide effort to monitor shortages and also recommends a boost in the EU-based production of active pharmaceutical ingredients. Additionally, Leem backs improvements to hospital public procurement mechanisms and to the exchange of information between the various stakeholders in the medicine supply chain. Leem’s proposals follow in large part the findings of a report which the French Senate released in October 2018. The pressure on the incoming European Commission to put medicine shortages high on its list of priorities is considerable and is thrown into sharp relief by Member State initiatives such as that of Belgium which try and address medicine shortages at the local level (see, Van Bael & Bellis Life Sciences Newsflashes of 8 and 17 May 2019).

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    • 17/05/2019
    • Articles

    Belgium - Medicine Shortages - New Developments

    On 14 May 2019 the head of the Federal Agency for Medicines and Health Products (“FAMHP”), Xavier De Cuyper, sent a letter to all stakeholders in the pharmaceutical supply chain explaining his organisation’s view on the effects of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (the “Letter” - see attached). The Letter has since been published on the FAMHP website.   The Law of 7 April 2019 introduces a range of measures to reduce medicine shortages in Belgium (see, Van Bael & Bellis Life Sciences Newsflash of 8 May 2019). The Letter focuses on the practical consequences of the specific rule that limits the categories of customers to which a wholesaler (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) is allowed to supply. These groups of potential customers are (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules. As a result, WS with a public service WS status will no longer be able to sell medicines abroad.   The Letter highlights what FAMHP considers to be the following practical effects: Suppliers will no longer be able to refuse supplies to WS with a public-service WS status who will have to meet their public-service obligations in Belgium at all times and for that purpose require reliable and uninterrupted sources of medicines. The Letter stresses that FAMHP will monitor and enforce the supply obligation.  WS with a public-service WS status can no longer sell abroad. To the extent their owners want to continue pursuing export activities, these will have to act through a distinct legal entity that will require a separate WS licence. FAMHP will also monitor the obligation imposed on WS with a public-service WS status only to supply the limited categories of customers defined by law. The status of community pharmacists and hospital pharmacists does not change. Holders of marketing authorisations are required to report the unavailability of specific medicines. Additionally, WS with a public-service WS status and pharmacies are urged to report medicines that as a practical matter are not available even though they do not feature on the dedicated website of medicines reported as unavailable by the marketing authorisation holders.   The Letter addresses the status of ordinary WS only in passing (for example, by indicating – as noted – that ordinary WS will still be able to engage in export activities). In reality, the role and status of ordinary WS does not change under the Law of 7 April 2019.

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    • 08/05/2019
    • Articles

    Belgium - Medicine Shortages | Wholesaler-Distributors Curtailed

    Today’s Belgian Official Journal contains the text of the “Law of 7 April 2019 modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet tot wijziging van de wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft / Loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (the “Law”). The Law (i) allows the concept of “temporary cessation of supply of medicines” to be determined by Royal Decree; (ii) allows the Minister to make recommendations of suitable therapeutical alternatives in case of temporary shortages of specific medicines; (iii) allows wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) only to supply specific categories of clients, namely (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules; and (iv) imposes particular shortage-related obligations on parallel traders which previously only applied to the marketing authorisation holders. The Federal Agency for Medicines and Health Products has already announced implementing rules that will define the unavailability of a medicine and the period within which the orders of a WS with a public-service WS status will have to be supplied ( NL / FR ) The statutory limitation of the authorised categories of clients of WS with a public-service WS status (which are all based in Belgium and service the Belgian market) is designed to ensure the steady supply of medicines to the Belgian market and, conversely, cut down on exports that threaten public health. Under specific conditions, that limitation will not apply to medicines earmarked for clinical trials. To be sure, unlike WS with a public-service WS status, marketing authorisation holders and regular wholesalers will still be able to sell abroad. Lastly, the Law implements European rules that combat the trade in falsified medicines by creating criminal sanctions for specific violations of Regulation 2016/161 which lays down safety features for the packaging of medicines for human use.

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