Corporate, Commercial & Regulatory

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Van Bael & Bellis advises multinational clients on corporate, commercial and regulatory issues in the EU and Belgium.

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  • "The lawyers are excellent; very responsive and to the point."

    Chambers Europe

Latest news

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    • 06/12/2018
    • News

    Andreas Reindl speaks at conference on diversity and inclusion in the legal profession in Brussels

    On 4 December 2018, Van Bael & Bellis senior counsel Andreas Reindl spoke at a conference titled Diversity & Inclusion in the Legal Profession: Exchanging Ideas, Sharing Experiences, and Developing a Strategy for Europe organised by the Institute for Inclusion in the Legal Profession and held in Brussels. Andreas participated in a panel discussion on what law firms in Europe are doing to address diversity and inclusion issues, what particular challenges they face and how they are handling them. Other members of the panel were Harry Small (Baker McKenzie), Etienne Dessy (Linklaters), Vanessa Turner (Allen & Overy) and Kathleen Vercraeye (Past President of the Dutch-speaking Brussels Bar). The panel was moderated by Luisa Menezes (Philip Morris International).

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    • 16/11/2018
    • News

    Jean-François Bellis moderates panel at LeadershIP EU’s 2nd annual conference in Brussels

    On 13 November 2018, Van Bael & Bellis co-managing partner Jean-François Bellis moderated a panel at LeadershIP EU’s 2nd annual conference, which explored the impact of IP and competition policy on global business and innovation looking toward the future, 5G and emerging technologies. The panel was titled Effects-Based Analysis: Where Do We Stand on Both Sides of the Atlantic? and the discussion focused on the competition law trends in the US and the EU in the area of effects-based analysis. The other panel members were the Honourable Douglas Ginsburg, Senior Circuit Judge, US Court of Appeals for the District of Columbia and Sir Robin Jacob, Sir Hugh Laddie Chair of Intellectual Property Law, University College London and Former Justice in the Court of Appeal of England and Wales. Further details about the conference are available here.

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Recommendations

  • The quality of the advice is great - we have been asking some complex questions and they have given clear and to-the-point advice and have been very proactive in providing alternative solutions.

    Chambers Europe
  • Van Bael & Bellis has ‘impressive knowledge of dispute resolution, including mediation’. The firm is notable for its strong regulatory and administrative law contentious practice as well as its impressive life sciences sector presence.

    Legal 500
  • They patiently try to understand the mentality of people in different cultures and pay full respect to that. This attitude is rare in a highly expert world. We are fully satisfied with their practice and the results therefrom.

    IFLR1000
  • They are very responsive, and experienced in pharma and compliance-related matters. They always indicate the timelines of the work they do and keep the client informed on the status of the work.

    Chambers Europe

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Van Bael & Bellis is well known for its client-centred approach, commitment to excellence, exceptional client service and personalised attention.

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Recent publications

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    • 03/12/2018
    • Articles

    Five Further Member State Inspectorates Recognised under EU - US Mutual Recognition System for Medicines

    The Agreement on Mutual Recognition between the European Union and the United States of America continues its roll-out in the realm of pharmaceutical inspections. On two separate occasions in November 2018, the US Food and Drug Administration (“FDA”) added 5 new EU Member States to its list of countries which it considers to have capable inspectorates to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that observed in the US. These Member States are Belgium, Denmark, Estonia, Finland and Latvia. The updated list of in total 20 Member States whose inspection results the FDA considers can replace its own inspections can be found here: https://www.fda.gov/internationalprograms/agreements/ucm598735.htm. The EU and the US thus seem to be on track to have all EU Member States recognised as capable of carrying out pharmaceutical inspections by 15 July 2019. For its part, the FDA had already been earmarked as a capable inspectorate on 1 November 2017.

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    • 30/11/2018
    • Articles

    OECD - Pharmaceutical Innovation and Access to Medicines

    The Organisation for Economic Cooperation and Development (“OECD”) has just published a study on Pharmaceutical Innovation and Access to Medicines (the “Study” - available here: Pharmaceutical Innovation and Access to Medicines). The Study forms a response to a request by 35 member countries to prepare a report detailing the challenges for governments in ensuring that their populations have access to novel medicines at a reasonable cost while at the same time maintaining the pharmaceutical sector’s capacity for innovation.

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    • 22/11/2018
    • Articles

    "National Healthcare Insurance Systems Are Allowed To Reimburse Off-Label Use of Medicine" Says ECJ

    The Court of Justice of the European Union (“ECJ”) held this morning that under EU law national healthcare insurance systems are allowed to reimburse a medicine for a use not covered by that product’s marketing authorisation (see attached – Case C-29/17, Novartis and others v. Agenzia Italiana del Farmaco and others, judgment of 21 November 2018). The ECJ’s judgment came at the request of the Italian Council of State which had been asked to handle litigation between Novartis and various Italian health authorities over the reimbursement of Avastin for off-label use in the management of the eye-condition wet age-related macular degeneration (“AMD”).

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