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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    • 01/07/2020
    • News

    Suspension of the notice period during temporary unemployment due to Covid-19 force majeure

    On 22 June 2020, the law aiming to suspend notice periods notified by the employer before or during temporary unemployment due to Covid-19 force majeure (Wet tot opschorting van de opzeggingstermijn voor ontslagen gegeven voor of tijdens de periode van tijdelijke schorsing van de uitvoering van de arbeidsovereenkomst omwille van overmacht ingevolge de COVID-19-crisis / Loi visant à suspendre les délais de préavis des congés donnés avant ou durant la période de suspension temporaire de l’exécution du contrat de travail pour cause de force majeure en raison de la crise du COVID-19) was published in the Belgian Official Journal (the Law).

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    • 26/06/2020
    • News

    Novartis Settles Bribery Charges under Foreign Corrupt Practices Act in Relation to Medicine-Related Conduct in Greece

    Novartis AG, its subsidiary Novartis Hellas S.A.C.I., and its former subsidiary Alcon Pte Ltd (together Novartis) have agreed to pay total fines in excess of US $ 345 million to settle cases started by the US Department of Justice (the DOJ) and the US Securities and Exchange Commission (the SEC) under the US Foreign Corrupt Practices Act (FCPA) (see, attached press releases of 25 June 2020). A significant part of the practices alleged to be in violation of the FCPA took place in Greece. Novartis was under investigation because it had made illicit payments to employees of state-owned or state-controlled health institutions in Greece and had also mischaracterised and falsely recorded these payments in its company books and accounts. For the US agencies, these payments amounted to bribery and their false characterisation as an attempt to cover up a crime. The case serves as a reminder that conduct in Europe engaged in by a European firm and possibly in violation of European pharmaceutical and anti-bribery rules may also give rise to extensive exposure under US anti-corruption laws. Novartis admitted that, between 2012 and 2015, it bribed healthcare professionals in Greece in an attempt to increase the sale of Novartis-branded pharmaceutical products. Specifically, Novartis allowed healthcare professionals to travel overseas to medical congresses, including events held in the United States, in exchange for an assurance that these healthcare professionals would augment the number of prescriptions for Lucentis, a prescription-only ophthalmological medicine. Novartis also admitted that, between 2009 and 2010, it made improper payments to healthcare professionals in connection with an epidemiological study that was intended to increase sales of Novartis-branded prescription medicines. Novartis staff recognised that many participating healthcare professionals understood that they were being paid in exchange for writing prescriptions of Novartis products and not for supplying data as part of a clinical study.

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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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    • 09/07/2020
    • Articles

    Court of Justice of European Union Is Asked Preliminary Questions on Application of Falsified Medicines

    Attached is a note discussing a German reference for a preliminary ruling seeking clarification from the Court of Justice of the European Union regarding the application of the Falsified Medicines Directive to parallel-traded medicines. A judgment is due in 2021.

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    • 07/07/2020
    • Articles

    European Commission Reviews First Two Years of GDPR: A Success Story with Room for Improvement

    On 24 June 2020, the European Commission has published its first report on the General Data Protection Regulation (the GDPR) which has applied in the EU since May 2018. Overall, the Commission considers the GDPR to be a success story, but, at the same time, it identifies certain areas where there is room for improvement and the challenges that lie ahead. In particular, the Commission notes that the efficient and coordinated enforcement of the GDPR among all Member States is of paramount importance. Moreover, the application of the GDPR to new technologies, such as artificial intelligence and blockchain, requires continuous monitoring. According to the Commission, the Covid-19 crisis has proved that the use of new technologies and data protection go hand in hand. Please click below for a note summarising the Commission’s report.

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    • 07/07/2020
    • Articles

    European Medicines Agencies Network Strategy to 2025

    The European Medicines Agency (EMA) and the national competent authorities (NCAs) of the 27 EU Member States in addition to those of Iceland, Liechtenstein and Norway presented on 6 July 2020 a proposed network strategy for tackling healthcare challenges in a rapidly evolving environment (see, attachment). The strategy is supposed to apply until 2025 and stakeholders are invited to submit their comments in response to an online questionnaire by 4 September 2020.

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