Corporate, Commercial & Regulatory

Impressive depth of specialised experience

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

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

    Chambers Europe

Latest news

Sign up for updates
    • 15/07/2022
    • News

    European Commission Publishes Proposal for Regulation on Substances of Human Origin

    On 14 July 2022, the European Commission (the Commission) published its long-awaited Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (COM(2022) 338 final; the proposed Regulation) and an accompanying Q&A document (see, attachments). The proposed Regulation updates the current regulatory framework to improve safety and quality standards applicable to substances of human origin (so-called SoHOs). SoHOs include blood, tissues, cells and any other substances of human origin like human breast milk and microbiota. SoHOs can be directly intended for human application but can also be used in preparations or in manufactured products. Article 2 of the proposed Regulation provides for a list of “SoHO activities” that fall within the scope of the proposed Regulation. The list includes activities such as donor recruitment, processing of SoHOs, distribution, import and export of SoHOs and human application of SoHOs.   The proposed Regulation will apply to all SoHOs. Only solid organs used for transplantation will remain regulated separately under the Organs Directive (Directive 2010/45/EU). In view of the broad definition of the term SoHOs, the proposed Regulation will be future-proof in the sense that it will automatically apply to new substances of human origin that can be applied to patients. A key aspect of the proposed Regulation is that it empowers the Commission to adopt implementing acts regarding patient, donor and offspring protection. However, in the absence of such implementing acts, “SoHO entities” (which are defined in Article 3(24) as “organisation[s] legally established in the Union that carr[y] out one or more of the SoHO activities”) will have to apply standards established by the European Centre for Disease Prevention and Control and the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe. The aim is to ensure that technical rules applicable to SoHO activities remain updated and to avert the accumulation of obsolete rules which would stand in the way of novel SoHO-based treatments and new medical techniques. For purposes of enforcement, the Commission devised a supervision mechanism based on national Competent Authorities. Chapters II and III of the proposed Regulation are dedicated to, respectively, “Competent Authorities” and “SoHO Supervisory Activities”. The rules enable extensive coordination between the different national Competent Authorities and the Commission. According to the Commission, increased harmonisation in the field of SoHO activities between EU countries could bring significant improvements in treatments such as stem, cornea, or skin transplants. Facilitated exchanges of SoHOs could even save lives, especially for conditions like blood cancer for which blood supply is of critical importance. The proposed Regulation will now be discussed by the Council and the European Parliament. Once the final text is agreed, adopted and published, most of the provisions will take effect after a transition period of two years.

    Read more
    • 20/06/2022
    • News

    European Commission Starts Competition Investigation against Vifor Pharma regarding Disparaging Statements Made against Rival's Medicine

    The European Commission (the Commission) announced today that it would investigate disparaging statements made by Vifor Pharma, the marketing authorisation holder of Ferinject, an intravenous iron treatment medicine, regarding the safety of that product’s closest rival, Monofer, an intravenous iron treatment owned by Pharmacosmos. The Commission is of the opinion that these statements may amount to an abuse of dominant position contrary to Article 102, Treaty on the Functioning of the European Union. The statements allegedly formed part of a communication campaign that targeted healthcare professionals and created obstacles to the uptake of Monofer in the European Union and the United Kingdom where the parties appear to have had a a long-standing dispute about code-of-practice violations dating back to 2011. Competition authorities have repeatedly pursued parties in an allegedly dominant position over deprecating statements made regarding competing products. Such statements often seek to create doubts regarding the targeted medicine’s safety, obviously a sensitive subject in the healthcare sector. In March 2021, the Commission had already started a similar case against Teva (Van Bael & Bellis Life Sciences News and Insights, 5 March 2021). In France, enforcement actions by the French competition authority, confirmed on at least two occasions following judicial review, gave rise to fines against Reckitt Benckiser, Janssen-Cilag (Van Bael & Bellis Life Sciences News and Insights, 26 December 2017 and 8 June 2022), and Genentech, Novartis and Roche (Van Bael & Bellis Life Sciences News and Insights, 9 September 2020).

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *

Get in touch

Please fill out the form below along with your query and someone from the team will get back to you. Alternatively you can email [email protected]

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

Team focus

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

Get in touch with our Commercial, Regulatory and Transactions teams today

Recent publications

Sign up for updates
    • 05/08/2022
    • Newsletters

    VBB on Belgian Business Law, Volume 2022, No. 07

    The July 2022 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

    Read more
    • 20/07/2022
    • Newsletters

    VBB on Belgian Business Law, Volume 2022, No. 06

    The June 2022 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

    Read more
    • 19/07/2022
    • Articles

    European Commission Continues to Pursue "Gun Jumping" Merger Control Proceedings against Illumina and Grail

    On 20 August 2021, the European Commission (the Commission) said that it would investigate whether Illumina’s decision, made public on 18 August 2021, to acquire Grail pending the Commission’s review of that transaction under Regulation 139/2004 on the control of concentrations between undertakings (the Merger Regulation) is in breach of the “standstill obligation” provided for by Article 7, Merger Regulation. Pursuant to this provision, a concentration notifiable under the Merger Regulation must not be implemented until after the Commission has approved it (see, Van Bael & Bellis Life Sciences News and Insights of 24 August 2021).

    Read more
Keep updated Sign up for VBB insights

Be the first amongst your peers to get the latest publications and insights in Corporate, Commercial & Regulatory law.