Corporate, Commercial & Regulatory

Impressive depth of specialised experience

Van Bael & Bellis advises multinational clients on corporate, 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

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 Corporate, Commercial & Regulatory teams today

Recent publications

Sign up for updates
    • 21/01/2020
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 12

    The December 2019 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
    • 14/01/2020
    • Articles

    Advocate General Confirms Validity of EU Standard Contractual Clauses

    Advocate General Henrik Saugmandsgaard Øe recently delivered his opinion in the Facebook Ireland and Schrems case, (also known as the Schrems II case). The Advocate General states that the validity of the Commission Decision approving standard contractual clauses for the transfer of personal data (SCCs) cannot be called into question. At the same time, the Advocate General indicated that controllers and supervisory authorities have an obligation to suspend transfers on the basis of SCCs if the obligations contained in the clauses cannot be guaranteed under the laws of the data importer. Please click below for a short client memorandum on these guidelines.

    Read more
    • 14/01/2020
    • Articles

    OECD Makes Recommendations for Improvement of Performance-Based Managed Entry Agreements for Medicines

    The Organisation for Economic Co-operation and Development (“OECD”) published a health working paper (the “Paper”) authored by Martin Wenzl and Suzannah Chapman that offers recommendations for the use of performance-based managed entry agreements in OECD countries and EU Member States (see, attached). The Paper reflects the results of a review of managed entry agreements (“MEAs”) carried out in 2018 and 2019. MEAs are arrangements between healthcare payers and pharmaceutical firms that provide for the reimbursement of generally new health technologies, including medicines, while controlling the financial impact of that reimbursement and keeping price concessions confidential. These financial agreements are thus tools for achieving patient access to medicines while managing uncertainty. A further group of MEA’s, far less common than these purely financial agreements, are performance-based contracts. Both financial MEA’s and performance-based MEA’s can be assessed either at the level of individual patients or at that of a given population. The Paper indicates that the experience with performance-based MEA’s is both limited and mixed. This is in large part due to the dearth of available information as few countries have formally assessed their experience with performance-based MEA’s. The Paper therefore relies on limited public sources and a number of expert interviews. Only Belgium and Sweden had independent evaluations conducted by third parties. The tentative conclusion of the Paper is that performance-based MEA’s have made only a limited contribution towards reducing uncertainty regarding product performance. This is why the Paper makes recommendations for good practices that make it more likely for performance-based MEA’s to reach their objectives. These are: i. to use performance-based MEA’s strategically and in the wider context of information derived from the use of other instruments such as horizon-scanning; ii. to identify uncertainties and design the performance-based MEA’s to address such uncertainties; iii. to create a governance framework that ensures transparency of process and guarantees that results are actually acted upon; iv. to ensure an appropriate level of transparency of content, even though some parts of the MEA’s, such as prices, may have to remain confidential. The Paper points out that countries could benefit from sharing information but very little information is at present published or shared. Still, the Paper cites approvingly a number of collaborative initiatives of the European Medicines Agency such as the EU-wide framework on patient registries or the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

    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.