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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    Chambers Europe

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  • 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.

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  • 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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Recent publications

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    • 12/04/2021
    • Articles

    European Union and South Korea Conclude Adequacy Talks

    On 30 March 2021, the European Commission and the Republic of Korea successfully concluded their negotiations on adequacy. An “adequacy finding” will enable free and safe data flows from the European Union to South Korea. The conclusion of the negotiations allows the European Commission to adopt an “adequacy finding” under Article 45.3 of the GDPR, confirming that South Korea’s Personal Information Act (PIPA) provides a comparable level of protection of personal data to European data protection laws. Such an “adequacy finding” will cover both private and public sector data controllers established in South Korea. The negotiations on adequacy were initiated in the context of the Free Trade Agreement that was concluded between the European Union and Korea. Within the framework of these negotiations, South Korea has enacted a series of reforms to its data protection laws. For instance, South Korea committed to implementing additional safeguards to protect European citizens’ personal data (e.g., introducing the concept of “pseudonymised information”, as well as the “purpose limitation” principle) and streamlined South Korea’s data protection regulatory authorities to one authority, while previously data protection breaches and issues were handled by multiple agencies. These new rules will be binding on companies importing data from the European Union and enforceable by South Korea’s Personal Information Protection Commission (PIPC). The European Commission will now launch the procedure for the adoption of a formal adequacy decision. This involves obtaining an opinion from the European Data Protection Board and approval by a committee composed of representatives of the EU Member States. Once the formal decision has been adopted, personal data can flow freely from the EU Member States to South Korea without any further safeguards or authorisations such as binding corporate rules and contractual clauses.

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    • 09/04/2021
    • Articles

    Conclusion of Pharmaceutical Pricing Investigation in Austria

    On 2 April 2021, the Austrian competition authority accepted commitments and closed its case concerning pricing strategies alleged to unlawfully hinder entry by generic competitors. More specifically, the pricing strategies in question involved special offers to hospitals of below-cost prices or free products, with higher prices charged for supply to community pharmacies. The attached note provides a summary of the case.

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    • 02/04/2021
    • Articles

    European Commission Starts Revising Pharmaceutical Legislation and Publishes Evaluation Roadmap and Inception Impact Assessment

    Earlier this week, the European Commission (the Commission) started the process of revising the general pharmaceutical legislation – Directive 2001/83/EC and Regulation (EC) 726/2004 - which it labels as one of the flagships of the Pharmaceutical Strategy for Europe (PSE) (see, Van Bael Bellis Life Sciences News Alert of 26 November 2020). Both the general public and the stakeholders are invited to submit their views on the “Combined Evaluation Roadmap/Inception Impact Assessment” (see, attachment). The Commission is seeking contributions on the broad range of issues covered by the PSE such as (i) unmet medical needs in areas outside the scope of the rules governing rare diseases and paediatric medicines; (ii) unequal access to affordable medicines; (iii) new technologies, including genomic sequencing, genome editing, artificial intelligence and medication based on genetically modified organisms; (iv) simplification of applicable rules and procedures; (v) vulnerable supply chains, security of supply and shortages; (vi) competition issues, including the role played by generics and biosimilar products; (vii) incentives designed to stimulate innovation; and (viii) antimicrobials. This initial public assessment started on 30 March 2021 and will end on 27 April 2021. A more thorough public consultation featuring targeted questions will be held in the fourth quarter of 2021. The Commission plans to propose draft legislation one year later in the fourth quarter of 2022.

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