News & Insights

  • 29/06/2021
  • News

Van Bael & Bellis awarded triple ISO certification as an Integrated Management System

Van Bael & Bellis is pleased to announce that the firm has been awarded the ISO 9001, ISO 22301 and ISO 27001 certificates. This achievement demonstrates the firm’s dedication to ensuring compliance with the highest standards of cybersecurity, business continuity and quality management. Van Bael & Bellis is the first European law firm that has obtained all three certificates thereby showing once again the firm’s commitment to providing optimal legal services to its clients. Van Bael & Bellis Managing Partner Philippe De Baere commented: “Meeting our client’s needs has always been our top priority. Clients expect not only that we provide them with the best legal advice but also that they can trust that their data are secure and our systems are robust. ISO certification offers them the confidence that we have in place the systems and processes necessary to ensure the efficiency, resilience and security of our services.” The external auditing of our implementation of these standards was conducted by Brand Compliance B.V. who presented us with certificates of recognition on 28 June 2021. For further information please contact Thibaut D’hulst _____________ About the ISO Standards 1. ISO 9001:2015 The Quality Management Standard ISO 9001:2015 is based on seven quality management principles that can be used by top management to lead an organization towards improved performance. It is the world’s foremost quality management standard, used by hundreds of thousands of organizations in over 170 countries around the globe. It sets out the essential requirements for a practical and effective quality management system (QMS) which is, in essence, a system for minimising risk and maximising opportunity. ISO 9001 sets out seven key principles of quality management: • Customer focus • Leadership • Engagement of people • Process approach • Improvement • Evidence-based decision making • Relationship management These seven principles are not auditable, but are fundamental attributes of any quality management system. ISO 9001 is based on the PDCA cycle – Plan-Do-Check-Act – and its key elements are: • Establishing the quality management system • Documenting the system • Implementing the system • Reviewing the results • Maintaining the system • Improving the system. 2. ISO 27001:2017 Implementation of Information Security Management System The worldwide international standard for information security: ISO 27001 sets out the auditable specification for an information security management system (ISMS). An ISMS is a set of policies, procedures, processes and systems that manage information risks, such as cyber attacks, hacks, data leaks or theft. The standard adopts a best practice approach and helps organizations manage their information security by addressing people, processes and technology. Certification to the standard is recognized worldwide as an indication that an organization has put in place an ISMS aligned with information security best practice, enabling it to avoid the potentially devastating financial losses caused by data breaches, and helping to protect information in line with regulatory requirements such as the EU General Data Protection Regulation (GDPR). This standard is a framework that helps organizations “establish, implement, operate, monitor, review, maintain and continually improve an ISMS”. It helps businesses become more productive through, for instance, clearly setting out who is responsible for information risk. It ensures that the systems organizations put in place are effective, reliable and auditable. In so doing, the certification to the standard protects and enhances an organization’s reputation. 3. ISO 22301:2019 Business Continuity ISO 22301 is the international standard for implementing and maintaining effective business continuity plans, systems and processes. This standard specifies requirements to implement a management system that allows an organization not only to deal with disruptions to business when and howsoever they arise, but also reduce the likelihood of their occurrence through enhancing an organization’s resilience.

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    • 21/09/2021
    • News

    European Commission Announces Interim Measures to Avert Possibly Irreversible Consequences of Grail's Acquisition by Illumina

    Less than a month ago, the European Commission (the Commission) announced that it would open an investigation to determine whether Illumina’s decision to acquire Grail pending its 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 (see, Van Bael & Bellis Life Sciences News & Insights of 24 August 2021). The Commission has now raised the stakes by issuing a Statement of Objections against Illumina in which it threatens to adopt interim measures designed, in the Commission’s words, to “prevent the potentially irreparable detrimental impact of the transaction on competition, as well as [the] possible irreversible integration of the merging parties, pending the outcome of the Commission's merger investigation” (see, attached press release of 20 September 2021). The Commission took pains to point out that Illumina’s autonomous decision to keep Grail separate following its acquisition (and thus avoid the possibly irreversible consequences which the Commission professes to avert) was not sufficient and presented several “serious shortcomings”. It also insisted that any adoption of interim measures would not preclude a possible later finding on the merits that Illumina’s conduct was in violation of the standstill obligation. The new hostilities come against the background of the Commission’s controversial assertion of merger control jurisdiction over the Illumina-Grail transaction which Illumina challenged before the European General Court.

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    • 20/09/2021
    • Articles

    Propuesta de la Comisión Europea de un Reglamento por el que se establece un Mecanismo de Ajuste en Frontera por Carbono (“MAFC”)

    El 14 de julio de 2021, como parte del paquete de medidas “Objetivo 55”, la Comisión Europea publicó una propuesta de reglamento por el que se establece un Mecanismo de Ajuste en Frontera por Carbono (“MAFC” o “CBAM”, por sus siglas en inglés). Esta alerta resume los principales elementos de la propuesta de la Comisión.

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    • 20/09/2021
    • Articles

    The EU Carbon Border Adjustment Mechanism in Seven Questions for MENA Industries

    On 14 July 2021, the European Commission published a proposal for a regulation establishing a carbon border adjustment mechanism (“CBAM”). The proposed regulation is part of the European Union’s (“EU”) initiatives to address climate change, in line with the objectives of the Paris Agreement.

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    • 20/09/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 8

    The August 2021 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.

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    • 17/09/2021
    • Articles

    European Commission Launches European Health Emergency Preparedness and Response Authority

    On 16 September 2021, the European Commission (the Commission) decided to establish the European Health Emergency Preparedness and Response Authority (HERA) which will seek to prevent, detect, and respond to health emergencies and will complement the work carried out by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). However, unlike these autonomous agencies, HERA will be created as a Commission service, headed by a Director-General, and will therefore remain under its control. As such, it will form an important part of the emerging European Health Union (see, Van Bael & Bellis Life Sciences News & Insights of 30 June 2021, 19 February 2021, and 12 November 2020). According to Article 2 of the Commission Decision establishing HERA, the new service will be given a range of tasks, including assessing health threats and ensuring directly or indirectly the research, development, production, procurement, distribution, stockpiling and knowledge building in relation to what are referred to as “medical countermeasures” (MCM). MCM are products used to face serious health threats and include antibiotics, chemical antidotes, diagnostic tests, medical equipment, personal protective equipment, therapeutics and vaccines. In addition to the decision establishing HERA, the Commission also tabled a proposed Regulation “on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level”. While HERA will be a Commission service, its board will consist of one representative of each Member State. In a move unlikely to meet with a warm welcome, the European Parliament will only be invited to designate an observer to the HERA board and will thus be placed on an equal footing with several specialised EU agencies and bodies. HERA will rely on a budget of EUR 6 billion from the current Multiannual Financial Framework for the period covering 2022-2027, but other EU programmes will also make contributions, thus causing the total European support to reach an estimated EUR 30 billion. The Commission points out that the project’s firing power will even be larger as a result of additional Member State initiatives and private sector ventures. The attached extensive documentation includes a (i) Commission press release; (ii) Commission questions and answers file; (iii) Commission Communication on the subject; (iv) annex to the Communication; (v) Commission decision establishing HERA; and (vi) proposed Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.

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    • 10/09/2021
    • Articles

    Belgium Prepares to Implement Regulation (EU) 2019/6 on Veterinary Medicinal Products

    Earlier this week, Belgian plans for implementing Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC (the Vet Reg) were made partially publicly available pursuant to the notification procedure governing possible technical barriers to trade provided for by Directive (EU) 2015/1535. This Technical Regulation Information System or “TRIS” procedure allows both the European Commission and the EU Member States to review before their adoption technical regulations which Member States intend to introduce for products and Information Society services. The TRIS procedure thus created a mechanism to increase the likelihood that the proposed texts are compatible with EU law, including the Internal Market principles. The European Commission’s TRIS platform now displays the text of a draft Law governing veterinary medicinal products (“Voorontwerp van Wet betreffende diergeneesmiddelen”/“Avant-projet de loi sur les médicaments vétérinaires” – the Draft Vet Law – see, attached Dutch and French versions) which will be submitted to Parliament and is intended to apply on 28 January 2022, the date of application of the Vet Reg. As a Regulation the Vet Reg is directly applicable in EU Member States and, theoretically, does not require national implementation. However, as was the case for many Regulations across diverse fields of law, implementing measures also proved necessary for the Vet Reg. Accordingly, the Draft Vet Law contains an extensive set of detailed rules and provides for the prospect of even more elaborate implementing rules that will be enacted by Royal Decree. The Draft Vet Law regulates a set of important issues, including clinical trials with veterinary medicinal products; marketing authorisations; post marketing authorisation measures; pharmacovigilance; the manufacturing, preparation, importation and exportation of veterinary medicinal products; wholesale and retail trade, including sales at a distance; parallel trade; publicity; inspection, supervision and criminal penalties; administrative settlements; and the processing of inspection data. As a result of the Draft Vet Law, the Law of 25 March 1964 governing medicines will no longer apply to veterinary medicinal products and is for that reason made subject to a lot of modifications.

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    • 09/09/2021
    • Articles

    Case C-741/19: The CJEU decides that intra-EU ECT arbitration is incompatible with EU law and interprets the definition of “investment” in the ECT

    On 2 September 2021, in its judgment in Case C-741/19, Republic of Moldova v. Komstroy LLC, the Court of Justice of the European Union (“CJEU”) decided that intra-EU arbitration under the Energy Charter Treaty (“ECT”) is incompatible with EU law. It also gave a restrictive interpretation to the definition of “investment” in the ECT.

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