News & Insights

  • 19/10/2021
  • Books

Van Bael & Bellis’ Competition Law of the European Union, Sixth edition, receives high praise from Professor Nicolas Petit

Nicolas Petit, Professor at the European University Institute (EUI), describes the Sixth Edition of Van Bael & Bellis’ Competition Law of the European Union as "A great wine, “the” Van Bael & Bellis gets better edition after edition. The book dominates the competition by its clarity of exposition and comprehensive treatment of an ever changing field. A must read for all legal practitioners, academics and antitrust economists."

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    • 02/12/2021
    • Books

    Van Bael & Bellis partners Philippe De Baere, Clotilde du Parc and Isabelle Van Damme publish commentary on the WTO Anti-Dumping Agreement

    Publisher
    Cambridge University Press

    Cambridge University Press has just published “The WTO Anti-Dumping Agreement” authored by Van Bael & Bellis partners Philippe De Baere, Clotilde du Parc and Isabelle Van Damme. The book provides a unique article-by-article commentary on the WTO Anti-Dumping Agreement, offering an essential and comprehensive insight into WTO case law. This commentary is an indispensable reference tool for all those working in the area of anti-dumping. Experts in international trade law, the authors have all been involved in a large number of WTO disputes and have extensive experience in anti-dumping investigations and in challenging anti-dumping determinations before the WTO and before national courts. The book is available to order here.

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    • 30/11/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 10

    The October 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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    • 25/11/2021
    • Articles

    EDPB Explains Concept of International Transfers under GDPR and Discusses Interplay with Territorial

    On 19 November 2021, the European Data Protection Board (the EDPB) published Guidelines 05/2021 on the Interplay between the application of Article 3 and the provisions on international transfers as per Chapter V of the General Data Protection Regulation (the GDPR) (the Guidelines) for public consultation. The Guidelines are intended to clarify which international transfers of data fall within the scope of Chapter V of the GDPR and therefore require safeguards or other measures to ensure protection of the personal data that are being transferred. In addition, the EDPB calls on the European Commission to adopt a new set of Standard Contractual Clauses for cases where the importer established in a third country is already subject to the GDPR on the basis of the application of GDPR to non-EU based organisations under Article 3(2) of the GDPR. First, the Guidelines set out when a processing constitutes a “transfer of personal data to a third country or to an international organisation” (a Transfer) which triggers the application of the provisions of Chapter V of the GDPR. The Guidelines provide three cumulative criteria that, when satisfied, means a processing qualifies as a Transfer: thus, data must be sent or made available: (i) by a controller or a processor (i.e., an exporter), which, regarding the given processing, is subject to the GDPR pursuant to Article 3 (i.e., the territorial application of GDPR); (ii) to a different controller, joint controller or processor (i.e., an importer); (iii) which is in a third country, regardless of whether or not this importer is subject to the GDPR in respect of the given processing. The Guidelines further describe each criterion, providing some practical examples. Moreover, the Guidelines stress that Chapter V of the GDPR also applies to transfers or disclosures of personal data carried out by controllers or processors which are not established in the European Union (EU) but are subject to the GDPR pursuant to Article 3(2) because they: (a) offer goods or services to data subjects in the EU; or (b) monitor the behaviour of data subjects in the EU, to another controller or processor. By contrast, if the three cumulative criteria identified by the Guidelines are not met, there is no Transfer and Chapter V of the GDPR does not apply. For instance, the Guidelines explain that a situation whereby a controller in a third country collects data directly from data subjects in the EU does not constitute a Transfer. However, in such a case, the EDPB makes it clear that the controller or processor which is subject to the GDPR under Article 3 is still accountable for all processing that it controls, regardless of where such processing takes places, and that the risks of data processing in third countries must still be managed in order to comply with the GDPR. Second, the Guidelines outline that where all the above criteria are met, the processing will be considered to be a Transfer and the exporter must comply with the conditions laid down in Chapter V of the GDPR. This means that the controller or processor must use the instruments that aim to protect personal data after they have been transferred to a third country or to an international organisation. These instruments include: • the existence of an adequate level of protection in the third country or international organisation, pursuant to Article 45 of the GDPR or, in the absence of such adequate level of protection; • the implementation by the exporter of appropriate safeguards, pursuant to Article 46 of the GDPR (i.e., standard contractual clauses, binding corporate rules, codes of conduct, certification mechanisms, ad hoc contractual clauses, international or administrative agreements); or • derogations under Article 49 of the GDPR. In that regard, the Guidelines explain that the content of these safeguards must be customised based on each situation. When controllers and processors develop relevant transfer tools, such as Standard Contractual Clauses, they must take account of Article 3(2) so as not to duplicate the GDPR obligations, but rather to address what is missing and hence, fill the gaps. For example, such tools must address the measures to be taken in cases of a conflict of laws between third country legislation and the GDPR. In line with this approach, the EDPB encourages the development of a transfer tool for those cases where the importer is subject to the GDPR for a given processing pursuant to Article 3(2). The Guidelines can be consulted here and are subject to public consultation until the end of January 2022.

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    • 24/11/2021
    • Articles

    European Commission proposes deforestation due diligence rules

    On 17 November 2021, the European Commission (“Commission”) published a Proposal for a Regulation on placing on the EU market and exporting from the European Union wood, cattle (beef), cocoa, coffee, palm oil and soy and derived products associated with deforestation and forest degradation (“Proposed Regulation” or “Proposal”). According to the Proposal, those products can no longer be placed or made available on the EU market, nor can they be exported from the EU market, unless they are deforestation-free. The Proposal is presented as part of the European Union’s initiatives to address climate change, such as the European Green Deal. The publication of the Commission’s legislative proposal comes in the wake of COP26, where global leaders, including the European Union, made pledges to stop deforestation. This Client Alert sets out the key elements of the Proposal that are of interest to producers, traders, importers and exporters of wood, cattle (beef), cocoa, coffee, palm oil and soy as well as some derived products.

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    • 16/11/2021
    • News

    Isabelle Van Damme participates in UKAEL webinar on the CJEU’s Komstroy judgment

    On 10 November 2021, Van Bael & Bellis partner Isabelle Van Damme participated in a webinar on “CJEU Jurisdiction, the Autonomy of the EU Legal Order and Arbitration”, commenting on the judgment of the CJEU in Case C-741/19 Republic of Moldova v Komstroy LLC. The webinar was organised by the UK Association for European Law. The other speakers were Prof. Sir Alan Dashwood QC and Prof. Takis Tridimas; the discussion was chaired by Prof. Paul Craig. Further information about the webinar is available here.

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    • 12/11/2021
    • Articles

    Belgium - Publication and Presentation of Policy Note Public Health - Impact on Pharmaceutical and Medical Devices Sectors

    The Minister of Social Affairs and Public Health (the Minister) just published his policy note (beleidsnota/note de politique générale) which he is scheduled to present to the Committee for Health and Equal Opportunities of the federal Chamber of Representatives on 16 November 2021 (the Policy Note – see, attachment). The Policy Note goes in tandem with the healthcare budget (estimated to reach EUR 31,755,422,000,000 in 2022). The Policy Note discusses the full range of public health policy aspects, including financing, managing health crises, reorganising public healthcare, access, quality control, care efficacy, evidence-based care, healthcare professions, preventive measures, addictions, digitisation of care, related policies, international relations and financial control of payers (sick funds) and healthcare practitioners. Unsurprisingly, the Policy Note deals extensively with pharmaceuticals and medical devices as well. The following points stand out: • Industry cooperation - As was the case for his predecessor, the Minister will again conclude agreements with the pharmaceutical and medical devices sectors to “define the priorities of each stakeholder in the interest of public health and specifically the patient” (p. 54). • Shortages - The Minister will complete the regulatory framework governing medicine shortages (p. 54) and promises to publish “very soon” a first implementing decree in relation to the transparency of wholesaler-distributors. Other implementing decrees will follow and Belgium will also advocate for the expansion of the existing joint procurement and emergency stock measures at EU level (p. 55 and p. 77). • Regulatory reorganisation and efficacy-enhancing measures for in vitro diagnostics and personalised medicine – The Minister will streamline and accelerate procedures by reorganising the various authorities involved in authorising and reimbursing care. An example is that of the joint contributions towards one specific form of treatment by clinical biology, companion diagnostics and medicines (p. 55 and p. 56). • Unmet medical need – The Minister announces a range of initiatives with regard to clinical trials, access and financing of innovative therapies, and medicine repurposing (p. 40, p. 41, p. 58, and p. 59). • Reimbursement of medicines – The Policy Note repeats an earlier promise that the procedure governing the reimbursement of medicines, including Managed Entry Agreements, will be assessed and revised (p. 57). Contrary to earlier indications, the Policy Note does not tackle the role of the pharmaceutical sector in financing hospitals, even though hospital financing is addressed extensively (p. 5, p. 22, p. 23, p. 24, p. 25, p. 31, and p. 32).

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    • 12/11/2021
    • Articles

    Council of EU Approves Health Technology Assessment Regulation

    On 9 November 2021, the Council of the European Union (Council) gave its green light for the adoption of the proposed Regulation on Health Technology Assessment (HTA) (the Regulation). Attached are a copy of the text as approved by the Council (See, first attachment) and the Council’s accompanying statement of reasons (See, second attachment). Raising subsidiarity concerns, Bulgaria and Poland issued statements indicating that they are unable to support the proposed Regulation (See, third attachment) and, therefore, abstained from voting. With the Council’s approval, the Regulation’s legislative process is nearing completion. This process was initiated in January 2018 when the European Commission first issued its proposed Regulation (See, Van Bael & Bellis Life Sciences News & Insights of 1 February 2018 and 8 October 2018). The Regulation now just requires a final vote by the European Parliament to become law. This step is expected to be a formality. Pursuant to its Article 36, the Regulation will start to apply three years after its entry into force (which will happen 20 days after the Regulation’s publication in the EU Official Journal). HTA is a technique to evaluate the medical, social, economic, organisational and ethical issues of a health technology, including medicines, medical devices and medical interventions. The main purpose of conducting an assessment is to inform policy decision-making. In practical terms, the Regulation envisages the following four avenues of cooperation: • joint clinical assessments; • joint scientific consultations in response to requests for advice from the life sciences sector; • identification of emerging health technologies (known as “horizon scanning”); and • voluntary cooperation in areas outside the scope of mandatory cooperation.

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