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    • 06/08/2020
    • Newsletters

    VBB on Competition Law, Volume 2020, No. 7

    The July 2020 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at both the European Union and Member State levels.

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    • 31/07/2020
    • Articles

    British Medical Journal Publishes Critical Review of Orphan Medicines Rules Ahead of Release of European Commission's Own Studies

    As part of the preparatory work for its Pharmaceutical Strategy for Europe which is due in the fourth quarter of 2020, the European Commission (the Commission) is expected to publish shortly an external study and own work assessing the regulatory framework governing orphan medicines and the paediatric rules.

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    • 28/07/2020
    • Articles

    US President Signs Executive Order Implementing International Pricing Index Model

    On 24 July 2020 the US President signed four executive orders designed to lower medicine prices in the United States (see, attached press release). One of these orders, which has not yet been made publicly available, implements a form of international reference pricing and “take[s] action to ensure that the Medicare program and seniors pay no more for [a series of costly medicines] than any economically comparable OECD country, ending foreign countries’ free loading off the backs of American taxpayers and pharmaceutical investments” (the “International Pricing Index Model” or “IPI Model”).

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    • 23/07/2020
    • Articles

    Belgium - Belgian Competition Authority Offers Guidance on Mergers of Local Hospital Networks

    On 22 July 2020, the Belgian Competition Authority (BCA) published a note (the Note) which discusses the application of the Belgian merger control rules to the creation of local hospital networks (locoregionale ziekenhuisnetwerken; réseaux hospitaliers locorégionaux – see the attached Note and press release in different language versions).

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    • 23/07/2020
    • Articles

    Court of Justice of European Union Invalidates EU-US Privacy Shield

    On 16 July 2020, the Court of Justice of the European Union (CJEU) delivered its judgment in the Facebook Ireland and Schrems case (C-311/18, Schrems II case). The CJEU invalidated Decision 2016/1250 on the adequacy of the protection provided by the EU-US Privacy Shield. The CJEU ruled that the EU-US Privacy Shield does not provide adequate protection and can therefore no longer serve as a legal instrument permitting the transfer of personal data from the EU to the US. As a result, transfers of personal data between the EU and the US that rely on the EU-US Privacy Shield are now illegal. However, the CJEU considered that Commission Decision 2010/87 on standard contractual clauses (SCCs) for the transfer of personal data to processors established in third countries is valid and can be relied upon, provided that the applicable legislation does not prevent the recipient from complying with its contractual obligations under the SCCs. Please click below to read a note summarizing the CJEU's judgment.

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    • 20/07/2020
    • Articles

    Extension of the possibility to apply temporary unemployment due to Covid-19 force majeure

    On 17 July 2020, a Royal Decree was published in the Belgian Official Journal (Koninklijk besluit tot verlenging van de maatregelen genomen op vlak van werkloosheid in het kader van de strijd tegen de verspreiding van het coronavirus Covid-19 / Arrêté royal prolongeant les mesures prises en matière de chômage dans le cadre de la lutte contre la propagation du coronavirus Covid-19) in order to extend the possibility to apply temporary unemployment due to Covid-19 force majeure (i) until 31 August 2020 included for all companies and (ii) until 31 December 2020 included for “companies and sectors particularly affected by the corona crisis”, namely:

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    • 20/07/2020
    • Articles

    Belgium - Constitutional Court Rejects Request for Suspension of Key Provisions of Latest Medicine Shortages Law

    On 16 July 2020, the Constitutional Court rejected several requests for suspension of Articles 2, 3 and 4 of the Law of 20 December 2019 modifying various laws to tackle medicine shortages (Wet van 20 december 2019 tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Loi du 20 décembre 2020 modifiant diverses législations, en ce qui concerne les pénuries de medicaments – the Law – see attachments). The requests had been introduced by the Belgian Association of Parallel Importers and Exporters, various other parties active in the parallel trade in medicines and pharmacists in the Democratic Republic of the Congo and Rwanda (the Applicants).

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    • 20/07/2020
    • Newsletters

    VBB on Belgian Business Law, Volume 2020, No. 6

    The June 2020 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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    • 17/07/2020
    • Articles

    Court of Justice of European Union Overrules Neurim Case Law and Excludes Right to SPC for New Medicinal Product

    Attached is a note discussing the judgment of the Court of Justice of the European Union in Santen which excludes the right to an SPC for new medical uses of a previously authorised medicinal product. The judgment has far reaching consequences in denying SPC’s to specific repurposed medicines. It is also remarkable in that it expressly overrules and reverses the Neurim case law.

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