News & Insights

  • 23/05/2019
  • News

Van Bael & Bellis launches the sixth edition of its “EU Anti-Dumping and Other Trade Defence Instruments"

The definitive book on EU trade defence law appears in a fully updated sixth edition. As comprehensive in its coverage as its predecessors, this new edition of the Van Bael & Bellis book on “EU Anti-Dumping and Other Trade Defence Instruments” provides incisive analysis and critical commentary on all relevant aspects of the EU trade defence instruments as actually applied by the EU Institutions against the backdrop of WTO law. The book covers every issue likely to arise in any trade defence matter and examines the numerous cases decided under the EU anti-dumping, countervailing, safeguard and trade barriers regulations, including all of the following and more: • determining the dumping and injury margins; • rules for the determination of permissible adjustments; • clarification of the terms ‘significant distortions’ and ‘distortions on raw materials’; • determining the subsidy margin; • determining the causal link between dumping or subsidy and injury; • determining if “Union interest” calls for intervention; • examining the differences between anti-dumping and anti-subsidy legislation; • procedural rules applicable to complaints, initiation of proceedings, investigations, protective measures, reviews and refunds; • conditions for accepting an undertaking; • measures that may be taken to prevent ‘circumvention’ of anti-dumping or countervailing measures; • rules governing the standing of various interested parties before the European Courts; • allocation and administration of quantitative quotas; and • surveillance measures. As a detailed and practical commentary on the relevant aspects of the EU trade defence instruments as actually applied by the EU institutions in the light of WTO law, the sixth edition of this book remains without peer as a guide to EU trade defence law. To order a copy of the book from Kluwer, click on this link.

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    • 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.

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    • 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.

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    • 13/01/2020
    • Newsletters

    VBB on Competition Law, Volume 2019, No. 12

    The December 2019 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at both the European Union and Member State levels.    Click below to view and download the issue

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    • 13/01/2020
    • News

    Brussels Court of Appeal Confirms Infringement of Competition Rules by Professional Organisation of Pharmacists but Directs BCA to Recalculate Fine

    On 8 January 2020 the Market Court of the Brussels Court of Appeal confirmed a finding of the Belgian Competition Authority (“BCA”) that the professional organisation of pharmacists had infringed the competition rules. However, it also directed the BCA to recalculate the fine which is now expected to turn out significantly lower. Please find attached a note on the judgment as well as its text.

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    • 10/01/2020
    • Articles

    MEP Cindy Franssen Raises Important Questions Regarding Medicine Shortages in European Union

    Member of the European Parliament Cindy Franssen submitted to the European Commission (the “Commission”) a series of interesting questions regarding medicine shortages (see, attachment). Broadly, the questions probe for (i) possible violations of Directive 2001/83/EC if pharmaceutical firms “caus[e] shortages [of medicines] on the basis of commercial decisions”; (ii) the measures which the Commission plans to take to tackle shortages; and (iii) the proposals which the Commission intends to put forward in order to enhance local production of medicines. While some of these questions exhibit bias against the pharmaceutical industry, they are likely to prompt important answers from the Commission in relation to (i) the public service obligation associated with supplying medicines as contained in Article 81 of Directive 2001/83/EC; (ii) the initiatives which the Commission will take to address medicine shortages (see, Van Bael & Bellis Life Sciences Newsflash of 26 November 2019 and Van Bael & Bellis Life Sciences Newsflash of 11 September 2019); and (iii) calls made in various circles to make sure that the production of key pharmaceutical ingredients is moved to Europe (see for example, Van Bael & Bellis Life Sciences Newsflash of 9 July 2019).

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    • 06/01/2020
    • Articles

    Grand-Duchy of Luxembourg - Creation of National Medicines Agency

    The Council of Government of the Grand-Duchy of Luxembourg approved on 20 December 2019 a draft bill that provides for the creation of a national medicines agency which will be known as "Agence luxembourgeoise des médicaments et des produits de santé" (« ALMPS ») (see attached press release). As its name suggests, ALMPS will be responsible for a range of products, including pharmaceuticals, medical devices, cosmetics, food supplements and other health products. As a result, Luxembourg will cease to be one of the few European countries without a medicines agency that is separate from the executive branch of government. According to the press release, once operational, ALMPS will be in a better position to cope with a range of public health issues, including health risk management, medicine shortages and universal access to medicines. Additionally and significantly, ALMPS will also be given an economic remit in that it will facilitate and preserve investment in the life sciences sector (the press release expressly mentions the biotechnology industry). ALMPS is supposed to achieve that goal by creating legal certainty in the form of a regulatory framework which will be “precise” and “administered efficiently” and will govern activities such as production, commercialisation and clinical trials.

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    • 30/12/2019
    • Articles

    Brexit’s Implications for Data Protection in 8 Questions

    The UK is set to leave the EU on 31 January 2019. As the EU and the UK prepare for Brexit, companies should too. Brexit continues to raise many legal questions and uncertainties, not the least for the protection of personal data which flows between the UK and the rest of Europe. Will organisations in the UK still have to comply with the General Data Protection Regulation (GDPR)? Can they still transfer personal data to the EU? Will they need to appoint a representative in the EU? And what will happen with the one-stop-shop? On the basis of eight frequently asked questions, we provide an overview of issues to consider and steps to take to start preparing now in order to be ready for Brexit. Please find enclosed our memorandum on the topic.

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    • 24/12/2019
    • Articles

    EU General Court Backs European Commission in Refusal to Approve Schizophrenia Medicine

    Please find attached short comments on a judgment which the EU’s General Court handed down on 19 December 2019. The judgment confirms the broad discretionary powers of the European Commission and the European Medicines Agency when handling a request for marketing authorisation of a medicine under the centralised procedure.

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    • 23/12/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 11

    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.

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