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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    • 24/06/2019
    • Articles

    More Details Emerge Regarding Fine Imposed by Belgian Competition Authority on Professional Organisation of Pharmacists

    At the end of May 2019, the Belgian Competition Authority (“BCA”) imposed a fine of EUR 1 million on the professional organisation of pharmacists (“Orde der Apothekers”/ “Ordre des pharmaciens”) (the “PO”) because the PO had taken a range of exclusionary measures to thwart the development of MediCare-Market, a successful retailer of both medicines and other, less regulated health products (see, Van Bael & Bellis Life Science Newsflash of 5 June 2019). The BCA has now published the non-confidential version of its decision of 28 May 2019 (the “Decision”) which, as is customary, contains the report of the prosecutor in competition matters (“auditeur”/”auditeur”), submissions of the complainant and of the targeted entity, as well as the actual reasoning of the competition college, the decision-making body of the ABC (see, attached). The BCA found that the PO had relied on a range of techniques to hamper MediCare-Market’s development, including disciplinary proceedings and court action. Interestingly, the BCA also blamed the PO for limiting price competition, even though the scope for such competition was narrow as far as medicines are concerned. However, the BCA took issue first and foremost with attempts made by PO to stifle competition for health products other than medicines. For example, PO had taken court action against MediCare-Market on account of publicity made by that company which promised price reductions on non-pharmaceutical products. In PO’s view, this constituted unethical behavior unbecoming of a pharmacist. The ABC disagreed and added that, to the contrary, MediCare-Market’s actions had been welcome in that they made pharmacists aware of the legitimacy of price competition for products other than medicines. While the BCA is somewhat ambiguous on this, it also seemed to favour price competition for medicines in forms such as end-of-year reductions. This is illustrated by the start of the BCA’s analysis which refers to an OECD finding of 2017 that the pricing level for medicines in Belgium is too high compared to that of its neighbouring countries. Additionally, the BCA made short shrift of the PO’s public service remit. Relying in part on a 2014 judgment of the EU General Court which confirmed a European Commission decision which had found the French “Ordre national des pharmaciens” to be in breach of the competition rules (case T-90/11, Ordre national des pharmaciens and others v. European Commission, ECLI:EU:T:2014:1049), the BCA maintained that legitimate public-service obligations cannot serve as a pretext for anti-competitive behaviour. Similarly, the BCA also rejected the general interest arguments that PO was supposedly right in pursuing MediCare-Market in order to (i) protect the credibility of the pharmacist’s profession; (ii) safeguard public health; and (iii) guard against the excessive consumption of medicines. The BCA went even further by positing that the general approach followed by the PO to foreclose MediCare-Market or at least stunt its development amounted to a restriction of competition by object. Showing its anticompetitive effects was therefore not necessary (the BCA still went on to demonstrate the adverse effects on competition resulting from the PO’s conduct).

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    • 14/06/2019
    • News

    Andreas Reindl speaks on “SEPs, FRAND, and EU Competition Law” at the Workshop on Big Data and Anti-Monopoly in Beijing

    On 7 June 2019, Van Bael & Bellis partner Andreas Reindl spoke at the Workshop on Big Data and Anti-Monopoly in Beijing before an audience consisting mainly of members of China’s judiciary. Andreas discussed in particular under what circumstances EU competition law may limit the right of SEP holders to obtain injunctive relief against implementers when the parties have failed to enter into a FRAND license agreement, emphasizing that courts may still grant an injuction if they find that the implementer has not negotiated in good faith.

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    • 14/06/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 05

    The May 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. Please click below to read the issue.

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    • 13/06/2019
    • Articles

    Pharmaceuticals - Export Manufacturing Waiver and Stockpiling Waiver Enter into Force on 1 July 2019

    Pharmaceuticals - Export Manufacturing Waiver and Stockpiling Waiver Enter into Force on 1 July 2019 On 11 June 2019, the Official Journal of the European Union published Regulation (EU) 2019/933 of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate (“SPC”) for medicinal products (the “Regulation”). The modifications introduced by the Regulation encroach on the normal operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. More precisely, they allow EU-based companies to manufacture in the EU a generic or biosimilar version of an SPC-protected medicine during the term of the SPC, for the double purpose of either exporting to non-EU countries where protection has expired or never existed (“manufacturing waiver”), or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market immediately after the SPC has lapsed (EU Day-1 entry) (“stockpiling waiver”). The manufacturing and stockpiling waivers extend to related acts that are “strictly necessary” for such manufacturing or storing, even though such acts would otherwise require the consent of the SPC holder. According to the preamble to the Regulation, such related acts could include possessing, offering to supply, supplying, importing, using or synthesising an active ingredient for the purpose of making a medicinal product, or temporary storing or advertising for the exclusive purpose of exporting to third-country destinations. The Regulation requires producers of generic or biosimilar medicines to (i) notify the relevant competent authority in the EU Member State in which the manufacturing is to take place; and (ii) inform the SPC holder of their intention to manufacture a generic or biosimilar version of the protected medicine. Manufacturers will have to provide information on issues such as the markets where the new products will be exported to. For its part, the national authority will have to make that information publicly available. Further, in the case of products manufactured for the purpose of export to third countries, a specific logo will have to be affixed to the product’s outer packaging and, if feasible, to its immediate packaging. The Regulation will enter into force on 1 July 2019 and will become directly applicable in all EU Member States. However, the new rules will not apply to SPCs that have already taken effect before 1 July 2019. As regards SPCs that have not taken effect before that date, the following principles apply: • immediate application to SPCs that are applied for on or after 1 July 2019; and • application from 2 July 2022 to SPCs that have been applied for before 1 July 2019 and that take effect on or after that date. According to the Regulation’s preamble, the new rules are supposed to “strike a balance between restoring a level playing field between [producers of generic or biosimilar medicines established in the EU and those established in third countries, the former allegedly being “at a significant competitive disadvantage”] and ensuring that the essence of the exclusive rights of [SPC] holders […] is guaranteed in relation to the Union market”. However, advocates of intellectual property rights regard the manufacturing and stockpiling waivers as major victories for the generic and biosimilar industries and a dangerous step down the path of erosion of intellectual property rights (see, Van Bael & Bellis Life Sciences Newsflashes of 28 May 2018, 21 January 2019 and 23 April 2019).

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    • 12/06/2019
    • News

    Does your company recognize the importance of EU customs compliance?

    Brexit has raised awareness among economic operators of the relevance of EU customs law to their supply chain operations. Against that background, one legitimate and timely question is whether the importance of complying with EU customs law is sufficiently recognised within your company, and if so, where EU customs compliance sits – or should sit – within your company’s organigram. Both issues are addressed by Van Bael & Bellis partner Pablo Muñiz in this article recently published in The Global Legal Post. Although there is never a one-size-fits-all-solution, Pablo’s article may be helpful to initiate a debate about these issues within your company and hopefully lead to an interesting and challenging internal discussion. The article is available at http://www.globallegalpost.com/global-view/brexit-is-changing-the-rules-for-eu-customs-law-74291292/?utm_campaign=D1_07_06_19&utm_medium=email&utm_source=newsletter_d1 Please feel free to contact Pablo Muñiz if you would like to discuss further.

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    • 12/06/2019
    • Articles

    Luxembourg and The Netherlands Next in Line To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

    Luxembourg and The Netherlands have become the 25th and 26th EU Member State able to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US. The US Food and Drug Administration (“FDA”) confirmed as much on 10 June 2019. As a result, Luxembourg and The Netherlands now form part of the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. For their part, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017. There are now just two more Member States left for assessment and this process is anticipated to be completed on 15 July 2019. The latest announcement of the European Medicines Agency ("EMA") on the subject can be found here: https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-1. The EMA also updated again its Questions and Answers document on the impact of the MRA: https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-10-june_en.pdf.

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    • 11/06/2019
    • News

    Philippe De Baere speaks on the new EU anti-dumping rules at the G2 Annual Conference on WTO and Global Economic Regulation in Geneva

    On 7 June 2019, Philippe De Baere spoke on a panel addressing “Trade Remedies When Markets Are “Distorted”: Non-Market Economy. Status and Alternative Approaches” at a conference jointly organized by Georgetown Law’s Institute of International Economic Law and the Graduate Institute’s Centre for Trade and Economic Integration. Philippe De Baere gave an overview of the EU’s amended anti-dumping regulation and briefly examined the WTO compatibility of the new “significant distortions” approach introduced by the EU. Further information about the conference is available below. You can also watch the panel discussion here. Philippe De Baere’s intervention starts at 4:14:18.

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    • 11/06/2019
    • Articles

    Belgium - New Combined Reimbursement Rules for Personalised Medicines and Companion Diagnostics

    The Belgian Official Journal of 5 June 2019 contains two Royal Decrees that create the regulatory framework for the combined reimbursement procedure of personalised medicines and companion diagnostics (“CDx”) in accordance with the tight reimbursement deadlines that apply to medicines but did not previously govern the CDx. As a result, the reimbursement of new CDx (or predictive biomarkers) often lagged that of the associated medicines and resulted in a reimbursement gap. The new combined reimbursement procedure involves the cooperation of bodies responsible for respectively medicines and CDx in a “Platform CDx” and implies a single Health Technology Assessment of the “package” that consists of the medicine and the predictive biomarker. The Minister of Social Affairs will authorise or reject the package for reimbursement in a single reimbursement decision. The combined reimbursement procedure will also entail the registration of all reimbursed tests and of the test results. In future, these will allow for more informed policy decisions regarding personalised medicine and the reimbursement of healthcare services in this area. The modified regulatory framework consists of a new chapter VIII dedicated to personalised medicines in Annex 1 to the Royal Decree of 1 February 2018 governing the reimbursement of medicines. In addition, the list of categories of healthcare services (“nomenclatuur van geneeskundige verstrekkingen”/“nomenclature des prestations de santé”) contained in the annex to the Royal Decree of 14 September 1984 was expanded with a new Article 33ter that will specifically contain a category of CDx and will be updated frequently to reflect technological and scientific developments. The new rules will enter into force on 1 July 2019.

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