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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    • 19/11/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 10

    The October 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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    • 18/11/2019
    • Articles

    Medicine Shortages - Latest Developments Across Europe

    Medicine shortages remain a high-priority issue for governments across Europe. During the last few days, a new slew of measures and policy initiatives emerged. Norway On 7 November 2019, Norway notified to the European Commission (the “Commission”) proposed powers that would enable the Norwegian Medicines Agency to prohibit medicine wholesalers from making parallel exports of specific medicines if their continuous supply in Norway is at risk (see, attached notification). The notification is based on Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services. This Directive also applies to the EFTA countries, including Norway, and allows the Commission, EU Member States and EFTA countries to offer their view on the compatibility of the proposed measures with European pharmaceutical law and with the free movement of goods principle. In this case, the consultation period runs until 10 February 2020. Norway stresses that medicine shortages form a growing problem of international dimensions in the face of which small countries such as Norway are nearly powerless. According to Norway, a tailored export prohibition on wholesalers is one of the few adequate and proportionate instruments available to protect the health of the local population. Portugal In Portugal, the Portuguese medicines agency Infarmed published new rules to manage medicine shortages (see, attached rules). They come in the wake of recent statutory powers that sought to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. (see, Van Bael & Bellis Life Sciences Newsflash of 23 August 2019). Wholesalers must have at least one month’s worth of supplies, while medicine suppliers must ensure two months’ worth of supplies. Suppliers, wholesalers and pharmacies are required to notify the authorities of shortages within 24 hours of becoming aware of the issue, while suppliers with advance knowledge of an emerging shortage issue should notify the authorities at least two months ahead of the shortage. Belgium Belgium has taken a number of practical steps to confine the problem by creating an interagency database for medicines subject to shortages, intensifying the channels of communication between the supply chain stakeholders and generally raising awareness of the existing rules and obligations. At the same time, the Constitutional Court struck down a law limiting parallel exports of medicines as inadequate and incompatible with EU free movement principles (see, Van Bael & Bellis Life Sciences Newsflash of 17 October 2019). As a result, there would seem to be a groundswell of opinion in favour of further measures tackling medicine shortages. For example, a number of members of parliament advocate for higher fines to be imposed on medicine suppliers that fail to comply with existing obligations. Additionally, tighter supply obligations are also under consideration. Meanwhile, the caretaker government is also understood to work on a draft Royal Decree. Medicine shortages are now a politically charged subject and this is illustrated by the lengthy report which the chamber of representatives of the federal parliament just made publicly available. The report covers three hearings on medicine shortages which took place over the last few months before the parliament’s committee on health and equal opportunities (see, attached report). Europe Even though the incoming Commission will not take office until 1 December 2019 at the earliest, it now looks certain that medicine shortages will be high on its healthcare agenda. As a first step, officials of Directorate General SANTE have reportedly already earmarked a study that would look at harmonised rules governing supply obligations, notifications of shortages and monitoring systems. A further study would analyse parallel trade and market withdrawals.

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    • 13/11/2019
    • News

    Koen T'Syen named “Rising Star: Belgium” at inaugural Euromoney LMG Europe Rising Stars Awards

    Van Bael & Bellis counsel Koen T’Syen was recently named as Rising Star for Belgium at Euromoney LMG’s inaugural Europe Rising Stars Awards. The awards celebrate the best lawyers in Europe who are under the age of 40. They were announced in London on 7 November 2019. Koen T’Syen has broad experience in commercial and competition law matters. He is also particularly knowledgeable in life sciences regulatory affairs. Further information on the awards can be found here.

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    • 13/11/2019
    • News

    Andreas Reindl chairs panel on selective distribution at the Marques Luxury Brand Symposium in Milan

    On 7 November 2019, Van Bael & Bellis partner Andreas Reindl chaired and spoke on a panel on selective distribution at the Marques Luxury Brand Symposium in Milan. The panel discussed a range of EU competition law issues affecting distribution strategies for luxury and well-known brands, including the relationship between trademark law and competition law, online sales restrictions, restrictions on sales over third party platforms, restrictions on the use of trade names in search engines, and hot topics in the ongoing review of the Vertical Restraints Block Exemption. Other panel members included Manuel Kleinemenke, Porsche, Benjamin Neyt, LVMH, and Bernd Weichhaus, Lubberger Lehment. More information on the event can be found here.

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    • 05/11/2019
    • Articles

    Dutch Competition Authority Will Clarify Guidelines on Joint Purchasing of Medicines

    The Dutch competition authority announced yesterday that it would clarify its 2016 guidelines on the joint purchasing of medicines (“Leidraad gezamenlijke aankoop geneesmiddelen voor de medisch-specialistische zorg” - https://www.acm.nl/sites/default/files/old_publication/publicaties/15959_leidraad-gezamenlijke-inkoop-geneesmiddelen-voor-medisch-specialistische-zorg-2016-06-22.pdf – the “Guidelines”). It did so in response to an assessment of the Guidelines carried out by “Strategies in Regulated Markets”, a consultancy (the “Assessment” – see attached). The Guidelines were designed to encourage the joint purchasing of medicines by a range of hospitals, a group of insurers or a combination of hospitals and insurers. They are supposed to offer a safe haven for specific forms of cooperation on the buying side of medicines. According to the Assessment, the Guidelines have increased the dynamics of oligopolistic medicine markets but have also added a layer of complexity to cooperation. As a result, the net effect of the Guidelines on competition in such markets is limited. By contrast, the Guidelines have had a larger impact, including price reductions, on monopolistic medicines. Conversely, the Guidelines had no stimulating effect on the market for medicines in full competition, because these markets work well and joint purchasing of such medicines has existed for decades. On this basis, the Assessment advocates for a broader safe haven which will bolster competition in the markets where the mechanics of competition are still imperfect. For example, the Assessment recommends the possibility for buyers to exchange more information regarding medicines. Additionally, the Assessment identifies non-competition related obstacles to the efficient buying of medicines. These include the fact that there is still no consensus on the switching of patients between therapeutically equivalent medicines. Similarly, buyers do not have reliable information on the relevant costs of the medicines which they procure.

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    • 04/11/2019
    • News

    Jean-François Bellis speaks on exploitative abuses in the pharma and digital markets at the European University Institute in Fiesole, Italy

    On 25 October 2019, Van Bael & Bellis founding partner Jean-François Bellis participated in a panel on exploitative abuses in the pharma and digital markets at the European University Institute in Fiesole, Italy. The panel was part of the Fourth Annual Conference of the Florence Competition Programme entitled ‘Hipster Antitrust, the European Way?”. The panel in which Jean-François participated was chaired by Marco Botta, European University Institute. Other panel members were Pedro Caro de Sousa , OECD Secretariat, Maria Teresa Maggiolino, Bocconi University and Avantika Chowdhury, Oxera. For more information on the conference, please click here.

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    • 04/11/2019
    • Articles

    Medicine Shortages - The Netherlands To Create "Iron Stock" Of Medicines

    The latest European country to announce measures to tackle medicine shortages is The Netherlands. Minister of Medical Care Bruno Bruins announced this morning the creation of what he referred to as an “iron stock” (“ijzeren voorraad”) of medicines that would cover five months of supplies (see, attached press release). The stock would include all medicines available on the Dutch market and would be built up gradually from 2020 onwards. It is expected to reach completion in 2022. The system will require a range of agreements among suppliers, wholesalers, pharmacists and payers on both operational and funding issues. Some of these arrangements will give rise to competition law scrutiny. For example, the Minister anticipates the parties “better to predict the demand for medicines in order to match supply and demand optimally”. The new rules will be laid down in a policy measure that will be overseen by the Inspection for Medical Care and Youth (“Inspectie Gezondheidszorg en Jeugd”). The Minister estimates the cost of the iron stock to amount to approximatively EUR 25 million. The press release does not indicate whether this is a one-off or a recurring expense. Finally, Minister Bruins once more advocates for a European approach to some of the medicine shortage problems. Echoing a proposal made by the French government (see, Van Bael & Bellis Life Sciences Newsflash of 9 July 2019), he suggests that the production of specific “crucial medicines” and pharmaceutical ingredients should return to Europe.

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    • 30/10/2019
    • Newsletters

    VBB on Competition Law, Volume 2019, No. 10

    The October 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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