News & Insights

  • 27/02/2019
  • News

Van Bael & Bellis shines in Chambers Global 2019 with top-tier rankings for its EU competition and international trade practices

Van Bael & Bellis has once again achieved outstanding results in Chambers Global 2019, recently published online, where the firm and its lawyers are described in superlative terms by clients and peers. While the firm’s larger teams of EU competition and international trade continue to occupy the top bands, and our head of dispute resolution is “excellent”, our corporate M&A team is once again ranked amongst the top independents in the Brussels market. Our international trade and WTO team receives accolades for being “really sharp” with a “very good reputation” and work that is “strong and robust” and for the lawyers’ ability to “easily understand [clients’] needs, including not only the legal issues but also the commercial aspects. They are very good at finding the best solution considering all aspects of the issue”. Jean-François Bellis “remains a prominent figure in the trade market in Brussels”. Philippe De Baere is “‘an outstanding professional’ with a wealth of experience in the field of trade disputes and customs”. Richard Luff is noted for his expansive experience in the trade law field: both on EU mandates and in WTO trade disputes. Benoît Servais is lauded as being “‘a very strong lawyer’, particularly praising his ability in disputes and noting that ‘he is very strong at the European courts’”. Fabrizio Di Gianni is praised by clients for being “very fast and giving very clear advice” and for his “positive and reasoned approach”. Pablo Muñiz is “very good at reverting to our needs and considering all aspects of the question”, while Yuriy Rudyuk “is described by clients as ‘constructive and inventive’”. The EU competition team receives equally high praise. Jean-François Bellis is “like an encyclopaedia of EU competition and trade law, the best person for the cross-over between trade and competition”. David Hull is a “pragmatic lawyer with a cutting edge understanding of legal developments and regulatory trends, who offers very clear risk-based advice”. Clients appreciate that Andrzej Kmiecik “provides very thorough analysis, but also very pragmatic and practical solutions, and is always attentive to clients’ needs”. Porter Elliott is described as a “true expert in his field who gives very practical advice and is willing to pitch in and participate with the business”. Kris Van Hove is “responsive and does a good job of providing a broad overview but also giving concrete answers”. Clients appreciate that Markus Wellinger is “humble, open to discussions, very supportive and responsive, and is here to help”. Johan Van Acker displays a “really good understanding of [clients’] business and the commercial risk within a short space of time”. Fabrizio Di Gianni and Gabriele Coppo are both listed as Foreign Experts for Italy. Corporate/M&A partner Michel Bonne is described by clients as a “very commercial, efficient lawyer with fast reaction times and good follow-up”. Dispute resolution partner Catherine Longeval is praised for being “excellent, very detail-oriented and responsive”.

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    • 25/04/2019
    • Articles

    Spanish Competition Authority Raids Pharmaceutical Firm over Suspicions of Abusive Market Behaviour in Relation to Autoimmune Medicine

    The Comisión Nacional de Los Mercados y La Competencia, the Spanish competition authority (“CNMC”), announced today that, earlier this week, it carried out a dawn raid at the premises of an unidentified pharmaceutical firm (see, attached press release). The targeted firm is thought to have abused its dominant position in one or more markets involving the treatment of various unspecified autoimmune diseases. The CNMC suspects that the firm pursued an exclusionary commercial strategy in its dealings with health services (“Servicios de Salud”) and hospitals. The CNMC points out that the medicine at issue went off-patent and that any attempt to corner a market that is supposed to be free following the expiry of relevant patents amounts to a very serious infringement of the competition rules.

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    • 23/04/2019
    • Articles

    European Parliament Approves Manufacturing Waiver and Reduces Scope of SPC-Based Patent Rights in Medicines

    On 17 April 2019, the European Parliament (“EP”) approved a modification to Regulation No. 469/2009 which governs the supplementary protection certificate (“SPC”) for medicinal products. The modification creates a “manufacturing waiver” that encroaches on the operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. The modification will allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, for the double purpose of either exporting to a non-EU market where protection has expired or never existed, or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market once the SPC has lapsed. The “stockpiling” exception goes beyond the proposal which the European Commission initially tabled in May 2018 (see, Van Bael & Bellis Life Sciences Newsflash of 28 May 2018) and did not form part of the text which the Member States determined as their negotiating position in January 2019 (see, Van Bael & Bellis Life Sciences Newsflash of 21 January 2019). Still, the Council of the European Union is now expected to endorse the text adopted by the EP following a political agreement reached among the EU institutions in February 2019. Once published in the Official Journal of the EU, the modification to Regulation No. 469/2009 will enter into force 20 days later and will become directly applicable in all EU Member States. However, the full effects of the SPC waiver will only kick in 3 years after the date of that entry into force, currently expected to be around 1 July 2022. The creation of a manufacturing waiver is regarded as a major victory for the generic and biosimilar industries. Conversely, EFPIA, the European association of innovative pharmaceutical companies, has labelled the move as a “negative signal to the world that Europe is devaluing its intellectual property framework”. EFPIA therefore hopes that the next European Commission, which will take office following the European elections to be held between 23 and 26 May 2019, will “redress the balance, supporting research, development and innovation more broadly” (EFPIA press release of 17 April 2019).

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    • 23/04/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 03

    The March 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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    • 19/04/2019
    • Articles

    ECJ - Free Supply of Medicine Samples to Pharmacists "For Demonstration Purposes"

    The case-list of the Court of Justice of the European Union (“ECJ”) now features a request for a preliminary ruling submitted by the German Bundesgerichtshof (“BGH”) involving samples of medicines (see attached). The BGH seeks to learn whether the rules governing the supply of medicine samples to physicians as defined by Article 96 of Directive 2001/83/EC on the Community Code relating to medicinal products for human use could also be extended to pharmacists. In a dispute with Ratiopharm, Novartis Consumer Health tries to prevent the supply of samples of a generic version of “Voltaren Schmerzgel” (active substance: diclofenac) “for demonstration purposes” to pharmacists. Depending on the regulatory framework, pharmacists play in many countries a crucial role in the competitive dynamics between pioneer pharmaceuticals and their generic copies. Despite the seemingly clear terms of Article 96, the BGH would still seem to harbour doubts regarding its applicability to pharmacists and regarding the compatibility with that provision of a statutory ban on supplying medicine samples to pharmacists.

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    • 18/04/2019
    • News

    Ugur Can Hekim speaks at the Horasis Global Meeting 2019

    Van Bael & Bellis lawyer Ugur Can Hekim spoke on 8 April 2019 as a member of a panel at the Horasis Global Meeting in Cascais, Portugal. The topic under discussion was the future ideal regimes of regional trade groupings and their current impact on multilateral trade liberalisation in the era of globalisation. Other speakers on the panel were Mr. Mats Hellström, Sweden’s former Minister for Foreign Trade; Parvis Hanson, President of Manor Group; Michele Orzan, President of European Chamber; Pascal Anosike, Director of the Centre for African Entrepreneurship. The panel was moderated by Mr. Stiphan Beher, CEO of SpaceTek and the former Trade Advisor of Kyrgyz Republic. Horasis events bring together influential groups of business leaders to discuss collaborative approaches to addressing sustainable growth. The meetings are the foremost annual gatherings of business leaders from emerging markets and their global counterparts. The events are open to the Chief Executive Officers of the world’s leading companies. Further information is available here.

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    • 16/04/2019
    • News

    Van Bael & Bellis successfully assists Italian exporters in obtaining the repeal of the Australian anti-dumping measures on imports of prepared or preserved tomatoes from Italy

    Van Bael & Bellis successfully assisted three Italian exporters (Attianese, Mutti, and Princes) in obtaining the repeal of anti-dumping measures imposed by the Australian Anti-Dumping Commission on imports of prepared or preserved tomatoes from Italy. This result was achieved in a sunset review in which the Australian Anti-Dumping Commission decided that the anti-dumping duties of up to 17.6% applicable to imports of tomatoes from Italy should be repealed as it determined that there is no likelihood of continuation or recurrence of injurious dumping for the product concerned in the future, Attianese, Mutti, and Princes were assisted by Van Bael & Bellis partner Gabriele Coppo. The Anti-Dumping Notice was published today on the website of the Australian Anti-Dumping Commission.

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    • 12/04/2019
    • Articles

    European Commission Publishes Guidance on Interplay between Clinical Trials Regulation and General Data Protection Regulation

    The European Commission published on 10 April 2019 a Question & Answer document on the interplay between General Data Protection Regulation 2016/679 (the GDPR), which entered into force on 25 May 2018, and Clinical Trials Regulation 536/2014 (the CTR), which is currently expected to enter into force in 2020. The Q&A document provides clarifications in areas where the interplay between both sets of rules, which apply simultaneously, is complicated. It recalls that under the GDPR, it will be for data controllers to demonstrate that personal data are processed in accordance with the GDPR. Satisfying this obligation implies respecting the data protection principles, providing adequate information to clinical trial participants, appointing a Data Protection Officer (if required), maintaining records of processing activities and facilitating the exercise of individual’s rights, along with meeting other requirements. The controller should also determine the legal basis for the various processing activities. In this task lies a common misunderstanding which the Q&A document seeks to rectify: the informed consent required under the CTR serves as an ethical standard and procedural obligation, and this should not be confused with consent as a legal basis for the processing of personal data under the GDPR. As regards the legal basis under the GDPR, the Q&A document explains that various processing operations involving the use of clinical trial data, which include operations related to research as well as operations that are required for the protection of health, may rely on a different legal basis. Requesting consent from the participants (in addition to the consent required under the CTR) may be one option, but the Q&A document also offers alternative options, depending on the situation at hand. It will be for the controller to assess and implement the most adequate legal basis. In that regard, if clinical trial data are used for further research outside the scope of the protocol (secondary use), another legal basis may be required. The Q&A document also assesses the impact of the entry into application of the GDPR on ongoing clinical trials which are governed by Clinical Trials Directive 2001/20/EC. In particular, the European Commission indicates that additional information may have to be provided to the clinical trial participants. In principle, the legal basis that was valid under national data protection rules implementing Directive 2001/20/EC prior to the GDPR remains applicable. However, if the processing of clinical trial participant data relies on the participant’s consent, it must be assessed whether such consent satisfies the stricter requirements of the GDPR. If this is not the case, a renewed consent may prove necessary. The full text of the Q&A document can be found here and is also attached.

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    • 12/04/2019
    • News

    GCR quotes Andreas Reindl in article on EU digital competition policy

    Van Bael & Bellis partner Andreas Reindl was quoted extensively by Global Competition Review (GCR) in an article detailing lawyers’ reaction to the recently published expert report commissioned by the European Commission on the European Union’s digital competition policy. GCR interviewed several competition lawyers from prominent Brussels law firms and all of them voiced concerns about some of the report’s recommendations. Andreas queried the lack of support for the baseline assumption in the report that more intervention in digital markets would deliver greater benefits to consumers, and noted the absence of a balanced discussion in the report of whether more frequent competition law enforcement would indeed be desirable from a public policy perspective. He also highlighted the problematic recommendation that enforcers more frequently consider data access remedies, considering the considerable difficulties in formulating, implementing and constantly monitoring such remedies. The article is available here.

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