Corporate, Commercial & Regulatory

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Van Bael & Bellis advises multinational clients on corporate, commercial and regulatory issues in the EU and Belgium.

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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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    • 31/05/2019
    • News

    Jean-François Bellis Appointed Chairman of Van Bael & Bellis

    Van Bael & Bellis has announced a new corporate structure, effective from 1 June 2019. Under the new structure, founding and co-managing partner, Jean-François Bellis, will become Chairman of the firm. Co-managing partner, Philippe De Baere, will be the sole managing partner while Andrzej Kmiecik will take over as head of the firm’s EU competition practice. Jean-François has led the firm since its inception in 1986. He is widely recognised as one of the eminent practitioners in the field of EU competition and trade law. In his new role as Chairman, he will continue to remain active in his practice, working directly with clients and contributing to the development of the firm through his case work. While he will remain a key member of the EU competition team, senior competition partner, Andrzej Kmiecik, will act as head of the EU competition practice. Philippe has been a partner at Van Bael & Bellis since 1994. In September 2016, he was appointed co-managing partner. He is widely recognised as one of the leading practitioners in the field of EU and international trade law and he will continue to act as head of the international trade practice. Alongside working directly with clients, he will be active in shaping the firm’s continued development and direction. Philippe remarks “This is an exciting time for Van Bael & Bellis and I am honoured to step into this role. I am committed to building on the firm’s legacy of first-rate legal expertise and outstanding client care. We are witnessing more rapid change than at any other time in our history. Our role is to make sure that we put our clients and their needs first, so that we can continue delivering more value to their businesses.” Andrzej has been a partner at Van Bael & Bellis since 1994. He is widely recognised as one of the world’s leading EU competition law experts. Over the years, he has been involved in several of the most high-profile EU cases and investigations, particularly with regard to cartels, merger control proceedings and distribution and licensing.

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    • 23/05/2019
    • News

    Koen T’Syen speaks at EU Pharmaceutical Law Forum in Brussels

    On 22 May 2019, Van Bael & Bellis counsel Koen T’Syen participated in a panel at the three-day EU Pharmaceutical Law Forum in Brussels, Europe’s leading pharmaceutical law conference. The topic under discussion was market access and the convergence of regulation, pricing and reimbursement. Other members of the panel were Arianna Greco (Vice President, Head of International Legal, Alnylam Pharmaceuticals, Switzerland) and Hanneke Later-Nijland (Counsel, Axon Lawyers, the Netherlands). Details of the conference can be found here.

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Recommendations

  • The quality of the advice is great - we have been asking some complex questions and they have given clear and to-the-point advice and have been very proactive in providing alternative solutions.

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  • Van Bael & Bellis has ‘impressive knowledge of dispute resolution, including mediation’. The firm is notable for its strong regulatory and administrative law contentious practice as well as its impressive life sciences sector presence.

    Legal 500
  • They patiently try to understand the mentality of people in different cultures and pay full respect to that. This attitude is rare in a highly expert world. We are fully satisfied with their practice and the results therefrom.

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  • They are very responsive, and experienced in pharma and compliance-related matters. They always indicate the timelines of the work they do and keep the client informed on the status of the work.

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Recent publications

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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
    • 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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