News & Insights

  • 29/06/2020
  • News

Van Bael & Bellis to open London office

Van Bael & Bellis announces today that it will open a London office on 1 September 2020, subject to SRA approval.  Located at 5 Chancery Lane, the office will be led by senior partner David Hull, managing partner Philippe De Baere and partner Alex Stratakis, who will join from Baker McKenzie’s London office.

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    • 09/07/2020
    • Articles

    Court of Justice of European Union Is Asked Preliminary Questions on Application of Falsified Medicines

    Attached is a note discussing a German reference for a preliminary ruling seeking clarification from the Court of Justice of the European Union regarding the application of the Falsified Medicines Directive to parallel-traded medicines. A judgment is due in 2021.

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    • 07/07/2020
    • Articles

    European Commission Reviews First Two Years of GDPR: A Success Story with Room for Improvement

    On 24 June 2020, the European Commission has published its first report on the General Data Protection Regulation (the GDPR) which has applied in the EU since May 2018. Overall, the Commission considers the GDPR to be a success story, but, at the same time, it identifies certain areas where there is room for improvement and the challenges that lie ahead. In particular, the Commission notes that the efficient and coordinated enforcement of the GDPR among all Member States is of paramount importance. Moreover, the application of the GDPR to new technologies, such as artificial intelligence and blockchain, requires continuous monitoring. According to the Commission, the Covid-19 crisis has proved that the use of new technologies and data protection go hand in hand. Please click below for a note summarising the Commission’s report.

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    • 07/07/2020
    • Articles

    European Medicines Agencies Network Strategy to 2025

    The European Medicines Agency (EMA) and the national competent authorities (NCAs) of the 27 EU Member States in addition to those of Iceland, Liechtenstein and Norway presented on 6 July 2020 a proposed network strategy for tackling healthcare challenges in a rapidly evolving environment (see, attachment). The strategy is supposed to apply until 2025 and stakeholders are invited to submit their comments in response to an online questionnaire by 4 September 2020.

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    • 06/07/2020
    • Newsletters

    VBB on Competition Law, Volume 2020, No. 6

    The June 2020 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at both the European Union and Member State levels.

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    • 02/07/2020
    • Articles

    Healthcare Priorities of German Presidency of EU Council

    The German government assumed yesterday for the latter part of 2020 the rotating Presidency of the Council of the European Union. The policy priorities of that Presidency were spelled out in the attached document entitled “Together for Europe’s recovery”. Not surprisingly, healthcare forms a focal point of these priorities in a number of diverging ways:

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    • 01/07/2020
    • Articles

    European Commission’s White Paper on Levelling the Playing Field as regards Foreign Subsidies

    Key Takeaway: The EU (and Member States) may be given new, far-reaching powers to tackle the perceived harmful effects of third-country subsidies benefitting businesses operating in the EU. Remedies could be imposed limiting participation in all sectors of the internal market, including prohibiting businesses from making subsidised acquisitions and participating in public procurement in the EU. On 17 June 2020, the European Commission (the “Commission”) published a White Paper on how to respond to third countries giving subsidies to companies active in the EU (“foreign subsidies”). In an effort to level the playing field, the Commission proposes new tools to address what it perceives as unfair competition from foreign players in the EU’s internal market. The Commission considers that existing tools, in the areas of notably trade defence, competition law and public procurement, are insufficient to avoid distortions resulting from foreign subsidies. The proposed new tool box fits within the EU’s new policy of “open strategic autonomy”. It signals a more pro-active approach on the part of the EU in responding to unfair and abusive practices distorting the EU internal market and undermining the level playing field.

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    • 01/07/2020
    • News

    Suspension of the notice period during temporary unemployment due to Covid-19 force majeure

    On 22 June 2020, the law aiming to suspend notice periods notified by the employer before or during temporary unemployment due to Covid-19 force majeure (Wet tot opschorting van de opzeggingstermijn voor ontslagen gegeven voor of tijdens de periode van tijdelijke schorsing van de uitvoering van de arbeidsovereenkomst omwille van overmacht ingevolge de COVID-19-crisis / Loi visant à suspendre les délais de préavis des congés donnés avant ou durant la période de suspension temporaire de l’exécution du contrat de travail pour cause de force majeure en raison de la crise du COVID-19) was published in the Belgian Official Journal (the Law).

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    • 01/07/2020
    • News

    Van Bael & Bellis welcomes Alex Stratakis as a Partner

    Van Bael & Bellis is pleased to announce that Alex Stratakis is joining the firm this week as a Partner. Based in London, and with almost 15 years of experience in all aspects of competition law, Alex will lead the UK Competition practice out of Van Bael & Bellis’ new London office, opening in September (subject to SRA approval). Alex’s practice covers predominantly UK, but also EU, Greek and Cypriot competition law, focusing on complex merger control, distribution, dominance and state aid. He has extensive experience successfully representing clients before the UK Competition and Markets Authority (CMA), the European Commission and various (non-UK) national competition authorities across the globe, as well as before European and national courts. He has also advised a number of companies on the implications of the UK’s Foreign Direct Investment Screening Regime. Alex’s practice covers a wide range of sectors, including life sciences (originators and medical device manufacturers), aviation, automotive, energy & mining, industrials, chemicals, luxury goods, telecoms, media, transport and infrastructure. Alex says “I am delighted to be re-joining Van Bael & Bellis as Partner to spearhead the enhancement of the firm’s UK capabilities together with a very gifted and experienced team of solicitors. Van Bael & Bellis’ stellar competition practice and unique market proposition needs no introduction; and I will be relying heavily on my colleagues to succeed together.” Philippe De Baere, managing partner, comments “The forthcoming opening of our London office is an important step in Van Bael & Bellis’ growth as a firm. To make this a success, the quality of our UK team will be essential. I am therefore extremely pleased that Alex decided to join us in this venture. Not only is he a leading UK competition lawyer, he also forms part of the Van Bael & Bellis family, having started his career with us in 2005. I am convinced that this unique combination will make him an effective leader of our new UK Competition practice.“ Alex Stratakis’ arrival means that Van Bael & Bellis’ Competition team now includes 15 partners and 7 counsel.

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    • 29/06/2020
    • Articles

    Belgium – Royal Decree Enables Use of Unauthorised Medicines to Treat COVID-19 Patients

    On 26 June 2020, the Belgian Official Journal published a Royal Decree of 23 June 2020 (the RD) which introduces an exemption from the marketing authorisation requirement to account for shortages in authorised medicinal products to treat COVID-19 patients. The RD confers on the Minister of Social Affairs and Public Health, or her representative, the Administrator General of the Federal Agency of Medicines and Health Products (FAMHP), the requisite powers to authorise the supply to COVID-19 patients of unauthorised medicinal products from Belgium’s strategic national stockpile if (i) the FAMHP determines that the medicinal products which are authorised in Belgium for the treatment or the adjunct treatment of COVID-19 are unavailable; and (ii) there is no authorised alternative available either. While the unauthorised medicines are in principle intended for use by hospitals, the RD provides that, upon the request of community pharmacies and subject to the production of a medical prescription, the Minister or her representative can also deliver an unauthorised alternative to community pharmacies. Strict safety reporting obligations apply. Interestingly, it follows from the Council of State’s opinion on the draft RD that the authorities entertain some doubt as to whether the exemption from the marketing authorisation requirement is compatible with EU law. In particular, the question arises whether the exemption falls within the scope of Article 5(1) and/or Article 5(2) of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (Directive 2001/83/EC). Article 5(1) of Directive 2001/83/EC exempts from the need for a marketing authorisation medicinal products which are supplied to satisfy special needs “in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility”. Article 5(2) of Directive 2001/83/EC, in turn, allows EU Member States to “temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm”. In view of these doubts, the Council of State strongly recommended that clarifications be sought from the European Commission (the Commission) on the occasion of the RD’s notification to the Commission pursuant to Directive 2015/1535. This Directive requires Member States to advise the Commission and other Member States of the technical regulations which they intend to introduce for products and for Information Society services before their adoption. While such regulations are in principle subject to a mandatory standstill period of at least 3 months, Directive 2015/1535 provides for an exception to this standstill requirement in the case of, amongst others, “urgent reasons occasioned by serious and unforeseeable circumstances relating to the protection of public health”. In view of the urgent need to protect public health, the main provisions of the RD apply retroactively from 13 March 2020. They will expire once the coronavirus COVID-19 pandemic is over in Belgium and at the latest on 31 March 2021.

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