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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    Chambers Europe

Latest news

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    • 05/04/2019
    • News

    Van Bael & Bellis assists the retail industry in securing an injunction by the European Commission suspending Slovakia’s tax on the food retail sector

    On 2 April 2019, the European Commission opened an in-depth investigation into a tax on the food retail sector in Slovakia over concerns that the way in which the tax is structured gives some retailers a selective advantage over their competitors, thus involving State aid in breach of EU rules. At the same time, the Commission issued an injunction requiring Slovakia to suspend the application of the measure until the Commission has concluded its assessment under EU State aid rules. The complaints giving rise to the Commission’s afore-mentioned decisions were lodged in December 2018. Van Bael & Bellis counsel Gábor Báthory assisted the retail industry in this matter. Further details on this case can be found here.

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    • 29/03/2019
    • News

    Fifteen Member States Sign Agreements for Supply of Pandemic Influenza Vaccines under Umbrella of Joint Procurement Agreement

    On 28 March 2019 the European Commission announced that 15 EU Member States and the Commission signed framework contracts with the pharmaceutical firm Seqirus for the supply of pandemic influenza vaccines to 30 contracting authorities in these Member States in the event of an influenza pandemic (https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/ev_20190328_memo_en.pdf). The agreements will run for at least 4 years and are subject to a possible extension of 2 more years. Under the agreements, Seqirus will not only supply vaccines but will also reserve part of its weekly manufacturing capacity and will be paid in return an annual preparedness fee. The agreements were concluded under the Joint Procurement Agreement (“JPA”), a framework established on the basis of Article 5 of Decision 1082/2013/EU tackling serious cross-border threats to health. A similar set of agreements was entered into in 2016 to organise the joint procurement of botulinum anti-toxin. A further series of agreements to expand the vaccine coverage is under preparation. Additional joint procurement procedures for diphtheria anti-toxin, tuberculin and Bacillus Calmette–Guérin (“BCG”) vaccines, and personal protective equipment are under consideration. The JPA was conceived of to improve the state of preparedness of Member States for serious cross-border threats to health, ensure equal treatment of patients affected and increase the buying power of Member States when anticipating emergency situations.

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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.

    Chambers Europe
  • 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.

    IFLR1000
  • 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.

    Chambers Europe

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Van Bael & Bellis is well known for its client-centred approach, commitment to excellence, exceptional client service and personalised attention.

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Recent publications

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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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