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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    • 10/02/2021
    • News

    Covid-19 | Statutory moratorium on creditors’ rights ended on 31 January 2021

    On 31 January 2021, the temporal scope of the second statutory moratorium for certain enterprises forced to close as a result of the restrictions imposed within the context of the Covid-19 crisis ended. The statutory moratorium was applicable from 24 December 2020 until 31 January 2021 and provided that these enterprises were protected against (i) bankruptcy and judicial dissolution, (ii) attachment and enforcement measures and (iii) termination of existing contracts due to non-payment. As a result of the non-extension of the protection measures, enterprises are now again exposed against claims for bankruptcy and creditors can seize their assets. It is currently envisaged that a new law will be adopted that aims at simplifying the judicial reorganisation procedure, for example by easing the formal conditions to open such procedure, extending the situations in which a judicial officer can be appointed, etc. This draft bill is expected to be adopted by March 2021.

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    • 10/02/2021
    • News

    'Pink Boxes' for Parents-to-be Fined by Belgian DPA

    The Belgian Data Protection Authority imposed a fine of EUR 50,000 on the marketing company Family Service, which distributes “pink boxes” – well known by mothers and fathers-to-be in Belgium – for various breaches of the GDPR. Not only did the company rent out and/or sell the data of more than one million customers, including the data of children, for commercial purposes without informing its customers in a clear and comprehensible manner. The company also transferred these personal data to its business partner without obtaining a freely given, specific and informed consent. The Data Protection Authority considers the decision to be a warning to data brokers that rent or sell personal data under similar business models without proper compliance with the GDPR.

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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.

    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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Recent publications

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    • 19/02/2021
    • Articles

    European Commission Presents Hera Incubator to Bolster Fight against Coronavirus

    On 17 February 2021, the European Commission (the Commission) presented an updated version of the Vaccine Strategy which it had adopted in June 2020 to tackle the coronavirus (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020). The update was prompted by the need to address the increased threat of Covid-19 variants and is called somewhat bombastically the Hera Incubator because it foreshadows the future European Health Emergency Preparedness and Response Authority (HERA), whose advent was announced in November 2020 as part of the incipient European Health Union (see, Van Bael & Bellis Life Sciences News Alert of 12 November 2020). The Hera Incubator has 3 main components that, in turn, cover a range of detailed action points: • To detect, analyse and assess variants – The EU will support the development of specialised tests to detect new variants and support with at least EUR 75 million the associated genomic sequencing. The research and data exchange on variants will be bolstered with separate funding of EUR 150 million. The Commission also plans to launch the VACCELERATE COVID-19 clinical trial network which brings together 16 EU Member States and five associated countries, including Switzerland and Israel, to exchange data and include children and young adults as trial participants. • To speed up regulatory approval of adapted vaccines – The new rules will be modelled on the annual influenza vaccine model. The EU will also facilitate the certification of new or repurposed manufacturing sites by involving the regulatory authorities early. • To increase the production of COVID-19 vaccines – The Commission plans to adapt existing Advance Purchase Agreements and conclude new such agreements to support the development of new and adapted vaccines through EU funding. On 17 February 2021, the Commission already approved a second contract with Moderna that provides for an additional purchase of 300 million doses. Furthermore, the Commission also promises to establish “a detailed and credible plan showing capability to produce vaccines in the EU”. The overall EU manufacturing capacity will be expanded by the “EU FAB” project, a network of emergency response production facilities for vaccine and medicine manufacturing at EU level. Separately, the Commission will develop a voluntary dedicated licensing mechanism to facilitate technology transfer. This is probably a signal that the Commission will not follow the path of compulsory patent licences. The attached documents contain detailed information on the Commission’s plans.

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    • 19/02/2021
    • Articles

    European Commission | Assessment of Member State Rules on Health Data in Light of GDPR

    On 12 February 2021, the European Commission’s DG Health and Food Safety published an assessment of the EU Member State rules governing health data in the light of the General Data Protection Regulation (EU) 2016/679 (GDPR). The study’s objective was to examine possible differences between Member States and identify elements that might affect the cross-border exchange of health data in the EU for the purposes of healthcare, research, innovation and policy-making. The European Commission concluded that the existing fragmented approach of national rules governing health data between Member States hampers cross-border co-operation in the provision of healthcare, the administration of healthcare systems and research carried out so as to further public health objectives. The study discusses the use of health data for primary purposes (patient care), for secondary use in public health and for scientific or historical purposes. For each of these uses, the study analyses the legal bases for processing the data under the GDPR and inquires whether local legislation provides for alternatives to the use of consent as a legal basis. In response to the challenges identified, the study suggests actions at EU level to support the European Health Data Space and ensure the best possible use of health data. Furthermore, the study shows that co-operation between the EU Member States is crucial as it should draw on the work of national data protection authorities that come together as the European Data Protection Board, as well as on the numerous national and EU level bodies. Please click on the link below for a short article on the Commission’s assessment.

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    • 15/02/2021
    • Articles

    Belgium Creates Exceptional Regime for Temporary Reimbursement of Medicines

    The Royal Decree of 26 January 2021, which entered into force on 13 February 2021, establishes a regime for the temporary reimbursement of medicines “under exceptional circumstances or in situations of force majeure” that must be defined by the Council of Ministers (the Royal Decree). The temporary reimbursement will be achieved following a short procedure that only involves a proposal by the Service Medical Treatment of the National Institute for the Insurance of Disease and Invalidity (Dienst voor geneeskundige verzorging van het Rijksinstituut voor Ziekte-en Invaliditeitsverzekering/Service des soins de santé de l'Institut national d'assurance maladie-invalidité), an opinion by the Commission for the Reimbursement of Medicines (Commissie Tegemoetkoming Geneesmiddelen/Commission de remboursement des médicaments) (CRM) and a final reasoned decision by the Minister for Social Affairs and Public Health (Minister van Sociale Zaken en Volksgezondheid/Ministre des Affaires sociales et de la Santé publique). Crucially, the marketing authorisation holder (MAH) of the medicine at issue will not be heard. This is a dramatic departure from the regular reimbursement procedure governed by the Royal Decree of 1 February 2018 which can only be initiated by an application of the MAH and which provides for a repeated back and forth between the MAH and the CRM. The temporary reimbursement is designed to ensure that patients will not be deprived of “proper therapeutical means” (deugdelijke therapeutische middelen/moyens thérapeutiques valables) for financial reasons or otherwise. The new regime came into being because of the Covid-19 pandemic, but its application clearly transcends this crisis. The temporary reimbursement of a given medicine will apply during a stated period, during the time of the specific crisis that prompted the reimbursement or until the medicine becomes reimbursable as a result of a reimbursement decision which is based on a regular reimbursement application.

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