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    • 27/03/2020
    • News

    Is The Covid-19 Pandemic A Force Majeure Event Under Belgian Law? Frequently Asked Questions

    Covid-19, also known as the coronavirus, continues to spread across the globe, including in Belgium.  The Belgian authorities have imposed a lock down on all private individuals and enterprises as from 18 March 2020 until 4 April 2020 (the Lock Down Period), but this Lock Down Period will in all likelihood be extended.

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    • 26/03/2020
    • Articles

    Covid-19 - 1. Belgium: Addendum to EU Guidance on Management of Clinical Trials | 2. Europe: EMA Public Consultation on Ongoing Clinical Trials

    The Belgian Federal Agency for Medicines and Health Products (FAGG/AFMPS; FAMHP) published yesterday its national addendum (the Addendum) to the EU Guidance on the Management of clinical Trials during the COVID-19 (Coronavirus) Pandemic that was released on 20 March 2020 (see, Van Bael & Bellis Life Sciences News Alert of 23 March 2020; the EU Guidance). The Addendum was prepared jointly by the FAMHP, the Clinical Trial College, the Belgian Association of Research Ethics Committees (BAREC) and certain research centres. It complements the EU Guidance with practical guidelines tailored to the Belgian context in relation to the following topics:

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    • 26/03/2020
    • Articles

    Belgium Tackles Medicine Shortages Caused by Spreading of Coronavirus

    The Belgian Official Journal of 25 March 2020 contains the text of the Royal Decree of 24 March 2020 providing for special measures to combat medicine shortages resulting from the pandemic created by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Koninklijk Besluit houdende bijzondere maatregelen ter bestrijding van tekorten van geneesmiddelen in het kader van de SARS-CoV-2 pandemie/Arrêté royal relatif à des mesures spéciales de lutte contre la pénurie de médicaments dans le contexte de la pandémie de SARS-CoV-2) (the Royal Decree – see, attachment). The Royal Decree confers on the Minister responsible for public health, or her representative, the Administrator General of the Federal Agency of Medicines and Health Products, the requisite powers to avert shortages of medicines necessary to combat the coronavirus. These powers include a range of measures, including imposing an export prohibition of medicines or ingredients; limiting the distribution or retail of medicines; rearranging the distribution of medicines or ingredients; and requisitioning stocks of medicines or ingredients. These measures cannot last longer than renewable periods of one month, subject to a total of 12 months. The Royal Decree itself will expire on 25 March 2021.

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    • 24/03/2020
    • Articles

    European Competition Network | Statement on Application of Competition Law during Corona Crisis

    On 23 March 2020, the European Competition Network (ECN), which includes the European Commission and the national competition authorities of the EU, issued a statement “on application of competition law during the Corona crisis” – see attachment. The ECN explains that it “understands that this extraordinary situation may trigger the need for companies to cooperate in order to ensure the supply and fair distribution of scarce products to all consumers”. Given this state of affairs, the ECN “will not actively intervene against necessary and temporary measures put in place in order to avoid a shortage of supply”. According to the ECN, such measures would not be anticompetitive: either they would not amount to a restriction of competition or they would be exempted as the efficiencies generated would “most likely outweigh any such restriction”. The ECN invites any company in doubt regarding the legality of a possible cooperation initiative to contact the European Commission, the EFTA Surveillance Authority or a national competition authority for informal guidance. At the same time, the ECN also stresses that “it is of utmost importance to ensure that products considered essential to protect the health of consumers in the current situation (e.g. face masks and sanitising gel) remain available at competitive prices”. Therefore, the ECN will “not hesitate to take action against companies taking advantage of the current situation by cartelising or abusing their dominant position”. The ECN also reminds manufacturers that they can impose maximum resale prices for their products, which “could prove useful to limit unjustified price increases at the distribution level”. This statement echoes the position which was adopted recently by the Competition and Markets Authority in the UK and by the Bundeskartellamt in Germany.

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    • 23/03/2020
    • Articles

    EU Guidance on Conduct of Clinical Trials During COVID-19 Pandemic and Specific Advice on Initiation of Clinical Trials for Treatments of COVID-19

    The European Commission, the European Medicines Agency (EMA) and the national Heads of Medicines Agencies (HMA) released on 20 March 2020 guidance for clinical trial sponsors on how to manage their clinical trials during the COVID-19 pandemic (the Guidance; available here). The Guidance aims to serve as an EU-level harmonised set of recommendations on changes and protocol deviations which may needed due to, e.g., trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections and health care professionals being reallocated. Furthermore, the Guidance provides specific advice on the initiation of new clinical trials for potential COVID-19 treatments or vaccines. Guidance on Conduct of Clinical Trials During COVID-19 Pandemic The key objective of the Guidance is to ensure the safety of trial subjects across the EU while preserving the quality of the data generated by the trials. According to the Guidance, sponsors should consider specific measures such as:

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    • 19/03/2020
    • Articles

    Coronavirus : Update on Measures Related to Safeguarding Employment Following the Lockdown Measures of 12 and 17 March 2020

    Referring to our newsflash dated 10 March 2020, you will find below an overview of the complementary employment-related measures which have been put in place following the lockdown measures within the framework of Covid-19 as announced by the Belgian government on 12 and 17 March 2020. These measures are subject to continuous changes. The current newsflash provides an overview of the situation to date and we will keep you informed about any important developments in this respect. Click below to read the complementary employment-related measures.

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    • 16/03/2020
    • Newsletters

    VBB on Belgian Business Law, Volume 2020, No. 2

    The February 2020 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.

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    • 16/03/2020
    • Articles

    European Commission Publishes European Union Strategic Approach to Pharmaceuticals in the Environment

    The European Commission (the Commission) presented on 11 March 2020 its “European Union Strategic Approach to Pharmaceuticals in the Environment” (the Strategic Approach) (see, attached Commission press release, communication and fact sheet). The Strategic Approach seeks to combat the pollution of surface water, ground water and soil with pharmaceutical residues. It has been long in the making: the legal sources which the Commission cites as a basis for the Strategic Approach, namely the Priority Substances Directive and the pharmacovigilance rules, date back to 2008 and 2010 respectively. Similarly, the publication of the Commission’s policy roadmap and public consultations have already taken place in 2017 (see, Van Bael & Bellis Life Sciences Newsflash of 2 May 2017). The Strategic Approach now sets out six areas for action, each of them encompassing a range of concrete measures which will be initiated (and some of them completed) in 2020: • Increasing awareness and promote prudent use of pharmaceuticals; • Supporting the development of pharmaceuticals that are intrinsically less harmful for the environment; • Improving the environmental risk assessment and its review; • Reducing wastage; • Expanding environmental monitoring; and • Filling the remaining knowledge gaps.

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    • 12/03/2020
    • Articles

    European Commission Presents Digital Strategy on Data and Artificial Intelligence

    On 19 February 2020, the European Commission published its white paper on artificial intelligence (AI) – “A European approach to excellence and trust” (the White Paper). According to the White Paper, in simple terms, AI is a collection of technologies that combine data, algorithms and computing power for the benefit of citizens, businesses and the public interest in general. In essence, the White Paper sets out policy options on how to achieve a balance between encouraging the uptake of AI while addressing the associated risks through potential regulation. On the same day as the publication of its white paper on artificial intelligence, the European Commission unveiled a new European data strategy. With this five-year plan, the Commission wants to create a single European data space, which is a single market for data that will be open to data from across the world. The European data strategy and the white paper on artificial intelligence are the first pillars of broader policy initiatives that involve a digital strategy and a framework for the development of Artificial Intelligence.

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