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Belgium - Creation of New Commission for Reimbursement of Pharmaceutical Products and Benefits

  • 11/03/2020
  • News

Please find attached a note on Belgium’s new Commission for Reimbursement of Pharmaceutical Products and Benefits.


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    • 26/03/2020
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    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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