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    • 03/12/2018
    • Articles

    Five Further Member State Inspectorates Recognised under EU - US Mutual Recognition System for Medicines

    The Agreement on Mutual Recognition between the European Union and the United States of America continues its roll-out in the realm of pharmaceutical inspections. On two separate occasions in November 2018, the US Food and Drug Administration (“FDA”) added 5 new EU Member States to its list of countries which it considers to have capable inspectorates to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that observed in the US. These Member States are Belgium, Denmark, Estonia, Finland and Latvia. The updated list of in total 20 Member States whose inspection results the FDA considers can replace its own inspections can be found here: https://www.fda.gov/internationalprograms/agreements/ucm598735.htm. The EU and the US thus seem to be on track to have all EU Member States recognised as capable of carrying out pharmaceutical inspections by 15 July 2019. For its part, the FDA had already been earmarked as a capable inspectorate on 1 November 2017.

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    • 30/11/2018
    • Articles

    OECD - Pharmaceutical Innovation and Access to Medicines

    The Organisation for Economic Cooperation and Development (“OECD”) has just published a study on Pharmaceutical Innovation and Access to Medicines (the “Study” - available here: Pharmaceutical Innovation and Access to Medicines). The Study forms a response to a request by 35 member countries to prepare a report detailing the challenges for governments in ensuring that their populations have access to novel medicines at a reasonable cost while at the same time maintaining the pharmaceutical sector’s capacity for innovation.

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    • 22/11/2018
    • Articles

    "National Healthcare Insurance Systems Are Allowed To Reimburse Off-Label Use of Medicine" Says ECJ

    The Court of Justice of the European Union (“ECJ”) held this morning that under EU law national healthcare insurance systems are allowed to reimburse a medicine for a use not covered by that product’s marketing authorisation (see attached – Case C-29/17, Novartis and others v. Agenzia Italiana del Farmaco and others, judgment of 21 November 2018). The ECJ’s judgment came at the request of the Italian Council of State which had been asked to handle litigation between Novartis and various Italian health authorities over the reimbursement of Avastin for off-label use in the management of the eye-condition wet age-related macular degeneration (“AMD”).

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    • 16/11/2018
    • News

    Jean-François Bellis moderates panel at LeadershIP EU’s 2nd annual conference in Brussels

    On 13 November 2018, Van Bael & Bellis co-managing partner Jean-François Bellis moderated a panel at LeadershIP EU’s 2nd annual conference, which explored the impact of IP and competition policy on global business and innovation looking toward the future, 5G and emerging technologies. The panel was titled Effects-Based Analysis: Where Do We Stand on Both Sides of the Atlantic? and the discussion focused on the competition law trends in the US and the EU in the area of effects-based analysis. The other panel members were the Honourable Douglas Ginsburg, Senior Circuit Judge, US Court of Appeals for the District of Columbia and Sir Robin Jacob, Sir Hugh Laddie Chair of Intellectual Property Law, University College London and Former Justice in the Court of Appeal of England and Wales. Further details about the conference are available here.

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    • 16/11/2018
    • Articles

    Novelties regarding Clinical Trials - Law of 30 October 2018 containing Miscellaneous Provisions regarding Health

    The Belgian Official Journal publishes today a Law of 30 October 2018 containing miscellaneous provisions regarding health. The attached case note sheds light on new rules governing clinical trials.

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    • 13/11/2018
    • Articles

    UK House of Commons Health and Social Care Committee Makes Broad Pricing Information Request Regarding Orkambi®

    The Chair of the Health and Social Care Committee of the UK House of Commons wrote on 7 November 2018 to Vertex, the National Health Service (“NHS England”) and the National Institute for Health and Care Excellence (“NICE”) to request pricing information regarding the cystic fibrosis medicine Orkambi® (see attached letters). The move follows two-and-a-half years of unsuccessful pricing negotiations between these parties.

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    • 12/11/2018
    • Articles

    New Belgian Ultimate Beneficial Owners Register

    The Royal Decree of 30 July 2018 (the Royal Decree), which entered into force on 31 October 2018, sets out the legal framework in relation to the new central register of beneficial ownership (the UBO Register) and the obligation for all Belgian companies and other entities to communicate information in relation to their ultimate beneficial owner(s) (UBOs) for inclusion in the UBO Register.

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    • 09/11/2018
    • Articles

    Belgian Competition Authority Adopts Draft Decision Against Professional Organisation of Pharmacists

    The College of Prosecutors of the Belgian Competition Authority (“BCA”) announced on 8 November 2018 that it has submitted a draft infringement decision to the Competition College with the request to review the Prosecutors’ findings and take a final decision against the professional organisation of pharmacists known as “Orde der Apothekers”/”Ordre des pharmaciens” (the “PO”).

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    • 08/11/2018
    • Articles

    Court of Justice of European Union Refuses to Grant SPCs for Medical Devices

    The Court of Justice of the European Union held on 25 October 2018 in Boston Scientific that a medical device which incorporates an ancillary medicinal product does not qualify for patent protection under a Supplementary Protection Certificate. The attached case note sheds light on the Court’s reasoning.

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