News & Insights

  • 29/06/2020
  • News

Van Bael & Bellis to open London office

Van Bael & Bellis announces today that it will open a London office on 1 September 2020, subject to SRA approval.  Located at 5 Chancery Lane, the office will be led by senior partner David Hull, managing partner Philippe De Baere and partner Alex Stratakis, who will join from Baker McKenzie’s London office.

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    • 27/11/2020
    • Articles

    European Commission Fines Cephalon and Teva On Account of "Pay-for-Delay" Patent Settlement Agreement

    On 26 November 2020, the European Commission (the Commission) brought to an end a long running competition case by finding against Cephalon and Teva on account of a “pay-for-delay” patent settlement agreement involving modafinil, the active substance of a sleeping disorder medicine (see, attached Commission press release).

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    • 26/11/2020
    • Articles

    European Commission Presents Pharmaceutical Strategy for Europe

    On 25 November 2020, the European Commission (the Commission) unveiled its Pharmaceutical Strategy for Europe (PSE), a wide-ranging document that discusses a series of broad policy statements, tentative considerations and concrete measures to tackle the many challenges faced by the pharmaceutical sector and its diverse stakeholders (see, attached Commission Communication (2020) 761 final; Commission press release; and Commission Q&A). The announcement follows an extensive period of consultation, study and preparation (see, Van Bael & Bellis Life Sciences News Alerts of 20 October 2020; 12 August 2020; 17 June 2020; 3 June 2020; and 28 May 2020).

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    • 25/11/2020
    • Articles

    EU publishes proposed amendments to the Dual-use Regulation

    On 10 November 2020, the European Council and the European Parliament agreed on the text of a long-awaited amendment to Regulation 428/2009 setting up an EU regime for the control of exports, transfer, brokering and transit of dual-use items (“Dual-use Regulation”). The proposal widens the scope of the EU dual-use control regime to cover cyber-surveillance technology and the supply of technical services related to dual-use items. Changes also include new conditions to obtain an export authorisation and the introduction of national control lists. This Client Alert sets out the proposal’s key points.

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    • 25/11/2020
    • Articles

    Potential Covid-19 Vaccine Supplier Moderna Sixth Contract Partner of European Commission

    On 24 November 2020, European Commission President von der Leyen released a statement announcing that she would approve a sixth agreement with a supplier of a potential Covid-19 vaccine (see, attachment). The Commission’s new contract partner is Moderna. Under the agreement, the Commission will have the right to buy up to 160 million doses of the vaccine, if and when that product obtains a marketing authorisation from the European Medicines Agency. In recent days, the Commission announced similar deals with CureVac (see, Van Bael & Bellis Life Sciences News Alert of 17 November 2020) and with BioNTech and Pfizer (see, Van Bael & Bellis Life Sciences News Alert of 12 November 2020). The Commission President suggested that a seventh agreement is being negotiated which paves the way for the creation in Europe of “one of the most comprehensive COVID-19 vaccine portfolios in the world”.

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    • 24/11/2020
    • Articles

    United Kingdom - CMA Consulting on Proposed Commitments from Essential Pharma to Keep Bipolar Medicine on Market at Affordable Prices

    Early last month, the Competition and Markets Authority (CMA) started an investigation into Essential Pharma because of suspicions that the firm might have abused an allegedly dominant position by taking steps to withdraw Priadel® from the UK market. This is a lithium based medicine indicated for the first line treatment of bipolar disorder and other mental conditions (see, Van Bael & Bellis Life Sciences News Alert, 7 October 2020).

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    • 23/11/2020
    • News

    Outgoing U.S. Administration Adopts Most Favoured Nation Payment Model for Medicines

    On 20 November 2020, U.S. Department of Health and Human Services Secretary Alex Azar announced the creation of a medicine payment model that would reduce the price of specific medicines in the United States to the level of the lowest price for similar medicines in comparison countries (see, attached press release). The model, now dubbed Most Favoured Nation (MFN) Model, follows a plan (see, Van Bael & Bellis Life Sciences News Alert of 14 May 2018) and a series of Executive Orders of the U.S. President to bring medicine prices down for U.S. patients while terminating what the President has repeatedly referred to as “foreign freeriding” (see, Van Bael & Bellis Life Sciences News Alert of 15 September 2020 for a discussion of the most recent Executive Order on the subject).

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