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    • 21/09/2021
    • News

    European Commission Announces Interim Measures to Avert Possibly Irreversible Consequences of Grail's Acquisition by Illumina

    Less than a month ago, the European Commission (the Commission) announced that it would open an investigation to determine whether Illumina’s decision to acquire Grail pending its review of that transaction under Regulation 139/2004 on the control of concentrations between undertakings (the Merger Regulation) is in breach of the “standstill obligation” provided for by Article 7, Merger Regulation (see, Van Bael & Bellis Life Sciences News & Insights of 24 August 2021). The Commission has now raised the stakes by issuing a Statement of Objections against Illumina in which it threatens to adopt interim measures designed, in the Commission’s words, to “prevent the potentially irreparable detrimental impact of the transaction on competition, as well as [the] possible irreversible integration of the merging parties, pending the outcome of the Commission's merger investigation” (see, attached press release of 20 September 2021). The Commission took pains to point out that Illumina’s autonomous decision to keep Grail separate following its acquisition (and thus avoid the possibly irreversible consequences which the Commission professes to avert) was not sufficient and presented several “serious shortcomings”. It also insisted that any adoption of interim measures would not preclude a possible later finding on the merits that Illumina’s conduct was in violation of the standstill obligation. The new hostilities come against the background of the Commission’s controversial assertion of merger control jurisdiction over the Illumina-Grail transaction which Illumina challenged before the European General Court.

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    • 25/10/2021
    • Articles

    European Commission Carries Out Dawn Raid at Belgian Premises of Animal Health Firm

    The European Commission (the Commission) announced this morning that it is carrying out unannounced inspections at the Belgian premises of a firm active in the animal health sector (see, attachment). The firm is suspected of having engaged in conduct in breach of Article 102, Treaty on the Functioning of the European Union, which prohibits the abuse of a dominant position on the relevant market. However, the Commission did not offer any details regarding the practices under review. The inspections follow on the heels of a speech on the subject of cartel enforcement which Commissioner Margrethe Vestager, responsible for competition policy, delivered last Friday in Rome. In that talk, the Commissioner not only referred to the high-profile inspections which the Commission had already carried out earlier in October 2021 in the wood pulp sector. She made it also clear that more would follow: “And that’s just the start of a series of raids that we’re planning for the months to come – you’ll understand if I don’t say exactly when or where they’re going to happen”. The Commissioner thus issued a strong warning to the business community that the Commission had emerged from the Covid-19 pandemic and that the Commission’s “work on collecting evidence [would be] gathering pace”. Commissioner Vestager also explained that, given the decrease in the number of leniency applications, the Commission is investing in alternative ways of detecting cartels. In leniency applications, members of a cartel take the initiative to contact a competition authority, confess their participation in the cartel and help the competition law enforcers to dismantle and sanction the cartel. The alternative detecting methods contemplated by Commissioner Vestager include (i) the development of an electronic tool for use by whistle blowers; (ii) the increased reliance on intelligence analysts and data scientists; (iii) informal discussions with industry members (“people on the ground”); and (iv) the sharing of ex officio leads with fellow competition authorities and other law enforcement agencies.

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    • 19/10/2021
    • Articles

    European Commission Updates Q&A on EU Clinical Trials Regulation

    On 18 October 2021, the European Commission published in Volume 10 (“Clinical trials guidelines”) of EudraLex an updated version of its Q&A document on the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014 – the CTR). The updated Q&A document replaces the previous version issued in July 2021. The document: • provides additional guidance on the content and way of submission of the protocol synopsis as referenced in Annex I, point D.24 of the CTR (see, updated answer to question 5.8); • clarifies how sponsors should determine and report the anticipated submission date of the annual safety report (see, answer to new question 7.39); • clarifies that “[i]nformation regarding the [good manufacturing practice] compliance of the active pharmaceutical ingredients is not required by the CTR (and can therefore not be required by the Member States Concerned)” (see, updated answer to question 8.4); and • is accompanied by an updated Annex II (“Language requirements for part I documents”). The CTR will enter into force on 31 January 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021, 9 August 2021 and 11 October 2021). It provides for a three-year transitional period during which clinical trials will be gradually transitioned into the CTR system. By 1 February 2025, all clinical trials will be governed by the CTR, regardless of their submission date.

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    • 14/10/2021
    • Articles

    European Commission Proposes to Delay Application of Regulation on In Vitro Diagnostic Medical Devices

    The European Commission (the Commission) published today a proposal for a Regulation delaying the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) by three to five years, depending on the risk involved in the devices concerned (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices – the Proposal; see, attached copy). The IVDR was set to take effect on 26 May 2022. Referring to the extraordinary circumstances created by the COVID-19 pandemic and the resulting delay in the designation and work of notified bodies under the IVDR, the Proposal stresses that immediate action is necessary to avert a “significant disruption in the supply of in vitro diagnostic medical devices on the market both for health institutions and for the public” (p. 2). To date, only six notified bodies have been designated under the IVDR. Moreover, these six notified bodies are established in only three countries (France, Germany and the Netherlands). Extending the existing transitional period for devices covered by a valid certificate issued under the current in vitro diagnostic medical devices Directive (Directive 98/79/EC) by one year, the Proposal provides that these devices can continue to be placed on the market or put into service until 26 May 2025. Furthermore, the Proposal introduces tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVDR. For these devices, the length of the transitional period will depend on the risk class of the device concerned. Lower risk devices such as class B and class A sterile devices will benefit from a transition period until 26 May 2027, whereas higher risk devices (class D and class C devices) will only have a transition period until, respectively, 26 May 2025 and 26 May 2026. The Proposal responds to a widespread call for delayed application of the IVDR. This call is not new though. As early as in April 2020, the European trade association for the medical devices sector, MedTech Europe, warned that “even before the COVID-19 pandemic, very little progress had been achieved yet, to get the new IVDR regulatory system ready” and that “since the present COVID-19 outbreak, the IVDR implementation progress has come to a total halt” (see, Van Bael & Bellis Life Sciences News and Insights of 24 April 2020).

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