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

  • 25/10/2021
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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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    • 12/11/2021
    • Articles

    Belgium - Publication and Presentation of Policy Note Public Health - Impact on Pharmaceutical and Medical Devices Sectors

    The Minister of Social Affairs and Public Health (the Minister) just published his policy note (beleidsnota/note de politique générale) which he is scheduled to present to the Committee for Health and Equal Opportunities of the federal Chamber of Representatives on 16 November 2021 (the Policy Note – see, attachment). The Policy Note goes in tandem with the healthcare budget (estimated to reach EUR 31,755,422,000,000 in 2022). The Policy Note discusses the full range of public health policy aspects, including financing, managing health crises, reorganising public healthcare, access, quality control, care efficacy, evidence-based care, healthcare professions, preventive measures, addictions, digitisation of care, related policies, international relations and financial control of payers (sick funds) and healthcare practitioners. Unsurprisingly, the Policy Note deals extensively with pharmaceuticals and medical devices as well. The following points stand out: • Industry cooperation - As was the case for his predecessor, the Minister will again conclude agreements with the pharmaceutical and medical devices sectors to “define the priorities of each stakeholder in the interest of public health and specifically the patient” (p. 54). • Shortages - The Minister will complete the regulatory framework governing medicine shortages (p. 54) and promises to publish “very soon” a first implementing decree in relation to the transparency of wholesaler-distributors. Other implementing decrees will follow and Belgium will also advocate for the expansion of the existing joint procurement and emergency stock measures at EU level (p. 55 and p. 77). • Regulatory reorganisation and efficacy-enhancing measures for in vitro diagnostics and personalised medicine – The Minister will streamline and accelerate procedures by reorganising the various authorities involved in authorising and reimbursing care. An example is that of the joint contributions towards one specific form of treatment by clinical biology, companion diagnostics and medicines (p. 55 and p. 56). • Unmet medical need – The Minister announces a range of initiatives with regard to clinical trials, access and financing of innovative therapies, and medicine repurposing (p. 40, p. 41, p. 58, and p. 59). • Reimbursement of medicines – The Policy Note repeats an earlier promise that the procedure governing the reimbursement of medicines, including Managed Entry Agreements, will be assessed and revised (p. 57). Contrary to earlier indications, the Policy Note does not tackle the role of the pharmaceutical sector in financing hospitals, even though hospital financing is addressed extensively (p. 5, p. 22, p. 23, p. 24, p. 25, p. 31, and p. 32).

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    • 12/11/2021
    • Articles

    Council of EU Approves Health Technology Assessment Regulation

    On 9 November 2021, the Council of the European Union (Council) gave its green light for the adoption of the proposed Regulation on Health Technology Assessment (HTA) (the Regulation). Attached are a copy of the text as approved by the Council (See, first attachment) and the Council’s accompanying statement of reasons (See, second attachment). Raising subsidiarity concerns, Bulgaria and Poland issued statements indicating that they are unable to support the proposed Regulation (See, third attachment) and, therefore, abstained from voting. With the Council’s approval, the Regulation’s legislative process is nearing completion. This process was initiated in January 2018 when the European Commission first issued its proposed Regulation (See, Van Bael & Bellis Life Sciences News & Insights of 1 February 2018 and 8 October 2018). The Regulation now just requires a final vote by the European Parliament to become law. This step is expected to be a formality. Pursuant to its Article 36, the Regulation will start to apply three years after its entry into force (which will happen 20 days after the Regulation’s publication in the EU Official Journal). HTA is a technique to evaluate the medical, social, economic, organisational and ethical issues of a health technology, including medicines, medical devices and medical interventions. The main purpose of conducting an assessment is to inform policy decision-making. In practical terms, the Regulation envisages the following four avenues of cooperation: • joint clinical assessments; • joint scientific consultations in response to requests for advice from the life sciences sector; • identification of emerging health technologies (known as “horizon scanning”); and • voluntary cooperation in areas outside the scope of mandatory cooperation.

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    • 29/10/2021
    • Articles

    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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