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European Commission Launches European Health Emergency Preparedness and Response Authority

  • 17/09/2021
  • Articles

On 16 September 2021, the European Commission (the Commission) decided to establish the European Health Emergency Preparedness and Response Authority (HERA) which will seek to prevent, detect, and respond to health emergencies and will complement the work carried out by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). However, unlike these autonomous agencies, HERA will be created as a Commission service, headed by a Director-General, and will therefore remain under its control. As such, it will form an important part of the emerging European Health Union (see, Van Bael & Bellis Life Sciences News & Insights of 30 June 2021, 19 February 2021, and 12 November 2020).
 
According to Article 2 of the Commission Decision establishing HERA, the new service will be given a range of tasks, including assessing health threats and ensuring directly or indirectly the research, development, production, procurement, distribution, stockpiling and knowledge building in relation to what are referred to as “medical countermeasures” (MCM).
 
MCM are products used to face serious health threats and include antibiotics, chemical antidotes, diagnostic tests, medical equipment, personal protective equipment, therapeutics and vaccines. In addition to the decision establishing HERA, the Commission also tabled a proposed Regulation “on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level”.
 
While HERA will be a Commission service, its board will consist of one representative of each Member State.  In a move unlikely to meet with a warm welcome, the European Parliament will only be invited to designate an observer to the HERA board and will thus be placed on an equal footing with several specialised EU agencies and bodies.
 
HERA will rely on a budget of EUR 6 billion from the current Multiannual Financial Framework for the period covering 2022-2027, but other EU programmes will also make contributions, thus causing the total European support to reach an estimated EUR 30 billion. The Commission points out that the project’s firing power will even be larger as a result of additional Member State initiatives and private sector ventures.
 
The attached extensive documentation includes a (i) Commission press release; (ii) Commission questions and answers file; (iii) Commission Communication on the subject; (iv) annex to the Communication; (v) Commission decision establishing HERA; and (vi) proposed Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.

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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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    • 11/10/2021
    • Articles

    EU Clinical Trials Regulation - EMA Publishes Clinical Trial Information System Go-live Plan

    On 8 October 2021, the European Medicines Agency (EMA) provided an update on the progress in the development and preparations for the ‘go-live’ of the Clinical Trial Information System (CTIS) on 31 January 2022. EMA also published a 12-page CTIS go-live plan summarising the key steps remaining before the launch of CTIS (the Plan; see, attached copy). According to EMA and the Plan, CTIS is currently being extensively tested to identify any potential remaining stability issues. A key priority in preparing CTIS for launch is ensuring that the sponsor workspace is fully functional. Once this has happened, the workspace for health authorities will be finished, followed by the public portal. Other priorities are to set up a dedicated helpdesk for CTIS users and to prepare materials for “extended stakeholder training”. These materials will complement the existing training materials already issued by EMA, including online training modules and a sponsor handbook (see, Van Bael & Bellis Life Sciences News and Insights of 9 August 2021). Further preparations are also necessary to allow for clinical trial safety reporting and monitoring as included in the initial scope of CTIS activities. The Plan provides for all of the outstanding matters a chart with a timeline for their implementation. In the first quarter of 2022, EMA will publish a follow-up plan focusing on the activities post 31 January 2022 which will cover post go-live releases, CTIS operation and maintenance, continued training offerings and stakeholder support and interaction. CTIS is the cornerstone for the application of the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014). Comprising an EU Portal and EU Database, CTIS will ensure a single-entry point for the submission of data and information relating to clinical trials by sponsors, evaluation and supervision by Member State health authorities, and access to publicly available data and information relating to clinical trials by the public (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021 and Van Bael & Bellis Life Sciences News and Insights of 9 August 2021).

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    • 11/10/2021
    • Articles

    Belgium, Ireland, and The Netherlands Jointly Agree under Aegis of Beneluxa Initiative to Reimburse Zolgensma®

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