The European Commission’s targeted evaluation of the strategy to support medical countermeasures against public health threats: Comment from the Institute for Quality and Efficiency in Health Care (IQWiG) 5 May 2025

05.05.2025

Hinweis

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The Institute for Quality and Efficiency in Health Care (IQWiG) is Germany’s independent agency for health technology assessment (HTA, https://www.iqwig.de/en/). IQWiG produces scientific reports on various topics, including medicinal products, medical device inter­ventions, and other interventions (e.g. screening). These HTA reports are used by the Federal Joint Committee (G-BA), the main decision-making body in the German health care system, to decide about reimbursement and pricing within Germany’s statutory health care insurance.

As the Commission has rightly pointed out, strengthening the EU’s crisis preparedness requires a framework to ensure the development, assessment, and supply of crisis-relevant medical countermeasures. In the event of a public health emergency at Union level, it is essential, inter alia, to develop evidence-based recommendations on common temporary public health measures (as stated in Article 22 of Regulation (EU) 2022/2371). This task will mainly be entrusted to the Advisory Committee on Public Health Emergencies (according to Article 24 of Regulation (EU) 2022/2371).

As part of the EU Member State Coordination Group on (HTACG), IQWiG would like to highlight the beneficial synergies between HTA (as defined in Regulation (EU) 2021/2282) and the selection of emergency public health measures (as defined in Article 22 of Regulation (EU) 2022/2371). The contribution of HTA bodies in providing comparative effectiveness and safety information on medical countermeasures could support decision-making on the selection of effective and efficient measures. The EU HTA Regulation specifically mentions that “voluntary cooperation on HTA can cover” almost any area, including treatment, prevention, screening and health promotion programmes. At Union or national level, HTA agencies should cooperate with or participate in the Advisory Committee on Public Health Emergencies or the European Centre for Disease Prevention and Control.

The methods and the processes for assessing emergency public health measures are similar to those for other health technologies. The main difference comes from the fact that public health threats require decisions within days or weeks rather than months. To speed up systematic reviews, rapid review methods were developed about 15 years ago (https://doi.org/10.1111/j.1744-1609.2012.00290.x). During and after the COVID19 pandemic, systematic reviewers and HTA scientists optimized the methods for conducting rapid reviews and so-called ‘living’ reviews, which summarize all relevant scientific information. These rapid reviews were produced within days (https://doi.org/10.2807/1560-7917.es.2020.25.19.2000687) or weeks (https://doi.org/10.1002/jrsm.1580) and had a considerable impact on public health decisions during the COVID19 pandemic, as shown by data from Canada and Australia (https://doi.org/10.1016/j.jclinepi.2025.111673).

Especially in urgent situations, when early evidence is sparse and new evidence emerges rapidly, it may be crucial to continuously monitor and synthesize the available evidence. Living systematic reviews (https://doi.org/10.1016/j.jclinepi.2017.08.010) provide a methodology that proved successful during the COVID19 pandemic (https://doi.org/10.1016/j.jclinepi.2021.09.013), with tight updating intervals being feasible (https://doi.org/10.1186/s13643-019-1248-5). Such reviews have been shown to be helpful in supporting public health decision-making (https://doi.org/10.2105/ajph.2023.307450 ).

Therefore, it is worthwhile to add rapid and living HTA methods to the armamentarium that can be used in a public health crisis.