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.