The proposal is consistent with the initiatives taken under EU policies such as the European Health Union and the Pharmaceutical Strategy for Europe. It is particularly consistent with the initiatives described below.

On 14 April 2020, the Council activated the Emergency Support Instrument (ESI), which helps Member States respond to the COVID-19 pandemic by addressing urgent needs in a strategic and coordinated manner at EU level.

On 2 June 2020, the Commission proposed targeted changes to the EU Civil Protection Mechanism, allowing the Union and the Member States to be better prepared for and react quickly and effectively to future crises, in particular those with a high-impact given the potential disruption to our economies and societies, as seen so clearly in the COVID-19 emergency. The overall objective of the EU Civil Protection Mechanism is to strengthen cooperation between the EU Member States and six participating States in the field of civil protection, with a view to improve prevention, preparedness and response to disasters. When the scale of an emergency overwhelms the response capabilities of a country, it can request assistance via the Mechanism. Through the Mechanism, the Commission plays a key role in coordinating the response to disasters in Europe and beyond and contributes to at least 75% of the transport and/or operational costs of deployments. The Emergency Response Coordination Centre (ERCC) of the Commission is the heart of the EU Civil Protection Mechanism and coordinates the delivery of assistance to disaster stricken countries, such as relief items, expertise, civil protection teams and specialised equipment.

In the 2020 State of the Union address of 16 September 2020, the President of the Commission stressed the need to draw lessons from the current crisis and build a European Health Union. In parallel, she outlined the corresponding key initiatives for 2021 in a Letter of Intent to the President of the European Parliament and the Council Presidency. Those initiatives also contain legislative proposals aimed at establishing a new European Biomedical Research and Development Agency, extending the mandates of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) as well as establishing a European health data space.

In its 2021 Work Programme, the Commission underlined the need to strengthen our crisis preparedness and management of cross-border health threats and confirmed that it is time to build a stronger European Health Union. The Work Programme contains legislative proposals to reinforce the EU’s framework for detecting and responding to serious cross-border health threats, and to strengthen the roles of existing agencies. Further initiatives will cover a proposal to establish an agency for biomedical advanced research and development, a new pharmaceutical strategy ensuring citizens can rely on safe, affordable and high quality medicines and a European health data space to harness data for better healthcare, better research, and better policy making to the benefit of patients.

In March 2021, the new Programme for the Union’s action in the field of health (‘EU4Health Programme’) was adopted, which aims to make health systems more resilient to deal with cross-border health threats like COVID-19 and improve crisis management capacity. Moreover, it will make the European Health Union a reality by investing in cancer care, better pandemic preparedness, availability of medicines and innovation and boost digital health and disease prevention.

With its Communication of 11 November 2020, the Commission set out the first building blocks for a European Health Union. The Communication was accompanied by three legislative proposals: a Regulation on serious cross-border threats to health replacing Decision 1082/2013/EU, a strengthening of the mandates of the ECDC and of the EMA.

The new European Health Union initiative advocates the strengthening of existing structures and mechanisms for better EU level protection, prevention, preparedness and response against human health hazards. It recommends a reinforced framework for cross-border cooperation against all health threats in order to protect lives better and to safeguard the internal market as well as to maintain the highest standards in the protection of human rights and civil liberties. It also strengthens the EU role in international coordination and cooperation to prevent and control cross-border health threats and improve global health security.

In the context of the new European Health Union, the Commission also announced a legislative proposal to be presented before the end of 2021 setting up the Health Emergency Response Authority (HERA).

With its Communication of 25 November 2020, the Commission put forward a new Pharmaceutical Strategy for Europe, presenting concrete actions to ensure accessibility, availability and affordability of medicines. These will support diversified and secure supply chains, ensuring the EU's open strategic autonomy in the world, and will promote environmentally sustainable pharmaceuticals. The strategy also aims at enhancing crisis preparedness and response mechanisms.

It is important to note that existing and future EU agencies as well as other EU bodies play an increasingly important role in pursuing the objectives of the aforementioned or other future initiatives. Hence, the present legislative proposal should also cover supplies made to or imports made by these agencies or bodies.

The EMA was founded in 1995 and its mission is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health. Its mandate will be reinforced in the context of the new European Health Union as to include monitoring and mitigating potential shortages of critical medicines and medical devices, providing scientific advice on medicines with potential to treat, prevent or diagnose diseases causing crises, coordinating studies to monitor the effectiveness and safety of vaccines as well as coordinating clinical trials.

Established in 2005, the ECDC’s mission is to identify, assess and communicate current and emerging threats to human health posed by infectious diseases. Its future mandate will cover epidemiological (real-time) surveillance, preparedness and response planning, reporting and auditing, provision of non-binding recommendations and options for risk management, capacity to mobilise and deploy EU Health Task Force to assist local response in Member States and building a network of EU reference laboratories and a network for substances of human origin.

The future HERA’s mission will be to enable the EU and its Member States to deploy rapidly the most advanced medical and other measures in the event of a health emergency, by covering the whole value chain from conception to distribution and use.

Several joint procurements have been carried out or are planned during 2020/2021 covering goods necessary to cope with the COVID-19 pandemic such as personal protective equipment (PPE), ventilators, laboratory equipment, vaccination material, rapid-antigen tests and therapeutics (e.g. Remdesivir). Under the Emergency Support Instrument, the Commission has directly procured masks, therapeutics and tests for donation to Member States.