Regulation 2022/123 - Reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices - Main contents

EN

Official Journal of the European Union

L 20/1

Pursuant to Articles 9 and 168 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in the definition and implementation of all Union policies and activities.

The COVID-19 pandemic has highlighted the interconnectedness of human, animal, and ecosystem health and the risks posed by the loss of biodiversity on Earth. As recognised by the World Health Organization, many of the same microbes infect animals and humans, so efforts that focus only on human health or only on animal health cannot prevent or eliminate the problem of disease transmission. Diseases may be transmitted from humans to animals or vice versa and therefore need to be tackled in both humans and animals, taking advantage of potential synergies in research and treatments. Approximately 70 % of emerging diseases, and almost all known pandemics, namely influenza, HIV/AIDS and COVID-19, are zoonoses. Those diseases have increased globally over the past 60 years. Changes in land use, deforestation, urbanisation, agricultural expansion and intensification, wildlife trafficking and consumption patterns are factors that have contributed to that increase. Zoonotic pathogens can be bacterial, viral or parasitic, and can include unconventional agents that are able to spread to humans through direct contact or through food, water or the environment. The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the Union to achieve better public health outcomes, since, as stated in Regulation (EU) 2021/522 of the European Parliament and of the Council (4), ‘human health is connected to animal health and to the environment and … actions to tackle threats to health must take into account those three dimensions’.

The unprecedented experience of the COVID-19 pandemic has also highlighted the difficulties of the Union and the Member States in addressing such a public health emergency. In that regard, it has demonstrated the need to strengthen the Union’s role in order to be more effective in managing the availability of medicinal products and the availability of medical devices and in vitro diagnostic medical devices and their respective accessories (collectively ‘medical devices’) and in developing medical countermeasures to address the threats posed to public health at an early stage in a harmonised way that ensures cooperation and coordination between Union, national and regional competent authorities, medicinal products and medical devices industry and other actors in the supply chains for medicinal products and medical devices, including healthcare professionals. While the Union needs to give a higher priority to health, its ability to ensure the continued provision of high quality healthcare services and to be prepared to address pandemics and other health threats has been severely...