rec_53

(53) Given the nature and potential scale of cross-border threats to health, the objectives of protecting people in the Union from such threats and increasing health crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 TEU, action at Union level can also be taken to support Member States’ efforts in the pursuit of a high level of protection of public health, to improve the availability, sustainability, acceptability, accessibility, safety and affordability in the Union of medicinal products, medical devices and crisis-relevant products and services, to support innovation, to support integrated and coordinated work and the implementation of best practices among Member States, and to address inequalities and inequities in access to healthcare throughout the Union in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level, while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.