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Health and Food Safety 2022

2022 Annual Report on monitoring the application of EU law - Infringement cases by policy area

Infringement cases open at year-end 2018 - 2022

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By clicking on the multi-level chart, you can consult, for 2022, the number of infringement cases open at the year-end per policy sector and per type of infringement.

Compliance promotion activities in 2022

Guidelines on how to implement EU law

To assist Member States in the transposition and implementation of the Cross-Border Healthcare Directive (Directive 2011/24/EU) with the aim of facilitating the access to safe and high-quality cross-border healthcare, the Commission published a guidance document. The purpose of this guidance is to set out key principles to help National Contact Points provide more transparent, accessible, and understandable patient-oriented information on prior authorisation. This will make it easier for patients to know what treatments require prior authorisation from their health insurance institution and how to obtain this prior authorisation for their treatment abroad. Patients and healthcare providers will furthermore benefit from this guidance as it enhances the transparency of the prior authorisation systems and the legal rights of patients to information on how to access cross-border healthcare.

Meetings with Member States

Other compliance promotion tools

  • With the aim of ensuring patients’ rights to access cross-border healthcare, the Commission published a report on the application of patients’ rights in cross border healthcare, including an evaluation of the Cross-Border Healthcare Directive and an action plan to address the shortcomings and enhance the implementation of the Directive. The evaluation concluded that the Directive is still relevant to address current patients’ needs, and has enshrined important patient rights, such as equal treatment of EU and domestic patients. To assist Member States in the transposition and implementation of the Directive in a number of areas, for instance to reduce administrative obstacles for patients seeking prior authorisation and reimbursement of cross-border healthcare across the EU, the Commission published the Mapping and Analysis of Administrative Procedures: analytical report.
    In addition, under Article 20 of the Cross-Border Healthcare Directive, the Commission contracted a study to provide an overview of cross-border patient mobility and the reimbursement system used for planned healthcare treatment in a number of selected border regions and between neighbouring Member States.
  • In 2022, a large part of the draft technical regulations notified to the Commission in accordance with the Single market transparency directive were related to the areas of health and food safety. Such notifications were assessed and the notifications raising concerns as to their compatibility with EU law were followed up by detailed opinions or comments in accordance with the Directive.
  • Furthermore, the Commission performed 84 audits and similar checks during 2022 to verify the correct implementation of EU standards on food (including food safety, feed safety, food quality, animal health and welfare, plant health) and certain areas of human health within the Member States. By systematically following up on its audit recommendations in follow-up audits to Member States, the Commission was able to resolve most shortcomings identified. The outcome of the audits and similar controls is made available to the public on the website of the Commission.

Follow-up given to petitions

In 2022, the Commission did not handle any petition concerning an alleged breach of EU law in the policy area of Health and Food Safety.

Important preliminary rulings

Outlook for 2023

In 2023, the Commission will conduct important enforcement actions on both policy areas, health and food safety.

As a matter of priority, the Commission will follow-up on pending infringement procedures and audits, and support implementation of EU rules by actions at policy level.

Regarding public health, and in particular in relation to the Cross-Border Healthcare Directive (Directive 2011/24/EU), the following actions to promote its implementation and application are planned for 2023:

  • Organise bilateral dialogues with Member States to monitor and improve how they apply the Directive, for example as regards the proportionality of administrative procedures to access cross-border healthcare.
  • Exchange best practices with Member States on streamlining procedures to access cross-border healthcare through digitalisation.
  • Exchange best practices with Member States on the transparency of prices for cross-border patients and on the estimated level of reimbursement (with a view to extending the voluntary prior notification system applied by eight Member States).
  • Support a knowledge and capacity-building workshop with the National Contact Points (NCPs) to improve the information provided to cross-border patients.
  • Promote and monitor the implementation of the guiding principles on information provision on cross-border healthcare and the multi-lingual manual for patients.
  • Encourage all NCPs to make available information on the European Reference Networks (ERNs) and ensure their websites are accessible for people with disabilities.
  • Organise an awareness-raising event at EU level on patients’ rights to cross-border healthcare with the participation of Member States, NCPs, patient organisations, health insurers, health professionals, ERNs, and regional stakeholders in cross-border healthcare.
  • Update the 2012 guidance note on the Cross-Border Healthcare Directive (Directive 2011/24/EU) and Regulation on social security systems coordination (Regulation (EC) 883/2004) with the Administrative Commission of Member States.
  • Conduct bilateral dialogues with Member States to find solutions to improve data completeness and robustness as required by the Cross-Border Healthcare Directive (Article 20).
  • Launch and continue structured bilateral dialogues with Member States to achieve best possible transposition of the Cross-Border Healthcare Directive and pursue further enforcement actions in cases of non-compliance.