(fra kommisjonsforordningen)

(1) Regulation (EU) 2022/2371 provides for the cooperation of the Union in the field of public health surveillance with third countries and international organisations, as defined by Article 3(21) of Regulation (EU) 2018/1725 of the European Parliament and the Council. 

(2) Regulation (EU) 2022/2371 specifically emphasises the importance for the Union of cooperating with the World Health Organization (‘WHO’). The WHO’s mandate in the field of communicable diseases is similar to the mandate of the European Centre for Disease Prevention and Control (‘the ECDC’). The WHO European Region includes all Member States. A few diseases are under joint surveillance by the ECDC and the WHO. A synergistic cooperation with the WHO ensures complementarity of efforts while avoiding duplication of work for the Member States. 

(3) Article 13 of Regulation (EU) 2022/2371 covers two complementary surveillance approaches. Indicator-based surveillance relies on predefined structured data that are collected routinely at regular intervals to monitor epidemiological indicators. Article 13(3), point (a), establishes the obligation to communicate comparable and compatible data and information in relation to the epidemiological surveillance of communicable diseases and related health issues referred to in Article 2(1), points (a)(i) and (a)(ii). Event-based surveillance collects ad hoc information about unusual health events that may signal a serious cross-border threat to health. Article 13(3), points (b) and (c), require communicating of relevant information concerning the progression of epidemic situations and unusual epidemic phenomena or new communicable diseases of unknown origin. 

(4) The digital platform for surveillance of communicable diseases at Union level (‘EpiPulse’) consists of two functionalities. ‘EpiPulse Cases’, the module for indicator-based surveillance, allows the periodic collection, validation, storage and dissemination of structured national data on cases and pathogen isolates of diseases and related special health issues subject to epidemiological surveillance at Union level pursuant to Annex I of Commission Implementing Regulation (EU) 2026/XXX3 [OP please insert reference to C(2026)6011]. ‘EpiPulse Events’, the module for eventbased surveillance, supports the prompt reporting and monitoring of any national event that may pose a cross-border threat to public health. 

(5) In order to prepare Union candidate countries and potential candidates for accession to the Union, they may report national surveillance data to EpiPulse Cases. Third countries in the WHO European Region may also report to EpiPulse Cases under joint surveillance arrangements between the ECDC and the WHO to promote synergies and avoid duplication of data collection efforts. In order to protect the indicator-based surveillance data of the Member States, the access of any third country to surveillance data in EpiPulse Cases should be limited to the surveillance data provided by the country itself. 

(6) To avoid double reporting to the ECDC and the WHO, the WHO may be granted access to surveillance data in EpiPulse Cases for the diseases under joint surveillance and the diseases that are to be reported to the WHO under the International Health Regulations (2005) or under other regional or global surveillance initiatives. 

(7) Third countries may be granted partial access to EpiPulse Events if they are affected by an ongoing serious cross-border threat to health that is of relevance to the Union or if a threat detected within the Union may also be of relevance to public health in third countries and therefore requires the exchange of information between those third countries and the Union. For early warning and response purposes, the WHO may be granted access to items in EpiPulse Events if these are of cross-border significance within the Union, potentially novel, or of relevance to third countries. 

(8) Any transfer of personal data to third countries and international organisations is to comply with the obligations laid down under Regulation (EU) 2018/1725 and Regulation (EU) 2016/679 of the European Parliament and of the Council. 

(9) The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered an opinion on 10 August 2026