Transparency and conflict of interest
1. The HSC and the Advisory Committee shall carry out their activities in an independent, impartial and transparent manner and shall undertake to act in the public interest.
2. Representatives appointed to the HSC and to the Advisory Committee and, where relevant, observers shall not have any financial or other interests which might be considered prejudicial to their independence.
3. The representatives appointed to the HSC and to the Advisory Committee and, where relevant, observers shall make a declaration of their financial and other interests and update them annually and whenever necessary. They shall disclose any other facts of which they become aware that might in good faith reasonably be expected to involve or give rise to a conflict of interest.
4. Representatives who participate in meetings of the HSC or of the Advisory Committee and, where relevant, observers, shall declare, before each meeting, any interests which could be considered to be prejudicial to their independence or impartiality with regard to the items on the agenda.
5. Where the Commission decides that a representative’s declared interest constitutes a conflict of interest, that representative shall not take part in any discussions or decisions, nor shall that representative obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.
6. Representatives who participate in meetings of the HSC or the Advisory Committee, and, where relevant, observers shall be subject to requirements of professional secrecy, even after their duties have ceased.
Personal data protection
1. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) 2016/679 and Directive 2002/58/EC, and to the obligations of the Union institutions, bodies, offices and agencies relating to their processing of personal data under Regulation (EU) 2018/1725, when fulfilling their responsibilities.
2. The Commission and, where applicable, other Union institutions, bodies, offices and agencies shall not process personal data except in cases where it is necessary for the fulfilment of their mission. Where appropriate, personal data shall be rendered anonymous in such a manner that the data subject is not identifiable.
Protection of personal data concerning the EWRS selective messaging functionality
1. The EWRS shall include a selective messaging functionality allowing personal data, including contact and health data, to be communicated only to the national competent authorities involved in contact-tracing measures and medical evacuation procedures. That selective messaging functionality shall be designed and operated so as to ensure safe and lawful processing of personal data and to link with contact-tracing systems at Union level.
2. Where national competent authorities implementing contact-tracing measures or medical evacuation procedures communicate, through the EWRS, personal data necessary for contact-tracing purposes pursuant to Article 19(3), they shall use the selective messaging functionality referred to in paragraph 1 of this Article and communicate the data only to the other Member States involved in the contact-tracing or medical evacuation measures.
3. When communicating the data referred to in paragraph 2, the national competent authorities shall refer to the alert communicated previously through the EWRS.
4. The selective message functionality shall be used solely for the purpose of contact tracing and medical evacuation. It shall only allow national competent authorities to receive data that were sent to them by other national competent authorities. The ECDC shall only access the data required to ensure the proper functioning of the selective message functionality. Messages containing personal data shall automatically be erased from the selective message functionality 14 days after the date of their posting at the latest.
5. Where necessary for the purpose of contact tracing, personal data may also be exchanged using contact-tracing technologies. The national competent authorities shall not retain the contact data and health data received through the selective message functionality for longer than the retention period applicable in the context of their national contact-tracing activities.
6. The Commission shall adopt delegated acts in accordance with Article 31 to supplement this Regulation by establishing:
(a)
detailed requirements necessary to ensure that the operation of the EWRS and the processing of data complies with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including the respective responsibilities of the national competent authorities and of the ECDC; and
(b)
a list of the categories of personal data that may be exchanged for the purpose of the coordination of contact-tracing measures.
7. The Commission shall, by means of implementing acts, adopt:
(a)
procedures for the interlinking of the EWRS with contact-tracing systems at Union and international levels; and
(b)
the modalities for processing contact-tracing technologies and their interoperability, as well as the cases where, and the conditions under which, the third countries may be granted access to contact-tracing interoperability and the practical arrangements for such access, in full compliance with Regulation (EU) 2016/679and the applicable case law of the Court of Justice of the European Union.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Committee procedure
1. The Commission shall be assisted by a committee on serious cross-border threats to health. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Cooperation with the WHO
The Union shall establish a framework for enhanced cooperation with the WHO, in particular as regards reporting and reviewing activities.
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 8(4), Article 14(7) and Article 28(6) shall be conferred on the Commission for an indeterminate period of time from 27 December 2022.
3. The delegation of power referred to in Article 8(4), Article 14(7) and Article 28(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 8(4), Article 14(7) or Article 28(6) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Urgency procedure
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 31(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
Evaluations concerning this Regulation
By 31 December 2024 and every five years thereafter at the latest, the Commission shall carry out an evaluation of this Regulation and present a report on the main findings of that evaluation to the European Parliament and to the Council. The evaluation shall include, in particular, an assessment of the operation of the EWRS and the epidemiological surveillance network, as well as the coordination of the response within the HSC.
The evaluation referred to in the first paragraph shall also include an evaluation of the Commission's work in preparedness and response activities provided for in this Regulation including, where relevant, a review of the implementation of this Regulation by the Health Emergency Preparedness and Response Authority (HERA), as well as an assessment of the need to establish HERA as a distinct entity, considering relevant agencies or authorities active in the field of health preparedness and response. The Commission shall, if appropriate, present legislative proposals based on that evaluation in order to amend this Regulation or make further proposals.
Repeal
1. Decision No 1082/2013/EU is repealed.
2. References to the repealed Decision shall be construed as references to this Regulation and read in accordance with the correlation table in Annex II.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
