Cooperation between the MSSG, the MDSSG, the ETF and the expert panels
1. The Agency shall ensure that the MSSG and the MDSSG cooperate in relation to measures to address public health emergencies and major events.
2. Members of the MSSG and MDSSG, and members of the working parties referred to in Article 3(6) and in Article 25(2), point (a), respectively, may attend one another’s meetings and working parties and, where appropriate, cooperate on monitoring exercises, reporting and the preparation of opinions.
3. With the agreement of the respective chairs or co-chairs, joint meetings of the MSSG and the MDSSG may be held.
4. Where relevant, the Agency shall ensure that the ETF and the expert panels cooperate in relation to preparedness and management of public health emergencies.
Transparency and conflicts of interest
1. The MSSG and the MDSSG shall carry out their activities in an independent, impartial and transparent manner.
2. The members of the MSSG and of the MDSSG and, where relevant, observers, shall not have any financial or other interests in the medicinal products industry or medical devices industry which could affect their independence or impartiality.
3. The members of the MSSG and the MDSSG and, where relevant, observers, shall make a declaration of their financial and other interests and shall update those declarations of interest annually and whenever necessary.
The declarations referred to in the first subparagraph shall be made publicly available on the Agency’s web portal.
4. The members of the MSSG and the MDSSG and, where relevant, observers, shall disclose any other facts of which they become aware that might reasonably be expected in good faith to involve or give rise to a conflict of interest.
5. Before each meeting, the members of the MSSG and the MDSSG and, where relevant, observers who participate in meetings of the MSSG and the MDSSG shall declare any interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda.
6. Where the Agency decides that an interest declared in accordance with paragraph 5 constitutes a conflict of interest, the member or observer concerned shall not take part in any discussions or decision making, or obtain any information, concerning the item of concern on the agenda.
7. The declarations and the decisions of the Agency referred to in paragraphs 5 and 6, respectively, shall be recorded in the summary minutes of the meeting.
8. The members of the MSSG and the MDSSG and, where relevant, observers, shall be subject to a requirement of professional secrecy, even after their duties have ceased.
9. Members of the ETF shall update the annual declaration of their financial or other interests provided for in Article 63 of Regulation (EC) No 726/2004 whenever a relevant change to their declaration occurs.
Protection against cyber attacks
The Agency shall equip itself with a high level of security controls and processes against cyber attacks, cyber espionage and other data breaches to ensure the protection of health data and the normal functioning of the Agency at all times, especially during public health emergencies or major events at Union level.
For the purposes of the first paragraph, the Agency shall actively identify and implement cybersecurity best practices adopted within Union institutions, bodies, offices and agencies for preventing, detecting, mitigating, and responding to cyber attacks.
Confidentiality
1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council ( 19 ) and Directive (EU) 2019/1937 of the European Parliament and of the Council ( 20 ) , and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council ( 21 ) , including intellectual property rights.
2. Without prejudice to paragraph 1, all parties involved in the application of this Regulation shall ensure that no commercially confidential information is shared in a way which has the potential to enable undertakings to restrict or distort competition within the meaning of Article 101 TFEU.
3. Without prejudice to paragraph 1, information exchanged on a confidential basis between national competent authorities and between national competent authorities and the Commission and the Agency shall not be disclosed without the prior agreement of the authority from which that information originates.
4. Paragraphs 1, 2, and 3 do not affect the rights and obligations of the Commission, the Agency, Member States or other actors identified in this Regulation with regard to the exchange of information and the dissemination of warnings, nor do they affect the obligations of the persons concerned to provide information under criminal law.
5. The Commission, the Agency, and Member States may exchange commercially confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Personal data protection
1. Transfers of personal data under this Regulation shall be subject to Regulations (EU) 2016/679 and (EU) 2018/1725, as applicable.
2. As regards transfers of personal data to a third country, in the absence of an adequacy decision or appropriate safeguards as referred to in Article 46 of Regulation (EU) 2016/679 and Article 48 of Regulation (EU) 2018/1725 respectively, the Commission, the Agency, and Member States may carry out certain transfers of personal data to regulatory authorities of third countries with which they have put in place confidentiality arrangements where those transfers are necessary for important reasons of public interest, such as the protection of public health. Such transfers shall be made in conformity with the conditions laid down in Article 49 of Regulation (EU) 2016/679 and Article 50 of Regulation (EU) 2018/1725.
Reporting and review
1. By 31 December 2026, and every fourth year thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. In particular, that report shall review:
(a)
the crisis preparedness and management framework for medicinal products and medical devices, including the outcomes of periodic stress tests;
(b)
instances of non-compliance with the obligations set out in Articles 10 and 26 by marketing authorisation holders, manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies;
(c)
the remit and functioning of the ESMP.
2. Notwithstanding paragraph 1, following a public health emergency or a major event, the Commission shall present, in a timely manner, a report to the European Parliament and the Council on the instances referred to in paragraph 1, point (b).
3. Based on the report referred to in paragraph 1, the Commission shall, where appropriate, present a legislative proposal in order to amend this Regulation. In particular, the Commission shall consider the need for:
(a)
extending the scope of this Regulation to veterinary medicinal products and to personal protective equipment for medical use;
(b)
amending Article 2;
(c)
introducing measures to strengthen at Union or national level compliance with the obligations established in Articles 10 and 26; and
(d)
expanding the remit of the ESMP, the need for further facilitating the ESMP interoperability with national and Union IT systems, the need for national shortage monitoring platforms, and the need for meeting any additional requirements to address structural shortages of medicinal products that may be introduced in the context of a revision of Directive 2001/83/EC and Regulation (EC) No 726/2004.
Union financing
1. The Union shall provide the financing of the Agency’s activities in support of the work of the MSSG and the MDSSG, the ETF, the working parties referred to in Article 3(6) and in Article 25(1), point (c), and the expert panels, that involve its cooperation with the Commission and the ECDC.
The Union’s financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council ( 22 ) .
2. The Agency shall remunerate the assessment activities of the rapporteurs in relation to the ETF under this Regulation, in addition to reimbursing the expenses incurred by Member States’ representatives and experts in relation to the meetings of the MSSG, the MDSSG, the ETF and the working parties referred to in Article 3(6) and in Article 21(5), in accordance with financial arrangements established by the Management Board of the Agency. Such remuneration shall be paid to the relevant national competent authorities.
3. The Union contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the tasks of the Agency provided for under this Regulation, and shall cover the full amount of remuneration paid to national competent authorities for medicinal products where fee exemptions apply in accordance with Council Regulation (EC) No 297/95 ( 23 ) .
Entry into Force and date of application
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 March 2022.
However, with the exception of Article 30, Chapter IV shall apply from 2 February 2023.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
