Changes from plenary report to adopted text

▸8 unchanged paragraphs

Article 71 – paragraph 1 a (new): In the event that the guidelines referred to in the first paragraph diverge from the interests of the Union and the Member States, the Commission may adopt complementary guidance for Member States on how and when to apply those guidelines.

Article 73 – paragraph 1: 1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange, registration and storage of information concerning SoHO activities and supply of critical SoHOs in the Union, as provided for in this Regulation.

Article 73 – paragraph 2: 2. The Commission shall make a summary of data of public interest and make it accessible to the public on the EU SoHO Platform in aggregated and anonymised formats. The EU SoHO Platform shall provide a channel for restricted exchange of information and data between competent authorities.

Article 73 – paragraph 4: 4. The Commission shall adopt delegated acts in accordance with Article 77 supplementing this Regulation by laying down technical specifications regarding the establishment, management and maintenance of the EU SoHO Platform, and establishing access rights for national competent authorities and Union bodies and agencies to carry out their tasks, and minimum categories of information to be shared pursuant to paragraph 2 of this Article.

Article 73 – paragraph 5 a (new): 5a. In order in particular to prevent supply tensions and to ensure donor and recipient security, the Commission shall ensure that the EU SoHO Platform is interoperable with the other existing Union platforms, in particular the EMA’s European Shortages Monitoring Platform established by Article 13 of Regulation (EU) 2022/123 of the European Parliament and of the Council 1a. / 1a Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).

Article 74 – paragraph 2: 2. The EU SoHO platform shall also provide a secure environment for the exchange of information between competent authorities and the competent Directorates General of the Commission, in particular in relation to SAO, rapid alerts and SoHO supply alerts, and between competent authorities and the SCB, the EMA and the ECDC. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.

Article 74 – paragraph 2 a (new): 2a. The EU SoHO Platform shall also be the main intermediary for reporting SoHO shortages, for cross-border requests for SoHOs and for import and export of SoHOs. National authorities shall issue and receive alerts concerning shortages that cannot be resolved at Member State level, as well as SoHO cross-border requests and shall be able to respond to them. National authorities, aware of the national availability of SoHOs, as referred to in Article 34a, shall use the EU SoHO Platform to report any SoHO shortages that may lead to a public health emergency or severe occurrence.

Article 74 – paragraph 2 b (new): 2b. In the event of a SoHO-related health emergency or for the purpose of preventing potential threats, alerts issued through the EU SoHO Platform shall enable the Commission, competent authorities and other relevant bodies to rapidly develop awareness of such emergency or of potential threats so that action can be taken as soon as possible in accordance with Regulation (EU) 2022/2371.

Change 9

ChangedArticle 74 – paragraph 2 c (new): 2c. The EU SoHO Platform shall contain a record of SoHO clinical studies and their results, as referred to in Article 36a.

Article 74 – paragraph 3: 3. The Commission shall adopt delegated acts in accordance with Article 77 to supplement this Regulation and to ensure uniformity, compatibility and comparability of data exchanged through the platform by laying down technical specifications for the EU SoHO Platform, including its functions, the roles and responsibilities of each of the parties listed in paragraph 1, the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed. / (deleted)

Article 75 – paragraph 1 – point a: (a) natural persons with regard to the processing of personal data in accordance with Article 76;

Article 75 – paragraph 3: 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and competent authorities with regard to the exchange of information and the dissemination of alerts, nor the obligations of persons to provide information under national criminal law or other applicable law, including on access to information.

Change 10

RemovedArticle 75 – paragraph 6 – point b: (b) the information or data made available to the public does not unnecessarily undermine the protection of commercial interests of a SoHO entity or any other natural or legal person any other natural or legal person;

Article 76 – paragraph 3: 3. Personal data, including data concerning health, required for the application of Articles 35, 36, 41 and 47, Article 53(1), points (f) and (g), Article 53(3), and Article 58(11), (13) and (14), shall only be processed for the purpose of ensuring safety and quality of SoHOs and protecting the concerned SoHO donors, SoHO recipients and offspring from medically assisted reproduction. Those data shall be directly related to the performance of the supervisory activities and SoHO activities concerned and be limited to the extent necessary and proportionate for that purpose. The Commission may adopt implementing acts laying down categories of personal data necessary for such processing. / Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

Article 76 – paragraph 6: 6. In relation to their responsibilities to process personal data to comply with the obligations of this Regulation, the SoHO entities and competent authorities of the Member States shall be regarded as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679 and they are bound by the rules of that Regulation. The same provisions shall apply to any third party contracted by a SoHO entity for the processing of personal data. Such third party shall be considered to be a processor as defined in Article 4, point (8), of Regulation (EU) 2016/679.

Article 77 – paragraph 2: 2. The power to adopt delegated acts referred to in Article 28(10), Article 42(3), Article 53(6), Article 56(1), Article 58(15), Article 62(7), Article 67(7), Article 69(6), Article 73(4), Article 74(3) and Article 76(8) shall be conferred on the Commission for an indeterminate period of time from … [OP please insert the date = date of entry into force of this Regulation].

Change 11

ChangedArticle 77 – paragraph 3: 3. The delegation of power referred to in Article 28(10), Article 42(3), Article 53(6), Article 56(1), Article 58(15), Article 62(7), Article 67(7), Article 69(6), Article 73(4), Article 74(3) and Article 76(8)may76(8) 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.

Article 84 – paragraph 1: Without prejudice to the dates of application referred to in Article 87 and the transitional provisions provided for in this Chapter, the Commission is empowered to adopt the delegated acts referred to in Article 42(3), Article 67(7), Article 73(4) and Article 74(3) and the implementing acts referred to in Article 26(4), Article 43(6), Article 44(3) and Article 46(3) as from … [OP please insert the date = one day after the date of entry into force of this Regulation]. Such acts shall apply from the date of application in accordance with Article 87(1), second subparagraph, without prejudice to any transitional rules provided for in this Chapter.

Article 86 – paragraph 1: The Commission shall, by … [OP please insert the date = five years after the date of application of this Regulation] assess the application of this Regulation, produce an evaluation report on the progress towards achievement of the objectives of this Regulation and present the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. In that report, the Commission shall also consider the feasibility of and the need for establishing a central register for SoHO donations.

Article 86 – paragraph 3: Member States shall provide the Commission with additional information necessary and proportionate for the preparation of the evaluation report. The evaluation report shall, where appropriate, be accompanied by a legislative proposal to amend this Regulation.