What changed between the draft committee report and the plenary report

Added:Article 64: deleted / (deleted) / (deleted) / (deleted)

Removed:Article 65 – paragraph 1 a (new): In accordance with the Treaties, application of this Article shall be based on public-health protection grounds determined in proportion to risks in such a way as to minimise the effect on the free movement of goods and persons within the Union.

Added:Article 65 – title: Additional emergency and supply measures by Member States

Removed:Article 67 – paragraph 2: 2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies shall have an observer role. The Commission shall ensure the best possible coordination between all its departments and shall in particular ensure that HERA has access to information.

Added:Article 65 – paragraph 1: Member States may take additional measures to the ones set out in their national SoHO emergency and supply plans to ensure critical SoHOs supply in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States, the SCB and the Commission without undue delay and give reasons for the measures taken.

Removed:Article 67 – paragraph 2 a (new): 2a. The Commission shall ensure the independence and impartiality of experts and observers invited to attend SoHO Coordination Board meetings.

Added:Article 66 – title: SoHO entity emergency and continuity of supply plans

Removed:Article 67 – paragraph 6 – point i: (i) invitation of individuals, private organisations or associations, or public entities in the capacity of observers;

Added:Article 66 – paragraph 1: Each SoHO entity carrying out SoHO activities that concern critical SoHOs shall have a continuity of supply plan and a SoHO entity emergency plan. Those plans shall support the implementation of the national continuity of supply and SoHO emergency plans as referred to in Article 62.

Removed:Article 67 – paragraph 6 – point j a (new): (ja) publicity and transparency, as well as access to minutes of meetings;

Added:Article 67 – paragraph 2: 2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Such experts and stakeholders may include consumers, patients, health professionals and researchers. Other relevant Union institutions, bodies, offices and agencies or services shall have an observer role. The European Parliament shall designate a technical representative to participate in the SCB as an observer.

Removed:Article 68 – paragraph 1 – point a: (a) preparing opinions at the request of competent authorities in accordance with Article 14(2) first sub-paragraph, on the regulatory status under this Regulation of a substance, product or activity and transmitting its opinions to the compendium and to the authorities established in other relevant Union legislation referred to in Article 2(3), such as the EMA and the Medical Device Coordination Group (MDCG);

Added:Article 67 – paragraph 3: 3. Member States shall submit the names and affiliation of their nominated members to the Commission, who shall make publicly available the membership list on the EU SoHO Platform. The list setting out the authorities, organisations or bodies to which the SCB participants belong shall be published on the Commission's website.

Removed:Article 68 – paragraph 1 – point e: (e) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards, with the EMA on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2003/63/EC, and with the ECDC and HERA regarding prevention, preparedness and response in connection with serious cross-border threats to health pursuant to Regulation (EU) 2022/23711a, to support the harmonised implementation of standards and technical guidelines; / 1a Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).

Added:Article 67 – paragraph 3 a (new): 3a. The Commission shall make publicly available the rules of procedure and guidance of the SCB, as well as the agendas and the minutes of the meetings of the SCB on the EU SoHO Platform, unless such publication undermines the protection of a public or private interest, as referred to in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council1a. / 1a Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

Removed:Article 68 – paragraph 1 – point g a (new): (ga) drawing up recommendations on modifications to preparations requiring fresh applications for authorisation in accordance with Articles 40 and 41.

Added:Article 67 – paragraph 4: 4. The SCB shall be co-chaired by a representative of the Commission and by one rotating representative of the Member States, who shall be elected by and from among the representatives of the Member States in the SCB. The chair shall not take part in votes of the SCB.

Removed:Article 71 – paragraph 1 a (new): The Commission shall ensure that those guidelines reflect the interests of Member States and, where appropriate, may adopt implementing acts laying down standards in line with those interests.

Added:Article 67 – paragraph 6 – point j: (j) the rules for declarations regarding conflict of interests of SCB members, alternates, observers and invited experts;

Removed: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, between SoHO entities and their respective competent authorities, and between the various Union institutions, bodies, offices and agencies that are active on the coordination board established by this Regulation.

Added:Article 67 – paragraph 6 – point k a (new): (ka) make available to the public a summary of the topics discussed at the meetings.

Removed: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 Regulation (EU) 2022/1231a. / 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).

Added:Article 67 – paragraph 7: 7. The Commission shall adopt delegated acts in accordance with Article 77 to supplement this Regulation by setting out the necessary measures for the establishment, management and functioning of the SCB. / (deleted)

Removed:Article 73 – paragraph 5 b (new): 5b. The Commission shall ensure that the EMA, ECDC and HERA have access to the SoHO Platform information falling within their respective remits, as laid down in Regulation (EU) 2022/123, Regulation (EU) 2022/23701a and Commission Decision 2021/C 393. / 1a Regulation (EU) 2022/123 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control (OJ L 314, 6.12.2022, p. 1).

Added:Article 67 – paragraph 7 a (new): 7a. Members of the SCB shall not have financial or other interests in related industries which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Commission which is accessible to the public, on request, at the Commission’s offices. / The SCB’s code of conduct shall make reference to the implementation of this Article, in particular in relation to the acceptance of gifts.

Removed: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 departments of the Commission, in particular in relation to SAO, rapid alerts and SoHO supply alerts, and between competent authorities and HERA, 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.

Added:Article 67 – paragraph 7 b (new): 7b. Members of the SCB, experts and observers shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence with respect to the items on the agenda. Such declarations shall be made available to the public.

Removed:Article 77 – paragraph 2: 2. The power to adopt delegated acts referred to in Articles 28(10), 42(3), 53(6), 54(3)(c), 58(15), 69(6), 73(4) and 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].

Added:Article 68 – paragraph 1 – point a: (a) in collaboration with other authorities designated pursuant to other relevant Union legislation, preparing opinions at the request of competent authorities in accordance with Article 14(1) and (2), on the regulatory status under this Regulation of a substance, product or activity and transmitting its opinions to the compendium;

Removed:Article 77 – paragraph 3: 3. The delegation of power referred to in Articles 28(10), 42(3), 53(6), 54(3)(c), 58(15), 69(6), 73(4), and 76(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.

Added:Article 68 – paragraph 1 – point e: (e) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, and with the EMA on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2003/63/EC, to support the harmonised implementation of standards and technical guidelines;

Removed:Article 87 – paragraph 1 – subparagraph 2: Unless otherwise provided for in paragraphs 2 and 2a, it shall apply from … [OP please insert the date = two years after the date of entry into force of this Regulation].

Added:Article 68 – paragraph 1 – point f a (new): (fa) ensuring coordination regarding continuity and sufficiency of supply of critical SoHOs;

Removed:Article 87 – paragraph 2 a (new): 2a. Article 62 shall apply from … [OP please insert the date = twelve months after the date of entry into force of this Regulation].

Added:Article 68 – paragraph 1 – point g a (new): (ga) in the event of a SoHO-related health emergency or for the purpose of preventing potential threats, collaborate with the Commission, the Advisory Committee on Public Health Emergencies and the ECDC, as established in Regulation (EU) 2022/2371.

Added:Article 69 – paragraph 1 – subparagraph 1: The Commission shall organise Union training in cooperation with the Member States.

Added:Article 71 – paragraph 1: The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation shall be based on the highest scientific standards, be proactive in identifying future needs and be transparent, involving the relevant stakeholders in consultations related to the development of the guidelines. Such cooperation shall be without prejudice to Union law and shall take into account Union principles on transparency and stakeholder participation.

Added: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.

Added: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.

Added: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.

Added: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.

Added: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).

Added: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.

Added: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.

Added: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.

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

Added: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)

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

Added: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.

Added:Article 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;

Added: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).

Added: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.

Added: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].

Added:Article 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)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.

Added: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.

Added: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.

Added: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.