What changed between the adopted text of 12 Sept 2023 and the adopted text of 24 Apr 2024

Removed:Article 55 – title: Standards concerning information to be provided prior to informed consent or authorisation to donate SoHOs

Removed:Article 55 – paragraph 2: 2. SoHO entities shall provide the information referred to in paragraph 1 before the consent is given or authorisation is granted for the donation. SoHO entities shall provide the information in an accurate and clear manner, using terms that are easily understood by the prospective donors or the persons to consent or authorise the donation, and ensure that the consent given is informed consent. It shall not mislead the prospective donors or persons granting authorisation on their behalf, in particular, as to the benefits of the donation to future recipients of the SoHO concerned.

Removed:Article 55 – paragraph 3 – point d: (d) the intended use of the donated SoHO, in particular covering proven benefits for the future recipients and any possible research or commercial uses to which the donor should give informed consent;

Removed:Article 55 – paragraph 3 – point e: (e) the analytical tests that will be performed in course of the donor health evaluation and the purpose thereof;

Removed:Article 56 – paragraph 1 – subparagraph 1: When the Commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in Articles 53, 54 or 55, in order to ensure convergent and high levels of donor safety, the Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation by describing particular procedures to be followed and applied to meet such standard, or element thereof.

Removed:Article 56 – paragraph 1 – subparagraph 2: deleted

Removed:Article 56 – paragraph 2: 2. Where, in the case of a risk to donor health, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.

Removed:Article 56 – paragraph 3: 3. In order to apply the standards concerning donor protection or elements thereof, referred to in Articles 53, 54 and 55, SoHO entities shall follow the procedures laid down in any delegated act adopted in accordance with paragraphs 1 and 2 of this Article.

Removed:Article 56 – paragraph 4 – introductory part: 4. For those standards concerning donor protection or elements thereof for which no delegated act has been adopted, in order to apply such standards or elements thereof, SoHO entities shall follow in order of priority:

Removed:Article 56 – paragraph 4 – point a – introductory part: (a) the most recent technical guidelines established through a transparent and comprehensive consultation process with a broad selection of stakeholders based on the latest scientific knowledge and relevant expertise, and as indicated on the EU SoHO Platform referred to in Chapter XI, as follows:

Removed:Article 56 – paragraph 6: deleted

Removed:Article 57 – paragraph 1: SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.

Removed:Article 57 – paragraph 1 a (new): SoHO entities shall not discriminate against SoHO recipients on any of the grounds listed in Article 21 of the Charter of Fundamental Rights of the European Union, unless it is necessary to protect the health of the SoHO recipient or of the SoHO donor. Such discriminatory action shall be based on scientific evidence.

Removed:Article 58 – paragraph 1: 1. SoHO entities shall, based on the guidelines referred to in Article 59, establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.

Removed:Article 58 – paragraph 1 a (new): 1a. Where possible, SoHO entities shall use technologies to reduce clinical risks for SoHO recipients and offspring from medically assisted reproduction, and to improve the quality of SoHOs.

Removed:Article 58 – paragraph 2 – point b: (b) testing of donors for communicable diseases using certified and validated testing methods or other methods deemed appropriate in EDQM and ECDC guidelines;

Removed:Article 58 – paragraph 2 – point c: (c) when feasible, using processing technologies that reduce, eliminate or inactivate any potential communicable pathogens.

Removed:Article 58 – paragraph 5 – point c a (new): (ca) where possible and appropriate, using methods of detection, inactivation or elimination of microorganisms.

Removed:Article 58 – paragraph 10 – point a: (a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by their competent authority pursuant to Article 41(4) or in the context of compassionate use and experimental therapy in the situations referred to in Articles 61 and 61a or a clinical study referred to in Article 41a;

Removed:Article 58 – paragraph 10 – point b: (b) apply SoHO preparations to recipients unnecessarily; SoHO entities shall make optimal use of SoHOs, taking into account therapeutic alternatives, and following the most up-to-date scientific guidelines as referred to in Article 59;

Removed:Article 58 – paragraph 10 – point c a (new): (ca) prioritise aesthetic uses over therapeutic uses, especially in the event of a possible shortage of SoHOs.

Removed:Article 58 – paragraph 11 – subparagraph 1: For the measures referred to in paragraphs 2 and 3, SoHO entities shall verify the eligibility of a donor by means of an interview with him/her, his/her legal guardian or, in case of a donation after death, a relevant individual that is informed regarding the donor’s health and lifestyle history. The interview may be combined with any interview conducted as part of the evaluation referred to in Article 53.

Removed:Article 58 – paragraph 11 – subparagraph 2: For donors that donate repeatedly, the interviews referred to in the first subparagraph may be limited to aspects that might have changed and may be replaced with questionnaires, while ensuring that all obligations under Article 53(1), points (e) and (f), and Article 53(2) are met.

Removed:Article 59 – paragraph 4 – introductory part: 4. For those standards or elements of standards concerning recipient and offspring protection for which no implementing act has been adopted, in order to apply such standards or elements thereof, SoHO entities shall follow in order of priority:

Removed:Article 59 – paragraph 6: deleted

Removed:Article 61 a (new): Article 61a / Derogation from the obligations to authorise SoHO preparations in emergency situations or in situations where there is no therapeutic alternative / 1. By way of derogation from Article 21, competent authorities may permit, at the request of a SoHO entity and where duly justified by a health emergency, the distribution or preparation for immediate application of SoHO preparations within their territory in cases where the procedures referred to in that Article have not been carried out, provided that the use of those SoHO preparations is in the interest of public health. Competent authorities shall indicate the period of time for which the permission is granted or shall define conditions that make it possible to clearly establish that period of time. / 2. Competent authorities may furthermore grant, on an exceptional basis, a conditional and temporary authorisation for SoHO preparations at the request of a prescribing physician within a SoHO entity, in situations where there is no therapeutic alternative, provided that: / (a) provision has been made for the use of such preparations for a given patient, in the event that treatment cannot be postponed or when the patient’s vital interests so require; / (b) the preparations can be deemed to be safe and effective on the basis of the available clinical data. / 3. Competent authorities shall immediately inform the SoHO National Authority of any exceptional authorisation and, without undue delay, enter information on any…

Removed:Article 62 – title: Establishment of national SoHO emergency plans and of plans to ensure continuity of supply of SoHOs

Removed:Article 62 – paragraph 1: 1. Member States, in collaboration with National SoHO Authorities, shall draw up national plans to strive for sufficiency of supply of critical SoHOs and contribute to European autonomy in the context of a resilient supply chain. / The national plans shall in particular include measures to ensure that the donor base is resilient, actions to make a more efficient use of SoHOs, monitoring of trends in the supply of critical SoHOs as well as measures for cases where national SoHO stocks exceed the national demand and SoHOs are exported to other countries with SoHO shortages. / When drawing up and reviewing their national plans, Member States shall take into account the recommendations issued by the Commission in accordance with Article 62a and best practices documented by the SCB in accordance with Article 68.

Removed:Article 62 – paragraph 2: 2. Member States shall make all reasonable efforts, in line with the principle of voluntary and unpaid donation, to promote public participation in SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. In so doing, they shall, among other measures: / (a) include all relevant stakeholders in the drawing up of their national plans; / (b) ensure that there is an adequate number of SoHO collection entities, with a strong public and non-profit sector involvement, and of SoHO establishments as well as adequate opening times; / (c) ensure appropriate working conditions and adequate training are provided for relevant SoHO professions; / (d) ensure that critical SoHO donor recruitment and retainment strategies are put in place, including communication campaigns and education programmes; / (e) establish quantitative collection targets for critical SoHOs.

Removed:Article 62 – paragraph 2 a (new): 2a. SoHO entities shall report to the competent authorities on potential shortages of SoHOs or upon request from the competent authorities in accordance with Article 34a. The competent authorities shall be responsible for monitoring the availability of SoHOs at national level.

Removed:Article 62 – paragraph 3: 3. In cases where the availability of SoHOs or products derived from them depends on potential commercial interests, each Member State shall ensure that those SoHO entities, within the limit of their responsibilities, provide an appropriate and continuous supply of SoHOs, or their derivatives, to patients in their territory . Member States shall negotiate fair and transparent prices for SoHO-derived products that are based on altruistic and unpaid donations. Member States shall also ensure that affordable products are available to patients and that there is continuous investment in research and innovation in relation to those products. / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Removed:Article 62 – paragraph 3 a (new): 3a. By ... [2 years after the date of entry into force of this Regulation], Member States shall submit their national plans to the Commission and the SCB. They shall review their national plans every two years, and inform the Commission and the SCB of any substantial change to those plans.

Removed:Article 62 – paragraph 4: 4. In order to be able to deal with emergency situations that arise, when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health, Member States shall specify the following in the plans referred to in paragraph 1: / (a) potential risks to the supply of critical SoHOs and measures that impact the demand for SoHOs; / (b) the critical SoHO entities to be involved; / (c) the powers and responsibilities of competent authorities; / (d) channels and procedures for sharing information between competent authorities, including competent authorities of other Member States and other parties concerned, as appropriate; / (e) a procedure for the development of preparedness plans for specific identified risks, in particular those concerning communicable disease outbreaks; / (f) a procedure for the assessment and authorisation, when justified, of requests from SoHO entities for derogations from the standards defined in Chapters VI and VII; / (g) actions to prioritise therapeutic uses of critical SoHOs and certain patients in the event of shortages.

Removed:Article 62 – paragraph 5: 5. Member States shall ensure that any derogation granted in accordance with paragraph 4, point (f), is time-limited and is justified insofar as it implies risks that are lower than the risk of shortage of the specific SoHO.

Removed:Article 62 – paragraph 6: 6. Member States shall take into account the guidance of the ECDC, for emergencies related to epidemiological outbreaks, in particular to ensure pandemic prevention and preparedness, and the guidelines published by the EDQM, for emergency planning in general.

Removed:Article 62 – paragraph 7 – subparagraph 1 – introductory part: The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation by describing:

Removed:Article 62 – paragraph 7 – subparagraph 1 – point a: (a) rules for the establishment of the national plans provided for in paragraph 1 to the extent necessary to ensure the consistent and effective management of supply interruptions;

Removed:Article 62 – paragraph 7 – subparagraph 1 – point b: (b) the role of stakeholders and the supportive role of the ECDC and the EDQM in the establishment and operation of national plans;

Removed:Article 62 – paragraph 7 – subparagraph 2: deleted

Removed:Article 62 a (new): Article 62a / Development of a strategy for the promotion of European SoHO supply autonomy / 1. By ... [two years after the date of entry into force of this Regulation], the Commission shall publish a strategy for the promotion of European SoHO supply autonomy. That strategy shall set out a roadmap with ambitious targets for each critical SoHO, laid down by the Commission in coordination with national competent authorities, the SCB, the ECDC, the European Parliament, scientists from professional associations and patient associations, as well as with all other relevant stakeholders. Without prejudice to Articles 53 and 54, the strategy shall promote actions to: / (a) support and coordinate communication campaigns at European and national level on the various types of SoHO donations that are available; / (b) support, through relevant programmes, the training of healthcare workers in hospital and healthcare facilities, to raise awareness concerning SoHO donations; / (c) coordinate the exchange of best practices linked to optimisation of the use of critical SoHOs. / 2. The strategy referred to in paragraph 1 shall include actions to establish a Union list of critical SoHOs. / 3. The strategy referred to in paragraph 1 shall include actions to ensure that the reports referred to in Article 34a are regularly monitored via the EU SoHO Platform referred to in Chapter XI. Such monitoring shall be aimed at identifying at Union level any actual or potential shortages which would endange…

Removed:Article 63 – paragraph 1: 1. Critical SoHO entities shall without undue delay launch a SoHO supply alert to their competent authorities in case of a significant interruption, indicating the underlying reason, the expected impact on patients and any mitigating actions taken including possible alternative supply channels if appropriate. Interruptions shall be considered significant when the application of critical SoHO is cancelled or postponed due to unavailability and this poses a serious risk to human health.

Removed:Article 63 – paragraph 2 – point b: (b) implement measures to mitigate the risks to the extent possible; and

Removed:Article 63 – paragraph 3: 3. The SoHO National Authorities shall, without undue delay, submit to the EU SoHO Platform the SoHO supply alert received.

Removed:Article 64: deleted / (deleted) / (deleted) / (deleted)

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

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

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

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