What changed between the draft committee report and the plenary report

Added: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 57 – paragraph 1 – point a (new): (a) identifying, minimising or eliminating those risks;

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

Removed:Article 57 – paragraph 1 – point b (new): (b) ensuring compliance with the voluntary and unpaid nature of donations of substances of human origin in accordance with Article 54.

Added: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 58 – paragraph 1: 1. SoHO entities shall 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. Where possible, they shall use technologies designed to reduce the risk of human error and improve the quality of substances of human origin.

Added: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 58 – paragraph 5 – point c a (new): (ca) where appropriate, specifying and using technologies for detecting and deactivating pathogens affecting SoHOs.

Added: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 58 – paragraph 7 – point a: (a) conducting comprehensive process validation and equipment qualification as referred to in Article 41(2), point (a)(vii), unless the equipment has already been assessed and carries EC certification as provided for in Regulations (EU) 2017/7461a and (EU) 2017/745; / 1a Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

Added: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 58 – paragraph 8 – point b a (new): (ba) when feasible, using processing technologies that reduce or eliminate any possible immune or infection risk to the recipient.

Added:Article 56 – paragraph 6: deleted

Removed:Article 58 – paragraph 10 – point b: (b) apply SoHO preparations to recipients unnecessarily based on widespread patient blood management practices;

Added: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 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, without prejudice to Article 53(1)(e) and (f) and 53(2).

Added: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 61 – paragraph 1: The responsible person for release of SoHOs pursuant to Article 38 may release a certain SoHO preparation for application to a certain recipient in cases where that SoHO preparation does not meet all of the relevant standards and guidelines referred to in Article 59, when the significant potential benefit for the recipient outweighs the risks and no alternative is available. The responsible person shall authorise such an exceptional release only when the physician treating the intended recipient is in agreement. The responsible person shall document the decision process in a risk-benefit assessment. In such circumstances, the intended recipient shall be informed of the exceptional release and shall give consent in accordance with national legislation prior to the SoHO application.

Added: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:Under this article, the physician treating the recipient bears the responsibility for exceptional release. It appears disproportionate to involve two physicians and a responsible person, especially as the responsible person and the physician referred to in Article 51 could be the same person.

Added: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 62 – paragraph 1: 1. Member States, in collaboration with National SoHO Authorities, shall draw up national SoHO emergency plans focusing on the therapeutic uses of SoHOs and setting out measures to be applied without undue delay when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health.

Added: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:Although it is necessary for the safety of recipients that this regulation apply to all uses of SoHOs (therapeutic, aesthetic, nutritional...), it may be necessary to establish priorities in case of supply problems.

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

Removed:Article 62 – paragraph 2: 2. Member States shall make all reasonable efforts 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:

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

Removed:Article 62 – paragraph 2 – point a (new): (a) they shall encourage the collection of SoHO with a strong public and non-profit sector involvement;

Added: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 62 – paragraph 2 – point b (new): (b) they shall endeavour to implement the measures recommended in the European strategy for promoting the donation of substances of human origin in accordance with Article 62a.

Added: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;

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Changed:Article 6258 – paragraph 310 – point a: (a) potentialc risksa to(new): the(ca) supplyprioritise ofaesthetic criticaluses SoHOs,over intherapeutic particularuses, asespecially regardsin the resilienceevent of the donor basea inpossible ashortage crisisof situation;SoHOs.

Change 34

Removed:Article 62 – paragraph 3 – point e: (e) a procedure for the development of preparedness plans for specific identified risks, in particular those concerning communicable disease outbreaks, in order in particular to ensure pandemic prevention and preparedness;

Added: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 62 – paragraph 5: 5. Member States shall take into account the guidance of the ECDC, for emergencies related to epidemiological outbreaks, in order in particular to ensure pandemic prevention and preparedness, and of the guidelines published by the EDQM, for emergency planning in general.

Added: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 62 – paragraph 6: 6. Member States shall review annually their national SoHO emergency plans to take into account changes in the organisation of competent authorities and experience gained from implementing the plans and simulation exercises.

Added: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 62 a (new): Article 62a / Development of a strategy for the promotion of European SoHO supply self-sufficiency / 1. Within two years after adoption of this Regulation, the Commission shall publish a strategy for the promotion of European SoHO supply self-sufficiency. That strategy shall set ambitious targets for each SoHO, laid down by the Commission in coordination with national competent authorities, the European Parliament, scientists from professional associations and patient associations, as well as all other relevant stakeholders. Without prejudice to Articles 53 and 54, and in particular the principle of voluntary and unpaid donation, it shall promote action to: / (a) publicise at European level the various types of SoHO donations that are achievable; / (b) introduce a European day given over to the donation of essential SoHOs; / (c) encourage extending opening days and hours of SoHO collection entities and establishments outside traditional working hours; / (d) make the professions essential for carrying out SoHO donations more attractive; / (e) ensure awareness raising in connection with SoHO donations by healthcare workers in hospitals and healthcare facilities; / (f) ensure sound blood stock management in accordance with patient blood management practices. / 2. Within two years after publication of that European strategy, Member States shall adopt national priority action programmes for donor recruitment. / 3. Those national plans shall take into account the Commission’s strat…

Added:Article 59 – paragraph 6: deleted

Removed:Union dependence on third countries for SoHOs, in particular for plasma, is not inevitable. It is essential that Union self-sufficiency be gradually built up on the basis of a European strategy. Relying on imports exposes Member States and the Union to supply disruptions in the event of a sudden interruption of trade with exporting third countries.

Added: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 …

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

Added: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.

Added: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.

Added: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.

Added: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)

Added: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.

Added: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.

Added: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.

Added: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.

Added: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:

Added: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;

Added: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;

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

Added: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…

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.

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

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

Change 36

Removed:Article 64 – paragraph 2: 2. Competent authorities shall inform the SoHO National Authority of the emergency authorisation. The SoHO National Authority shall inform the Commission and the other Member States of any decision to permit the distribution or preparation for immediate application of SoHO preparations in accordance with paragraph 1.