Text · Comparison of two versions

Changes from plenary report to adopted text

A-9-2023-0250 → TA-9-2023-0299

From: A-9-2023-0250 Plenary report of 26 Jul 2023
To: TA-9-2023-0299 Adopted text of 12 Sept 2023
Changes: 11 changes to the text
Paragraphs: +5 added · −48 removed · 9 changed

More facts (2)

Title (from): on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Title (to): Standards of quality and safety for substances of human origin intended for human application

Title (from): on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Title (to): Standards of quality and safety for substances of human origin intended for human application

Changes that matter, 11

Changes to the text in document order — the ones the change notes describe. Cover page, renumbering and punctuation-only edits are left out (see “Every difference”); changes to citations and references stay in and are marked as formal in the notes.

Change 1

Removed~~– after consulting the Committee of the Regions,~~

Change 2

ChangedRecital 10: (10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. Furthermore, this Regulation should not apply where the handling of SoHOs ~~toccurs~~occurs during a surgical intervention within a sterile field or within a closed-system medical device. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination, contamination of medical personnel or environmental contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy or functionality in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply.

Change 3

ChangedRecital 16: (16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs, where such legislation is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member ~~States and, in particular, no provision of this Regulation should be construed as imposing an obligation on Member States to use types of SoHOs that are legally prohibited in that Member State.~~States. However, decisions should adhere to the Charter of Fundamental Rights of the European Union. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.

Change 4

AddedRecital 18 a (new): (18a) As indicated by the Council of Europe Committee on Bioethics24a, it should be possible to compensate donors for any quantifiable expenses and losses, financial or non-financial, that they incur as a result of a donation. When calculating such compensation, SoHO entities should be able to take into account non-financial variables to determine the appropriate level and form of compensation to be given to donors, as long as such compensation complies with the principle of voluntary and unpaid donation laid down in this Regulation. / 24a Council of Europe Committee on Bioethics, Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors, March 2018. Available at: https://rm.coe.int/guide-financial-gain/16807bfc9a.

Change 5

ChangedArticle 5 – paragraph 3 – point b – point ii: (ii) to order the immediate suspension or cessation of a SoHO activity that poses immediate risk to SoHO donors, SoHO recipients or the general public or that does not comply with the conditions of its authorisation or ~~withthis~~with this Regulation;

Change 6

ChangedArticle 21 – paragraph 2 – ~~point~~subparagraph c1 a (new): ~~(ca) where~~Where the conditional authorisation referred to in point (c) has been granted, appropriate information for practitioners and patients on the conditional nature of the authorisation shall be provided by the SoHO ~~entity;~~entity.

Change 7

ChangedArticle 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 ,~~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.

Change 8

ChangedArticle 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. / 22. 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 …~~any…

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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.

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;

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)may~~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.

Sources & citation

Where the facts on this page come from, and how to cite it.

Permalink: https://news.eu-parl.st-solutions.dev/texts/A-9-2023-0250/compare/TA-9-2023-0299
Data source: European Parliament Open Data
Licensed CC BY 4.0.
Retrieved: 25 September 2026

Cite as

European Parliament (2023). “Changes between A-9-2023-0250 and TA-9-2023-0299”. Text, 12 September 2023. from A-9-2023-0250, to TA-9-2023-0299. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/A-9-2023-0250/compare/TA-9-2023-0299 (retrieved 25 September 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).

BibTeX

@misc{epw-text-2023-09-12,
  author = {{European Parliament}},
  title = {{Changes between A-9-2023-0250 and TA-9-2023-0299}},
  year = {2023},
  date = {2023-09-12},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/A-9-2023-0250/compare/TA-9-2023-0299}},
  url = {https://news.eu-parl.st-solutions.dev/texts/A-9-2023-0250/compare/TA-9-2023-0299},
  urldate = {2026-09-25},
  publisher = {EU Parl Watch Research},
  note = {Text. from A-9-2023-0250, to TA-9-2023-0299. Data: European Parliament Open Data (CC BY 4.0)}
}