What changed between the draft committee report and the plenary report

Added:Article 3 – paragraph 1 – point 61: (61) ‘SoHO for reproduction’ means all cells intended to be used for the purpose of medically assisted reproduction, and embryos resulting from fertilisation;

Added:Article 3 – paragraph 1 – point 62: (62) ‘third party donation’ means a donation of a SoHO for reproduction by a person to a recipient or a couple with whom the donor does not have an intimate physical relationship;

Added:Article 3 – paragraph 1 – point 62 a (new): (62a) ‘ID release’ means the disclosure of information that permits the identification of donors of a SoHO for reproduction to donor-conceived offspring or their legal parents, as provided for in national legislation;

Added:Article 3 – paragraph 1 – point 63: (63) ‘within relationship use’ means use of reproductive cells for medically assisted reproduction between persons with an intimate physical relationship, where a person provides their own oocytes and another person supplies their own sperm for the human application to a person within the relationship;

Added:Article 3 – paragraph 1 – point 64: (64) ‘compensation’ means making good of any quantifiable losses and reimbursement of expenses associated with donation;

Article 3 – paragraph 1 – point 64 a (new): (64a) ‘financial neutrality of donation’ means that no financial gain or loss will be incurred by the donor as a result of the donation;

Change 18

Removed:This definition is added for consistency with the EDQM’s 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, which is cited numerous times in the Commission proposal and is useful to clarify the principle of voluntary and unpaid donation.

Added:Article 3 – paragraph 1 – point 70 a (new): (70a) ‘donor base resilience’ means the capacity of the donation collection system to rely on a large number of donors for a given SoHO category;

Removed:Article 3 – paragraph 1 – point 70 a (new): (70a) ‘patient blood management’ means an innovative organisational approach for the best possible management of patients undergoing surgery at risk of bleeding, based on the following three pillars: / (a) optimising the patient’s blood mass; / (b) minimising blood loss; / (c) improving the patient’s tolerance to anaemia;

Added:Article 3 – paragraph 1 – point 70 b (new): (70b) ‘informed consent’ means that the donor’s agreement has been obtained freely without coercion and after the donor has been provided with access to clear, comprehensive information in line with the donor’s capacity to understand, for SoHO donation or use;

Removed:Definition based on the World Health Organisation resolution mentioned in recital 24(a),

Added:Article 3 – paragraph 1 – point 70 c (new): (70c) ‘SoHO clinical study’ means an experimental evaluation of a SoHO or a SoHO preparation in humans, with the objective of drawing conclusions regarding its efficacy and safety;

Change 19

Changed:Article 3 – paragraph 1 – point 70 bd (new): (70b) ‘donor(70d) base‘European resilience’autonomy’ means the capacityUnion’s ofdegree theof donationindependence collectionfrom systemthird tocountries relyin onrelation ato largethe numbercollection of donors to addressSoHOs, the emergencemanufacture of aSoHO healthpreparations crisis;and any other SoHO activities.

Change 20

Removed:Article 3 – paragraph 1 – point 70 c (new): (70c) ‘free and informed consent’ means the donor’s agreement has been obtained freely without coercion and after access to clear, comprehensive information in line with his or her capacity to understand;

Added:Article 4 – paragraph 1: 1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are based on scientific evidence, are compatible with Union law, and are proportionate to the risk to human health. / Such measures: / (a) shall not directly or indirectly constitute discrimination between SoHO donors based on any of the grounds recognised by Article 21 of the Charter of Fundamental Rights of the European Union, in particular discrimination based on sexual orientation. Member States shall report to the Commission any restrictions that they or SoHO entities in their territory impose that can reasonably be considered to constitute such discrimination and provide a summary of the scientific evidence used to justify these measures to protect SoHO donors, SoHO recipients or offspring from medically assisted reproduction; / (b) may contribute to setting up a European supply chain and to achieving the objective of European autonomy and coordination between Member States; they may also be aimed at reinforcing the principle of voluntary and unpaid donation.

Removed:Article 3 – paragraph 1 – point 70 d (new): (70d) ‘European self-sufficiency’ means the Union’s degree of independence on third countries for the collection of substances of human origin, the manufacture of preparations based on SoHOs and any other SoHO-related activities.

Added:Article 5 – paragraph 3 – point a: (a) have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined in national legislation;

Removed:Article 4 – paragraph 1 a (new): 1(a) Member States may introduce additional measures to help set up a European supply chain and to achieve the objective of European self-sufficiency. Such measures may also aim to reinforce the principle of voluntary and unpaid donation.

Added:Article 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 Regulation;

Removed:It would be advisable to specify that Member States are free to take stricter measures with a view to restricting SoHO imports from third countries, whose collection systems are not necessarily based on the principle of voluntary and unpaid donation set out in this proposal for a regulation. This amendment is consistent with the desire to promote European self-sufficiency concerning SoHOs.

Added:Article 5 – paragraph 3 – point c: (c) have sufficient human and financial resources, operational capacity, and expertise, including technical expertise, to achieve the aims of, and fulfil their obligations under, this Regulation;

Removed:Article 7 – paragraph 2 a (new): 2a. Paragraph 2 shall also apply to the previous activities of staff members for a reasonable period, to be defined and made public by the competent authorities.

Added:Article 5 – paragraph 4: 4. Each Member State shall designate a single SoHO National Authority, in conformity with Member States’ constitutional requirements, responsible for coordinating exchanges with the Commission and with other Member States’ SoHO National Authorities. The Commission shall make publicly available the list of SoHO National Authorities on the EU SoHO Platform.

Removed:Article 9 – paragraph 2 – point c: (c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities safely, efficiently and effectively;

Added:Article 7 – paragraph 1: 1. Competent authorities and members of the SCB shall act independently, in the public interest and free from any external influence.

Removed:Article 14 – paragraph 1: 1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with authorities established in other relevant Union legislation referred to in Article 2(3), such as the EMA and the Medical Device Coordination Group (MDCG). In such cases, competent authorities shall also consult the compendium referred to Article 3 point (33).

Added:Article 7 – paragraph 2: 2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. All relevant personnel shall make an annual declaration of their interests, which shall be published on the competent authorities’ website.

Change 21

Changed:Article 147 – paragraph 2 – subparagraph 1:a In(new): the2a. courseParagraph of2 theshall consultationalso referredapply to in paragraphthe 1,previous theactivities competentof authoritiesstaff shallmembers submitfor a requestreasonable toperiod theprior SCBto forthem itsbeing opinionrecruited onby the regulatorycompetent statusauthorities, ofto thebe substance,determined productand ormade activitypublic underby thisthe Regulation.competent authorities.

Change 22

Removed:Article 14 – paragraph 2 – subparagraph 2: The SCB shall consult, in accordance with Article 68(1), point (b), with the equivalent advisory bodies 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 8 – paragraph 1: 1. Without prejudice to Article 75, competent authorities and members of the SCB shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health, including decisions to revoke, suspend or reinstate an authorisation for SoHO activities. Competent authorities shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.

Removed:Article 14 – paragraph 3: 3. Following the consultations referred to in paragraph 1 of this Article, regarding the regulatory status of the substance, product or activity concerned under this Regulation, the competent authorities shall inform the SCB on any consensus reached as a result of those consultations for publication in the compendium by the SCB. / To the extent possible, the competent authorities shall comply with the opinion of the SCB. In the event of non-compliance, they shall inform the SCB as soon as possible of the decision taken and justify their decision.

Added:Article 9 – paragraph 1: 1. Competent authorities shall be responsible for the SoHO supervisory activities referred to in Chapter III in order to verify the effective compliance of SoHO entities and SoHO preparations authorised in their territory with the requirements set out in this Regulation.

Removed:Article 18 – paragraph 2: 2. Instead of establishing a register of SoHO entities, as referred to in paragraph 1, a SoHO National Authority shall be encouraged to use the EU SoHO Platform as referred to in Chapter XI. In this case, the SoHO National Authority shall instruct competent authorities, where necessary, and SoHO entities to register directly on the EU SoHO Platform.

Added:Article 9 – paragraph 2 – point a: (a) human and financial resources, operational capacity, and expertise, including technical expertise, to carry out the supervisory functions provided for in this Regulation;

Removed:Article 20 – paragraph 3: 3. SoHO preparation authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity of the SoHO preparation authorisation of another Member State. That refusal shall end once the Member State which has adopted a more stringent measure has verified that the correct application of that measure by the Member State which granted the authorisation has been met. Where a Member State refuses to recognise the validity of the authorisation granted by another Member State, it shall without undue delay notify the SoHO Platform established by this Regulation.

Added:Article 9 – paragraph 2 – point b: (b) procedures to ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;

Removed:Article 21 a (new): Article 21a / Exceptional derogation from the obligation to authorise SoHO preparations in situations where there is no therapeutic alternative / 1. By way of derogation from Article 21 of this Regulation, and after consulting the relevant best practices approved and documented by the SCB in accordance with Article 68(1)(c), the competent authorities may authorise, on an exceptional basis and at the request of a prescribing doctor within a SoHO entity, preparations of substances of human origin in situations where the procedures referred to in Article 21 have not been followed, provided that: / (a) provision has been made for the use of such preparations for a given patient, in cases where that patient has no therapeutic alternative, when treatment cannot be postponed or when his or her condition is life threatening; / (b) the preparation is deemed to be safe and effective on the basis of the available clinical data. / 2. The competent authorities shall inform the national SoHO authority of the authorised derogation. The national SoHO authority shall inform the Commission and the other Member States of any decision to authorise the distribution or preparation for immediate application of substances of human origin in accordance with paragraph 1.

Added:Article 9 – paragraph 2 – point c: (c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities efficiently, safely and effectively;

Removed:The only possibility for derogation in the Commission proposal concerns continuity of supply. An additional derogation seems necessary where therapeutic alternatives cannot be offered to a given patient. Such cases could be, for example, cell therapies for burn victims or for patients who have suffered accidental irradiation.

Added:Article 14 – paragraph 1: 1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with the national authorities established in other relevant Union legislation referred to in Article 2(3), as relevant In such cases, competent authorities shall also consult the compendium referred to Article 3, point (33).

Removed:Article 25 – paragraph 2: 2. Competent authorities shall authorise as SoHO establishments the SoHO entities that both process and store or process and release or store and release SoHOs in accordance with Article 27.

Added:Article 14 – paragraph 2 – subparagraph 2: If the SCB deems it necessary, it shall consult, in accordance with Article 68(1), point (b), with the equivalent advisory bodies established in other relevant Union legislation referred to in Article 2(3).

Removed:Article 25 – paragraph 3 – introductory part: 3. Competent authorities may decide that certain SoHO entities that do not process and store or process and release or store and release SoHO also need to be authorised as SoHO establishments, in particular SoHO entities that:

Added:Article 14 – paragraph 3 – subparagraph 1 a (new): To the extent possible, the competent authorities shall comply with the opinion of the SCB. In the event of non-compliance, they shall inform the SCB as soon as possible of the decision taken and justify their decision.

Removed:Article 25 – paragraph 5: 5. SoHO establishment authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation or the establishment has ceased to conduct SoHO activities. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO establishment authorisation, that Member State may decline to recognise the validity of the SoHO establishment authorisation of another Member State. That refusal shall end once the Member State which has adopted a more stringent measure has verified that the correct application of that measure by the Member State which granted the authorisation has been met.

Added:Article 16 – paragraph 1 – point a a (new): (aa) make the declarations of interest referred to in Article 7(2) publicly available on their website;

Change 23

Changed:Article 2620 – paragraph 3: 3. Importing SoHO entitypreparation authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation or the entity has ceased to conduct SoHO activities.authorisation. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific importing SoHO entity authorisation,preparation, that Member State may decline to recognise the validity of the importing SoHO entitypreparation authorisation of another Member State. That refusal shall end once the Member State which has adopted a more stringent measure haspending verifiedverification that the correct application ofmore thatstringent measure by the Member State which granted the authorisation has been met. It may be based on the principle ofThis voluntaryinformation andshall unpaidbe donation,notified, inwithout accordanceundue withdelay, Articleon 4(1)(a)the ofEU thisSoHO Regulation.Platform.

Change 24

Removed:Article 32 – paragraph 1 – subparagraph 2: In exceptional cases, competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. Their designation shall be the result of procedures which guarantee their independence and impartiality.

Added:Article 21 – paragraph 2 – point c a (new): (ca) 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;

Removed:Article 32 – paragraph 2: 2. Competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. For the specific induction training, competent authorities shall ensure the independence and impartiality of inspectors and shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).

Added:Article 21 – paragraph 4: 4. Competent authorities shall conclude the SoHO preparation authorisation steps, referred to in paragraph 2 of this Article, within 3 months from receipt of the application, excluding the time needed for clinical outcome monitoring or studies. They may suspend this time limit for the duration of the consultation processes referred to in Article 14(1) and (2) or if further information is required from the SoHO entity that made the request.

Removed:Article 34 – paragraph 2: 2. Competent authorities shall establish procedures for the unique identification of SoHO establishments that are subject to the provisions on the Single European Code in Article 46. Competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. For this purpose, competent authorities shall use a SoHO establishment identification code generated by the EU SoHO Platform.

Added:Article 21 – paragraph 6 – subparagraph 1 – point a: (a) such preparation, or any of the activities performed for that preparation, do not comply with the conditions of its authorisation or the requirements of this Regulation; or

Removed:Article 36 – paragraph 5 a (new): 5a. Where the IIG has consequences falling within the remit of HERA, the ECDC or the EMA, competent authorities shall provide them without undue delay with information that could reasonably be considered useful.

Added:Article 21 – paragraph 8: 8. Competent authorities may, in accordance with national legislation, withdraw the authorisation of a SoHO preparation if the competent authorities have confirmed that the SoHO preparation in question does not comply with subsequently updated criteria for authorisation or the SoHO entity has failed to comply with the conditions of its authorisation.

Removed:Article 38 – paragraph 2: 2. The responsible person for release of SoHOs shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field and shall receive continuous training throughout his or her career in relation to innovative processing technologies and processes.

Added:Article 27 – paragraph 1: 1. Competent authorities shall provide guidelines and templates to allow that applications from SoHO entities for their authorisation as SoHO establishments are submitted in accordance with Article 49. When developing those guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).

Removed:Article 38 – paragraph 3: 3. The responsible person for release of SoHOs may delegate the tasks specified in paragraph 1 to other persons who shall be qualified by training and experience to perform such tasks without necessarily having two years’ experience. In such cases, that person shall perform those tasks under the responsibility of the responsible person for release of SoHOs.

Added:Article 27 – paragraph 3 – subparagraph 1 – point a: (a) does not comply with the conditions of its authorisation or the provisions of this Regulation; or

Removed:Article 40 – paragraph 1: 1. SoHO entities shall not release or, in an autologous context, prepare and apply immediately to a recipient, SoHO preparations without prior SoHO preparation authorisation. In cases where a SoHO entity substantially modifies an activity carried out for an authorised SoHO preparation, it shall obtain an authorisation for that modified SoHO preparation.