What changed between the draft committee report and the plenary report

Added:Article 27 – paragraph 3 – subparagraph 1 – point a a (new): (aa) does not take corrective or preventive action following an inspection by national authorities pursuant to Article 29(14); and

Removed:Forcing SoHO entities to apply for a new authorisation for any changes may be too burdensome and difficult to implement. The introduction of a small degree of flexibility in this article would appear to be better adapted to the reality on the ground.

Added:Article 27 – paragraph 5: 5. Competent authorities may, in accordance with national legislation, withdraw the authorisation of a SoHO establishment if the competent authorities have confirmed that the SoHO establishment no longer complies with updated criteria for authorisation or the SoHO establishment has failed to comply with the conditions of its authorisation.

Removed:Article 40 – paragraph 3: 3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 21a and 64.

Added:Article 28 – paragraph 5 – point a: (a) that the SoHO entity in question does not comply with the conditions of the authorisation or the provisions of this Regulation; or

Removed:Article 41 – paragraph 5: 5. SoHO entities shall not make any substantial change to the chain of activities performed for an authorised SoHO preparation, without the prior written approval of their competent authorities. SoHO entities shall also inform their competent authorities of changes in the SoHO preparation authorisation holder’s details.

Added:Article 28 – paragraph 5 – point b: (b) that this non-compliance, or suspected non-compliance, implies a risk to the safety of SoHO recipients or offspring from medically assisted reproduction.

Removed:Same justification as proposed in the amendment to Article 40.

Added:Article 28 – paragraph 7: 7. Competent authorities may, in accordance with national legislation, withdraw the authorisation of an importing SoHO entity if the competent authorities have confirmed that the importing SoHO entity no longer complies with updated criteria for authorisation or the importing SoHO entity has failed to comply with the conditions of its authorisation.

Added:Article 28 – paragraph 9: 9. By way of derogation from paragraph 1, in the exceptional situations referred to in Article 61a or in case of emergency, competent authorities may authorise imports of SoHOs for immediate application to a specific recipient when duly justified by the clinical circumstances on a case-by-case basis.

Added:Article 29 – paragraph 11: 11. The interval between inspections shall be decided on based on the frequency necessary to mitigate any identified risks and shall not exceed 4 years.

Added:Article 32 – paragraph 1 – subparagraph 2 a (new): Inspectors shall be designated in accordance with procedures which ensure that they act in a transparent, independent and impartial manner. The designation criteria shall be clear and transparent.

Added:Article 32 – paragraph 1 a (new): 1a. All inspectors shall act in an impartial manner and be independent of any direct or indirect conflicts of interest. Inspectors shall declare such impartiality in writing and such declarations shall be made available on the competent authorities’ website.

Added:Article 32 – paragraph 3 – point a: (a) the inspection techniques and procedures to be followed, including practical exercises and conflict of interest rules;

Added:Article 34 a (new): Article 34a / Exchange of information on SoHO availability and continuity of supply / 1. As part of the national plans to ensure the continuity of SoHO supply referred to in Article 62, the competent authorities shall establish a digital communication channel through which they can exchange information on the availability of SoHOs in the national territory in a fast and efficient manner. Through that digital communication channel, the competent authorities may, in specific situations of need, oblige national SoHO entities to provide information on the availability of a certain SoHO. They shall also take into account alerts sent by national SoHO entities concerning the availability of SoHOs and potential shortages. The competent authorities shall ensure that the digital communication channel is available no later than ... [two years after the date of entry into force of this Regulation]. / 2. The competent authorities shall monitor the availability of SoHOs at national level through the digital communication channel referred to in paragraph 1. They shall provide guidance to SoHO entities to facilitate the exchange of information on the availability of SoHOs. / 3. The competent authorities shall store and analyse information on the availability of SoHOs and the fluctuations in such availability over time, as well as trends in demand and potential shortages of SoHOs, and shall draw up reports containing that information which may be made available to other Member States through …

Added:Article 36 a (new): Article 36a / Authorisation and registry of SoHO clinical studies / 1. Competent authorities shall authorise SoHO clinical studies after granting the approval for the clinical study proposal referred to in Article 41a(5) and verifying that the clinical study has been the subject of a positive recommendation by a relevant ethics committee where necessary. / 2. Competent authorities shall inform, instruct and assist SoHO entities in their Member State with regard to the authorisation and registration processes for SoHO clinical studies. Competent authorities shall provide SoHO entities with guidelines and assistance regarding technical and ethical aspects of SoHO clinical studies. / 3. Competent authorities shall register each authorised SoHO clinical study on the EU SoHO Platform, providing the following information: / (a) the name or business name and address of the SoHO entity or entities carrying out the clinical study, and the name and contact details of the researchers and a contact person; / (b) where necessary, a positive recommendation by a relevant ethics committee; / (c) a summary of the study design; / (d) date of commencement and completion of the various stages of the clinical study; / (e) not more than one year after the end of the clinical study, a summary of the results and conclusions; / (f) a summary intended for the general public of the clinical study and the results obtained. / 4. In cases where more than one SoHO entity participates in a SoHO clinical stu…

Added: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. The SoHO entity shall ensure that the responsible person for release of SoHOs receives adequate and up-to-date training, appropriate to their job and responsibilities, including specific training on those SoHOs that necessitate such training.

Added: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. For the purposes of this Article, ‘substantial modification’ means a modification that has an impact on the purpose, quality, safety, efficacy or functionality of a SoHO preparation.

Added:Article 40 – paragraph 3: 3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 61 and 61a.

Added:Article 41 – paragraph 2 – point b: (b) the results of a risk assessment conducted in accordance with Article 41a(4); / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 41 – paragraph 2 – point c: (c) in cases where the indicated risk is other than negligible, a proposal for clinical outcome monitoring to demonstrate safety, quality and efficacy of the SoHO preparation, in line with the results of the risk assessment, and as set out in Article 41a(5);

Added:Article 41 – paragraph 3: deleted / (deleted) / (deleted) / (deleted)

Added:Article 41 – paragraph 4: 4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results and the analysis of those results to their competent authorities at the frequency determined in the authorisation. In conducting the clinical investigation study as referred to in Article 41a(5), points (a)(ii) and (a)(iii), for the SoHO preparation concerned, the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data. The applicant shall register that study and the results obtained on the EU SoHO Platform in accordance with Article 36a.

Added:Article 41 – paragraph 5: 5. SoHO entities shall not make any substantial change to the chain of activities performed for an authorised SoHO preparation, without the prior written approval of their competent authorities. For the purposes of this Article, ‘substantial change’ means a change that has an impact on the purpose, quality, safety, efficacy or functionality of a SoHO preparation. SoHO entities shall also inform their competent authorities of changes in the SoHO preparation authorisation holder’s details.

Added:Article 41 a (new): Article 41a / SoHO clinical studies / 1. When conducting SoHO clinical studies, in the context of the monitoring plans referred to in Article 41(2), point (c), or with the aim of comparing or improving previously authorised treatments, SoHO entities shall comply with the requirements set out in this Regulation. / 2. SoHO clinical studies shall always have the safety and well-being of the participants in the clinical study as a priority and they shall comply with Articles 53, 54, 55, 56, 58 and 59, concerning the protection of donors, recipients and offspring from medically assisted reproduction. SoHO entities intending to start a SoHO clinical study shall seek to obtain robust and reliable data, through collaboration with other SoHO entities, if necessary. / 3. SoHO entities shall submit a request for approval of the SoHO clinical study to competent authorities before starting the clinical study, in accordance with the procedure set out in paragraphs 4 and 5. SoHO entities may request assistance regarding administrative, technical and ethical aspects of the clinical study from the competent authorities, in accordance with Article 36a. / 4. Prior to starting a SoHO clinical study, the applicant shall conduct a risk assesment, on the combination of SoHO activities performed for the SoHO preparation, together with the intended clinical indication, taking into account: / (a) whether the SoHO preparations are described in, and aligned with, an EDQM SoHO monograph included in the t…

Added:Article 43 – paragraph 4: 4. The importing SoHO entity authorisation holder shall be based in the Union, and be responsible for the physical reception and visual examination and verification of imported SoHOs prior to their release. The importing SoHO entity shall verify coherence between the SoHO received and the associated documentation and conduct an examination of the integrity of packaging and the compliance of labelling and transport conditions with the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59. The importing SoHO entity shall ensure that the imported SoHOs meet safety and quality standards equivalent to those set out in this Regulation.

Added:Article 47 – paragraph 1: 1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse occurrences, including adverse occurrences detected during clinical outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 41 or as part of a SoHO clinical study as referred to in Article 41a.

Added:Article 47 – paragraph 3 a (new): 3a. Where a SAO notification concerns public health matters, competent authorities shall, without delay, communicate essential information to the general public and to the SCB.

Article 48 – paragraph 1: 1. SoHO establishments shall not carry out any SoHO activities without prior SoHO establishment authorisation. This shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another SoHO entity.

Change 25

Removed:Article 52 – paragraph 2 a (new): 2a. SoHO entities shall ensure that the state of health of donors does not pose a detectable risk to donations.

Added:Article 51 – title: Physicians

Removed:Article 53 – paragraph 1 – point b: (b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that enables them to give free and informed consent;

Added:Article 51 – paragraph 2 – point b: (b) investigation of suspected adverse occurrences in SoHO donors, SoHO recipients and, where relevant, offspring from medically assisted reproduction;

Change 26

Changed:Article 5351 – paragraph 3: 3. SoHO entities that collectBy SoHOsderogation from donors that are subjected to a surgicalparagraph procedure2, in order to donate, that are treated with hormonesthe tocase facilitateof donation,SoHO orentities that donate on aare frequentauthorised andas repeatedSoHO basis,establishments shallin registeraccordance suchwith donorsArticle and25(3), the results of their donorphysician healthshall evaluationsbe inresponsible afor cross-entitythose registrytasks that allows interconnection with other such registries, including cross-border ones, asare referredrelevant to inthe paragraphSoHO 1,activities pointperformed (j).by the SoHO entities that manage suchand registriesthat shallhave ensurea interconnectivitydirect betweeninfluence them.on Thethe concepthealth of frequent and repeated donations shall be definedSoHO indonors, accordanceSoHO withrecipients theand, EDQMwhere guidelinesrelevant, foroffspring eachfrom typemedically ofassisted donation.reproduction.

Change 27

Added:Article 52 – paragraph 2: 2. SoHO entities shall protect the physical and, where relevant, mental health of living SoHO donors before, during and after the donation.

Added:Article 52 – paragraph 2 a (new): 2a. SoHO entities shall ensure that the state of health of SoHO donors before the donation does not pose a disproportionate risk to the donation or to the health of such donors during or after the donation.

Added:Article 53 – paragraph 1 – point a: (a) meet all applicable informed consent or authorisation requirements in force in the Member State concerned;

Added:Article 53 – paragraph 1 – point b: (b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that enables them to give informed consent and request further information if needed;

Added:Article 53 – paragraph 1 – point j: (j) verify, by means of national registries, that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in Article 56 and demonstrate that their health is not compromised;

Added:Article 53 – paragraph 1 – point j a (new): (ja) verify, by means of national registries, that donors meet donor eligibility criteria, if required in the case of specific types of donation, on the basis of the latest available scientific evidence and medical expertise;

Added:Article 53 – paragraph 1 – point l a (new): (la) inform the SoHO recipients of donor anonymity requirements and the possibility of ID release and the implications thereof for medically assisted reproduction with third party donation of reproductive cells, pursuant to national legislation.

Added:Article 53 – paragraph 1 a (new): 1a. SoHO entities shall not discriminate against SoHO donors 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, of the offspring from medically assisted reproduction or of the SoHO donor. Such discriminatory action shall be based on scientific evidence.

Added:Article 53 – paragraph 2: 2. In the course of the donor health evaluations referred to in paragraph 1, point (f), SoHO entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical, and, where appropriate, mental health and their health histories to assure the safety of the donation process for those donors. SoHO entities may perform laboratory tests as part of the donor health evaluations. They shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. The physician, as referred to in Article 51, shall approve the procedure and criteria for donor health evaluations.

Added:Article 53 – paragraph 3: 3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHOs that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross-entity registry that allows interconnection with other such registries at Union level, including cross-border registries, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them. The concept of frequent and repeated donations shall be understood in accordance with the EDQM guidelines referred to in Article 71 for each type of donation.

Article 53 – paragraph 6: 6. The Commission is empowered to adopt delegated acts in accordance with Article 77 in order to be able to supplement this Regulation in cases where additional standards are needed in order to ensure the protection of donors, in particular as regards the permitted frequency of donations in the event of non-application of the guidelines referred to in Article 56.

Change 28

Changed:Article 54 – paragraph 2: 2. Member States may allow for the compensation or reimbursement from the SoHO entities to living SoHO donors for losses or expenses related to their participation in donations, in accordance with the compensationprinciple paymentsof beingvoluntary strictlyand proportionalunpaid todonation, anyand lossesfor incurred.example Intaking suchthe case,form of compensatory leave, tax reductions or flat rate allowances set at national level. Based on transparent criteria, Member States shall establish the conditions for such forms of compensation paymentsor reimbursement in national legislation, including the setting of an upper limit that ensuresensuring that they are always financially neutral and consistent with the standards laid down in this Article. / They may make compensation paymentsor reimbursement subject to the filing of applications by donors and delegate the setting of conditions for such paymentsforms of compensation or reimbursement to independent bodies that are established in accordance with national legislation. In that regard, the Commission shall support the exchange of best practices between Member States. The donordonors may also choose not to be compensated for losses or expenses associated with histheir donation.

Change 29

Removed:Article 54 – paragraph 3 a (new): 3a. Compensation payments must not serve as an incentive for donations or engender financial competition, including cross-border competition, between institutions and entities that are seeking donors.

Added:Article 54 – paragraph 3: 3. SoHO entities may compensate or reimburse living SoHO donors as provided for by their competent authorities pursuant to paragraph 2. SoHO entities shall report in a transparent manner to the competent authorities on any compensation and reimbursement measures they have in place, and on any changes they make in that respect.

Removed:Article 54 – paragraph 3 b (new): 3b Member States shall report to the Commission on the conditions for granting such compensation and setting the limits thereof two years after the entry into force of this Regulation and every three years thereafter. On the basis of those reports, the Commission shall inform the European Parliament and the Council of the necessary additional measures it intends to take at Union level to ensure compliance with the principle of voluntary and unpaid donation in accordance with Article 3 of the Charter of Fundamental Rights of the European Union.

Added:Article 54 – paragraph 3 a (new): 3a. Compensation or reimbursement shall not serve as an incentive for donations or engender financial competition, including cross-border competition, between institutions and entities that are seeking donors. It shall not lead to exploitation of vulnerable persons in society.

Change 30

Changed:Article 54 – paragraph 3 cb (new): 3c. On the basis of those reports, and3b. inMember orderStates toshall ensureregulate the implementationadvertising of the principlecollection of voluntary and unpaidSoHOs. donation,Any theadvertising Commissionof shallSoHO bedonations empoweredlinked to adopt delegated actsa infinancial accordancereward withshall Articlebe 77prohibited. inRecruitment ordercampaigns toand establishadvertisements ashall singlenot registerrefer ofto Europeanany donors.compensation.

Change 31

Removed:If deemed necessary and on the basis of the reports provided for in paragraph 3b, the Commission must be able to propose a delegated act establishing a single register of donors. This will ensure, for example, that it is not possible to donate more than is reasonable simply by crossing an EU internal border.

Added:Article 54 – paragraph 3 c (new): 3c. By ... [two years after the date of entry into force of this Regulation] and every three years thereafter, the Commission shall assess the national conditions for the level of compliance with the principle of voluntary and unpaid donation as set out in this Regulation. That assessment shall determine, inter alia, whether compensation and reimbursement, under any circumstances, harm donor or recipient safety, constitute an incentive or a claim to recruit donors or expose vulnerable people in society to exploitation. Member States shall provide the Commission with the information requested to perform that assessment. / On the basis of the assessments referred to in the first subparagraph, the Commission shall adopt guidelines for Member States based on best practices in the implementation of compensation schemes and, where appropriate, make recommendations to Member States on how such practices can be improved. Those guidelines and recommendations shall be made available to the public.

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, ensuring that this is a free and informed decision. 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.

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

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 free and informed consent;

Added: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.

Added: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;

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;

Change 32

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. They shall do so by: