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Objectives regarding protection of SoHO recipients and offspring from medically assisted reproduction
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO and their human application, within the scope of their competences. They shall do so by identifying and minimising or eliminating those risks.
Standards concerning protection of SoHO recipients and offspring from medically assisted reproduction
1. SoHO entities shall establish procedures that achieve high levels of quality and safety of SoHO. Such procedures shall ensure that benefits for SoHO recipients and offspring from medically assisted reproduction outweigh residual risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions that are potentially life-threatening, disabling or incapacitating and originate from a third-party donor, are not transmitted to SoHO recipients or offspring from medically assisted reproduction. Procedures to prevent the transmission of serious genetic conditions shall include genetic testing to the extent that national legislation allows for such testing. 2. In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of communicable disease transmission from SoHO donors to SoHO recipients by combining at least the following measures: (a) reviewing and evaluating SoHO donors’ current and past health, travel and relevant behavioural histories and, where relevant, their family history, to allow for the application of temporary or permanent deferrals of SoHO donors when risks cannot be minimised by SoHO donor testing; (b) testing of SoHO donors for communicable diseases in laboratories duly accredited, certified or authorised, by using certified and validated testing methods or, when not feasible, by using other methods validated by those laboratories; (c) when feasible, taking other measures that reduce or eliminate any potential communicable pathogens. 3. In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of non-communicable disease transmission, when they are relevant to the SoHO concerned, including the transmission of serious genetic conditions and cancer, from SoHO donors to the SoHO recipients or to offspring from medically assisted reproduction by combining at least the following measures: (a) reviewing the SoHO donors’ current and past health and, where relevant, their family history, to allow for the application of temporary or permanent deferral of SoHO donors that carry a risk of transmitting cancerous cells, serious genetic conditions or other non-communicable diseases that might be passed to a SoHO recipient by human application of SoHO; (b) where the transmission of serious genetic conditions is an identified risk, and in particular in the case of medically assisted reproduction with third-party donation, and insofar as national legislation allows for any of the following testing: (i) routinely testing SoHO donors for potentially life-threatening, disabling or incapacitating genetic conditions with a significant prevalence in the SoHO donor population; or (ii) testing SoHO recipients to identify genetic risk for potentially life-threatening, disabling or incapacitating conditions, according to family history, combined with testing third party SoHO donors for such identified serious genetic conditions to ensure matching that will prevent such conditions occurring in the offspring from medically assisted reproduction. 4. In the procedures referred to in paragraph 1, SoHO entities shall take measures to mitigate the risks of communicable or non-communicable disease transmission to the SoHO recipients resulting from cross-contamination between SoHO during collection, processing, storage and distribution. Such measures shall ensure that physical contact between SoHO from different SoHO donors, as well as SoHO collected from different persons for future autologous or within-relationship use, is avoided or, in cases where pooling of SoHO is necessary for the effectiveness or feasibility of the SoHO preparation, such contact is limited to a justifiable level. 5. In the procedures referred to in paragraph 1, SoHO entities shall mitigate risks arising from microbial contamination of SoHO from the environment, the personnel, the equipment and the materials coming into contact with SoHO during collection, processing, storage or distribution. SoHO entities shall mitigate such risks by combining at least the following measures: (a) specifying and verifying the hygiene procedures of the personnel of the SoHO entity in contact with the SoHO throughout the SoHO preparation chain; (b) specifying and verifying the cleanliness of collection areas, taking into account the degree of exposure of SoHO to the environment during collection, and of storage areas; (c) in cases where SoHO are exposed to the environment during processing, specifying, based on a structured and documented risk assessment for each SoHO preparation, validating and maintaining a defined air quality in processing areas; (d) specifying, procuring and decontaminating equipment and materials that come into contact with SoHO during collection, processing, storage or distribution, such that their sterility, where necessary, is ensured; (e) performing quality control testing of SoHO to detect microbial contamination and using methods of inactivation or elimination of microorganisms, where feasible and appropriate. 6. In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks that any reagents and solutions added to SoHO or coming into contact with SoHO during collection, processing, storage and distribution might be transferred to SoHO recipients and have a harmful effect on their health, by combining at least the following measures: (a) specifying such reagents and solutions prior to their purchase and use; (b) verifying any required certifications of such reagents and solutions; (c) demonstrating the removal of such reagents and solutions, when necessary, prior to distribution. 7. In the procedures referred to in paragraph 1 of this Article, SoHO entities shall mitigate the risks that inherent properties of SoHO, necessary for clinical effectiveness, might be changed by any SoHO activity performed, in a manner that renders the SoHO ineffective or less effective when applied to SoHO recipients, by combining at least the following measures: (a) conducting comprehensive process validation and equipment qualification as referred to in Article 39(2), point (b)(viii); (b) gathering evidence of effectiveness as referred to in Article 39(2), point (d), when needed. 8. In the procedures referred to in paragraph 1 of this Article, SoHO entities shall mitigate the risks that SoHO cause an unexpected immune reaction in SoHO recipients by combining at least the following measures: (a) adequately typing and matching of SoHO recipients to SoHO donors, when such matching is necessary; (b) putting in place procedures to reduce, when feasible, those elements of SoHO that stimulate an unintended immune response, as applicable; (c) correctly distributing and applying SoHO to the correct SoHO recipients pursuant to Article 42. 9. In the procedures referred to in paragraph 1, SoHO entities shall mitigate any other avoidable risk to the health, including where related to the protection of dignity, in accordance with national law, of SoHO recipients or of offspring from medically assisted reproduction arising from SoHO applied and not addressed in paragraphs 2 to 8, by applying procedures that SoHO entities have validated as safely and effectively mitigating the risk concerned or that are demonstrated by published scientific evidence as mitigating the risk. 10. SoHO entities that distribute reproductive SoHO from third-party donation shall comply with rules established in national legislation regarding the limits to the number of offspring from medically assisted reproduction or of human applications with reproductive SoHO from a single SoHO donor, where applicable. SoHO entities shall monitor compliance with such rules via registries for reproductive SoHO donors, in accordance with the national legislation. Without prejudice to such rules, when reproductive SoHO are distributed to another Member State, the distributing SoHO entity shall respect the limits imposed by the receiving Member State. This Article shall not affect Member States’ rules concerning limits on the cross-border distribution of reproductive SoHO. 11. When carrying out SoHO activities, SoHO entities shall, to the extent possible, make use of technologies that reduce the risk of human error. 12. SoHO entities shall not: (a) apply SoHO preparations to SoHO recipients without proven benefit, except in the context of: (i) a clinical-outcome monitoring plan approved by their SoHO competent authority pursuant to Article 19(2), point (d); (ii) an individual treatment attempt with respect to the treating physician’s therapeutic decision pursuant to Article 19(11); or (iii) a health emergency situation pursuant to Article 65; (b) apply SoHO preparations to SoHO recipients unnecessarily; SoHO entities shall make optimal use of SoHO, taking into account therapeutic alternatives, and following the most up-to-date guidelines as referred to in Article 59; (c) advertise or promote particular SoHO to potential SoHO recipients, or to any persons granting consent on their behalf, or to healthcare professionals using information that is misleading, in particular, as to the potential use and benefits to SoHO recipients, or minimising the associated risks of the SoHO concerned; (d) distribute or apply allogeneic SoHO for purposes other than the prevention or treatment of a medical condition, including through reconstructive surgery, or for medically assisted reproduction. 13. For the measures referred to in paragraphs 2 and 3, SoHO entities shall verify the eligibility of a SoHO donor by means of: (a) an interview with the SoHO donor, in the case of donation from a living SoHO donor or, where applicable, with any persons granting consent on their behalf; or (b) in the case of collection of SoHO from deceased SoHO donors, an interview with a relevant person that is informed regarding the SoHO donor’s health and lifestyle history. In the case of donation from a living SoHO donor, the interview referred to in the first subparagraph, point (a), of this paragraph may also include any part of the interview conducted as part of the evaluation referred to in Article 53(1), point (e). For living SoHO donors that donate repeatedly, the interviews referred to in the first subparagraph, point (a), of this paragraph may be limited to aspects that might have changed and may be replaced with questionnaires. Interviews shall be added in cases where responses provided in questionnaires indicate changes in relevant information. This shall be without prejudice to Article 53(1), points (d) and (e), and Article 53(2). 14. SoHO entities shall document the results of SoHO donor eligibility verification as referred to in paragraphs 2 and 3, and shall communicate and clearly explain the results of SoHO donor eligibility verification to SoHO donors or, where relevant, any persons granting consent on their behalf, in accordance with national legislation. Where SoHO is collected from deceased SoHO donors, SoHO entities shall communicate and explain the results of the SoHO donor eligibility verification, in particular any condition identified in the deceased SoHO donor that might imply a risk for the health of the deceased SoHO donors’ relatives or close contacts, to the relevant persons, in accordance with national legislation. 15. SoHO entities applying SoHO to SoHO recipients shall obtain their consent or, where relevant, that of any person granting consent on their behalf, in accordance with national legislation, for the human application of SoHO. SoHO entities shall inform the SoHO recipients or any person granting consent on their behalf, of, at least, the following: (a) the safeguards intended to protect the personal data, including health data, of the SoHO recipients and, where relevant, of the offspring from medically assisted reproduction; (b) the need for SoHO recipients to report back any unintended reactions following the human application of SoHO or any serious genetic conditions in offspring from medically assisted reproduction with third-party donation, as referred to in Article 44(2). 16. The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation in cases where additional standards are deemed necessary to ensure the protection of SoHO recipients or offspring from medically assisted reproduction from risks associated with SoHO. 17. Where, in the case of risk to SoHO recipients and offspring from medically assisted reproduction arising from inadequate levels of quality and safety of SoHO, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.
Implementation of the standards concerning protection of SoHO recipients and offspring from medically assisted reproduction
1. When the Commission deems it necessary to establish binding rules on the implementation of a particular standard, or elements thereof, referred to in Article 58, in order to ensure convergent and high levels of protection of SoHO recipients and offspring from medically assisted reproduction, the Commission may adopt implementing acts setting out particular procedures to be applied to meet such standard or element thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2). 2. On duly justified imperative grounds of urgency relating to a risk to the health of the SoHO recipient or of the offspring from medically assisted reproduction, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 79(3). 3. The implementing acts adopted in accordance with paragraphs 1 and 2 of this Article shall also apply to SoHO entities when they apply the standards, or elements thereof, concerning protection of SoHO recipients and offspring from medically assisted reproduction as referred to in Article 58. 4. For those standards, or elements thereof, concerning protection of SoHO recipients and offspring from medically assisted reproduction for which no implementing act has been adopted, SoHO entities shall take into account: (a) the most recent technical guidelines, as indicated on the EU SoHO Platform, as follows: (i) published by the ECDC concerning the prevention of communicable disease transmission; (ii) published by the EDQM concerning protection of SoHO recipients and offspring from medically assisted reproduction other than from transmission of communicable disease; (b) other guidelines, adopted by Member States, as referred to in Article 27(6), point (b); (c) other guidelines or technical methods, applied in specific circumstances, as referred to in Article 27(6), point (c). 5. In the cases referred to in paragraph 4, point (a), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the technical guidelines referred to in paragraph 4, point (a), of this Article. 6. In the cases referred to in paragraph 4, point (b), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the technical guidelines referred to in paragraph 4, point (b), of this Article. 7. In the cases referred to in paragraph 4, point (c), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall provide during inspection a justification to their SoHO competent authorities, for each specific standard, or element thereof, that the other guidelines are adequate to achieve the level of quality and safety set out in that standard. That justification may be based on a documented demonstration of equivalence with the technical guidelines published by the ECDC and by the EDQM referred to in paragraph 4, point (a), of this Article. Where other technical methods are applied, SoHO entities shall perform a risk assessment to demonstrate that the technical methods applied achieve a high level of protection of SoHO donors, and record the practice followed to establish the technical methods. They shall make the assessment and record available for review by their SoHO competent authorities during inspection or on specific request of the SoHO competent authorities.
SoHO release
A SoHO establishment that releases SoHO for distribution or export shall have a procedure in place, under the control of the releasing officer as referred to in Article 49, for SoHO release to ensure that the standards, or elements thereof, referred to in Articles 58 and 59 and their implementation, have been verified and documented prior to release and that all conditions included in any applicable authorisations granted in accordance with this Regulation have been complied with. SoHO processed for autologous use or within-relationship use, without SoHO storage, shall not require release before human application. In such cases, the SoHO preparation authorisation shall include a specification of the quality control parameters to be monitored during the processing.
Exceptional release
1. The physician referred to in Article 50 may authorise a releasing officer in a SoHO establishment referred to in Article 49, to release a certain SoHO preparation for distribution and for human application to an intended SoHO recipient even in cases where that SoHO preparation does not meet all of the relevant standards referred to in Articles 58 and 59, or does not fully comply with its SoHO preparation authorisation, or has been imported under the derogation referred to in Article 26(6), provided that the potential benefit for the SoHO recipient outweighs the risks and that no alternative is available. The exceptional release condition shall be explicitly indicated on the label or in the documentation accompanying the released SoHO preparation. 2. Exceptional release referred to in paragraph 1 of this Article shall be authorised in the case of release for distribution, on the basis of a documented request from the physician treating the intended SoHO recipient, where such a request includes a confirmation of full knowledge of, and agreement to, any deviation from this Regulation. The physician referred to in Article 50 shall document the agreement together with a benefit-risk assessment. In such circumstances, the intended SoHO recipient, or person granting consent on their behalf, shall be informed of the exceptional release and shall be required to give consent in accordance with national legislation prior to the human application of SoHO. The SoHO establishment which releases the SoHO preparation for distribution, in coordination with the SoHO entity which applies that SoHO preparation, where applicable, shall establish a plan for monitoring the SoHO recipient’s health after human application. The plan shall provide for monitoring the risks associated with the exceptional SoHO release. The SoHO establishment, in coordination with that SoHO entity, shall set out a time period during which the monitoring shall continue. 3. Exceptional release, as referred to in paragraph 1, may also be authorised in the case of release for export, on the basis of a documented request from a treating physician, or from a regulatory authority, in a third country, where such a request includes a confirmation of full knowledge of, and agreement to, any deviation from this Regulation. 4. Exceptional release, as referred to in paragraph 1 of this Article, may also be authorised in the case of certain SoHO to be used for the manufacture of a product regulated by other Union legislation and intended for a specific recipient, in cases where the SoHO preparation does not meet all of the relevant standards and guidelines referred to in Article 58 or 59 and on the basis of a documented request from the manufacturer, where such a request includes a confirmation of full knowledge of, and agreement to, any deviation from this Regulation.
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