Objectives regarding SoHO donor protection
1. SoHO entities shall ensure respect for the dignity and integrity of SoHO donors.
2. SoHO entities shall ensure high levels of safety and protect the health of living SoHO donors from risks related to the SoHO donation, by identifying and minimising such risks before, during and after the SoHO collection.
3. SoHO competent authorities shall verify the compliance with this Chapter as well as with national legislation on consent and voluntary and unpaid donation.
Standards concerning SoHO donor protection
1. Where SoHO are collected from SoHO donors, regardless of whether or not the SoHO donor is related to the intended recipient, SoHO entities shall:
(a)
meet all applicable consent or authorisation requirements in force in the Member State concerned;
(b)
provide SoHO donors or, where applicable, any persons granting consent on their behalf, in accordance with national legislation, with:
(i)
the information referred to in Article 55 in a way that is adequate in view of their capacity to understand it;
(ii)
the contact details of the SoHO entity responsible for collection from which they can request further information, if needed;
(c)
safeguard the rights of the living SoHO donor to physical and mental integrity, to non-discrimination, to privacy and to the protection of the personal data, including health data concerning them, in accordance with Regulation (EU) 2016/679;
(d)
ensure that SoHO donation is voluntary and unpaid, pursuant to Article 54;
(e)
verify the eligibility of the living SoHO donor on the basis of a donor health evaluation that aims to identify, with a view to minimising, any risk that the SoHO collection might pose to the SoHO donor’s health;
(f)
document the results of the living SoHO donor health evaluation;
(g)
communicate and clearly explain the results of the living SoHO donor health evaluation to the living SoHO donor or, where applicable, any persons granting consent on their behalf, in accordance with national legislation;
(h)
identify and minimise any risks to the health of the living SoHO donor during the SoHO collection procedure, including exposure to reagents or solutions that might be harmful to health;
(i)
in cases where SoHO can be donated repeatedly, and frequent donation might negatively influence the living SoHO donor’s health, verify, by means of registries, as referred to in paragraph 3 of this Article, that living SoHO donors are not donating more frequently than indicated as safe in technical guidelines referred to in Article 56(4) and monitor relevant health indicators to evaluate whether their health is not compromised;
(j)
in cases where SoHO donation implies a significant risk to a living SoHO donor, develop and implement a plan for monitoring the SoHO donor’s health after donation as referred to in paragraph 4;
(k)
in the case of an unrelated SoHO donation, refrain from revealing the SoHO donor’s identity to the recipient or to the offspring from medically assisted reproduction, apart from in circumstances where such information exchange is permitted in the Member State concerned.
2. In the course of the living SoHO donor health evaluations referred to in paragraph 1, point (e), of this Article, SoHO entities shall conduct interviews with the SoHO donors and gather information concerning the SoHO donors’ present and recent state of physical, and, where appropriate, mental health and their health histories to assure the safety of the SoHO donation process for those SoHO donors. SoHO entities may perform additional tests as part of the SoHO donor health evaluations. They shall perform such tests in cases where evaluations indicate that additional tests are necessary to establish the eligibility of those SoHO donors from the perspective of their own protection. The physician referred to in Article 50 shall approve the procedure and criteria for SoHO donor health evaluations.
3. SoHO entities that collect SoHO from living SoHO donors as referred to in paragraph 1, point (i), of this Article shall register such SoHO donors in a SoHO entity registry or, where available, in national or recognised international registries, to verify donation frequency. SoHO entity-level and national registries shall have the possibility of interconnectivity with other such registries. Where a SoHO entity-level registry or a national registry is used, and where the circumstances point to a risk that a SoHO donor is donating too frequently in more than one SoHO entity located in one or more Member States, SoHO entities shall verify whether this is the case by consulting with interconnected SoHO donor registries on a case-by-case basis. SoHO entities shall be in a position to demonstrate to their SoHO competent authorities, on request, that an appropriate procedure that mitigates such risk is in place. Such procedures shall take into account the technical guidelines referred to in Article 56(4).
4. SoHO entities that collect SoHO from living SoHO donors that are subjected to a surgical procedure in order to donate, or that are treated with prescribed medication to facilitate SoHO donation, shall ensure that the plan for monitoring the SoHO donor’s health after SoHO donation, as referred to in paragraph 1, point (j), is proportionate to the risks associated with the SoHO donation. SoHO entities shall include in the plan the time period during which the monitoring shall continue.
5. The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation in cases where additional standards are needed in order to ensure the protection of SoHO donors.
6. Where, in the case of risk to the safety of living SoHO donors, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.
Standards concerning voluntary and unpaid nature of SoHO donations
1. SoHO entities shall not provide financial incentives or inducements to SoHO donors or any persons granting consent on their behalf.
2. Where Member States allow for the compensation of living SoHO donors, in accordance with the principle of voluntary and unpaid donation and based on transparent criteria, including through fixed allowances, or through non-financial forms of compensation, the conditions for such compensation shall be established in national legislation, including by setting an upper limit for compensation that shall endeavour to guarantee financial neutrality, consistent with the standards laid down in this Article. Member States may delegate the setting of conditions for such compensation to independent bodies that are established in accordance with national legislation. The setting of conditions for such compensation shall be based on criteria that take into account the practices documented by the SCB, as referred to in Article 69(1), point (g). SoHO donors may choose not to be compensated.
3. When Member States allow for the compensation of SoHO donors as referred to in paragraph 2, the conditions for such compensation applied by each Member State shall be made available to the SCB for sharing with the SoHO national authorities of the other Member States via the EU SoHO Platform and the information shall be updated without undue delay if it has been modified.
4. Member States shall ensure that any promotion and publicity activities in support of the donation of SoHO do not refer to compensation, without prejudice to the right of SoHO donors to be informed of their rights, in accordance with national law.
5. SoHO entities may compensate living SoHO donors as provided for by their Member States pursuant to paragraph 2. At the request of their SoHO competent authority, SoHO entities shall provide information in a transparent manner on the details of how they have implemented the conditions laid down in national legislation.
6. Member States shall ensure compliance with standards concerning voluntary and unpaid donation, equivalent to those laid down in this Article, also when SoHO are donated exclusively for use in research without any human application.
Standards concerning information to be provided prior to consent
1. SoHO entities shall provide living SoHO donors or, where applicable, any persons granting consent on behalf of a SoHO donor, with all appropriate information relating to the SoHO donation process, in accordance with national legislation.
2. SoHO entities shall provide the information referred to in paragraph 1 before the consent to donate is granted. SoHO entities shall provide the information in an accurate and clear manner, using terms that are easily understood by the SoHO donors or, if applicable, any persons granting consent on their behalf. The information shall not be misleading, in particular as to the benefits of the donation for future recipients of the SoHO concerned.
3. In the case of living SoHO donors or, where applicable, persons granting consent on their behalf, SoHO entities shall provide information regarding:
(a)
the purpose and nature of the SoHO donation;
(b)
the intended use of the donated SoHO, specifically covering proven benefits for the future SoHO recipients and any possible research or commercial uses of SoHO, including the use to manufacture products regulated by other Union legislation, as referred to in Article 2(6), to which specific consent shall be granted;
(c)
the consequences and risks of the SoHO donation;
(d)
the obligation for consent, in accordance with national legislation, in order for SoHO collection to be carried out;
(e)
the right to revoke consent and any restrictions on that right after the collection;
(f)
the purpose of the tests that will be performed in the course of the SoHO donor health evaluation, in accordance with Article 53(2);
(g)
the right of the SoHO donor or, where applicable, the person granting consent on their behalf to receive the confirmed results of the tests when relevant for their health, in accordance with national legislation;
(h)
the recording and protection of SoHO donor’s personal data, including health data, and medical confidentiality, including any potential sharing of data in the interest of the SoHO donor health monitoring and of public health, as necessary and proportionate, in accordance with Article 76;
(i)
the possibility that the SoHO donor identity may be revealed to the offspring from medically assisted reproduction that is born as a result of their SoHO donation in cases where national legislation grants that right to such offspring;
(j)
other applicable safeguards to protect the SoHO donor.
4. In the case of deceased SoHO donors, SoHO entities shall provide any persons granting consent to collection on their behalf in accordance with national legislation, with the information referred to in paragraph 3, points (a), (b), (d) and (e).
Implementation of the standards concerning SoHO donor protection
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 Article 53 or 55, in order to ensure convergent and high levels of SoHO donor protection, the Commission may adopt implementing acts setting out particular procedures to be followed and 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 SoHO donor health, 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 concerning SoHO donor protection, or elements thereof, as referred to in Articles 53 and 55.
4. For those standards concerning SoHO donor protection, or elements thereof, 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 SoHO donor protection other than from transmission of communicable diseases;
(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 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 they shall record the practice followed to establish such 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
