# C_2022450EN.01000701.xml

| 28.11.2022 | EN | Official Journal of the European Union | C 450/7 |
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28.11.2022

EN

Official Journal of the European Union

C 450/7

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Summary of the Opinion of the European Data Protection Supervisor on the Proposal for a Regulation 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

(2022/C 450/06)

(The full text of this Opinion can be found in English, French and German on the EDPS website https://edps.europa.eu)

On 14 July 2022, the European Commission issued a 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 (1) (‘the Proposal’).

The Proposal aims to regulate the standards of quality and safety for substances of human origin intended for human application (‘SoHO’) by ensuring safety and quality for patients treated with Substances of Human Origin therapies and fully protect them from avoidable risks linked to SoHOs, ensuring safety and quality for SoHO donors and for children born from donated eggs, sperm or embryos, strengthening and allowing for harmonisation of oversight practices among Member States, facilitating the development of safe and effective innovative SoHO therapies and improving the resilience of the sector, mitigating risk of shortages.

The EDPS welcomes that the Proposal aims to bring positive impact on fundamental rights of citizens such as health protection, non-discrimination, privacy and informed consent, while also positively notes that programmes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. In this regard, the EDPS welcomes the references to specific principles of data protection in the context of the SoHO Platform, in particular the provisions that give effect to the principles of purpose limitation, data minimisation, as well as the requirements of necessity and proportionality.

The EDPS welcomes that the Proposal would require that informed consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material. At the same time, the EDPS recalls that the donor’s informed consent to the donation of material under the SoHO Regulation, while being an essential ethical and legal requirement, is not the same as consent referred to in the GDPR as one of the legal basis for the processing of personal data.

On the reuse of data, while the EDPS welcomes the explicit identification of all the categories of personal data listed in the Proposal and the specific purpose for which these will be processed, he also considers that the specific purpose for which data would be reused should be clearly identified in the enacting terms of the Proposal.

Lastly, the EDPS recommends that the co-legislator clearly define in the Proposal the maximum duration for which personal data may be stored.

1.   INTRODUCTION

| 1. | On 14 July 2022, the European Commission issued a 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. |
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1.

| 2. | The Proposal includes measures that aim to:






  — | ensure safety and quality for patients treated with Substances of Human Origin (‘SoHO’) therapies and fully protect them from avoidable risks linked to SoHOs; |
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2.

—

ensure safety and quality for patients treated with Substances of Human Origin (‘SoHO’) therapies and fully protect them from avoidable risks linked to SoHOs;

| — | ensure safety and quality for SoHO donors and for children born from donated eggs, sperm or embryos; |
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—

ensure safety and quality for SoHO donors and for children born from donated eggs, sperm or embryos;

| — | strengthen and allow for harmonisation of oversight practices among Member States; |
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strengthen and allow for harmonisation of oversight practices among Member States;

| — | facilitate the development of safe and effective innovative SoHO therapies; |
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facilitate the development of safe and effective innovative SoHO therapies;

| — | improve the resilience of the sector, mitigating risk of shortages (2). |
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improve the resilience of the sector, mitigating risk of shortages (2).

| 3. | The Proposal is part of the EU’s ambition to build a stronger European Health Union, in order to: (1) better protect the health of our citizens (including patients, donors and offspring); (2) equip the EU and its Member States to better prevent and address future pandemics (surveillance, data analysis, risk assessment, early warning and response) and (3) improve the resilience of EU health systems (3). |
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3.

| 4. | The present Opinion of the EDPS is issued in response to a consultation by the European Commission of 14 July 2022, pursuant to Article 42(1) EUDPR. The EDPS welcomes the reference to this consultation in Recital 51 of the Proposal. In this regard, the EDPS also positively notes that he was already previously informally consulted pursuant to recital 60 of EUDPR. |
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4.

4.   CONCLUSIONS

| 30. | In light of the above, the EDPS makes the following recommendations:






  (1) | to clarify that informed consent to the donation of material under the SoHO Regulation is not the same as consent referred to in the GDPR as one of the legal basis for the processing of personal data; |
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30.

(1)

to clarify that informed consent to the donation of material under the SoHO Regulation is not the same as consent referred to in the GDPR as one of the legal basis for the processing of personal data;

| (2) | to clarify for which specific purposes reuse of personal data, if any, related to donors and recipients, and offsprings, of SoHO is envisaged, taking into account the ethical and legal principle of informed consent laid down under Article 3(2) of the Charter, and the high risks for the persons concerned. |
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(2)

to clarify for which specific purposes reuse of personal data, if any, related to donors and recipients, and offsprings, of SoHO is envisaged, taking into account the ethical and legal principle of informed consent laid down under Article 3(2) of the Charter, and the high risks for the persons concerned.

| (3) | to clarify in the Proposal whether the ECDC would be processing personal data within the SoHO Platform and, if so, to explicitly identify its role within the meaning of data protection law; |
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(3)

to clarify in the Proposal whether the ECDC would be processing personal data within the SoHO Platform and, if so, to explicitly identify its role within the meaning of data protection law;

| (4) | to clearly identify in the enacting terms of the Proposal the specific purpose for which such data would be reused, particularly taking into account the high risks for the persons concerned and the key data protection principle of purpose limitation; |
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(4)

to clearly identify in the enacting terms of the Proposal the specific purpose for which such data would be reused, particularly taking into account the high risks for the persons concerned and the key data protection principle of purpose limitation;

| (5) | to clarify in Articles 44, 45 and 47 of the Proposal whether any processing of personal data would be taking place and, if so, to specify the purpose of such processing in Article 76 of the Proposal itself; |
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(5)

to clarify in Articles 44, 45 and 47 of the Proposal whether any processing of personal data would be taking place and, if so, to specify the purpose of such processing in Article 76 of the Proposal itself;

| (6) | to clearly define in the Proposal itself the maximum duration for which personal data may be stored; |
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(6)

to clearly define in the Proposal itself the maximum duration for which personal data may be stored;

| (7) | to insert a reference to risks stemming from the processing of personal data both in Article 52 of the Proposal, on the objectives regarding SoHO donor protection, as well as Article 57 of the Proposal, on the objectives regarding SoHO recipient and offspring protection; |
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(7)

to insert a reference to risks stemming from the processing of personal data both in Article 52 of the Proposal, on the objectives regarding SoHO donor protection, as well as Article 57 of the Proposal, on the objectives regarding SoHO recipient and offspring protection;

| (8) | to explicitly clarify in Article 55(g) of the Proposal the information to be processed in this context, as well as how would the necessity and proportionality assessment take place. |
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(8)

to explicitly clarify in Article 55(g) of the Proposal the information to be processed in this context, as well as how would the necessity and proportionality assessment take place.

Brussels, 7 September 2022.

Wojciech Rafał WIEWIÓROWSKI

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(1)  COM (2022) 338 final.

1

(2)  COM (2022) 338 final, p. 6.

2

(3)  COM (2022) 338 final, pp. 2-3.

3

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