Carol Nolan (Laois-Offaly, Independent)
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654. To ask the Minister for Health if his Department supports the decision of the European Parliament to adopt a common EU framework to allow the sale of human embryos and other bioproducts through its approval of new rules on the management of substances of human origin (SoHO), which took place at a plenary session 12 September 2023 in Strasbourg; if his Department contributed any policy analysis or objections to this proposal prior to the vote; and if he will make a statement on the matter. [42565/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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In July 2022, the European Commission submitted the proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application. Repealing Directives 2002/98/EC and 2004/23/EC, the proposal combines provisions on blood, tissues and cells in a broader legal framework covering and strengthening standards of quality and safety for all substances of human origin (except organs), including those previously unregulated at EU level.

The proposal also

• supports the continued provision of SoHO therapies, now and in the future, based on high safety and quality standards and up-to-date technical rules,
• extends protective measures to new groups of patients, to donors and to offspring born from assisted human reproduction,
• aims to improve harmonisation across Member States, facilitating cross-border exchange of SoHO and improving patient access to the therapies they need,
• creates conditions for safe, effective and accessible innovation in a unique sector driven by public health services, and voluntary and unpaid donations,
• improves crisis preparedness and resilience to safeguard access to therapies, and
• implements digital-ready policies.