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Quality and safety for substances of human origins: scientific evidence and the new EU regulations
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  • Published on:
    The SoHO Regulation: Aligning National and European objectives in the interests of Patients

    Dear editor,

    Both the commentary from Elias et al, “Quality and safety for substances of human origins: scientific evidence and the new EU regulations”, and the response to that commentary from Domínguez-Gil et al, recently published in BMJ Global Health (1) caught our attention. The response from Domínguez-Gil et al eloquently explains the recommitment to the principle of voluntary and unpaid donation in the new SoHO Regulation(2) and comprehensively addresses several statements in the commentary from Elias et al which required clarification. Some additional items in the commentary are addressed here.

    The commentary states that “in Europe, countries allowing monetary compensation for donors are the only ones achieving self-sufficiency in plasma collection for the production of immunoglobulin.’ While four countries collect more plasma than they theoretically need to meet their patients’ current needs (Austria, Czechia, Germany, and Hungary) the finished plasma-derived medicines, including Immunoglobulins, are dispatched to those countries where the company markets these products, independently from the origin of the plasma.(3,4) Czechia is noteworthy because its blood and plasma collection systems generate the highest per capita collection globally,(5) including a high volume of plasma collected in public hospitals. Concurrently, immunoglobulin provision in this same country is below half of the average per capita usage for this product across the EU, and yet...

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    Conflict of Interest:
    None declared.
  • Published on:
    • Beatriz Domínguez-Gil, Director General Organización Nacional de Trasplantes. Ministry of Health of Spain
    • Other Contributors:
      • Aránzazu De Celis, Technical advisor
      • Nuria García-Escribano, Technical advisor
      • Dolores Hernández Maraver, Medical advisor
      • Rosario Marazuela, Medical advisor
      • Inmaculada Navarro, Health Counsellor

    Dear Editor

    We have read with interest the paper from Elias JJ et al. on the Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO).(1,2) The authors properly highlight two main objectives of the SoHO Regulation, namely, ensuring the safety (and quality) of SoHO for clinical use and strengthening the sufficiency in supply of what the Regulation defines as critical SoHO, an objective particularly relevant to the availability of plasma-derived therapeutic products. However, we would like to correct some inaccuracies and explain our insights on voluntary and unpaid donation (VUD).

    First, the final text of the SoHO Regulation was adopted by the European Parliament on 24 April 2024 and the European Council is scheduled to formally adopt it later this month. Once adopted by the co-legislators and published in the Official Journal of the European Union (EU), the Regulation will enter into force and Member states (MS) will need to implement its provisions by 2027. Therefore, and contrary to what stated by the authors, the adopted text is no longer open to debate or amendments.

    Second, the principle of VUD is not newly established by the Regulation, but already reflected in Directive 2002/98/EC on blood and blood components (3) and Directive 2004/23/EC on tissues and cells,(4) in alignment with the EU Charter of Fundamental Rights. The Charter enshrines the fundamental principle of human dignity and,...

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    Conflict of Interest:
    None declared.