The European Union has recently introduced a landmark regulation aimed at enhancing the safety, quality, and accessibility of substances of human origin (SoHO) intended for medical use. The SoHO regulation represents a significant update to the EU’s legislative framework, and it shall apply from 7 August 2027, with an additional year for certain provisions to be implemented.
This blog post delves into the key aspects of this new regulation, its implications for healthcare, and what it means for patients, donors, and healthcare professionals across Europe.
What is SoHO?
SoHO refers to substances of human origin including blood, tissues, cells like haematopoietic and embryonic stem cells, breast milk, embryos, foetal tissues, reproductive cells and intestinal microbiota. It also covers blood preparations that are not used for transfusion, and any other SoHO that might be applied to humans in the future. The requirement to be defined as SoHO is that the substance must have a biological interaction with the body.
Given that SoHO are used in various medical treatments and therapies, ensuring their safety, quality, and availability is of utmost importance.
Objectives of the SoHO Regulation
The new SoHO regulation is designed with several objectives:
- Enhanced safety and quality standards: One of the primary goals of the regulation is to ensure that all SoHO used within the EU meet stringent safety and quality criteria. This includes the implementation of standardized procedures for the collection, processing, storage, and distribution of SoHO.
- Increased transparency and traceability: The regulation mandates improved traceability of SoHO from donor to recipient. This means that every step will be meticulously recorded, allowing for quick identification of any issues that may arise, thus enhancing patient safety.
- Broader scope of protection: The regulation extends its protection to donors and recipients alike. It introduces provisions to safeguard the health of donors, ensuring that donations are unpaid and voluntary, and that donors are fully informed about the risks involved. For recipients, the regulation ensures that they receive SoHO of the highest quality.
- Facilitation of cross-border exchange: The regulation aims to streamline the exchange of SoHO between EU member states. This is particularly crucial in cases where specific SoHO may be scarce in certain regions.
- Support for innovation: The regulation also aims to foster innovation in the field of SoHO by providing clear guidelines and a supportive regulatory environment for the development of new therapies and treatments involving SoHO.
Implications for Healthcare Providers and Patients
The implementation of the SoHO regulation brings several significant changes for the different stakeholders across Europe:
- For Healthcare Providers: medical staff and institutions involved in the handling of SoHO will need to adhere to the new standards and procedures set out in the regulation. This may require updating existing practices, investing in new technologies, and ensuring that all staff are trained in the latest protocols.
- For Patients: patients can expect a higher level of safety and quality in treatments involving SoHO. The regulation’s emphasis on traceability and transparency also means that patients will have more information about the origin and handling of the SoHO used in their treatments.
- For Donors: the regulation places a strong emphasis on the rights and well-being of donors. Donors can be assured that their contributions will be handled with the utmost care and that their health will be safeguarded throughout the donation process.
- For Healthcare Products Manufacturers using SoHO: manufacturers must ensure compliance with the EU SoHO Regulation, which sets strict standards for sourcing and traceability. Starting materials, like human cells or tissues, must come from facilities adhering to SoHO guidelines, and manufacturer’s quality systems should meet traceability requirements, documenting every step from donor to patient. Even if a product is manufactured outside the EU, such as in the U.S., it must comply with SoHO standards to be used or marketed within the EU, making it crucial for manufacturers to align their CMC processes with these regulations.
Challenges and Future Outlook
While the SoHO regulation marks a significant step forward, its implementation may present challenges. There may also be concerns about the administrative burden associated with increased reporting and traceability requirements. For example, a tissue bank might be required to document the entire supply chain of donated tissues, from donor to recipient, in greater detail. This could necessitate new software, additional personnel, or more time-consuming documentation practices.
However, the long-term benefits of the regulation are expected to outweigh these challenges, since the regulation will contribute to better patient outcomes and greater confidence in the use of SoHO in medical treatments.
Published on: Nov 20, 2024
