The European Union has new proposals for legislation on blood, tissues, and cells to protect stem cell patients. The ambition is to create more opportunities for patients across the EU to access the treatment they need, independently of where they live, explains Ian Youngman.
An increasing number of stem cell clinics, often not regulated, target medical travellers with many promises about stem cell treatment.
These new regulations will, at least in Europe, help regulate an area that if handled properly has massive potential for good.
Evolving stem cell legislation
Having been in place for almost 20 years, the current legislation on blood, on tissues and on cells is now out of date and does not reflect health and societal evolutions. New infectious disease risks have emerged and the biotechnologies available for preparing blood, tissues, and cells for clinical use have developed significantly.
The Commission published an evaluation in 2019 that showed that the framework had increased safety and quality across the EU, but the evaluation also identified five key areas where the legal framework no longer reflected the current state of the art.
Following a wide consultation with stakeholders, both on the objectives of the revision and its content, and incorporating lessons learnt from the COVID-19 pandemic, the proposed regulation includes measures tackling each of these five problems.
It ensures that:
(1) technical rules for safety and quality are responsive to changing risks and technologies.
(2) donors and offspring are protected.
(3) harmonisation of oversight requirements is strengthened.
(4) innovation is supported.
(5) measures supporting supply resilience are introduced.
The legislation will also improve cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities, while ensuring the same harmonised standards of quality and safety.
SoHO proposal
The aim of the Proposal for a Regulation on the safety and quality of substances of human origin (SoHO) is to promote pooling resources and achieving economies of scale.
SoHO based treatments are of high value; they provide large numbers of life-saving and life-enhancing therapies every year (25 million units of blood transfused, e.g. for surgery or trauma care; 36,000 stem cell transplants for blood cancers), life-creating therapies (medically assisted reproduction treatments, e.g. 940,000 cycles of IVF), and life-improving therapies (e.g. 14,500 cornea transplants for restoring sight, 2,000 skin transplants for burn wounds and other injuries).
The Commission proposal updates and reinforces the rules for safety and quality and extends them to other substances of human origin, which were previously left unregulated at EU level.
The result, the Commission believes, is a proposal for a future-proof and robust framework which better protects donors, recipients treated by transfusion, transplantation or medically assisted reproduction, and offspring born from donated sperm or eggs and that fosters innovation in this crucial biotech sector.
To improve harmonisation, ensuring a uniform level of protection across the EU and simplifying cross-border exchange and access of SoHO therapies, the Commission proposes to repeal the directives and replace them by a single regulation that will be equally applicable in all member states.
While this regulation will bring a high level of safety and quality standards, it still leaves member states the possibility to add more stringent requirements, in particular to ensure alignment to the set-up of national healthcare systems.
The proposal combines measures that apply to regulatory authorities, SoHO entities and establishments preparing therapies, as well as healthcare providers in the sector.
The proposed regulation covers all substances of human origin (except for solid organs for transplantation, which remain regulated separately under a dedicated directive). These include blood, tissues, and cells, as well as other substances such as human breast milk or microbiota that come with similar safety and quality concerns. Other substances of human origin that may, in the future, be applied to patients will automatically fall within the scope of this legislation;
Oversight, limitations and evolution
To ensure that these rules continually reflect scientific progress, they will mostly be developed by scientific expert bodies active in the sector. This means that new evidence can be included more rapidly than before, and safety requirements can be kept up to date (e.g. testing for infectious or non-infectious diseases).
Any entity conducting activities that affect the safety and quality of SoHO will have to register with their competent authorities. When these activities include processing and storage of SoHO, they will have to fulfil additional requirements to be authorised and inspected as a SoHO establishment, similar to current requirements.
Entities working with SoHO will be required to report their annual activity data. These data will allow member states to implement measures to improve donation collection rates when needed. Entities working with critical SoHO will need to alert their authority in the case of sudden fall in supply and will be required to have emergency plans in place.
Oversight requirements will be proportionate and risk based. This way, protection of patients, donors, and offspring can be increased without creating undue burdens for competent authorities. In addition, the Commission will support joint oversight activities (for example in authorising new SoHO preparations) as well as provide training, ICT support tools and opportunities for exchanging best practices.
The proposal also includes the establishment of the SoHO Coordination Board (SCB) as an advisory body that will support member states in the implementation of the regulation. The SCB will develop common good practices for inspection and vigilance, provide advice on the applicability of the regulation, and generally support the competent authorities in the oversight of the sector.
The availability of these therapies is dependent on the willingness of citizens to make donations and on the efforts in, mainly public, blood and transplant services to prepare and offer therapies at affordable costs.
The proposal incorporates the expertise of the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines and HealthCare (EDQM).
Both the ECDC and the EDQM have proven expertise in the sector, providing guidance on how to protect donors and patients treated with SoHO from communicable diseases (ECDC) or any other risks to quality and safety (EDQM).
Next steps
The proposal will be discussed by the Council and the European Parliament. Once the final text is agreed and adopted, it will come into force with a two-year transition period before most provisions apply and a three-year period for some particular provisions.
The Commission will adopt a series of Acts implementing certain provisions, such as import and traceability, in more detail.
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