Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) (together the “BTC Directives”). Although EU directives are legislative acts, they are not directly binding on Member States and merely set out a goal that all EU countries must achieve. It is up to the particular Member State to determine how best to achieve that goal and to make its application binding.
The Blood Directive is principally concerned with the safety and quality of whole blood and blood components for therapeutic use; it sets out various requirements, including:
- the establishment of quality assurance systems;
- notification of serious adverse events and reactions; and
- the testing of donations to ensure they comply with the relevant requirements (for example testing for HIV, hepatitis, and other infectious diseases).
The Tissues and Cells Directive governs safety and quality of human tissues and cells for therapeutic use. It does not apply to autologous grafts (e.g. skin grafts from the same patient), blood (which is covered by the Blood Directive) or organs. This directive prescribes rules for:
- inspections and control measures;
- import and export of tissues and cells;
- notification of serious adverse events and reactions;
- quality management; and
- processing/storage of tissues and cells.
The EU’s proposed SHO Regulation
On 14 July 2022 the European Commission adopted a proposal that would repeal the BTC Directives. The Commission’s press release can be accessed here. The aim is ultimately to advance patient safety by improving the quality of blood, cells, and tissue products for various human clinical applications. From a regulatory perspective this makes sense: the BTC Directives are almost two decades old. In that time, the development of clinical cell and tissue therapies has advanced significantly, whereas the rules and regulations safeguarding patients and donors have not.
Although the final text remains to be seen, the new SHO Regulation is expected to include (but is certainly not limited to) the following provisions:
- The establishment of a digital SHO platform, which will allow authorities and stakeholders to facilitate data exchange and administration.
- In collaboration with National SHO Authorities, Member States will draw up plans to mitigate vulnerabilities to supply disruptions. This is particularly important in emergency scenarios (e.g. the COVID-19 pandemic).
- Protection for substances such as human breast milk and intestinal microbiota (not currently covered by the BTC Directives).
- Protection for offspring born from medically assisted reproduction, as well as protection for donors (i.e. blood, stem cell and egg donors).
- Entities conducting activities that may affect the safety and quality of SHO will have to register with a competent authority, as well as having to report their annual activity data to ensure compliance.
- Importantly, Member States will retain full control of organisational and ethical decisions concerning the provision of SHO based treatments.
How will this affect the UK?
In the UK, blood and blood products are regulated in part by the Blood Safety and Quality Regulations 2005, whereas non-reproductive tissues and cells are regulated by the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Reproductive cells are regulated separately by the Human Fertilisation and Embryology Act 1990.
On 28 September 2022, the Department of Health and Social Care (“DHSC”) published a widely anticipated policy paper on the new SHO Regulation, considering its impact on the UK and Northern Ireland. The full paper can be accessed here.
The salient points to note from a UK perspective are:
- The new SHO Regulation will apply in Northern Ireland in accordance with the Ireland/Northern Ireland Protocol (the BTC Directives are listed in Annex 2). As a result, supplies of SHO to Northern Ireland could be affected, although the extent of these potential issues remains to be seen. Overall, the changes are expected to be positive for patients and donor safety in Northern Ireland.
- In Great Britain, the Blood Safety and Quality Provisional Common Framework and the Organs, Tissues and Cells (apart from embryos and gametes) Provisional Common Framework (which have both been operational since March 2020) allow government to suggest changes to the standards. Under these two frameworks, policy decisions made in Great Britain may permit the implementation of some of the changes proposed in the new SHO Regulation.
- Minimum safety and quality standards prescribed by the new SHO Regulation may lead to divergence between Great Britain and Northern Ireland, although the degree of any divergence remains to be seen.
- The UK Government is still reviewing the EU’s proposed SHO Regulation, and may decide to voluntarily implement some of the provisions at a UK-wide level.
- DHSC reiterated that SHO establishments in Great Britain continue to have a “strategic supply dependency” on some EU countries. Where patients are unable to match with a UK donor, various EU donor registers are often searched. It is essential that the importation of SHO from EU Member States (and Northern Ireland) is not disrupted.
The new proposed regulation still has to be approved by the European Parliament and Council. Once the final text is agreed, the new Regulation will come into force with a two-year transition period (extending to three years for some provisions).
It is unclear to what extent (if any) the UK Government will adopt parts of the SHO Regulation. The UK Government is not currently planning a public consultation in relation to the SHO Regulation, although targeted external consultation will take place with UK regulators and interested stakeholders such as The Human Fertilisation and Embryology Authority; The Medicines and Healthcare products Regulatory Agency; and NHS Blood and Transplant (to name a few).