Guidance

Chapter 2: legislation and accountability

Updated 21 May 2024

Legislation

We have endeavoured to align our advice in this guidance with the regulatory framework in this field, while remaining mindful of the clinical need for transplantation. In some respects, the recommendations in this guidance may exceed the requirements of statutory regulations, and in doing so are believed to reflect consensus views for good practice. This is particularly true for the implementation of routine molecular testing, where techniques of nucleic acid testing (NAT) and antigen detection testing offer a significant advantage in terms of both sensitivity and specificity, as well as reducing the window period of for the detection of pathogens but may not be immediately accessible. Where newer protocols for testing can replace existing protocols and give operational advantages with no impact upon microbiological safety this has been addressed. Tissue and transplant establishments receiving donations from outside the UK should ensure that donor testing meets the requirements of relevant European Union directives and recommendations within these guidelines either at retrieval or on receipt in the UK.

The standards for the quality and safety of organs for transplantation are set according to the European Union Organ Donation Directive 2010/53/EU (EUODD) which has been enacted into UK law through the through The Quality and Safety of Organs Intended for Transplantation Regulations 2012^{[footnote 1]} and The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014.^{[footnote 1]} This act allows for the establishment of a competent authority for the regulation of organ transplantation. In the UK the competent authority is the Human Tissue Authority (HTA), which has published the The Quality and Safety of Organs Intended for Transplantation: A Documentary Framework which details mandatory requirements as well as guidance on how those requirement may be met.

Tissue and cell donation and use is undertaken according to the European Union tissue and cells directives (EUTCD 2004/23/EC, 2006/17/EC and 2006/86/EC) which were implemented into UK law through the Human Tissue (Quality and Safety for Human Application) Regulations 2007. These regulations require for a competent authority to regulate activities. In the UK the HTA is the competent authority for regulating tissues and cells (other than gametes and embryos) for human applications. The HTA has published the Guide to the Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by Directions 003/2010 detailing the requirements for the use of tissues and cells (other than gametes and embryos) for human applications.

For establishments procuring or processing tissue intended for clinical use it is a statutory requirement to be licensed and inspected by the competent authority in the UK, the HTA, and to comply with their codes of practice. Establishments should comply with the standards which are detailed in the HTA’s ‘Guide to the Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment’ as implemented by Directions 003/2010.

The Human Fertilisation and Embryology Authority (HFEA) is the competent authority that has responsibility for gametes and embryos for human application.

HFEA is responsible for regulating the procurement of gametes and the associated processing involved in the creation of an embryo. This falls under the Human Fertilisation and Embryology Act 1990 (as amended in the Human Fertilisation and Embryology Act 2008) and guidance on regulation is available through its code of practice. HFEA’s remit includes the use of embryos in the derivation of stem cell lines, but does not extend to the regulation of these stem cell lines themselves.

During the cell line derivation process the embryo is dissociated and it is at this processing stage that HTA’s regulatory remit begins and HFEA’s regulatory remit ceases. During the processing or derivation phase, stem cell lines do not come within medicines regulation. However, once master cell banks have been created with a reasonable expectation of clinical utility in a medicinal product, they fall within the remit of the Medicines and Healthcare products Regulatory Agency (MHRA).

MHRA regulates medicines, medical devices and blood components for transfusion in the UK. This includes the regulation of advanced therapeutic medicinal products (ATMPs) that may be derived from tissues and cells including gametes and embryos. In this case the activities of procurement and testing would be regulated by HFEA and/or HTA.

Cross-regulatory advice on the development of stem cell lines and other regenerative medicines can be obtained from the Regulatory Advice Service for Regenerative Medicine.

Microbiological testing includes screening tests that are mandated by statutory requirements in the European Union tissue and cells directives (2004/23/EC, 2006/17/EC and 2006/86/EC) and the EU Directive on organ transplantation (2010/45/EU).

Accountability

In the case of organ donation, the ultimate responsibility for use of a donated organ lies with the surgeon undertaking the transplant.

The legal responsibility for donor assessment and testing lies with the ‘designated individual’ of the tissue or stem cell laboratory or storage facility, the assisted conception unit or hematopoietic stem and progenitor cell (HSPC) clinical collection facility. These units are collectively referred to as the tissue establishments. There are well defined roles for tissue establishments in national legislation for which HTA is the competent authority. The ‘designated individual’ may be supported a medical advisor providing advice and guidance.

In the case of donated tissues and cells, the ‘designated individual’ of the cord blood bank, tissue establishment or bone marrow registry has legal responsibility for making sure the risk of infection is assessed as accurately as possible. All of this information should be retained in the donor’s record at the tissue establishment. All donations should be coded to allow recipient hospitals to maintain a 2-way audit trail between donors and recipients to facilitate traceability. Full traceability from donor to recipient must be retained according to the ‘Guide to the Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment’ (version 2) (replacing HTA Directions 003/2010) and the necessary anonymisation, to prevent identification of the donor by the recipient, should not compromise this requirement.

In the case of gametes and embryos, the requirements for assisted conception units for the creation, storage and use of embryos for both fertility treatment and stem cell derivation are covered in the HFEA code of practice. The ‘person responsible for the licence’ is accountable under the terms of the Human Fertilisation and Embryology Act.

Unrelated donor registries should also conform to all relevant national and international requirements and guidance. Traceability and responsibility for reporting adverse events to the competent authority lies with the HTA and HFEA licensed establishments and their designated individuals for the licences.

See a list of all chapters in this guidance

1. The UK left the EU on 1 January 2021, but the UK quality and safety standards for organs tissues and cells remain unchanged. The 2019 Tissues and Cells EU Exit statutory instruments (SIs) retain the UK’s safety and quality standards for organs, tissues and cells under powers in the European Union (Withdrawal) Act 2018. Since the safety and quality of organs tissues and cells is an area of devolved competence, the SIs transferred to the UK, Scottish and Welsh governments and the Northern Ireland Department of Health the power to make regulations on matters previously included in implementing directives made by the European Commission. The 2019 SIs were amended by the 2020 tissues and cells SIs to implement the Northern Ireland Protocol. See the current legislation for organs (The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019) and tissues (The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020). ↩ ↩²