this is a prototype factsheet of the regulatory frameworks ...•derivated ips cells, however, fall...
TRANSCRIPT
This is a prototype factsheet of the regulatory frameworks of EUCelLEX countries. WP3 are currently analysing the regulatory frameworks and ethical norms in EUCelLEX countries, for comparison with stakeholder analysis (underway) to inform
understanding of how the regulation of the use of stem cells affects users, and to analyse whether the current regulatory environment is appropriately targeted.
UK Specific Stem Cell Legislation
The Human Fertilisation and Embryology Act
1990
The Human Fertilisation and Embryology Act
2008
Human Fertilisation and Embryology
(Research Purposes)
Regulations 2001 Human Tissue Act
2004
Human Tissue (Quality and Safety
for Human Application)
Regulations 2997
Human Embryonic Stem Cells (hESC)
• Human Fertilisation License required in order to use embyro for
the purpose of creating cell lines
• Research must satisfy one of the purposes outlined in Sch. 2, Para 3
(2) in HFE Act 1990.
• Research on embyros older than 14 days is prohibited.
Induced Pluripotent Stem Cells (iPSCs)
• Tissue stored with the intention of deriving iPSCs requires HTA
license (S. 16 Human Tissue Act 2004)
• Derivated iPS cells, however, fall outside of the remit of the HTA.
Cord Blood Stem Cells
• Q&S Regulations require establishments undertaking
activites such as procurement, testing, processing, storage and
distribution, import and export of cord blood cells to acquire a license.
• Cells or lines stored for human application require an HTA License
REG
ULA
TOR
S Human Fertilisation and
Embryology Authority Independent regulator of treatment
utilising human embryos
Human Tissue Authority
Regulates organisations that remove, store and use human tissue for research, medical
treatment, post-mortem examination, education and training
[email protected] [email protected] [email protected] [email protected]