09 January 2018
Ref CH (18) 01
Dear Colleague,
Implementation of EU Directives on the importation and coding of gametes and embryos
On 18 December 2017, Regulations amending the Human Fertilisation & Embryology Act 1990, concerning the coding and import of gametes and embryos, were laid in Parliament. The Regulations, which transpose two EU Directives(1, 2), The Human Fertilisation and Embryology (Amendment) Regulations 2018, can be found here. If approved by both Houses of Parliament we expect the new rules to apply from April 2018.
The purpose of the new Directives is to ensure that there are procedures for ensuring full traceability of gametes and embryos and verifying the standards of quality and safety of gametes and embryos that are imported into the UK from establishments outside of the EU, EEA (European Economic Area) and Gibraltar. The first Directive concerns importing eggs, sperm and embryos into the EU, EEA and Gibraltar, and the second concerns the application of the Single European Code to all tissues and cells being transported within the UK, EU and EEA or transported to Gibraltar.
We will be issuing guidance on both Directives by April. The Authority will be considering the relevant documents on 8 March 2018 and the guidance will then be incorporated into the Code of Practice when it is updated in October 2018. We recognise that centres will have less time than usual to prepare for these Directives and we will therefore be taking a proportionate approach in the first few months.
Import
If a UK clinic wants to import gametes/embryos from outside of the EU, EEA and Gibraltar, they will need to establish a relationship with the overseas clinic and assess that it is suitable and meets the standards of the EU Tissue and Cells Directive. The UK clinic then applies to the HFEA for authorisation of the importing relationship.
The HFEA then decides whether to authorise the import and issues a certificate. Further imports from that specific overseas clinic can take place without further oversight – however if the UK clinic decided to change the type of cell (sperm, eggs or embryos) they imported, they would need to notify the HFEA and we would need to consider an application for a new importing relationship and issue a new certificate. If the UK clinic wanted to import from a different overseas clinic, they would have to seek a new authorisation. The importing clinic also needs to notify the HFEA if there are any changes in the circumstances of third country supplier of which they become aware.
To meet the requirements set out in the Directive, UK-licensed clinics that import eggs, sperm and embryos from non-EU, EEA or Gibraltar establishments will need to:
- Satisfy themselves that the quality and safety standards set out in the Directive are met.
- Seek documentation from non-EU, EEA or Gibraltar establishments to back-up quality and safety assessments.
- Establish a written agreement with non-EU, EEA or Gibraltar establishments. Make an application to the Authority to set up an importing relationship with a non-EU, non-EEA and Gibraltar establishment.
- Notify the Authority when there is a change in an authorised importing relationship (eg, if a clinic stops importing from a non-EU, non-EEA and Gibraltar establishment that it was originally authorised to import from).
- Notify the Authority if they become aware of any negative impact at the non-EU, non-EEA and Gibraltar establishment, which could affect quality and safety.
Coding
The coding Directive concerns application of the Single European Code (SEC) to all tissues and cells being transported within the UK, EU, EEA or Gibraltar to ensure clear labelling, identification and traceability of the tissues and cells.
To meet the requirements set out in the Directive, UK-licensed clinics will need to apply the SEC to all donated eggs, sperm and embryos distributed for use in treatment by other centres within the UK, EU, EEA or Gibraltar. Please note that where label size precludes inclusion of the SEC on the container label, the SEC must appear on accompanying documentation.
Exemptions:
donated eggs, sperm and embryos that stay at the same UK-licensed centre after being procured or imported.
Transitional arrangements
- the SEC does not need to be applied to donated eggs, sperm and embryos in storage on 29/10/2016 provided they are released for circulation by 29/10/2021 and full traceability is ensured by alternative means.
We will keep you updated on any further progress on this piece of work.
Yours sincerely,
Sally Cheshire CBE
Chair, Human Fertilisation and Embryology Authority
- Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.
- Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.