17 April 2018
17 April 2018
Ref: CH(18) 02
Dear Colleague,
New legal requirements on the importation and coding of gametes and embryos
With immediate effect, this letter (further to Chair’s letter CH 18(01) 9 January 2018) requires HFEA licensed clinics:
- wishing to import gametes or embryos from a clinic in a country located outside of the EU, EEA or Gibraltar to apply to the HFEA for a certificate to do so;
- that distribute gametes or embryos to other licensed clinics within the EU (including the UK), EEA or Gibraltar to apply a Single European Code (SEC);
- to comply with the amended General Direction 0006 on Imports and Exports and the new General Directions 0013 on Coding of gametes and embryos. These Directions can be found on the Portal.
Import
The Human Fertilisation and Embryology Act 1990 (the 1990 Act) was amended as of 1 April 2018 by the Human Fertilisation and Embryology (Amendment) Regulations 2018 (the 2018 Regulations) to incorporate procedures for verifying the standards of quality and safety of imported gametes and embryos into the UK from tissue establishments outside of the EU, EEA or Gibraltar. Such establishments are classified as ‘third country suppliers’ (TCS).
For the purposes of the 2018 Regulations, any clinic in the EU importing gametes or embryos from a TCS is referred to as an ‘Importing Tissue Establishment’ (ITE). To import from a TCS, a UK centre needs to apply to the HFEA for a certificate before it imports any gametes or embryos, whether under General Directions or under Special Directions. This application can be for a one-off import or for ongoing imports, from one or multiple TCSs. The application form UK clinics must use to apply for a certificate sets out the requirements clinics must meet before a certificate will be issued. The requirements for one-off imports and ongoing imports differ.
Download the application form.
As a consequence of the changes to the 1990 Act, General Direction 0006 has been amended to set out the additional requirements that must be met before gametes or embryos can be imported into the UK from TCSs.
The application procedure is as follows. The clinic must complete an application from and submit it to the HFEA. The application will be considered by an HFEA executive Licensing Officer. If approved, the applicant clinic will be issued with a certificate permitting it to undertake one-off import and/or ongoing imports, from one or more TCSs, accordingly.
In cases where a Special Direction is required for an import to progress, a Special Direction application should be made and will be considered by the Statutory Approvals Committee, as now. Before or simultaneously with a Special Direction application, the ITE will need to apply for a certificate permitting it to undertake the import. This application will be determined by the executive Licensing Officer.
Any UK clinic importing on an on-going basis must establish a third party agreement with all TCS from which imports are made. This is a pre-requisite for the grant of a certificate.
The 1990 Act now gives the HFEA a new power to revoke a clinic’s licence on the grounds that the premises of a TCS from which the UK clinic imports are not considered suitable. This is the statutory incentive for UK clinics to ensure that all imports from a TCS meets required standards of quality and safety.
There are certain conditions placed on the provision of a certificate from the HFEA, these will be specified on the certificate.
Next steps for Import
The 2018 Regulations also incorporate a range of new legal requirements on standards of quality and safety for donation, procurement, testing, processing, preservation and distribution of all human tissue and cells intended for human application. It is now necessary for traceability, to establish a unique identifier and apply it to tissues and cells (including reproductive cells) distributed in the EU (this will be done by way of a Single European Code). The SEC will provide information on the main characteristics and properties of those tissues and cells. The legal requirements for the implementation of the SEC are set out in the amended General Direction 0006. Standard Licence Conditions 100, and 101 have also been amended (see ‘compliance with requirements’ below) and are deemed to apply to licences by virtue of paragraph 6 of the 2018 Regulations. The SEC is applied to the movement of donor gametes and embryos between licensed clinics (or tissue establishments) within the EU (including ‘domestic’ movements within the UK). It is, however, important to note that the movement of ‘partner’ embryos and gametes are exempt from the requirements. A further exemption relates to gametes and embryos that are imported from a tissue establishment and not distributed thereafter (that is for use in that clinic). The SEC need not be applied in such cases. The SEC enables the recipient licensed clinic (or tissue establishment) to contact the distributing clinic or establishment if there is an issue (now or in the future) relating to the quality or safety of the gametes or embryos, for example if a child develops a genetic condition associated with the use of donor sperm. There are three coding platforms permitted by the EU (and HFEA) one of which must be accessed to identify a product code. Each coding platform provides tools to create a SEC. The EU coding platform contains detailed information on all establishments in Europe in the Tissue Establishment compendium. If your clinic distributes embryos or gametes to a licensed clinic or tissue establishment, or similarly receives them, then you must access the EU coding platform to access the compendium. The HFEA has a responsibility for ensuring the details of all UK licensed clinics on the compendium are current. We will make the necessary changes to the Register of licensed clinics as part of our usual licensing activity. Clinics are required to comply with the requirements with immediate effect. The following standard licence conditions have been amended: T100: The documented procedures referred to in licence condition T99 include the following information: T101: The centre must ensure that all containers (dishes, vials, ampoules, tubes etc) used in the course of procurement, processing, use and storage of gametes and embryos are labelled with the patient’s/donor’s full name and a further identifier. If at some stages (eg, labelling patient/donor sperm) it is not possible to label the dishes or tubes with the patient/donor name then it must be ensured that the patient/donor code used is uniquely identifying. Containers holding gametes and embryos or the paperwork attaching to any containers must be labelled with a SEC in those circumstances specified in General Direction 0006. Please take the time necessary to ensure you and your staff are familiar with the requirements. Your inspector will provide support if needed. We will check compliance at inspection, by sampling donor gamete and embryo movements into and out of the clinic to ensure the SEC has been applied appropriately. FAQ’s about the EU Directives and the Guidance to completing the application form for import certification can be found on the Portal. Please take the time necessary to ensure you and your staff are familiar with the requirements. Your inspector will provide support if needed. Yours sincerely, Sally Cheshire CBE Chair, Human Fertilisation and Embryology Authority
Single European Code (SEC)
Compliance with the requirements for Coding
Next steps for Coding