Movement of gametes/embryos across borders Chris Hall and Anjeli Kara Annual conference workshop Thursday 24 March, 2016

Overview April 2015 Spring 2016 October 2016 April 2017 EU Directives published DH consultation Regulations laid in Parliament Implementation

EU Directive on coding www.hfea.gov.uk

The Single European Code (SEC) Ensuring clear labelling, identification and traceability of tissues and cells within the EU

Are there any exemptions or transitional arrangements in place? Partner eggs, sperm and embryos Imported non-partner eggs, sperm and embryos that stay within the centre Transitional arrangements Stored non-partner donated eggs, sperm and embryos stored prior to implementation

FAQs around the coding directive Will we be expected to create the SEC from scratch? Will the SEC need to be applied to a couple’s embryo that uses donor sperm? How would we notify you of the SEC?

EU Directive on import www.hfea.gov.uk

What requirements do you need to meet? Clinic requirements What you already do Satisfy yourselves that quality and safety standards are being met a Seek documentation to back-up quality and safety assessments Establish a written agreement Keep a record of all imports that take place Apply to the HFEA to set up an importing relationship X Notify the HFEA when there is a change to an importing relationship

Setting up an importing relationship with a non-EU establishment Clinic puts together the relevant paperwork HFEA processes the application - Relationship-by-relationship basis - One-off authorisation HFEA issues a certificate Following authorisation of an importing relationship - Notify HFEA of changes to the importing relationship - Regularly review the agreement

Code of Practice guidance How will these requirements be implemented? General Directions Special Directions Code of Practice guidance Inspection

FAQs about the import Directive Are there any exemptions in place? Will the Authority inspect non-EU establishments? Will my clinic need to apply for an importing relationship for non-EU establishments it already imports from? When will the changes go live?

Donor gametes and embryos imported from overseas www.hfea.gov.uk

Compensation for imported overseas donor gametes and embryos Round-table exercise On your table you will find a sheet with questions on the compensation policy Take 10 minutes to read and discuss these questions with others on your table. Write down any comments you have. We’ll have a 5 minutes to feedback and provide comments

Consent for imported overseas donor gametes and embryos Round-table exercise On your table you will find a sheet that sets out ways consent for imported overseas donors is recorded. Take 10 minutes to read and complete this grid with others on your table. We’ll have a five minutes to feedback and provide comments.