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

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

3. EU Directive on coding

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

5. 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

6. 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?

7. EU Directive on import

8. 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

9. 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

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

11. 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?

12. Donor gametes and embryos imported from overseas

13. 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

14. 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.