General questions about imports and exports of sperm, eggs and embryos
Transferring sperm, eggs or embryos within the European Economic Area (EEA)
Imports and Exports involving clinics outside of the EEA
As a patient, can I apply to import/export sperm, eggs or embryos from abroad?
Imports and exports should be dealt with by a licensed clinic on your behalf.
I want to find out about my application. Who do I need to talk to?
You should discuss this with your clinic and not the HFEA. They should be able to tell you the progress of the application.
Can you give me a list of sperm banks that clinics have previously used to acquire sperm?
Your clinic will be able to provide this as they are responsible for deciding which non-UK sperm banks they use to obtain sperm for your treatment and ensuring that imported sperm complies with UK law and HFEA guidance.
Do you regulate sperm banks outside of the UK?
No, the HFEA is a UK regulator and therefore does not regulate establishments outside the UK. With the introduction of European Union legislation, clinics providing donated sperm within the EU (including the UK) now have to comply with European standards.
What are the rules about importing and exporting embryos, sperm and eggs to and from European clinics?
The HFE Act 1990 was amended with effect from 5th July 2007 to bring the EU Tissues and Cells Directive (EUTCD) into UK law. The Directive sets out a common European-wide system of standards of quality and safety for patients and aims to ensure a high level of health protection within the European community.
The law says that the transfer of sperm, eggs and embryos within the European Economic Area (EEA) can only occur between clinics 'accredited, designated, authorised, or licensed' under the laws implementing the EU Tissue and Cells Directive (EUTCD). This means that both the sending and receiving clinics must be accredited to the standards set by the EUCTD by the by the relevant national body in each country. In the UK all clinics are accredited through the HFEA.
These requirements on importing and exporting from accredited clinics have been in place since the Directive was incorporated into UK law from 5 July 2007.
What is the procedure for sending sperm, eggs or embryos to a clinic in the EEA?
If you are considering sending sperm, eggs or embryos to another clinic within the EEA, your clinic will organise this on your behalf.
For this to be done the following requirements need to be met:
The UK clinic planning to transfer the sperm, eggs or embryos must make sure that these criteria are met in order for the transfer to take place.
What is the procedure for importing sperm, eggs or embryos from another EEA country?
If you are considering obtaining sperm, eggs or embryos from within the EEA, your clinic will organise this on your behalf.
For this to be done the following requirements need to be met:
The UK clinic receiving the sperm, eggs and embryos must make sure that the supplying EEA clinic has met these criteria in order for the transfer to take place.
I want to import my sperm, eggs or embryos to the UK from an unaccredited clinic in the EEA ? can I get special permission to do this?
No, the HFEA does not have the power to issue special directions for imports to unaccredited clinics within the EEA.
I want to export my sperm, eggs or embryos from the UK to an unaccredited clinic in the EEA ? can I get special permission to do this?
No, the HFEA has not been granted the power to issue special directions for exports from unaccredited clinics within the EEA.
Are there any special circumstances where exceptions can be made? For example, sibling sperm or embryos/sperm prepared for transport now.
No. The law does not give the HFEA any discretionary powers in these circumstances. As soon as your EEA clinic is accredited by the authorities in that country in accordance with the Directive, your UK clinic can transfer your sperm, eggs or embryos to or from the clinic, provided that conditions including those listed in the response to questions 6 and 7 are met
Which countries are affected by the requirement for accreditation? Are all clinics in each country affected or are some OK?
All countries in EEA are required to implement the EUTCD. It is not a case of whether imports or exports are allowed to a particular country, but whether the particular European clinic which you wish to export from or import to is currently accredited.
Your clinic will need to check with the EEA clinic to find out when it expects to be accredited to the standards set by the EUTCD by the relevant body in that country.
The clinic I´m planning to export or import with isn´t currently accredited ? when will this happen?
The clinic abroad that you plan to import or export with will be able to tell your UK clinic they expect to be accredited.
Individual countries in the EEA have their own structures for accrediting their clinics and in some countries, such as Spain, this will be done on a regional basis. However, we understand that at present (March 2008) several countries still have some way to go in implementing the EUTCD, so that final accreditation of individual clinics may take some time.
Why are you issuing this guidance now?
The HFEA Directions (formal instructions we give to clinics) issued in July 2007 reflected the UK legislation by saying that transfer of sperm, eggs and embryos can only occur between clinics 'accredited, designated, authorised, or licensed' under the laws implementing the EUTCD in each country. There have been no changes to UK legislation since July 2007: new guidance has been issued to remind clinics of their legal obligations given that some EEA countries are still in the process of accrediting their clinics.
When will I be able to import/export abroad again? When will the accreditation be rolled out completely?
Accreditation is a matter for individual clinics and the relevant body in each country. How quickly this is likely to happen will vary depending on how the EUTCD is being implemented in each country.
The European Commission is responsible for overseeing the implementation of European directives across the EU countries.
If the problem is with the other clinic´s accreditation, who do I talk to about when they will be accredited?
The HFEA does not hold information about this. You will need to speak to the UK clinic you are dealing with who will check with the other clinic to find out what their accreditation status is.
Accreditation is a matter for individual clinics and the relevant body in each country. How quickly this is likely to happen will vary depending on how the EUTCD is being implemented in each country.
My embryos/sperm/eggs are due for import/export shortly but the EEA clinic is not accredited as required. Am I going to be affected by this? What do I do?
Clinics have a duty to make arrangements that comply with the law and the HFEA has no discretion to allow clinics to transfer sperm, eggs and embryos unless it is in accordance with the law. You will need to speak to your clinic about what you should do next.
I started the import/export process in good faith. My clinic told me that all the licences etc that I needed were sorted out ? however, now I have found out that the transfer cannot take place. Will the HFEA be compensating me for the expense I have incurred?
The UK law that limits transfers of sperm, eggs and embryos within the EEA to accredited clinics has been in place since 5 July 2007. Clinics have a duty to comply with the law and the HFEA has no discretion to allow clinics to transport sperm, eggs or embryos unless it is in accordance with the law.
The HFEA has no role or power over the financial dealings between patients and clinics. You should discuss such matters with your clinic.
I have previously imported/exported from a clinic in the EEA which was not accredited in accordance with the Directives. Was it safe? Am I (or is my baby) at risk?
You should discuss any concerns that you have with your clinic.
Clinics have always had a duty to ensure the quality and safety of any materials exported from or imported to their centre. This law is about ensuring a common European-wide system of standards of quality and safety for patients.
How can I complain about this?
If your concern related to an import/export involving an EEA country which has not yet implemented the Directive we suggest that you could contact the European Commission.
The European Commission oversees the implementation of European Directives in each country.
You can contact the European Commission at http://ec.europa.eu/contact/members_en.htm
What is the procedure for importing sperm, eggs or embryos from outside the EEA?
If you are considering obtaining sperm, eggs or embryos from outside the EEA your clinic can organise this on your behalf and then notify the HFEA after the event.
For this to be done your clinic must ensure that certain requirements are met. Clinics are familiar with these requirements which include:
If the overseas clinic does not meet all the conditions the clinic will need to apply to the HFEA for special permission on your behalf to import from that country. These special applications will be considered by an HFEA Licence Committee, this could take between 4 - 8 weeks.
What is the procedure for exporting sperm, eggs or embryos to clinics outside the EEA?
If you are considering exporting sperm, eggs or embryos from outside the EEA your clinic can organise this on your behalf and then notify the HFEA after the event.
For this to be done your clinic must ensure that certain requirements are met. Clinics are familiar with these requirements which include:
If the overseas clinic does not meet all the conditions the clinic will need to apply to the HFEA for special permission on your behalf to export to that country. These applications will be considered by an HFEA Licence Committee and this could take between 4 - 8 weeks.