What are Special Directions?
Any centre intending to undertake an import or export of gametes or embryos must ensure that it can demonstrate compliance with the relevant Schedule set out in the version of General Direction 0006 specific to the centre’s location; these being:
GD0006(GB) version 9, for centres in Great Britain (i.e. England, Scotland or Wales).
GD0006(NI) version 1, for centres in Northern Ireland.
If you are not able to ensure compliance, then you cannot undertake the import or export under General Direction 0006. You can however apply to the HFEA for a Special Direction for permission to do so.
Applications for a Special Direction are reviewed by the Statutory Approvals Committee and, if approved, allow a licensed fertility clinic to carry out an import or export despite not meeting the requirements of General Direction 0006. The committee uses the information provided in the application and associated documents to make their decision on whether a departure from the condition(s) of General Direction 0006 is/are justified. The decision is based on the specifics of each application.
How do I apply for a Special Direction?
Before applying for a Special Direction, a clinic should assess whether there is a justifiable reason as to why the import or export should take place, despite not meeting the General Direction requirements specific to the planned transport.
Patients are not able to directly apply to the HFEA for a Special Direction; clinics make the application for the patient. To make an application, a clinic needs to login to their secure area of the Clinic Portal, and complete a Special Direction application form in the ‘licensing and applications’ module (‘New licences, returns and applications’). The completed application form must be submitted by the clinic’s Person Responsible, with all required documentation attached, through this clinic portal route.
The Special Direction application must be accompanied by a completed Further Information Form, the version used being specific to the version of General Direction 0006 acting on the planned transport:
Further Information Form for GD0006(GB) version 9: For centres in Great Britain (i.e. England, Scotland or Wales) transporting gametes and/or embryos after 30 June 2021;
Further Information Form for GD0006(NI) version 1: For centres in Northern Ireland transporting gametes and/or embryos after 31 December 2020.
Before completing the ‘Further Information Form’ relevant to the application, clinics should read the guidance on the form - this sets out the information that should be provided. The ‘Further Information Form’ allows a clinic to explain why, despite not meeting the requirements of the relevant version of General Direction 0006, a Special Direction permitting the import/export should be authorised. It is the clinic's responsibility to complete the application form and ‘Further Information Form’ fully and accurately. The onus is on the clinic to furnish the committee with the information necessary to make a decision.
Clinics should note the importance placed by the HFEA on clinics in third countries being accredited, designated, authorised or licensed under their relevant national legislation. Before 30 June 2021, transports of embryos and gametes between the UK and EU countries could only be made between clinics that were appropriately “accredited, designated, authorised or licensed”. The HFEA had no discretion to depart from this requirement. After 30 June 2021, the HFEA will have discretion in this area, however the need for centres abroad to be “accredited, designated, authorised or licensed” remains an important requirement of GD0006 which is likely to only be set aside if the strongest justifications are provided.
How are decisions made?
The committee will consider the information provided, balancing the specifics of the case with the requirements - such as upholding altruism in donation and ensuring donors are identifiable. Where the individual’s rights are engaged, among other things the committee will need to consider whether interference with the individual’s rights can be justified. In making this assessment the committee will consider whether interference:
- is in accordance with the law,
- pursues a legitimate aim,
- fulfills a pressing social need,
- is necessary in a democratic society, and
- is proportionate and non-discriminatory.
Where the committee considers it does not have enough information on which to decide, it may adjourn the meeting and request specific information, or if the committee considers that the information provided in the application does not support a decision to grant a Special Direction, it may reject the application.