Chief Executive's letter

04 July 2016

Ref: CE(16) 02(a)

To all Persons Responsible

Dear colleague

Changes to the interpretation of the 1991 and 1996 storage regulations

I am writing to let you know about changes to the interpretation of the Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991 (‘the 1991 Regulations’) and the Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996 (‘the 1996 Regulations’). These new interpretations will, in a limited number of cases, affect how long you may store sperm, eggs or embryos.

This letter follows the Alert which was published on 29 June, asking you not to destroy sperm, eggs or embryos in the cases below.

The new interpretations are set out in detail in Annex A. Annex B reproduces the Schedule to the 1991 Regulations (which can also be used for the 1996 regulations) and Annex C gives flow charts to work out which cases are affected.

Which cases are affected?

The changes mean that in the following circumstances sperm, eggs or embryos subjected to extended storage periods may be stored for periods longer than those calculated under the current interpretations of the 1991 and 1996 Regulations:

Sperm in storage now that was first placed in storage before 1 August 1991 and which has been kept lawfully for an extended period beyond the 10-year maximum storage period, and
Sperm, eggs or embryos that were first placed in storage between 1 August 1991 and 1 October 2009 and which are being kept lawfully for an extended period up to the provider’s 55th birthday, or in the case of embryos, up to the 55th birthday of the woman being treated

These changes do not affect sperm, eggs or embryos stored after 1 October 2009 or, if stored earlier than this, where the gamete provider subsequently provided a new consent under the Human Fertilisation and Embryology (Statutory Storage Period) Regulations 2009.

Why are we introducing these new interpretations?

A person storing sperm since before 1991 recently raised a legal challenge to the current interpretation of the 1991 and 1996 Regulations. The case raised questions about the correct interpretation as to:

the meaning of the words ‘date on which the gametes were provided’ for sperm stored before 1 August 1991; and
whether the effect of the 1991 and 1996 Regulations was that the extended period of storage expired on the occasion of the gamete provider’s 55th birthday

As a consequence of this case, the HFEA must now issue revised guidance on these two points.

What you should do

Firstly, you will need to work out whether you are storing gametes or embryos affected by these two changes. To help you work this out we enclose two flow charts at Annex C.

If you are storing sperm, eggs, or embryos that are affected by these changes, you will need to re-calculate the new expiry dates in line with the new interpretations. To help you work out the new expiry dates we have developed a calculator and user guide, which you can download here.

In order to use this calculator you will need to:

1. Identify the cases that are affected (see the flow charts at Annex C), and

2. For each case identify:

the date of birth of the gamete provider (in the case of embryos, the date of birth of the women being treated)
the date the sperm, eggs or embryos were put in storage.

If the sperm, eggs or embryos are coming up to their storage expiry date, please do not discard them without first checking whether the new expiry periods apply, as there may be a possibility that they can be stored for longer.

If you are in any doubt please contact your HFEA Inspector.

We will review your progress in taking these changes into account at your next inspection.
Yours faithfully