11 June 2020
In recognition of the potential impact that the COVID-19 pandemic may have on patients storing gametes or embryos and research projects involving the use of donated embryos, new Regulations, The Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 (Coronavirus Regulations) will be coming into force on 1st July 2020.
In the circumstances specified in paragraphs 3(2) (embryos) and 4(2) (gametes) of the Coronavirus Regulations, the statutory storage period of 10 years which is specified in section 14 of the Human Fertilisation and Embryology Act, will become 12 years.
These circumstances are:
- The gametes or embryos are being stored on licensed premises on 1 July 2020, the date that these Regulations come into effect; and
- The person who provided the gametes or persons whose gametes were used to create the embryos have consented in writing to the gametes or embryos being stored for at least 12 years. This written consent can be provided before, on or after 1 July 2020.
Paragraphs 6, to 10 of the Coronavirus Regulations make amendments to certain provisions of the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (the 2009 Regulations).
In particular, the definition of ‘relevant period' under the 2009 Regulations has been amended. The relevant period is the period within which a written medical opinion must be obtained in relation to premature infertility or the likelihood thereof in order for patients to extend storage beyond ten years, or further extended storage.
What the relevant period is will vary from patient to patient depending on whether their gametes or embryos are currently within their initial 10 year storage period, whether they are currently being stored for an extended period under the 2009 Regulations or, in future, whether they have previously extended their storage period to 12 years either under paragraph 3(2) (embryos) or 4(2) (gametes) of the Coronavirus Regulations. You will need to consult the Coronavirus Regulations and carefully review each patient’s case to determine what the relevant period is in their circumstances.
It is important to note however that the Coronavirus Regulations provide for a one-off extension of ‘the relevant period’ to 12 years due to the Coronavirus and provide thereafter, for the 2009 Regulations to continue to apply as they always have i.e. allowing extensions of storage of up to 10 years in cases of premature infertility.
have developed a new consent form ‘Your consent to extending the storage of your gametes or embryos as a result of the COVID-19 pandemic’ (CVS form) for you to use to record the consent of those patients who have not already consented to storage for 12 years or more.
The consent form is attached at Annex I below and will be available on the clinic portal [insert link if available]. At Annex II is a series of FAQs and at Annex III is an audit tool which clinics may wish to use to document the fact that they have reviewed their patient’s records in light of the provisions set out in the Coronavirus Regulations. At Annex IV below is the revised General Direction 0007 which mandates the use of the new CVS form where it is necessary for patients to consent to storage for 12 years.
- Annex I: New CVS consent form
- Annex II: FAQs
- Annex III: Audit tool for optional clinic use
- Annex IV: Revised General Direction 0007
Please be aware that the Coronavirus Regulations only apply to patients who have gametes or embryos in storage on the day the Regulations come into force (1 July 2020).
Patients whose gametes or embryos are placed into storage for the first time after 1 July 2020 will only be able to consent to storage for up to 10 years. Those patients will not be entitled to consent to storage for 12 years and they should not complete the new CVS form.
Please speak with your inspector if you have further questions about the new storage Regulations.
Yours sincerely
Chair, Human Fertilisation and Embryology Authority.