HFEA Briefing

Introduction

This briefing sets out why the Human Fertilisation and Embryology Authority (HFEA), as the UK regulator of fertility treatment and embryo research, supports the proposed amendment to the Health and Care Bill to change the statutory storage limits for gametes (eggs, and sperm) and embryos. This will bring the UK’s law in line with advances in science, changes in modern society and give individuals greater reproductive choices. It will also give patients more time to make important decisions about planning their family.

These laws deal with some of the most sensitive aspects of life, including the creation of embryos and their storage, the use of donor eggs or sperm or embryos, and surrogacy. They impact individuals facing different personal circumstances, including those who wish to preserve their fertility because future medical treatment might cause infertility (such as some cancer treatment drugs or gender transition treatments), those who are not ready for a family yet and wish to delay parenthood, or those who need the help of another person to have a family, such as in donor conception and surrogacy.

Benefits for patients

These proposals will ensure equality and freedom of choice for all patients accessing treatment in HFEA licensed centres regardless of their personal or medical circumstances.

Although the majority of patients who store embryos are storing them for use in later treatment cycles, some of the reasons that people access fertility treatment have changed over the years.

Reasons why patients choose to freeze their eggs, sperm or embryos

• Have additional embryos after fertility treatment
• Are not ready to have a family yet (known as ‘social’ or ’elective’ freezing)
• Are undergoing chemotherapy or radiotherapy (medical)
• Are having gender reassignment surgery or using medication which can affect fertility
• Are at risk of injury or death and wish to ensure their surviving partner can use their eggs, sperm or embryos in treatment after their death

More patients are choosing to freeze their eggs, sperm or embryos

As freezing techniques and live birth rates have improved, a typical IVF patient today will have a single fresh embryo transferred in their first treatment cycle, and any additional embryos of suitable quality can be stored for use in subsequent cycles. As a result, frozen embryo transfers increased by 86% from 2014 to 2019, while fresh embryo transfers decreased by 15% in the same period. In 1991, frozen embryo transfers made up just 10% of all IVF cycles, compared to 41% in 2019.

Changes will increase patient reproductive choice and improve outcomes

Women are at the peak of their fertility in their 20s, and the earlier a woman freezes her eggs, the better chance she has of achieving a healthy pregnancy when she is ready to use the stored eggs. HFEA figures show that birth rates decrease with age; while the birth rate per embryo transferred is above 25% for women under 35, this decreases to 15% or lower for women over 40, and to less than 5% for women over 44. However, freezing at the most optimal age means the existing 10-year storage limit may expire before some women are ready to start their families.

Increasing the storage limit promotes equality by enabling all patients and donors, not only those who are prematurely infertile, to benefit from a longer storage period. This improves reproductive choice especially for younger women who are disadvantaged by the current legal 10-year limit on storage. If eggs are frozen below age 35, the chances of success are higher when they are used.

Under existing legislative provisions (the 2009 Statutory Storage Period for Embryos and Gametes Regulations) extending storage beyond 10 years is only possible where a medical practitioner confirms that the person storing eggs, sperm or embryos, or their partner, is or is likely to become prematurely infertile.

The proposed changes will give patients more time to make important decisions about planning their family.

Posthumous storage and use, and losing capacity to consent

There will also be a new provision enabling storage and use of a deceased person’s eggs, sperm or embryos for an additional 10 years after their death, provided that, during their lifetime, they have given consent to posthumous use. This new provision will allow the deceased person’s bereaved partner more time to come to terms with their loss and, if they wish, to then use their deceased partner’s stored eggs, sperm or embryos in treatment.

In circumstances where a registered medical practitioner declares that a patient does not have the capacity to renew their consent, new provisions will also allow for the ongoing storage of a patient’s eggs, sperm or embryos for up to an additional 10 years notwithstanding that the patient has not been able to take the necessary steps to renew their consent. This is provided that, whilst capable of giving consent, the patient consented to the ongoing storage of their eggs, sperm or embryos in the event of their death or incapacity. Should the patient subsequently regain capacity to consent, they will then be required to decide about future storage or use and provide the necessary consent.

Benefits for those using donor eggs, sperm or embryos

Currently donated eggs, sperm and embryos can only be stored for a maximum of 10 years, unless the person being treated using the eggs, sperm or embryos, meets the criteria of being prematurely infertile, and the egg or sperm provider has consented to storage beyond 10 years.

Increasing use of donated eggs, sperm and embryos

Data from the HFEA Register shows that in 2019, there were 7,027 frozen eggs donated for treatment, an 80% increase on 2015. The number of frozen embryos donated during this period increased by 44%. Stored eggs and embryos are being increasingly donated for use in someone else’s treatment. Freezing donor eggs allows for increased safety around testing and quarantine for viral diseases.

Increasing donor availability and patient choice

Most donated eggs, sperm and embryos are used within the first few years of storage. However, extending the current statutory storage limit will enable greater use to be made of donated eggs, sperm and embryos because they will be able to be stored for longer than currently, thus enabling more people to have donor treatment.

Increasing the amount of time a clinic will have to use those eggs, sperm or embryos from 10 years to a maximum of 55 years may be especially important for patients looking for donor eggs, sperm or embryos from black and minority ethnic groups, of which there is less availability in the UK.

The increased storage limit will also ensure that a donor’s eggs, sperm or embryos are available and able to be used by patients for a greater amount of time. This will benefit patients who have a donor-conceived child and wish, in time, to have genetically related siblings for that child. They will be able to plan when to have further treatment rather than being forced to have treatment in the space of only 10 years.

Surrogacy

The increased storage limit will also benefit patients who are storing eggs, sperm and embryos for use in a surrogacy arrangement, who may need to store for longer because of the time it can take to find a suitable surrogate.

Benefits for fertility clinics

New rules will be clearer for clinics

The current 2009 Regulations are complex and can be difficult to implement. Consequently, through no fault of their own, some patients are disadvantaged by not being able to benefit from extended storage under these regulations. The new scheme will be simpler to implement and will promote equality by enabling all patients to benefit from a storage period of up to 55 years, rather than as is currently the case, only those who are declared prematurely infertile or likely to become so.

Patients will still need to renew their consent every 10 years, however the process of doing so will be considerably less complex and burdensome for both clinics and patients. This will also reduce the kind of errors which currently lead to unlawful storage.

The 2009 Regulations and the 2020 Regulations will be revoked and all patients currently storing eggs, sperm or embryos and those who choose to store in future will be able to benefit from a single scheme, making the process of complying with the law when renewing or extending storage far simpler for clinics and patients.

Benefits for research using donated eggs, sperm or embryos

Allowing a 10-year extension

We support responsible innovation and research in the UK using eggs, sperm and embryos that have been donated for research purposes and welcome the proposed changes which will maximise the availability of donated material for use in research. The new provisions allow for material to be stored for research purposes for up to 10 years from the date that consent to research is given.

Currently, if eggs, sperm or embryos are donated for use in research, they must be used within what remains of the 10-year statutory storage period that the donor had originally consented to. This means that researchers will often only have a very short amount of time, sometimes a matter of a few months, to use the donated material in their research before the consent period lapses. This results in the samples not being used and having to be allowed to perish when it was the donor’s wish that they should be used for the benefit of research and, ultimately, the wider public benefit.

A 10-year extension will:

• provide patients with the option to donate their eggs, sperm or embryos to research at the end of their 10-year storage and be satisfied that they will be stored for research use for an additional 10 years.
• result in increased availability of eggs, sperm or embryos for use in research
• give researchers more time to use the eggs, sperm or embryos and not have to rush research merely to ensure the material is used within the 10-year consent period.

FAQs

Will these changes lead to people becoming pregnant when they are older?

There is no law in the UK which stipulates an upper age limit for women receiving fertility treatment. However, the majority of clinics impose an upper age limit for patients they are willing to treat, and clinics can refuse to provide treatment if there are clinical reasons for such a decision. For example, because of concerns regarding the increased risk of medical complications due to the patient’s age. Clinics are also required by law to carry out an assessment of the welfare of any child born as a result of treatment.

Are there any safety and quality issues from prolonged storage?

There is no evidence that suggests any safety or quality issues for storing eggs, sperm and embryos for longer. Improvements in egg freezing technology have made it possible for more patients to freeze their eggs. The use of egg freezing has increased tenfold in the past ten years, from just under 230 cycles in 2009 to almost 2,400 cycles in 2019. It is likely that demand for egg freezing will continue to increase in the future.

Will all patients store for the maximum 55 years?

It is unlikely that most patients will choose to store for 55 years. Most patients use their eggs, sperm or embryos within 10 years of storing. Some patients are reluctant to allow their eggs or embryos (less so sperm) to perish, even if they are not planning to use them in their own treatment. This may be due to patients not being able to make the difficult decision to discard them, or for religious reasons. However, the 10-year renewal period will provide clinics with a time to check with patients whether they still want to store their eggs, sperm or embryos, and to offer counselling to patients struggling to make a decision to discard them.

If donated sperm, eggs or embryos are stored for longer, does it increase the risk that the donor may die before the donor conceived child reaches 18 and can access identifiable information about their donor?

In the UK, a donor conceived person can access identifiable information (i.e., the name, date of birth, last known address) about their donor from the HFEA from the age of 18. Increasing the storage limit for donated material will allow donors to store their sperm, eggs or embryos for a longer period of time and therefore may increase the chance that the donor dies before the child reaches 18. It also could increase the risk of large age gaps between potential donor conceived siblings. In practice however, most donated eggs, sperm and embryos are used early on in the 10-year statutory storage period. Donors are also able to specify the storage of their eggs, sperm or embryos for fewer than 55 years and can still decide to withdraw their consent before treatment takes place (as is the case now).

What if patients stop paying for storage – will this mean that the NHS or private clinics will need to pay for storage?

No. HFEA guidance makes it clear that clinics can put in place contractual agreements with their patients which explain that the clinic will only continue storing eggs, sperm and embryos provided they continue paying their storage fees in the case of private patients, or in the case of NHS patients, for as long as NHS funding for storage costs is available. Such contractual agreements are separate from a patient’s consent to storage. It is open to clinics to include standard terms and conditions which make it clear to patients that if they fail to pay storage costs, or fail to maintain regular contact with the clinic, the clinic may remove their eggs, sperm or embryos from storage, even if their consent period has not yet lapsed.

For more information on fertility treatment, please see hfea.gov.uk or contact enquiriesteam@hfea.gov.uk.