Consultation outcome

Home use of both pills for early medical abortion up to 10 weeks gestation

Updated 10 March 2022

Applies to England

Introduction

About this consultation

During the COVID-19 pandemic the UK government put in place a temporary approval in England, enabling women and girls to take both pills for early medical abortion (EMA) up to 10 weeks (9 weeks and 6 days) gestation in their own homes, following a telephone or e-consultation with a clinician, without the need to first attend a hospital or clinic. This measure has been put in place during the pandemic to reduce the risk of transmission of COVID-19 and ensure continued access to abortion services. It is time limited for 2 years, or until the pandemic is over ‒ whichever is earliest.

Prior to the pandemic government policy was that only the second pill for early medical abortion could be taken at home and that women should attend an abortion service to take the first pill. Existing guidance from the Department of Health and Social Care (DHSC) (2014) was developed to provide support for doctors and sets out how the 1967 Abortion Act is interpreted by the department.

The guidance dealt with a number of issues including the role of the certifying doctors and the steps they should take to assess risk to the woman’s physical or mental health, the role of the multi-disciplinary team and consultations via webcam or telephone. The guidance also sets out that while there is no statutory requirement for either doctor to have seen and/or examined the woman, it is the department’s interpretation of the law that both doctors should ensure that they have considered sufficient information specific to the woman seeking a termination to be able to assess whether the woman satisfies one of the lawful grounds under the Abortion Act. Although there is no legal requirement for at least one of the certifying doctors to have seen the pregnant woman before reaching a decision about a termination, the guidance expressed the department’s view is that it is good practice for this to be the case.

The temporary COVID-19 approval changed this practice and data shows that most women are now taking both pills at home following an on-line consultation. Following a commitment made in Parliament to consult on this issue, the UK government is seeking views on whether to make permanent the current temporary measure allowing for home use of both pills for EMA medical abortion up to 10 weeks gestation for all eligible women or whether, after the pandemic, the previous approval should be reinstated. The government recognises the sensitivities around the issue of abortion, and the strongly held views on all sides of the debate. This is why the government proposes to consult on this issue to give all sides an opportunity to input their views, evidence and data.

Scope

This consultation is solely seeking views on whether to keep the existing approach or to make permanent the temporary COVID-19 measure allowing for home use of both pills for EMA up to 10 weeks’ gestation for all eligible women in England. The scope does not extend to other abortion-related matters, including the wider legal framework. It does not include provision of abortion services in Scotland, Wales or Northern Ireland.

The policy objectives of this consultation are to understand the:

• impact and experience of the temporary measure
• benefits of making the temporary measure permanent
• risks of making the temporary measure permanent
• evidence base for making the temporary measure permanent

References in this consultation to “women and girls” include a person of any age who is pregnant.

Timetable

This consultation opens on 26 November 2020 and closes at 11:59pm on 26 February 2021.

Responding to the consultation

The government would welcome feedback from anyone with an interest or view on whether or not to make permanent the current temporary measure allowing for home use of both pills for early medical abortions (EMA) up to 10 weeks’ gestation for all eligible women, addressing the specific questions in this consultation document.

We particularly welcome views from those who have been directly affected by the current temporary measure, including:

• women and girls who have accessed abortion services during the COVID-19 pandemic and have taken both pills for EMA at home
• healthcare professionals and National Health Service (NHS) organisations
• NHS and independent sector abortion providers
• Royal Colleges and other professional bodies

Respond to this consultation online

All responses are confidential. You can choose to make an anonymous contribution, or you can give your details. When responding, please state whether you are doing so as an individual or representing the views of an organisation. If you are responding on behalf of an organisation, please make it clear who the organisation represents or the role of the organisation and, where applicable, how the views of members were assembled.

We would like to be able to quote people’s or organisation’s comments in the government response, in order to illustrate key points arising in the course of the consultation. If you’re happy for us to do this, please indicate this on the form. You can remain anonymous and still agree to your comments being quoted.

Early medical abortion (EMA) services

The Abortion Act 1967

The Abortion Act 1967 (“the Act”) sets out the legal framework under which abortions can be performed in England and Wales.

The Act sets out that 2 registered medical practitioners (doctors) must certify in good faith that grounds under the Act for an abortion have been met, and the registered medical practitioner taking responsibility for the procedure is legally required to notify the Chief Medical Officer of the abortion within 14 days of the termination.

Except in an emergency, an abortion can only be carried out in an NHS hospital or in a place approved for the purpose by the Secretary of State (for example, an independent sector clinic). The Secretary of State’s approval is conditional upon the provider’s compliance with the Abortion Act 1967, the Health and Social Care Act 2008, and the department’s Required Standard Operating Procedures (RSOPs). The RSOPs make explicit the conditions and requirements for independent sector places to be approved by Secretary of State to perform termination of pregnancy. Failure to comply can lead to withdrawal of approval at any time. The RSOPs have been developed to:

• ensure compliance with all legal requirements
• provide the best quality of care for patients
• provide sound management, organisational and clinical governance arrangements including issues such as child and adult safeguarding

Providers must also comply with the regulatory framework set out in the Health and Social Care Act 2008 and accompanying regulations and guidance. The Care Quality Commission (CQC) is responsible for implementing the regulatory framework set out in the regulations made under the Act. The (Regulated Activities) Regulations 2014 provides that the termination of pregnancy is a regulated activity. All providers of regulated activities must be registered with the CQC and meet fundamental standards of quality and safety. Registered providers must also meet the requirements set out in the Care Quality Commission (Registration) Regulations 2009. CQC registration must be in place before the Secretary of State will consider an application for approval.

Early medical abortion (EMA)

EMAs are defined as a termination of pregnancy that takes place within the first 10 weeks of the pregnancy using medical (non-surgical) methods. EMA involves administering 2 different tablets: mifepristone and misoprostol.

DHSC publishes abortion statistics on an annual basis for England and Wales. Since 2009, there has been an increase in the proportion of abortions that are performed under 10 weeks. In England and Wales in 2019, 82% of abortions were performed under 10 weeks, increasing from 75% in 2009. Accessing abortion using EMA rather than later in pregnancy helps to reduce the risk of complications, which increases the later the gestation.

Access to EMA prior to COVID-19

In 2018, the Secretary of State used powers in Section 1(3A) of the Abortion Act 1967 to approve English homes as a class of place where the second stage of treatment (misoprostol) for EMA up to 10 weeks gestation can be carried out (“the 2018 approval”). This decision was made to further improve patient safety and the welfare of women.

Under this approval, women eligible for an abortion attended the clinic to take the first pill (mifepristone) and were then offered the choice of administering the second pill (misoprostol) in their own home or returning to the clinic to take the second pill. In some cases women choose to take the misoprostol simultaneously with the mifepristone at the clinic. Women choosing to administer the misoprostol at home were given clear instructions about its use and where to seek help if required. In England and Wales in 2019, 36% of all EMAs carried out were where the second pill was taken at home.

DHSC worked with the Royal College of Obstetricians and Gynaecologists (RCOG) to develop clinical guidance for all professionals to follow for home use of the second pill. This guidance was published in January 2019.

Access to EMA services during the COVID-19 pandemic

The temporary approval that was put in place in response to the COVID-19 pandemic enables women and girls to take both pills (mifepristone and misoprostol) for EMA up to 10 weeks gestation in their own homes, following a telephone or e-consultation with a clinician, without the need to first attend a hospital or clinic. This temporary approval supersedes the 2018 approval described above.

After careful consideration of the risks and benefits, this measure was put in place during the pandemic as a way of ensuring continued access to abortion services and reduce the risk of transmission of COVID-19 (as above, prior to the temporary approval all women accessing an abortion had to attend a clinic or NHS hospital in person at least once, therefore the approval reduces the demand on abortion services to provide in-person care and requirement for women to travel to access services). The measure is time limited for 2 years, or until the pandemic is over, whichever is earliest. Equivalent approvals are in place in Scotland and Wales.

DHSC is monitoring how the temporary approval is working in practice through regular discussions with abortion providers and the RCOG and through emerging data and other evidence. The CQC are also continuing to monitor the provision of abortion services following the approval.

In this consultation we’re seeking views through the questions below on whether or not to make permanent the current temporary measure allowing for home use of both pills for EMA medical abortion up to 10 weeks gestation for all eligible women.

Relevant clinical guidance and patient pathways

In 2019, the National Institute of Health and Care Excellence (NICE) published a guideline which makes evidence-based recommendations on how to organise abortion services and on how to conduct abortions within the legal framework set out by the Abortion Act 1967. This made a number of recommendations including that:

• commissioners and providers should allow women to self-refer to abortion services
• providers should consider providing abortion assessments by phone or video call, for women who prefer this
• abortion providers should maximise the role of nurses and midwives in providing care
• as early as possible, provide women with detailed information to help them prepare for the abortion, covering:
  • what it involves and what happens afterwards
  • how much pain and bleeding to expect
• provide information in a range of formats, for example video or written information. Include information based on the experiences of women who have had an abortion
• provide women with information on signs and symptoms that indicate they need medical help after an abortion, and who to contact if they do
• provide women with information about the different options for management and disposal of pregnancy remains

In addition, in response to the COVID-19 pandemic, the RCOG issued clinical guidelines for healthcare professionals specifically on ‘Coronavirus infection and abortion care’. This guidance sets out the circumstances where women can be prescribed both pills for EMA to be administered at home in accordance with the temporary approval, and when women should be asked to attend a clinic for an ultra-sound scan. However, the guidance states that “most women can determine the gestational age of their pregnancy with reasonable accuracy by last menstrual period (LMP) alone”. The guidance also includes a decision aid for clinicians to use to help determine if an ultra-sound scan is required. RCOG data collected from independent sector abortion providers indicates that in the month of July 2020, around 44% of all patients who received an EMA were asked to attend a clinic and had a scan.

To help illustrate the changes to the provision of EMA services since the temporary approval was put in place, typical patient pathways for women accessing EMA prior to, and during, the COVID-19 pandemic are provided below.

Patient pathway for accessing EMA prior to COVID-19:

1. Patient requests an abortion either through telephone booking service or other means.

2. Some patients are offered a remote consultation prior to an in-clinic consultation (this is based on local contracts). In these cases, written information is provided in advance and at the end of the consultation the client’s consent to proceed is obtained.

3. All patients attend an in-clinic consultation with a healthcare professional. Enough information and time is provided to allow for questions and informed consent. A scan is performed to assess gestation and location of the pregnancy. Counselling is available on request.

4. If eligible for EMA, the first pill mifepristone is taken in-clinic, following which either: a treatment package is provided to take home; misoprostol is taken simultaneously in clinic; or the patient returns to the clinic after 24 to 48 hours to take the misoprostol. This is based on patient choice. The treatment package includes: misoprostol; any additional medication (for example analgesia, anti-emetics); low-sensitivity pregnancy test; written advice and information; and plan for remote follow-up.

5. Aftercare and follow-up for those patients who need it.

Patient pathway for accessing EMA during COVID-19:

1. Patient requests abortion.

2. All patients are offered a remote consultation (for example via video or telephone call). Written information is provided prior to the consultation (for example via email).

3. Remote consultation with healthcare professional. This follows the same standards as face-to-face consultations and enough information and time is provided to allow for questions and informed consent. Counselling is available on request.

4. Eligibility for home-use is determined based on: identification of any safeguarding concerns; ability of the patient to provide date of last menstrual period with reasonable certainty within regulatory thresholds; any history or symptoms suggestive of high risk of ectopic pregnancy such as unilateral abdominal pain and vaginal bleeding/spotting, intrauterine device in-situ, prior ectopic pregnancy or history of tubal damage.

5. If eligible for home-use, treatment package is posted or collected (this could be collection from a pharmacy or a clinic). The treatment package includes: mifepristone and misoprostol (both pills for EMA); any additional medication (for example analgesia, anti-emetics); low-sensitivity pregnancy test; written advice and information; and plan for remote follow-up.

6. If not eligible for home-use, an in-clinic appointment takes place to assess eligibility for abortion treatment.

7. Aftercare and follow-up for those patients who need it.

Safeguarding is an essential component of abortion services. All providers must comply with legal requirements and have regard to any statutory guidance relating to children, young people and vulnerable adults. Providers must ensure that all staff are trained in recognising the signs of potential abuse in adult women and know how to respond. Providers must have written guidance that staff are aware of and can easily refer to as well as easy access to a named lead in the organisation for guidance and advice. It is also a requirement that clinicians caring for women requesting abortion should be able to identify those who require more support than can be provided in the routine abortion service setting, for example young women, those with a pre-existing mental health condition, those who are subject to sexual violence or poor social support, or where there is evidence of coercion.

Impact of the temporary approval on provision of abortion services

On 10 September 2020 DHSC published Abortion Statistics for England and Wales during the COVID-19 pandemic. This report provides statistics on abortions recorded in England and Wales between January to June 2020. On 1 October 2020 DHSC published supplementary analysis on access to abortion during the COVID-19 period covering ethnicity, marital status and age.

Between April and June 2020, there were 23,061 medical abortions where both pills for EMA were administered at home under the temporary approval, representing 43% of abortions during this time. The percentage of abortions using this method increased between April and June, accounting for 33% of abortions in April and increasing to 51% of abortions in June.

Between January to June 2020:

• there were 109,836 abortions performed on residents of England and Wales. This compares with 105,540 over the same period in 2019. For every month between January to April of 2020, there were more abortions performed compared with the corresponding month of 2019 with 4,500 more abortions in April 2020 compared with April 2019. In May and June 2020, the number of abortions performed was less than the corresponding month in 2019
• 86% of abortions were performed at under 10 weeks. This compares with 81% in January to June 2019, an increase of 5 percentage points. Almost 50% of abortions were performed before 7 weeks gestation from January to June 2020, compared to almost 40% for the same period in 2019. A further 36% were done from weeks 7 to 9 in the first 6 months of 2020, compared to 42% in the first 6 months of 2019. The proportion of abortions performed at under 10 weeks has gradually been increasing since 2010, when it was 77%. Over the whole 2019 calendar year, 82% of abortions were performed at under 10 weeks
• medical abortions accounted for 82% of abortions. This compares with 72% of abortions over the same period in 2019, and 73% of abortions over the full 2019 calendar year. The majority (96%) of medical abortions in the first 6 months of 2020 were performed at under 10 weeks, similar to the proportion in the first 6 months of 2019 (95%). In March 2020, 78% of abortions were medical and 22% were surgical, while in April 2020, this changed to 88% of abortions being medical and 12% being surgical. This is likely to be a result of the temporary approval, but continues a gradual upward trend in medical abortions since 1991

It is important to note that while abortion is a safe procedure for which major complications are rare, it is not risk-free. For example, as set out in the 2019 England and Wales Abortion Statistics, complications were reported in 337 out of 207,384 cases in 2019, a rate of 1.6 per 1,000 abortions. It should also be noted that this data on complications is incomplete. It is not possible to fully verify complications recorded on abortion notification forms and complications that occur after discharge may not be always be recorded. For example, for terminations in 2019 where the second EMA pill was administered at home, complications may be less likely to be recorded on the abortion notification form.

Abortion providers will discuss possible complications with the woman in the consultation, and women will be provided with information about possible symptoms, including those which would necessitate urgent review. All women will have access to a 24-hour telephone helpline number if they have any concerns. The department is aware of a small number of incidents which may relate to the temporary approval which we’re looking into alongside the CQC, NHSE&I and other partners. DHSC regularly meet with the RCOG, the CQC, NHS England & Improvement (NHSE&I) and abortion service providers and are carefully monitoring the impact of and compliance with the temporary approval of home administration of both sets of abortion medication.

Consultation questions

Impact of home use of both pills for EMA up to 10 weeks gestation on delivery of abortion services

Service delivery has been transformed across the whole health and care system during the pandemic. Abortion services are no exception, and we’re taking this opportunity to reflect on the changes that have been implemented over the last eight months to ensure service provision remains safe and accessible, meets legal requirements, meets the needs of women and girls and is of high quality going forward.

We’re therefore seeking views and evidence on the impact of the temporary measure enabling home use of both pills for EMA up to 10 weeks gestation during the COVID-19 pandemic.

We’re particularly keen to hear views from those who have direct experience of accessing or providing abortion services during the pandemic.

Question: Do you consider that the temporary measure has had an impact on the provision of abortion services for women and girls accessing these services with particular regard to safety?

a) Yes, it has had a positive impact

b) Yes, it has had a negative impact

c) It has not had an impact

d) I don’t know

[If necessary, please provide text to support your answer]

Question: Do you consider that the temporary measure has had an impact on the provision of abortion services for women and girls accessing these services with particular regard to accessibility?

a) Yes, it has had a positive impact

b) Yes, it has had a negative impact

c) It has not had an impact

d) I don’t know

[If necessary, please provide text to support your answer]

Question: Do you consider that the temporary measure has had an impact on the provision of abortion services for women and girls accessing these services with particular regard to privacy and confidentiality of access?

a) Yes, it has had a positive impact

b) Yes, it has had a negative impact

c) It has not had an impact

d) I don’t know

[If necessary, please provide text to support your answer]

Question: Do you consider that the temporary measure has had an impact on the provision of abortion services for those providing services? This might include greater workforce flexibility, efficiency of service delivery, value for money etc.

a) Yes, it has had a positive impact

b) Yes, it has had a negative impact

c) It has not had an impact

d) I don’t know

[If necessary, please provide text to support your answer]

Question: Have other NHS services been affected by the temporary measure?

a) Yes [please provide details of which services]

b) No

c) I don’t know

[If necessary, please provide text to support your answer]

Question: What information do you consider should be given to women around the risks of accessing pills under the temporary measure if their pregnancy may potentially be over 10 weeks gestation?

[free text answer]

Question: Outside of the pandemic do you consider there are benefits or disadvantages in relation to safeguarding and women’s safety in requiring them to make at least one visit to a service to be assessed by a clinician?

a) Yes, benefits

b) Yes, disadvantages

c) No

d) I don’t know

[If necessary, please provide text to support your answer]

Public sector equality duty

As part of the consultation, we’re inviting views on the impact of making permanent home use of both pills for EMA on people with protected characteristics and steps that could be taken to mitigate against any adverse impact, against the government’s duties under the Equality Act 2010.

Protected characteristics are:

• age
• gender reassignment
• being married or in a civil partnership
• being pregnant or on maternity leave
• disability
• race including colour, nationality, ethnic or national origin
• religion or belief
• sex
• sexual orientation

Question: To what extent do you consider making permanent home use of both pills could have a differential impact on groups of people or communities?

For example, what is the impact of being able to take both pills for EMA at home on people with a disability or on people from different ethnic or religious backgrounds?

[free text answer]

Socioeconomic considerations

In addition to the protected characteristics as discussed above, we’re also seeking views on the potential for making permanent home use of both pills for EMA to reduce or increase inequality in health outcomes experienced by different socioeconomic groups.

Question: To what extent do you consider that making permanent home use of both pills for EMA would increase or reduce the difference in access to abortion for women from more deprived backgrounds or between geographical areas with different levels of disadvantage?

[free text answer]

Whether to make home use of both pills for EMA a permanent measure

As set out above, the current approval allowing home use of both pills for EMA up to 10 weeks gestation is not permanent. It will currently expire on the day on which the temporary provisions of the Coronavirus Act 2020 expire, or the end of the period of 2 years beginning with the day on which it is made, whichever is earlier. We’re seeking views on whether this should be made permanent (noting that, as with any other healthcare service, the measure would be kept under review should new evidence or information emerge), and if not, when the temporary measure should end.

It is important to note that the options for the future of the temporary measure set out in question 10 will be subject to any considerations regarding the COVID-19 pandemic that are relevant at the time the decision is taken.

Question: Should the temporary measure enabling home use of both pills for EMA [select one of the below]

a) Become a permanent measure?

b) End immediately?

c) As set out in the current temporary approval, be time limited for 2 years or end when the temporary provisions of the Coronavirus Act 2020 expire, whichever is earlier?

d) Be extended for one year from the date on which the response to this consultation is published, to enable further data on home use of both pills for EMA and evidence on the temporary approval’s impact on delivery of abortion services to be gathered?

e) Other [please provide details]?

Question: Have you any other comments you wish to make about whether to make home use of both pills for EMA a permanent measure?

[free text answer]