The Excessive Regulation of Early Abortion Medication in the UK: The Case for Reform

Early medical abortion (EMA) involves the administration of two medications—mifepristone and misoprostol—taken 24–48 hours apart, during the first 10 weeks of pregnancy. 1 EMA is the most common abortion method in Great Britain, accounting for 73% of terminations in England and Wales, 2 and 88% in Scotland 3 in 2019. These medications are recognised as safe and effective by the World Health Organization (WHO), which strongly recommends this combination of medications until 9 weeks’ gestation. 4 This highly effective drug regimen has a strong track record for safety 5 —even amongst those who self-administer without medical support. 6 There exists a strong body of evidence that suggests EMA is ‘a safer drug regimen than an injection of penicillin’. 7 Despite the safety and effectiveness of this drug regimen, however, there exists excessive regulation around EMA, which, we argue, is not the result of necessity to manage innate risks of these medications, but about supervising abortion decisions. In this article, we demonstrate that EMA is over-regulated in the UK. This is because of stringent requirements imposed in Great Britain by the Abortion Act 1967 (AA 1967) that require EMA to be prescribed under a strict set of conditions, specifically that it must be prescribed by doctors and requirements about where and under what conditions both drugs can be prescribed. The regulations in Northern Ireland, 8 while in some ways an improvement on the AA 1967, also over-regulate EMA with requirements about who can prescribe and where the medications can be administered. We argue that the over-regulation of EMA is inappropriate because it fails to reflect the fact that abortion is essential healthcare. 9 Over-regulation constitutes disproportionate interference with the provision of healthcare because it is medically unnecessary and prevents abortion providers in the UK from adapting their service provision in line with emerging evidence regarding best practice. 10 When the AA 1967 was first enacted in Great Britain, abortion was a far riskier surgical procedure. 11 Today, however, it involves the routine administration of safe medications. The regulation is thus out-of-date. New regulations in Northern Ireland, while somewhat an ‘evolution’ of the AA 1967, 12 continue to embody an approach that enables non-medically indicated interference. Excessive regulation across the UK perpetuates harmful narratives of people experiencing pregnancy (usually women) 13 as being in need of supervision when it comes to reproductive decision-making and of abortion as a ‘problem’ in need of management. This article contributes to the body of literature providing a feminist critique of the AA 1967 and calling for the decriminalisation of abortion. 14 There is limited commentary on the regulation of abortion medications themselves (particularly mifepristone) in the UK context. 15 This is in contrast to the USA, which has seen much discussion of the over-regulation of mifepristone by the Food and Drug Administration. 16 Many of the concerns raised about US regulation, however, are also apparent in UK regulation. In this article, we consider the excessive regulation of EMA (in particular, mifepristone) and the extent to which over-regulation has impacted on how abortion care is delivered. While other aspects of abortion regulation are cause for concern, the over-regulation of EMA directly impacts on service-user’s experiences of care. 17

Abortion is essential healthcare. UK law, however, does not appropriately reflect this. The law surrounding pharmaceuticals designates medications as ‘prescription-only’ to ensure that they are available to patients only when safe and clinically appropriate. Doctors are installed as gatekeepers of medications, but only in so far as it relates to clinical factors, and their discretion in prescribing is not further interfered with by the law. In contrast, the law enables excessive state interference into clinical discretion in abortion , including imposing conditions about when, where, and by whom EMA can be provided. These regulations are not grounded in clinical necessity, but instead reflect the reality that abortion is exceptionalised. The framing of the law perpetuates abortion stigma. 191 The legal framework causes harm in creating barriers to access. Excess regulation results in delays to care and prevents service providers from adapting provision in line with best practice to improve efficiency 192 and improve health. Substantive reform is necessary to reflect the reality that abortion is essential healthcare. In this article, we noted ways in which changes to the regulation of EMA are necessary, including, making remote prescription and home use of abortion medications permanent in Great Britain and bringing this to Northern Ireland, and enabling lawful prescription by healthcare professionals besides doctors. However, rather than patchwork amendment to the law—for example, the issuing of new permanent approval orders in Great Britain for home use, or amendment to the AA 1967 to allow prescribing by medical professionals rather than practitioners— broader change is necessary. The case for the decriminalisation of abortion has been made persuasively elsewhere. 193 As Herring and others observe, ‘it is important to make robust provision within abortion services for informed consent, confidentiality, safeguarding and access to counselling for those women who want it, the current criminal law framework plays no role in this regard’. 194 Were (early) abortion decriminalised, and decriminalised without the introduction of comprehensive regulation as in Northern Ireland, the law would not routinely interfere with the evolution of medical best practice. 195 Without additional criminal prohibition on abortion medications, they would remain available only following prescription by a healthcare professional. Healthcare professionals are better placed than politicians to determine the appropriate conditions for prescribing, and to exercise discretion to ensure patient safety. There is no justification, medical or ethical, for mifepristone and misoprostol being subject to more stringent regulation than other prescription-only medications. This bolsters the case for decriminalisation of abortion.

Failure to ensure access to legal abortion does not reduce the incidence of abortion. 18 The recognition of legal abortion as a matter of public health is long-standing; 19 the evidence ‘is clear and incontrovertible: access to safe, legal abortion on request improves health’. 20 Indeed, the motivation behind the 1967 Act enabling legal abortion in Great Britain was to curb the high mortality and morbidity associated with clandestine abortion. 21 The AA 1967 is often praised as a success story for having almost completely eliminated deaths resulting from ‘back-street’ terminations. 22 The impact that access to abortion has on individual—as well as public—health is important to acknowledge. The United Nations recognises the importance of reproductive health, which it defines as ‘a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and to its functions and processes’. 23 Similar recognition comes from the WHO, which acknowledges the ‘health evidence, technologies and human rights rationale for providing safe, comprehensive abortion care’. 24 Laws that limit abortion have serious implications for female reproductive, physical, and mental health. 25 Individuals encountering unwanted pregnancy in ‘a wide variety of medical and social circumstances experience pregnancy termination as an urgently felt need’ and as essential for their health and well-being. 26 Abortion preserves health, and it can be safely provided within a health system. The Royal College of Obstetricians and Gynaecologists notes that ‘[s]afe abortions are an essential part of sexual and reproductive health; they should be an integrated component of sexual and reproductive healthcare and be available as part of routine health services.’ 27 The current legal framework, however, classifies EMA as distinct from routine health services. This disadvantages people, and their health outcomes, in various ways.

Regulation of EMA is at odds with government and healthcare regulators’ policy within the context of pharmaceutical regulation. There is excessive intervention by the law into clinical discretion in prescribing and advising on the use of mifepristone and misoprostol compared to other medications. This makes abortion harder to access than other forms of routine healthcare, which constitutes an unjustified interference with people’s health. The Medicines Act 1968 requires that ‘prescription-only medicines’, 41 encompassing mifepristone and misoprostol, 42 must only be supplied by the prescription of an appropriate practitioner and administered as per the practitioner’s directions. The requirement that some drugs are available only by prescription exists to ensure that appropriate expertise is deployed where without it there is the potential for harm. Doctors ‘are empowered by governments to limit patients’ access to medicines out of a concern that patients with unrestricted access would otherwise make inadvisable treatment decisions, or abuse potentially dangerous medicines’. 43 A patient has no right to a prescription. The patient can request particular medications, but if the doctor (or other qualified health care professional) believes that the medications are not clinically indicated, or may be misused, the patient will likely leave the consultation ‘empty-handed’ as ultimately ‘patients do not decide which drugs they are prescribed’. 44 By virtue of regulation 214 of the Human Medicines Regulations 2012, professionals deemed qualified to prescribe a prescription-only medicine include (among others) doctors, nurse independent prescribers, and pharmacist independent prescribers. These professionals act as ‘gate-keepers’ to medicines. 45 The general conditions placed on prescription in the regulations are that: it must be signed in ink by the prescribing practitioner; 46 the contents of the prescription must be indelible; the prescription must contain the date on which the prescription is signed or the date on which it can be dispensed to the patient, identifying information about the practitioner including their working address, the name and address of the patient, and the patient’s age if they are under 12. 47 Where the prescription is provided electronically, conditions (a) and (b) need not be met, but the prescription must be signed with an ‘advanced electronic signature’ 48 and sent directly to the professional who will dispense it. 49 There is, in these regulations, no requirement that this practitioner has examined the patient to make a prescription, nor are there any other specific requirements in the law relating to the circumstances of prescription. 50 In contrast, however, there are numerous legal rules surrounding the circumstances of abortion medications. In this section, we outline the legal framework surrounding abortion (and consequently EMA) in the UK. There are some differences in regulation across the UK, as the legality of abortion differs between jurisdictions (England and Wales, Scotland, and Northern Ireland). The administration of abortion medications in England and Wales remains a criminal offence by virtue of the Offences Against the Person Act 1861 (OAPA 1861), which renders it an offence for a person to ‘unlawfully supply or procure any poison or any other noxious thing … knowing that the same is intended to be unlawfully used or employed with intent to procure the miscarriage of any woman’. 51 The OAPA 1861 does not apply in Scotland, but the administration of abortion medications is criminal by virtue of the common law. 52 Abortion medications can only be lawfully administered in compliance with the provisions of the AA 1967. This imposes a strict set of requirements on the administration of abortion medications in Great Britain, including specifying the circumstances in which prescription is appropriate, 53 specifying who can prescribe the medications, 54 and specifying where the medications can be prescribed and administered. 55 While the provisions of the OAPA 1861 that criminalised abortion applied in Northern Ireland (until recently), the AA 1967 did not. 56 Until 2019, abortion—at any point in pregnancy—could only be performed in Northern Ireland (on the grounds that it would not constitute unlawful miscarriage) where necessary to save the pregnant person’s life. 57 In 2019, abortion was partially decriminalised as the relevant provisions of the OAPA 1861 were repealed by the Northern Ireland (Executive Formation etc) Act 2019. 58 The AA 1967 never applied in Northern Ireland, which meant that there was no law concerning abortion before viability in Northern Ireland until new regulations were enacted in 2020. The Abortion (Northern Ireland) (No. 2) Regulations 2020 were introduced to regulate abortion on similar grounds to the AA 1967, though with some significant differences. The most notable is that the regulations create a new criminal offence—the provision of abortion outside the terms of the regulations. 59 This is an offence that is only committed by persons other than the pregnant person themselves, 60 who are subject to no criminal sanction when they abort in circumstances beyond those determined permissible. The AA 1967 is woefully out-of-step with modern day abortion provision—specifically the realities of EMA prescription and administration. Although in some ways the Northern Ireland regulations are, on paper, more permissive and reflective of the realities of modern abortion care, there is still much to be desired in their regulation of where abortions can take place, and their implementation in practice. For abortion to be lawful, it must be provided on one of the clinical grounds provided in section one of the AA 1967. 61 Pregnancy may be terminated where two medical practitioners form the opinion in good faith that: the pregnancy has not exceeded 24 weeks and continuance of the pregnancy involves greater risk than if the pregnancy were terminated of injury to the physical or mental health of the pregnant person or any existing children of their family; termination is necessary to prevent ‘grave permanent injury to the physical or mental health’ of the pregnant person; continuance of the pregnancy involves a greater risk to the pregnant person’s life than termination of pregnancy; and/or there is a substantial risk that ‘if the child were born it would suffer from such physical or mental abnormalities as to be seriously handicapped’. 62 The Act instructs doctors to take a person’s ‘actual and reasonably foreseeable environment’ into account when making decisions about risk of injury to health. 63 The Act does afford significant discretion to doctors, such that it is often described as making all early pregnancies ‘legally terminable’, 64 because it is interpreted broadly. 65 Early in pregnancy, abortion will always be statistically safer than carrying pregnancy to term and birthing. 66 It is easy to justify prescription of EMA under the AA 1967 because continuing the pregnancy is more detrimental to the patient than terminating it with medication. 67 Risk-benefit analysis supports the position that EMA is safe. We have outlined the mifepristone-misoprostol regimen’s safety credentials. Weighing EMA against not accessing abortion (and therefore being forced to birth) supports the comparative safety of the treatment. 68 Despite the law rendering EMA easily permissible , it is nevertheless incredibly prescriptive about when abortion can be provided (and thus when abortion medications can be prescribed). There is no other law that, in this way, significantly interferes with clinical discretion by specifying the circumstances in which prescribing a particular treatment is appropriate. The AA 1967 can be contrasted with the 2020 regulations in Northern Ireland, which has provision for abortion on similar grounds. Regulation 4 specifies that where the pregnancy has not exceeded 24 weeks, abortion can be lawfully provided where two medical practitioners form the opinion in good faith that ‘continuance of the pregnancy would involve risk of injury to the physical or mental health of the pregnant woman which is greater than if the pregnancy were terminated’. 69 However, under regulation 3, abortion can also be provided where a medical practitioner forms the opinion in good faith that the pregnancy has not exceeded 12 weeks with no further caveats. Before 12 weeks, there is no interference with the clinical discretion of the medical practitioner in making a prescription. On this count, the abortion regulations in Northern Ireland are—in no small way—an evolution of the AA 1967. Though the same criticism regarding the interference with clinical discretion still applies to the legal status of abortion performed after 12 weeks’ gestation. 70 The law in Great Britain (and Northern Ireland to a lesser extent) interferes with clinical discretion in prescribing mifepristone and misoprostol by specifying when prescription is appropriate. Prescription-only medicines can be provided by a variety of healthcare practitioners qualified to handle medications. However, additional requirements are placed on abortifacients when used for abortion. The AA 1967 specifies that only medical practitioners can perform abortions. This does not mean that they necessarily must perform/supervise every aspect of treatment. The House of Lords stipulated that what the Act requires is that ‘a registered medical practitioner, whom I will refer to as a doctor, should accept responsibility for all stages of the treatment for the termination of the pregnancy. The particular method to be used should be decided by the doctor in charge of the treatment for termination of the pregnancy’. 71 While National Institute of Health and Care Excellence (NICE) guidance recommends that providers of abortion care ‘maximise the role of nurses and midwives in providing care’ 72 it remains the case that a doctor is ‘in charge’. It must be a doctor, with the second opinion of another doctor certifying this action, who prescribes EMA—meaning quite literally providing the dispensing certificate and written instructions about how the patient is to administer the medications. There is no other medical procedure that—by virtue of legal requirements—means that two doctors must provide their signature before it can be performed. 73 That it is a doctor who must prescribe (and specifically after two doctors have agreed this is the person's circumstances fit within the socio-medical ground for abortion) sets apart EMA from other prescription-only medications. In Northern Ireland, by contrast, and with the importance of ‘task sharing’ in abortion care 74 appropriately recognised, the 2020 regulations stipulate that it is registered medical professionals that can provide or supervise abortion. 75 This term was deliberately adopted to be inclusive of registered nurses and midwives 76 deemed qualified to prescribe any prescription-only medications, but equally to be exclusive of other groups of persons who might be deemed qualified to prescribe in other contexts. The explanatory memorandum explains that ‘registered medical professional’ was adopted because ‘other terms can include a wider group of practitioners or healthcare professionals, for example, psychologists or pharmacists’. 77 EMA is still, though to a lesser degree than in Great Britain, distinguished from other medications. In addition to the AA 1967’s requirements that EMA prescriptions are provided on particular grounds and by doctors, the Act also has traditionally placed limitations on where EMA can be administered following prescription. These laws were (temporarily) amended in Great Britain in 2020 in response to the COVID-19 pandemic, 78 and at the time of writing/revising we await news about whether these changes will be made permanent following public consultations undertaken in late 2020/early 2021. 79 Changes to relax restrictions on where EMA can be administered were not introduced in Northern Ireland at this time. The AA 1967 affords relevant government ministers in Great Britain the power to specify where EMA can be administered. 80 Further, within the power to approve a place for the purposes of the performing of abortion (including EMA administration) ministers have the authority to specify how the use of medicines is carried out. 81 Not only can relevant government ministers determine where EMA may be appropriately administered—they can also provide detailed conditions about how and when the medications would have to be administered for that place to be suitable. That the power extends to dictating the circumstances of administration has been affirmed by the Scottish Court of Session 82 and the Court of Appeal. 83 Where the medications are not prescribed or administered in a way compliant with the given conditions this would be a commission of a criminal offence under the OAPA 1861—on the part of both the pregnant person and the prescribing doctor. 84 Similar provision is made in the Northern Ireland regulations, which specify that the Department of Health may approve a place for abortion including, in relation to EMA, ‘the use of such medicines as may be specified in the approval’ such that the administration of EMA in that place would be lawful only where carried out in the manner specified. 85 A doctor who prescribed medication in a manner not compliant with the given conditions (and a non-emergency) would be guilty of a criminal offence under the regulations. 86 These powers, in Great Britain and Northern Ireland, afford politicians considerable power to interfere with the clinical discretion of doctors because they can dictate, using approval orders, the exact circumstances of how a prescription is, for example, issued and dispensed, and the instructions for administration. That interference is enforced with potential criminal sanction. In December 2018, Matt Hancock, Secretary of State for Health and Social Care, issued an approval order declaring that, ‘the home of a pregnant woman who is undergoing treatment for the purposes of termination of her pregnancy is approved as a class of place where the second stage of treatment for termination of pregnancy may be carried out where the treatment is carried out in a manner specified [in England]’. 87 Termination was described as lawful where; ‘the pregnant woman has attended a clinic where she has been prescribed Mifepristone and Misoprostol to be taken for the purposes of termination of her pregnancy; and the pregnant woman has taken the Mifepristone at the clinic, wants to carry out the second stage of treatment at home and the gestation of the pregnancy has not exceeded nine weeks and six days at the time the Mifepristone is taken’. 88 This approval order sets out exactly the same procedure for prescription as the approval order issued by Scottish Minister for Public Health, Aileen Campbell, a year earlier, 89 and by Welsh Minister for Health and Social Services, Vaughan Gething, in June 2018. 90 The effect of all these declarations was that it became lawful for a person to self-administer misoprostol at home, however it remained unlawful to take mifepristone at home. It also was unlawful for a practitioner to prescribe both abortion medications anywhere except a hospital or clinic. The order specified in explicit terms that the clinic is where the person is prescribed EMA (here meaning the production and signing of the written document confirming the appropriateness of the medications and dispensing instructions). In a challenge to the Scottish approval order raised by the Society for the Protection for Unborn Children, 91 Lady Wise summarised the four conditions necessary for ‘at home’ administration of misoprostol to be lawful: ‘First, that she is ordinarily resident at the home in question, Secondly, that she wants to carry out the stage of the treatment that involves the taking of Misoprostol at that ordinary residence, Thirdly, that she does so having been prescribed both Mifepristone and Misoprostol at a clinic, and Fourthly, that she has taken the Mifepristone at that clinic’. There was, in these approval orders, no requirement that consultation take place in a clinic. NICE guidelines have for some time recommend in their Abortion Care guidance that doctors ‘consider providing abortion assessments by phone or video-call for women who prefer this’. 92 This remote consultation would be lawful only to advise a person about their options for accessing treatment or to provide a referral to an approved place to access treatment. Thus, it was lawful for doctors to make determinations about access to treatment via phone, online, or video-link, but they could not lawfully prescribe (meaning generate the dispensing instructions for the medications and sign it) in this interaction. In Northern Ireland, the 2020 regulations set out lawful grounds for home use of mifepristone. A pregnant person can administer misoprostol in their home (their permanent address/where they usually reside in Northern Ireland) 93 where they have attended a hospital or clinic ‘where she has been prescribed mifepristone and misoprostol to be taken for the purposes of terminating the pregnancy’; has taken mifepristone in that place and their pregnancy has not exceeded 10 weeks. 94 Before abortion was partially decriminalised in Northern Ireland in 2019, 95 law enforcement adopted a punitive approach in responding to individuals who procured abortifacients from unlawful online sources (such as Women on Web). 96 There is now no criminal sanction in Northern Ireland for pregnant people who obtain abortifacients through informal (unlawful) channels; 97 however, a medical practitioner who prescribes medications in a manner non-compliant with the conditions/process outlined in regulation would be guilty of a criminal offence. 98 In response to the COVID-19 pandemic making access to abortion clinics more difficult, 99 and considerable campaigning by public health and reproductive health specialists, approval orders were issued in late March 2020 across Great Britain to allow home administration of both abortion medications. The first order was issued on 30 March 2020 in England, which stipulated that, until such time that the Coronavirus Act 2020 ceases to apply or until 30 March 2022 (whichever is sooner), both mifepristone and misoprostol could be administered at home under the following conditions: The pregnant person must have had a consultation with an approved place via video-link, telephone conference, or other electronic means, or had a consultation with a registered medical practitioner by electronic means; and They must have been prescribed both drugs for the purposes of abortion; and They must not be more than nine weeks at six days pregnant at the point medications would be administered; and They must administer the medications in the place in England where they are ordinarily resident. 100 The significant changes are that prescription need not take place in a particular place (so the dispensing instructions can be issued and signed without the pregnant person needing to be in the clinic at the time this is produced), and that both medications can be administered in the pregnant person’s home. An approval order that mirrors this was issued in Wales the following day (31 March 2020) with the same conditions for pregnant people administering medications at home (the place they are ordinarily resident in Wales) and with the same sunset clause (expiration with the repeal of the Coronavirus Act 2020 or 31 March 2020—whichever is sooner). 101 Similar changes were made in Scotland on 31 March 2020 102 with some notable differences from those issued in England and Wales. First, there is no expiration date on the approval order, although the explanatory note from the Chief Medical Officer does indicate that it will be revoked in future. 103 Second, the approval order does not specify a gestational limit for home use of both medications, but the explanatory guidance suggests a maximum of 11 weeks and six days. Far more clinical discretion is afforded here. 104 Finally, the Scottish order specifies that consultation must be by telephone or video-link (without the caveat of ‘or any other electronic means’ like in England and Wales). 105 EMA prescribed in these conditions must also be administered at the address in Scotland where the person is ordinarily resident. 106 Notably, in all three jurisdictions the home remains restrictively defined, 107 which can result in access issues for people who do not have permanent homes, for example, people in temporary shelters or foster care. 108 In Northern Ireland, in contrast, no change has been made to allow home use of mifepristone (despite the Northern Irish Department of Health having the power to do so). 109 People in Northern Ireland must still attend a clinic to be prescribed EMA and be supervised self-administering mifepristone. 110 Since there have been public consultations in Great Britain about these changes to the law, organisations providing abortion care hope that the changes might become permanent. Northern Ireland ought to follow suit, as the failure of the Northern Irish Department of Health to act has resulted in substantial inequality in access to care between Northern Ireland and the rest of the UK—it is far more difficult for people in Northern Ireland living in rural areas, who are socio-economically disadvantaged or are otherwise vulnerable, to access care compared to counterparts in Great Britain. However, with the track record of Stormont and the position of the current Health Minister, Robin Swann, this is unlikely to happen in the near future. Parliament recognises that some medications should be prescription-only (as opposed to being ‘over-the-counter’) as a means of limiting access to those circumstances in which their use is safe and clinically advisable. 111 They have delegated the decision-making power to doctors. They do not regulate beyond specifying that some medications must be prescribed, because it is a matter of clinical discretion when a medication is clinically indicated and safe. We have described the detailed conditions in the regulations regarding where prescriptions can be issued and the circumstances in which doctors (and nurses/midwives in Northern Ireland) can direct the administration of EMA. Such regulations are not made in respect of other prescription-only medicines that are not additionally recognised as controlled substances per the Misuse of Drugs Regulations 2011.

EMA entails the use of mifepristone and misoprostol. Mifepristone is an antiprogestogen, meaning it inhibits the hormone progesterone—causing the breakdown of the lining of the uterus and preventing the continuation of the pregnancy. Misoprostol 28 —is a prostaglandin analogue, which causes the expulsion of the products of conception by triggering uterine contractions (not dissimilar to what occurs during spontaneous miscarriage in early pregnancy). It is possible to procure a medical abortion using only misoprostol and this is safe and effective, 29 though it is more common to use the combination treatment because it is quicker and has fewer side effects. The procedure is straightforward and routinely used worldwide. Mifepristone is ordinarily taken orally, but misoprostol can be administered orally, vaginally, buccally, or sublingually. While providers have preferences regarding routes of administration—often based on the latest available evidence of safety and effectiveness 30 —it is possible to offer a choice. Ideally, the two drugs are taken between 24 and 48 hours apart. They can safely be taken in quick succession, 31 but evidence suggests that doing so increases the likelihood of side effects. 32 EMA is widely accepted as safe, effective, and acceptable, and the WHO strongly recommends its use up to 9 weeks’ gestation. 33 Indeed, the WHO has placed misoprostol in its Model List of Essential Medicines. 34 Several systematic reviews clearly establish the credentials of EMA. Raymond and colleagues found that hospitalisation occurred in just 0.3% of cases, with rates of ongoing pregnancy ranging from 0% to just 3.7% (depending on dose and route of administration). 35 More recent evidence has corroborated these findings, 36 demonstrating that concerns about the safety and effectiveness of EMA are unfounded. While safe and effective, it must be acknowledged that EMA does come with a range of potential side effects. Some are drug related (e.g., diarrhoea, rash, and fever), and others result from the abortion process itself (e.g., lower abdominal pain). As with most drugs, side effects vary between patients. Chen and Creinin’s systematic review (which looked specifically at regimens including buccal administration of misoprostol), for example, found that between 1.9% and 61.2% of patients experiences diarrhoea across studies 37 —a significant difference. Importantly, these side effects are easily self-managed at home, with the use of over-the-counter painkillers in some circumstances. Further, in the context of patient-centred care and appropriate informed consent (which we discuss later) even a high prevalence of side effects is not cause for concern—provided patients are made aware of the risks, they should be free to accept them where the treatment aligns with their values and preferences. High satisfaction levels in patients undergoing EMA have consistently been reported. One systematic review found satisfaction to range from 72% to 99%—incidentally, satisfaction was higher among those who were able to undergo the treatment at home rather than in a clinic. 38 Acceptability has also been demonstrated across qualitative studies. One participant in a study on the Thailand-Burma border (a misoprostol-only regimen) remarked that it was ‘just like having a period with back pain’. 39 Patients often comment on privacy and convenience as positive aspects of the overall treatment process including that the ability to complete the procedure at home was ‘relieving’ because it is an environment in which they feel ‘safe and comfortable’. 40 As EMA is a demonstrably safe and effective drug treatment with easily managed side effects, it is clearly clinically unnecessary and inappropriate to treat these drugs differently from other prescription medicines. Excessive interference instead embodies political concerns about abortion itself as opposed to the safety of the procedure.