Select Committee on Science and Technology Twelfth Report


4  Access and procedure

83. There is wide agreement that, if society is to accept that legal abortions take place, it is preferable that these be carried out earlier rather than later in terms of gestational ages.[95] In this chapter we discussed ways of improving access to abortion services, particularly in the first trimester.

Requirement for two doctors' signatures

84. The Abortion Act 1967 requires that an abortion under ground A to E is certified by two doctors, who must each sign a Department of Health HSA 1 form to give notification that the abortion has been approved and on what grounds, and an HSA 4 form for information including patient details, the method of abortion and gestation time.

85. A range of explanations have been given for the introduction of the requirement for two doctors' signatures:

  • to ensure that the provisions in the legislation were being observed ;[96]
  • to protect women;[97]
  • to protect doctors from breaking the law ;[98]
  • to demonstrate the medico-legal concerns of Parliament, namely that the 1967 Act did not make abortion legal but conferred upon doctors a defence against illegality—the two doctors are expected to police each other; [99]
  • to show the seriousness of the decision to terminate; [100] and
  • to appease the pro-life lobby. [101]

86. The Department of Health has ruled that both doctors are able to sign the HSA forms without seeing the patient, so long as they believe, in good faith, that the woman meets the legal grounds for abortion on the basis of the clinical notes. [102] We have heard that the process of certifying abortions has become, in the words of the Christian Medical Fellowship, a "sham".[103] Dr Vincent Argent says that that the HSA1 form "is often considered to be just an administrative process where doctors make no attempt to form an opinion, in good faith, that the patient fulfils the grounds [for an abortion]".[104] He further claims to have witnessed HSA1 signing practices that include:

  • "Signing batches of forms before patients are even seen for consultation;
  • Signing the forms with no knowledge of the particular patient and without reading the notes;
  • Signing forms without seeing or examining the patients;
  • Signing forms after the abortion has been performed;
  • Faxing the forms to other locations for signature;
  • Use of signature stamps without consultation with the doctor."[105]

87. If requests for abortions are being 'rubber stamped' by doctors, either the requirement for two signatures does not play a meaningful role in abortion practice or the law is not being properly applied.

ARGUMENTS IN FAVOUR OF REMOVING THE REQUIREMENT

88. There is widespread concern that the requirement for two signatures delays access to abortion services.[106] Submissions from the medical profession highlighted the issue of two signatures as a barrier to abortion services: the British Medical Association (BMA),[107] the Royal College of Nursing (RCN),[108] the RCOG,[109] and service providers.[110] An additional factor to consider in this context is the role that conscientious objectors may play in delaying access and we return to this matter below.

89. According to the RCN, there is no other medical or surgical procedure that requires the signature of two doctors before it is carried out.[111] Further, Professor Sally Sheldon points out that the requirement for two doctors' signatures runs contrary to the concept of patient autonomy.[112] Her submission noted that judges have said that:

[A] medical practitioner must comply with clear instructions given by an adult of sound mind as to the treatment to be given or not given […] whether those instructions are rational or irrational.[113]

90. She also noted that pregnant women are not an exception: the Court of Appeal said that:

[P]regnancy […] does not diminish (a woman's) entitlement to decide whether or not to undergo medical treatment […] Her right is not reduced or diminished merely because her decision to exercise it may appear morally repugnant.[114]

91. We received evidence that the two signature requirement is an artefact of the legal basis of the Abortion Act 1967. Dr Peter Saunders, who spoke to us as a representative of the Alive & Kicking alliance, summed it up:

I think we have to understand this in its historical context. Abortion is quite unique because under the Offences Against the Person Act abortion is still illegal in this country, which means that if you commit an illegal abortion you can go to prison for 14 years. The reason there are two doctors in the Act has nothing to do with medicine or safety but everything to do with legality.[115]

92. Anne Weyman, from fpa, added:

There is absolutely no reason why we should have the two doctors' signatures, for medical or scientific reasons. It does seem rather odd that in 2007 we are still bound by an Act that was passed in 1861, the Offences Against the Person Act.[116]

93. We received submissions arguing that the need for two doctors signatures was superfluous since one of the grounds (C) was always met, at least in the first trimester. Most abortions in the UK take place under ground C: that "the pregnancy has not exceeded its twenty-fourth week and the continuance of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman".

94. Many submissions noted that the earlier an abortion is carried out, the safer it is, and that legal abortions carry lower risks than continued pregnancies. RCOG notes that:

This means that women in the first trimester could be seen as automatically fulfilling the criteria of the Abortion Act. Although this was not the original intention of the Act, in practice it facilitates access to induced abortion within the current law.[117]

95. There were dissenters to this view, but we found strong evidence that ground C is always met for first trimester abortions.

ARGUMENTS IN FAVOUR OF RETAINING THE REQUIREMENT

96. Abortion is not like other kinds of procedures. The Society for the Protection of Unborn Children (SPUC) points out that abortions are typically performed on healthy women and foetuses, and Rev Dr Peter Fleming, from SPUC, told us that:

This is a particular kind of procedure. You are talking about a medical procedure often being prescribed for a social reason or a psychiatric reason and that is highly unusual in medicine. Usually a medical procedure is done for a medical reason. This is not being done for a medical reason and in that case, if the professed reason initially is a psychiatric indication you would think that somebody who has psychiatric expertise would be able to do it.[118]

OUR CONCLUSIONS

97. We questioned the Government on the requirement for two doctor's signatures, since we have received evidence that the requirement is causing delays. If these claims are accurate, the requirement runs contrary to the Government's pursuance of its policy to increase the ratio of early to late abortions.[119] The Minister told us that the high percentage (89%) of abortions that take place in the first trimester is an indicator that "there is not a problem".[120] We recognise, however, that this does not cast any light on the question since improvements in the proportion of abortions taking place earlier may be despite these delays, rather than evidence that they do not exist. The Government is some way from meeting its aim of all PCTs carrying out a majority of abortions by 9 weeks and eventually 70% by 9 weeks.[121]

98. The RCOG have said that there are situations where a second opinion might be appropriate, for example, in complex cases like late foetal abnormality, the very young and those with learning disabilities.[122] We recognise that this is good clinical practice, involving a formal consultation between the doctors and is a separate matter from the requirement for two doctors' signatures on a form.

99. We were not presented with any good evidence that, at least in the first trimester, the requirement for two doctors' signatures serves to safeguard women or doctors in any meaningful way, or serves any other useful purpose. We are concerned that the requirement for two signatures may be causing delays in access to abortion services. If a goal of public policy is to encourage early as opposed to later abortion, we believe there is a strong case for removing the requirement for two doctors' signatures. We would like see the requirement for two doctors' signatures removed.

100. Members of Parliament, when considering whether the requirement for two signatures safeguards the interests of women and doctors or any other purpose, are invited to consider our conclusions.

Other causes of delay

101. As we discussed above in paragraph 88, we heard evidence that an additional factor to consider in relation to potential delay in accessing services is the role that conscientious objectors may play in delaying access. The fpa points out that 18-24% of medical practitioners describe themselves as broadly anti-abortion and do not refer women.[123] Although this finding is in a non-peer reviewed report, it is supported by another publicly available report, Ingham et al (2007),[124], which we discussed in relation to late presentation for abortion, and by Brook's submission.[125] While this is not conclusive, it is indicative of a problem. However, we do not question that the right for conscientious objection in the medical profession should be protected.

102. We note that in the guidelines commissioned and promoted by the Department of Health, it is recommended that practitioners who conscientiously object should refer the patient as soon as possible to another doctor who does not conscientiously object:

Practitioners who are ethically opposed to abortion should follow relevant professional guidance (see Guidance on practice) for those with conscientious objection. Where such practitioners receive an abortion request, they should follow professional and contractual obligations to refer without delay to another practitioner who has no such objection or directly to an abortion service.[126]

Professional guidance is not as clear as this and we urge the General Medical Council, while preserving the right of doctors to conscientiously object and not to refer directly to another doctor for an abortion unless it is an emergency, to make clear that conscientious objectors should alert patients to the fact that they do not consult on abortions and that if the issue arises during a consultation that they have a duty immediately to refer the patient to another doctor for the consultation.

Involvement of nurses

103. Current legislation requires that an abortion must be conducted by a 'registered medical practitioner'. This means 'registered with the GMC', which means that only doctors can perform abortions in the UK. When the law was drafted, abortion was exclusively a surgical procedure, and so the role of nurses was relatively restricted. Today, however, there are two forms of abortion: surgical and medical, and the techniques in each vary by gestation.[127] Early medical abortions (up to ten weeks) are carried out by the administration of two sets of pills. DH figures indicate that 70% of abortions were performed surgically and 30% were early medical abortions in 2006.

104. In 1981, the House of Lords ruled that for medical abortion the practitioner is not required to perform personally each and every action needed for the treatment. Many abortion services rely on nurses to run their medical abortion units, but nurses are not permitted to sign the authorisation forms or prescribe the necessary medication; nor are they allowed to perform early surgical abortions. However, nurses are involved in every other aspect of the procedure and the RCOG notes that "Many hospital based abortion services already rely on nurses to run their medical abortion units".[128] Further, Kathy French from the RCN, told us that "There is a small group of nurses within abortion services who would like, with appropriate training […] to be able to do the very early medical abortions".[129]

ARGUMENTS IN FAVOUR OF INCREASING NURSES' RESPONSIBILITIES

105. A number of submissions argue that trained nurses and midwives should be able to carry out medical and surgical abortions with appropriate supervision.[130] There are three key arguments.

a)  Nurses and midwives perform a range of complicated procedures including colposcopies and hysteroscopies, and fitting sub-dermal implants.[131] Nurses also routinely fit contraceptive coils (IUD/IUS), which require about the same level of skill as manual vacuum aspiration, a method of early surgical abortion (offered from 4-12 weeks of gestation) which involves the removal of the contents of the uterus using a gentle hand-operated suction pump.[132]

b)  Nurses are already allowed to prescribe mifepristone for medical needs other than abortion. Mifepristone is listed in the British National Formulary (BNF) for Nurse Independent Prescribing (NIP).[133] Women who have experienced a spontaneous miscarriage self-administer misoprostol at home to ensure the safe expulsion of the miscarried pregnancy.[134]

c)  Nurses already carry out medical and sometimes surgical abortions in some US states and in South Africa with good safety profiles.[135] Further, research has been conducted to assess the safety of allowing nurses rather than doctors to perform abortions. For example, complication rates for surgical abortions performed by physician assistants were compared with complication rates for surgical abortions performed by physicians in Vermont and New Hampshire. For physician assistant performed abortions, the complication rate was 22.0 per 1000 compared to 23.3 per 1000 for physician performed abortions, which is not statistically different.[136] The involvement of nurses and midwives in other countries, including Sweden, Norway, France, Vietnam, Cambodia, Bangladesh and Mozambique, is outlined by Reproductive Health Matters's submission.[137]

106. Dr Vincent Argent has suggested that, since nurses in practice carry out the whole of early medical abortions including consultation, treatment and after-care, nurses should be able to sign HSA1.[138] We heard from Kathy French that:

In terms of early medical abortion, currently nurses provide all of the care for the women, apart from prescribing the medication needed. Many of our colleagues tell us that this is a great disadvantage to them, that they could actually speed up the process once that woman has decided that is her option.[139]

ARGUMENTS AGAINST INCREASING NURSES' RESPONSIBILITIES

107. The principal argument used against increasing the role that nurses and midwives play in abortion services is one of safety. The Christian Medical Fellowship has argued that nurses should not be permitted to perform abortions since "Medical abortion is not as safe as commonly assumed and it is not always effective".[140] Further, the BMA recently voted against a motion to increase the role of nurses. Dr Tony Calland, Chair of the BMA Medical Ethics Committee, told us:

I cannot quote you any evidence but the […] the debate at the conference on this issue was about patient safety. It was felt, maybe not surprisingly since we were all doctors there, that it would be safer if doctors [performed early medical abortions] rather than nurses.[141]

OUR CONCLUSIONS

108. We consider the matter of safety of medical abortions in more detail in chapter 5. However, we are satisfied that there is adequate evidence, particularly in terms of the roles that nurses already play in service provision and in terms of the international experience, to conclude the following:

109. We recommend that when Members of Parliament consider whether the statutory ban on anyone else than doctors carrying out abortion should remain, they consider the evidence and conclusions in this report.

Places where abortions can be carried out

110. Current legislation stipulates that, except in an emergency, an abortion must be conducted in an NHS hospital or a place approved by the Secretary of State. This means that most abortions take place in NHS gynaecology wards, NHS day care units and private clinics. In 2006, 39% of abortions were performed in NHS hospitals and 48% in approved independent sector places under NHS contract.[142]

111. When this legislation was put in place, abortion was a surgical procedure. That is why places were specified where abortions could be carried out. However, in the last 10 years, medical abortions have increased in frequency, the requirements of which, from a medical provisions point of view, are markedly different. It is common practice in other countries for the second stage of an early medical abortion to be completed at home. We have taken evidence on the safety, effectiveness and acceptability of carrying out the second stage of a medical abortion at home.

112. Medical abortions take place in two stages. First, a single dose of mifepristone is given orally, which blocks the pregnancy hormones so that the pregnancy ceases to be viable. Upto 48 hours later—and conventionally 24-48 hours later—a second drug, either misoprostol or gemeprost, is then administered vaginally or is swallowed. It causes the uterus to contract and to expel the pregnancy much like a miscarriage. Women are now offered the option of going straight home after taking the second pill, which most do, in order to make themselves comfortable before this process starts. In the UK misoprostol is treated as an abortifacient, and therefore women must visit a clinic to obtain the second pill. In the USA, the second stage of a medical abortion is frequently self-administered by the woman in her own home.[143] The practice of administering the second drug in medical abortions at home would probably require legislative change, according to the Department of Health, citing legal advice.[144]

113. The Department was granted the power by Parliament to define 'class of place' in 1990, with a view to (at some point) enabling a woman's home to be considered appropriate for the administration of the second stage of medical abortion. The Department confirmed that if these regulations were issued, then it would be possible to enable women to have the option of taking the second stage of EMA at home.[145]

114. The Department of Health has told us that it is currently funding two hospital trials into early medical abortion services in non-traditional settings. One site is within a community hospital; the other is in a stand-alone unit within an acute hospital. A formal evaluation is underway to assess the safety, effectiveness and patient acceptability of this service.[146] However, on questioning the Minister, these trials appear to be so "cautious"[147] as to add little to the current body of evidence. They do not test home administration of the second stage of EMA, and it is hard to fathom precisely what different practice they are seeking to evaluate.

ARGUMENTS TO ALLOW THE SECOND PILL TO BE TAKEN AT HOME

115. A pilot study has already been undertaken to assess the safety, effectiveness and acceptability of completing the second stage of a medical abortion at home in the UK. However, further study has not been possible because DH indicated this was not lawful, without legislative change.[148]

116. Outside the UK, research has shown that self-administration of misoprostol at home is safe, effective and acceptable.[149] For example, in America where misoprostol is routinely self-administered at home, the estimated case-fatality rate for medical abortion is 0.8 deaths per 100,000 procedures, which is statistically indistinguishable from the risk of death from miscarriage, 0.7 per 100,000 miscarriages; in 1997, the pregnancy related mortality ratio in America was 12.9 deaths per 100,000 live births.[150] From a legal perspective, it is worth noting that in Norway, which has a law similar to the UK, only the mifepristone must be taken in a clinic, as this is regarded as the abortifacient. Misoprostol is viewed as a supporting medication, because it is taken to enable the safe and prompt expulsion of the products of conception.[151] It is noteworthy that in the UK misoprostol is prescribed for home-self-administration to women who have experienced a spontaneous miscarriage to ensure the safe expulsion of the miscarried pregnancy.[152]

ARGUMENTS AGAINST ALLOWING THE SECOND PILL TO BE TAKEN AT HOME

117. The concerns regarding home-self-administration are based around the safety of medical abortions. Dr Chris Richards and Dr Mark Houghton argue that relatively minor complications such as abdominal pain and nausea occur in the majority of women after taking mifepristone; vaginal bleeding usually continues for between 9-16 days, but sometimes much longer; and 5-8% of women require surgical intervention following medical termination.[153] Further, they argue that medical abortions have ten times the mortality of surgical abortion: there have been five deaths in North America following medical abortion using mifepristone, from infection, in most cases, with Clostridium sordellii.[154]

OUR CONCLUSION

118. The RCOG (echoed by Dr Vincent Argent) has recommended that a trial needs to be done to assess the safety, effectiveness and acceptability of self-administration of misoprostol at home, although no reason is given as to what concerns there are that a practice commonplace abroad, without problems with safety, efficacy and acceptability, requires trials here. [155]

119. Dr Argent further pointed out that:

For patient safety there needs to be a comprehensive advice service and back-up service with access to clinics that can see the patient fairly soon. That would mean having access at night and during the weekends.[156]

Such a service is already in place for those providers who allow women the choice of going home to complete the termination, but it may not yet be in place in more traditional settings.

120. We were impressed by the evidence that there are no particular safety concerns about early medical abortions on three grounds. First, the studies that have assessed the safety of medical abortions have been conducted so as to compare the relative safety of procedures with letting a pregnancy continue to term. The fact that medical abortions also cause unpleasant symptoms is not a reason for restricting the administration of misoprostol to a clinic; especially when the majority of women choose to go home after taking misoprostol, presumably because they want to be as comfortable as possible when these symptoms manifest. Second, the reported mortalities associated with medical abortions are "rarer than anaphylaxis after being given a shot of penicillin".[157] Thirdly, women already take misoprostol at home to complete natural miscarriages with no apparent safety concerns.

121. The RCOG guidelines, which have been peer-reviewed, state:

41 "For early medical abortion a dose of 200 mg of mifepristone in combination with a prostaglandin is appropriate", with an evidence base of class A[158]; and

43. "Based on available evidence, the following regimen appears to be optimal for early medical abortion up to 9 weeks (63 days) of gestation. This advice is based on considerations of efficacy, adverse-effect profile and cost:", with an evidence base of class B[159].

122. The Minister admitted to us in oral evidence that the slow progress in the Secretary of State specifying a class of place to include a woman's home for the purpose of the administration of the second stage of an EMA—over 16 years since the 1990 Act allowed this—was not due to concerns over safety, effectiveness or acceptability .[160]

123. We conclude that, subject to providers putting in place the appropriate follow up arrangements, there is no evidence relating to safety, effectiveness or patient acceptability that should serve to deter Parliament passing regulations which would enable women who chose to do so taking the second stage of early medical abortion at home, or that should deter Parliament from amending the act to exclude the second stage of early medical abortion from the definition of "carrying out a termination". This would enable a trial to take place.

124. We invite Members of Parliament to consider our conclusions when considering the question of whether the 1967 Act should be amended or regulations passed to enable the second stage of early medical abortion to be self-administered in a woman's home.


95   Q 319-20; SDA 1 para 39; SDA 13 para 11 Back

96   SDA 1 para 35 Back

97   SDA 07 para 9.1 Back

98   SDA 14 para 2.2.8 Back

99   SDA 35 para 19 Back

100   SDA 19 section 2(b)(1); SDA 30 para 2.2.1 Back

101   SDA 6 section 2(b) Back

102   SDA 48 para 2.2 Back

103   SDA 35 para 20 Back

104   SDA 23 para 2.4 Back

105   SDA 23 para 2.4 Back

106   SDA 10 para vi; SDA 14 para 2.2.7; SDA 18 para 3.2.4; SDA 19 section 2(b)(2); SDA 30 para 2.2.2; SDA 33 para 3.1; SDA 45 section 2(b); SDA 46 section 2(b); SDA 48 para 2.1 Back

107   SDA 13, para 11 Back

108   SDA 18 para 3.2.1-3.2.6 Back

109   SDA 30 para 2.2.2 Back

110   SDA 48 para 2; SDA 33 para 3; SDA 43 section 2 Back

111   SDA 14 para 2.2.7; SDA 18 3.2.5; SDA 45 section 2(b) Back

112   SDA 05 para 2.7 Back

113   Thomas Bingham M.R., Airedale N.H.S. Trust v Bland [1993] AC 789 at 808. Back

114   George's Healthcare N.H.S. Trust, v S [1998] 3 WLR 936 at 957 Back

115   Q 300 Back

116   Q 301 [Ms Weyman] Back

117   SDA 30, para 2.1.1 Back

118   Q 300 [Rev Dr Fleming] Back

119   SDA 01 para 39 Back

120   Q 322 Back

121   Ref: http://www.medfash.org.uk/publications/documents/Recommended_standards_for_sexual_health_services.pdf for standards and http://www.healthcarecommission.org.uk/healthcareproviders/nationalfindings/nationalthemedreports/sexualhealth/improvingsexualhealthservices.cfm for 2005/6 performance. Back

122   SDA 30 Back

123   SDA 10 para 2.10 cite General Practitioners: attitudes to abortion, Marie Stopes International, London 1999 Back

124   Ingham, R, E Lee, S Clements & N Stone, Second Trimester Abortions in England and Wales, April 2007 Back

125   SDA 33 para 3.1 Back

126   http://www.medfash.org.uk/publications/documents/recommended_standards_for sex health services.pdf Back

127   http://www.bpas.org/abortions/options.html Back

128   SDA 30 para 2.3.1 Back

129   Q 191 Back

130   SDA 18 para 1.2; SDA 19 section 2(c); SDA 23 para 1.2; SDA 30 para 2.3.1 Back

131   SDA 18 para 3.4.1 Back

132   SDA 48 para 3.3 Back

133   SDA 18 para 3.5.1 Back

134   SDA 48 para 4.4 Back

135   SDA 10 para 2.15; SDA 19 section 2 (c); SDA 23 para 1.2 Back

136   Goldman MB, JS Occhiuto, LE Peterson, JG Zapka, & RH Palmer, "Physician assistants as providers of surgically induced abortion services", American Journal of Public Health, vol 94, no 8 (2004) pp 1352-1357; quoted in SDA 10 para 2.15 Back

137   SDA 25 Back

138   SDA 23 para 2.6 Back

139   Q 187 Back

140   SDA 35 para 22 Back

141   Q201 Back

142   Statistical Bulletin: Abortion Statistics, England & Wales: 2006 Department of Health 2007 Back

143   SDA 10 para 2.18 Back

144   SDA 30 para 2.3.3; Q 360-361; SDA 01A, Annex C Back

145   SDA 01A Annex C Back

146   SDA 01 para 16 Back

147   Q 356-63 Back

148   Q 359, in reference to Hamoda H, P Ashok, G Flett & A Templeton, "Home self-administration of misoprostol for medical abortion up to 56 days' gestation", Journal of Family Planning and Reproductive Health Care, vol 31 no 3 (2005) pp 189-192 Back

149   SDA 10 para 2.2; SDA 19 section 2(c); SDA 48 para 4.3 Back

150   SDA 10 para 2.2 cites Grimes D, "Risks of mifepristone abortion in context", Contraception, vol 71 no 3 (2005) p 161 and Grimes D, "Estimation of pregnancy-related mortality risk by pregnancy outcome, United States, 1991 to 1999", American Journal of Obstetrics and Gynecology, vol 194 no 1 (2006) pp 92-94 Back

151   SDA 48 para 4.2 Back

152   SDA 48 para 4.4 Back

153   SDA 24 para 6.4.2 Back

154   SDA 24 para 6.4.3; Professor Allan Templeton, special adviser to the Committee, informs us that the number of deaths in North America is now six. Back

155   SDA 30 para 2.3.3; Q 235 Back

156   Q 225 Back

157   Q 156 [Dr Rowlands] Back

158   See Glossary for definition Back

159   See Glossary for definition Back

160  Q 363  Back


 
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