50. Miss P complains that the ICB will not fund a sterilisation for her or other women like her. Miss P was unable to have an NHS-funded sterilisation because the policy statement in place when she first complained (the 2021 Female Sterilisation Policy Statement, issued by Oxfordshire CCG) states that: ‘Due to associated levels of regret and the availability of more cost effective methods of contraception, female sterilisation is not normally funded’.
51. Miss P is still unable to have an NHS-funded sterilisation. The current ICB policy position on female sterilisation (the 2024 Female Sterilisation Policy Statement) is the same as the 2021 Female Sterilisation Policy Statement. In May 2023, the ICB also declined an individual funding request application from Miss P’s GP for Miss P to have an NHS-funded sterilisation on the grounds that it did not consider it demonstrated sufficient evidence of exceptionality.
52. Miss P is not complaining about the ICB’s decision about her individual funding request application, and that is not something this investigation has looked at. Miss P’s complaint is about the content of the 2021 Female Sterilisation Policy Statement that applied at the time (unchanged in the 2024 Female Sterilisation Policy Statement). Miss P complains that the ICB’s policy position: • is not in keeping with relevant guidelines • is not supported by the evidence considered during the decision-making process
• is not based on appropriate research and consultation • is creating health inequalities for women.
53. By law, the ICB is responsible for commissioning certain local NHS health services, including female sterilisation. The ICB decides how those services are funded and sets the eligibility criteria determining access to those services. It is not our role to challenge the ICB’s discretion or to replace its decision-making with our own. Our role is to investigate whether there are any failings (what we call maladministration) in the decision-making process.
54. If, as a result of an investigation by us, we find there are failings and we consider those failings to be serious enough to have led to an adverse impact to those affected (what we call an injustice), we usually make recommendations to try to ‘put things right’. Our recommendations may include asking an organisation to re-take its decision without failings.
55. We have looked at whether the ICB followed an appropriate process, took relevant evidence into account, and reached balanced, fair and evidence-based decisions in determining its policy position on female sterilisation (set out in the 2021 Female Sterilisation Policy Statement).
56. Prior to July 2022, the Committee made evidence-based policy recommendations about commissioning to the local CCGs. However, the CCGs remained responsible for setting the commissioning policy statements that determined what services were or were not funded and who was eligible. ICBs took over those commissioning responsibilities from the CCGs from July 2022. The ICB is therefore accountable for any CCG policy statement that it decided to adopt and implement, including the 2021 Female Sterilisation Policy Statement.
57. The 2021 Female Sterilisation Policy Statement is based on the Committee’s policy recommendation of July 2017 to not fund female sterilisation. The Committee made no changes to that policy recommendation after 2017. The evidence upon which the 2021 Female Sterilisation Policy Statement was based (and upon which the 2024 Female Sterilisation Policy Statement continues to be based) is therefore that which was presented to and considered by the Committee in July 2017.
Relevant guidelines
58. Miss P complains that the ICB’s decision to not fund female sterilisation is not in line with a ruling by the Supreme Court and advice from the United Nations on bodily autonomy in respect of treatment, academic research, or guidelines in place when the 2021 Female Sterilisation Policy Statement was published, including: • the pledge in the NHS Constitution to promote equality
• guidance on a patient’s right to make an informed decision about treatment: GMC, ‘Decision making and consent’, November 2020 (the GMC guidance) • guidance approving sterilisation as a permanent method of contraception: the National Institute for Health and Care Excellence (NICE), ‘Clinical Knowledge Summary: Contraception – sterilization’, May 2021 (the NICE guidance) • guidance saying women should not be pressured into choosing LARCs over sterilisation: ‘FSRH Guidelines – Contraception After Pregnancy’, January 2017, amended October 2020 (the First FSRH guidance).
59. The ICB told us that, as well as being a principle of human rights, autonomy is one of the four pillars of medical ethics, alongside beneficence (doing good), non-maleficence (not doing harm) and justice. It said that a commissioner’s duties in relation to a person’s autonomy must be managed alongside its duties to have commissioning policies that oversee the fair use of resources for the population in the local geographical area.
60. The ICB also told us that - with the exception of mandatory NICE technology appraisals - commissioners are not obligated to adhere to national clinical guidance. However, it said that they must take relevant national clinical guidance into account in their decision-making, and must provide clear explanations if they decide not to follow that guidance.
61. Our Principles state that, to ‘get it right’ in their decision-making, public organisations should have regard to the relevant legislation. Decision-making should take account of all relevant considerations, ignore irrelevant ones and balance the evidence appropriately. Organisations should also record the reasons why they have decided to depart from their own guidance, recognised quality standards or established good practice.
62. The Public Sector Equality Duty, set out in the Equality Act 2010, requires public organisations to give due regard in their decision-making to the impact on those who share particular protected characteristics. The NHS Constitution sets out the principles and values of the NHS in England, including the rights of patients, public and staff. One of the key principles is that the NHS ‘provides a comprehensive service, available to all’, promoting ‘equality through the services it provides’. Another is that the NHS provides the ‘best value for money’, making the ‘most effective, fair and sustainable use of finite resources’.
63. The Committee’s Ethical Framework states that its purpose was to ensure ‘that the principles and legal requirements of the NHS Constitution, the Public Sector Equality Duty and the requirement to involve the public when making significant changes to the provision of NHS healthcare [were] adhered to. It also states that the former CCGs were ‘… subject to a statutory duty not to exceed their annual financial allocation’ and had to ‘compare the cost of the treatment to its overall benefit, both to the individual and the community’.
64. The Committee’s Standard Operating Process states that, among other things, a review of a particular treatment would take into account the topic, background, national policy, clinical effectiveness, cost-effectiveness, safety, impact of current and potential activity, implementation issues and an equality analysis.
65. In its response to Miss P’s complaint, the ICB told her that, in setting the female sterilisation policy recommendation, the Committee had carried out ‘a full assessment of national guidance, best practices, clinical evidence, effectiveness, cost-effectiveness, related local policies and other relevant legal and ethical considerations’.
66. Based on the evidence we have seen, the Committee took relevant guidelines into account, including (but not limited to) clinical guidance about female sterilisation published by: • the World Health Organisation (WHO), ‘Medical eligibility criteria for contraceptive use’, Fifth Edition, 2015 (the WHO guidance) • the Royal College of Obstetricians (RCOG), ‘Female Sterilisation – Consent Advice No.
3’, February 2016 (the RCOG guidance) • the 2016 version of the NICE guidance Miss P refers to in her complaint • the First FSRH guidance Miss P refers to in her complaint • the FSRH, ‘Faculty of Sexual & Reproductive Healthcare Clinical Guidance - Male and Female Sterilisation – Clinical Effectiveness Unit’, September 2014 (the Second FSRH guidance).
67. The Committee also took account of relevant clinical studies, research, existing local CCG policies, activity data and cost-effectiveness data when evaluating the benefits of funding female sterilisation.
68. We therefore consider the Committee had access to the information it needed to balance its duty under the Public Sector Equality Duty, the NHS Constitution, its Ethical Framework and its Standard Operating Process to make services accessible to all alongside its duty to ensure affordability.
69. Some of the data, academic research and standards to which Miss P refers (such as the advice from the United Nations) post-dates the Committee’s decision. And some of the other evidence to which she refers (including the ruling from the Supreme Court and the GMC guidance) is not mentioned in the policy papers or Committee minutes. It is therefore unlikely that the Committee directly took that information into account as part of its decision-making process. That said, the guidance that it did consider already touches upon relevant issues, such as about autonomy and informed decisions about treatment. So, we consider the Committee had sufficient evidence in July 2017 to reach an appropriate recommendation about next steps in relation to funding for female sterilisation.
70. In general, the 2021 Female Sterilisation Policy Statement that the ICB inherited from Oxfordshire CCG (based on the Committee’s policy recommendation) was therefore based upon the relevant evidence and guidance available.
71. We go on to consider whether the Committee appropriately balanced that evidence in agreeing the policy recommendation that determined the criteria set out in the 2021 Female Sterilisation Policy Statement. We also consider whether it gave due regard to the evidence, and clearly explained any departure from the relevant guidance.
Balance of evidence considered
Regret
72. Miss P complains about the criterion in the 2021 Female Sterilisation Policy Statement that says the ICB does not normally fund sterilisation because of the associated levels of regret among women. She told the ICB that she had the mental capacity to make conscious, calculated and informed choices about her own body, including a permanent decision not to have any biological children. Miss P said that - as an educated, qualified and professional woman - she is fully aware of the risks associated with sterilisation, and that any regrets about that decision are her concern alone.
73. Miss P said that by setting eligibility criteria based on regret the ICB was accepting responsibility for people’s feelings, which is not something it could limit or control as an individual can regret ‘anything and everything’. She asked, for example, whether the ICB had considered the instances of people who regretted having chosen to have children.
74. Miss P also told the ICB about a review from the US that had found 5.9% of women over 30 at the time of a tubal ligation reported regret within 14 years of being sterilised. She said that, in contrast, a different review from the US had found that within a group of women stopped from having a sterilisation, 47% regretted that they were not sterilised.
75. Our Principles state that:
• to ‘get it right’, organisations should have regard to relevant legislation and take account of all relevant considerations, ignore irrelevant ones and balance the evidence appropriately in their decision-making. They should record the reasons why they have decided to depart from their own guidance, recognised quality standards or established good practice • to ‘be open and accountable’, organisations should give reasons for their decisions • to ‘act fairly and proportionately’, organisations should treat people fairly and consistently, so that those in similar circumstances are dealt with in a similar way.
76. The Mental Capacity Act 2005 states that a person with capacity should not be treated as unable to make a decision merely because others consider it to be an unwise decision.
77. The July 2017 paper submitted for the Committee’s consideration into local female sterilisation policy statements notes that there is a substantive body of evidence surrounding instances of regret in women who have had a sterilisation and that (according to the RCOG guidance) regret is common. It points to clinical guidance published in the US (cited in the Second FSRH guidance) referring to levels of regret following a tubal occlusion ranging from 0.9% to 26%.
78. The July 2017 paper says that ‘Regret and remorse are subjective and difficult to quantify’. It notes that there are several risk factors that can increase the likelihood of regret in a person wanting to be sterilised, including: timing, age, the number of children a person has or wants, whether a person has lost a child, a person’s relationship status, whether they are being coerced by a clinician or partner, psychological issues, and/or the information a person receives about alternative forms of contraception. It also notes that risk of regret is higher in women who ask for a sterilisation at the same time as a caesarean section or a termination.
79. The September 2017 paper submitted for the Committee’s consideration into local male sterilisation policy statements notes that comparison between studies into regret is problematic because of differences in the timing and measurement of regret. It points to the risk factors set out in the July 2017 paper as useful predictors of regret. It also says ‘There is broad consensus in the literature that regret following sterilisation is experienced by a minority of individuals’.
80. The January 2021 paper submitted for the Committee’s review into the female and male policy recommendations cites no new evidence about regret. The November 2021 paper into the reconsideration of the female sterilisation policy states that instances of regret noted in research about women who have a sterilisation at the same time as a termination cannot be applied to women wanting a sterilisation after they give birth to a full-term baby. There is no record of what (if any) further discussions about regret took place when the additional work proposed at the November 2021 meeting was marked complete in March 2022.
81. The July 2017 minutes record that one of the reasons the Committee recommended that female sterilisation should not normally be funded is because of the ‘substantial’ levels of regret among women who had been sterilised. The Committee did not change that decision in response to any of the evidence it looked at in September 2017, January and November 2021 and March 2022.
82. The 2018, 2021 and 2024 Female Sterilisation Policy Statements say that female sterilisation is not funded, in part, due to ‘associated’ regret.
83. In developing its policy recommendation on female sterilisation, the Committee considered relevant evidence of levels of regret among women and men who have had a sterilisation. The conclusion it reached about there being substantial levels of regret among women does not show it balanced the evidence appropriately, however.
84. The July and September 2017 papers both recognise that levels of regret are subjective and difficult to measure and quantify. The Committee has not given a rationale for deciding to use such a subjective measure as the basis for a policy recommendation that needed to be applied objectively.
85. Aside from the issues with applying demographic data from the US to the UK, the 25% difference between the upper and lower range of the clinical data set out in the July 2017 paper shows there is marked variation in levels of regret after a tubal occlusion. The risk factors discussed with the Committee could account for that variation. They indicate that time, place and circumstance may play a key role in predicting whether certain groups of women are more likely to regret having a sterilisation than others. The Committee did not critically analyse that variation - even after the November 2021 paper highlighted that the risk of regret affecting one group of women (those who have a termination) cannot be read across to other groups of women (those who have had a full-term birth). Nor did it explore whether the likelihood of regret diminishes if the risk factor stops or if a woman is made aware of the risks.
86. While the July 2017 paper cited RCOG guidance which said regret is common, the September 2017 paper points to regret being experienced by only a minority of individuals. That evidence directly contradicts the conclusion the Committee reached in July 2017 about there being ‘substantial’ levels of regret. Yet, the Committee decided to share the draft policy recommendation on female sterilisation with CCGs after the September 2017 meeting without exploring what (if any) impact that new evidence had on it.
87. Additionally, the Committee did not give enough due regard to the issue of informed consent in its decision-making around regret. Specifically, it did not explain why funding for sterilisation should not be provided to women who - in accordance with the Mental Capacity Act - have the capacity to consent to that procedure, irrespective of whether others consider that to be an unwise decision or one they may regret.
88. In fact, the clinical guidance referred to in the July 2017 paper does not recommend against sterilisation because of the recognised risk of regret. Instead, the WHO guidance and the First and Second FSRH guidance recommend clinicians should appropriately counsel women and men asking to be sterilised about the procedure being a permanent and
potentially irreversible method of contraception and about the associated risk of regret (with particular attention paid to those most at risk). The WHO guidance also states that an individual’s full, un-coerced, voluntary and informed consent should be obtained before they are sterilised. The Committee has not explained why it decided to depart from this clinical guidance in deciding to recommend that female sterilisation should not be funded.
89. Moreover, the 2021 Female Sterilisation Policy Statement in place when Miss P complained to the ICB (based on the Committee’s 2017 policy recommendation) declines funding for female sterilisation because of associated regret. By comparison, the 2021 Male Sterilisation Policy Statement (based on the Committee’s 2014 policy recommendation on male sterilisation, as amended) states that men should be counselled about the risk of regret.
90. The September 2017 paper says that, compared to women, the evidence of levels of regret among men who have had a sterilisation is limited. It refers to there being only one study into men who had requested a reversal of the sterilisation procedure, which found 2% of men sterilised had had the procedure reversed over the following 10 years. The September 2017 Committee noted that that study (published in 1986) is likely to have preceded pre- sterilisation counselling having become more widespread.
91. The data in the 2017 September paper may not fully capture the extent of potential male regret. It does not follow that all men who regret a decision to be sterilised will ask for a reversal. Also, men may be disinclined to ask for a reversal because they know it is not a procedure routinely funded by the NHS.
92. In any event, the evidence available to the Committee shows that both women and men who have had a sterilisation may experience regret. The Committee did not handle those similar circumstances in a fair or consistent way. Instead, it made assumptions that the introduction of pre-sterilisation counselling may help mitigate the risk of regret among men without evidence to that effect. In contrast, the Committee took no steps to explore what (if any) impact comparable pre-sterilisation counselling may have on the risk of regret among women.
93. In summary, the Committee: • did not balance the evidence appropriately in concluding there to be evidence of substantial levels of regret in women who had been sterilised • applied a subjective, rather than objective criterion in framing the female sterilisation policy recommendation around levels of regret • did not give due regard to issues of consent (specifically, the Mental Capacity Act) in recommending female sterilisation should not be funded on the grounds of levels of regret
• did not explain the reasons for diverging from clinical guidance that indicates sterilisation should be a contraceptive option for women, and says that women asking for sterilisation should be counselled about the associated risk of regret • did not handle similar circumstances involving levels of regret about sterilisation among men and women in a fair or consistent way.
94. Given that the 2021 Female Sterilisation Policy Statement was based on the Committee policy statement on female sterilisation, the ICB: • failed to ‘get it right’ by adopting a policy statement where the evidence was not appropriately balanced, which did not give due regard to relevant legislation, and which did not explain the reasons why it departed from clinical guidance • failed to be ‘open and accountable’ because the reasons for the policy statement were not clearly recorded • failed to ‘act fairly and proportionately’ in adopting the Committee’s policy recommendation to not fund female sterilisation on the grounds of regret, while offering male sterilisations to men who have been appropriately counselled about regret.
95. The ICB has not put right these failings to date.
Cost-effectiveness
96. Miss P complains about the criterion in the 2021 Female Sterilisation Policy Statement that says the ICB does not normally fund sterilisation because there are other, more cost- effective methods of contraception available. She told the ICB that evidence in the July 2017 minutes points to female sterilisation actually being more cost-effective than other methods.
97. Miss P gave the ICB evidence of the long-term cost to the NHS of women continuing to take the contraceptive pill. She asked if the ICB had considered the personal, practical, emotional and psychological cost that hormonal contraceptives can have on women, including side effects of bleeding, thrush, bloating, weight gain, loss of libido, and being unable to take certain antibiotics. She also asked if the ICB had considered the additional costs to the NHS some of those impacts may have, such as the need for therapy.
98. Our Principles state that:
• to ‘get it right’, organisations should take account of all relevant considerations, ignore irrelevant ones and balance the evidence appropriately in their decision-making • to ‘act fairly and proportionately’, organisations should treat people fairly and consistently, so that those in similar circumstances are dealt with in a similar way.
99. The July 2017 paper refers to clinical guidance into the effectiveness of different forms of contraception (such as the WHO guidance, the First and Second FSRH guidance and the NICE guidance). It also refers to a 2008 study into the cost-effectiveness of LARC methods in the UK. It notes that this study found female sterilisation to be more cost-effective than LARCs after six years of use, if LARCs were not stopped.
100. The July and September 2017 papers both note that studies done between 1995 and 2004 had found female and male sterilisation to be more cost-effective than LARCs after 15 years of contraceptive use (based on 2004 NHS reference costs). The September 2017 paper notes that other studies from the US and Thailand suggest that ‘Female and male sterilisation were shown to be the most cost effective methods (highest level of effectiveness at lowest cost) in the long term’.
101. The January 2021 paper cites no new cost effectiveness data. The November 2021 paper includes more information about relative costs of sterilisation compared to other methods of contraception. The further work carried out after the November 2021 meeting looked more closely at the local cost data. However, there is no record of what (if any) discussions took place when that work was marked as complete at the March 2022 Committee.
102. The July 2017 minutes record that one of the reasons the Committee recommended that female sterilisation should not be funded was due to a lack of recent data and analyses on its cost-effectiveness, and because alternative non-invasive LARCs were available that were as or more effective. The Committee did not change that decision in response to any of the evidence it looked at in September 2017, January and November 2021, and March 2022.
103. The 2018, 2021 and 2024 Female Sterilisation Policy Statements say that female sterilisation is not funded, in part, due to ‘the availability of more cost effective methods of contraception’.
104. In developing its policy recommendation on female sterilisation, the Committee considered appropriate clinical guidance about the effectiveness of different methods of contraception and took account of relevant UK studies into the cost-effectiveness of those methods. Its conclusion that there are other types of contraception that may be as good or better at preventing pregnancy than female sterilisation is supported by the clinical evidence available in the WHO guidance (though, it is worth noting that – contrary to the July 2017 decision - those methods are all invasive). Given that the data available in July 2017 was from 2004 and 2008, the Committee’s conclusion that there was limited up-to-date evidence on the cost-effectiveness of female sterilisation is also evidence-based.
105. In balancing this evidence, the Committee did not demonstrate that alternative methods of contraception are more ‘cost effective’ than female sterilisation. In fact, the
July and September 2017 papers show female sterilisation may actually be a more cost- effective method of permanent contraception alone than other methods at either six or 15 years of use. While less applicable (because it relates to data from other countries), the September 2017 paper also points to sterilisation potentially providing the highest level of effectiveness at lowest cost. It is therefore illogical for the 2021 Female Sterilisation Policy Statement to have said there are more cost effective methods of contraception available as a reason for not funding female sterilisation, especially in light of the July 2017 Committee’s conclusion about there being limited recent data on the cost-effectiveness of female sterilisation.
106. The September 2017 paper also points to available data only taking into account the direct costs and potential failure costs of each contraceptive method, and not the indirect costs, societal costs of unintended pregnancy, and/or long-term costs of raising a child. The September 2017 minutes add that the data does not account for the cost of managing the side effects of hormonal contraception. The September 2017 Committee concluded that a decision to stop funding male sterilisations may lead to an increase in: • the cost of alternative contraceptive or emergency contraceptive use • the number of female sterilisation procedures or terminations • birth rates, leading to long-term implications for health and social care.
107. In comparison, these same considerations were not weighed up in the Committee’s decision-making about whether to fund female sterilisation. That is irrational, given that they are factors that directly impact on women themselves. In fact, there are clear personal and societal advantages of women, rather than men, being in charge of decisions about what contraception they use to protect themselves from becoming pregnant. By not taking all relevant considerations about indirect costings into account in its decision-making, the Committee did not treat its consideration of the female sterilisation policy recommendation in a fair and consistent way with its consideration of the male sterilisation policy recommendation.
108. The Committee did, however, appropriately consider local cost data on providing female and male sterilisations. What that data showed at the time is that male sterilisations were less costly than female sterilisations. What it also showed is that there were fewer male sterilisations being done locally than female sterilisations.
109. The September 2017 Committee made assumptions that the data about male sterilisations was low because it concerned procedures done in hospital rather than in the community. It proposed to gather more activity and cost data about this to include with papers for the CCGs’ governing bodies. In November, it noted that papers had been submitted to the CCGs’ governing bodies without that data.
110. The September 2017 Committee also proposed to gather information relevant to Berkshire West CCG’s decision to stop funding male sterilisation. In January 2018, it then decided it did not need that information because it had already decided to fund male sterilisation.
111. Once again, the Committee did not handle its consideration of the female sterilisation policy recommendation in a consistent way to its consideration of the male sterilisation policy recommendation here. It recommended the CCGs fund male sterilisation without ensuring the further information and additional activity and cost data it originally felt it needed had been gathered. However, it recommended that female sterilisation should not be funded in the absence of recent cost-effectiveness data or local cost data about female sterilisations (such as the cost of alternative contraception use). Even once further data was provided at the time of, and following the November 2021 meeting, the Committee did not show how it balanced that evidence to explain why it decided to keep its female sterilisation policy recommendation the same.
112. The October 2017 paper Oxfordshire CCG presented to its board includes additional cost data about female sterilisation. It also states that if female sterilisation is not funded there may be an increase in the cost of alternative contraception or an increase in the cost of terminations. While it goes further to draw together some of the relevant cost data overlooked by the Committee, it does not balance that evidence against the data about the numbers of female sterilisations done locally to show whether or not the policy recommendation on female sterilisation is justifiable. Nor does it weigh up other costings, such as the cost of managing the side effects of alternative contraception.
113. In summary: • the Committee did not balance the evidence appropriately in deciding alternative forms of contraception were more cost-effective than female sterilisation • the Committee did not handle similar circumstances involving the personal, public health and societal costs of not funding sterilisation for women in a fair or consistent way as in its consideration of not funding sterilisation for men • the Committee and Oxfordshire CCG did not appropriately weigh up the cost of female sterilisation against the cost of other contraceptives and their side effects.
114. Given that the 2021 Female Sterilisation Policy Statement the ICB inherited from Oxfordshire CCG was based on the Committee policy recommendation on female sterilisation, the ICB: • failed to ‘get it right’ in adopting a policy statement where the evidence was not appropriately balanced • failed to ‘act fairly and proportionately’ in adopting the Committee’s policy recommendation to not fund female sterilisation on the grounds of cost-effectiveness
when it had not been handled in a fair and consistent way with the Committee’s comparable policy recommendation to fund male sterilisations.
115. The ICB has not put right these failings to date.
Risks of alternative contraception
116. Miss P told the ICB that its decision not to fund female sterilisation on the grounds that alternative forms of contraception are available does not account for the risks associated with those alternatives. She said that, while she understands that female sterilisation carries its own risk, the ICB had not appropriately considered the various side effects (such as debilitating pain or thrush) or the increased risk of cancers or blood clots linked to hormonal contraception use when adopting the 2021 Female Sterilisation Policy Statement.
117. Miss P also told the ICB that its decision not to fund female sterilisation did not account for the emotional and psychological impact other forms of contraception have, including the personal worry of irregular periods, the physical and emotional pain of having a termination, or an individual’s aversion to having a contraceptive device put into their body.
118. Our Principles state that: • to ‘get it right’, an organisation’s decision-making should take account of all relevant considerations, ignore irrelevant ones and balance the evidence appropriately • to ‘be open and accountable’, if an organisation promises to do something, they should keep to it or explain why they cannot.
119. The July 2017 paper includes clinical guidance (such as the WHO guidance, the First and Second FSRH guidance, the RCOG guidance and the NICE guidance) that refers to risks and benefits associated with different forms of contraception. It highlights relevant risks associated with female sterilisation, such as the procedure not being completed, or a person experiencing blood pressure or nervous system damage, or dying during the procedure. It recognises there is an increased long-term risk of ectopic pregnancy (when a fertilised egg implants and grows outside of the womb) linked to female sterilisation.
120. The July 2017 paper also highlights that the RCOG guidance says that certain LARCs offer the same degree of contraceptive protection as sterilisation, but with lower risks and disadvantages. It does not expand on what the risks and disadvantages of those LARCs are. The attached CCG policy statements point to potential ‘severe’ and ‘adverse’ side effects that ‘affect … quality of life’. Again, they do not expand on what those side effects are.
121. The September 2017 paper recognises the possible link between hormonal contraception use and an increased risk of blood clots, stroke, breast cancer and cervical
cancers. In contrast, it states that hormonal contraceptives may decrease the risk of other types of cancers, such as those of the womb or ovaries.
122. A Family Planning Association leaflet included with the September 2017 paper sets out some advantages and disadvantages of different methods of contraception. It states that one advantage of female and male sterilisation is that there are ‘no long or short-term serious side effects’. This downplays the significant risks highlighted in the July 2017 paper. However, the same leaflet summarises some notable disadvantages of other methods of contraception, including that: • hormonal contraceptive pills may not be as effective if a woman vomits, has diarrhoea, or forgets to take one • an intrauterine system (IUS - a plastic implant that a doctor or nurse puts into a woman’s womb that stops pregnancy through the release of hormones) can commonly cause irregular bleeding or spotting in the first six months after it is put in • an intrauterine device (IUD - a plastic implant that a doctor or nurse puts into a woman’s womb that stops pregnancy through the release of copper) can cause a woman’s periods to be ‘heavier, longer or more painful’.
123. The side effects and health risks set out in the September 2017 paper are not directly referenced in the evidence the Committee considered when it agreed the female sterilisation policy recommendation in July 2017. The September 2017 minutes do not record whether the Committee considered the content of the September 2017 paper in relation to the female sterilisation policy recommendation either. What we do know is the Committee made no changes to the female sterilisation policy recommendation at the time.
124. The October 2018 paper produced by Oxfordshire CCG recognised that ‘There may be groups of patients for which different methods of hormone containing … LARC are unacceptable.’ We have not seen any evidence that shows Oxfordshire CCG carried out further work at that stage to determine whether or not it should fund sterilisations for those group(s) of women. In fact, the January 2021 paper presented at the time of the Committee’s review into the female and male sterilisation policy recommendations notes no significant changes to the evidence-based since 2017.
125. However, in November 2021, the CCGs asked the Committee to reconsider the female sterilisation policy recommendation in response to new evidence that had come to light. That evidence included reports from one of the CCGs that it was receiving individual funding requests for female sterilisation for women who had ‘reached the end of the pathway’ (that is, exhausted other contraceptive alternatives due to associated side effects, such as low mood and weight gain, or due to the risks associated with a family history of cancer).
126. The CCGs asked the Committee to specifically consider whether female sterilisation should be considered for certain groups of women, including ‘those who cannot tolerate any other contraception’. The Committee proposed that Oxfordshire CCG should do more to scope and explore that data. There is no record of what (if any) work was then done to consider the potential side effects of alternative contraception, or what decision the Committee made as a result of that work when it closed the action as complete in March 2022.
127. In summary, the Committee gathered relevant evidence in 2017 about the risks and benefits associated with different forms of contraception. However:
• the Committee did not properly balance that evidence appropriately to determine whether the benefits of expecting women to access alternative contraception over female sterilisation outweighed the potential risks and side effects of those forms of contraception • Oxfordshire CCG did not carry out further work after October 2018 to determine whether or not it should fund sterilisation for women who could not tolerate LARCs • the Committee did not do what it said it would in November 2021 to determine whether it would be appropriate to fund sterilisations for women who could not tolerate other forms of contraceptive (for example, due to side effects).
128. Given that the 2021 Female Sterilisation Policy Statement the ICB inherited from Oxfordshire CCG was based on the Committee policy recommendation on female sterilisation, the ICB: • failed to ‘get it right’ in adopting a policy statement where the evidence was not appropriately balanced • failed to ‘be open and accountable’ by adopting a policy statement that had not adequately explored whether there were groups of women for whom alternative contraception was not suitable, as requested.
129. The ICB has not put right these failings to date.
Consultation/research
130. Miss P complains that a post-meeting note in the September 2017 Committee minutes says that special advisors in ethics and health law had recommended the CCGs consult on the changes to the male and female sterilisation policy statements. She told the ICB that she could see no evidence of any research or consultation having taken place, which she said was not in line with the Committee’s Ethical Framework.
131. Our Principles state that to ‘get it right’ in their decision-making, public organisations should have regard to the relevant legislation. To ‘be customer focused’, public organisations should do what they say they are going to do. If they make a commitment to do something, they should keep to it or explain why they cannot.
132. The Public Sector Equality Duty, set out in the Equality Act 2010, requires public organisations to have due regard in their decision-making to people who share protected characteristics. The NHS Act 2006 says that CCGs (and the ICBs that replaced them) should involve service users in the planning of commissioning arrangements, or in any changes to those commissioning arrangements (either through consultation or by providing them with information in other ways).
133. The Committee’s Standard Operating Process states that the Committee would make recommendations to its CCGs about the need for public engagement or consultation on each policy. Its Ethical Framework states that the Committee’s purpose was to ensure ‘that the principles and legal requirements of the NHS Constitution, the Public Sector Equality Duty and the requirement to involve the public when making significant changes to the provision of NHS healthcare [were] adhered to’.
134. The policy papers produced for the Committee show that some appropriate research into the costs and benefits of female sterilisation did take place. The September 2017 minutes and (Oxfordshire CCG’s) October 2017 paper both include the advice from the special advisors in ethics and health law Miss P refers to. This advice recommends that ‘any significant change in the way the NHS provides services must be submitted for consultation.
A withdrawal of an NHS service looks significant and should be consulted on’.
135. The advice also recommends that, in the interests of ‘fairness and consistency in policy-making’, the CCGs should consider consulting on their female and male sterilisation policy statements together. It recommends that, in balancing the duties to individuals and the community as a whole when maximising the benefits of finite resources, the CCGs should consider explaining where any savings would be re-invested.
136. The ICB told us that emails show that consultation took place between the Commissioning Lead, Contracting Lead, Quality Team, management and clinicians at Oxfordshire CCG, but did not extend further than that. So, there is no evidence that Oxfordshire CCG carried out any public consultation before the 2018 Female Sterilisation Policy Statement was first issued. This means, in turn, that the 2021 Female Sterilisation Policy that replaced it was also not consulted on.
137. In line with the NHS Act 2006, the Public Sector Equality Duty, the Committee’s Standard Operating Process and its Ethical Framework, and based on the recommendations
made by special advisors in ethics and health law noted in the September 2017 minutes and October 2017 paper, Oxfordshire CCG should have consulted the public on the changes it proposed to make to its female sterilisation policy statement before the policy statement was adopted. There is no evidence that happened. Given the scale of the change Oxfordshire CCG made (a decision to stop funding a particular treatment), that was a significant omission.
138. Since the 2021 Female Sterilisation Policy Statement remained unchanged from the 2018 version, the ICB failed to ‘get it right’ or ‘be customer focused’ when it inherited and adopted a policy statement from Oxfordshire CCG that had never been put out for consultation.
139. The ICB questioned whether it was proportionate to find it failed to consult on the 2021 Female Sterilisation Policy Statement it inherited, given that it had not made any changes to the policy statement at the time.
140. In response, we consider the ICB was responsible for recognising that the 2021 Female Sterilisation Policy Statement had not been consulted on when it inherited it, and should have taken steps to remedy that. At the very least, the ICB should have acted in line with the NHS Act 2006 to involve service users in its decision not to change the 2021 Female Sterilisation Policy Statement at the time. That may not have required a full consultation, but should have involved sharing information about the decision with the public, and inviting feedback. Instead, the 2021 Female Sterilisation Policy was published on the ICB’s website without any consultation taking place.
141. The ICB has not put right those failings to date.
Health inequalities
142. Miss P complains about the ICB routinely funding male sterilisation but not funding female sterilisation. She considers this is not in keeping with the NHS Constitution duty to promote equality in services. She also considers it is creating health inequalities for women.
143. Our Principles state: • to ‘get it right’, organisations should record the reasons why they have decided to depart from their own guidance, recognised quality standards or established good practice • to ‘be open and accountable’ they should state their criteria for decision-making and give reasons for their decisions • to ‘act fairly and proportionately’, organisations should treat people fairly and consistently, so that those in similar circumstances are dealt with in a similar way.
Any difference in treatment should be justified by the individual circumstances of the case.
144. The NHS Constitution states that the NHS ‘provides a comprehensive service, available to all’, promoting ‘equality through the services it provides’.
145. There are several differences between the male and female sterilisation procedures that the Committee appropriately took into account as part of their decision-making process. They include that: • male sterilisation is a less risky procedure than female sterilisation • male sterilisation involves minor surgery done under local anaesthesia (treatment to numb the area) while female sterilisation is done under general anaesthesia (treatment that puts a patient to sleep while the procedure is carried out) • male sterilisation can take place in the community (at a GP practice or sexual health clinic), while female sterilisation must take place in hospital • men and women can usually return home on the same day as a sterilisation takes place, but female sterilisation can sometimes result in a patient having to stay in hospital • male sterilisation carries fewer risks following surgery than female sterilisation • male sterilisation is less likely to fail than female sterilisation • there are alternative contraceptive methods for women that are as or more effective than sterilisation; the only alternative for men (the condom) is less effective • the male sterilisation procedure is less costly than the female sterilisation procedure • male sterilisation requires a test after the operation to check that it has worked, while female sterilisation does not.
146. In light of the above – and, as discussed previously - relevant clinical guidance referred to in both the July and September 2017 papers (specifically, the WHO guidance and the First and Second FSRH guidance) states that individuals and (where applicable) couples should be counselled about sterilisation based on their individual circumstances and the range of contraceptive options available to them. This includes discussions about the risks and benefits of each method, including that male sterilisation is safer and quicker with less risk of complications than female sterilisation.
147. The First FSRH guidance (about contraception after pregnancy) also states people should be told that LARCs can be as effective a contraceptive as female sterilisation. However, that guidance is clear that ‘women should not feel pressured into choosing LARC over female sterilisation’.
148. We have already explained why we consider the Committee’s policy recommendation not to fund sterilisation for women on the grounds of regret is not evidence-based. And why
it does not afford women the same opportunity to make an informed decision about sterilisation, after being counselled about those risks, as the male sterilisation policy statement does for men.
149. We also consider the Committee’s decision not to fund female sterilisation (in part) on the grounds that there are alternative contraceptives that are as or more effective is - in effect - pressurising women to choose LARCs over female sterilisation. That is not in line with the clinical guidance from the FSRH for groups of women seeking contraception after pregnancy (though potentially intended more widely). Further, although the Committee references that guidance directly in the July 2017 minutes, it has not explained why it decided to diverge from that guidance in its decision-making.
150. The September 2017 paper notes some limited evidence of women from lower socio- economic backgrounds not having as much access to contraception as those from higher socio- economic backgrounds. It suggests that a decision not to fund male sterilisation may widen this health inequality. In contrast, the Committee has not taken account of what, if any, impact the comparable decision to stop funding female sterilisation will have on widening those health inequalities for those women directly affected.
151. The ICB told us that the decision not to fund sterilisation did not equate to putting a patient under pressure to use LARCs. It said that national clinical guidance commonly recommends that patients should trial a range of safer and/or lower resource treatments (first or second line treatments) before clinicians offer riskier and/or higher resource treatments (second or third line treatments). It said that any competent clinician would consider this tiered approach when treating patients based on their individual circumstances.
152. The ICB does not routinely fund female sterilisation at present. So, sterilisation is not an NHS treatment available as part of any tiered approach to a woman’s contraceptive options locally. As a result of sterilisation not being funded, we consider many women will likely feel pressured to use alternative methods of contraception, such as LARCs.
153. The ICB also told us that although it does not routinely fund female sterilisation, this is not a blanket ban. It said that, in circumstances where a person does not meet the eligibility criteria for a procedure or the procedure is not normally funded (as with sterilisation), a clinician can make an individual funding request on their behalf if they consider the person demonstrates clinical exceptionality. In order to secure funding, the clinician must evidence the person is both significantly clinically different to the population of patients with the same condition and at the same stage of the condition, and likely to gain significantly more clinical benefit than that population of patients.
154. Women can only secure funding for female sterilisation through an individual funding request. This, in itself, creates health inequalities in the way men and women access
sterilisation. Men can ask to be sterilised and receive that treatment subject to certain criteria, while women encounter additional barriers by having to have a clinician make an individual funding request on their behalf, and by the clinician having to demonstrate they have clinical exceptionality.
155. Notably, in November 2021 the CCGs asked the Committee to review its policy recommendation on female sterilisation because of the increased number of individual funding requests they had been receiving asking for NHS-funded sterilisations (alongside evidence that sterilisations were taking place at a hospital trust at the same time as caesarean sections were being done). The November 2021 paper notes that ‘… it is felt that the number of requests … is now a cohort and not exceptional cases’.
156. The Committee decided to keep the female sterilisation policy recommendation the same at the time. However, as discussed previously, it asked for Oxfordshire CCG to carry out further work to ‘consider the provision of female sterilisation to certain groups of women, for example those who cannot tolerate any other contraception, have had multiple caesarean sections, or for whom a further pregnancy is contraindicated’. This work included scoping and exploring the data and considering ‘the associated ethics and equalities issues’.
157. The evidence available shows that Oxfordshire CCG took some appropriate steps after November 2021 to obtain more activity and cost data about female sterilisations done locally. It also considered whether it was appropriate for sterilisations to happen in hospital at the same time as caesarean sections. This is appropriate, given the higher instance of regret noted in the First and Second FSRH guidance in women who had had a sterilisation at the time of a caesarean section.
158. At that same time, the individual funding requests for women asking for an NHS-funded sterilisation to take place at the time of caesarean sections point to evidence of clear and affirmative consent to sterilisations. And, rather than preclude that from happening, the First and Second FSRH guidance recommends that informed consent for a sterilisation at the time of a caesarean section should be sought at least two weeks before the caesarean section, or sterilisation should take place some time after a birth. However, based on the evidence, Oxfordshire CCG took no steps to explore whether it was suitable to fund sterilisation for cohorts of women asking for that procedure in advance of, or following, a caesarean section.
159. As discussed previously, there is no evidence of Oxfordshire CCG having done work to explore whether sterilisations were appropriate for the other groups of women discussed at the November 2021 Committee, including those who could not tolerate LARCs. Aside from the consideration about sterilisations done in hospital at the same time of caesarean sections, there is also no further evidence of the wider ethical and equalities issues surrounding the funding of female sterilisations. The action was closed as complete at the Committee meeting
in March 2022 without any record of if or how the work that had taken place impacted on the female sterilisation policy recommendation.
160. The Committee held evidence by November 2021 that the number of women asking for a sterilisation no longer pointed to exceptionality and may actually represent a cohort or group for whom (like men) the treatment may need to be commissioned. The Committee’s original decision to not recommend funding for female sterilisation in July 2017 had not been taken on the basis of demand. However, the new evidence pointed to instances of some women having exhausted the alternative methods of contraception the Committee felt to be as effective as, or more effective than sterilisation. It also pointed to cost benefits reported by the hospital trust of carrying out sterilisation at the same time as caesarean sections. There was a missed opportunity here for the Committee to fully review whether or not its female sterilisation policy recommendation needed to be updated in light of this new evidence.
161. The Committee did not do what it said it would do to explore whether there were groups of women for whom the commissioning of sterilisation may be appropriate, nor did it give a clear indication of why it decided not to change the female sterilisation recommendation in March 2022. In fact, an email exchange from November 2022 between the South Central and West Commissioning Support Unit and the ICB shows that there was uncertainty about whether this review was still ongoing.
162. In summary: • the Committee did not explain why its decision to expect women to choose LARCs over sterilisation diverged from the Second FSRH guidance • the Committee did not take into account what, if any, impact its decision not to recommend funding female sterilisation would have on health inequalities for women from lower socio-economic backgrounds in the same way it did for its consideration of the male sterilisation policy recommendation • there was a missed opportunity for the Committee to fully review whether or not its female sterilisation policy recommendation needed to be updated in light of new evidence that certain groups of women were a cohort rather than an exception.
163. Given that the 2021 Female Sterilisation Policy Statement was based on the Committee policy recommendation on female sterilisation, the ICB: • failed to ‘get it right’ in adopting a policy statement that did not explain the reasons why it departed from clinical guidance • failed to ‘be open and accountable’ in adopting a policy statement that was not clearly based on relevant decision-making
• failed to ‘act fairly and proportionately’ in adopting a policy statement that was not fair and consistent with the 2021 Male Sterilisation Policy Statement.
164. The ICB has not put right these failings to date.
Summary of failings about the policy statement
165. In summary, because the 2021 Female Sterilisation Policy Statement (the ICB inherited from Oxfordshire CCG) was based on the Committee policy recommendation on female sterilisation, we find the ICB: • failed to ‘get it right’ by adopting a policy statement where the evidence was not appropriately balanced, which did not give due regard to relevant legislation, and which did not explain the reasons why the policy statement departed from clinical guidance • failed to be ‘open and accountable’ by adopting a policy statement that was not clearly based on relevant decision-making, that had not adequately explored whether there were groups of women for whom alternative contraception was not suitable (as requested), and where the reasons for the policy statement were not clearly recorded • failed to ‘act fairly and proportionately’ by adopting a policy statement based on a policy recommendation on female sterilisation that was not handled in a fair and consistent way with the comparable policy recommendation on male sterilisation • failed to ‘be customer focused’ by adopting a policy statement that had not been put out for consultation.
166. The ICB has not put right these failings to date.
Complaint handling
Delay
167. The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 (the 2009 Regulations), Regulation 13(7) says the body responsible for dealing with a complaint must offer to discuss with the person making the complaint how their complaint will be handled and the relevant timescales. Regulation 14 says it must keep the complainant informed on the progress of the investigation, as far as reasonably practicable. It says the responsible body should respond to the complaint within six months of receipt and, if it does not do so, it must notify the complainant of the reason for this in writing and send a response as soon as is reasonably practicable.
168. Our NHS Complaint Handling Standards say an effective complaints system welcomes complaints in a positive way, including staff responding to complaints at the earliest
opportunity and consistently meeting expected timescales for acknowledging a complaint. They give clear timeframes for how long it will take to look into the issues, taking into account the complexity of the matter. They say an effective complaints system is thorough and fair, including staff discussing timescales with everyone involved in the complaint and agreeing how people will be kept informed and involved. This includes providing regular updates as agreed with the parties, throughout.
169. The ICB acknowledged Miss P’s complaint promptly by email and said it would aim to respond within 25 working days. It did not offer to discuss this timescale with her and how her complaint would be handled, or how it would keep her informed and involved, in accordance with the 2009 Regulations and our NHS Complaint Handling Standards.
170. We acknowledge the ICB provided Miss P with a response to her complaint within the timescale it set of 25 working days, but this was not a complete response. We note the ICB did not make it clear this was not its final response until Miss P emailed it to check.
171. The ICB did send Miss P a final response to her complaint within 6 months, as set out in the 2009 Regulations. However, throughout the investigation, despite knowing the initial timeframe it had provided had passed and Miss P was still awaiting a full response, the ICB consistently failed to proactively send her regular updates and Miss P chased a response by email on four separate occasions. The ICB’s responses to these emails did not include a clear timeframe and so we can understand why Miss P found them vague. This was not in accordance with the NHS Complaint Handling Standards.
The ICB’s response to Miss P’s complaint
172. Miss P has complained that the ICB’s response did not address the issues she raised in her complaint.
173. Our NHS Complaint Handling Standards say an effective complaint handling system makes sure staff take a thorough, proportionate and balanced look into the issues raised in a complaint. It gives people fair and open answers to their questions based on the facts, and takes full accountability for mistakes identified. This includes staff actively listening and demonstrating a clear understanding of what the main issues are for the person who has made the complaint, and the outcomes they seek.
174. In her complaint, Miss P raised several concerns about the ICB’s female sterilisation policy statement, including that it was not in line with relevant standards and ethical guidance, it created health inequalities for women in the ICB’s area and that the criteria it set out was not evidence-based. She also described the health, emotional and social reasons why she and other women requested sterilisation and the impacts of not having the procedure.
175. The ICB’s first response of 7 August 2023 outlined the differing male and female sterilisation policy statements the ICB had inherited from the three former CCGs and explained that work still needed to be done to align the policies. We accept this was not the ICB’s full response, but it did not make any reference to the concerns Miss P had raised about whether the policy statements were in accordance with relevant guidance or evidence-based. The details the ICB provided about the differences between the male and female sterilisation policies did not address Miss P’s key concern, which was that she felt the ICB’s decision to fund sterilisation for men, but not for women, was discriminatory. Nor did it reflect the significant impact Miss P said she was experiencing as a result of not having the procedure.
176. The ICB said Miss P could ask a clinician to make an individual funding request application on her behalf if she wanted, but failed to acknowledge that she was also seeking a review of the female sterilisation policy statement.
177. The ICB did not explain why it had failed to respond to all the issues Miss P had raised and it did not give any indication it planned to send a further response, until Miss P queried this.
178. The ICB’s email of 1 September 2023 acknowledged Miss P’s concern that the ICB’s policy statement was discriminatory. Its response was to tell her that it did not commission vasectomies for all men. The response did not address her complaint that the ICB was not promoting equality, in line with the NHS Constitution, and was denying women bodily autonomy. It also said that female sterilisation was not routinely funded because of the high level of regret, because reversal is complex and may not be successful, and because there were good alternative forms of contraception. Miss P was already aware of this and had quoted this in her complaint. She had also queried what evidence the ICB had relied upon regarding levels of regret and set out her concerns about the risks, side effects and costs associated with alternative methods of contraception. The ICB simply repeated its policy statement and did not explain what evidence it was based on or address the concerns Miss P had expressed about this.
179. Again, the ICB did not acknowledge it had not responded to all of Miss P’s concerns, or indicate it would be providing a further response. As such, we can understand why Miss P was left querying whether the ICB intended to respond to the ‘vital’ elements of her complaint.
180. The ICB’s final response of 22 November 2023 acknowledged Miss P’s concerns about gender discrimination, whether the female sterilisation policy statement was in line with guidance and side effects associated with alternative contraception for women. It said it would address these issues by describing how the decisions about clinical commissioning had been made. The ICB partially responded to Miss P’s concerns about the evidence base for the
policy. It provided the minutes from the July 2017 Committee meeting and told her the Committee’s review had included ‘a full assessment of national guidelines, best practice, clinical evidence, cost effectiveness, related local policies and other relevant legal and ethical considerations’. What it did not do is address Miss P’s questions about this, such as what research it had relied upon regarding levels of regret and why it did not consider the difference in the male and female policy statements amounted to discrimination. It also did not respond to her concerns about how the Committee had taken account of women’s bodily autonomy in reaching a decision.
181. On the issue of cost effectiveness, in her complaint Miss P asked whether the Committee had considered the cost of hormonal contraception. She quoted data from the minutes of the July 2017 Committee meeting, that sterilisation was more cost-effective than LARCS after 15 years of use. The ICB’s response made no reference to this data, or how the Committee had taken account of this evidence in making its assessment of cost-effectiveness.
182. Miss P also highlighted a post-meeting note that the Committee had been advised by a special advisor in ethics and health law that decommissioning female sterilisation was significant and there should be a public consultation before doing so. She asked whether this consultation happened. Despite the ICB saying the Committee’s review had included a full assessment of ethical considerations, it did not answer this question or offer any explanation as to why it appears no consultation was carried out.
183. We appreciate that Miss P’s initial complaint came about because she was denied sterilisation. As such, it was appropriate for the ICB’s response to include details of the criteria for an individual funding request, as this could have potentially provided a route for Miss P to access the procedure. However, Miss P made it clear that she had wider concerns about the policy-making process and how the policy affected other women in the ICB’s area, and said she was seeking a review of the policy statement. The strong focus on the individual funding request process in the ICB’s response was not proportionate and did not demonstrate the ICB clearly understood the key issues in her complaint.
Summary of failings about complaint handling
184. We consider the ICB did not act in accordance with the Regulations and our NHS Complaint Handling Standards in failing to make Miss P aware of the timescales for its response to her complaint and keep her updated on progress. When it did respond to her complaint, it did not demonstrate a clear understanding of the main issues for her and the outcomes she was seeking. The ICB’s response disproportionately focused on reiterating its policy statement and providing information about the individual funding request process. It did not include a thorough consideration of Miss P’s concerns about how the Committee had arrived at its decision to decommission female sterilisation, or answer her questions about
the evidence the policy was based on. This was not in accordance with our NHS Complaint Handling Standards.
Impact
185. We now consider what, if any, impact the ICB’s failings have had on Miss P.
186. Miss P says that the 2021 Female Sterilisation Policy Statement adopted by the ICB has taken away her right to make autonomous decisions about her body. She says it has made her feel ‘mentally and physically drained’ and ‘defeated’.
187. Miss P is not able to have an NHS-funded sterilisation because the 2021 Female Sterilisation Policy Statement (and the 2024 Female Sterilisation Policy Statement that replaced it) state that the ICB does not generally fund this procedure for women. The 2024 Female Sterilisation Policy Statement is unchanged at present, though the ICB is reviewing its position on funding in light of the 2024 Policy Recommendation. The ICB has also declined an individual funding request application from Miss P’s GP because it does not consider it demonstrated sufficient evidence of exceptionality.
188. We have found there are failings in the way the evidence was balanced and in the decision-making process that led to the 2021 Female Sterilisation Policy Statement. Were it not for those failings, it is more likely than not that the criteria set out in the 2021 Female Sterilisation Policy Statement would have been different. This is because, but for the failings, the criteria would have reflected the relevant evidence, for example the evidence that female and male sterilisation has been shown to be the most cost-effective method of contraception in the long-term.
189. However, the ICB has discretion to decide what treatments it funds locally. In deciding whether to a fund a treatment, it must take relevant considerations into account (such as what clinical guidance says) and weigh up those considerations alongside the cost of treatment and the overall benefits, both to the individual and community. Even though the ICB adopted a commissioning policy that was based on flawed decision-making, we cannot now know what that commissioning policy statement would have looked like had it reviewed the evidence and reached an appropriately balanced decision after it took over that policy from Oxfordshire CCG. So, based on the evidence, we cannot determine - even on the balance of probabilities - that Miss P would have qualified for an NHS-funded sterilisation had the ICB done what it should have.
190. More specifically, had the ICB done what it should, it is possible it may have funded female sterilisation for some groups of women, but not others. It is also possible that, to make sure its female sterilisation policy statement was fair and consistent with its male sterilisation policy statement, the ICB may have needed to reflect on (and potentially amend)
the eligibility criteria in the 2021 Male Sterilisation Policy Statement too. We therefore have insufficient evidence to determine whether or not Miss P would have met the eligibility criteria for an NHS-funded sterilisation were it not for the ICB’s failings.
191. In reaching our findings, we note that the 2024 Policy Recommendation agreed by the Third Committee now recommends that local ICBs (including the ICB) should fund sterilisation for women, subject to certain criteria. We also note the ICB is currently reviewing its policy position on female sterilisation in response to the 2024 Policy Recommendation.
192. The Third Committee decided to review the policy recommendation on female sterilisation because four of its six ICBs fund female sterilisations, while two (the ICB and its counterpart from the Second Committee) do not. The Third Committee also recognised potential equality issues associated with those two ICBs funding sterilisations for men and not women.
193. Had the ICB done what it should have to reconsider its policy position sooner, we feel it is unlikely to have had the same motivation to align its policy statement with other local ICBs prior to the Third Committee having been set up. This is because it was not until July 2024 that the Third Committee took on the role of making policy recommendations for six local ICBs, giving cause to align them. The ICB is also unlikely to have had access to the same evidence (such as cost and activity data) as that which the Third Committee considered. So, we have insufficient evidence to determine that the ICB is more likely than not to have set the same or similar eligibility criteria as set out in the 2024 Policy Recommendation had it reconsidered its position sooner.
194. We hope that what we have said helps to explain why we do not consider the failings we have found mean that the ICB has withdrawn access to an NHS-funded sterilisation Miss P would otherwise have had.
195. What we do know with certainty – in light of Miss P’s complaint – is that she felt the 2021 Female Sterilisation Policy Statement was based on evidence that had not been appropriately balanced, was not consulted upon, and that did not seem to have handled similar circumstances about sterilisation affecting women in a fair and consistent way with those affecting men. Miss P also felt that the decision-making upon which the policy statement was based had not given due regard to relevant evidence, and had not explained the reasons for the decision or why it departed from clinical guidance.
196. Our findings show that Miss P’s views about the 2021 Female Sterilisation Policy Statement were right. Miss P has consistently and clearly set out the evidence base for her assertion that the ICB’s decision-making process was flawed. We can fully appreciate why she found the ICB’s approach offensive, and it caused her to feel she was being treated as not
competent to make decisions about her own body. The uncertainty about whether or not she would have qualified for a sterilisation had the ICB done what it should have will undoubtedly be a source of considerable, ongoing emotional upset for her. This is likely to be exacerbated by the knowledge that there was a missed opportunity for the policy statement to have been properly reviewed in response to the new evidence presented to the Committee in November 2021. This is the impact on Miss P.
197. Miss P said she found the ICB’s response to her complaint profoundly disappointing and offensive. She said it left several crucial questions unanswered and this diminished her confidence that it would acknowledge failings and make changes as a result.
198. We consider the ICB’s failure to make Miss P aware of timescales for its response to her complaint, or to keep her updated on progress, left her feeling she had to actively pursue the ICB for that response. We are left in no doubt that this must have added to the emotional impact to her.
199. We also consider that the ICB’s disproportionate focus on reiterating the policy statement and providing information about the individual funding request process, and its lack of a thorough consideration of Miss P’s concerns about how the Committee had arrived at its decision to recommend female sterilisation no longer be funded, or answer her questions about the evidence the policy statement was based on in its response is likely to have made that emotional impact worse. This is the further impact to Miss P.