Chamber and committees

Scottish Government's Response - Transvaginal Mesh Removal (Cost Reimbursement) Bill - 22 November 2021

Letter from the Cabinet Secretary for Health and Social Care in response to Committee's Stage 1 report on Transvaginal Mesh Removal (Cost Reimbursement) Bill

Dear Convener,

I enclose with this letter the Scottish Government’s response to the recommendations made in the Health, Social Care and Sport Committee’s stage one report on the Transvaginal Mesh Removal (Cost Reimbursement) Bill.

I want to reiterate my thanks to your committee members for this Report, both for their support for the Bill, and for their agreement to work to an expedited timescale to allow resolution for those women so badly affected. I would also like to thank the Delegated Powers and Law Reform Committee and the Finance and Public Administration Committee for their consideration of the Bill. Separately, I would again thank the women who have come forward to share their experiences which I appreciate will not have been easy. I am extremely grateful to them and to the Health and Social Care Alliance for their expert assistance.

The response enclosed at the Annex offers the Government’s view on each of the
Committee’s recommendations, but I wanted just to comment a few of the main points of closest interest to the Committee, which I discussed when I offered evidence.

I welcome your recommendation with respect to residency criteria and I do agree in principle with the Committee’s concern that the Bill draws residence eligibility too narrowly. The Government will consider the issue further and bring forward appropriate amendments at stage two.

Like you, I do appreciate that women have been waiting for contracts with independent providers of mesh removal surgery to be finalised. I would like to assure the Committee that work is ongoing to conclude these arrangements as quickly as possible and there is no desire, by any party involved, to prolong the wait that women have already had to endure. But, as I noted in my evidence to the Committee, I will consider carefully whether any change to the cut off-date for eligible arrangements for private surgery, presently set for 12 July, might be appropriate in light of all the relevant circumstances. I propose to confirm the Government’s position at stage two, if the Parliament agrees to the Bill at stage one.
The Committee and I share I think a focus in ensuring that the reimbursement scheme under the Bill is flexible such that individual circumstances can be taken into account, but also provides sufficient detail to potential applicants, to allow them to assess their eligibility. The Government’s response explains why, in these circumstances, we do not consider that these objectives will be best pursued by making the scheme in regulations, but I do fully understand that the Committee wishes to understand more about how the scheme will operate in practice. To that end, I propose to send a draft of the scheme to the Committee before the commencement of stage two proceedings, if the Bill is agreed to at stage one.

I hope the Committee finds this response helpful and I look forward to working with members as the Bill is considered further.

Kind Regards
Humza Yousaf
Cabinet Secretary for Health and Social Care

ANNEX HEALTH, SOCIAL CARE AND SPORT COMMITTEE
RESPONSE FROM THE SCOTTISH GOVERNMENT TO THE STAGE ONE REPORT ON THE TRANSVAGINAL MESH REMOVAL (COST REIMBURSEMENT) BILL

Committee Findings

104. The Committee is content to support the general principles of the Bill and
recommends to the Parliament that they be agreed to.

105. The Committee draws the Scottish Government’s attention to the various
recommendations it has made about the details of the scheme. To ensure these
recommendations are satisfactorily addressed, it further requests that the
regulations setting out the details of the scheme are made subject to a procedure
that will enable them to undergo full and proper scrutiny prior to their entry into
force.

The Scottish Government welcomes the support of the Committee for the general principles of the Bill and hopes that the Bill will gain support from across the Parliament.

The Government notes the Committee’s recommendation in paragraph 105 and agrees that it is important to the successful offering of reimbursement for the scheme under which applications are made to provide applicants with sufficiently detailed guidance, while also allowing scope for flexibility in the determination of applications.

The Government notes the Committee’s reference to regulations setting out details of the scheme, and would clarify that the scheme that section 1 of the Bill gives power to the Scottish Ministers to make is not proposed to be contained within regulations. The Bill requires that the scheme is laid before the Parliament and published.

The Committee heard evidence from affected women about the inevitable complexity and variety of financial arrangements that it had been necessary for individuals to enter into before it was possible for them to arrange mesh removal surgery privately. The Government is very conscious therefore that there is a plausible risk that any scheme, however carefully prepared and broadly drafted, might well be found in time to omit or mischaracterise costs reasonably borne in the arrangement of surgeries in a way that rendered a claim for those costs ineligible for reimbursement.

In the event that the scheme was in regulations, and those regulations were found to be incomplete in some unanticipated fashion, it would be necessary for them to be amended, which would add time in any process to fill in gaps. Moreover, if amendment regulations had to made, it may then be necessary to ask for applications to be re-submitted.

The Government is also very conscious that the individuals who have borne costs privately will have been managing the personal and financial consequences of having done so for some time, perhaps a number of years. In this context, the preparation and passage of any regulations will inevitably involve further delay before women can receive reimbursement. Under the Government’s present proposals for an administrative scheme, it will be possible to lay and publish the scheme almost immediately after the Act comes into force and to invite applications quickly after that.

It is in light of these factors that the Government does not consider it to be advantageous to the women affected for the scheme details to be specified in regulations. The Government prefers an administrative scheme, which can be published and implemented promptly after the Act comes into force, and can be amended equally promptly if, for example, it is considered appropriate to add to the descriptions of reasonable costs. The Government would also refer to the terms of the Delegated Powers Memorandum in this regard and does also note the conclusions of the Delegated Powers and Law Reform Committee, which determined that it did not need to draw the attention of the Parliament to the delegated powers in the Bill.

Nonetheless, the Government does wholly appreciate that the Committee, the Parliament and of course the women affected have an essential interest in understanding how the scheme under the Bill will operate in practice, and the elements of flexibility that will be available to administrators responsible for determining applications. To this end, therefore, the Government will make available to the Committee a draft of the scheme which it proposes to make under the Bill. A draft of the scheme will be provided to the Committee prior to the commencement of stage two proceedings, if the Parliament agrees to the Bill at stage one.

Qualifying mesh removal surgery

39. The Committee believes that, to adhere to the principles of fairness and equity of
treatment, greater clarity is needed around the residency criteria set out in the
Bill. Specifically, the Committee believes there is a strong case for individuals
who had their original mesh implant surgery undertaken by NHS Scotland but
who were not ordinarily resident in Scotland at the time their mesh removal
surgery was arranged to also qualify for reimbursement under the terms of the
Bill. The Committee supports a widening of the eligibility criteria in such cases,
provided those individuals have not already claimed for reimbursement of these
costs elsewhere.

40. In accordance with the commitments made by the Cabinet Secretary when giving
evidence, the Committee calls on the Scottish Government, in bringing forward
regulations under section 3 of the Bill, to demonstrate appropriate flexibility in the
definition of “making an arrangement” for mesh removal surgery”.

41. We further call on the Scottish Government, in bringing forward those same
regulations, to address the potential time gap in eligibility for reimbursement
between the proposed cut-off date of 12 July 2021 and the actual date when
contracts with independent providers of mesh removal surgery are ultimately
concluded.

The Government welcomes the Committee’s consideration of the question of residency criteria in relation to qualifying mesh removal surgery and agrees with the recommendation in paragraph 39 of the Committee’s report. The Government notes and agrees in principle with the Committee’s concern that the Bill draws residence eligibility too narrowly. The Government will consider the issue further and bring forward appropriate amendments at stage two.

The Government notes the Committee’s recommendation in paragraph 40 and, with respect to the general issue of making the scheme in regulations, draws the Committee’s attention to the response offered in relation to the recommendation at paragraph 105. Further, however, it is the Government’s intention that the scheme document that will be provided to the Committee in draft will provide some detail with respect to the meaning of “making an arrangement”, without unduly fettering the discretion of administrative decision makers to take into account other circumstances which appear reasonably also to constitute “making an arrangement”.

The Government notes the Committee’s recommendation in paragraph 41. The Government appreciates of course that women wishing surgery for mesh removal provided outside the NHS, who continue to suffer significant and painful complications, will have been frustrated that referrals to independent providers were not available immediately after the Government’s announcement on 12 July this year.
Since 12 July NHS National Services Scotland (NSS) has been working to agree terms and conditions with the selected providers. Of prime importance in agreeing these terms and conditions has of course been the requirement to confirm arrangements in the facilities for appropriate wrap-around and emergency care, if the need for such arises unexpectedly. The Government does consider, and expects that the Committee will agree, that it is essential that such arrangements are in place at a high level of confidence.

NSS is seeking to conclude arrangements with both providers as quickly as possible, and the Government has, since 12 July, advised affected women not to enter into new arrangements for private mesh removal surgery, in light of the plan to provide this option through the NHS. Notwithstanding this, the Government does undertake to consider whether any change to the cut-off date envisaged in section 1(3)(c) of the Bill - which will be specified in the scheme - might be appropriate and reasonable in light of all of the relevant circumstances, and plans to confirm its position at stage two, if the Parliament agrees to the Bill at stage one.

Costs associated with reimbursement

50. The Committee notes the Cabinet Secretary's commitment to take a flexible
approach in determining what costs will be reimbursed under the Bill. To provide
clarity for the individuals concerned and the scheme administrators, in bringing
forward the details of the scheme in regulations, the Committee calls on the
Scottish Government to outline in much greater detail the categories of costs that
will be covered but equally to set out the flexible approach to be taken in
processing individual cases.

The Government welcomes the Committee’s recommendation in paragraph 50 and agrees that it is important for the successful offering of reimbursement for the scheme under which applications are made to provide applicants with sufficiently detailed guidance, while also allowing scope for flexibility in the determination of applications.

To this end, therefore, the Government will make available to the Committee a draft of the scheme which it proposes to make under the Bill. A draft of the scheme will be provided to the Committee prior to the commencement of stage two proceedings, if the Parliament agrees to the Bill at stage one.

Costs associated with administration of scheme

58. The Committee notes the uncertainty around how many individuals will ultimately apply for reimbursement under the scheme. The Committee strongly urges the Scottish Government to review costs to administer the scheme to ensure NHS NSS has sufficient resource to manage the scheme effectively without causing undue stress and anxiety to its workforce.

The Government welcomes the Committee’s recommendation in paragraph 58 and agrees that it is important that the scheme administrator has sufficient resource to manage the scheme effectively. This will therefore be kept under regular review.

Deadline for applications

63. Ensuring all those who are entitled to reimbursement are aware of the
reimbursement scheme and the deadline for making an application is crucial.
Given there is no clear indication in the Bill documentation of how many
individuals are likely to be affected, the Committee asks the Scottish Government
to set out how it will ensure anyone that could be eligible is made aware of the
scheme well in advance of the deadline for applications.

The Government welcomes the Committee’s recommendation in paragraph 63 and we will make every effort to ensure those who may be eligible for reimbursement are made aware.

When the Government opened the existing mesh fund, the previous Cabinet Secretary wrote out to women who had been in contact with the Government, and the Government publicised the fund through the Health and Social Care Alliance (the Alliance) and NHS Inform. Further, NHS NSS, the fund administrators, wrote to NHS Scotland Health Boards and GPs to raise awareness. We would expect a combination of these methods will be used again here – whilst acknowledging that there are likely to be a much smaller cohort of eligible applicants.

Who can apply for reimbursement

69. The Committee is concerned that there is no clear indication in the Bill whether
crowdfunding or family donations will be eligible for reimbursement. The
Committee would welcome further clarity on the approach to treatment of such
alternative avenues for sourcing funding for mesh removal surgery, including
reference to any duties or obligations related to the management of public
finances that may have informed the Scottish Government’s approach in this
area.

The Government welcomes the Committee’s recommendation in paragraph 69. It is the Government’s intention that the scheme document that will be provided to the Committee will describe who may apply for reimbursement.

The policy objective is that reimbursement of reasonable costs will be available to the person who has undergone the surgery (or who has arranged to do so) and also to a person who accompanies the person undergoing the surgery, to the extent that these persons have borne costs personally. It is not the policy objective to reimburse other persons who may have volunteered monies to a person to assist that person to arrange mesh removal surgery, and thus persons who may have made charitable donations through organised channels, such as in response to a published public appeal, or through a ‘crowd-funding’ website, will not be eligible for reimbursement under the Bill. Applicants will be expected to declare monies that were received through organised charitable routes.

The Government has also considered the position of monies received through informal routes, such as from friends or family members. Upon consideration, the Government does not consider it sensible or proportionate for the administrative scheme under the Bill to seek to step into private arrangements between family members and friends. Applicants will not be expected to declare monies received informally, and will be at liberty of course to distribute any monies they receive further to a scheme application as they consider appropriate.

Evidence of expenditure

74. The Committee reiterates its view that the details of the scheme to be brought
forward via regulations needs to include a clear explanation of a flexible approach
to reimbursement that takes account of individual circumstances, as committed to
by the Cabinet Secretary and Scottish Government officials while giving
evidence.

The Government takes note of the Committee’s recommendation in paragraph 74. It is the Government’s intention that the scheme under the Bill will take a proportionate and flexible approach to the provision of evidence of costs incurred, particularly with regard to more minor items of expenditure (for example, taxi fares) and how long ago they were incurred.

Decisions on whether reimbursement is paid

81. The Committee is of the view that individuals should be entitled to reimbursement where they have had any form of private mesh removal surgery, whether that surgery was successful or not.

82. The Committee expects the scheme to detail the criteria for reimbursement,
which should include clinical input to support scheme administrators. However,
the Committee understands there should be a balance between ensuring the surgery has led to positive and lasting outcomes and not causing additional
stress and anxiety to individuals by creating an onerous or difficult application
process. The Committee looks forward to seeing detail of how this can be
achieved in the final scheme, as well as the processes to be put in place for
reviewing and challenging such decisions.

83. Ensuring individuals affected by transvaginal mesh have positive and lasting
outcomes must remain a key priority. The Committee welcomes further detail
from the Scottish Government on additional work to ensure those individuals who
have paid for private removal surgery and are reimbursed under the Bill, have
timely access to post-operative support.

The Government agrees with the Committee in its recommendation in paragraph 81. Section 1(2) of the Bill defines mesh removal surgery with reference to the purpose for which the surgery is carried out, not whether it achieves that purpose. Therefore, the Government can confirm that the scheme made under the Bill will allow persons who have arranged mesh removal surgery will be eligible to apply for reimbursement whether that surgery was ‘successful’ or not.

Accordingly, the Government considers that the issues explored in paragraph 82, and the connected observations, do not in fact arise. The Government does not envisage that the administration of the scheme will require any significant clinical input, unless applicants have made arrangements for mesh removal surgery to be undertaken by providers presently unknown to NHS National Services Scotland (NSS), when it might be necessary to take clinical advice as to whether a centre was / is capable of undertaking such surgery. But, in reality, the Government considers it very likely that all persons who might apply for reimbursement will have arranged surgery at the centres already known to NSS, and thereafter the consideration of applications will be an administrative matter, not requiring clinical advice.

The Government agrees with the Committee in its recommendations and observations in paragraph 83. The Scottish Government and NHS Scotland are committed to continuously improving support for women suffering complications from mesh implants and also to women who have arranged to have mesh removed privately. All such women should have access to care and support in NHS Scotland. The National Specialist Mesh Removal Service in NHS Greater Glasgow and Clyde (GGC) is of course one important part of this support: equally important is support from GPs and Health Boards locally.

Ancillary provision

87. The Committee is aware that many of the specific issues it has raised about the
operation of the scheme will be addressed in implementing regulations to be
submitted to the Parliament for scrutiny in the form of subordinate legislation. The
Committee believes that these regulations must therefore be subject to a
procedure that will enable an appropriate level of scrutiny to take place.

The Government notes the observations of the Committee in paragraph 87. In relation to paragraph 87, which follows commentary about the purposes of section 3 and 4, the Government notes – for completeness - that regulations made under section 3 are limited to making provision that is for the purposes of, in connection with, or for giving full effect to the Bill (section 3(1)). So, for example, the power would allow for some supplementary provision to be made in regulations to enable the Bill to operate effectively. An example of such provision is given in the Explanatory Notes for the Bill, at paragraph 26. The power in section 3 is not wide enough to allow for defining or extending terms used within the Bill.

If it is the case that regulations are made under section 3, then section 3(3) sets out the procedure that those regulations would be subject to (affirmative procedure if provision in the regulations amend an Act, negative procedure otherwise).

The Government does of course note the Committee’s view, expressed in paragraph 105 and in other places, that the scheme under the Bill should be made via regulations. Our response offers a view on that suggestion above.

Inequality

92. The Committee supports the principles of fairness, equity and parity which, in its
view, underpin the Bill. However, it is concerned there may be additional
considerations surrounding and included within the Bill that could give rise to
inequality. To address these concerns, the Committee considers it is vitally
important that any individual who has experienced complications due to
transvaginal mesh has their case reviewed and receives appropriate treatment as
quickly as practically possible via the complex mesh national surgical service.

The Government welcomes the Committee’s recommendation in paragraph 92 and agrees that it is important for those who have experienced complications to be seen and treated as quickly as possible through the National Specialist Service.

Unfortunately, the reality of Covid-19 has meant that women are waiting far longer than we would like to be assessed at the National Specialist Service. We are committed to working with NHS NSS and the National Specialist Service to look at ways to improve this.

Specialist mesh removal services in Scotland

99. The Committee would welcome further detail from the Scottish Government on
campaigns to publicise the complex mesh national surgical service, training for
primary care staff on mesh complications and person-centred approaches for
supporting individuals through treatment including pre and post-operative
support. To this end, the Committee will continue to take an active interest in the
operation of the complex mesh national surgical service and intends to take
further evidence on this topic in the course of 2022.

The Government notes the Committee’s request in paragraph 99 for further information on what measures are being taken to ensure that both the public and Health Boards are aware of the National Specialist Mesh Removal Service in NHS GGC. We fully recognise that GPs and other local clinical staff need to be aware, not only that the service exists but also of what it offers in terms of services, so that they are then able to explain this to the women who present with mesh complications.

In light of the halt placed on the use of transvaginal mesh for Stress Urinary Incontinence and Pelvic Organ Prolapse in September 2018, the then Chief Medical Officer asked each Health Board to nominate an Accountable Officer. These Accountable Officers meet several times per year, and supported the development of the National Specialist Service in NHS GGC, with a view to ensuring equitable access to healthcare. The Accountable Officers have been actively involved in the development of the Service, and have a role to play in ensuring that colleagues within their local Health Board are abreast of developments in this field.

In addition to this, nursing specialists and physiotherapists from the National Specialist Service are linked with their local counterparts to ensure continuity of care and a seamless pathway of care.

The pathway of care will continue to be a key focus for the Government, and it must take into account patient experience. For that reason, the Government has asked the Health and Social Care Alliance to take forward work on developing a patient focused ‘map’ of the care pathway. This will be created from a patient perspective, which will help future patients understand the referral process and what it means for them.