Policy paper

Infected Blood Inquiry Response Expert Group Addendum to Final Report

Published 12 February 2025

Foreword by the Minister for the Cabinet Office

The Infected Blood Compensation Scheme will deliver comprehensive compensation to victims of the Infected Blood Scandalwho have waited far too long for justice. 

The infected blood community has suffered immeasurably over many decades as a result of this scandal and I would like to pay tribute to all victims who have campaigned over the years.

I am deeply appreciative of the Infected Blood Inquiry Response Expert Group. Over the last year, their expert advice has enabled the Government to take critical decisions on the design of the Scheme. I would like to reiterate my thanks to the chair, Professor Sir Jonathan Montgomery, for providing leadership to the Group while  it  offered support to the Government, as we make progress with this important work. 

The Expert Group has previously published an Interim and a Final Report. These reports set out its detailed advice to the Government, which has informed the development of the Infected Blood Compensation Scheme. In the months since the publication of its Final Report, the Group has undertaken further work to help the Government develop the Infected Blood Compensation Scheme Regulations 2025. Specifically, we have sought its expertise on how the supplementary route can work effectively and remain accessible to the claimant. The Group’s advice has been absolutely vital to the development of the Infected Blood Compensation Scheme.

The infected blood community must sit at the heart of the Infected Blood Compensation Scheme. The Infected Blood Inquiry and Sir Robert Francis reflected on the experience of the community to inform their recommendations, and these recommendations continue to form the basis of the Scheme. The Expert Group has brought together decades of clinical, legal, actuarial and social care experience to advise Government on how these recommendations could be implemented in a scheme which is fair and accessible for everyone who is eligible. I hope this Addendum Report brings reassurance that the choices that I have made in the development of the regulations are fully informed by the knowledge and experience of experts and the insights of the community.

Introduction

In August 2024, we published our final report setting out the advice we provided to the Government to assist them in designing the Infected Blood Compensation Scheme. We revised our initial advice in a number of respects based on the feedback from the engagement events convened by Sir Robert Francis KC as Interim Chair of the Infected Blood Compensation Authority. This revised advice was set out in our final report. Following their acceptance of the recommendations made by Sir Robert Francis, we were invited by the Government to provide further detailed advice on three issues in order to assist with the drawing up of the Scheme in a second set of regulations. We have been pleased to have the opportunity to consider these issues further, which we have done in light of the engagement meetings held by Sir Robert. This addendum to our existing report offers advice on these issues, which are:

• Supplementary ‘Severe Health Condition’ awards where the beneficiaries experience significantly greater loss of financial earnings and/ or care needs than envisaged in the calculations that underpin core awards.
• Additional autonomy awards for those subjected to unethical research practices.
• Exceptional Loss awards to substitute actual amounts for financial loss awards or care awards where it is shown that the loss or cost significantly exceeds the assumption that underpin the core awards.

In formulating our advice on these supplementary awards, we have retained the fundamentals of the scheme that we described in our main report. In particular, that any evidence required should be: 

• Accessible to claimants (and assessors), so that only information that is reasonably expected to be available if requested;
• Assessable, so that the relevant question about eligibility can be answered;
• Verifiable, so the integrity of the scheme is maintained;
• Proportionate to the need to answer the question to determine eligibility or quantify awards, so that: 
  • Privacy is maintained although applicants can be asked to consent to access to medical records if that would provide the evidence needed to establish their eligibility; and
  • Excessive detail is not sought that would be unnecessarily time consuming (leading to delay and expense in processing cases).

Severe Health Condition awards

A key principle of the scheme is that clinical markers and diagnoses are used to identify severity bandings and to set step changes in compensation. We have approached Severe Health Condition awards with this in mind. We suggest that there are some conditions where the result of the infection or treatment of the infection would have had a greater impact than is reflected in the core award. Whilst these conditions may be rare, they should still be recognised within the scheme. We propose six groups of specific conditions where this would apply and suggest how the awards should be revised to account for  their  additional  impact.

In considering rare complications of infections, we also propose that reactivation of a previous blood or blood product acquired Hepatitis B infection leading to acute liver failure and death within 12 months should be added as an eligibility criteria for the infection severity band ‘Hepatitis B- Acute infection (where the infection resulted in a fatality in the acute period)’. 

Conditions that have already been taken into account in the core awards are not included in the scope of Severe Health Condition supplementary awards.

HIV

These include:

• HIV distal sensory peripheral neuropathy
• Distal sensory peripheral neuropathy secondary to treatment with nucleoside  analogue reverse transcriptase inhibitors
• HIV mononeuritis multiplex 

Distal sensory peripheral neuropathy  caused by HIV and/ or treatment with early nucleoside analogue reverse transcriptase inhibitors was  very common in people living with HIV.  Given that almost all individuals infected with HIV through contaminated blood/blood products were  exposed to these early generation treatments, peripheral neuropathy is considered in the universality of the HIV compensation scheme rather than as a separate entity.

Diabetes

In general, Hepatitis and HIV infections are not considered to make a material enough contribution to the severity of diabetes related conditions to warrant additional awards. 

Our advice is based on identifying clinical markers, in accordance with the architecture of the Infected Blood Compensation Scheme. This means that the proposed supplementary Severe Health Condition awards are not directly comparable with the existing support schemes, although we have incorporated the clinical definitions used for their enhanced payments or special category mechanisms. In approaching this issue, we have taken into account the fact that existing support scheme beneficiaries will be able to choose to continue to draw those benefits as an alternative to the new compensation scheme regardless of their eligibility for a supplementary route award.

Severe Health Condition awards have been designed using the same structural framework as the core route. Financial loss per annum is based on a rate of median +5% annual salary, netted for tax and National Insurance. A ‘100% financial loss’ award equates to £29,657 per annum for the working period and 50% of this rate from retirement age to life expectancy as a pension award. In advising on the core route care award, the Expert Group set out a typical pattern of care needs after infection for each infection severity band. The Expert Group defined and costed five categories of care needs: end of life care, high care, moderate care, low care, and ‘domestic support and ad hoc care’. The care bands are described in the Expert Group’s report published on 23 August 2024. 

1. Severe visual impairment

Severe visual impairment can be a complication of HIV infection. Eligibility for a supplementary award would be established when applicants can show that they are registered as severely sight impaired (blind) and have evidence of one of the following opportunistic infections secondary to advanced HIV disease:

A. Cytomegalovirus retinitis 

B. Varicella zoster virus necrotising retinitis

C. Herpes simplex virus necrotising retinitis

D. Toxoplasmosis chorioretinitis

E. Optic neuropathy secondary to cryptococcal meningitis

F. Cortical blindness secondary to Progressive Multifocal Leucoencephalopathy

There would be no supplement to financial loss awards because 100% loss of earnings is already recognised in the core award. A supplementary care award would ensure domestic support and ad hoc care (£5,460 per annum) was included for all years when the eligible applicant suffered severe visual impairment that were not already attracting this level of payment or higher under the core award.

Severe visual impairment is not recognised as associated with HCV or HBV infection and therefore this category of supplementary award is only available when an HIV infection is present.

2. Neurological disorders resulting in physical disability

Neurological disorders resulting in long-term severe physical/ mobility disability can be associated with HIV, HBV and HCV. In people infected with hepatitis viruses, they are more likely to occur with cirrhosis and decompensated cirrhosis but this a supplementary Severe Health Condition award should be available to all those infected persons with such disorders who are eligible for core awards.

To be eligible for this supplementary award, applicants would need to provide evidence of a social services needs assessment confirming requirement for long term personal and domestic care as defined by the scheme in the low care band for a physical or mobility disability. The rationale is that the health conditions listed below may vary in clinical severity and thus the  impact on long term disability will be variable. A social services needs assessment will provide evidence of that impact and severity.  

Applicants would then need to show a relevant clinical diagnosis, which will be different depending on the virus.

HIV diagnostic categories

Applicants with an HIV infection would need to provide evidence to show they fall within one of the three categories below:

(A) One of the following central nervous system (CNS) opportunistic infections or neoplasms  secondary to advanced HIV disease:

I. Cerebral toxoplasmosis

II. CNS Tuberculosis

III. Cytomegalovirus encephalitis 

IV. Varicella zoster virus encephalitis

V. Herpes simplex virus encephalitis

VI. Epstein Barr virus encephalitis

VII. Progressive multifocal leukoencephalopathy

VIII. Cryptococcal meningitis

IX. Primary CNS lymphoma

X. Thromboembolic disease secondary to bacterial / fungal endocarditis 

(B) One of the following (CNS) conditions secondary to or associated with HIV infection:

I. HIV vacuolar myelopathy

II. Transverse myelitis

III. Thrombotic thrombocytopaenic purpura

IV. Cerebrovascular ischaemic / haemorrhagic  stroke 

V. Coagulopathies: Antiphospholipid syndrome 

(C) One of the following peripheral nervous system or myopathic conditions secondary to or associated with HIV infection:

I. Chronic inflammatory demyelinating polyneuropathy

II. Cytomegalovirus  polyradiculopathy

III. HIV myopathy

Cerebrovascular ischaemic and haemorrhagic stroke is included as people living with HIV infection have  a substantially  higher risk of cerebrovascular disease compared with people living without HIV, even when controlling for traditional risk factors such as smoking. There is insufficient high quality data to support the conclusion that infection with Hepatitis B or Hepatitis C significantly increases a person’s risk of cerebrovascular morbidity.  

Hepatitis diagnostic categories

Applicants with a Hepatitis C infection would need to provide evidence of:

(A) Cryoglobulinaemic vasculitis induced neurological disease that results in severe mobility disability

(B) Peripheral neuropathy caused by mixed cryoglobulinaemic vasculitis that results in severe mobility disability

Applicants with a Hepatitis B infection would need to provide evidence of:

(A) Peripheral neuropathy caused by mixed cryoglobulinaemic vasculitis that results in severe mobility disability

(B) Peripheral neuropathy occurring in the context of Hepatitis B associated polyarteritis nodosa

Peripheral neuropathy is included for Hepatitis B and C but not HIV because it is  included in HIV core awards. This is because early treatments for HIV almost invariably resulted in peripheral neuropathy and almost all individuals infected with HIV through contaminated blood/blood products would have been exposed to these early generation treatments.

Quantification 

Care awards for those eligible for this category of supplementary award would be at the low care band for those years when the relevant conditions were met that were not already attracting this level of payment or higher under the core award. This band equates to 16.5 hours per week consisting of 6 hours per week domestic support  and 1.5 hours per day personal care. 

Financial loss awards for those eligible applicants with Hepatitis would be adjusted to 100% upon evidence that an applicant was unable to return to work following diagnosis of the condition. No adjustment is made to financial loss awards for those in this supplementary award category with HIV as the core award already recognises 100% financial loss. 

3. Neurological disorders resulting in neurocognitive impairment and/or behavioural disorders

Neurological disorders resulting in long-term severe neurocognitive impairment and/ or behavioural disorders can be associated with HIV, HBV and HCV. In people infected with hepatitis viruses, these are common in those with decompensated cirrhosis severity bands, and 4 years support are included in the core award, but it may also occur in other severity bands where applications for supplementary awards would be considered. 

To be eligible for this supplementary award, applicants would need to provide evidence of a social services needs assessment confirming requirement for long term personal and domestic care as defined by the scheme in the low care band for a neurocognitive impairment. The rationale is that the health conditions listed below may vary in clinical severity and thus the  impact on long term disability. A social services needs assessment will provide evidence of that impact and severity.  

They would then need to show a relevant clinical diagnosis, which will be different depending on the virus.

Applicants with an HIV infection would need to provide evidence of one the following conditions for which HIV infection is considered the main underlying cause or is a major contributing factor:

A. HIV brain and/or HIV (cerebrovascular disease) resulting in neurocognitive impairment (dementia) and/or behavioural disorders

B. Legacy opportunistic CNS infections secondary to advanced HIV disease, (for example Post infectious encephalitis or Progressive Multifocal Leucoencephalopathy, resulting in neurocognitive impairment (dementia) and or behavioural disorders

Applicants with a Hepatitis B or Hepatitis C infection would need to provide evidence of the following condition:

A. Chronic hepatic encephalopathy of duration in excess of 4 years (the first four years being covered in the decompensated cirrhosis core award)

Care awards for those eligible for this category of supplementary award would be at low care (£23,424 per annum) for those years when the relevant conditions were met that were not already attracting this level of payment or higher under the core award. This band equates to 16.5 hours per week consisting of 6 hours per week domestic support  and 1.5 hours per day personal care. 

Financial loss awards for those eligible applicants with Hepatitis for years following diagnosis would be adjusted to 100% financial loss for years of Severe Health Condition diagnosis beyond 4 years upon evidence that the applicant was unable to return to work after diagnosis. No adjustment is made to financial loss awards for those in this supplementary award category with HIV as the core award already recognises 100% financial loss. 

4. Psychiatric disorders resulting in long term mental health disability

Psychiatric disorders resulting in long term mental health disability may be experienced by some people with HIV, HBV or HCV. Supplementary Severe Health Condition awards would be available to infected persons eligible for core awards who can show that one of the following diagnoses has been caused or significantly exacerbated by their blood-borne infection and that this has led to long-term consultant-led treatment needs.

Mental health conditions are common in people infected with blood borne viruses and thus compensation for these impacts is considered to be part of the core award available to all infected people. However, it is acknowledged that for some people the Severe Health Condition from mental health conditions is much more severe and longer lasting than may be for the majority. Applicants for the supplementary award would need to confirm diagnosis and severity and provide evidence to demonstrate a reduced capacity to work and or greater care needs over and above that stipulated in the schedule for the core awards. As potential  indicators of severity,  these mental health conditions would have resulted in episodes of inpatient psychiatric care (including detainment under the Mental Health Act)  and individuals would have been under regular psychiatry-led  follow up for a prolonged period of time.

The diagnoses that give rise to eligibility for the supplementary award, which can be caused or exacerbated by a blood-borne infection are:

A. Mood disorders:

i. Depressive disorders

ii. Bipolar disorders when brought forward (e.g. exacerbated or onset is accelerated) by the blood infection or interferon treatment.

B. Anxiety and stress related disorders:

i. Generalised anxiety and panic disorders

ii. Post traumatic stress disorders

iii. Adjustment disorders

C. Psychotic disorders:

i. Secondary psychotic disorders due to HIV brain disease, HIV related CNS opportunistic infection or neoplasia, or interferon treatment 

Applications for this Severe Health Condition award would need to be supported by:

1. A report from a consultant psychiatrist confirming (i) the diagnosis; (ii) the major role of blood borne infection or interferon treatment in the aetiology and / or of course the mental health disorder, AND

2. One of the following:

a. Report from a consultant psychiatrist confirming the patient received consultant-led secondary mental health treatment for six months or more. 

b. Evidence of inpatient admissions for treatment of mental health disorder

c. Evidence of history of sectioning or detention under the Mental Health Act; AND

3. For an applicant to receive an uplift award to reflect provision of  low care, assessment by local social care team detailing low care requirements.

To be eligible for an uplift in care award to the low care band, applicants would need to provide evidence of a social services needs assessment confirming requirement for long term personal and domestic care as defined by the scheme in the low care band. The rationale is that the health conditions listed may vary in clinical severity and thus the  impact on long term disability. A social services needs assessment will provide evidence of that impact and severity.  

Care awards for those eligible for this category of supplementary award would be at low care (£23,424 per annum) for those years when the relevant conditions were met that were not already attracting this level of payment or higher under the core award. This band equates to 16.5 hours per week consisting of 6 hours per week domestic support  and 1.5 hours per day personal care. 

Financial loss awards for those eligible applicants with Hepatitis for years following diagnosis would be adjusted to 100% upon provision of evidence that the applicant was unable to return to work after diagnosis of Severe Health Condition. No adjustment is made to financial loss awards for those in this supplementary award category with HIV as the core award already recognises 100% financial loss. 

5. End-stage kidney disease requiring renal replacement therapy 

End-stage kidney disease requiring renal replacement therapy (RRT) may be required by some eligible infected persons with HIV, HBV, and HCV. Hepatitis patients in any of the chronic, cirrhosis, or decompensated cirrhosis severity bands may be affected.

Applicants with an HIV infection would need to provide evidence of an end-stage kidney disease listed below which has required renal replacement therapy (RRT) for a minimum of 3 months:

(A). HIV associated nephropathy

(B). HIV associated immune complex chronic kidney disease

(C). Drug associated kidney disease in conjunction with treatment with foscarnet sodium or cidofovir or tenofovir disoproxil

Applicants with a Hepatitis B infection would need to provide evidence of condition below in addition to renal replacement therapy (RRT) for a minimum of 3 months:

(A). Membranous Nephropathy

(B). Membranoproliferative glomerulonephritis including in the presence of mixed cryoglobulinaemic vasculitis

(C). IgA nephropathy

(D). Tenofovir disoproxil induced renal failure

Applicants with a Hepatitis C infection would need to provide evidence of condition below in addition to renal replacement therapy (RRT) for a minimum of 3 months:

(A). Membranoproliferative glomerulonephritis including in the presence of mixed cryoglobulinaemic vasculitis

Care awards for those eligible for this category of supplementary award would be at low care (£23,424 per annum) for those years when the relevant conditions were met that were not already attracting this level of payment or higher under the core award. This band equates to 16.5 hours per week consisting of 6 hours per week domestic support  and 1.5 hours per day personal care. 

Financial loss awards for those eligible applicants with Hepatitis for years following diagnosis would be adjusted to 100% for years on dialysis. No adjustment is made to financial loss awards for those in this supplementary award category with HIV as the core award already recognises 100% financial loss. 

6. Other Hepatitis-associated disorders resulting in long-term severe disability

The Expert Group has reviewed the criteria used in existing Infected Blood Support Schemes for ‘enhanced’, ‘advanced’ or ‘special category’ payments in respect of beneficiaries who experience significantly increased impact from their infections. As with the support schemes, this supplementary Severe Health Condition group addresses the situation of those eligible under the compensation scheme with Hepatitis B and/or Hepatitis C Chronic infections.

The Expert Group has identified the following additional (i.e. not already addressed in the earlier supplementary categories) Hepatitis-associated disorders that can result in long-term severe disability. As the compensation scheme is based on clinical markers that will be accessible, assessable and verifiable, the Group does not think it is appropriate or proportionate to require applicants to make personal life impact statements. It notes that applicants who currently receive enhanced awards under the existing support schemes will be able to choose to continue with those payments instead of taking the amounts that would be awarded for future years financial loss and care. This ensures that they are not disadvantaged by the approach we have taken.

(1) Applicants with a Hepatitis C infection would need to provide evidence of one of the following autoimmune diseases caused by or exacerbated by interferon treatment for Hepatitis C:

A. Coombs positive haemolytic anaemia

B. Idiopathic fibrosing alveolitis of the lung

C. Rheumatoid arthritis

(2) Applicants with a Hepatitis C infection would need to provide evidence of one of the following:

A. Sporadic porphyria cutanea tarda causing photosensitivity with blistering;

B. Immune thrombocytopenic purpura;

C. Type 2 or 3 mixed cryoglobulinaemia accompanied by: cerebral vasculitis; dermal vasculitis; or, peripheral neuropathy with neuropathic pain.

(3) Applicants with a Hepatitis B infection would need to provide evidence of one of the following autoimmune diseases:

A. Coombs positive haemolytic anaemia – caused by or exacerbated by interferon treatment for Hepatitis B

B. Idiopathic fibrosing alveolitis of the lung – caused by or exacerbated by interferon treatment for Hepatitis B

C. Rheumatoid arthritis – either related to the virus directly or caused by or exacerbated by interferon treatment for Hepatitis B

D. Aplastic anaemia where treatment results in long term severe disability

Quantification for living infected victims

For those who qualify for a supplementary Severe Health Condition award in this category, financial loss awards need to reflect that there is a greater impact on the earning capacity than the core award anticipates. The core awards are based on the expectation that victims with chronic HBV and HCV infections would experience a 40% loss of earning capacity until effective treatments became available. 

Adjustments were made for those able to benefit from treatment advances (although these were not applied for those who had reached the age of 55 on the relevant date as it was unreasonable to expect them to be able to re-enter the workforce after a period of absence). The point in time when effective management became sufficiently widely available is different for HBV and HCV (and consequently that date of birth of those who would be aged 55 at that point is also different). In our previous report we gave our reasons for setting the dates of 2008 for HBV (aged 55 or more years being those born in or before 1953) and 2016 for HCV (aged 55 or more years being those born in or before 1961). 

We advise that the earning potential reductions on which awards should be calculated for those in this supplementary Severe Health Condition category should fall between the core chronic band (40% loss of earning capacity) and the Cirrhosis band (80% loss of earning capacity). We advise that this should be set at 70% for the period prior to effective management becoming available and 60% for later years.

This means that our advice is that for those with a Hepatitis B infection:

• born in or before 1953:  70% financial loss (£20,760 per annum)
• born after 1953: from diagnosis until 2009: 70% financial loss (£20,760 per annum)
• For those born after 1953: 2009 onwards: 60% financial loss (£17,794 per annum)

 For those with a Hepatitis C infection:

• born in or before 1961:  70% financial loss (£20,760 per annum)
• born after 1961: from diagnosis until 2017: 70% financial loss (£20,760 per annum)
• born after 1961: 2017 onwards: 60% financial loss (£17,794 per annum)

Care awards also need to be uplifted to recognise greater support needs. This should take the form of paying the domestic support and ad hoc care award from the date of diagnosis of the condition, so that it is no longer limited to 10 years duration as in the core award.

Quantification for deceased victims

Financial Loss: We recognise that some deceased victims will have suffered these Hepatitis-associated disorders. For these, we suggest that the financial loss supplementary award should be a fixed sum equivalent to a top-up award for six years of the difference between financial loss for the chronic and and cirrhosis bands. It would not be reasonable to expect attribution to specific years of financial loss as that is likely to be varied for each SCM applicant. This supplementary amount is £71,178.

Care award: The current care profile for the hepatitis chronic severity band is 10 years domestic and ad hoc care. For those deceased persons receiving a supplementary award in this category this should be extended up to an additional 10 years for that part of their life when they met the eligibility criteria.

Exceptional Loss awards

Financial Loss

The aim of the Exceptional Loss supplementary route is to address the position of beneficiaries whose earning potential is greater than the core award of UK median earnings plus 5%. This requires the compensation scheme to estimate the financial loss that would have been suffered by an infected person with higher earning potential. It must take into account the fact that while they may have evidence of their salary before the wrongful infection, their earning power will be reduced once they are infected.

To address this, the advice of the Expert Group is that the supplementary award should take into account both the general pattern of pay increases and also the likely progression of someone who was similarly placed in the range of salaries. 

To ensure that general pay increases are recognised, the applicant’s salary at the point where their ability to work was first reduced should be matched with the equivalent salary for the same percentile point in the range of salaries in 2023. Thus, someone who received a salary at the 70th percentile (i.e. that 69% of the population earned less than them and 30% earned more) when they became infected would have their earnings assessed at the 70th percentile of earners in 2023 rather than their actual earnings when infected.These salary levels would be netted off for tax and national insurance, as in the core awards. 

To address the concern that likely promotions would not be recognised, a progression multiplier is advised for those aged between 18 and 39.  For these applicants, the 2023 salary matching the percentile that they were earning at when infected will be multiplied by the figure in the table below. This is based on the pattern of increases in earnings that are seen for those in the relevant percentile of salary, taking into account the age when the applicant’s ability to work was reduced. The figures underpinning this calculation are drawn from the Annual Survey of Hours and Earnings (ASHE). The ASHE tables provide the most reliable and consistently available sources to track earnings over time. The Expert Group has advised to not use gender split earnings tables where possible to help mitigate against aspects of historic gender pay gap inequalities.

Table 1) Progression multipliers for annual earnings based on ASHE table data

Percentile of earnings

Age group	10	20	30	40	50	60	70	80	90
18-21	1.82	1.67	1.63	1.65	1.7	1.8	1.88	1.99	2.26
22-29	1.09	1.12	1.15	1.19	1.24	1.27	1.3	1.35	1.45
30-39	1	1	1	1	1.01	1.02	1.04	1.05	1.09
39+	1	1	1	1	1	1	1	1	1

For those over the age of 39 when they were infected, the average pattern of ASHE earnings would suggest a reduction in earnings, that is the multiplier would be less than 1. However, the expert group recommends that this should be disregarded and these older applicants would be assumed to continue to earn their matched salary. 

These calculations account for salaries received, but not pension contributions that would also be likely to be paid by employers. This is addressed by including a defined pension contribution rate of 6.1%, reflective of private sector occupational pension contribution rates in the period 2000-2013.

This approach allows the financial loss of higher earners to be calculated for each year of infection period to death for deceased infected persons or health life expectancy for living infected persons based on evidence of their earnings prior to infection without requiring detailed evidence for every year that they are unlikely to be able to obtain.  

The cap on Exceptional Loss awards

Ministers previously announced the intention that there should be a cap on the awards for financial loss payable through the compensation scheme. We have been asked to advise on how such a cap might be set.

The Expert group notes that at the highest levels of earnings, it is difficult to assess salaries.  The Annual Survey of Hours and Earnings (ASHE) tables readily enable calculations to be made for employees up to the 90th centile (i.e. for 90% of employees in any year). We note the inherent limitations that arise because ASHE covers employee jobs in the United Kingdom as data is drawn from HM Revenue and Customs Pay As You Earn (PAYE) records. However, this method is in line with recommendations from Sir Robert to use comparable ASHE statistics when calculating additional financial loss awards. The Expert Group agrees that this provides greater objectivity than any available alternative, noting that higher earning applicants retain the right to go to court. The Expert Group advises that it would be appropriate to cap the Exceptional Loss awards at the 90th centile to enable the ASHE data to be used as it gives objectivity to the calculations without requiring disproportionate evidence from beneficiaries. 

For those cases where financial loss exceeds this cap, then a court application will be required. Such high awards are likely to require assistance from forensic accountants as there is often a complex structure of remuneration. Similar difficulties arise in respect of  non-PAYE income as there can be no confidence that the tax and progression assumptions that we have used would apply. The Expert Group considers that a tariff-based Infected Blood Compensation Scheme is not suitable for such cases. It recognises that some applicants will be able to produce reliable evidence of earnings outside of PAYE and would advise Ministers that options should be explored further than has been possible within the Expert Group’s remit.

Care

The Core Awards are based on anticipated patterns of care for each of the severity bands. For past care, where evidence is likely to be unavailable, the core awards assumed that care was provided without charge by friends and family. This led to a discounting by 25% of commercial rates to reflect that tax, national insurance and other costs would not have been paid. If, in fact, applicants have evidence that they have paid for care, then it follows that this discount should be removed and the full rate paid.

While it is possible that applicants will have paid for care at rates in excess of the average commercial tariffs that we have used for care awards, the recommendation from Sir Robert Francis was to meet this where the actual costs incurred were a reasonable reflection of the infected person’s needs. The Expert Group notes that it will be complex to assess the impact of inflation on actual payments and also difficult to determine whether the more expensive care was a ‘reasonable reflection’ of needs. For the core awards, we have adopted 2024 commercial rates as a reasonable proxy for calculating historical rates and then uplifting for inflation. This does not address the ‘reasonable reflection’ criterion. In the interests of fairness between applicants, proportionality in relation to evidence requirements, and stewardship of public funds, the Expert Group thinks that it is reasonable to regard 25% uplift on the core award for care costs as a cap on what should be awarded via the supplementary route. 

We have also reviewed the patterns of care that we anticipated would follow from infection according to the relevant severity band. We have taken into account the feedback that sometimes care needs are greater. We have therefore made proposals for additional categories of supplementary ‘Severe Health Condition’ awards (see above). Beyond these groups, our advice is that further care costs are more likely to be due to care needs associated with other comorbidities or age rather than with HIV or Hepatitis. We think these should be beyond the scope of the scheme. We note that monies received by the scheme are disregarded from the financial assessment for social care charging by local authorities so would not impact on an applicant’s access to support for care related to other comorbidities or age. 

Autonomy award for victims of unethical research

Sir Robert Francis KC recommended that a supplementary autonomy award be made available to victims of unethical research projects, and that eligibility for such an award should be based on the evidence set out in the IBI Report.

We have reviewed the sections of the Inquiry Report that report on research practices at Treloar College (Vol 2) and at Haemophilia Centres (Vol 4) and searched all the other five volumes for references to research. Those studies criticised in these sections have been reviewed to identify how eligibility for the unethical research award should be defined. Following that review, we have considered three potential criteria for eligibility for the unethical research autonomy award and advised on the one that we think best reflects the recommendation of Sir Robert Francis that there should be a supplementary autonomy award for those subjected to unethical research. This covers studies where treatment has been determined by study design rather than individual clinical need. 

We have also considered the challenges that applicants would face providing evidence and suggest that the best way forward is to make eligibility for this supplementary award follow from treatment in research active Haemophilia Centres during the date range during which the studies identified in the Report were carried out. This approach has been tested with groups representing the infected blood community and the range of centres to be included has been extended in the light of the responses received.

Eligibility criteria

The criterion we advise using to determine eligibility covers studies that altered treatment of patients without fully informed consent through which participants chose to accept the risks. We think this is most consistent with the suggestion of Sir Robert Francis that ‘the additional compensation is for the denial of the right to consent to or refuse experimental treatment, and the resulting distress at the denial of autonomy.’ Our advice is therefore that it is participation in such studies that should make infected persons eligible for the supplementary unethical research autonomy awards. 

We considered and have advised that we do not think that it would be proportionate to investigate the possibility that some such interventional studies may have been conducted ethically. This is because:

• Where evidence of Research Ethics Committee (REC) views was available, the IBI found that ethical problems remained. Consequently, evidence of REC approval should not make an applicant ineligible for an unethical research supplementary award. Further, the IBI was not satisfied that statements in publications that REC approval had been given and informed consent had been obtained were sufficient to show that studies were ethical. Consequently, it is not appropriate to rely on such statements when eligibility is determined. Equally, the lack of a consistent approach of the establishment of Research Ethics Committees (RECs) at the time of these studies and the absence of comprehensive historical records of REC decisions make it inappropriate to rely on the absence of such records as evidence that REC approval was not given.

• The IBI found that consent practices of the time were insufficient to constitute fully informed consent, so that the existence of a consent form should not negate eligibility. 
• The Inquiry considered a number of ways in which research could be categorised, but it also found that these classifications were not always reliable. The main assessment was that there were systemic ethical deficiencies in a culture that treated victims as the subjects of research scrutiny rather than participant partners as we now recognise is required by research ethics. The contemporary culture of research failed to respect victims’ autonomy as it should. 

Given these challenges of assessing particular studies, the view of the Expert Group is that all those who were subjected to interventional studies should be eligible for the unethical research award without further inquiry.

We also considered, and have advised against, two further potential criteria for eligibility. The first of these concerns cases where tests for infection were carried out within studies without the results being disclosed to participants. We advise that this should not be used as an eligibility criterion for the additional autonomy award as this practice was not limited to the research context (as noted by Sir Brian Lanstaff in Volume 2 at page 214) and is already recognised as one of the factors in setting the tariff amounts of autonomy awards for all infected persons. 

The second potential basis for eligibility arises where data about patients were used without appropriately informed consent, as in a number of surveillance studies carried out through haemophilia centres. Sir Brian Langstaff was critical of this in relation to specific studies carried out in the 1970s but did not express the same criticisms of the similar collation of data from 1969-74.  If the collection of data on clinical outcomes were to be the criterion for eligibility for the unethical research award, then our advice is that, to be consistent, eligibility would need to extend to all eligible infected persons treated in a haemophilia centre after 1969. This is because the centres routinely shared data on products used and outcomes for patients in order to understand the challenges better. However, this would take the date range beyond that expressly identified by Sir Brian Langstaff of the 1970s and early 80s (Vol 1 p 19, Vol 2 p 214, Vol 4 p3 09). We therefore advise that it should fall outside the scope of the supplementary award.

Evidence of Eligibility

While the criteria for eligibility can be specified, we recognise that it will be difficult in some cases for applicants to produce evidence that they were a participant in an eligible study. Confidentiality requirements will have precluded the naming of participants in publications. For some victims, evidence placed before the Inquiry proves their participation in these projects, for example the existence of a consent form. However, these types of evidence have not been systematically retained. For other victims, it may be possible to infer participation from the data in publications about recruitment of participants. One example would be where a study reports analysis of significant numbers of those treated in particular centres during an identified recruitment period. It would be reasonable to infer that someone treated for the condition in that centre during that period was a participant even when there is no direct evidence of this. On the basis of the research sections of the IBI Report, this was the case in relation to some of the Haemophilia Centres and Treloar College. 

Haemophilia Centres

If our advice is followed that the unethical research autonomy supplementary award should be paid to those whose treatment has, or may have been, altered because of their participation in a research study, then eligibility should be determined by treatment at those centres where the studies were conducted during the dates when they were carried out.

A review of the Report suggested that the relevant date range was 1974-1984. It also identified the following Haemophilia Centres: 

• Oxford 
• Edinburgh 
• Newcastle 
• Royal Free 
• Glasgow 

Following the community engagement process suggestions for additions were reviewed and the following centres were added:

• Sheffield 
• Cardiff
• Manchester
• St Thomas’

The engagement process also prompted a careful review of a number of identified studies but this did not lead to the date range being extended. A re-examination was made of the comments in the IBI Report on children’s centres. This led to the conclusion that they were treatment centres rather than involved in research. Even when novel treatments were tried, this seemed to be for clinical reasons not determined by a study protocol. For this reason, they were different to the situation at Treloar College and the advice is that they should remain outside of the scope of the unethical research supplementary autonomy award.

‘Dr Craske’s Research’

The National Haemophilia Database (NHD) assigned a number of entries to ‘Dr Craske’s Research’ rather than a specific physical centre. These entries were understood by the Inquiry to relate in part to a retrospective survey published in 1978 based on the sharing of data with Dr Craske by the haemophilia centres. This falls within the second potential eligibility criterion as it involved the sharing of personal data without knowledge or consent on the part of the patients but their treatment was not determined by the design of the study. 

Some of those recorded on the NHD as participants in ‘Dr Craske’s research’ were, however, involved in specific studies that did change their treatment, at least to the extent of additional samples being taken. Victims who were part of these studies should be eligible for the unethical research award under the proposed eligibility criterion. Most eligible applicants will have been treated in centres and within a time window where we propose eligibility will be demonstrated. However, it is not possible to be certain that this covers all cases and the Inquiry noted the distress caused to victims by the entries in the NHD recording that they had been part of ‘Dr Craske’s research’. We therefore advise that any patient whose NHD entry records them as being involved in Dr Craske’s research should be eligible for the unethical research autonomy award even if they would not otherwise have demonstrated their eligibility.

Lord Mayor Treloar College

Sir Brian Langstaff’s summary noted that there were multiple research projects at Treloar College, during the 1970s to early 1980s. Examining the text and footnotes in the report, there was a study of incidence of hepatitis associated antigen antibodies that involved observation from the summer term of 1970 to 1971 covering 54 boys (Cossart & Rainsford, HHFT0000332). A number of studies were conducted by Dr Aronstam between 1973 and 1979 (TREL0000517). The latest trial identified in the Report appears to be in 1983 (Vol 2 p 193).  The Expert Group therefore advises that  all those victims who were pupils/patients at Treloar College from 1970 to 1983 (inclusive) are regarded as eligible for the  supplementary autonomy award for unethical research without further enquiry as to whether they were involved in any particular trial. The Report also mentions testing without knowledge or consent in 1984/5 but this appeared to be as part of clinical practice rather than research and it was noted that this approach was widespread in the UK at the time (Vol 2 p 214).  We suggest that all those who receive compensation under the scheme and who were patients at Treloar College between 1970 and the end of 1983 should receive the £15,000 addition to their autonomy award.