Thursday 26 November 2020
Business, Energy and Industrial Strategy
Departmental Contingent Liability Notification: Human Challenge Project
I am tabling this statement for the benefit of right hon. and hon. Members to bring to their attention the contingent liabilities relating to the contract signed between the Government and Imperial College London for the human challenge project.
This project was announced on 20 October and is aimed at supporting the search for a covid-19 vaccine. A £33.6 million Government investment will back the project in partnership with Imperial College London, hVIVO and the Royal Free London NHS Foundation Trust.
In human challenge studies, a vaccine candidate that has proven to be safe in initial trials is given to a small number of carefully selected healthy, young adult volunteers who are then exposed to the virus in a safe and controlled environment. These studies offer the chance to accelerate development of promising vaccines against covid-19, bringing them to people more quickly and potentially saving thousands of lives.
The first step of the project is the virus characterisation study. This will begin in January 2021 and establish the smallest amount of virus needed to cause covid-19 infection in the volunteers. Robust safety, ethics, and regulatory approvals will be put in place before the study begins. Imperial College is the academic study sponsor for the characterisation study. As study sponsor, Imperial will be liable for any negative side-effects volunteers may experience in this study. Imperial has therefore taken out its own insurance, up to the sum of £10 million and for up to 36 months after completion of the study.
My Department has agreed to provide the excess for a relief claim that Imperial may make for a maximum of £15,000 per volunteer (to a maximum of the 90 volunteers involved in this study). This is only applicable where the claim arises as the result of the study but not as the result of one of the parties’ negligence. In addition to the agreed excess, my Department has agreed to provide unlimited indemnity beyond the £10 million.
My Department believes that this is a justifiable position given the very low risk of exceeding the maximum liability. In a reasonable worst-case scenario, our analysis estimates that liability would be under £1.5 million. Therefore, we do not expect the maximum liability to be exceeded.
A full departmental minute will be laid in the House of Commons providing more detail on this contingent liability.
Health and Social Care
Covid-19 Winter Plan: Tiers
On 23 November, the Prime Minister set out our covid-19 winter plan in Parliament. Our covid-19 winter plan puts forward the UK Government programme for suppressing the virus, protecting the NHS and the vulnerable, keeping education and the economy going, and providing a route back to normality.
Thanks to the shared sacrifice of everyone in recent weeks, in following the national restrictions, we have been able to start to bring the virus back under control and slow its growth, easing some of the pressure on the NHS.
We will do this by returning to a regional tiered approach, saving the toughest measures for the parts of the country where prevalence remains too high.
The tiering approach provides a framework that, if used firmly, should prevent the need to introduce stricter national measures.
On 2 December, we will lift the national restrictions across all of England and the following restrictions will be eased:
The stay-at-home requirement will end.
Non-essential retail, gyms, personal care will reopen. The wider leisure and entertainment sectors will also reopen, although to varying degrees.
Communal worship, weddings and outdoor sports can resume.
People will no longer be limited to seeing one other person in outdoor public spaces, where the rule of six will now apply.
The new regulations set out the restrictions applicable in each tier. We have taken into account advice from SAGE on the impact of the previous tiers to strengthen the measures in the tiers, and help enable areas to move more swiftly into lower tiers.
The changes to the tiers are as follows:
In tier 1, the Government will reinforce the importance that, where people can work from home, they should do so.
In tier 2, hospitality settings that serve alcohol must close, unless operating as restaurants. Hospitality venues can only serve alcohol with substantial meals.
In tier 3, hospitality will close except for delivery, drive-through and takeaway, hotels and other accommodation providers must close (except for specific exemptions, such as people staying for work purposes, where people are attending a funeral, or where they cannot return home) and indoor entertainment venues such as cinemas, theatres and bowling allies must also close. Elite sport will be played without spectators. Organised outdoor sport can resume, but the Government will advise against higher risk contact sports.
These are not easy decisions, but they have been made according to the best clinical advice, and the criteria that we set out in the covid-19 winter plan.
Case detection rates in all age groups
Case detection rates in the over-60s
The rate at which cases are rising or falling
Positivity rate (the number of positive cases detected as a percentage of tests taken)
Pressure on the NHS.
The indicators have been designed to give the Government a picture of what is happening with the virus in any area so that suitable action can be taken. These key indicators need to be viewed in the context of how they interact with each other as well as the wider context but provide an important framework for decision making, assessing the underlying prevalence in addition to how the spread of the disease is changing in areas. Given these sensitivities, it is not possible to set rigid thresholds for these indicators.
The regulations will require the Government to review the allocations every 14 days, with the first review complete by the end of 16 December.
We have been able to announce UK-wide arrangements for Christmas, allowing friends and loved ones to reunite, and form a Christmas bubble of three households for five days over the Christmas period.
We have increased funding through our contain outbreak management fund, which will provide monthly payments to local authorities facing higher restrictions.
We are also launching a major community testing programme, homing in on the areas with the greatest rate of infection.
This programme is open to local authorities in tier 3 areas and offers help to get out of the toughest restrictions as fast as possible.
The listed areas will be in each tier from the 2 December. This list will also be published on gov.uk and a postcode tracker will be available for the public to check what rules apply in their local area.
A list of allocations can be found at: https://questions-statements.parliament.uk/written-statements/detail/2020-11-26/HCWS608
Public Health England: Annual Report and Accounts 2019-20
I wish to inform the House of the publication of Public Health England’s annual report and accounts for the financial year 2019-20. A copy of the annual report and accounts 2019-20 (“the Report”) has been laid before both Houses.
Public Health England (PHE) is an Executive agency of the Department of Health and Social Care, providing the evidence, support and advice needed locally, nationally and internationally. PHE is responsible for four critical functions: protecting the public’s health; improving the public’s health, improving population health; and supporting the capacity and capability of the public health system in England.
The report sets out the activity, performance and expenditure of PHE for key areas of its business for 2019-2020 financial year and reflects the position as at 31 March 2020. The report is based on activity in the 2019-20 financial year and notes that some performance in the final quarter was impacted because PHE rigorously reprioritised to free up significant internal resource for the covid-19 response.
As referenced in the report, on 18 August 2020, the Government announced the establishment of a new National Institute for Health Protection (NIHP), which will bring together the additional testing capacity at scale of NHS test and trace, the joint biosecurity centre intelligence and analytical capability with the public health science and health protection expertise of PHE. NIHP will be formally and fully established in 2021.
NHS test and trace and PHE put in place integrated arrangements on the covid-19 response and created a joint situational awareness team to provide analysis and insight into the progression of the virus, under single leadership.
Until further formal changes are made, PHE continues to operate and deliver its core functions in line with its framework agreement and continues to be held to account for delivery against the priorities set by Government in the annual strategic remit and priorities letter and agreed business plans through formal quarterly accountability meetings. PHE’s governance boards and groups and PHE’s advisory board also continue to operate. There will be a continued focus on responding to covid-19, now and throughout the winter. Health improvement, preventing ill health and reducing inequalities will also remain priorities for PHE, prior to full transition to new arrangements.
Work is underway to determine the right future arrangements for PHE’s vital non-health protection functions, including health improvement responsibilities, and we will engage widely on proposals before implementing new arrangements in 2021.
Elizabeth Dixon Investigation Report
Today we have published the report into the events surrounding the death of Elizabeth Dixon—a baby who sadly died in December 2001 from asphyxiation resulting from a blocked tracheostomy tube and while under the care of a private nursing agency.
I offer my heart-felt condolences to Elizabeth’s family, to Anne and Graeme Dixon for their loss, compounded by the length of time—the passage of 20 years—before the facts of this case have been brought to light.
The investigation led by Dr Bill Kirkup was tasked with reviewing the care given to Elizabeth Dixon between her birth on 14 December 2000 and her death on 4 December 2001—and the response of the health system to a catalogue of errors and serious failings in that care.
This report describes a harrowing and shocking series of mistakes associated with the care received by Elizabeth and a response to her death that was completely inadequate and at times inhumane. Elizabeth and her family were let down by a failure to diagnose or respond to her underlying condition, to put in place the care she required, to acknowledge the circumstances of her death or provide her parents with an honest account of these failings.
The investigation sheds light on what the report describes as a “20 year cover up”. It alleges that some individuals have been persistently dishonest in accounting for their actions or inaction.
Underlying all of this was the acceptance of a flawed prognosis that influenced the future course of events. It created a situation in which
“facts were wilfully ignored, and alternatives fabricated”.
Shocking too is the implication in the report’s recommendations that the presence of her physical and mental health needs may have been used to justify or excuse the inadequate care she had received.
On behalf of Government and the health system I would like to say I am truly sorry for the devastating impact this must have had upon the Dixon family.
Individuals made mistakes and acted unprofessionally, but the system allowed it. The report makes it clear that
“clinical error, openly disclosed, investigated and learned from, should not result in blame or censure; equally, conscious choices to cover up or to be dishonest should not be tolerated”.
It is also unacceptable for patients ever to be exposed to unsafe or poor care, and I remain fully committed to ensuring we provide the highest standards of quality and safe services to all patients.
I am grateful to my right hon. Friend the Member for South West Surrey (Jeremy Hunt) for commissioning this investigation in June 2017 when he was Secretary of State for Health and bringing these events into the open. I would also like to thank Dr Bill Kirkup and his team for the diligence and hard work that has informed their report.
Particularly, I would like to pay tribute to Anne and Graeme Dixon who have fought so hard for answers. I hope this report is the beginning of a process that will bring some closure for the family. They should not have had to wait for so long.
This report shines a light on a culture of denial and cover up 20 years ago that left a family with little choice but report their concerns to the police. Families should not have to fight a closed system for answers and I will not hesitate to expose this sort of behaviour whenever it appears today. Indeed, Elizabeth’s legacy should be that other families will always be told the truth.
Relevant organisations will need to consider and reflect carefully on the report’s recommendations. There is no room for complacency. The continual appearance of shocking reports about patient safety—historical or more recent—implies there is much for the NHS to focus on. My Department will therefore have oversight of their responses and report back to the House. There needs to be learning and implementation, but above all I want to be assured that we are doing all we can to make sure such events cannot happen again.
No other family should ever again have to go through the heartache and frustration experienced by the Dixons and I apologise again for the failings set out in this report.
Copies of the report have been laid before the House.