Welcome to our monthly healthcare update with all the latest developments you need to know about
Highlights this month include; an overview of the Health and Care Act and how the changes will impact the organisations that make up the NHS; details of a new funding cap introduced on personal care; and the announcement of new data protection laws and their potential impacts on patients.
- Covid Inquiry
The Covid-19 pandemic was a material test of the state’s preparedness, resilience and co-ordination. The response from the UK Government and devolved administrations raised broader questions about how effectively the challenges were met. There have been longstanding calls for a public inquiry to be held into the UK’s response to the COVID-19 pandemic. Two public inquiries have now been set up, one by the UK Government and one by the Scottish Government. Baroness Hallett, a former Court of Appeal judge, is chairing the UK Government’s inquiry. She has advised that public hearings are unlikely to begin before 2023. The Scottish Government’s inquiry is being chaired by Lady Poole, a Court of Session judge. The inquiry is expected to launch properly in “early summer 2022”. The Welsh Government resisted calls to hold its own public inquiry. It argued that it was better to have a co-ordinated, UK-wide approach that recognises relevant devolved dimensions.
It has however been suggested that the COVID inquiry has been set up to fail. This is because the inquiry chair, Lady Hallett, “will not be asked to apportion blame for any failures she identifies”. In addition, the barrister Adam Wagner has stated that a notable omission from the UK inquiry’s terms is that there is no reference to the impact of pandemic decision-making on human rights. The Scottish inquiry’s terms do refer specifically to this. Wagner has urged that it be added following the engagement process and consultation.
- Integrated Care Systems
In September 2021, The Department of Health and Social Care (DHSC), NHS England (NHSE) and the Local Government Association (LGA) published an ICP engagement document Integrated Care System (ICS) Implementation. The document focuses on the role of integrated care partnerships (ICPs) within statutory arrangements for integrated care systems (ICSs). Following that publication, the DHSC, NHSE and LGA conducted a trilateral engagement exercise with those who have an interest in the formation of integrated care partnerships (ICPs). This paper sets out the key findings of that exercise and proposes next steps. It also outlines how DHSC, NHSE and the LGA intend to support and guide the development of these new partnership arrangements going forward. Following this, the Government has acknowledged that some may not hit the deadline. The government advice states, “Whilst we recognise that ICPs will be at different stages of development and that 2022 to 2023 is a transition year as systems get established, we are encouraging, but not mandating, that all ICPs have at least an interim integrated care strategy by the end of 2022.”
- NHS Legislation: The Health and Care Act
The Health and Care Act 2022 received Royal Assent in April 2022, enacting the most significant health legislation in a decade into law. The Act introduces measures to tackle the COVID-19 backlogs and rebuild health and social care services from the pandemic, backed by £36 billion over the next 3 years through the Health and Care Levy. It will also contain measures to tackle health disparities.
How will these changes impact the organisations that make up the NHS and what does it mean for patients? More people are living longer and many people have multiple conditions that require ongoing care. This is not reflected in the current NHS structure, which patients can find difficult to navigate. The act looks to resolve this in the following ways:
- Stopping automatic tendering of NHS services which will stop enforced competition, which was perceived as leading to fragmentation of services;
- Supporting the development of Integrated Care Systems (ICSs) by requiring all health bodies to cooperatively pursue, better care for all patients, and better health and wellbeing for everyone;
- Expanding the powers of the Secretary of State for health, as they will have increased power to direct the NHS, create new NHS trusts and intervene in local service reconfiguration;
- The Secretary of State will be required to publish a report at least once every five years on workforce planning; and
- A new £86,000 cap on the amount anyone in England will need to spend on their personal care over their lifetime. Only personal contributions to the cost of care will count towards the cap.
Critics of some of these amendments, including the BMA, are concerned that there is not enough government accountability for ensuring that the health and care system has adequate staffing numbers. Another concern is that the NHS should be established as the default option for providing NHS contracts to protect the NHS from costly procurement. It is also believed that there should be safeguards and limitations over the Secretary of State’s powers within the Bill to avoid them having unnecessary political influence.
The Department of Health and Social Care (DHSC) has tabled a landmark amendment to the Health and Social Care Act, which aims to ensure that the NHS is not buying or using goods or services produced by or involving any kind of slave labour. This represents a significant step forward in the UK’s mission to crack down on the evils of modern slavery. The power will allow tough regulations to be made which can set out steps that the NHS should be taking to assess the level of risk associated with individual suppliers, and the basis on which they should exclude them from a tendering process.
- NHS Legislation: Further Updates
The Government's 2022-23 mandate to NHS England confirms the objectives and budget for the year ahead. The objectives include:
- Continuing to lead the NHS in managing the impact of COVID-19 on health and care;
- Renewing focus on delivering against the NHS Long Term Plan and broader commitments for the NHS;
- Embedding a population health management approach within local systems, stepping up action to tackle health disparities; and
- Ensuring effective NHS leadership, culture, and use of organisational resource to realise the benefits from future structural changes within health and care.
The National Institute for Health and Care Excellence seeks views on an updated evidence standards framework (ESF) for digital health technologies. A consultation on an updated version of the ESF framework is an opportunity to help shape the framework and ensure it meets developer and adopter needs. It is also seeks views on an updated real-world evidence framework. The consultation ended on 25 April 2022.
The European Council has adopted proposals by the European Commission to ensure the continued long-term supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. These markets have been historically supplied through or by Great Britain. These measures will apply retroactively from 1 January 2022. It is expected that within three years, until 31 December 2024, these markets will gradually phase out the temporary derogations and decrease the dependency of their domestic markets on the supply with medicinal products from or through parts of the UK other than Northern Ireland.
- Data Privacy
The Information Commissioner’s Office (ICO) issued a reprimand to the Scottish Government and NHS National Services Scotland over both organisations failure to provide people with clear information about how their personal information is used by the NHS Scotland COVID Status app. The ICO received the full details setting out how the NHS Scotland COVID Status app would be using people’s information on 27 September 2021.
The ICO raised concerns with the Scottish Government and NHS National Services Scotland that this critical information was only supplied three days before mandatory status checks were due to be rolled out in Scotland. After reviewing the details, the ICO advised the both organisations that they had a number of concerns about the way the app was going to use people’s information. The ICO advised that the app should not be launched until its concerns about this had been addressed. The organisations halted plans to share personal data with the software company, but the app was launched on 30 September 2021 as planned without fully addressing the ICO’s wider concerns about compliance with data protection law.
The ICO then launched an investigation and issued a reprimand to the Scottish Government and the NHS National Services Scotland. The ICO expects the organisations to act swiftly on these findings and apply the wider learning from the roll out of the app to any similar activities in the future to make sure people can continue to have trust in the way both organisations use their information. If both bodies fail to take action to address the ongoing issues with the app then the ICO will consider whether further regulatory action is required.
- New UK Data Protection Bill Underway
The announcement of new data protection laws in the Queen's Speech takes place after the Government's consultation last year on "Data: A new Direction" proposing to reform the UK GDPR and the Data Protection Act 2018.
The Government aims to reduce barriers to responsible innovation, reduce burdens on businesses for better outcomes, boost trade and reduce barriers to data flows, deliver better public services and reform the Information Commissioner's Office. Proposals related to changes to the application of Article 22 of the UK GDPR on Automated individual decision-making, including profiling which would no longer require human intervention have raised concerns. Automated decision making with legal effects. This is may be the case for example in the context of an individual patient on a managed access or clinical trial programme. If this instance, the patient would be entitled to a review of the decision by a human being.
On the other hand, proposals to create a new separate lawful ground for research, subject to suitable safeguards, in addition to those already present in Article 89(1) of the UK GDPR and to establish that the further use of data for research purposes are both (1) always compatible with the original purpose and (2) lawful under Article 6(1) of the UK GDPR, are being welcomed by the industry. The new UK Bill is expected during summer 2022.
- Care Funding Cap
From October 2023, as part of the Health and Care Act 2022, there has been a new £86,000 cap introduced on the amount anyone in England will have to spend on personal care over their lifetime. There was substantial debate over how someone progresses to the cap, particularly if means-tested local authority support should count towards it. The legislative framework for a cap on care costs was included in the Care Act 2014 but the relevant provisions were not in force. The new cap means that if a local authority is financially contributing towards a person’s personal care, this spending will count towards the cap on care costs, in addition to any contribution the person has made themselves.
- Research & Development
Parliamentary Under-Secretary of State for Innovation at the Department of Health and Social Care, Lord Kamall, and the Swedish Minister for Education, Anna Ekström, signed a Memorandum of Understanding (MoU) committing the UK and Sweden to ongoing co-operation in the life sciences. The MoU the two nations promoting joint progress across policy development, technical standards, industry collaboration, research, and the development and implementation of new technologies and treatments. The Memorandum of Understanding covers fields from precision medicine, clinical trials, pandemic preparedness and antimicrobial resistance to sustainability, trade, and investment for the sector.
- Connected Health
Four out of five biopharma companies view connected health products as a viable market opportunity, though take up remains low. This is according to Capgemini, who have recently published a report on this. They have found that only 16% of biopharma companies are currently either testing connected health devices or have products on the market. However, Capgemini believe that the digital health products market will grow by 40% over the next five years. As the popularity of these devices soared during the pandemic, they suggest this is the time to capitalise on this.
- Life Sciences Innovation Fund
UK companies working in the human medicine, medical diagnostics and medical device sectors now have access to funding to support their manufacturing projects and promote growth in the UK’s life sciences sector. The Life Sciences Innovative Manufacturing Fund (LSIMF) was launched in March 2022 and is part of the Global Britain Investment Fund, of which £354 million will support life sciences manufacturing. The LSIMF will provide £60 million in capital grants for investment in the manufacture of human medicines, medical diagnostics and MedTech products.
The Government is particularly encouraging applications from companies ready to deploy their emerging technologies at scale in commercial manufacturing. This removes a significant barrier for many companies, as the costs of setting up production, can be prohibitive. They are particularly interested in receiving applications from companies developing products such as:
- complex medicines such as advanced therapies, non-biological complex medicines and medicines that require complex delivery mechanisms;
- innovative medical technologies such as nanomedicine applications in imaging, sensing, diagnosis, and 5G enabled devices; and
- diagnostics such as ‘breathalysers’ for the early detection of inflammatory and infectious diseases.
- Provider Selection Regime
The Department of Health and Social Care (DHSC) has published supplementary consultation on regulations for Provider Selection Regime (PSR). This provides details of proposals for regulations comprising a new set of rules for healthcare services in England. These are intended to allow commissioners to move away from competition and to have greater flexibility when arranging services. It will be introduced by regulations made under the Health and Care Act. The regime is intended to replace the existing procurement rules for healthcare services and to make it easier to integrate services and enhance collaboration.
However, the competitive procurement of health services will continue to have a role where this is in the best interests of patients, taxpayers and the population. The regime will be applied as part of a commissioning process whenever contracts for healthcare services are coming to an end, changing considerably or being awarded for the first time. The DHSC has not confirmed when the new PSR regime comes into force; however, it is unlikely to be implemented before 1 August 2022.
- Cosmetic Procedures
The government has confirmed its intention to introduce a licensing regime for non-surgical cosmetic procedures. The Health and Care Bill has given the Secretary of State for Health and Social Care the power to introduce a licensing regime for Botox and fillers. The scope and details of this will be determined via extensive engagement including a public consultation; therefore, it may be some time before the licensing scheme comes into effect.
Although the majority of the aesthetics industry shows good practice when it comes to patient safety, this step will ensure consistent standards and protect individuals from those without licences, including from the potentially harmful physical and mental impacts of poorly performed cosmetic procedures.