Healthcare Hot Topics - July 2022

Addleshaw Goddard’s Stephanie Townley has hosted a discussion on expiry, currently the most pressing and complex issue facing the PFI industry. With more than 550 PFI contracts due to end within the next decade, the need to get this right is crucial to avoid creating issues like operational disruption and loss of service continuity. 

Those taking part in the discussion included Christian Tyson, project director at the Infrastructure Projects Authority (IPA) and Kirsty O’Brien, director of asset management at Equitix. They discussed topics such as bringing forward the starting point for expiry conversation and how the IPA can help guide authorities towards using a collaborative approach.

Look out for the new Handback Hub, which is coming soon.

The UK's new national security screening regime established under the National Security and Investment Act 2021 (NSIA) has now been in force for just over six months. Recently released statistics from the Department for BEIS' Investment Security Unit show transactions and collaborations in the healthcare space account nominally for around 8% of the transactions reviewed in the first three months of the regime (to March 2022). However, this figure is likely to be higher in reality as the widely defined 'sensitive sectors' touch the healthcare space in a number of different ways including transactions relating to synthetic biology, advanced materials (including nanotechnology and 'critical materials' including the types of metals and substances used in medical and surgical machinery), data infrastructure provided to central government organisations, artificial intelligence and critical suppliers to ambulance services. 

The NSIA introduced the requirement for mandatory government clearance for anyone acquiring shares or voting rights above certain thresholds (or otherwise acquiring control in certain circumstances) including for minority investments where the transaction is in one of 17 'sensitive sectors'. The Secretary of State has very wide powers to intervene in those transactions. The Secretary of State also has very wide powers to intervene where parties acquire 'material influence' over entities or assets and there is a national security concern. Given the very wide drafting of 'sensitive sectors' and 'material influence', these powers can apply very widely. 

These powers complement existing powers to intervene in transactions on public interest grounds relating to securing supply in public health emergencies and are part of a wider global trend of tightening national security and foreign investment rules. 

Further information is available on our FDI hub. 

Regulations will bring into force specified provisions of the Health and Care Act 2022, on 1 July, 31 July and 30 August 2022. The Secretary of State makes these Regulations in exercise of the powers conferred by sections 182 and 183(1) of the Health and Care Act 2022(1) and paragraph 4(1) of Schedule 4 to the National Health Service Act 2006(2). 

Amendments include the establishment of ICBs by NHS England, to replace clinical commissioning groups (CCGs) as the main commissioners of secondary care. Local Education and Training boards (LETBs) will be abolished. The policy rationale for abolishing these is to enable Health Education England (HEE) to develop and adapt its own flexible regional operating model to best deliver its objectives over time. Workforce planning will continue to be undertaken at local and regional level but in a more flexible manner.

The Department of Health and Social Care has announced the Government is accepting all seven of the recommendations of a landmark review into health and social care leadership led by General Sir Gordon Messenger and Dame Linda Pollard.

The review team met over a thousand passionate frontline staff, managers and leaders across health and social care to hear their views, which informed their recommendations. While it recognised the current pressures faced by the workforce and identified many examples of inspirational leadership, it found overall, there was a lack of consistency and coordination. In particular that there has developed over time an “institutional inadequacy” in the way that leadership and management is trained, developed and valued.

The report also sets out new plans to attract great leaders to the most challenged areas in the NHS, with a package of support and incentives to recruit the top talent into these positions. Through support networks, peer mentoring, training and development, this will ensure the government and the NHS can continue to tackle disparities across the country. It also found evidence of poor behaviours and attitudes such as discrimination, bullying and blame cultures in certain parts of the health and social care system, with some staff not feeling comfortable to speak up.

The recommendations include, targeted interventions on collaborative leadership and a unified set of values across health and social care, action to improve equality, diversity and inclusion, and consistent management standards delivered through accredited training, including a single set of unified, core leadership and management standards for NHS managers.

The Department of Health and Social Care has published a final version of the Health and Social Care Data Strategy: "Data saves lives: reshaping health and social care with data", which incorporates its response to the Goldacre Report. This report was released in April 2022 and gathers findings and recommendations on how to ensure efficient and safe use of NHS data for research and analysis for the benefit of patients and the healthcare sector. Please see the article on Data Protection considerations on the Goldacre Report.

The strategy aims to provide an appropriate framework for proposed reforms of the health sector and standards including in relation to the use and security of data in the health sector. In particular, by investing in secure data environments to power life-saving research and treatments and by providing better access to patient's own data through shared care records and the NHS App.

The heart of the strategy envisioned by the DHSC is to allow data and data-driven technologies to provide further and better use of NHS data while improving trust in the health and care system’s use of data. It is expected that the government will engage with stakeholders and the public to make sure "that changes to the regulations are implemented transparently and that appropriate safeguards are in place.”

People across the country will benefit from faster, more personalised healthcare, following a digital revolution to make the health and social care system fit for the 21st century. The plan for digital health and social care, published at the end of June, sets out the government’s ambitious vision for transforming health and care with digital technology. Rapid expansion of use of technology, which includes virtual wards and remote monitoring, will be used to drive efficiency, free up hospital space and clinician time, and bust the COVID backlogs. 

The plan sets out how the Government will improve access to information for people and their care teams. This includes bringing information together into the app and enabling people to view and manage hospital appointments, have virtual consultations, and see notifications from their GP. It also outlines the acceleration of the use of digital technology across the NHS and social care to improve efficiency and free up frontline workers’ time. By increasing the availability of remote monitoring, a further 500,000 people could be better supported by March 2023. Over 280,000 people already used remote monitoring at home and in care homes for long-term conditions in the last year, freeing up hospital beds and saving clinicians’ valuable time. This has resulted in improvements in patient outcomes – with problems picked up earlier, shorter stays in hospital, and fewer admissions in the first place. 

£2 billion has been earmarked from the spending review to help digitise the NHS and social care sector, and this plan will help achieve that aim by rolling out electronic patient records in the NHS to drive efficiency, which, in turn, will release billions of pounds back to the NHS.

Linked to and enabled by NHS reforms contained within the Health and Care Act 2022, the government plans to replace current rules for procurement of healthcare services with a new provider selection regime later this year. While consultations have been under way on the new regime for some time, the most recent development in this area is the release of a new consultation by the Department of Health and Social Care considering some of the detail of the regulations underpinning the new regime.

The new regime is intended to apply to health services that provide directly for individuals or have an outcome directly for individuals. Independent sector providers may feel concern at the imposition of a new regime that reduces the frequency of competitive tendering processes, limiting the opportunity to bid to provide healthcare services to the NHS. However, there is an opportunity in terms of high-performing providers being reappointed in existing arrangements without needing to go through a tender process against either other independent sector or public sector providers and potentially being appointed to new arrangements without a competitive process. 

Maintaining a clear understanding of the key criteria and being able to evidence how proposed and existing arrangements support these will be crucial to taking best advantage of the new regime. Independent sector providers may particularly well positioned to deliver innovative solutions.

The Scottish Government is requesting views on what a new Mental Health and Wellbeing Strategy for Scotland should look like. This Strategy will then guide the work that the Government will do to improve mental health and wellbeing in Scotland. This will include an overall shared vision, a set of outcomes and details on how they will achieve these.

The Government want the Strategy to focus on every part of what mental health and wellbeing means. This covers a range of things, including, addressing the underlying reasons behind poor mental health, challenging the stigma around mental health, and providing specialist help and support for mental illness.

They want the Strategy to guide how support is provided to everyone who has a role in improving and supporting people’s mental health and wellbeing. This ranges from the specialist mental health workforce to those working in all health and social care settings, in communities, schools, police custody suites, and prisons. 

The Strategy will mainly cover the next five years, up to 2027. However, it will set out a much longer-term vision and outcomes for the mental health and wellbeing of the population. The Government will also publish delivery plans to set out the work they will do over the coming years. These will show how they will make progress towards the outcomes, and how they will measure that progress.

The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide. This was announced by the Medicines and Healthcare products Regulatory Agency (MHRA), after being accepted as a full member of three international work-sharing partnerships. Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on improving the harmonisation and convergence of medicines and medical devices regulation globally.

Through these partnerships, the MHRA will share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally. The MHRA has also been accepted as a member of the US-based Medical Devices Innovation Consortium (MDIC). This public-private partnership brings together representatives of regulatory bodies, industry, non-profits, and patient organisations from different countries to improve the processes for development, assessment, and review of new medical technologies. This enables transformational medical technology to get to the people who need it sooner, by shortening the path from innovation to safety to access.

Medicines and Healthcare products Regulatory Agency (MHRA) have issued guidance on the steps manufacturers and suppliers can take to ease supply shortages. Where there is a potential shortage of supply of a medical product that could have a negative impact on public health, MHRA may prioritise the assessment of new product applications and changes to existing products, which could help reduce that risk.

Marketing authorisation holders (MAHs) can apply for a temporary exemption to supply packs intended for another country to Great Britain (GB) or Northern Ireland (NI) to mitigate supply disruptions. Exemptions are granted for a defined period of time or to cover specific batches. The product supplied must be identical to the UK licensed product, except for the packaging. Licensed medicines may be imported to an alternative authorised site under quarantine with appropriate quality controls whilst testing concludes. Manufacturers can also apply to import unlicensed medicines for the UK market to meet a patient’s individual needs.