On the 75th anniversary of the National Health Service, GK Strategic Advisor and former Minister of State for Care Services, Phil Hope, reflects on the NHS in its current form and looks ahead to how the UK’s major political parties will position their offering for the health system. Find Phil’s commentary here: NHS 75th Anniversary
Read GK’s newest insight paper on the Government’s Levelling Up White Paper here: Levelling Up White Paper Insights
To discuss what the White Paper means for your business or investments email firstname.lastname@example.org to fix up some time.
GK Adviser, and former Health Minister, Phil Hope shares his thoughts on the Government’s proposals for health and care reform in our newest blog ‘Integration White Paper Joining up care for people, places and populations: A genuinely radical leap forward’
Read Phil’s thought’s here: Integration White Paper – Joining up care for people places and populations
The Omicron variant, parliamentary scrutiny and a distracted Government are all hindering the development of Integrated Care Systems (ICSs) and there are concerns about the framework that sits around them.
Amidst the capacity and workforce pressures faced by the health service this winter, longer-term ambitions for the transformation of our health and care system are also feeling the strain.
The timelines for formalisation and statutory responsibility of the 42 Integrated Care Systems (ICSs) in England have been pushed back. The intention is now for them to be given their full statutory responsibilities by 1st July this year rather than 1st April as originally planned. The primary reason given for this delay is to allow parliament an acceptable amount of time to review and approve the proposed changes.
Even with this extension, there is growing frustration that this wholescale reconfiguration of the health system is not being accompanied by the required due diligence and planning.
The Health and Care Bill – the legislation that will enable these reforms – has reached the House of Lords and the early signs are the Government are in for a bumpy ride.
It’s times like this where the second chamber can demonstrate both its value and its limitations. More sector specialists, less constrained by time pressures and careerism often makes for a better assessment of the changes proposed. Any substantive improvements to the legislation are likely to come from the Lords, the challenge or opportunity depending on your perspective is that any amendments must be approved by the Commons, where the Government has a strong majority and can whip MPs effectively. Therefore, sensible Lords amendments may well be reversed prior to the Bill receiving Royal Assent.
The concern for the Government is that the Lords are starting to highlight that the legislation is poorly planned and drafted. In the Autumn of 2021, Health Secretary Sajid Javid admitted that “significant areas of contention” had yet to be resolved with the reconfiguration of the health system the Bill and he’s being proved right.
The initial assessment from the Lords has been both scathing and embarrassing for the Government. the Delegated Powers and Regulatory Reform Committee has stated that the Bill “falls so short of the standards which the Committee — and Parliament — are entitled to expect” and the legislation is a perfect example of a wider issue of “how much disguised legislation a Bill can contain and offends against the democratic principles of parliamentary scrutiny”.
Furthermore, just as the Bill was due to begin its Committee Stage the Lords Shadow Health Spokesperson, Baroness Thornton, also identified that proceedings couldn’t legally begin without an impact assessment related to parts of the legislation. The Government has apologised for the oversight and the very short notice that they were shared.
Taken together, these issues all add to the impression that the reforms are being rushed through, at a time of extreme pressure on the health system with not enough evaluation of the impact and practical implementation of new powers and accountabilities. The biggest concern among those who favour greater health devolution is that the Bill will reinforce the instinctive tendencies of the government and NHSE towards greater centralisation and prescription, and continued NHS dominance of the health and care agenda.
During January and early February 2022, the Lords will undertake a line-by-line examination and vote on each clause of the legislation – including the long list of amendments tabled by Peers.
Trying to predict which amendments will garner enough support is difficult – let alone which the Government may concede on – but topics that have high profile backers and cross-party support include:
- The extent of Ministerial control – Limiting the so-called ‘power grab’ by the Health Secretary as part of this bill – the extension of powers will enable the Minister to intervene directly on local and regional health matters. This is being opposed by Opposition parties and prominent NHS representative bodies such as NHS Confederation.
- Workforce planning and updates – there is strong cross party and cross chamber backing for Regular, independent and public workforce projection data. Former Health Secretary, and Chair of the Health and Social Care Select Committee Jeremy Hunt tabled an amendment in the Commons and the Lords will now try to force the issue again.
- Mental health funding – former NHS England Chief Executive – now crossbench peer – Sir Simon Stevens has proposed amendments that require government, NHSE and ICSs to publish mental health spending detail including whether spending was increasing as a share of overall funding.
- Parity of esteem for mental health is still a work in progress and despite this being an emotive issue with an increasing demand for services, it is unlikely that the Government will tie itself to this type of funding scrutiny given the financial pressures faced across the board.
Of course, it’s not just the Parliamentarians that are frustrated, many ICS leaders – preparing to go live with their accountable duties – only found out about the delay via third party sources with the Department of Health & Social Care and NHS England’s communications leaving much to be desired. Louise Patten, Chief Executive of NHS Clinical Commissioners recently outlined that that the delay causes confusion about local leadership responsibilities and partnership working with local government and threatens accountability.
Moreover, the delay in publication of the Integration White Paper, further guidance on developing place-based Integrated Care Partnerships and the Levelling Up White Paper also means that many areas are continuing to develop new local partnership governance arrangements in the absence of a national policy framework.
And of course, all of this hugely matters to patients, the healthcare workforce and organisations trying to supply the health system with the services and technology it needs.
Organisations with a stake in health care delivery need to ensure that they monitor the passage of this legislation and importantly seek the practical understanding of where accountability and commissioning responsibility lies within ICS ‘footprint’ regions.
For further information about the implementation and impact of ICS’, please email email@example.com
Following the publication of the highly anticipated Adult Social Care White Paper, Phil Hope, former Care Minister, assesses the plans announced and identifies what more needs to be done to improve the sector.
Read Phil’s thoughts in Deeds not Words.
For more information, please contact GK’s Head of Health, Joe Cormack on firstname.lastname@example.org
On the 2nd March 2020, the Medicines and Medical Devices Bill 2019-20 went through its second reading in parliament. It has been one of the first pieces of domestic legislation to be introduced since the Queen’s Speech in December 2019 and represents a critical area of post-Brexit regulatory change.
The Bill is politically uncontroversial. It passed first and second readings unopposed by the Labour Party and is more about the need for legislation to return regulatory powers to central government rather than a Brexit-fuelled political move.
Nevertheless, the legislation can define the medicines and medical devices regulatory environment for years to come.
Specifically, the legislation could have a significant impact on contract research organisations (CROs) whose interest is in stymying excessive divergence from US and EU clinical trial regulation. The following are just a few areas the bill might interfere:
The speed of approval processes for clinical trial applications
The UK has a reputation for world-leading standards in clinical research. It has several world-leading universities, research organisations, institutes and scientists operating around the ‘Golden Triangle’ (London, Cambridge and Oxford) and beyond. These hubs ensure pharmaceutical companies get the most out of phase I-III research, while also having applications approved quickly by the renowned Medicines and Healthcare products Regulatory Agency (MHRA). The combination of an effective and accessible regulator in the MHRA and its close relationship with NICE must be protected.
Alignment to the EU Clinical Trial Regulations (CTR)
The UK and, specifically, the Clinical Trials Unit of the MHRA played an active and leading role in the development of the EU Clinical Trial Regulations over the past five years – due for implementation during 2020. The regulations aim to create a single set of standards across the EU, establish a single method for submissions to assessment processes and increase transparency, collaboration and information sharing across EU Member States.
While the UK’s departure from the EU means that it won’t be implementing the regulations it helped to develop, CROs across the country will want to ensure that the future of the UK’s clinical research regulation is as closely aligned to the EU as possible. This will ensure its ability to deliver competitive, expeditious and high-quality research. The Medicines and Medical Devices Bill should facilitate this alignment.
The introduction of bureaucratic processes and regulatory burden for CROs
There is some anxiety in the CRO sector that the new regulatory environment will cause a significant bureaucratic burden when it comes to clinical trial applications. If the legislation oversees a divergence in regulatory standards and processes from other markets, applications to the MHRA could require more and different information to the U.S. Food and Drug Administration and the European Medicines Agency. CROs will be eager to mitigate this risk.
These are just a handful of areas where the Bill might affect CROs and the life sciences industry. Others include patient safety, pharmacies and medicine supply chains, as well as manufacturing, labelling and packaging.
GK Strategy are experts in political and government engagement, with long-standing experience and understanding of the life sciences and clinical research sectors. To discuss further with our team, please do get in touch via email@example.com