The government’s legislative proposals for a new Health and Care Bill incorporate many of NHS England’s formal requests and reflect key changes that have occurred in recent years, particularly with regard to joined-up care.
Indeed, the Integration and Innovation: working together to improve health and social care for all white paper marks a clear shift away from competition towards a new model of collaborative working.
However, it has attracted some controversy since it proposes to strengthen government powers over local reconfigurations and also the work of NHS England (NHSE).
This article explores the key elements of the document, including its plans for integrated care, the potential impact of more central government intervention and the proposed introduction of national medicines registries.
Integrated care
The white paper solidifies and codifies much of what has been happening in health policy around integration over the past five years as reflected in the NHS Long Term Plan and its predecessor, the Five Year Forward View.
It confirms that NHSE is backing legislation to abolish Clinical Commissioning Groups (CCGs) – a move that could see the core statutory functions of CCGs absorbed into Integrated Care Systems (ICSs), which will ultimately become statutory bodies. Alternatively, CCGs may merge to become ICS-sized structures.
The changes in CCGs are likely to affect Area Prescribing Committees (APCs). For example, if two or three CCGs that currently have separate APCs merge to fit the size of an ICS, or are absorbed into the system, then the number of APCs could decline.
Other changes needed to facilitate joined-up working include integrated finances with ‘a single pot’ of money shared between ICSs or groups of providers, and the introduction of provider collaboratives that span multiple systems.
Of particular note in the white paper is the inclusion of NHSE’s recommendation for a reserve power to set a capital spending limit on Foundation Trusts, which currently have additional freedoms to borrow from commercial lenders and spend surpluses on capital projects, such as new buildings, equipment or IT. This move underlines the system-level approach and the ‘all in it together’ ethos that lies at the heart of it.
The structural changes that are required to facilitate integrated care will have major implications for territory and account planning for pharma. Key stakeholder maps will need to be constantly updated as the move towards ICSs continues apace, and CCGs are expected to merge at scale and pace.
In finance, industry will need to identify the payers in the new organisations that are emerging, including the people who control rebates, and track how APCs are operating and on whose behalf.
Government control
An unexpected measure within the white paper, and one that has been particularly controversial, is the bid to award more power to ministers to intervene in decisions made about healthcare services at both NHSE and local levels.
Under the proposals, the government would be able to get involved in decisions on local ‘reconfigurations’ – ie the work undertaken by each part of the system. In many areas, this may involve plans to close or downgrade hospitals as more services are moved out of secondary care – decisions that are, of course, likely to be highly contentious within the local communities these hospitals serve.
As some critics have pointed out, the new proposed central powers could, therefore, come at a price for the government since the public would be likely to blame it generally for unpopular decisions around services or setbacks rather than local healthcare system leaders.
On a national scale, the government also wants powers to intervene in, direct and oversee the work of NHSE itself, which threatens to remove its current independence in making decisions about the future of services.
If these moves were implemented in this form, the white paper would largely undo the legacy of the 2012 Health and Social Care Act, placing integration and ICSs centrally, and returning accountability to government instead of what was previously essentially, a ‘hands-off’ approach.
Medicines registries
One area mentioned in the white paper that is of particular significance for industry is the proposed introduction of national medicines registries. Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) would develop and maintain publicly funded and operated medicines registries and work with the NHS to populate and maintain them where there is a clear patient safety or other important clinical interest.
According to the white paper: ‘Registries would be established for a medicine where the public need is clear and the benefits of a publicly held national registry that can access routinely collected data where it is available are required. For example, where we know risks of a medicine can result in serious adverse health outcomes and consistent adherence to risk minimisation measures is critical, or where there are substantive unknowns about the safety or effectiveness of a medicine in a population and urgent evidence is required to support safe access to it’.
The medicines registries would provide patients and their prescribers, as well as regulators and the NHS, with the information they need to make evidence-based decisions. They could consolidate prescribing data for specific medicines with data from clinical care and other databases and be further developed to capture more detailed and bespoke data on the cohorts of patients receiving these medicines.
Currently, the MHRA receives data from pharma companies when there is a knowledge gap, or when it is needed to make a decision on efficacy or safety, however, the new medicines registries would give a more joined-up view.
With the new registries, there would also be an element of patient reported outcome measures – ie feedback from patients about particular drugs and whether they are enhancing their quality of life, which is a very important part of the data picture that does not currently exist.
Access to all kinds of data around patient care and outcomes is, of course, essential for the NHS to capitalise on innovations and continue to drive improvements and it is a key area in which pharma could provide support. Hence, the establishment of medicines registries could provide an opportunity for pharma to be proactive in gathering real-world data around patient experience. This could help back up clinical trial results and inform industry’s value propositions, particularly around high cost drugs.
Conclusion
While the prospect of more central government control places a question mark over the autonomy of decision-making at both local and NHSE levels, the white paper makes it clear that the government is committed to delivering integrated care.
Consequently, this year, we expect to see the move towards population-based healthcare, joint accountability for patients in systems and shared local budgeting, continue to gather pace, prior to ICSs being given statutory powers.
This is going to bring major changes for pharma from the need to regularly review its key stakeholder maps to the ability to fully embrace the whole system approach and ensure that its value propositions help the NHS to improve patient outcomes and also deliver on wider priorities.
By thinking broadly and innovatively about how it can provide support and gathering and analysing relevant data to back up its proposals, industry can seize opportunities to work in partnership with the NHS as the move towards integrated care looks set to continue to underpin major changes in the way services are designed and delivered.
Oli Hudson is content director at Wilmington Healthcare. For information on Wilmington Healthcare, visit www.wilmingtonhealthcare.com
