A New National Purpose: Harnessing Data for Health – 21st May 2024

Summary

Former Prime Minister of Great Britain and Northern Ireland Tony Blair founded TBI on the belief that a country’s success and ability to enact transformational change is dependent on the effectiveness of its leadership and governance. TBI works with political leaders around the world advising on strategy, policy and delivery with technology as an enabler of all three.

Key Focus

The document proposes the creation of a National Data Trust (NDT) to streamline and maximise the use of the UK’s vast but fragmented health-data assets. The NDT aims to improve research, enhance patient care, and boost economic growth while ensuring public trust and robust data governance.

Current Challenges within the UK’s Health-Data Infrastructure

The UK is the world’s largest publicly funded health service and repository of health care data, spanning NHS records, biobanks, and genomics initiatives. However, several barriers prevent efficient use of these data:

• Fragmentation – Thousands of individual organisations control different aspects of patient healthcare data making it difficult for researchers to access and utilise data effectively. The quality of recorded data varies and so do the rules to access them, creating barriers to research and innovation.
• Bureaucratic hurdles – Lengthy and inconsistent approval processes slow down access for researchers.
• Short-term funding cycles – Many health-data initiatives receive limited or sporadic funding, leading to inefficiencies and project failures.
• Declining investment in UK clinical trials – The number of clinical trials in the UK has dropped 44% since 2017, making the country a less attractive destination for life-science research.
• Public trust issues – Previous NHS data initiatives have failed due to concerns over privacy and transparency, leading to high opt-out rates. The General Practice Data for Planning and Research programme faced a significant backlash in 2021, leading to a delay in its implementation, as patients and advocacy groups raised alarms about inadequate transparency and the potential for data misuse.  Public trust must be gained through engagement, transparency and robust data-protection measures.
• Missed economic opportunities – The global health-data industry is growing rapidly, and without reform, the UK risks falling behind its competitors. The EU has reached cross national agreement on the secondary use of health-care data and countries such as Germany have passed legislation to provide central access to their data. Sweden, Finland, Denmark and Estonia are among the countries leading in the provision of quality, population-wide data, and are attracting top research and development companies as a result. In its health data, the UK has one of the most potentially important resources of the AI era.

A Radical Solution: The Creation of a National Data Trust (NDT)

The document proposes the creation of a National Data Trust (NDT) – a centralised entity that would manage and coordinate access to UK health data.

Key Features of the NDT

• A commercial entity with majority ownership by the government and the NHS with a proposed public-private ownership ratio of 70:30. To be modelled on the BBC’s approach of combining public service with commercial success.  The broadcaster provides a public service while also operating BBC Studios (a revenue-generating subsidiary that upholds public trust).  It would blend public oversight with financial sustainability.  Having the government and the NHS as majority-controlling owners will build and maintain public trust and ensure that acting in the public interest remains the key driver of the NDT’s mission.
• An independent entity, separate from the NHS – Setting up the NDT outside the NHS as an external commercial entity would enable the commercial edge and sustainability that it needs to succeed and will shield it from political pressures that have previously impeded efforts to create a modern data infrastructure.  Maintaining a high degree of political engagement to secure buy-in remains crucial.  Establishing the NDT as a private entity with greater fiscal agility would enable it to raise and hold external funding from industry and other sources.  Operating outside the NHS and DHSC frameworks would allow competitive employment terms to be offered, enabling recruitment of talented individuals into critical management and technical roles.
• A single access point for health data – By connecting our fragmented data landscape, researchers, biotechnology companies, and the NHS would be able to access data efficiently through a “concierge service”.  It would provide seamless access to a range of data assets, starting with NHS data – such as the national Secure Data Environment (SDE).  The NDT will not hold the actual data, which remains the prerogative of individual data controllers through a federated data-access model.  Access to data would be governed by a pre-accreditation licensing system, with use of patient-level de-identified data via a streamlined data access-committee process.
• A one-stop shop for health-data research and innovation in the UK offering a comprehensive range of services to trusted researchers. Including data discovery, direct access to health-care data for accredited parties, basic descriptive and automated search functionality, feasibility studies for trials, trial recruitment, provision of data about individuals from a single source for locally recruited trials, health economics and analytical services, and the ability to validate and develop machine-learning algorithms.
• Privacy-first approach – The NDT would never sell data but would provide controlled, anonymised access while prioritising public benefits.  It would operate with high levels of transparency and robust data protection.  A coherent approach to optout rules for the public (including making it easier to opt back in) will be necessary.

Perceived Benefits of an NDT

The document outlines how the creation of an NDT could provide significant benefits to healthcare, research, and the economy:

1. Improved Healthcare Innovation

• By integrating NHS data with genomic and biobank data, the NDT would accelerate drug development and personalised medicine.
• AI-powered health solutions could be deployed faster, leading to earlier diagnoses and more effective treatments.
• Easier access to data via one system with shared services to investigate the data, will accelerate and drive cutting-edge research into disease prevention and treatment.

2. Better Patient Outcomes

• Research-active healthcare systems deliver better care, as seen in clinical trials where patients often receive improved treatments.
• Faster access to medical data would allow for quicker responses to public health challenges (e.g. During a pandemic).
• AI-powered diagnostics could result in earlier interventions and reduced hospital admissions.

3. Economic Growth

• By restoring the UK’s global position in clinical trials, the NDT could generate £2 billion in additional economic growth by 2030.
• If the UK reclaims 6.8% of the global clinical-trial market share, it could add £1 billion in revenue by 2024 and £4.1 billion by 2030.
• The NDT would create a sustainable funding model for the NHS reducing reliance on public taxation with a transparent pricing model informed by public engagement, market intelligence and the experience of existing organisations in this space. The NDT’s commercial strategy will be aligned with public values.
• Any surplus generated by the NDT would be reinvested into services and infrastructure or distributed among owners and data contributors, guided by principles codesigned with the public, investors and data controllers.
• Revenue could be ringfenced for specific purposes, such as prevention, public health or the overall research budget, providing incentives for the NHS and R&D community to prioritise commercialisation of access to data.

4. Reinvigorated UK Clinical Trials

• Faster approval processes and data access would make the UK more attractive for global pharmaceutical companies.
• Clinical-trial activity could generate over £250 million annually, helping reverse the recent decline in UK medical research.

Implementation

The NDT would be gradually developed and integrated into the UK’s healthcare ecosystem:

1. By 2026 the NDT would be established as a government and NHS-owned company with co-investment from industry.  Within two years, it would fully build the capabilities and achieve integration and interoperability across the health system.  Co-designed with the public, it will aim to raise at least £100- £150 million externally in additional funding.
2. Consolidation of existing health-data sources under a single umbrella over two years, including:
   • Secure Data Environments (SDEs) – Existing NHS platforms that store and protect health data. They act as “reading libraries” designed to ensure the secure handling and processing of sensitive information, enabling ease of access to data by accredited researchers in a privacy preserving manner.
   • Genomics England (GEL) – The government-led genome sequencing initiative.  A public-private partnership attracting industry investment, with partners providing upfront investment at a 5 % rate to support the use of health data for research and innovation.
   • UK Biobank – A research database containing genetic and health records of 500,000 participants.
   • Clinical Practice Research Datalink (CPRD) – A government-owned research service providing anonymised patient data.
3. Integration of clinical-trials services – Combine the efforts of NHS England and the National Institute for Health and Care Research (NIHR) to create a single system for trial recruitment and data access.  It would enable commercial clients including large life-sciences companies, tech companies, start-ups, innovators and academic research organisations – companies that provide support to the pharmaceutical, biotechnology and medical-device industries in the form of research services – to utilise the NDT as the single, authoritative source of data for individuals enrolled in clinical trials.
4. Legislative reforms – Update laws to simplify data access and move data controllership away from individual general practitioners to a centralised model.  Prioritise legislative changes to streamline the process of requesting access to data for research purposes for access within weeks rather than months, while ensuring robust safeguards for patient confidentiality.

Challenges and Risks

Several challenges must be addressed prior to implementation including:

1. Public Trust and Privacy Concerns
   • Previous NHS data initiatives failed due to public opposition.  The public should be involved in the governance structure either by having them directly represented on the board or through a citizens advisory group.  The NDT must prioritise transparency, ethical governance, and patient control over data to avoid similar failures.
   • Striking the right balance between not stifling access to data and legitimate concerns about privacy and transparency will be essential and will require strong public engagement.
   • Public concerns about a private company commercialising access to sensitive health data could undermine trust and support for the initiative.
2. Funding and Investment
   • The NDT will need £200-300 million in initial investment, with at least £100 million from private sources.  Government funding should come from the broader economic growth agenda, rather than relying solely on the health department’s budget.  No exclusive access to data would be granted in return for investment from industry; instead, external investors would be offered preferential access rates where appropriate. A compelling offering for industry co-investment must be developed. This will entail providing high-quality data access, analytics and clinical-trial services, as well as demonstrating the ability to commercialise these services and generate revenue.
   • Ensuring financial sustainability without relying on government grants will be key.  Balance sheets of public sector organisations are prone to financial clawbacks which undermines the incentives for commercialising data access from within the NHS. With Treasury oversight, the NDT could retain, ringfence and reinvest its revenues into key NHS projects over sustained periods of time, rather than having surpluses absorbed into the general government coffers.
3. Legal and Policy Changes
   • Two urgent legal changes should be prioritised to allow for faster, more efficient approvals:

– A single sign-off process for access to all de-identified data, bringing multiple integrated care boards (ICSs) under a single data-access-committee process. This would streamline the currently fragmented and inconsistent data access landscape.

– Addressing data controllership, potentially by establishing joint controllership between NHS England and individual data controllers.  This would clarify roles and responsibilities, reduce the risks and liabilities faced by individual data controllers, and facilitate a more coordinated approach to data sharing and commercialisation.

1. Operational Complexity
   • Integrating thousands of NHS data sources and aligning them with private research needs is a highly complex task. There is a need to tackle the fragmentation of data across multiple systems and organisations and improve data quality and standardisation.
   • The NDT will require a phased approach, starting with existing Secure Data Environments before expanding to broader datasets.
   • Many detailed questions about the commercial model, pricing, and the exact scale and scope of services are still to be agreed upon.
   • Short-term thinking and political pressure are deeply entrenched within NHS culture. Clinicians are primarily focused on immediate patient care and the NHS itself is subject to shifting priorities and reorganisations driven by an electoral cycle every five years.
   • The NHS front line and data controllers must feel the benefits of commercialising data, in terms of both financial return and better data infrastructure.
   • There is potential for a single point of failure if the NDT does not provide an efficient, user-centric service, which could damage the UK’s reputation and attractiveness as a destination for health-data research and innovation. Design and structure are key to mitigating this risk.

Conclusion

• The UK has a unique opportunity by bringing together government, the NHS, and private-sector expertise to transform the UK’s health-data landscape and cement its position as a global leader in life-sciences research and innovation. The NDT represents a transformational shift in how health data are used unlocking the value of the UK’s health data for medical innovation, research, economic growth, and better patient care.  Success will require strong leadership, public engagement, and legislative support, as well as a commitment to long-term investment and trust-building.