In brief:
- NHS England has published its long-awaited Genomics Strategy (the Strategy), which sets out its ambitions for the acceleration of embedding genomics into the NHS standard of care.
- The Strategy is based around four priority areas, and key themes emerge of particular interest:
- the importance of key partnerships and collaborations to the Strategy including with industry and internationally;
- the data priorities and challenges of genomics which broadly align with those experienced by the UK government more generally in efforts to unlock health data;
- the interrelation with clinical trials; and
- a focus on diversity of genomic data.
- The ABPI is broadly supportive of the Strategy, although it intends to publish a full response in November which will include further recommendations.
In further detail:
On 12 October 2022, NHS England published its first ever Genomics Strategy, Accelerating genomic medicine in the NHS.
This (long-awaited) Strategy sets out the NHS’s ambitions for embedding genomics in the NHS over the next five years, including ambitions for genomics to “be at the heart of… the next generation of healthcare in the NHS” and for the use of genomic medicine to be accelerated across the NHS “providing a world leading, equitable service to populations and individuals.” NHS England’s ultimate vision is that genomics should be “accessible to all as part of routine care in the NHS.”
The publication of the Strategy is the result of a work programme developed by the NHS Genomic Medicine Service (GMS, launched in 2018), including workshops earlier this year and a related prioritisation survey which ran from August to September 2022. The Strategy builds on the Genome UK: 2021 to 2022 implementation plan published by the UK government last year.
NHS Chief Executive, Amanda Pritchard, described the development as signalling “the next big step in healthcare in the NHS” and describes the NHS’s genomics ambitions as the means of delivering a sustainable model of healthcare for the future.
The four priority areas of the Strategy
The Strategy details the progress of the NHS’s genomics efforts so far, in particular, since the establishment of the GMS in 2018, and builds the approach towards achieving acceleration and embedding of progress around four priority areas:
- Embedding genomics across the NHS via an “innovative”, dynamic “genomics service model” covering primary and community care through to specialist and tertiary care, requiring the co-creating of services and relevant infrastructure and through the development of national and international collaboration and partnerships;
- Delivering equitable genomic testing for improved prediction, prevention, diagnosis and precision medicine, including for improved outcomes in cancer, rare, inherited and common diseases. This will involve, for example, the systematic introduction of new clinical indications for and the embedding of genomic testing;
- Enabling genomics to be at the forefront of the data and digital revolution. The Strategy elaborates that genomics “has an important role to play” in the UK’s data strategy ambitions, and that the NHS will provide support by, for example, developing interoperable data infrastructure that enables the use and sharing of genomic data alongside other health data; and
- Evolving the service through cutting-edge science, research and innovation to ensure that patients can benefit from rapid implementation of advances.
Key themes emerging from the Strategy:
While much of the Strategy is focussed on the implementation of the Strategy across the NHS as a national governmental organisation, including policy aspects and upskilling the workforce, certain themes emerge which may be of particular interest to the life sciences industry:
1. Key partnerships, including with industry
The Strategy acknowledges the importance of national and international collaborations and partnerships to its success, including academia and industry partners, and “developing national and international collaborations and partnerships” is listed as a priority.
Going forward, the NHS intends to continue to share learning and best practice with national and international partners and to “align to and inform international standards.” It will continue to strengthen and build on its national partnerships, including industry partnerships, “where they are relevant and appropriate for the NHS and its leadership of the NHS GMS.”
The Strategy specifically recognises that closer engagement and alignment is needed with industry “with a specific mechanism in place – to signal the needs of the NHS in genomics and to provide an opportunity for industry to respond to those needs”, and states that the “NHS will explore new opportunities to work with industry to signal the needs of the NHS GMS.”
2. Genomics “at the forefront of the data and digital revolution”?
NHS GMS generates significant amounts of health data (including genomic, clinical and management data). Finding a way to develop, use and share genomics data effectively and safely appears to be central to the Strategy.
The Strategy acknowledges that a number of informatics systems with varying levels of digital maturity currently exist and are in use in relation to NHS genomic testing activity. The NHS plans to support digital interoperability and an appropriate data sharing infrastructure, and improve the accessibility to order, follow and return genomic test results. In the short term, this will involve the development of shared data standards and the publication of a genomics informatics implementation development plan.
The aims expressed in the Strategy to unlock and harness this rich genomic data are consistent with the UK government’s broader health data strategy published in June, and similar challenges lie ahead, for example with respect to data infrastructure and interoperability (see further here).
3. Interrelation with clinical trials
As part of the priority to accelerate the use of precision treatments and to optimise the use of medicines through genomics, the Strategy sets as a priority to “drive equity in access to clinical trials by aligning clinical trial targets with standard of care NHS testing.”
There is not a huge amount of detail contained in the Strategy as to how this will be implemented in practice, which remains to be seen. However, it will include partnerships with clinical trial units and industry to identify eligible patients and will involve, for example, the implementation of appropriate “horizon scanning” for upcoming clinical trials to ensure appropriate targets are added to the national directory. It will be interesting to see how this is implemented in practice and how it will be reflected in the anticipated new clinical trials regime for the UK (see further here).
4. A focus on diversity in genomic data
The Strategy notes that Genomics England is undertaking an initiative to enrich and diversify genomic datasets by engaging with relevant communities and sequencing cohorts from diverse backgrounds. The evidence gathered from this research initiative will inform the NHS’s future decisions about commissioning of services. The focus on diversity is consistent with broader government statements and initiatives around improving diversity in access to healthcare, for example, in reducing bias in health datasets and in the ongoing Whitehead review into the diversity of medical devices in the UK (see further here and here).
ABPI response
The Strategy was broadly welcomed by the ABPI’s Chief Executive, Richard Torbett, who described the need for the UK to “get better at taking new scientific innovations from industry labs and into NHS clinics where they can start to benefit patients.” The ABPI was “pleased to see the strategy’s focus on expanding genomic testing, upskilling the workforce, and supporting genomic research and the introduction of new technologies, which will be essential to supercharging patient access to the genomic medicine service and driving more cutting-edge scientific research.”
However, this was not the ABPI’s full response and it intends to publish a full report with “additional recommendations on how to take this strategy further” in early November.
