New organisation launched to lead genomics in the NHS

Posted on July 8, 2013 by

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The Secretary of State for Health, Jeremy Hunt, has announced the creation of a new government-owned organisation called Genomics England to integrate genomic services into NHS care and support further research into the genetic causes of disease. The company will take forward the “Mapping 100,000 genomes project” announced by David Cameron in December and link genomic data with other NHS databases. It will work with academia and industry.

Background:

Genomics is the study of the function of the entire genetic code in each cell. People of course have a genome, mutations in which can cause diseases, but cancer cells also have their own genomes because the person’s genome has mutated to make those cells cancerous, and disease-causing microorganisms also have genomes. Sequencing and then analysing these allows us to identify the gene – or more often, multiple genes – that cause disease. This enables a person’s susceptibility to be determined to help prevent disease, aids diagnosis and allows for more personalised treatment.

In December last year David Cameron announced plans for the UK to become a world leader in genomics and bioinformatics. His speech launched the Strategy for UK Life Sciences: one year on report, which included two actions to achieve this:

  • Develop the capability to undertake whole-genome sequencing at scale for the benefit of patients in the NHS
  • Develop the genomic platforms to make the UK the destination of choice for life sciences

The Department of Health (DH) committed £100 million to the project with the aim of sequencing the genomes of 100,000 individuals with cancer, rare diseases and infectious diseases within 3-5 years. David Nicholson, Chief Executive of the NHS, was put in charge to lead the process to have an initial service design in place by June 2013 – so they’ve not done bad!

Genomics England – the clue’s in the name

Well almost… Genomics England looks like it will be the conduit between the NHS and organisations that will do the sequencing and analysis. The DH press release says it will:

manage contracts for specialist UK-based companies, universities and hospitals to supply services on sequencing, data linkage and analysis.

It’s hoped through doing this Genomics England will give doctors the option of whole-genome sequencing to help them diagnose and better treat disease. More and more new drugs are specially designed to work on a particular patient population with specific genetic profiles (known as personalised or stratified medicine) so it’s really important the NHS is set up to take advantage of this new technology. By managing the contracts and investing government money, Genomics England hopes to promote innovations in genomics to strengthen the UK’s world-leading position in the field and drive down costs.

One of the new organisation’s aims is to create a database linking the individual’s whole genome sequence with their medical records. Patient data will only be added to the database with the permission of the patient and all data will be held securely in the UK, strictly protecting confidentiality in line with stringent existing NHS arrangements. This will give Genomics England a hugely valuable resource which it will make available to researchers. How it will do this isn’t clear yet, presumably it will charge but we will wait to see.

Sir John Chisolm, former chair of the Medical Research Council, will head up Genomics England as executive chair and Professor Mark Caulfield will be chief scientist. The government is the sole shareholder. It is being financed in the medium term by DH and will use “any surplus to benefit the public health community”.   It will also be advised by an Ethics committee.

The government also set up some working groups last year to look at Genomic England’s strategic priorities, ethics and data handling. These have published their recommendations, including:

  • Consent – they think a broad consent is both necessary and acceptable
  • Data access – there needs to be a secure central repository with carefully managed access, recognising the extremely sensitive data that could identify people but also that this project needs to be for public benefit and that means promoting access
  • Feedback – how or whether patients will be told about any findings from their genome will need to be decided before they enter the project
  • Public confidence and involvement – recognising that broad engagement will be key to the project’s success
  • Oversight and governance – there are already many past experiences and principles to draw upon, including the Caldicott Review and the NHS Constitution. They also say that they will want to “revisit the existing moratorium on the use of genetic data in the context of insurance as the programme becomes more clearly defined.”

A workforce ready to take advantage of genomics

The £100 million pledged by the government for genomics will also be used to “train a new generation of British genetic scientists to develop life-saving new drugs, treatments and scientific breakthroughs and train the wider healthcare community to use the technology”. There’s no suggestion on Genomic England’s website that it will be managing this, there may be roles for NHS England and Health Education England. We will investigate further to find out how they plan to do this.

What next?

It’s good to see the government moving forward with its plans to make sure the NHS is able to use the latest technology to improve the diagnosis and treatment of patients and also make more data available to researchers. This is something we have called for in our recent response to the House of Lords inquiry into scientific infrastructure, including ensuring there is a well-trained workforce.

We think it is really important that data is made available for research in a way that is safe and secure, with regard for people’s right to confidentiality. The government will need to make sure the public understand how their data is used and why this is important. When the NHS Constitution was updated – which includes commitments to discuss research opportunities with patients, use their anonymised data for research and to give them the opportunity to opt out of their identifiable data being used in research – a second phase of consultation was proposed on how to raise awareness. Our vision for research in the NHS includes a call to ‘Promote the NHS Constitution among patients and NHS staff’. Charities can also play a role in making sure the public are fully informed.

We’ll be watching this one closely and feeding in where we can.

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