Political science

Thanks to vast increases in computing power and medical knowledge, it’s now possible to determine the exact order and combination of the genetic material that makes each of us unique. Through ‘genome sequencing’, doctors can determine our personal DNA code – a capability that could revolutionise medical treatment.

To unlock this potential, the prime minister announced last December that the Department of Health would set up its own company, Genomics England, to sequence the genomes of up to 100,000 patients using £100m of funding. “The sky’s the limit: it will give us new insights into disease risk and causation, which will allow us to offer different advice to patients,” explains Dame Sally Davies, the government’s chief medical officer. The science of genomics could also allow for better clinical trials, improved drug targeting and reduced side effects from treatments.

There are further, broader aims behind Genomics England. “Some of it is about pulling the NHS into a genome era, and training people in the NHS so that they can play their part in delivering genomic medicine for patients,” she says. It will also help the NHS design the rules governing genomic medicine, including patient consent, licensing of the data to external researchers, and how to tell patients that they have genes linked to diseases. Meanwhile, the company will partner with industry to try and reduce the cost of genomic medicine, and gather investment to make more of this scientific breakthrough.

Genomics England is just one initiative being launched by government as part of a concerted life sciences drive – one designed not only to transform the medical treatments patients receive from the health service, but also to bolster Britain’s substantial life sciences industry and support the world-class research efforts of our universities.

Regenerative medicine
The UK’s life sciences sector is “a really big employer, it’s research-intensive, and it links up with our health service,” says Davies. It also creates “very large exports for the UK; a much higher share than is [typically] seen globally,” adds Louise Wood, head of NHS research, infrastructure and growth.

From the discovery of penicillin to the structure of DNA and the invention of MRI scanning, Britain has a strong track record in this sector. The pharmaceuticals, medical biotechnology and medical technology sectors together comprise around 4,500 firms, employing 165,000 staff, with an annual turnover of over £50bn.

But the government hasn’t always supported this industry. “If you look back to the 1990s, we were preeminent as a nation, but then we began to lose market share of research for a variety of reasons,” Davies says. “One is because markets are opening up in different parts of the world – China, India, Latin America – so [pharmaceuticals companies] want to do their research where the markets are opening up. Another was actually the NHS, which in the early 2000s lost the plot on clinical research, so industry did not want to do their research in this country.”

The NHS focussed on targets and patient care at the expense of research and innovation, and also didn’t invest in necessary infrastructure such as imaging technology, Davies believes. “My colleagues sat back on their laurels and took too long to set studies up,” she adds. The government’s life sciences strategy also notes that industry became frustrated by the regulatory approvals process, and an inability to secure a quick financial return on investment to satisfy shareholders.

Cracking the economic code
Government realised it had made a mistake by 2006, and launched a new strategy for health research. That set up the National Institute of Health Research, which works with industry to create opportunities for research in the NHS. In 2010, the incoming coalition government was “pleased” with the institute’s work, and “wanted to build a bigger, national strategy,” Davies says. The result was the 2011 life sciences strategy, which was jointly launched by the Department of Health and the Department for Business, Innovation and Skills.

“The first objective was to make sure that we at least kept the activity that was going on [in the UK], and not let it decline further,” Davies says. “We’ve delivered that objective, but we’re now going for increasing our global share”.

The strategy is a ten-year vision for industry, the NHS and academia. To boost business, there’s a programme of direct investment and tax incentives to encourage more research from big corporations and small start-up companies (see box below for more details).

Meanwhile, the NHS is expected to play a more active role in the life sciences industry, being “the ‘pull’ behind the industry ‘push’,” the strategy says. So there’s been a big drive to include patients in more clinical research, and “the evidence is that patients like it: there’s something special about being in a study and there’s early access to innovative treatment,” Davies says. Also, for ethical reasons those involved in medical research can only be used to contrast new innovative treatments with the best treatments already available – so even the patients in control groups benefit from taking part.

To facilitate this new drive, the NHS constitution pledges “to inform [patients] of research studies in which [they] may be eligible to participate”. A somewhat clunky ‘Clinical Gateway’ website has been set up to help patients search for potentially beneficial treatments; the NHS is now trying to make it more “patient-friendly”, Davies says.

The new NHS constitution also pledges to anonymise patient data, but there will be a push to share this data – particularly clinical trial results info – more widely. This is intended to create a platform for better academic research within the sector. Already, the Department for Transport has linked road traffic injury data to hospital statistics, enabling health researchers to model fluctuations in demand for the NHS resulting from traffic accidents.

Pleasing the profs
This new, more open approach from the NHS has already started to attract strong interest from the academic sector. For example, Queen Mary, University of London is planning to invest up to £500m – with an initial fund of £100m – in a new life sciences campus at Whitechapel.

The campus will be on the site of the old Royal London Hospital, and staff will collaborate closely with the local NHS trust. Queen Mary University will also bring in its own bio-incubator unit, which partners with private sector investors to develop spin-off companies.

“The concentration on, and openness to, the research agenda [from the NHS] has been quite markedly different in the last few years,” says Dean Curtis, Queen Mary’s chief strategy officer. “Giving the space for research and teaching has been a noticeable change – that’s been one of the reasons that Queen Mary has decided that this is the right time to expand.”

The changed approach from the NHS, says Curtis, gives British academia a unique advantage. “The ability of the UK to combine academia and health organisations is probably unrivalled across the globe. If you look at the range of activities that are undertaken in the NHS, and the co-location with academia, it feels like we’ve got a true selling point that you don’t come across in any of the developed world.”

Other collaborations between the NHS and academia include the £700m Francis Crick Institute: with £200m funding from the Department of Health, it works with the third sector and three leading London universities to understand the basic biology underlying human health. Government has also promised to support the development of the skills necessary for Britain’s life sciences industry through apprenticeships, PhD funding, and the encouragement of partnerships between academia and industry.

Who’s who?
The life sciences strategy is a cross-Whitehall initiative. The Office for Life Sciences is based in the Department for Business, Innovation and Skills, and works closely with the Department of Health, the Treasury and UKTI. There are also two independent life sciences champions – one for academia and one for industry – and an MP adviser, George Freeman. Meanwhile, the NHS has various research councils and forums, which include patient representatives.

Davies says the DH has met its commitments in the strategy, but “the issue for us is pushing the NHS [trusts] and NHS England to ensure consistency of implementation.” They are stepping up to the mark, she adds, but “it is important that we keep that consistency of delivery; we’ll always have to keep a close eye on that.”

The Health and Social Care Act introduced a duty requiring trusts to give patients access to research. Davies says this is “having a big impact at the top, but we need to make sure that that’s promulgated in spirit in the NHS”. Davies’ colleague Wood is responsible for keeping that close eye, and adds that Whitehall has “a new relationship with the NHS, so the mandate is an important way of covering our interactions”.

There’s a determination within government that Britain build on its reputation for life sciences, and investing in a new genomics company is a unique step. So far, genomic sequencing hasn’t yielded any revolutionary treatments, but there’s great potential – not only directly for NHS patients, but also for research and training. The NHS is often presented as a cumbersome, crumbling organisation, but this innovation proves that – at its best – it can help the UK lead the world in medical research and techniques