Out-Law News 4 min. read
15 Jul 2021, 2:02 pm
Greater use of genomics and health data is envisaged in the UK to provide “much deeper, real world evidence” about the safety of new medicines and health technologies.
The plans were set out in a new life sciences vision developed by the UK government in consultation with health bodies such as NHS England as well as regulators, industry, academia and medical research charities.
The vision represents a shared 10-year strategy for UK life sciences, updating the life sciences strategy set in 2017, with the overarching aim for the UK to become “the leading global hub for life sciences”. It aims to build on the knowledge gained from the Covid-19 pandemic to tackle future disease missions. The vision seeks to tackle seven specific “future disease challenges”, including those centered on dementia research, the early-stage diagnosis and treatment of diseases such as cancer, and prevention of cardiovascular diseases.
The wide-ranging vision includes actions designed to cut the time it takes new medicines and health technologies to be adopted by health bodies such as the NHS, as well as steps to improve access to finance in the life sciences sector and make the UK a more attractive location for innovative life sciences companies to establish or grow their operations. The importance of improving skills in the life sciences sector was also acknowledged.
However, at the heart of the vision are plans to build on the UK’s existing strengths in genomics and health data.
The government said it wants to “make the UK a highly effective and efficient place in which to test and trial new technologies for the most important healthcare challenges”, and to build on the UK’s existing strengths in genomics and health data to do so. In this respect, it plans to “fully integrate genomics into health service delivery through the Genomic Medicine Service” and “harness the NHS’s unique health data to understand and tackle population health challenges”, among other things.
On genomics specifically, the vision is for the UK to “create the most advanced and integrated genomic research healthcare ecosystem in the world” over the next 10 years. The government said there is an opportunity to “deliver genomics-enabled clinical trials” and has pledged to “radically improve” clinical trials regulation so as to “create a more efficient and effective research environment”.
In relation to health data, the government said “high quality health data will be one of the primary drivers of global life sciences research and innovation and improved health outcomes” over the next 10 years. It said that simplifying the governance and oversight of NHS health data is a “precondition” for the success of the new vision.
“To support our vision of a healthcare system that is able to focus more on early diagnosis, treatment and prevention of disease and harnesses cutting edge innovation, we need to make data accessible, in a trustworthy and transparent way,” the vision said. “This is a significant opportunity, recognised by other countries, that will underpin transformative improvements in health outcomes and service delivery, and provide profound insights to support the development of new medicines and technologies.”
“Routinely, we must ensure that data from multiple sources can be linked to create a consolidated ‘picture’ of the whole person and continuum of care pathway, identify the most suitable patients for clinical research, and continue efforts to improve quality and standardisation,” it said. The government acknowledged that data sharing arrangements must be organised “in a way that secures and retains public trust and consent around who has access to their data and for what reason”.
One of the actions identified in the new vision is to “provide innovators with smoother and quicker access to reliable, high quality ‘real world’ data alongside clinical and genomic data”. The government said that this would “support more effective and efficient clinical trials; ease robust regulatory approval through the rapid accumulation of high quality and holistic data; and allow more accurate assessment and evaluation of new innovations and technologies”.
In pursuit of that aim, the government has pledged to establish accredited ‘trusted research environments’ through which NHS data can be accessed. It also said it would “overhaul” the governance on data access “to ensure that patients, NHS organisations and registries have the confidence and clarity they need to engage with innovators, bringing more consistency and efficiency in decision-making whilst adhering to the highest data protection standards”.
Other measures outlined in the vision include plans for a new framework for the reimbursement of digital health technologies and digital therapeutics to be developed in England, as well as renewed support for “the innovative use of off-patent drugs and technologies where no approved treatment exists, to address unmet patient need”, which Nicole Jadeja, life sciences expert at Pinsent Masons, the law firm behind Out-Law, said was encouraging to see given the potential impact of re-purposed drugs.
The government also said that the Medicines and Healthcare products Regulatory Agency (MHRA) would “deliver the world’s leading regulatory model for digital health products”. It said these are “not well regulated anywhere in the world currently”. Further reforms to UK medical devices regulation was also trailed, as were plans to build up the UK’s life sciences manufacturing capabilities in “target areas” such as cell and gene therapies over the coming decade.
UK prime minister Boris Johnson said: “We will utilise the full breadth of our regulatory freedoms from Brexit to make the UK the best place in Europe to invest in a life-science business, helping to create high-skilled and high-paid jobs that will level up communities right across the country.”
Jadeja said “The vision demonstrates the government’s commitment to its aim of making the UK a leading global hub for life sciences. While we will have to wait until the outcome of the government’s Spending Review in November to see how it plans to deliver the bold ambitions set out in the vision, it certainly provides a positive framework to support the life sciences sector in the UK.”
25 Jun 2021
25 Feb 2021