Earlier this summer the UK government launched a new and wide-ranging Life Sciences Vision with the aim of unlocking innovation and tackling some of the biggest healthcare challenges of our generation.
The vision replaces the hugely successful industrial strategy for life sciences, which had a major bearing on the sector’s recent growth and direction, creating solid foundations on which to build.
With the help of a new Life Science Scale Up Taskforce, the central focus of the vision is to support and cultivate a dynamic business environment that unlocks the potential of innovative UK life sciences companies and harnesses expertise, while stripping away unnecessary bureaucracy. Taking its lead from the success of the UK Vaccines Taskforce, set up to tackle Covid-19, its mission is to enable future healthcare challenges to be tackled effectively at speed and at risk.
The vision has launched with an initial £200 million investment to provide innovative life sciences firms with access to finance and accompanying regulatory freedoms and opportunities that aim to incentivise production and commercialisation of drugs and devices in the UK. The investment will be boosted to £1 billion through the UK-UAE Sovereign Investment Partnership signed in March 2021 whereby Abu Dhabi’s Mubadala Investment Company has pledged to plough £800 million into the UK life sciences sector over the next five years.
The MHRA will act as an independent sovereign regulator.
In particular, it focuses on:
- Preventing, diagnosing, disease monitoring and treating disease early
- Development of breakthrough products and treatments through innovative clinical trials
- Accelerating the development and adoption of new drugs, diagnostics, medical technology and digital tools
Regulatory implications and how we can assist
Existing clinical trial legislation will no longer reflect the EU’s Clinical Trial Directive, requiring compliance instead with the UK government’s recently passed Medicines and Medical Devices Act 2021. The directive will allow the MHRA to work with NHS partners and international regulators to deliver faster regulatory assessments and decisions for medicines.
The MHRA will also consult with the sector in 2021 on the proposed new regulatory framework for medical devices and in-vitro diagnostics in 2021, making changes that support innovation and patient safety.
UK manufacturing implications
The vision aims to incentivise high-value manufacturing in the UK to create a competitive manufacturing infrastructure capable not only of supporting future pandemic preparedness but improving capacity and capability across all settings.
Improvements in patient delivery
The vision sets out threefold aims with regard to patient delivery:
- To increase NHS England’s commercial capacity to deliver innovative deals for medicines, digital and diagnostic tools and medtech devices so that clinicians’ access to them and adoption of the technologies is significantly improved.
- To support unmet patient need where no approved treatment exists by supporting the innovative use of off-patent drugs and technologies
- To harness the enormous potential of health data, while ensuring stringent data privacy safeguards are in place.