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Leela Barham casts her eye over the UK's plans for its life sciences industry in the post-Brexit world.
Professor Sir John Bell, one of the UK government’s champions for life sciences, has set out his thoughts – informed by the Life Sciences Industrial Strategy Board – on just how the UK can make the most of the mostly unwanted move out of the EU. His Life Sciences Industrial Strategy sets the scene for a deal between Government and the life sciences industry.
The term world-leading features right in the foreword from Bell. There’s some merit, after all why not aim high? The reality though may fall short since the life science industry is, in very large part, global in nature and can take it’s pick of a number of locations to do the job of research, development and even selling as other economies offer much bigger markets.
Just like any good strategy there are some key pillars:
The strategy covers a lot, in part, because it takes a very wide definition of life sciences, anything from digital to genomics. Arguably though, by taking such a wide perspective, the opportunities for the pharmaceutical industry will be in how it too can embrace the full range of life sciences opportunities, although perhaps a trend that was already happening anyway.
Within the recommendations and reinforcing actions set out in the Strategy are some measurable ambitions. They include:
Having measurable ambitions is important because there are some who have been disappointed time and time again, at least on the access to innovative drugs agenda. This has been the subject of much joint work and joint ambitions but the UK still seems to lag behind other countries.
The strategy expressly calls on Government to adopt the findings of the independent inquiry into how to speed up adoption of the best innovations across the NHS, the Accelerated Access Review (AAR).
It’s arguably in the implementation of the AAR where traditional big pharma might see benefits. Specifics include a call for a conditional reimbursement approval that could be used at the time of licensing as well as forum for early engagement between industry, NHS and arms-length agencies, with both the cost-effectiveness agency National Institute for Health and Care Excellence (NICE) and the regulator, the Medicines and Healthcare Regulatory Products Agency (MHRA) named to agree commercial access agreements.
Although not part of the strategy that relates to the AAR, there is also a call for a new regulation, Health Technology Assessment (HTA) and commercial framework to capture for the UK the value in ‘algorithms generated using NHS data’. Therapy-based registries are called for too. These could very well help in supporting review of conditional reimbursement; assuming that the conditional element relates to getting outcomes that are measured as part of the registries.
The strategy also talks about using AAR recommendations to help streamline processes and methods of assessment of new products with a single clear decision point. Not only that but where this is part of a holistic medicines policy and an evolution of value assessment.
Whilst these are difficult to pin down, there are also measurable ambitions in this part of the strategy too:
• Fifty collaborative programmes in late-stage clinical trials, real world data collection, or in the evaluation of diagnostics and devices.
• The UK should be in the top quartile of comparator countries for the speed of adoption and overall uptake of innovative, cost-effective products by the end of 2023, measured by the Life Sciences Competitiveness Indicators report.
The report explicitly says that pricing was not in the scope of the report. That may or may not be wise. The pharmaceutical industry in particular - the bedrock of the life sciences sector - often argues that there is a link between pricing and attractiveness of a country as a site for R&D. This strategy just ducks the issue.
The strategy notes that the next step is for “constructive discussions on an early agreement between the sector and Government”. It adds that there needs to be work done on both governance and implementation. Whatever people think of the strategy, it’s the action and changes it prompts that will matter. That will be difficult, in part because of the diverse nature of life sciences, but also because even in the same area of pharmaceuticals, agreement across industry isn’t easy nor straight-forward.
For pharmaceuticals negotiating a sector deal will be at the same time as negotiating the successor to the 2014 Pharmaceutical Price Regulation Scheme (PPRS). So making the deal will be complex: balancing the promise of a life sciences deal to promote industry with the need to secure value for money. It’s going to be some negotiation!
Leela Barham is providing input as a subject matter expert into medicines pricing policy development with a UK government client and for the duration of her involvement in that project, she is restricted on what she can write about.