Our Work
Building Our Future
Industry and Government have a shared goal of attracting inward investment from the life sciences industry.
This is now thrown into sharper focus as we look to rebuild the economy with a new Government.
A new Government will need to understand the opportunities that emanate from the new VPAG and EMIG and its Members can explain how this Agreement can:
- Provide access to the latest advances from our pharmaceutical company Members that will include advanced therapies
- Attract inward investment to stimulate the UK as a global centre of science and innovation
- Help build our economy in a way that benefits patients from all walks of life
The scientific and technological revolution of the Life Sciences sector - from the use of AI and machine learning in R&D to the latest manufacturing technologies and new treatment paradigms - bringing real value to solving health challenges through new therapies and vaccines.
A Five-point Plan for Investment in UK Life Sciences
EMIG's Five-point Plan is designed to help protect, nurture and grow the life sciences sector by strengthening what we consider to be the foundations of a healthy life sciences sector.
- 1
To support a vibrant research community, the Government should create a Life Sciences Sector Research Collaborative, bringing together public funders of research with those who guide global pharma R&D investment decisions. Through this collaborative, we hope to see bodies such as the National Institute for Health Research better target their funds to develop the evidence base for new treatments and technologies, as well as being better equipped to respond to the requirements of those seeking to invest globally in R&D.
- 2
To build a large and highly skilled manufacturing sector, the Government should set capital investment allowances and tax credits at competitive levels as well as regulation is fit for purpose. This will help attract new manufacturing investment by pharmaceutical companies and contract manufacturing organisations, as well as help create UK hubs for manufacturing ATMPs.
- 3
To help deliver flexible and supportive clinical research and licensing following EU Exit. There are opportunities to link together the MHRA's Early Access to Medicines Scheme (EAMS) with rapid reimbursement decisions, by aligning real-world data collection under EAMS with the needs of not only the MHRA but also NICE and NHS England. The latest version of ILAP promises more effective and connected collaboration between regulation and HTA.
- 4
To encourage global pharmaceutical HQs to locate their commercial centres in the UK, the Government should support the development of a concentration of expertise, including in HTA.
- 5
Make use of the flexibilities of the VPAG to remove unnecessary impediments to patient access to new medicines, including by broadening the NICE HST thresholds.
Better Research for Better Patient Outcomes
EMIG believes that improved access to medicines for patients in the UK can be achieved through inputs into UK health technology appraisals (HTA) which reduce uncertainty and improve product value propositions. EMIG has established a collaborative initiative, 'Better Research for Better Outcomes' that seeks to create the conditions that facilitate the generation of a package of evidence capable of satisfying both regulatory and HTA bodies.
This will establish a win-win:
driving inward investment
addressing some Brexit issues/risks
optimising NIHR funding and funding from medical research charities
making the UK the standout country for market access
helping the NHS buy outcomes and not costs
supporting patients to live longer and with a better quality of life
EMIG believes that all stakeholders have an interest and therefore a shared responsibility to work towards better research to achieve better outcomes.
EMIG proposes the following action plan for a sustainable and long-term solution for better patient access to medicines in the UK:
Develop a UK value framework for better research
Make NICE Scientific Advice a mandatory part of a NICE appraisal
NIHR funding and the badging of academic (NCRI) clinical studies to incentivise generation of data to support regulatory and HTA submissions, as well as academic end points
Establish key performance indicators and incentives by creating a specific commissioning pathway for the results of academic studies that shows the contribution to regulatory or HTA approvals
Support the concept of 'hybrid' trials where academic and commercial agendas converge
Incentivise innovative academic clinical trial designs for the UK to become the world-leader in trial design
Create agile and flexible treatment algorithms that optimise treatments, drive clinical innovation and create choice for patients within a resource constrained model
Enable and design flexible approaches to pricing and to patient access schemes
Shorten the time between regulatory approval, HTA and adoption by the NHS
The VPAG
The VPAG 5 Year Agreement between the Pharma Industry and Government.
The purposes of the VPAG
Control the spend on medicines to 4% (moving to 6% late in the Scheme)
Enable patient access to new, effective medicines and technologies
Encourage innovation
Encourage inward investment in the UK
How it works
The industry funds capped growth in medicines spend to 4% (moving to 6%) by paying quarterly rebates to the NHS (via the DHSC). The level of these rebates is determined by the annual rate of growth of newer medicines - the current rate is 23.5% of a company's sales to the NHS.
There are exemptions in the Scheme for small companies and products that have recently been licensed.
Important perspectives
Before the NHS will use a new product (NAS - New Active Substance), it needs to be:
- Cost Effective as determined by NICE - According to NICE, the average discount to the List Price to become Cost Effective is 70%-80%
- Affordable when reviewed by NHS England (NHSE). The additional discount to become Affordable is confidential and likely to be different from product to product, but unlikely to be insignificant.
Cost Effectiveness and Affordability will now drive sales growth to the NHS. As stated previously, the annual sales growth also drives the VPAG rebate rate (currently 23.5%)
EMIG Members believe that their commitment to Cost Effectiveness and Affordability punishes them in the form of constantly rising rebate levels. They believe there should be a cap on the rebate levels.
In addition to the financial mechanism that underpins the agreement, there are a number of Government commitments in the deal. These include:
A New UK-wide cross-Departmental Working Group to better co-ordinate activities across Depts
The Medicines and Medical Devices Access Steering Committee - NHSE, NICE, MHRA - 4 Nations will create an end-to-end 'pathway guide' by end 2024:
- Outlining routes to market
- How regulatory, HTA and commercial pathways align
- Mechanisms for company engagement
- NHSE will consult on Commercial Framework updates which will include:
- A broader use of commercial flexibilities
- When they can be offered - predictable
- Indication based pricing - circumstances under which they can be considered e.g. unmet clinical need
- Combination therapies under specific circumstances in the light of the CMA statement in 2023 regarding companies' interactions on pricing
- Two new innovative payment model pilots to support access to ATMPs
- NHSE/NICE consult on BIT threshold increase to £40m, within the first 6 months of the Scheme
- A Database to monitor Local Formulary variation
- Database to increase visibility of Patient Support Programmes
Transforming the Partnership Between Industry and the NHS
Industry and government have a shared goal of attracting inward investment from the life sciences industry. EMIG connects healthcare professionals with companies, from global leaders to small innovators, helping to secure the UK's position as a world-leading hub for life sciences.
Industry will pay c. £13 billion in rebates to the NHS over the next 5 years as part of this agreement to funding all expenditure on medicines that exceeds the current 4% allowed growth in the medicines bill.
Industry has also agreed to fund a £400m Investment Facility to support:
- A new joint government-industry programme to strengthen the UK's position in health and life sciences
The Programme is progressing and is made up of three UK-wide initiatives:
- Clinical Trials, attracting 75% of the Fund to boost UK workforce capacity and infrastructure to expedite delivery of commercial trials
- Innovative HTA approaches, c. 5% of the Fund, to support NICE, SMC, AWTTC and N. Ireland DoH to improve pre/post assessment methods/processes for access and adoption of clinically and cost-effective medicines
- Manufacturing, the remaining 20% of the Fund, to further improve the manufacturing innovation ecosystem in the UK
The Fund will be co-chaired by the Office for Life Sciences (OLS) and the ABPI and we look forward to following the progress of this considerable investment by industry.