AstraZeneca – Written evidence (LSI0117)

Summary

AstraZeneca is pleased to participate in the Committee’s timely inquiry into the Life Sciences Industrial Strategy (LSIS).

We welcome and support the report from Sir John Bell published on 30 August. The LSIS presents a comprehensive, ambitious and exciting future for the life sciences sector in the UK that can drive economic growth and deliver improved health, with the NHS playing a critical role in both elements.

We recognise that the report is from the life sciences sector and its ultimate success will depend on support secured from Government and, crucially, implementation of its recommendations. This inquiry will be helpful in developing clarity on how the strategy’s recommendations can be prioritised, developed and implemented, including through the proposed Sector Deal. Experience from previous strategies and the challenges and opportunities presented by the UK’s exit from the EU will also be important considerations.

We look forward to the Committee’s conclusions and to working with the sector and Government to realise the strategy’s goal of making the UK a truly world leading location for life sciences.

Introduction

AstraZeneca is the UK’s largest pure play biopharmaceutical company. We operate throughout the world with major footprints in the UK, Sweden, USA and China.

In the UK, in 2016 we:

• employed 6,500 people in the UK working across a range of R&D, manufacturing, commercial and support functions
• invested £2.0b in R&D associated with our UK operations, accounting for over a third of total UK pharma industry R&D investment
• exported £4.7b worth of goods, accounting for 4.5% of the total UK pharmaceuticals exports (0.9% of all goods)
• supported some 30,000 UK jobs with a Gross Added Value to the UK economy of £2.64b

AstraZeneca and its MedImmune biologics arm employ over 2,000 people in the Cambridge area. Our decision in 2013 to move our global HQ and UK research centre to Cambridge reflects the importance we attribute to the UK’s science ecosystem, skills base, academic excellence, and incentives for innovation. Staff will begin moving in to our £500m strategic research centre at the end of 2018 and it will be fully operational in the following year.

In the North West, we are investing £115m in new packing and warehousing facilities at our manufacturing and pharmaceutical development centre in Macclesfield. An additional £120m upgrade to the manufacturing infrastructure on site has just been completed. We employ close to 4,000 people in our North West operations in Macclesfield, Speke and Alderley Park. We are a major supplier of innovative medicines to all parts of the NHS and have more than 700 staff in our UK marketing company.

We have been closely involved with the development of the LSIS report published on 30 August by Sir John Bell on behalf of the sector. We thank Sir John for his leadership and congratulate him on delivering a comprehensive and ambitious report. The Report includes contribution from public, private and charitable organisations spanning from research and development to the delivery of healthcare and was conducted in a collaborative environment. The involvement of Government, and particularly the Office of Life Sciences, throughout the process was notable and, although the Report is made to Government on behalf of the sector, we urge the Government to respond to it and work with the sector to deliver its recommendations.

In particular, we support the recommendations to:

• Invest more in science and innovation, both public and private, to bring funding for R&D to a level closer to that of other leading nations such as the US or Germany
• Develop large scale collaborative Research Programmes such as the proposed HARP (Health Advanced Research Programme) to fuel imagination, growth and stimulate future funding
• Leverage the potential of the NHS to drive UK science – for example, by working in partnership to harness the power of medical data; delivering more clinical trials and research; and supporting the development and greater use of precision medicines and genomics
• Play to our science strengths by developing clusters of global excellence in research (such as the Golden Triangle) and advanced manufacturing
• Foster through policy and fiscal mechanisms the development and growth of new UK businesses founded on science to create jobs and economic value
• Support the skills required for the sector’s growth, including continued access to the best global talent post Brexit
• Underpin the future growth of the whole sector, from fundamental science through to advanced manufacturing, by ensuring patients in the UK have timely access to innovative new medicines and technologies in the NHS
• Place by 2023 the UK in the top quartile of comparator countries for the speed of adoption and the overall uptake of innovative medicines
• Build on the Accelerated Access Review to ensure a streamlined access framework as part of a holistic medicines policy including a new voluntary agreement (on pricing)

Detailed response

We are pleased to comment to the Committee and our responses below relate to specific questions in the call for evidence.

Section 1: Science and innovation

1. How can investors be encouraged to invest in turning basic life science research into new innovations in treatment? Why has investment been lacking in this sector?

Does the research base have the necessary infrastructure to be world-leading?

2. Why has the UK underperformed in turning basic research in the life sciences into intellectual property? What needs to be done to address this historic weakness in the UK and grow new companies to commercialise new research and related technologies in the life sciences?

We believe that creating more UK business and commercial success from the UK’s science base is pivotal to the future success of the LSIS. The country must reverse the recent trend of closure of research facilities and create and retain more economic value from its success in science.

The UK has the best life sciences product development pipeline in Europe, before Germany, France and Switzerland. Despite this, the UK lacks the ability to translate the great science discovered and developed here into innovative products and technologies made in the UK.

To make a step change we need to:

• Play to our strengths in science by developing clusters of global excellence in research (such as the Golden Triangle of Cambridge, London and Oxford) and advanced manufacturing (such as in the North of England)
• Address the current lack of support for new start-ups to commercialise their innovation within the UK – this is preventing the UK from retaining significant value as the current trend is for commercialisation to happen in other markets
• Improve the commercial environment to support the development of more SMEs and mid-sized companies into larger organisations. We have no mid-sized biopharmaceutical companies in the UK and only a handful of SMEs that may make the transition to mid-cap

The BioIndustry Association’s Report “Building something great: UK's Global Bioscience Cluster 2016” argues that the UK is in a strong position to close the gap on the leading life sciences clusters in Boston and San Francisco and maintain its lead in Europe:

• In 2016, the UK led Europe in venture capital funding: £275m was raised in post-series B fundraises, up from £110m in 2015, and an increase in series-B funding, with £184m raised, up from £136m in 2015. There were seven IPOs for UK listed companies and many companies returned for follow-on funding on the Alternative Investment Market (AIM)
• The report also reveals that the combined venture capital of the UK and Switzerland is now 55% of the European total. If this trend continues it will mean that more than half of the biotech financing in Europe will be outside of the European Union (EU) post Brexit

We now need to channel this funding capacity in the UK into the commercialisation of innovation. The LSIS report highlights this challenge and recommends the need to incentivise entrepreneurs and large investors to innovate and manufacture here, through fiscal and policy measures including improved tax credits and maintaining the globally attractive Patent Box. When compared to the USA, funding is comparatively weak; UK companies received £680 million in venture capital in 2016 vs £1.5bn (San Francisco), £0.5m (San Diego) and £1.5bn (Boston). US Private Equity and Venture Capital funding in life sciences is also 20 times that of UK.

Overall, the UK Government and sector need to work better with private sector investors, ensuring they can provide viable and competitive funding options for our biotech entrepreneurs – and that they are recognised as an integral part of the life science ecosystem to stop the flow to the US and other parts of the world. We must also work to ensure that EU and specifically UK assets are on the radar of US investors.

3. What can be done to ensure the UK has the necessary skills and manpower to build a world class life sciences sector, both within the research base and the NHS?

The UK should aim to be the world’s leading science and translational powerhouse, attracting the best global talent and developing a pre-eminent workforce driving innovation in life sciences. A mechanism that permits and welcomes the movement of skilled scientists and executives and their families between the UK and the EU is an essential requirement of the Brexit negotiations. 4

The UK cannot aspire to be a world leading location for life sciences, or any other high tech globally competitive sector, without maintaining access to the best talent from across the world. We need to build the UK research skills base across all STEM disciplines. We strongly support the LSIS Report’s recommendation to invest more in science and innovation, through both public and private funding to bring total R&D spend to a level closer to that of other leading nations such as the US or Germany.

The LSIS Report suggests a globally competitive target of 2.6% GDP for R&D in 5 years, up from the current level of 1.63% (US and Germany currently at 2.8% GDP). To reach 2.6%, we calculate that an additional £17bn pa is required. Under the current ratio of public:private investment, this equates to approximately £5bn of Government and £12bn of private sector funding. In its response on 12 September to the House of Commons Science and Technology Committee’s Report on the Industrial Strategy, the Government re-affirmed its intent to reach 2.4% GDP by 2027 and 3% in the longer term. This target is lower and achieved more slowly than the sector would like to see. Given that a study last month from the Warwick Business School concluded that public funding for R&D totalling £8bn led to economic growth worth £43bn and created around 150 000 jobs over a six-year period, we would urge the Government to consider whether and how it may be able to accelerate its funding target.

The quality of the UK science base is a major explanatory factor for our substantial R&D and manufacturing investment in the UK. However, we see acute skills shortages arising in several areas of importance to us, particularly in R&D disciplines such computational science, data management, toxicology and pathology, with shortages also in oncology, translational science, epidemiology, health economics and genomics. Widening the scope of the Apprenticeship Levy fund could help address this.

We believe more focus on education and training in STEM subjects is also required to improve the UK’s competitiveness in the life sciences sector. We operate our own apprenticeship programmes, a comprehensive graduate training scheme, an industrial placement scheme for undergraduate students, and we engage the next generation of scientists though our STEM outreach programmes.

In the longer-term, Government policy needs to ensure:

• A focus on relevant interdisciplinary skills e.g. maths plus biology, computer science plus biology, to support bioinformatics and other areas of science at the interface of individual disciplines
• Enhanced post-16 maths for scientists as a critical component for science degrees
• Making science and other areas of STEM more attractive as a career

There is scope to establish a national skills training and education centre for the sector, building on the growth of apprenticeships. This could be located in the North of England together with a Centre of Excellence in advanced biopharmaceutical manufacturing. This is something which could be delivered in partnership with Government as part of the Sector Deal.

Section 2: Industrial Strategy

5. What can be learnt from the impact of the 2011 UK Life Sciences Strategy? What evidence is there that a strategy will work for the life sciences sector? How can its success be measured against its stated objectives?

The 2011 Life Sciences Strategy has delivered considerable advances in the sector, and although it was intended to be a 10-year plan, it has stalled in recent years. The strategy was developed by the 5 coalition Government in consultation with the sector and was overseen by a dedicated Life Sciences Minister spanning the Departments of Health and Business. The Minister acted as Champion for the sector, but it was unclear where responsibility and accountability lay for the overall implementation of the strategy, particularly in elements where there were different lead departments or executive bodies. This was especially the case within the NHS at both national and local levels. Clearer accountability with the development of clear and agreed metrics would have helped to create greater ownership and support delivery.

Nonetheless, the strategy directly or indirectly introduced several initiatives including:

• The establishment of the R&D tax credit, to improve the visibility and certainty of R&D tax relief to attract large scale investment in innovation and, from April 2013, the Patent Box. Both are important fiscal incentives across the sector
• In R&D, the strategy gave rise to £310m to support the discovery, development and commercialisation of research. This included £130m for Stratified Medicines and £180m for a Biomedical Catalyst Fund under which, in a collaboration with the MRC, AstraZeneca made 22 compounds available to academic researchers to develop medicines
• The creation of research catapults to help commercialise new science. These continue to be developed, although the Precision Medicine Catapult has closed and some functions have moved to the Medicines Discovery Catapult. The National Biologics Manufacturing Centre was also created and serves as model for similar centres proposed by the MMIP
• The Early Access to Medicines Scheme (EAMS) was intended to bring new medicines to patients faster, allowing access prior to marketing authorisation. We used this scheme to provide patient access to an innovative cancer medicine. However, the lack of connection with the reimbursement process meant that we had to implement an emergency access scheme once the product received a licence for the period until the decision by the National Institute for Health and Clinical Excellence (NICE) was finalised. For this scheme to be successful, products approved for EAMS should be reimbursed from the point of licence and the reimbursement assessment should be fast-tracked
• Adaptive Licensing was encouraged with joint NICE/MHRA advice meetings to increase uptake so that companies can consider regulation and Health Technology Assessment issues in parallel
• The NICE Implementation Collaborative (NIC) was developed to improve access to medicines. It brought together NICE, the NHS, the Life Sciences industry, healthcare professional bodies, and key health organisations such as patient groups. We participated in this programme to support the implementation of NICE guidance on the treatment of Acute Coronary Syndromes and would welcome more opportunities for this type of collaboration
• The Innovation Scorecard to show the usage of new medicines. However, figures are presented without any meaningful context and the Index could be improved if they were compared to the expected usage if NICE guidance was fully implemented across the NHS

The above represents considerable progress, but as the LSIS makes clear, the UK does not yet enjoy the policy, fiscal, science and skills environment necessary to reach the level of global attractiveness and competitiveness that it aspires.

6. Does the strategy contain the right recommendations? What should it contain/what is missing? How will the life sciences strategy interact with the wider industrial strategy, including regional and devolved administration strategies? How will the strategies be coordinated so that they don’t operate in ‘silos’?

We welcome Sir John Bell’s report which sets out an ambitious set of recommendations on how the UK can build a world leading position in the life sciences and help to drive economic growth.

The themes and recommendations in the report are comprehensive and importantly, the strategy highlights how the NHS can act as a key differentiator for the UK and help the sector grow through early adoption of innovation, the use of big data and digitisation to inform scientific and clinical research and improve patient care.

There are no strategic areas of the sector that the report does not address. Accordingly, our view is to not look for more areas to include, but to now turn attention on how to implement and deliver the recommendations.

Implementation is dependent upon the support of Government and the development of a mechanism that can be held accountable for delivery. The proposed Sector Deal will play an important part in this, but it cannot be the sole platform for delivery as many of the recommendations in the report will require action from Government – increased funding for R&D, improved capital allowances for industrial plant and building, and improved transport infrastructure to enable clusters to function effectively are just three examples.

A valuable lesson from the development of the LSIS report has been the way that the whole sector has worked together – academics, charities, NHS, diagnostics, devices, health technologies, biotechs and pharma. The mechanism to deliver the LSIS should maintain this whole ecosystem approach to the sector and work to improve the provision of healthcare and delivery of innovative new products and services in a holistic manner.

The topic of pricing was explicitly excluded from the scope of the report. However it will be important to ensure pricing discussions recognise the value of innovation, in alignment with the ambition of the Life Sciences Strategy.

7. What opportunities for small and medium sized enterprises (SMEs) are there/should there be in the strategy? How can they be involved in its development and implementation?

The success of the LSIS will revolve on its inclusion of all parts of the life sciences ecosystem, public and private, large and small. The strategy needs to encourage the establishment of more SMEs and the funding and commercial support required to enable them to make the successful journey for more of them to grow into medium sized companies within the UK (See Qs 1,2 and 6 above).

8. Where should the funding come from to support the implementation of the strategy?

The LSIS report has not costed many of its proposed recommendations. As the sector and Government work on the next steps for the report’s implementation, the costs to the public purse of key recommendations will need to be calculated and judged against their likely return on investment. Public investment in science generally generates increased private sector investment, and a supportive environment in the UK for research, development, clinical trials, and advanced manufacturing will attract new investment in the UK from companies like AstraZeneca and importantly, from companies with little or no current presence in the UK. Nevertheless, it is likely that a considerable amount of the initial funding for the LSIS will need to be from Government.

9. How do the devolved administrations and city regions fit into the strategy? Scotland has its own life sciences strategy, how will the two interact?

It is important that the Industrial Strategy and the LSIS below it work to distribute jobs, economic activity and wealth creation more equally throughout the UK. At the same time, the strategy and its sectoral components need to promote the growth of those parts of the UK that are centres of excellence in certain skills or activities and work to grow these into world leading centres. We do not believe that these objectives are mutually exclusive.

For research, the South East / Cambridge cluster is the only UK cluster that can viably compete in the world top three and we would look to the Industrial Strategy to strengthen the cluster and reinforce its global position. In the North of England, we would look to the Industrial Strategy to develop the region as a centre for advanced manufacturing and drug development and skills training. In both these geographies and in others including Scotland and Wales there is a major role for local, regional and devolved Government and agencies to promote policies to support the growth of their life sciences assets.

Improved infrastructure cannot be overlooked as a necessary component for economic growth and here, local and regional government will be critical players in delivery. We expect this to be a major focus of the high level Industrial Strategy White paper in the autumn. Infrastructure is a common need across all sectors but, as an example, to make a research cluster in Cambridge and the golden triangle work will require:

• A Cambridge South train station and rail link to serve the growing and nationally important Cambridge Biomedical Campus (CBC). The CBC will be will be Europe’s largest life sciences cluster with our new global HQ and R&D centre, the Laboratory of Molecular Biology, Cancer Research Institute, Addenbrooke’s hospital, the new Papworth Hospital and is on the doorstep of the University of Cambridge. Currently 15,000 people visit the CBC every day and this figure will increase sharply over the coming years

•        A rail station would ease local traffic congestion and could be integrated into improved commuter links to East Anglia where more affordable and accessible housing is available

•        Improved road network around the city and better public transport links to the north and east of the city to support more connection with these geographical areas

•        Ubiquitous access to high-speed internet and reliable mobile telephone signals must be a priority for delivery if business is to develop and thrive. This simply does not exist in parts of the UK, including in the areas around our new investment in Cambridge

•        The supply of affordable housing, schools and other public infrastructure and services is also a major concern in the South East

A project such as a new train station to serve the Cambridge Biomedical Campus is an example of where the private sector can support public infrastructure. However, despite the clear need and business case, progressing it takes a great deal of time, due the need to deal with disparate public and private organisations and authorities, each with their own priorities and procedures. The different local and regional groups and authorities involved must work together to align their priorities and plans in a timely manner. Continued delays simply act as a disincentive to private sector investment.

Section 3: NHS Procurement and collaboration

10. How can public procurement, in particular by the NHS, be an effective stimulus for innovation in the Life Sciences Sector? Can it help support emerging businesses in the Life Sciences sector?

Government must ensure that the dominant customer in the UK of healthcare technology and medicines, the NHS, adopts new technologies and innovative medicines as quickly as other parts of the world. This will benefit patients through better healthcare, and the life sciences sector by providing confidence that there is a market and demand for innovation in the UK.

We believe Government should align NHS purchasing decisions to the life sciences strategy. Specifically, the medicines reimbursement system must recognise the full value of a medicine and reward innovation. For the UK to retain and attract more and new investment in medical research, drug discovery and development and manufacture, companies need to see increased use by the NHS of the resulting innovations. Where companies partner with NHS organisations to demonstrate the value of new technologies, there must be a clear mechanism and route for widespread adoption across the NHS. We wholeheartedly endorse the Report’s recommendation that “the UK should be in the top quartile of comparator countries for the adoption of innovative cost effective products.”

With respect to collaboration, the NHS has the potential to be a major asset to attract life sciences investment in the UK, but this will require commitment from Government. The LSIS is anchored on the premise that the NHS could, and should, work better with the UK’s Life Sciences sector. Partnership between the NHS and the sector is important for the overall growth of the UK economy and the NHS should rightly expect to benefit from partnerships.

Key collaborations will revolve around the NHS working better with the sector in research and the development of new products and technologies. The report rightly highlights the potential for the properly protected and aggregated patient data held within the NHS. Investing in the digitisation of the NHS for diagnostics, pathology, imaging, health records, prescriptions, linking primary and secondary care and many other uses is critical both for patient care and to differentiate the UK globally as a location where the resultant data has the potential to transform healthcare and attract life sciences. Improved patient care, better service delivery, faster diagnosis and accurate monitoring of treatment with the ability to use the data in clinical trials and long term large scale population level research programmes are just some of the benefits from investing in digitisation.

The Secretary of State for Health has recognised this and in his speech on 12 September 2017 to the Healthcare and Innovation Expo, said that by the end of 2018 all NHS patients (in England) should be able to access their electronic health records, book appointments and repeat prescriptions using an app. This is a step in the right direction for the full digitisation of the NHS, but it comes 12 years after similar goals were announced as part of the “Connecting for Health” programme which was abandoned in 2013 after a £12 billion investment. Clearly this experience may weigh heavily on Government when considering any major new investment in digitising the NHS. However, we would hope that many lessons have been learned and the need for new investment and the benefits it would deliver to patients, the NHS, the UK’s life sciences sector, and the economy are clear.

11. How can the recommendations of the Accelerated Access Review be taken forward alongside the strategy? Will the recent changes to the NHS England approval process for drugs have a positive or negative effect on the availability of new and innovative treatments in the NHS? How can quick access to new treatments and the need to provide value for money be reconciled?

In the UK, patient access to new medicines is slower than in many comparative countries. The UK uptake of medicines approved by NICE as cost-effective was just 18% of the international average of other high-income countries in the first year after launch.[1] As recommended in the LSIS, the UK should be positioned in the top quartile of comparator countries for the speed of adoption and the overall uptake of new medicines by 2023.

For context, the UK spends 9.9% of GDP on health, compared to France which spends 11.1% and Germany 11%.[2] In the EU, on average, around 15% of healthcare budgets are spent on medicines. In the UK, this is around 12%.[3] We believe the UK government should increase investment in the NHS to improve patient outcomes.

The access and adoption of medicines has a pivotal role in supporting the NHS and overall Life Sciences ecosystem by:

•        Providing the end-to-end pathway for the latest innovative medicines to be accessed systematically by millions of NHS patients

•        Ensuring that the NHS harnesses fully the resulting improvements in patient outcomes in key therapy areas, and in turn

•        Creating a more attractive research environment by ensuring the global Standard of Care is used for purposes of clinical trials, and ensuring NHS data is used to constantly improve the way medicines are delivered and used.

The LSIS report proposes ways to improve patient access to new medicines in the UK. We endorse these recommendations and urge Government to respond to them as a priority. Of key importance is the recommendation that Government should “streamline the processes and methods of assessment for all new products, simplifying and accelerating access and using a single clear decision point.” The assessment must capture the full value of medicines, and reward innovation.

This streamlined access framework should be part of new a holistic medicines policy that is aligned to the ambition of the LSIS. We support the negotiation of a new agreement with Government (as a successor to the current Pharmaceutical Price Regulation Scheme (PPRS)) that seeks to achieve budget stability for the NHS, a fair reward on investment for pharmaceutical companies and improves patient access to new medicines. Any rebates under the future scheme must be returned to budget holders, to support the uptake of innovative treatments.

The recent changes to the NICE approval process for drugs is likely to have a negative effect on the availability of new and innovative treatments in the NHS. The changes will result in delayed patient access to cost-effective medicines, and we believe this policy should be reversed. The rationale for introducing the budget impact test and phased implementation of new treatments is unclear, and counter to the NHS Constitution which states that patients have the right to access NICE approved medicines. Government already has a mechanism to manage affordability in the PPRS. This safeguards the affordability of the overall branded medicines bill, as any spend on medicines above agreed levels is returned to Government. To date payments have totalled £1.87bn.

We believe the budget impact test should be replaced with a robust process for enhanced early horizon scanning, jointly developed between NHS England and industry. Ensuring appropriate planning systems are in place will help NHS England to make new medicines available to patients.

Industry is ready to work with Government to create a medicines access framework that enables quick access to treatments and provides value for the health service. Government should enable more flexible commercial arrangements such as outcomes-based agreements, patient access schemes and price-volume agreements. We believe Government should establish an Office for Patient Outcomes to provide an impartial assessment of health outcomes and help identify areas for investment. This new body should benchmark the UK’s relative performance against other countries in a range of key therapy areas, including cancer. This will help focus NHS performance on health improvement and provide patients with more meaningful information.

12. How can collaboration between researchers and the NHS be improved, particularly in light of increased fiscal pressures in the NHS? Will the NHS England research plan help in this regard? How can the ability of the NHS to contribute to the development of and adopting new technology be improved?

The UK should lead the world in optimal healthcare delivery and best research capabilities, through comprehensive use of electronic health records and digital healthcare. This can become a reality if the UK can link health records held in the NHS to genomics and other biomedical data to create a closed loop system to facilitate drug discovery, development, assessment and new interventions.

To achieve this, we need to make the NHS a long-term research partner in the life science ecosystem, embedding a culture of research that is focused on areas of UK strength. This requires:

•        A health data system specified for patient health and research, with clean, good quality, complete data and population coverage and regional deep dive studies that can be placed in the context of national standards and national interoperability

•        Culture change to promote the research agenda within the NHS at all levels, driven by incentives, scorecards, senior and leadership accountability as well as investment in consistent quality data capture and sharing (including transparent standards for sharing, interoperability and simplified access)

•        Creating a more attractive environment for clinical trials by ensuring global Standards of Care are in place, and ensuring NHS data is used to constantly improve the way medicines are delivered.

Within five years we would like to see the regional data sets proposed in the LSIS developed into a nationally federated data system that would transition into a centralised data system by 2025 with more than 80% of each Trusts’ electronic health records meeting data quality standards and easily usable for research.

Section 4: Responsibility and accountability

13. Who should take responsibility for the implementation of the Life Sciences Industrial Strategy and to whom should they be accountable? What should the UK Government’s role be? What should the role of the academic, charitable and business sectors be?

Ultimately, we do not believe the LSIS recommendations can be delivered without the support of Government which will require new policies and public funding. The sector cannot be accountable for that, but the sector must be responsible for delivering the new investment and growth that the action it seeks from Government will facilitate. A cross sectoral/Government governance group, ideally with an independent chair and a joint sector/government secretariat should be formed to review and monitor progress of the strategy.

14. What is the role of companies within the sector, particularly the large pharmaceutical companies, in the implementation of the strategy? How are they accountable for its success?

There is an obligation on large companies to ensure there is leadership and a fully representative structure for the development and implementation of the strategy. Larger companies like AstraZeneca have taken leadership roles in the development of the LSIS, preparing for Brexit, pressing for access to innovative technologies for patients and developing advanced manufacturing and the skills base. However, this is on behalf of and in collaboration with the sector and companies of all sizes. Ultimately, should the LSIS be successful there will be more than a handful of large and medium companies thriving in the UK.

15. Does the Government have the right structures in place to support the life science sector? Is the Office of Life Sciences effective? Should the Government appoint a dedicated Life Sciences Minister? If so, should that Minister have UK-wide or England-only responsibilities?

A Cabinet Minister must be accountable for promoting the strategy in Government and advocating for necessary policy changes and public funding. Below this, there are various existing groups such as Medicines Manufacturing Industry Partnership, the Ministerial Industry Strategy Group and sectoral trade associations that can play an active part in the development and execution of the strategy.

The Office of Life Sciences is appreciated by AstraZeneca and the sector. It was easier to engage at Ministerial level when there was a single dedicated Life Sciences Minister, but we cannot say whether that was more effective than the current structure where there are two Ministers, one in Health and one in BEIS, that oversee the OLS but neither are “Life Science Ministers”. There may be a case for making day to day accountability for the strategy and liaison with the sector the main role of one of the Ministers and having Cabinet level responsibility with the Secretary of State for BEIS.

Section 5: Brexit

16. What impact will Brexit have on the Life Sciences sector? Will the strategy help the sector to mitigate the risks and take advantage of the opportunities of Brexit?

17. How should the regulatory framework be changed or improved after Brexit to support the sector?

18. To what extent should the UK remain involved with and contribute to agencies such as the EMA post Brexit?

Brexit and its implications is a major factor at present in any consideration of the future of life sciences in the UK. The sector is extensively involved in EU research, development, regulation, trade and the movement of skilled people and is working closely with the UK Government and increasingly with the EU Institutions and other Member States to seek an agreement between the UK and EU27 that causes the least disruption to patients and the sector throughout Europe.

While we can supply our views on Brexit in detail, for the purposes of this submission, in brief, we ask the UK Government and EU27 to reach a future trading and regulatory agreement that will:

•        Provide a suitable transition period from April 2019 until new trade and regulatory arrangements come into place. It is important for our business to know as soon as possible that a transition period will be introduced

•        Maintain a close relationship between the UK and the EU regulatory framework, including ongoing alignment with the European Medicines Agency for medicines access to the important EU market. This could involve joint recognition of medicines approvals and inspections between the EMA and the UK’s Medicines Regulation Agency

•        Secure the best post-Brexit trading arrangements between the UK and Europe, including global markets currently part of EU free trade agreements. Maintaining the frictionless movement of goods is particularly critical for our global supply chains, imports and exports of raw materials, clinical trial materials and samples

•        Provide continued access to pan-European clinical trials and research collaborations. We support the UK Government’s desire to remain involved in Horizon 2020 and other pan European research platforms

•        Enable us to use skilled talent throughout Europe. We have over 480 EU nationals working in the UK and 80 UK nationals in the EU. Our business is global and requires access to all global talent with over 60 nationalities currently employed in the UK

We recognise that these matters will be part of the detailed negotiations that are still to begin between the UK and EU27 and some aspects may involve new mechanisms that would require ongoing payments to the EU. The earlier these negotiations can begin and some clarity provided, the better for business planning and continuity and to minimise the risk of disruption to the supply of medicines to patients throughout Europe.

The LSIS provides a framework to help support the growth of the sector after Brexit. Much depends on how the sector can work with a transformed NHS to develop new medicines and technologies and speed up their uptake. If it can deliver that, with increased public and private investment in R&D to drive the commercialisation of new products developed and made in the UK, then it will have succeeded.

22 September 2017