LSI0073 - Evidence on Life Sciences and the Industrial Strategy

Roche – Written evidence (LSI0073)

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?

1.1 Investment in research and development by the life sciences sector is tied to the adoption and reimbursement of new technologies that deliver improvements in outcomes for patients. This can include innovative new tests for previously hard to diagnose treatments, devices that make medical practice easier for clinicians, or treatments that offer patients the opportunity to live longer, healthier lives. The life sciences sector relies on a sustainable commercial environment for the fruits of research to enable long term decisions to be made on investment.

1.2 As the Government’s Accelerated Access Review (AAR) highlighted, many institutions are involved in facilitating an environment that allows the development and commercialisation of new innovations in treatment. Increasingly, we are finding that the main barrier in this process is at the end of the development pathway, when funding decisions are made by the NHS and NICE. While industry has a part to play in ensuring that there is a sound funding rationale for each medicine or diagnostic we bring to market, the institutions making the funding decisions need to be supported to make decisions that will enable British patients to benefit from scientific advances that are developed in the UK.

1.3 To encourage further investment in the development of new medicines in the UK, the Government needs to ensure that appropriate incentives are in place to ensure a return on investment. The primary barrier that exists in the current system is the methodology used by the National Institute for Health and Care Excellence (NICE), which has not substantively changed for almost 20 years. Many significant scientific advances have taken place since, from those that enabled the introduction of consumer-focused technologies such as smart phones, to those that have led to the development of precision medicines and diagnostics in healthcare. We believe that the Government should explore updating NICE’s methodology to reflect the advances of modern science and medicine. This would provide greater confidence on the part of those considering the development of such medicines that they would be adopted in the UK.

1.4 There also needs to be more work done to encourage the uptake and development of diagnostic technologies and solutions. This is supported by the AAR, which recommended that ‘NICE should refocus its work to place more emphasis on medical technologies, diagnostics and precision medicine tools, and a funding requirement should apply for those products that improve efficiency’. Presently, there is no funding requirement when NICE issues positive guidance for a medical technology or diagnostic. There needs to be greater parity between medicines and diagnostics in this respect; In vitro diagnostics have been found to be clinically and cost effective as well as in many cases cost saving, but the lack of mandate coming out of positive guidance is a barrier to their successful uptake and diffusion across the health system. It is estimated that 70% of clinical decisions are made using some form of in vitro diagnostic, making them a front-line-safe, affordable tool in all settings, yet only 1% of the total NHS budget is spent on these products. The Life Sciences Strategy itself notes that the process of evaluating non-pharmaceutical products has begun but needs to be accelerated and expanded.

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?

2.1 One of the reasons for the UK’s underperformance in this area may be lower levels of investment from the life sciences sector. While we do not have direct evidence to definitively confirm UK levels of investment relative to other economies, the factors that could increase investment include having a market where firms a) see growth, b) feel welcome and are confident that there will be c) stability. Too often the stance from the UK seems to rely on the third factor without providing enough energy behind the first two. Companies with many choices on where to deploy capital will perform sophisticated, multi-variate analyses that are highly competitive and so countries that do not perform well will not be as competitive as others that do.

2.2 In terms of in vitro diagnostics specifically, the causes of lower rate of fixed capital investment in the UK are multi-factorial. The key causes that we have identified are:

● The slow adoption of new technologies in the UK which can typically take up to 10 years

● Lack of central government mandate or legal obligation to implement new technologies once they have received a positive health technology appraisal

● Lack of inclusion of diagnostics on the NHS Supply Chain Innovation Scorecard which directly encourages companies to bring innovative products to market in the UK and thus encourages investment

● Skills shortage, in particular in the pathology workforce

● Relatively lower levels of spending on health in the UK

● More prevalent short term fiscal focus within the NHS compared to other healthcare systems

● High cost of living in major urban areas

● Poor transport infrastructure combined with lower level of government spending on infrastructure

2.3 Roche would advocate access to fixed-rate capital to non-quoted companies and for tax incentives to stimulate investment.

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?

3.1 The ability of the life sciences sector to recruit the best talent has been an important part of the UK’s competiveness to date, enabling us to attract high quality scientists and healthcare professionals from around the world. For example, Roche’s UK workforce of 1,400 people includes 42 different nationalities. We recognise that there are concerns about immigration that need to be addressed as part of the Brexit negotiations. However, talent has never been restricted to countries within the EU and Brexit creates an opportunity to enable the fast track recruitment of skilled personnel from across the world.

3.2 The advent of ‘big data’ offers the opportunity for the UK to build on the UK’s competitiveness in life sciences. However, while more sophisticated use of information can enable the NHS to deliver an increasingly ‘personalised’ form of healthcare, this will only be possible if there is a high level of access to data scientists. To ensure the UK has the necessary skills and manpower needed to build a world class life science sector, the Government could create a ‘health and science passport’ to ensure accelerated access to visas for skilled personnel working in the NHS and life sciences sectors. Administered by employers, this would provide fast track permission to work for people in designated sectors where skills shortages exist or there is high growth potential.

3.3 In addition to recruiting the best talent from abroad, the Government should also focus on developing domestic talent. The fundamentals of the UK’s science base are extremely strong. Academic excellence and good links between universities and health services combine with a rigorous approach to evidence and a good location for global partnerships to make the UK amongst the best places in the world to conduct research. Nonetheless, the Swiss experience of the impact of restrictions in access to Horizon 2020 funding suggests that UK academia will feel the impact of Brexit in terms of longer-term research funding and the ability to forge European partnerships.

3.4 To support the academic community through Brexit, the UK government should work to support collaboration between academia and the life science industry, which invests just under £4 billion a year in UK research and development. The Government could launch a science partnership accelerator to support universities, industry and the NHS in creating productive and sustainable relationships. This could combine practical support in forming partnerships with expertise in marketing and commercialising early scientific discoveries.

3.5 Our experience in Switzerland suggests that there is also more that we could do, in partnership with the Government, to create new career pathways for people interested in science-based careers through a life sciences apprenticeship programme.

3.6 To gauge the popularity of our initial ideas on Brexit, we commissioned ComRes to test these ideas with the public. The polling revealed the majority of respondents were in favour of the ideas listed above.

● 60% of British adults would be more likely to support a political party if they had a policy to introduce a ‘health and science passport’ to enable the NHS and science-based industries to recruit the best staff, irrespective of their nationality

● 67% of British adults would be more likely to support a political party if they had a policy to help UK universities to partner with the life sciences industry and the NHS to rapidly develop new treatments for serious illnesses, by launching a science partnership accelerator

● 59% of British adults would be more likely to support a political party if they had a policy to develop a life sciences apprenticeship programme to provide new career opportunities for UK citizens

3.7 We would welcome the opportunity to discuss each of these ideas and the supporting evidence in greater detail.

4. How does the UK compare to other countries in this sector, for example Germany and the United States.

4.1 The life sciences sector is already an important generator of wealth for the UK. Yet competition for investment is increasingly fierce and too often the UK loses out to other countries. In the post-Brexit world, Britain needs to do better than simply making the shortlist as a destination for life sciences: we can and should be the location of choice.

4.2 Most successful environments for life science investment also have strong purchasing environments for life sciences products. There is a growing perception that this is not the case in the UK. The life sciences sector deal should recognise that the Government has a critical role, as the major purchaser of medicines and diagnostics, to impact on domestic demand and to send positive (or negative) signals about the UK as a receptive environment for life sciences.

4.3 Many other governments recognise the healthy tension of paying for innovation for their population in a way that is sustainable for the overall healthcare spend. This is commonly delivered through dual mechanisms that incentivise innovation, but do so with a time limited window for premium pricing and reducing that premium in a predictable way that makes overall health spend sustainable, while making room for new innovation. Roche believes the approaches taken in Switzerland and Denmark are particularly encouraging and worthy of consideration as the UK Government develops its sector deal.

4.4 Switzerland is a good example as the Swiss government has successfully fostered a positive environment for innovation and public-private collaboration. The Swiss population has a good opinion of the pharmaceutical industry, understanding the strength it brings to the economy by contributing to employment and driving exports. The government, supported by the public, is willing to work together with the pharma industry through partnerships with university hospitals and academia.

4.5 Switzerland focuses on key principles to drive innovation, such as committing to strengthening competitiveness by encouraging policies that are oriented on free access to markets, private ownership of means of production, contractual freedom, principle of liability, and constancy of economic policy. Switzerland also aims to promote maths and sciences by recognising the need for more investment into STEM programs as this is the base for innovation, especially in healthcare. They also promote a dual education system which increases the transferability for students across different work streams and allows them to pursue higher level degrees after apprenticeship training for a complementary education of skills and theory. The Swiss government also maintains an open market policy for foreign companies and individuals to invest. While their lower tax rates could be seen as a pull factor much like Ireland, the country’s quality of life and stable political and legal conditions make it a more sustainable choice. Lastly, Switzerland promotes international networking to offset the disadvantages of being a smaller country. The freedom this gives to multinationals allows for increased productivity and job creation in the country.

4.6 Elsewhere, the Danish government is in the process of building its National Life Science Strategy by emulating aspects from Switzerland. In March 2017, a group of public and private experts launched 17 recommendations on creating a world class life science environment in Denmark, and four government ministers visited Switzerland this summer to see how the environment works.

4.7 Denmark already supports companies interested in establishing research facilities, supplying life science products, or engaging in strategic alliances/joint ventures. The country also has many well-established Contract Research Organizations with expertise in setting up and conducting trials at all stages (from pre-clinical through phase III), as well as favourable hospital conditions and a well-registered patient population, ensuring an excellent climate for companies wishing to engage in clinical trials.

4.8 Both Denmark and Switzerland also recognize the huge importance to fund research in order to remain competitive in driving innovation. Approximately 3% of both their GDP is invested into R&D. While countries like China have been steadily increasing their spend (2% of GDP in 2014), the UK has been slowly decreasing, with spending now only 1.7%.

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?

5.1 Previous life sciences strategies have set out ambitious objectives and promised initiatives that have often not been delivered. For example, the 2011 Life Sciences Strategy set out a commitment to develop an ‘innovation scorecard’ that would track the usage of new medicines approved for use in England. While a scorecard was eventually launched, it was extremely limited in scope and had a number of issues with accuracy of data which prevented it from being of use in measuring the speed of adoption of NHS medicines or in vitro diagnostics and technologies, or holding hospitals to account for unwarranted variation in uptake. In addition to this the scorecard was used predominantly for medicines, and as such in vitro diagnostics and medical technologies continued to fall behind in terms of uptake and adoption.

5.2 The high number of recommendations set out in the 2011 Strategy and the absence of defined timelines or lines of ministerial accountability may have contributed to issues with implementation. It will be important for the lessons of previous efforts to be learned when considering the oversight and accountability mechanisms that will be put in place to ensure delivery of the sector deal.

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’?

6.1 With respect to life sciences, the effectiveness of the Industrial Strategy will be dependent on improved collaboration and alignment between national institutions. This will include the Department of Health, Department for Business, Energy and Industrial Strategy, Treasury, NHS England, NICE and the Medicines and Healthcare Regulatory Agency. Regional organisations also have a strong role in supporting improvements in patient outcomes and in efficiency savings. Regional networks such as Academic Health Science Networks and the NIHR Medtech and in vitro diagnostics Cooperatives, which are launching in 2018, provide crucial real world testbeds for the development of new technologies, bringing together patients, researchers, commissioners and clinicians to develop expertise. Ensuring that these regional innovation implementation catalysts are effectively hooked up with national institutes and government is vital in ensuring the uptake and adoption of the technologies and successful ways of working that they develop.

6.2 Currently, the actions of different organisations serve to send conflicting signals to potential investors, undermining confidence in the commitment of the UK to life sciences. For example, NHS England and NICE have recently introduced changes to the way in which decisions are made on which medicines are made available to patients in England and Wales. These changes will have the effect of restricting access to clinically effective medicines and will serve to contradict the intentions of the AAR, which was developed at the same time but by different parts of government.

Additionally, the lack of funding requirement for positive NICE guidance for diagnostics means that investors cannot be confident that successful technologies will be adopted throughout the NHS. This makes the UK a less desirable place to invest in as there is no guarantee that successful products will be used to their full potential. This is something the AAR referenced when it recommended that a funding requirement be applied to diagnostics, and this is something that has also been emphasised by the Life Sciences Industrial Strategy, which endorses the AAR’s recommendations on bringing products to market.

6.3 The most important signal that the Government could make about its intention to address the misalignment in the current approach would be to explicitly state that medicines pricing policy – through both the Pharmaceutical Price Regulation Scheme (PPRS) and the statutory medicines pricing scheme – is recognised to be an important part of industrial policy. This would help to ensure greater alignment between statutory organisations in the way in which they seek to create an environment that is conducive to a thriving life sciences sector.

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?

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

8.1 Roche considers that the primary funding challenge associated with the proposals included within this submission is related to the affordability of investment in new medicines. The primary mechanism to deliver affordability and sustainability in medicines spending is the PPRS. Under the current Scheme, all expenditure on branded medicines above levels agreed by the industry and government is rebated back to the Department of Health. These limits on expenditure effectively ensure that there is no risk to the public finances associated with spending on medicines. However, in practice the rebates and NHS budget are not aligned and the failure to ensure that rebate payments are made directly available to the NHS has undermined the ability of the scheme to deliver sustainable access to medicines, as demonstrated by the introduction of NHS England’s own affordability mechanism in March 2017.

8.2 The current Scheme runs until January 2019 and there is therefore an opportunity for the Government and industry to come together to address the issues with the current scheme in negotiating its successor. The next PPRS should be designed to ensure patients can benefit from new treatments, provide financial certainty to the NHS, and create the conditions for growth in the life sciences sector.

8.3 Ahead of the agreement of the next PPRS, it is likely that there will be a need for some additional government investment to support the delivery of commitments made in the life sciences sector deal that are not related directly to the adoption of medicines. Where possible, funding that has already been announced but not allocated should be used to support these recommendations. For example, in July 2017 the Government announced an £86 million funding package to implement recommendations made in the AAR. Of this funding, £39 million has been allocated to Academic Health Science Networks (AHSNs). However, there has been no further clarity on how this funding will be used. AHSNs will play an important role in implementing the life sciences strategy and Roche expects that this funding will play a part in enabling the delivery of recommendations.

8.4 In terms of in vitro diagnostics, Roche considers that funding should come from a range of sources including industry, government, NHS and the charity sector. The allocation of funding should recognise the value of diagnostics in identifying the most effective and efficient treatments for patients. Particular attention should be paid to technologies that have been developed or manufactured in the UK, or where the clinical evidence was generated in the UK, in order to support those companies who are investing in the skills and R&D capability of the UK. To encourage greater consistency in funding, evidence that has been reviewed by NICE or through other Technology Appraisal processes should be mandated to be implemented across the UK. The security that is provided through the knowledge that products will be mandated will incentivise companies to continue to develop and manufacture products in the UK.

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?

9.1 Northern Ireland, Scotland, and Wales have each developed overarching strategies or plans to ensure the success of their own life sciences sectors. The Life Sciences Industrial Strategy is clear that it aims to support these strategies, and help to build on the strengths of the devolved nations. For example, the Strategy seeks to support the medtech and diagnostic clusters which have been developed in Wales through the optimisation of financial incentives to support long term investment. Equally, Northern Ireland’s key strengths have been identified by the Strategy as being diagnostics development, enhanced clinical trials and health analytics, which have been developed through Northern Ireland’s own strategy; the Government’s Life Sciences Industrial Strategy seeks to support this. The Strategy explains how it will use HARP to work with Scotland’s NHS, universities, and industry to look to the future and prepare Scotland to take advantage of the opportunities that will develop. The Life Sciences Industrial Strategy recognises the successes of the devolved administrations and has identified their strengths, which it will help support. This will ensure collaboration between all the regions, leading to a life sciences strategy that works across the UK. This will be crucial for ensuring that there are equal opportunities for the devolved nations within the strategy.

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?

10.1 The Government should ensure that it is utilising the right processes to guarantee that innovation is available and affordable in the UK. The primary mechanism for achieving this should be through pricing agreements, such as the PPRS, but there will be times when additional procurement discussions are required, either for products or managed services. Procurement processes need to enable – rather than hinder – the sectors the Government wishes to encourage, as well as provide good value for the taxpayer.

10.2 European law governs the procurement of health services and products. Current regulations have been criticised by some in the NHS as unnecessarily cumbersome and expensive to implement, reducing freedom to innovate in the interests of patients. The same challenges have occurred in relation to reaching commercial agreements on the supply of new medicines and diagnostics services, preventing deals that enable access.

10.3 It is important that the UK’s approach to purchasing and procurement reflects the complexities of modern medicine and in vitro diagnostics, and maximises value. The UK’s track record in health technology assessment and its potential to collect sophisticated data means that it could become the world-leader on outcomes based payments but it is using a 20 year old process. As medicine and in vitro diagnostic technologies become more complex, it will be increasingly vital to introduce new treatments and diagnostics in a rapid, fair and affordable manner. The UK Government should use the opportunity created by Brexit to reinvent the framework for procurement processes within the NHS, enabling it to strike deals that provide access for patients, value to the taxpayer and opportunity to the life sciences sector.

10.4 Procurement of Goods and Services under EU regulations is designed to provide a fair and equitable treatment process to bidders applying for these contracts. Although it could be argued that this has been achieved, the number of Framework Agreements, Prime Contract Arrangements and Procurement Collaboratives currently in operation indicates that challenges exist in the current system. These arrangements exist largely to counteract the inflexibility and cumbersome nature relating to the application of the regulations. Rather than expand the remit of these arrangements, the Government should take this opportunity to review the EU procurement regulations. By taking best case practices from non-EU and non-public procurement methods, the Government could take a more national approach that allows healthcare organisations to be more agile.

10.5 It is our view that healthcare organisations and professionals can be limited by current public procurement regulations. Under the current regulations (and if the contracting authority does not set its scope of services correctly) healthcare organisations can be bound in inflexible commercial contracts with suppliers. We are aware of examples where high sensitive Troponin T Cardiac Markers provided by Roche and Abbott are not being implemented (even after recommendation by NICE) due to (i) a lack of flexibility in the existing contract with another supplier and/or (ii) the value exceeding the Official Journal of the EU threshold. In the case of the latter, organisations are delaying uptake until a point when they can run a larger procurement including innovative new diagnostics, which can take several years. This results in patients unnecessarily waiting in A&E for up to 12 hours with lower sensitivity markers when they could be discharged within 1-3 hours.

10.6 NHS Supply Chain uses the Innovation Scorecard to encourage innovation in the NHS, but it could be utilised more effectively to encourage innovation and investment in diagnostics. If diagnostics or new technologies receive positive technology appraisals they are not included on the Innovation Scorecard. This prevents effective adoption of new and cost saving solutions by the NHS and dissuades companies from investing in new solutions in the UK. It is estimated that 70% of clinical decisions are made using some form of in vitro diagnostic, making them a front-line-safe, affordable tool in all settings, yet only 1% of the total NHS budget is spent on these products. The Government should encourage the NHS Supply Chain to include these products on the Scorecard to further enhance the NHS’s efforts to innovate through its procurement processes.

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?

11.1 The launch of the AAR represented welcome acknowledgement of the barriers to the rapid adoption of new medicines, in vitro diagnostics and medical technologies in the UK. However, the scope of the recommendations in the final report was limited to developing a pathway for a very limited number of interventions each year. As a result, the Review does not go far enough in recommending changes that would deliver improved access to a wide range of new and innovative treatments in the NHS. Indeed, some of its recommendations were used as a justification for the introduction of the changes to the NICE and NHS England approval process for medicines, which will result in limitations being placed on patients’ access to new treatments.

11.2 The full impact of the changes is unclear, as a treatment has yet to meet the ‘affordability test’ whereby expenditure in any of the first three years of use in the NHS would be expected to reach £20 million. However, there is a case study that indicates the approach that NHS England may take to restricting patients’ access to treatment under the changes. Despite offering the prospect of a cure for patients with a chronic, progressive infection that is associated with high long-term costs for the health service if untreated, NHS England has placed strict caps on the number of patients allowed to receive new hepatitis C treatments each year.

11.3 Many charities and clinicians have expressed concerns regarding the potential implications of similar caps or delays in access to new treatments for patients with more common conditions, such as diabetes, Alzheimer’s and breast cancer. NHS England and NICE have stated that the overall impact of the changes will be reviewed after three years, however in the life sciences sector deal there is an immediate opportunity to find a lasting solution that balances access to new treatments and value for money.

11.4 In developing the sector deal, the Government and industry should set out a high-level agreement to work together to address the issues with the current PPRS that contributed to the introduction of the affordability test, as well as a commitment to develop a pricing agreement that can support innovation in an affordable way which benefits patients.

11.5 One of the most important recommendations the AAR made, in terms of in vitro diagnostics, was the recommendation that NICE should place more emphasis on medical technologies, diagnostics and precision medicines tools – particularly the element which recommended that a funding requirement be applied to those products. Roche would like to see the full ambition of this recommendation realised and would like to see a full government response to this recommendation. This is an area that proves a real barrier to the diagnostics industry and the AAR’s recommendations here must be implemented alongside the Life Sciences Industrial Strategy, particularly as the strategy endorsed the AAR’s recommendations in this area.

11.6 Presently, uptake of diagnostics can take up to ten years, so there is a need to improve this process to achieve quick access to tests. This does not have to incur additional costs, as existing diagnostics have been proven to be cost effective – they influence over seven out of ten clinical decisions but only account for less than 2p in every pound of healthcare spending. In vitro diagnostics are at the heart of clinical decision making and inform the optimal treatment regime. Emerging areas of testing, such as genome sequencing, have the potential to further transform the way in which diseases are diagnosed. The promise of such advances will only be realised in the UK if the NHS works in partnership with the life sciences sector to become an early adopter and build world leading capacity and capability in key areas such as data analytics.

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?

12.1 NHS England’s Research Plan provides a useful summary of the organisation’s work to fulfil its legal duty to promote research and the use of research evidence in the NHS. The ambition set out in the document to work with academia and industry under the auspices of the life sciences strategy, as well as the inclusion of commitments on specific initiatives such as a comprehensive genomic testing strategy, is welcome. However, there is a limited number of these commitments and the funding that has been made available to support them is unclear. True collaboration will only be possible if the NHS views the life sciences sector as a full partner in research, rather than just as a source of funding.

12.2 To increase levels of collaboration between the NHS and researchers, the Government should launch a science partnership accelerator to support universities, industry and the NHS in creating productive and sustainable relationships. This could combine practical support in forming partnerships with expertise in marketing and commercialising early scientific discoveries. Roche would welcome the opportunity to use our experience from Switzerland and the USA to support the creation of such an accelerator.

12.3 In relation to the adoption of new diagnostic technologies, the right institutions are currently in place but they do not currently have enough power to enforce implementation. For example, in vitro diagnostics are not treated on a par with pharmaceuticals with regard to NICE guidance. When diagnostics and medical technologies receive a positive recommendation there is no legal obligation to implement and no funding requirement, and when in vitro diagnostics and medical technologies receive positive health technology appraisals they are not included on NHS Supply Chain’s Innovation Scorecard. Both of these issues prevent effective uptake of new products. In order to support the diagnostics aspect of the life sciences as part of the Industrial Strategy, Roche recommends that the Government reviews the existing institutions and addresses these barriers to uptake as part of the sector deal.

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?

13.1 The effectiveness of the Industrial Strategy and life sciences sector deal will be dependent on improved collaboration and alignment between national institutions. This will include the Department of Health, Department for Business, Energy and Industrial Strategy, Treasury, NHS England, NICE and the Medicines and Healthcare Regulatory Agency. As a party to the sector deal, the life sciences industry must also commit to playing its part in delivering its recommendations. As referenced previously, there is also a need to ensure that regional organisations such as AHSNs and the NIHR Medtech and In vitro diagnostics Cooperatives are liaising effectively with national institutions to ensure that positive local work and technology developments are recognised at a national level and adopted throughout the UK where appropriate. The national and regional organisations both have a responsibility to ensure there is effective joint working leading to successful implementation and adoption of technology.

13.2 The Government should work with the NHS and industry to establish clear lines of responsibility and accountability for implementing individual recommendations made in the sector deal, as well as timelines for the achievement of key milestones.

13.3 Roche welcomes the opportunity to contribute to the development of the sector deal. However, if the deal is to deliver real improvements for the life sciences environment it will be essential that industry, charities and academia not only participate in its establishment but also lead the monitoring and evaluation of its implementation.

13.4 Roche also considers that in order to achieve the ambitions of the Life Sciences Industrial Strategy and to effect large scale transformative changes, there needs to be an arms-length body which reports into government and the NHS. Such a body could have accountability to a Life Sciences Minister who would have responsibility for the successful implementation of the Life Sciences Industrial 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?

14.1 Roche has a clear and longstanding commitment to the UK life sciences environment. In 2016, we:

● Invested £460 million in UK research and development

● Registered 12% of all industry-sponsored clinical trials

● Conducted 127 trials in the UK involving thousands of patients

● Supported the treatment of 700,000 patients in the UK

● Enabled the NHS to carry out 450 million diagnostic tests

● Paid back £53 million to the NHS in rebates through the PPRS

14.2 Roche is committed to working with the NHS and Government to ensure that patients in the UK continue to benefit from our investment in research and are able to access in vitro diagnostics and new medicines that we develop as quickly as possible. We acknowledge the challenges for health systems that are created by medical progress and we are committed to developing solutions that work for patients, the NHS and industry.

14.3 We expect that companies’ precise role in the implementation of the sector deal will be explicitly set out as part of the deal itself and that accountability will be clearly delineated across all the partners involved in delivering the recommendations.

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?

15.1 The UK is well-catered for in relation to its institutional architecture. The challenge is to ensure that institutions work together across sectors and initiatives. For example, while the Office of Life Sciences played a key role in supporting the development of the AAR, the objective set out in the review were undermined by the changes made by NHS England in March 2017 to NICE’s processes.

15.2: Any future Life Sciences minister would need to have: first-hand experience of engaging with the Life Sciences Industry and the challenges it faces as we reshape our relationship with the EU. An in-depth understanding of the important role that Life-Sciences play in the UK economy gained in all-party parliamentary work. Passionate and tenacious in seeing through the implementation of recommendations made in the AAR and Life Sciences Industrial Strategy.

Brexit

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

16.1 As well as rewriting the rules of British politics, Brexit means important changes to the parameters in which policy affecting the health and life sciences sectors is formulated. There will be scope to consider changes that were previously not thought to be possible. This opportunity must be seized to create both a platform for investment and a springboard for discovery and translation into routine patient care.

16.2 We hope the strategy will support the sector to take advantage of the opportunities of Brexit by demonstrating the case to the Government for:

● Encouraging exploration of opportunities to reinvent the framework for procurement processes with the NHS, enabling it to strike deals that provide access for patients, value to the taxpayer and opportunity to the life sciences sector

● Accelerating access to visas for skilled personnel from across the world to work in the NHS and life sciences sector

● Ensuring that gods and products, including pharmaceuticals, can flow across borders without additional impediments

● Supporting the UK in being a world leader in the use of data to improve health

● Committing to fully funding the health services. This in turn enables everyone to benefit from the fruits of scientific discover, while supporting the wider economy by delivering high quality employment and training opportunities, acting as an engine for economic growth and supporting the workforce in staying well and recovering from ill-health

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

17.1 Brexit creates an opportunity to establish a leading position on the regulation of emerging areas of science, such as gene therapy, stem cell research and genetic screening. The UK has already proven itself to be a leader in the regulation of technologies such as direct to consumer genetic testing and should now have an opportunity to adopt a nimbler approach to regulation in areas of science which are rapidly evolving, ensuring they can be applied safely and ethically. This should include alignment with the newly introduced EU Medical Technology code which is vitally important and must be continued.

17.2 Our ComRes polling revealed the majority of British adults were in favour of an ambitious regulatory position, with 64% of British adults more likely to vote for a political party if they had a policy to ensure that the UK leads the world in the regulation of medicines and medical devices, ensuring that regulations are flexible enough to accommodate new and cutting edge discoveries.

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

18.1 Decisions on the UK’s relationship with the European Medicines Agency (EMA) are necessarily bound up with wider considerations about the UK’s relationship with the single market. In order to enable early registration of new medicines, it will be important that the UK is aligned with a regulatory system covering a large population and there are a number of options for achieving this. This could be the EMA, the FDA or through an alliance with other regulatory agencies, such as Health Canada and Swissmedic. If and when changes are made to the regulatory regime, it will be important that these are implemented in a phased manner so as to avoid any disruption to patient access to new diagnostics and treatments.

15 September 2017