Novartis – Written evidence (LSI0075)

 

Novartis is a leading healthcare company that strives to discover new ways to improve and extend people's lives. The company uses science-based innovation to help address some of society’s most challenging healthcare issues. The group comprises of three unique divisions: Innovative Medicines, Sandoz, and Alcon, which offer a broad portfolio of healthcare products spanning innovative pharmaceuticals, low cost and high quality generic medicines, biosimilars and eye care devices. It has a strong heritage and presence in the UK. Work spans manufacturing, clinical research and joint working partnerships with the NHS, as well as research and development. Patients are at the heart of everything we do. We work closely with the NHS and Government to improve patient outcomes and find access solutions. The UK is a major centre for Novartis research, development, sales, marketing and manufacturing, and the company employs approximately 1,500 people across the UK. Novartis is also the UK’s leading sponsor of clinical trials.

 

The Committee’s call for evidence on the Government’s long-awaited Life Sciences Industrial Strategy (LSIS) is timely – the Government has begun negotiating the terms of the UK’s departure from the European Union and is assessing how it supports the pharmaceutical industry to deliver a thriving UK life sciences sector over the long-term. Novartis’ submission to the Lords’ Committee on Science and Technology is based on this extensive experience of working intensively with the UK life sciences sector; the health system; and UK and European agencies more broadly. Novartis would like to endorse the recent submission of the Association of the British Pharmaceutical Industry – of which it is a member - to this inquiry. In line with the Committee’s instructions, Novartis is responding to most of the questions it has sought evidence for. A summary of Novartis’s response and full answers to applicable questions are set out below.

 

Summary of submission

 

Science and Innovation

 

Industrial Strategy

 

NHS procurement and collaboration

 

Responsibility and accountability

 

Brexit

 

 

Submission

 

SCIENCE AND INNOVATION

 

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?

 

  1. Industry expressed in their submissions to the Life Sciences Industrial Strategy a considerable desire for investment in an innovation landscape that facilitates research, development, commercialisation and manufacturing of medicines and life sciences products in the UK.[1]

 

  1. Turning basic research into commercial value rests on a stable intellectual property regime with appropriate intellectual property incentives to foster ongoing investment into complex and risky pharmaceutical research, development and manufacturing. Incentives for intellectual property are the foundation for innovation, and maintenance of the intellectual property regime and incentives is critical. Given the regulatory uncertainty that Brexit has created, it is important that policymakers move swiftly to ensure that intellectual property rights and incentives are not affected.

 

  1. Novartis would also point out that funding challenges and the need to realise the value of deals reached between industry and the government are issues that need to be addressed to support the research environment.

 

  1. Novartis is cognisant that between now and 2019 the government will be releasing a number of consultation papers that may in part seek to ensure the UK adopts a favourable post-Brexit intellectual property framework. It is important that the Government works in partnership with the life sciences sector to ensure that IP regulations continue to provide fair incentives for commercialisation of research.

 

  1. In addition, a persistent issue facing the UK life sciences sector is the lack of ‘patient capital’ investment in small scale companies to develop and grow. The Life Sciences Industrial Strategy states: “The lack of long-term capital – or patient capital – has recently been recognised and, as a result, new funds have emerged with the capability of supporting companies for a longer term through the scale-up phase.[2] However, even with these funds, the UK continues to lag behind the US on a per capita basis, by billions of pounds of capital necessary to grow solid and sustainable companies.”[3]

 

  1. We welcome the focus on fiscal support to support small-medium enterprise (SME) growth and retention contained in the Life Sciences Industrial Strategy and its recommendation to support HM Treasury’s review into patient capital needs.[4] This issue is not new. As early as 2013, in its response to the Commons’ Science and Technology’s committee inquiry ‘Bridging the “Valley of Death”: improving the commercialisation of research’, the BioIndustry Association stated that: “While the UK has world leading science it has been recognised that the UK has a poor record at translating this research. This could be due to a number of reasons, including the technology transfer infrastructure, but a lack of available funding for applying basic research and proving its product potential is a significant factor.”[5] Novartis hopes that the Government will pick this issue up as it implements the Life Sciences Industrial Strategy and improves the sector’s position when compared with other markets such as Germany, the United States and others.

 

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?

 

  1. There are many steps that can be taken by the UK to secure the skill and resource needed to support a world class life sciences sector with regard to the research base and the wider NHS.

 

  1. Specifically, the security of labour and the retention of talent is a core part of achieving a world-class life sciences sector and these are issues for Novartis and the wider industry. The life sciences sector alone employs nearly 482,000 people which includes many professionals with high levels of expertise who are non-UK EU citizens that will likely be affected by changes to existing immigration policy following Britain’s departure from the EU. Indeed, there are already barriers to attracting international talent outside of the potential implications that Brexit could have for recruitment in the future.

 

  1. As a contributor to the UK’s research base, Novartis views it as critical that following Brexit the UK maintains a streamlined system that enables companies to continue to access skilled workers to support a thriving life sciences sector.

 

  1. Aside from the movement of labour, Novartis would also note the ABPI Skills Report Bridging the Skills Gap in the Biopharmaceutical Industry which identifies skills gaps including in data sciences and clinical pharmacology. Many of the highest skills concerns[6] require knowledge and competence in both science and maths – for example bioinformatics, statistics, data mining, health informatics and health economics. The availability of degree courses in both medicine and pharmacy is equally critical as to how talent is upskilled, developed and retained in future and that this is yet another area to be considered in implementing the Life Sciences Industrial Strategy.

 

  1. The previous Strategy for Life Sciences and the recently announced Life Sciences Industrial Strategy offer solutions to retain and attract talent through investment in training and skills.

 

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

 

  1. The UK’s life sciences sector is world leading and has a number of important assets. In particular its research and development capacity; single payer funding model and highly skilled workforce. Despite these advantages, however, uptake of innovation in the UK lags behind other countries.

 

  1. The Office for Life Sciences’ Competitiveness Indicators[7] include a number of metrics comparing the UK life sciences sector with selected comparator countries. This includes data on the uptake of new medicines, research spending and imports and exports. The data show that in 2014, the UK fell behind France and Germany in the amount of private equity investment in life sciences. The data also show a decrease in the number of companies receiving investment from 118 in 2011 to 71 in 2015.

 

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?

 

  1. There is encouraging evidence to support the positive impact of the Strategy for Life Sciences in 2011.

 

  1. A number of welcome initiatives arose from that 2011 strategy which invested £310 million in research and commercialisation. Of this allocation £180 million was invested in the Biomedical Catalyst Fund to support small to medium sized businesses and academic institutions in the healthcare space.

 

  1. The early access to medicines scheme (EAMS) was an initiative that arose directly from the implementation of the 2011 Life Sciences Strategy. The findings of an independent review of the scheme published early last year has noted that EAMS had received 18 applications, approved 5 products and provided early access to innovative medicines for over 500 patients in the UK since 2014.[8] The report noted that from an industry perspective “the EAMS has offered a valuable opportunity for early dialogue with government and arm’s length bodies about product uptake within the NHS. Further, applicants we interviewed also praised the introduction of the Promising Innovative Medicines designation, the support offered by the MHRA [Medicines and Healthcare Products Regulatory Agency], and the role of the EAMS task group as key strengths of the current EAMS process.”[9] Our view is that this initiative has been very positive in enabling rapid access to life saving medicines and the work of the MHRA to this end is to be applauded. We hope that this work will be built on as the new Life Sciences Industrial Strategy is implemented.

 

  1. More than half a million people take part in clinical trials every year but researchers often find it difficult to recruit enough participants for their studies.[10] The UK Clinical Trials Gateway was established as part of the 2011 strategy to give patients the confidence to participate in clinical trials. According to the National Institute for Health Research’s (NIHR) 2016/17 figures, more than 665,000 participants took part in clinical research studies supported by the Network that year - 10 per cent more than the previous year.[11] Moreover, nearly 35,000 participants were recruited to studies sponsored by the life sciences industry.[12] This has meant that over the last five years, more than 150,000 participants have had the opportunity to participate in high quality life sciences industry research and access cutting edge treatments.[13]

 

  1. Novartis Group conducts about 10% of all clinical trials in the UK – more than any other company. Despite the improvements brought about by the 2011 Strategy, our ambition to bring major trial investment to the UK is being frustrated by issues of high cost compared to comparator countries, slow and low recruitment, and lack of reimbursement of some ‘standard of care’ medicines in England. Novartis would invest more in the UK if these issues were addressed.

 

  1. The 2011 strategy aimed to create 420 high-level apprenticeships to better support the life sciences sector and in 2014 the Government announced a £52 million investment in new and emerging science talent to create 7,800 educational and skills opportunities over a two year period as part of the Science Industrial Partnership.[14] Specifically, this provided for 1,360 apprenticeships.[15]

 

  1. These are welcome initiatives from the government that are already making a demonstrable impact. Our hope is that this progress will be built on as the new Life Sciences Industrial Strategy is acted on.

 

6. (If published) 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’?

 

  1. Novartis welcomes the Life Sciences Industrial Strategy as an initiative to support research and innovation in a sector critical to the UK economy and its future. The UK Government has expressed an aim to be a world leader in life sciences, and we are supportive of this ambition. Nonetheless, the challenges that we will face with the implementation of Brexit have created many uncertainties for the sector, thus making an effective industrial strategy evermore critical to the aim.

 

  1. The Life Sciences Industrial Strategy is a blueprint for collaboration between the Government, the NHS and industry on medical innovation. By implementing its recommendations we can deliver a virtuous circle where clinical research thrives and patients are able to access innovative medicines to enhance health and improve productivity.

 

  1. Novartis looks forward to working with Government and other partners to implement the recommendations of the Strategy – first, through a strong sector deal, followed by a voluntary agreement on UK medicines policy between industry and the Department of Health. These measures combined will help to grow the UK life sciences sector by providing confidence for global companies to invest in the UK during and beyond Brexit.

 

  1. It is our position that to best support the life sciences sector, the strategy should focus on skills and training; provide incentives for research and development; and improve the adoption of innovation in the UK. Initiatives proposed in the new strategy such as a Skills Action Plan across the NHS, commercial and academic sectors, achieved through an appropriate gap analysis, are a welcome move with regard to this area. Ensuring the NHS becomes a more effective adopter of innovation could be achieved by simplifying the process for the NHS to procure new medicines. We welcome the proposals contained in the Life Sciences Industrial Strategy to simplify and accelerate access and create a single set of clear, national and local routes to get medicines to patients.

 

  1. Novartis would like to point out that alongside this, the Budget Impact Threshold (BIT) introduced earlier this year has already impacted funding following the conclusion of the original NICE approval process for some cost-effective medicines. We were concerned to read that this was not referred to in the Life Sciences Industrial Strategy. As such, we believe that mechanisms could be put in place to ensure that NHS England’s remit of cost-containment is balanced with the imperative of creating a sustainable life sciences sector. NHS England’s role and the resulting funding models for new medicines and treatments need to be developed in a manner that do not potentially threaten mandatory funding of NICE approved medicines, the NICE threshold, or access to NICE approved medicines as a result of further policy developments. Novartis welcomes the Strategy’s broader aim to achieve better outcomes for patients through the power of innovation and the contribution of life sciences to better quality services. The effectiveness of the resulting sector deal will have a key role in realising this.

 

  1.                                                                                                                                                                                                                        Accountability for implementation is another point to consider. The release of the Life Sciences Industrial Strategy and the negotiation of Britain’s departure from the European Union provides a timely opportunity to review how investment is made in new medicines and treatments and where it comes from. This might extend to considering a more explicit direction being made via the NHS Mandate (“the Mandate”) to promote the pharmaceutical sector. It should be noted that the Mandate does not mention the importance of the life sciences sector. Indeed, while the Mandate includes commitments to both measurable improvement in the NHS’s uptake of affordable and cost-effective new innovations and implementing the recommendations of the Accelerated Access Review, more detail is needed as to how these commitments will be implemented and the impact for industry in not doing so. Novartis’s position is that a more explicit direction to invest in innovation and more adequately support research and development needs to be made.

 

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

 

  1.                                                                                                                                                                                                                        To support the implementation of the Life Sciences Industrial Strategy, funding should be made available by Government, though Government should also explore how additional supportive funding from the life sciences industry and wider sector could be unlocked to accelerate investment and development. For example, through the PPRS and other sector deals, Government can endorse the recommendations of the Strategy and direct policy, and thereby secure global investments in the life sciences sector in the UK.

 

  1.                                                                                                                                                                                                                        For example, industry has so far contributed £1.87 billion in payments to underwrite the growth in branded medicines covered by the PPRS.[16] The PPRS could be used as a vehicle for funding the Life Sciences Industrial Strategy’s implementation. The Government could also further look at using revenue generated from its apprenticeship levy from employers that is expected to raise £3 billion annually.

 

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?

 

  1. The 2011 strategy noted that the Government would work closely with the devolved administrations in delivering its vision for the UK life sciences sector.[17] In developing the Industrial Strategy the Government has invited devolved administrations, local councils and mayors to work together with them to jointly develop plans to help every place meet its potential.[18] Scotland’s New Medicines Fund is an example of some of the good work that is being done in the devolved nations with regards to support for the life sciences sector. We would note that the new Life Sciences Industrial Strategy has been intended as a framework for the improvement of the life sciences sector across the whole of the United Kingdom.

 

  1. Novartis welcomes this overarching framework and its intended application across the whole of the UK for a number of reasons. The Brexit negotiations process will likely produce a considerable regulatory and policy impact affecting patients and industry. As already expressed in this submission intellectual property and medicines approval are two such areas that relate to this. It is therefore necessary for the UK to have a coordinated, nationwide approach that anticipates these changes and builds a thriving life sciences sector not just immediately following Brexit, but in the long-term as the UK seeks to support and develop the sector as a core part of its strategy for economic growth.

 

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?

 

  1. NHS procurement plays a central role in stimulating investment in research and innovation with regard to the UK life sciences sector.

 

  1. Novartis recognises the financial pressures that the NHS is under, and we are committed to working with the UK Government and the NHS to deliver value for money from medicines, better patient access to medicines and to ensure innovation and research are rewarded.

 

  1. The PPRS, a five year agreement negotiated between the ABPI and Government recognised this pressure, and industry agreed to cap and underwrite growth in the branded medicines bill and to refund NHS spend in excess of the agreement.

 

  1. However, despite these measures, NHS procurement has been recently focusing solely on reducing costs which does not lead to the best value treatments for the NHS nor the best outcomes for patients. In driving down costs and not valuing innovative treatments or prioritising patient outcomes, such procurement practices damage the incentive for life sciences investment.

 

  1. For pharmaceutical companies in the UK, the process to assess and then procure medicines has undergone significant recent changes. Traditionally NICE and the Scottish Medicines Consortium (SMC) approval processes provided a transparent and robust route to assess new medicines. However, the recent introduction of the budget impact threshold by NHS England that now follows the NICE approval process has made the road to patient access unpredictable, complex and longer. This could eventually result in reduced access for patients to potentially life-saving medicines and treatment.

 

  1. The Life Sciences Industrial Strategy dedicated a substantial portion of its attention to collaboration that is to be welcomed. There has already been a great deal of positive collaboration between government and industry prior to this. As well as helping clarify routes of access, collaboration can lead to the delivery of life-changing new medicines for diseases: advice and expertise provided by healthcare professionals to organisations such as Novartis can help ensure that the research and development of medicines is adapted to best meet patient need.

 

  1. An example of how this research and development can be adapted was when Novartis partnered with Public Health Wales NHS Trust to conduct an in-depth diagnostic of a lung cancer patient’s experience, from diagnosis through to treatment, in Wales. The data is being used to identify ways to improve parts of the services for patients needing care and treatment for these conditions. As a result of this partnership, it is expected that improved survival and diagnosis rates; treatment initiation times; and quality of life and patient experience during care, will occur as a result of this collaboration.

 

  1. Outcomes based commissioning is another tool by which value for money and better outcomes for patients are rewarded and could be better utilised by the NHS in supporting the UK life sciences sector.

 

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?

 

  1. It is our position that the Accelerated Access Review (AAR), while a positive step in advancing access to new medicines and innovative treatments for patients, could indeed go further. We endorse the recommendation in Sir John Bell’s report that the Government should implement in full the recommendations of the AAR. However, we do have some concerns relating to the BIT that we have outlined in further detail in responding to this question.

 

  1. The AAR is an opportunity to enable earlier patient access through a more agile system which responds to the future pipeline of medicines.

 

  1. There are a number of areas within the AAR that we identified that could be looked at and a good number have been touched on in Life Sciences Industrial Strategy:

 

  1. Cost-effectiveness: Novartis endorses quicker access to medicines overall, the emphasis originally placed on accessing medicines more “cheaply” is at odds with the appropriate valuation of medical or scientific innovation and that the AAR overall could go further to fully address uptake of new medicines. We are realistic in terms of the number treatments that could be accelerated, the transformative designation is likely to apply to very few medicines and more could be looked at in terms of uptake.

 

  1. Accelerated Access Pathway: While the setup of an Accelerated Access Pathway is an initiative we view positively, we are mindful that the proposed four-year acceleration timeframe is ambitious and likely to be shorter in practice. We agree with the bodies proposed to compromise of the Accelerated Access Partnership – NIHR, MHRA, NICE, NHS England, the Department of Health and NHS Improvement.

 

  1. Spread of Innovation: Leading up to the AAR report, significant work was undertaken by the Office for Life Sciences and industry to characterise the significant challenges of poor uptake of innovative medicines in the UK. There is widespread recognition that patient access to new medicines in the UK is low and slow compared to comparably developed countries. The Office for Life Sciences Competitiveness Indicators show that for every 100 patients that receive a treatment in its first year of launch in a comparable country, only 18 UK patients receive the same treatment. Whilst the AAR proposes a range of different measures to incentivise uptake of innovation, Novartis does have concern that the products this is aimed at are presently earmarked as only those in the Accelerated Access Pathway, and we would like to see uptake incentives across a wider range of innovative medicines.

 

  1. Transparency: We welcome proposals for greater transparency of the commissioning process and agree that an evolution of the health technology assessment mechanism is required – much of this evolution is already underway.

 

  1. Digitisation: Proposals for greater digitisation contained in the AAR are to be applauded although methods for achieving have not been laid out. This is perhaps an area that could be built on as the Life Sciences Industrial Strategy is implemented.

 

  1. Aside from the AAR, the introduction of the Budget Impact Threshold will impact access to new, innovative and life-saving medicines in contravention of the aims of the AAR and the Life Sciences Industrial Strategy. The Life Sciences Industrial Strategy announced at the end of last month is silent on this issue

 

  1. Novartis recognises the challenges faced by the NHS and is committed to developing solutions to help ensure NHS sustainability. However, the recently implemented BIT is not needed to address the medicines spend in the UK. Branded medicines spend in the UK has remained constant at 10% for many years and the overall spend on branded medicines is capped through the PPRS. The Budget Impact Threshold has been implemented in excess of the commercial planning infrastructure already in place: enhanced horizon scanning, advance planning and the PPRS are the primary mechanisms for managing the sustainable introduction of new medicines. Only in exceptional circumstances do we recognise the need for additional bespoke commercial planning discussions.

 

  1. Already the budget impact threshold is having a negative impact on the most innovative medicines with some treatments already affected. Indeed, where unmet need is greatest, the budget impact for medicines is likely to be higher for first-to-market entrants. This puts the implemented threshold at odds with the aims of the AAR. Moreover, it creates a state of affairs where perverse incentives favour the least innovative medicines.

 

  1. Prior to the budget impact threshold’s introduction, medicines in England were already subject to a rigorous value assessment by NICE – a process that is world-renowned for this rigour in assessing the clinical and cost-effectiveness of medicines and treatment. Moreover, the assessment of budget impact was already being undertaken during the NICE topic selection process that informs DH referral which ensured medicines with a potentially high budget impact could be rigorously assessed by NICE to ensure they would deliver a cost-effective use of NHS resources.

 

  1. The Budget Impact Threshold’s introduction has weakened the legal funding obligation on NHS commissioners to comply with NICE recommendations and could yet compromise patient rights under the NHS Constitution. It is important that NICE’s independence and authority is maintained. The Budget Impact Threshold slows the speed of the introduction of new cancer drugs and implications such as this are in contravention to the aims providing patients faster access to lifesaving treatments. This is notwithstanding the practical challenge in fairly and accurately calculating budget impact.

 

  1. There is a role as part of the new strategy for flexible commercial models to address existing affordability challenges within the health system, especially in the context of a NICE approval process that already rigorously assesses clinical-cost effectiveness. It is our aspiration that this be considered as the new Life Sciences Industrial Strategy is implemented.

 

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?

 

  1. There is a need to change the culture and improve change management capability within research and innovation. The move by government in responding to the Dowling Review conducted in 2015 to establish UK Research and Innovation is a welcome step that will likely improve the relationship between researchers and industry. The Life Sciences Industrial Strategy contains a number of positive aims for improving the UK’s clinical trial capabilities, in particular a translational fund for clinically useable molecules that can be explored at pre and early stage clinical studies. It also proposes the establishment of a forum for early engagement between industry, the NHS and arms-length bodies.

 

  1. Novartis believes that providing access to information on clinical research studies and their results serves study participants, researchers, patients and their healthcare providers as well as the public at large. Novartis has been voluntarily disclosing summaries of clinical study reports, both positive and negative, on our website www.novartisclinicaltrials.com since 2005, and providing access to our trial data to qualified external researchers since 2014.

 

RESPONSIBILTY 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?

 

  1. To achieve the ambitions of the Life Sciences Industrial Strategy, we would want to see cabinet-level ministerial sponsorship from both the Department for Business, Energy and Industrial Strategy and the Department of Health and the development of a robust implementation plan. We would recommend the appointment of an independent chair to lead the implementation with clear governance and accountability frameworks in place.

 

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?

 

  1. In considering this question it is important to acknowledge the vital role large pharmaceutical companies play as part of the innovation ecosystem that ultimately bring most medical innovations to the marketplace.

 

  1. The pharmaceutical industry can play a significant role in taking forward the recommendations of the AAR and the Life Sciences Industrial Strategy, working with government in a manner that is conducive to speeding up access to innovative treatments and medicines. One example where this could be best progressed is with the formation of innovation hubs to provide data, the development of therapy specific registries, a practice already widely embraced in non-EU markets such as the United States. Skills development is another area where the pharmaceutical industry can support the government to deliver a competitive life sciences sector that retains and develops its talent.

 

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?

 

  1. An inherent conflict of interest exists with regard to the DH’s role in the sponsorship of industry which is problematic. In the last year the Department has been willing to sacrifice aspects of the underpinning access framework to achieve short-term cost containment. We would cite that the loss of the Directorate for Innovation, Growth and Technology has been detrimental from the perspective of industry in seeking to engage with government.

 

  1. Moving forward the government should consider cabinet-level responsibility for the LSIS strategy and its full implementation at a critical time for the United Kingdom, as mentioned in the response to Question 13.

 

  1. The Office for Life Sciences is designed to be a joint department between the Department of Health and the Department for Business, Energy and Industrial Strategy (DBEIS) which provides departmental support to the sector. Our experience is that the influence of DBEIS has been limited and that the Office for Life Sciences is more closely aligned with the Department of Health, lacking the prominence and influence that was afforded to it when there was a responsible minister in post. We hope that the Government will revisit this matter as it progresses the Life Sciences Industrial Strategy and that changing this structure will have a UK-wide focus.

 

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?

 

  1. While the Government has given some indication as to its priorities for the Brexit negotiations, characterised in the position papers it will be releasing in coming months, the long-term impact that Brexit may have on the life sciences industry, and on Novartis, remains unclear as there remain numerous uncertainties which affect our business on multiple fronts. Novartis implores the Government to provide a greater level of detail on these issues as soon as possible, and is keen to work with the Government to ensure that the UK’s relationship delivers for patients, the NHS, and our industry.

 

  1. The UK is an important market for Novartis alongside other important European markets not in the EU such as Switzerland where Novartis continues to invest. Our key areas of concern are:

a.      The stability of the movement of people and the retention of highly skilled and expert talent following Brexit;

b.      The need to ensure a favourable trade and tariff regime which minimizes impact on both securing UK medicines supply and the distribution of medicines manufactured in the UK;

c.      As well as a stable regulatory framework for industry that continues to enable the life sciences sector to innovate, grow and thrive in the long-term

 

  1. Our sentiment here is equally applicable to the funding and incentive model for research and development that emerges following Britain’s departure from the European Union as well.

 

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

 

  1. For the mutual benefit of patients and industry in the UK and the EU, the UK should seek to negotiate alignment and commonality with the EU for the regulation of medicines, through:

a.      Seeking a regulatory cooperation agreement, or a mutual recognition agreement with the European Medicines Agency;

b.      Agreeing continued alignment of current and future regulations;

c.      Ensuring continued UK participation in EU regulatory and medicines safety processes.

 

  1. Any changes to the regulatory framework, particularly with regard to medicines approval and intellectual property creates barriers and additional complexity for global organisations that have set up in the United Kingdom. It is our position that many of the core tenets that uniquely position the existing regulatory framework which afford earlier access to more innovative treatments should be preserved as much as possible following the negotiations.

 

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

 

  1. Strong collaboration between UK and EU agencies is something we would like to see continue following the negotiations especially in the context of a more European-centric regulatory framework that is likely emerge with the relocation of the European Medicines Agency to be confirmed later this year. In our business continuity plan we set out how better cross-country collaboration could look.

 

15 September 2017

 

[1]Page 69, Life Sciences Industrial Strategy.

[2] Page 32, Life Sciences Industrial Strategy

[3] Ibid.

[4] Ibid.

[5] Page 2, ‘Bridging the “Valley of Death”: improving the commercialisation of research’- submission to the House of Commons Science and Technology Inquiry. BioIndustry Association (BIA). (file:///C:/Users/zcastles/Downloads/bia-0212-valley-of-death-inquiry-response.pdf)

[6] Bridging the skills gap in the biopharmaceutical industry, ABPI http://www.abpi.org.uk/our-work/library/industry/Documents/Skills_Gap_Industry.pdf

[7] https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/606651/life-science-competitiveness-indicators-report-2017.pdf

[8] Independent Review of Early Access to Medicines. Accelerated Access Review. (https://www.gov.uk/government/publications/independent-review-of-early-access-to-medicines-scheme-eams)

[9] Ibid.

[10] UK Clinical Trials Gateway. National Institute for Health and Research. (https://www.ukctg.nihr.ac.uk/any-questions/)

[11] Key Statistics 2016/17. National Institute for Health and Research. (https://www.nihr.ac.uk/about-us/how-we-are-managed/managing-centres/crn/key-statistics.htm)

[12] Ibid.

[13] Ibid.

[14] £52 million boost for skills and training in UK science sectors. Ministerial Press Release, UK Government. (https://www.gov.uk/government/news/52-million-boost-for-skills-and-training-in-uk-science-sectors)

[15] Ibid.

[16] Industry pays further £94 million PPRS scheme in Q1 2017. Association for the British Pharmaceutical Industry Press Release. (http://www.abpi.org.uk/media-centre/newsreleases/2017/Pages/Industry-pays-further-%C2%A394-million-to-PPRS-scheme-in-Q1-2017.aspx)

[17]‘Strategy for UK Life Sciences’ (2011). Department for Business, Innovation and Skills, Office for Life Sciences. (https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/32457/11-1429-strategy-for-uk-life-sciences.pdf)

[18] ‘May set out plans to boost productivity in Industrial Strategy’. Economia. (http://economia.icaew.com/en/news/january-2017/may-sets-out-plans-to-boost-productivity-in-industrial-strategy-brexit-business-future)