GSK – Written evidence (LSI0115)

Introduction

GSK welcomes the recent publication of the Life Sciences Industrial Strategy (LSIS). The ambition and intent of the Strategy has the potential to make the UK a global Life Science powerhouse for the next decade and beyond. A clear, long-term and holistic vision for the Sector is more valuable now than ever given the rate of technological change, pressures on public budgets and geopolitical uncertainty from Brexit and elsewhere. We congratulate Sir John Bell on pulling together such a comprehensive set of proposals. If implemented, the Strategy will not only attract investment from GSK and other companies in a globally competitive environment, but will deliver benefits to the NHS, patients in UK and the other stakeholders in the LS ecosystem.

As the largest Life Sciences company in the UK, GSK is actively participating in all elements of the Strategy. We contribute >£6bn to the UK economy every year, invest >£1bn in R&D here (~25% of the Sector total) and employ >17k people in the UK.

Of all the promising recommendations in the LSIS, GSK recommends prioritising areas of research where UK can build on a promising starting point including academic expertise and partnerships with small and big companies. In both the HARP recommendation on genomics and genetic testing, and the focus on cell and gene therapy, the UK has a clear opportunity to cement its position as global leader in these growth areas for the Sector. We also support the ambition for the NHS to become a world-leading innovation hub, leveraging its data, the AAR and world-class trial capabilities and delivering the proposed metric for adoption of innovation.

In addition, fundamental for success of the Strategy will be the governance and accountability for implementation by all stakeholders, as well as the relationship with Europe after Brexit.

In our answers below, we prioritise the questions we believe to be the most important and where we have relevant experience and evidence to offer. We make additional points on other questions later this submission.

We recognise that the goals set in the LSIS are challenging. We are convinced that they are also achievable and that they could build a platform for Sector growth, patient benefit and the UK’s competitive advantage for many years to come. GSK is committed to stepping up and working with other companies and stakeholders to deliver the full potential of this Strategy. We welcome this Inquiry as an important mechanism to guide the way LSIS moves forward.

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. The 2011 Life Sciences Strategy has been partially successful in supporting the Sector. However, it has not delivered in the key area of accelerating the pull-through of innovations to patients across the whole of UK.

2. When looking at what we can learn from this partial success, it is clear that the issue was not with the vision – which was strong and holistic in 2011 – but in how it was translated and implemented. For example, there wasn’t an equivalent to a Sector Deal to define binding commitments from all stakeholders. There wasn’t a clear set of high-level goals, agreed with all stakeholders that would guide work programmes to drive delivery. Accountability for delivery wasn’t clear and governance wasn’t effective. And finally, implementation where it happened was piecemeal and did not follow the holistic, joined-up structure of the Strategy.

3. Therefore, the 2017 LSIS rightly recognises the need to address this through clear and strong accountability and governance mechanisms. This is discussed further in later questions. We recognise that delivering a transformation involving so many stakeholders (multiple government departments, many companies and universities, all across the NHS and related arms-length bodies, charities, etc.) is a challenge, but the following key requirements would help us make measurable progress:

1. Set clear, SMART objectives, that are committed to by all key stakeholders. The proposal in the LSIS, that UK moves into the upper quartile for adoption of innovative products by 2023, is an excellent example.
2. Agree clear accountabilities to meet those objectives and targets, with high-level plans and commitments from key stakeholders that give confidence and transparency as to how they will be met. The Sector Deal must lay all of this out.
3. Establish a governance system that monitors progress from all stakeholders against their plans to drive delivery. It needs to provide a holistic oversight of implementation across the whole Strategy, as well as progress on individual elements. Means of enforcement should be considered.

4. The evidence of successful implementation of elements of the last Strategy, therefore reflects the fragmented progress made. GSK would highlight the following examples we have been involved in:

1. Patent Box – although indirectly linked to the last Strategy, the introduction of the Patent Box did transform the way GSK looks at investing in the UK. Since it was introduced in 2012, GSK has invested ~£1.3bn in manufacturing and has committed to invest >£400m more by 2020. We have also consolidated our global R&D footprint, making Stevenage one of our 2 global hubs: we invest ~£1bn per year here
2. UK Biobank, GSK and Regeneron recently announced the largest gene sequencing initiative on world’s most detailed health database to improve drug discovery and disease diagnosis. RGC and GSK have committed an initial investment to enable the sequencing of the first 50,000 samples, to be completed before the end of 2017. Sequencing of the full 500,000 samples in UK Biobank is expected to take three to five years. UK Government and charity medical research funders have invested about £200 million in UK Biobank. An estimated cost of $150million if all 500,000 participants are sequenced.
3. Stevenage Biosciences Catalyst was founded by GSK, together with the Department for Business, Innovation and Skills, Innovate UK and the Wellcome Trust. It opened in 2012 as a unique bioscience community co-located next to GSK’s Stevenage R&D site to provide start-ups and SMEs with access to the expertise, networks and facilities traditionally associated with multi-national pharmaceutical companies. GSK provided land, facilities and investment totalling ~ £11m to help build and launch it.

5. It is also important to look at where the 2011 Strategy has failed, to avoid making the same mistakes. ‘Innovation, Health & Wealth: Accelerating Adoption and Diffusion in the NHS’, did not gain wide spread traction in the NHS. Measuring outcomes of the strategy is not sufficient alone to drive activity: the data[1] shows that in the first year after launch, NICE approved medicines have 18% of the average uptake levels in 14 comparable countries, rising to 62% in year 2. Medicines which have not been reviewed by NICE are worse. These figures have not changed much since measurement began.

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’?

1. The LSIS sets out a broad and welcome vision to ensure that the UK remains an attractive place for life sciences. The recommendations are a very helpful start and cover all relevant areas. We see the challenge going forward arising from the breadth and number of recommendations included. There will be a clear need for prioritisation, deliberate sequencing and rigorous implementation planning.

2. GSK recommends prioritising two areas of research where UK can build on a promising starting point consisting of academic expertise and a nascent ecosystem of partnerships with small and big companies. In the HARP recommendation to advance the genomics and genetic testing work, the UK has a unique opportunity to cement its position as global leader, by linking large cohorts of genotyped and phenotyped patients (e.g. UK Biobank participants) to clinical data. We welcome the focus in the LSIS on Cell & Gene Therapy, as this emerging technology will benefit many patients over the coming decades and UK could be a world-leader – adopting the recommendations of the ATMT would be a good start.

3. The focus on accelerating adoption of innovative medicines is also important, as it will impact other parts of the Strategy. A lack of a modern standard of care in the NHS reduces companies’ ability to conduct late-stage trials in UK. It would also be unethical to conduct studies for certain medicines, if it is unlikely that they will be launched and made available to patients in the UK. Hence this issue needs to be addressed to ensure success from the 2017 Strategy.

4. We see the proposed “data hubs” as an important infrastructure that should not only support research, but also support earlier adoption, by facilitating generation of Real World data that can be used in accelerated, conditional reimbursement schemes. GSK’s experience of running the Salford Lung Study, the first such trial globally, provides much practical knowledge to inform the “data hubs”, which will be core to this opportunity. If the NHS offered data hubs and world-class competitive clinical trials capabilities, together with an enthusiasm for adopting new medicines, it would make a compelling package.

5. We believe that the Sector Deal should be a UK deal. Several parts of the Strategy are relevant to all Regions, such as the recently-announced competition to host the MMIC. We don’t see a significant risk of silo implementation between Regions for the most part. There will be local areas of focus and priorities, but these should naturally build on and complement the National ones. The exception is likely to be for the NHS Collaborations and the implementation of the AAR and other reforms. While the goal is to deliver upper quartile performance nationally for adoption of new medicines, many of the changes needed will be at local and devolved levels. Subsequent discussions, therefore, need to include the devolved administrations and NHS England given they have direct control over many aspects of local NHS operation. Overall strategy and oversight in this area must be national, whereas accountability will be shared.

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

1. Looking across the whole strategy, success will be secured if funding is provided from several sources, including the Government (directly and via arms-length bodies), the private sector (companies and investors) and charities/institutional funding bodies.

2. Public-private partnerships offer a very clear opportunity to leverage public money to attract private sector investment. GSK’s investment into the “Open Targets” programme with the EBI and the Wellcome Trust Sanger Institute is a great example that has subsequently attracted investment from other private sector partners. GSK’s contribution to the Stevenage Biosciences Catalyst is another successful example that could be replicated within the “Cluster” recommendation of the LSIS.

3. We see significant potential for similar models within the construct of the Sector Deal. The Government will need to play a strong facilitation role to make this happen, as well as being a party to the negotiations. Firstly, listen to what companies are saying about needs and opportunities, then creating a package of work to deliver against those and finally, brokering the necessary investment from the multiple parties involved. This will be challenging, as the private sector is not homogenous, and this will require an active and persistent role by Government. However, it is necessary to prevent the limited amounts of public money from being invested in areas that do not realize further private capital; either because they are constructed in a closed manner, or because they are not attractive to, and therefore not used by, the Private Sector.

4. The Government will also need to use careful investment of public money to catalyse changes needed to deliver on key parts of the Strategy:

1. Firstly, on medicines adoption, a relatively small incremental amount of funding for medicines will be needed to secure sustainable access to all new value-adding medicines, for all patients who need them. Note that initial estimates suggest that between £1-2bn is needed, much of which can come from re-prioritisation of current medicine spend. The positive (rapid delivery of new treatments to patients) and negative (unclear decision-making, lack of data generation and over-spend) lessons learned from the CDF experience should be taken into account. Relative to other countries, the UK currently underinvests in the funding of medicines.
2. Secondly, Government investment into research, such as that announced for the ISCF, is likely to attract subsequent private sector investment if targeted to areas of interest. Some, but not all, of the initial proposals appear to meet this criterion.
3. Finally, targeted direct support via Innovate UK and others can be used to anchor private sector investment into key projects and create the critical mass needed for them to proceed. Good examples of this could be to continue multi-company programmes to improve the manufacturing technology in UK.

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. The NHS is the sole customer for industry’s medicines and therefore offers a very powerful mechanism to both stimulate and benefit from rapid and broad adoption of innovation.

2. The unique asset of the NHS offers the UK the potential to create a seamless ecosystem for rapid and efficient development of innovative treatments by enabling companies and the NHS to gather Real World Evidence while delivering the earliest and most appropriate access to patients. We see this as an extremely powerful proposal that the NHS could make. Elements of it are included in both the LSIS and the AAR. However, it needs to be developed in partnership: we are keen to contribute, but we seek mechanisms to do so.

3. Currently, we are a long way from realising the full potential of the NHS. The LSIS (and the AAR before it) captures well the current complex, slow and bureaucratic multitude of systems for medicines evaluation and adoption. Ambitious and fundamental change is needed for the UK to achieve the stated goal of upper quartile adoption of new innovative medicines compared to comparable countries, while achieving value for money and limiting budget increases.

4. We already have several important initiatives/levers that can help deliver this change, specifically the “TRAM” (Transforming Access to Medicines) project, the PPRS and the AAR. However, each of these is currently not progressing. These should be taken forward as a priority, as part of the implementation of the Strategy. We need strong leadership and flexibility from the Industry and the NHS, supported by Government, to do this.

5. As GSK, we are calling on all parties to be pragmatic in their approach. While we don’t agree with the recent reforms of NICE and the NHSE, we have stated publicly that the Judicial Review launched by the ABPI is not a constructive way to resolve the differences. Similarly, the Government’s current consultations on branded health service medicines costs regulations, and legal requirements to provide information on health service products could cause further problems. They outline new powers for government in both pricing in the statutory scheme and information requirements which would make the UK less attractive as an adopter of innovation, directly contradicting the intent of the LSIS.

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. GSK fully supports the intent of the AAR, but we believe that the recommendations are not sufficiently bold to deliver against its stated objectives. Firstly, the core proposals of an Accelerated Pathway should be available to a wider set of products, including those which are being, or will be, researched or manufactured in the UK. Second, the assessment framework for access to new medicines should be streamlined in a holistic manner so that the full extent of the value beyond the QALY can be considered and realised. And thirdly, to deliver improved patient outcomes to more patients, the adoption of innovative medicines should be accelerated.

2.              The recent changes in NHSE will likely have a negative impact on access and adoption of important new medicines. We understand the need to manage the introduction of the truly exceptional medicines that would otherwise have a material impact on the total medicines spend. However, by setting the threshold at £20m (~0.1% of the total), many of the medicines that the LSIS and AAR aim to accelerate to patients, will in fact be delayed in additional rounds of negotiation. More broadly, the reforms erode the value of the NICE assessment which currently provides for mandatory funding for approved products and a level of predictability to both industry and patients. We call for joint work to develop policy approaches to achieve this goal without the risk for unintended delays for patients.

3.              The TRAM project has agreed three core areas of work: i) Commercial negotiations: develop and test a new framework for multi-stakeholder dialogue for medicines where more flexible commercial models would be beneficial; ii) Access and investment decision-making: create a new access route for selected new medicines which call for a broader decision making framework than currently used by NICE; and iii) Determining value of new treatments: Applying the Extended Value Appraisal (EVA) criteria, methodology and stakeholder engagement processes to suitable candidate products in order to test and pilot the new framework.

4.              Finally, a future voluntary agreement, as a successor to the current PPRS will also be necessary to underpin the delivery of accelerated access to new treatments, while ensuring value for money for the NHS.

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?

1. As already described in our answer to Q5, it is important that we learn from the previous LS Strategy. The key requirement moving forward are clear and binding commitments from all relevant stakeholders within the Sector Deal, and a Steering Group that is able to make decisions and hold stakeholders to account.

2. GSK would propose a number of features to the governance mechanism:

1. A Steering Group including the relevant Ministers, representative private sector CEOs, and the CEOs of NHS and UKRI and Wellcome Trust Director.
2. Two Co-Chairs are needed - an independent Private Sector leader and a Senior Minister who has broad accountability to make necessary decisions.
3. Each of the main sections of the Strategy also need Implementation Committees, similarly empowered to take decisions needed to progress the key initiatives.
4. A significant level of resource will be needed to project manage the overall programme, measure progress and results and report back. We suggest that this is made up of a mix of public and private sector representatives working together.

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. Companies, including large pharmaceutical companies like GSK should play two important roles:

1. Firstly, we should provide ideas and resources to drive progress jointly with the other stakeholders on the key initiatives that we are committing to. This includes delivering on investments and other contributions that we are making in the Sector Deal. We should also be very clear about the contributions and actions from Government, NHS and others, that could accelerate, optimize and strengthen these key initiatives. And finally, we need to provide realistic but clear guidance of what will not work for us. For example, the costs of clinical trials that will make UK globally competitive.
2. Secondly, we need to work closely in partnership with the Government and other stakeholders to advise and guide the implementation of their commitments in the Sector Deal. This is essential to ensure that what is delivered will work for the Private Sector and fulfil the goal of attracting additional investments in the future.

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. This question has been largely addressed above (Q13). The Office of Life Sciences will need to play a pivotal role in driving delivery of the Strategy. We believe that this is a significant and resource-intensive role, lasting for the next several years, and it will require a meaningful increase in expert resource in OLS to deliver this function, on top of the work it is doing on Brexit and other areas.

2. We don’t see the question of whether to appoint a dedicated Life Sciences Minister as the critical one. Delivering on this Strategy, as well as a Brexit outcome that will not damage our Sector, will require close collaboration across multiple Government Departments including with the NHS. While having a single Ministerial point of contact can simplify our engagements, critical for success is a broader commitment from Government and the NHS to deliver on the same set of goals. It is very important that there is cross-Government accountability for delivery of the Strategy, and an ability to hold relevant stakeholders to account, it isn’t necessarily the case that this is better done under a single LS Minister.

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. Our sector has integrated into EU systems over many years and unpicking these relationships and processes is complex. Without a sufficient period to plan and transition to any new arrangements, we risk disruption to supply of medicines, vaccines and healthcare products to patients.

2. Brexit impacts for our sector potentially include:

-          Increased supply chain costs with the need for additional facilities in the UK and EU for the testing of products.

-          Additional regulatory burden, through changes to existing EU & UK licences, and duplication of regulatory filing processes and EU Pharmacovigilance processes in UK, and increased regulatory inspections

-          Increased duty on trade between UK and EU/EU FTA and ongoing cashflow cost to fund (recoverable) VAT on imports & exports between EU & UK.

-          Limiting our ability to attract and recruit talented EU nationals to a range of roles in our sector

-          Affecting the UK’s status as a leading scientific nation, if limitations are placed on UK-EU collaboration on science and innovation, including medical research.

3. It is fundamental that these areas are resolved to allow the life sciences strategy to deliver its ambition of securing a strong life sciences industry in the UK. The Life Sciences sector requires frictionless movement of our goods across the EU/UK border with mutual recognition agreements in place, alignment with the EU regulatory environment, the ability to attract, recruit and move our people and talent with ease and assurance that UK /EU R&D collaborations continue.

4. The LSIS will not mitigate directly these potential negative impacts of Brexit. Rather it will strengthen some of the current opportunities for investment in the UK, by leveraging unique advantages the UK has compared to other countries – such as the strong science base, the potential for the NHS to be a data and innovation hub and the collaborative work of Government, charities, funders and the private sector.

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

The EU has a well-established regulatory framework for the development, authorisation, manufacture and supervision of medicinal and healthcare products, and for their use by patients and consumers. The current processes work well, and the UK played a significant role in the development, and continued efficient functioning, of this framework.

Our sector is seeking increased harmonisation in the regulatory environment, not divergence. Both the EMA and FDA cover large patient populations and as such are first tier regulators for the launch of new products. There is benefit in the UK continuing to work with the EU and to align regulations. Any future regulatory processes in the UK must avoid introducing delays, significant new costs or unpredictable outcomes to ensure patients and consumers in the UK continue to benefit from the access they have today.

There has been discussion about the opportunity to create new levers to accelerate regulatory processes for innovative medicines. However, this opportunity is very limited and is only of benefit if systems with NICE and the NHS also provide rapid access to these medicines to patients without the numerous and time-consuming hurdles that exist today and with certainty of outcome.

Flexible, clear and balanced legislation that provides the life sciences sector with legal certainty when making R&D investment decisions will be fundamental to supporting the health sector’s success post Brexit. Sadly, this has not been the case with the EU’s implementation of the Nagoya Protocol - an international Protocol that requires its parties to introduce measures to ensure that genetic resources used on their territory comply with certain conditions set by the countries from which they originated - through Regulation 511/2014. Although originally intended to be light touch regulation, it has turned into a bureaucratic, impractical piece of legislation which all sectors (commercial and non-commercial) involved in the use of genetic resources view as highly problematic.

As a result, not only is the Regulation likely to impede rather than promote the generation of benefits to be shared (which is the objective of the Protocol) but it is likely to hinder innovation and may delay or prevent responses to public health threats (a matter now being considered by the WHO). Brexit and the Great Repeal Bill, therefore, provide an opportunity for the UK to address the Regulation’s shortcomings and to support commercialisation of innovation by the life sciences sector (and others) in the UK by adopting a new, more supportive and practical approach to implementing Nagoya.

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

GSK’s priority is to have a regulatory system that ensures rapid, predictable and continued patient and consumer access to existing and new medicines, vaccines, healthcare products and devices. We believe that this is best achieved by ensuring the UK continues to participate in and contribute to processes and systems across the EU regulatory framework to the fullest extent possible. It is essential that the UK avoid duplication of requirements and additional regulatory hurdles, otherwise it risks being a non-priority launch market for industry, as outlined above.

We would like to ensure that the MHRA continues to participate in EU marketing authorisation, pharmacovigilance, inspection, and clinical trials procedures and committees, and to have access to existing EU data systems, including EudraVigilance (for safety), EudraCT (for clinical trials) and the new Clinical Trial Portal and Database. The use of these databases and the collation of this data across a wide patient population is important for industry to develop medicines and ensure patient safety. This would help to avoid duplication and ensure that regulatory decisions are based on consistent and comprehensive data. In addition, mutual recognition of standards, such as GMP, and of testing and release conducted in either territory, would avoid duplicating procedures, delays and additional bureaucracy in both the UK and EU, which would benefit patient access.

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. There isn’t a clear answer to this question, but we believe that a mix of cultural factors and incentives are behind it.

1. There are few/no incentives in the UK for academics to apply for patents, unlike for example in the US and Germany where they can benefit financially from the resulting IP. Patent applications involve the inventor sitting down for some time with a patent attorney to get the application right and may involve the inventor’s further involvement as the application progresses. It will also involve delaying publication (often a key mark of academic status), until after the application is filed. These activities will take academics away from the activities for which they are rewarded – research and publications.
2. Secondly, at least in part of the UK academic community, there is a belief that academic research is paid for by the public and should be dedicated to the public (i.e. made freely available) rather than restricted by commercial interests like patents.

2. If these are true, cultural change (maybe by emphasising that patents help academia fund further research) and provision of incentives (or even instructions) to file for patents may go some way to alleviating the problem.

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. The first priority is to ensure that the new migration system to be established allows recruitment and retention of highly skilled workers from the EU and beyond, and does not impede intra-company transfers.

2. Secondly, we seek a significant focus on key areas of skills development that will help future-proof potential employees. The top priority we see for the next 5 years is around health informatics/data science. Although a skills gap has been emerging in both public and private sectors in this area, the system has been slow to respond. We welcome the approval of the data science apprenticeship. The Science Industry Partnership is currently working on a bioinformatics apprenticeship and we hope this gets approval towards the end of the year. Coupled to this, we continue to seek greater flexibility in the way the Apprentice Levy gets used, to broaden the range of benefits across our supply chain and for different types of Apprentice. Specifically, we seek to extend the range of Higher Apprentices such as for PhD Apprenticeship STEM Teacher training. The latter would help meet the LSIS STEM objective we share, to increase the number of students studying maths to level 3 and beyond.

3. Finally, we welcome the proposed joined up approach to the Skills Action Plan, combining needs across the NHS, commercial and third sectors based on a gap analysis of key skills for science. We would like to see this joined up approach taken further, to deliver joint training initiatives to help break down the barriers between NHS, business and the third sectors.  There should be support for entrepreneur training at all levels, incentivising varied careers and migration of academic scientists into industry and back to academia to increase influx of talented scientists and entrepreneurs in the public and private sectors. Some of our best knowledge exchange is through secondments in both directions, e.g. GSK senior scientists with visiting chairs (we have half a dozen of these); the Immunology Network at Stevenage.

29 September 2017