Association of the British Pharmaceutical Industry (ABPI) – Written evidence (LSI0102)

 

  1. Introduction

 

A1.       The Association of the British Pharmaceutical Industry (ABPI) is grateful for this opportunity to give evidence to the committee. The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases. Globally our industry is researching and developing more than 7,000 new medicines[1].

 

A2.       The ABPI was a member of the Life Sciences Industrial Strategy Board. As a result, this submission reflects much of the Life Sciences Industrial Strategy recently published by Sir John Bell.

 

  1. Executive Summary

 

B1.       There is significant competition globally for life sciences investment. The US is the global leader in the life sciences industry. It is an early adopter of new classes of medicines with a large market, has good access to risk capital plus state or federal level support for research and innovation and state or city level financial incentives for manufacturing investments. Other countries have or are developing a strategy for attracting pharmaceutical investment and jobs. However the UK has some key opportunities:

 

B2.       The way that the global pharmaceutical industry is developing medicines and vaccines is changing in response to new science and technologies. There is a unique opportunity for the UK to become the life science industry’s development partner of choice, bringing huge benefits for the NHS and for patients as well as the UK economy.

 

B3.       To deliver this, the Government’s response to the Life Sciences Industrial Strategy needs to be ambitious about making the UK the best place in the world to discover, develop, manufacture and launch medicines and vaccines based on our international comparative strengths. To do this, Government support for the sector needs to be consistent throughout the life sciences ecosystem as a whole, and particularly grounded in a vision for the UK as a world-leading hub for life sciences with the NHS at its heart.

 

B4.       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 NHS hospitals get access to clinical trials, doctors can prescribe the gold standard of care earlier, patients can get the best treatments available, and researchers can use and build on real-world data. The ABPI 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 pricing scheme 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.

 

B5.       Turning basic research into new biopharmaceutical treatments is a global, not UK endeavour. The UK has a historically strong research base and while a lot of potential new medicines are discovered and developed in the UK, the UK does not have a similar advantage in the later stages of medicines development, particularly manufacturing.

 

B6.       An example where the UK’s global leadership in early science should be leveraged with urgency is advanced therapies, where the Action Plan developed by the Advanced Therapies Manufacturing Taskforce (set up by the Medicines Manufacturing Industry Partnership, which the ABPI is a member of and supports) should be pursued.

 

B7.       Ensuring the sector has the best and brightest talent available is a requirement that spans the Life Sciences Industrial Strategy and the sector’s priorities as the UK leaves the EU. The UK needs a migration system which supports recruitment and retention of international talent to work in the UK, both in industry and in academia and which does not impede intra-company transfers. Within the UK education and training system, it is increasingly important for students to develop their knowledge and competence in both science and maths, and for greater flexibility to be associated with the development of new apprenticeship standards and employment of apprentices.

 

B8.       The UK’s chances to win high value, internationally mobile investment in life sciences manufacturing would be boosted by a review of the incentives landscape, including becoming more competitive for capital allowances, and introducing company account management for both inward investors and domestic companies seeking to expand in the UK.

 

B9.       An industrial strategy approach is particularly suited to pharmaceuticals because it is a sector that is highly impacted by government policy at every stage of the product lifecycle. Therefore, a holistic approach and comprehensive delivery across government is a powerful way to support the sector’s economic contribution to the UK; history tells us that this is most difficult to accomplish in health policy and we would recommend that this be a particular focus of efforts to develop implementation governance and plans.

 

B10.  NHS evaluation and commissioning of innovative treatments produced by the Life Sciences Sector is an important part of the broad ecosystem for the sector. However, the current pressures on the health service budget mean that investment in new innovative medicines is under significant strain.

 

B11.  The ABPI recommends that the government implement the AAR and use this to streamline the processes and methods of assessment for all new medicines; simplifying and accelerating access and using a single clear decision point[2]. As part of this, health technology assessments should take a broader view of the value of new treatments and innovations. This streamlined access framework should be part of a holistic medicines policy with a leading role for NICE and including a new voluntary pricing scheme negotiated with the ABPI as a successor to the current PPRS. This vision would reconcile the ambition of the Strategy with the requirement of value for money for the NHS.

 

B12.  Proposals to improve the speed, efficiency and effectiveness of UK clinical trial capabilities and capacity will make the UK a clinical trial environment that commercial sponsors would be more willing to invest in. These include an aligned approach for companies across the UK’s four nations, addressing delays in budget review and approval by hospitals, and the ability to use electronic health records. In addition, we recommend that industry is included as a partner in the NHS research plan. The commitment in the plan to providing an environment where technologies can be developed and tested is welcome; this needs to be operationalised in a way that is reliable and predictable so it can be built into commercial development plans, and this is best achieved by engagement with industry.

 

B13.  To ensure implementation of the Strategy, based on our assessment of the previous strategy the following steps would be beneficial[3]

 

B14.  A Cabinet Minister should hold ultimate responsibility for implementation of the Strategy. The Strategy should also be integrated into departmental plans for the Department for Business, Energy and Industrial Strategy and the Department of Health.

 

B15.  Our understanding is that the Government will work with industry to respond to the Strategy with a Sector Deal and we look forward to more details on this process of engagement. By arriving at a strong sector deal, the Government can confirm its support for the recommendations of the Life Sciences Industrial Strategy whilst securing short, medium and long term investment from the industry. This is a way in which all parties can hold each other to account for the implementation of the Strategy.

 

B16.  In the inter-connected life sciences ecosystem, it is vital that the Strategy (and its implementation through a Sector Deal) is a joint endeavour with government, NHS, business and the charity and research sectors as partners holding each other to account.

 

B17.  The UK’s membership of the EU has provided much of the scientific, regulatory and trade infrastructure for the pharmaceutical industry in the UK. As such, the negotiations that determine Britain’s new relationship with the European Union (EU) will be critical to how medicines are delivered to patients in the UK and in Europe, and the future success of the pharmaceutical industry.

 

B18.  Following the result of the referendum on the UK’s membership of the European Union in June 2016, the ABPI welcomed the creation of the UK EU Life Sciences Steering Group to determine how to create a world-leading Life Sciences environment in the UK outside of the EU. Policy analysis produced by the ABPI and BIA and submitted to this group identified four key priority policy areas for the pharmaceutical industry:

 

B19.  The use of health data can transform the provision of health care, by both improving the quality and reducing the cost of health care services, and driving research and innovation in the life sciences. Further development should be expected in improving the quality of data collection, the consistent implementation of data standards and the linkage of health data throughout the patient pathway, from primary care into secondary and specialised care.

 

B20.  A single application process, ethics, and a single licence for the use of all NHS data will help to unlock the potential of this resource for UK innovation and research. Such harmonisation would enable data users to make the best informed decisions based on the quality and content of the data, and would help build and sustain public trust in the way their information is used and protected. The Government should continue to support the Department of Health led “Maximising research through health data programme” to deliver a single entry point to access catalogued, linkage-ready, routinely collected health and social care data, within a clear and proportionate governance framework.

 

  1. Science and Innovation

 

Question 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?

 

C1.       Once established, pharmaceutical companies invest a higher share of their earnings on research and development than virtually any other sector, with R&D totalling 14.4% of all earnings in 2015 (with closest IT sectoral competitors at only 10%)[4]. In total, the industry invested just over £100 billion in R&D globally in 2015. In the UK, the pharmaceutical industry remains the highest R&D spending business sector and it invests the most in health research.[5] Increasingly, however, commentators have noted the difficulty of starting, and growing, new companies and the House of Commons Science & Technology Committee examined this issue in 2013[6].

 

C2.       Many analysts have explored the challenges related to developing new medicines, with many estimates of the costs (some estimates of £1.15bn per medicine and higher) and averages given for the time taken from “bench to bedside” (e.g. 12 years). Our industry has been working hard to improve the efficiency and focus of our R&D efforts and in our collaborations with other organisations to improve our success rate. Recent benchmarking studies have shown a steady improvement, such that candidate medicines entering the trials of the first patient dose now have a 1 in 5 chance of making it through to approval and to patients. Candidate medicines reaching Phase III (or the first pivotal dose) of trials have a 65% chance of making it through.[7] Clearly this remains a considerable challenge for our research and development teams, and our focus is firmly on better understanding human and disease biology and to research new supporting technologies (visualisation, informatics, nanotechnologies, etc) to address this uncertainty. These challenges and the resource and time extensive process to develop new medicines are set against a patent life for technologies underpinning a medicine of 20 years. In practice, companies only typically have around 8–10 years of exclusivity for their medicines after regulatory approval has been gained. Beyond this lie the challenges of health technology assessment and health service commissioning before any return on investment can be made. All this adds a further financial challenge for the investor to the scientific and technological ones already described.

 

C3.       Attractive returns on investment are required to incentivise investors to take any risk, and clearly uncertainty and risk are core features of the pharmaceutical industry. In his paper Affording the Future, David Taylor suggests that “The available evidence from sources such as the European Commission (EU 2012, 2015) is that once the level of research investment risk is taken into account the pharmaceutical industry is no more profitable than is to be expected on the basis of data from other industrial sectors”[8].

 

C4.       Not all investment in life science research is from the private sector. While businesses spend £4.1bn on life sciences research in the UK, £2.7bn is spent by the higher education sector, £1.3bn by Public Sector Research Institutes and £0.39bn by not-for-profit organisations[9].

 

C5.       Turning basic research into new treatments is a global, not UK endeavour. The UK has a historically strong research base. The UK represents only around 2.5%[10] of the global medicines market, but accounts for 4%[11] of global medicines research and development. While a lot of potential new medicines are discovered and developed in the UK, the UK does not have a similar advantage in the later stages of medicines development, particularly manufacturing. For example, although the UK led the research and development of monoclonal antibodies, the manufacture of these therapies went overseas and the UK effectively lost a significant market opportunity.

 

C6.       The UK already has a world-leading research base, but must do more to ensure it retains it and leverages it to further grow the UK economy. The UK Government’s commitment to increase R&D spending relative to the OECD is a step in the right direction. We believe it should go further to increase funding for basic science research so that the UK reaches a target of 3% by 2022.

 

C7.       Innovate UK has made available a number of collaborative R&D competitions, the Biomedical Catalyst and more recently new grants and loans. These measures de-risk the early stages of technology development and allow smaller companies to evolve their products and processes to encourage follow-on partners, funding and commercialisation.

 

C8.       However, the translation of innovative science to new treatments needs more than funding. Infrastructure and collaboration are both important too. Innovate UK’s Catapult Programme does a lot to help bring together relevant stakeholders to work on commercialising basic science. The organisation also provides new infrastructure and facilities where smaller organisations can access some of the equipment and machinery they may otherwise not be able to afford. For example, the Cell and Gene Therapy Manufacturing Centre is a £55m large-scale manufacturing centre in Stevenage created to help bring cell and gene therapies to market in the UK and internationally. The National Biologics Manufacturing Centre, which is part of the Centre for Process Innovation in Darlington fulfils a similar role.

 

C9.       An example where the UK’s global leadership in early science should be leveraged with urgency is advanced therapies. The Medicines Manufacturing Industry Partnership[12] was established as an industry and Government partnership in 2014. In 2016, it ran a taskforce on advanced therapies manufacturing due to rapid clinical progress, commercial interest and the strong parallels with the early days of monoclonal antibodies. The taskforce concluded that the UK had quickly established itself as a global leader in pre-commercial activities and published a clear action plan[13] to ensure the UK benefits from the commercialisation of this research. This action plan needs to be implemented. Critically, all of these actions are directly applicable to other areas of life science development, so their impact can multiply and expand in reach. We welcome the Life Science Industrial Strategy’s recommendation that the Action Plan should be adopted.

 

C10.  Our recommendations:

 

Question 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?

 

C11.  The presumption that the UK has underperformed in turning basic research in the life sciences into intellectual property has been explored and increasingly challenged by a number of authors (most recently Owen and Hopkins[14]). The UK is now the third largest biotech cluster in the world, according to recent research[15]. Yet, the commentary remains very pessimistic, spurred on by the observation that over the last 10-15 years, the UK has struggled to capture significant new manufacturing investments, particularly the opportunity from new therapeutic classes. Despite being responsible for the discovery of monoclonal antibodies, the UK failed to capitalise by securing commercial-scale manufacturing. Recent industry analysis has concluded that the US dominated at the early stage. Raising money from venture capital for manufacturing in the UK was impossible; the UK had no real contract manufacturing sector and major UK pharmaceuticals in the UK who might have led investments, were slow adopters of this new technology. The second wave of manufacturing investments has largely gone to Ireland and Singapore, Germany and the US which together have attracted the bulk of $125 billion investment on new plant and equipment for the manufacture of biologics and other novel medicines in the last six years[16].

 

C12.  The UK has had numerous opportunities to scale up and create new companies with excellent products in the Life Sciences sector providing the opportunity for them to grow into new commercial champions. The list of such companies is long and includes Cambridge Antibody Technologies, Aztech, Celltech, Solexa, Domantis and others. These companies were sold at a stage where they had promising products but were confronting the challenge of completing pivotal trials, gaining full regulatory approval, creating and deploying a commercial team globally, and solving the problem of manufacturing. These hurdles represent a significant obstacle to company growth, particularly in the context of the very substantial investment that would have been required to get these companies to the point where they were in a position to take on these final challenges.

 

C13.  The Life Sciences Industrial Strategy recognises that the UK has had many successful companies that have been ready for this final stage of scale-up but unable to take that step and recommends further action to address the obstacles these companies face that prevent them from becoming successful, mature UK companies.

 

C14.  An important facilitator in the development of new technology and new business is actually the larger biopharmaceutical company, which through its collaboration and investment has a critical role to play. Our recent research has calculated that since 2001, corporate venture capital and their partners have financed over 178 companies in the UK, with investments over £4.6 billion (in current values)[17]. Beyond finance, collaboration models between large pharmaceutical companies and SMEs and academia have evolved substantially. Our recent research has underscored the importance of our extended collaborations in the UK, most recently centred on target identification and validation.[18] The ABPI is aiming to support this collaborative process through the launch of our Library of Initiatives for Novel Collaborations (ABPI LINC).[19]

 

C15.  As we leave the EU, it will be important to transpose and enshrine in UK law the current EU IP incentives such as SPCs, orphan drug and paediatric incentives.

 

C16.  Our Recommendations

 

Question 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?

 

C17.  Firstly we would refer you to our answers on Brexit in section G. Access to the best and brightest talent is a significant priority for the sector as the UK leaves the EU.

 

C18.  The ABPI Skills Report Bridging the Skills Gap in the Biopharmaceutical Industry identifies skills gaps including in data sciences and clinical pharmacology. Many of the highest skills concerns[20] require knowledge and competence in both science and maths – for example bioinformatics, statistics, data mining, health informatics and health economics. The relatively low number of bioscientists who have studied maths at level 3 contributes to the difficulty in recruiting in these areas. To address this issue students taking science subjects at ages 16-19 should be required to also study a level 3 maths qualification; either an A or AS level in maths, or level 3 Core Maths. This will better prepare those who go on to higher education courses to feel confident in their mathematical skills and will encourage them to take up modules in quantitative topics.

 

C19.  Existing gaps in life sciences skills need to be addressed in key areas such as data sciences and clinical pharmacology. There are also emerging skills gaps for the sector, especially in the highly specialised and multidisciplinary areas of drug discovery and manufacturing. Funding for the National Institute for Health Research (NIHR) should be maintained to support clinical research and to develop the clinical thought leaders of the future.

 

C20.  For the UK life science sector to flourish will require the ability to recruit from across the EU and from the rest of the world. Hence, the UK needs a system which supports recruitment of talented international scientists and entrepreneurs to work in the UK, both in industry and in academia. Current regulations can be a barrier to accessing the best talent due to their complexity, cost, restrictions, delays and bureaucratic process. International companies also need to be able to provide opportunities for existing members of staff to transfer to the UK for short to medium periods of time to enhance their global experience and/or to upskill UK employees. To make the UK a destination of choice for the talented people the sector needs, a positive narrative should be created and promoted focussing on the value that highly skilled talent from the EU and beyond brings to the UK life sciences sector and the wider economy.

 

C21.  There is a limited current provision of high level apprenticeships for the life science sector. The apprenticeship levy provides an opportunity to address this, including the development of degree and post-graduate apprenticeships to meet the skills needs of industry, the NHS and academia. Development of these should be encouraged through reducing the bureaucracy associated with the development of new apprenticeship standards and employment of apprentices. Under the levy regulations the opportunities for a company to train apprentices who are not directly employed by the company are extremely limited. Apprenticeship training agencies (ATAs), such as Cogent Skills, have developed appropriate systems including group training provision but, without relaxation in the rules, only 10% of the companies levy contribution will be able to be directed to an ATA for this purpose. This will restrict growth of apprenticeship numbers in the life science sector. A lack of flexibility in the ways in which the levy funds can be used will also limit a company’s ability to upskill their workforce to address immediate skill gaps and longer term development of skills which are not best addressed through apprenticeships.

 

C22.  Skills training should encourage the development of UK scientific and clinical thought leadership, through PhD and post-doctoral funding. It is also important to promote mobility and movement between sectors and that any skills solutions bring together the life sciences industry, academia, the NHS and third sector to jointly address skills gaps and encourage greater joint working.

 

C23.  Our recommendations

 

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

 

C24.  Other countries, notably Ireland, Germany, Finland, Belgium[21], Singapore and the United States have or are developing a strategy for attracting pharmaceutical investment and jobs. Denmark and others are also looking at the pharmaceutical industry as a priority for the future. The UK has some key opportunities where it can pull ahead of the competition:

 

C25.  The Office for Life Sciences’ Competitiveness Indicators[22] include a number of metrics comparing the UK life sciences sector with selected countries which is the best available dataset for measuring the impact of the Strategy on the UK’s competitive position.

 

C26.  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.

 

 

C27.  The US is the global leader in the life sciences industry. It is an early adopter of new classes of medicines with a large market, has good access to risk capital plus state or federal level support for research and innovation and state or city level financial incentives for manufacturing investments. All of these have ensured the US has a substantial life sciences sector. Both Germany and Switzerland have major pharmaceutical and chemicals industries, well developed supply chains coupled with low tax (Switzerland) and strong innovation support (Germany). Financial incentives are made available at local and regional level.

 

C28.  Moreover, our key competitors (Germany, the US, Switzerland, Ireland and Singapore) have all prioritised life sciences. Ireland has landed manufacturing investments from 9 out of 10 top pharmaceutical companies and 13 of 15 top medtech companies. It has become a European manufacturing base for many US companies[23] achieved through establishing an autonomous Industrial Development Agency with ambitious FDI targets supported by very strong fiscal and financial offers. Singapore established its Economic Development Board and like Ireland provided it with autonomy to implement specific economic development programmes backed up again by attractive fiscal and financial incentives; today more than 30 of the world’s leading biopharmaceutical companies have HQs in Singapore.

 

C29.  We also know that late-stage development, scaling and early commercial manufacturing tends to stay where it is first located, giving the most competitive countries for those investments a long-term benefit and advantage. Companies increasingly choose to site high tech manufacturing close to development and scale up as enablers. The UK already does a good job of capturing life sciences discovery and clinical development activity, as well as downstream commercial activity (such as EHQs), but there is a lot of leakage at the point of manufacture to lower cost, lower tax, or higher incentive locations.

 

C30.  The UK’s current Corporation Tax rate is the lowest in the G20, but the UK only has a mid-table ranking in terms of Capital Allowances (CA) for investment in equipment, making it relatively less attractive to invest in pilot and full-scale manufacturing facilities in comparison to other countries. The UK removed its investment allowance for industrial buildings entirely in 2011.Competitor G20 countries typically offer capital allowances for investment in buildings of between 2-10%. On capital equipment, France and Canada offer CA rates of 28 and 50% respectively, in comparison to an annual rate of 18% on a reducing balance basis in the UK.

 

C31.  The UK is operating in an internationally competitive environment to attract inward investment and to capture and retain domestic investment in Development and manufacturing. Key international competitors such as Singapore and Ireland have worked harder to attract inward investments. They have targeted multinational companies and deployed highly effective account management with a strong ‘offer’ including financial incentives and flexible support to help companies get the skills required. Both countries have also focused on ease of access to major markets, with Ireland positioning themselves as a gateway to the EU and the US, while Singapore has been seen a gateway to Asia.

 

C32.  In competitor countries, financial incentives in the form of grants, loans or ‘in kind’ support are available to support capital and revenue investment at a rate of between 10% and 15% of the total commitment. These countries make these incentives available to attract and anchor manufacturing and hence exports in the host location. This is well-established behaviour and the scale of the recurring economic benefit for the host location mean that both SMEs and multinational organisations expect to be able to access incentives wherever they look to invest.

 

C33.  Currently, the UK has limited capacity to compete on grants or loans, especially for single company or ‘on demand’ access. A Regional Growth Fund (RGF) ran in previous years and was used creatively to attract or retain high-value R&D and manufacturing investment in the English regions. This has been phased out except for exceptional cases where applications are accepted at the national and not regional level. RGF funding has helped support manufacturing investments by companies including UCB, Oxford Biomedica, Depuy, Synthes, Actavis, Novartis, and Aesica.

 

C34.  In addition to offering fiscal and financial incentives, both domestic and international companies should be supported to make the decision to invest in life sciences in the UK. Competitor countries offer a ‘one stop shop’, and the UK should seek to emulate this support. The incentives and support that are currently on offer through Innovate UK, NIHR or local growth funds are highly varied in scope and may be available from a variety of national and local sources. It is a landscape that both domestic and global industry representatives have highlighted is challenging to navigate, understand and access. The Department for International Trade Life Sciences Organisation (DIT LSO) DIT LSO offers free and confidential support for inward investors, to make the case to invest in the UK. Once a company has shortlisted the UK, DIT LSO also brokers access to subnational partners and support levers. This same level of support should be made available to scale-up domestic companies, by expanding the remit and resource of the DIT LSO.

 

C35.  Offering UK support through the perspective of the company (customer) journey is important. To be internationally competitive, companies need a senior national-level account manager fully accountable for delivery. The majority of support and incentives need to be available “on demand”, and sufficiently mobile within the UK even if the offer needs to be drawn from multiple sources. Reviewing the incentives landscape and simplifying the customer journey could boost the UK’s chances to win high value, internationally mobile investment in life sciences manufacturing.

 

C36.  Our recommendations

 

  1. Industrial Strategy

 

Question 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?

 

D1.      The review[24] by the ABPI in partnership with the BIA, ABHI and BIVDA of the first two years of the Life Sciences Strategy (launched by David Cameron in December 2011) identified mixed progress and some actions remain unimplemented and without plans for further progress. From this came some of the impetus for the Accelerated Access Review published in October 2016, for which the government response is awaited.

 

D2.      The review of implementation of the Life Sciences Strategy came to the following conclusions on successful implementation of an industrial strategy:

 

D3.      Taking each of these points in turn, we stand ready to work with government, the NHS and other parties to develop the Sector Deal and an implementation programme, along the principles outlined in the Strategy.

 

D4.      We would emphasise that an industrial strategy approach is particularly suited to pharmaceuticals because it is a sector that is highly impacted by government policy at every stage of the product lifecycle. Therefore, a holistic approach and comprehensive delivery across government is a powerful way to support the sector’s economic contribution to the UK; history tells us that this is most difficult to accomplish in health policy and we would recommend that this be a particular focus of efforts to develop implementation governance and plans.

 

Question 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’?

 

D5.      The way that the global pharmaceutical industry is developing medicines and vaccines is changing in response to new technologies. There is a unique opportunity for the UK to become the life science industry’s development partner of choice, bringing huge benefits for the NHS and for patients as well as the UK economy. To deliver this, the Government’s response to the Life Sciences Industrial Strategy needs to be focused on what will truly make the UK the best place in the world to discover, develop, manufacture and launch medicines and vaccines based on our international comparative strengths. Above all, implementation of the strategy needs to be holistic and grounded in a political vision for the UK as a world-leading hub for life sciences with the NHS at its heart.

 

D6.      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 NHS hospitals get access to clinical trials, doctors can prescribe the gold standard of care earlier, patients can get the best treatments available, and researchers can use and build on real-world data. The bio-pharmaceutical industry 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 pricing scheme 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.

 

D7.      We expect the life sciences strategy to align with the wider industrial strategy particularly around cross-cutting areas such as skills, manufacturing, the tax environment and the way that the Department for International Trade encourages inward investment. It will also be important that the industrial strategy can evolve in light of emerging outputs of the negotiations with the EU.

 

Question 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?

 

D8.      The ABPI represents companies large, medium and small. SMEs in the sector will benefit from the strategy and from increased opportunities to collaborate with universities, charities and larger pharmaceutical companies. There are a number of measures in the strategy that will, if implemented, be of particular benefit to SMEs.

 

D9.                Capital allowances and other financial incentives, including tax rates, Patent Box and R&D incentives, can be used to maintain and grow the UK’s competitiveness in attracting investments. The availability of a finance package would be a vital lever to specifically attract life science investments (in areas such as loans/grants, targeted tax relief on incremental capital investments in high tech plants, buildings and machinery), as well as supporting SMEs at key points in their evolution, should be further considered.

 

D10.           Our recommendation is that capital allowances and other financial incentives, including tax rates, Patent Box and R&D incentives should be developed.

 

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

 

D11. Funding should be made available by Government to support the implementation of the strategy. However, Government should also explore how its funding can unlock additional supportive funding from the life sciences industry and wider sector to accelerate investment and development. For example, through the sector deals, Government can provide clarity on policy direction, by endorsing the recommendations of the Strategy, and thereby secure global investments in the life sciences sector in the UK.

 

D12. Funding has already been made available through the Industrial Strategy Challenge Fund. The first wave of the Challenge Fund includes funding to accelerating “patient access to new drugs and treatments through developing brand new medicine manufacturing technologies, helping to improve public health.”[25] At the launch of the Life Sciences Industrial Strategy, £146m of Government investment was detailed[26].

 

D13. Further information on replacing European funding is contained in the Brexit section of this response.

 

D14. Our recommendations

 

Question 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?

 

D15. The Welsh Government, in recent correspondence with the Secretary of State for Business, Energy and Industrial Strategy[27], commented on the ability of governments to work together to take work forward in this space. However, as the Cabinet Secretary for Economy and Infrastructure emphasised, the mix of fully devolved, partially devolved and reserved areas within the scope of this work will affect the opportunities for UK delivery. The Welsh Government plans to launch four, clear overarching strategies this year, which will recognise “the most effective way to support prosperity and growth”. Without these strategies being available in the public domain, it is difficult to comment on potential interaction in the future.

 

D16. The Scottish Government’s Life Sciences Strategy (2017 to 2025) Accelerating Growth, Driving Innovation is focused on four key areas: Innovation and commercialisation, sustainable production, internationalisation, and the business environment. The Strategy is guided by three overarching principles: that life science business is anchored, built and attracted to Scotland. Scotland is now one of Europe’s largest life science clusters, employing over 37,000 people and contributing £2bn in GVA to the UK economy. As such, there are clear opportunities among the strong research base and the potential in health data, for Scotland to be an exemplar and a leading driver of the wider UK life sciences sector. The Scottish Life Sciences Industry Leadership Group has had input to the UK strategy, and we will wait to see how this is reflected as both strategies are implemented.

 

  1. NHS procurement and collaboration

 

Question 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?

 

E1.       Points on NHS collaboration on research are included in our response to Question 12 and the role of NHS data in stimulating the Life Sciences Sector is considered in section H of this submission, in addition to the questions asked by the committee.

 

E2.       The role for the NHS in supporting economic growth is already recognised. For instance, the NHS Mandate[28] for NHS England includes the objective to support research, innovation and growth. This section particularly focuses on the role of the NHS in encouraging participation in research, in harnessing innovation to enable cost-effective and affordable innovative treatments to reach patients more quickly, and making better use of digital services and technology.

 

E3.       NHS evaluation and commissioning of innovative treatments produced by the Life Sciences Sector is an important part of the broad ecosystem for the sector. However, the current pressures on the health service budget mean that investment in new innovative medicines is under significant strain.

 

E4.       The Strategy has set out the reforms to the systems for valuing and providing patient access to new treatments that the sector needs and we look forward to an early endorsement and action on these by Government and the NHS through a Sector Deal. These changes will deliver the Strategy’s vision of an NHS that is a leading early adopter of innovative medicines.

 

E5.       There are three core elements to the reforms sought:

 

E6.       The NHS is one of the UK’s biggest assets to encourage greater life sciences investment by making the UK more competitive for such investment decisions. Understanding the NHS as an engine for growth as described in the Life Sciences Industrial Strategy would help it to achieve its objective in the NHS mandate of ‘supporting research, innovation and growth’.

 

Question 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?

 

E7.       The Accelerated Access Review was initiated due to the 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[29]. The Strategy’s ambition is for the UK to be in the top quartile of these comparator countries by the end of 2023.

 

 

E8.       To help improve patient access, the Life Sciences Industrial Strategy recommends that Accelerated Access Review should be adopted and the accelerated access pathway should be applied to a wider set of products. The proposals laid out in the Accelerated Access Review should be taken forward as an integral part of implementing the Life Sciences Industrial Strategy, and should be seen as closely linked to the Strategy’s other recommendations in the area of NHS collaboration.

 

E9.       The changes introduced on 1 April to the NICE HTA process for medicines are likely to have a negative effect on the availability to patients of new and innovative treatments in England. NICE’s consultation stated that the measures will affect around 12 medicines every year, or around one in five new medicines. The new measures are also fuelling the concerns of innovators about the UK environment for life sciences by signalling that the UK is not willing to pay for cost-effective medicines. The UK already has some of the most stringent cost-effectiveness controls in the developed world and seemingly arbitrarily set ‘affordability’ caps.

 

E10.  Quick access to new treatments and value for money for the NHS can be reconciled using both existing mechanisms and moving towards more flexible commercial models between industry and the NHS as recommended in the AAR.

 

E11.  In terms of existing mechanisms, NICE assessments already ensure that recommended medicines are cost-effective for the NHS to adopt. There is also the Pharmaceutical Price Regulation Scheme (PPRS), which runs from 2014 to 2019. This was designed to address problems of affordability and allow NHS managers and doctors to prescribe cost-effective new medicines. The scheme limits the growth in the overall cost of the branded medicines purchased by the NHS. In spite of an ageing population and other factors leading to a significant rise in the number of medicines being prescribed, the PPRS has limited growth in the medicines bill effectively, thereby providing excellent value for money for the UK from branded medicines. As the Life Sciences Industrial Strategy recommends, the Government should enter into discussion with the ABPI on a new voluntary pricing scheme to succeed the current PPRS which aims to reward innovation, prioritise new medicines to improve patient care, and support the requirement of the NHS to manage its budget effectively.

 

E12.  Our recommendations:

 

Question 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?

E13.  According to the CMR 2016 International R&D Factbook[30], typically over a third (36.9%) of pharmaceutical company R&D spend is in clinical trials; this share may be even higher in the UK for our R&D investment expenditure (£4.2 billion in 2015[31]) for NHS clinical trials. Any proposals to improve the speed, efficiency and effectiveness of UK clinical trial capabilities and capacity will make the UK a clinical trial environment that commercial sponsors would be more willing to invest in.

 

E14.  Specific recommendations to improve UK clinical trials include; increased effectiveness of the Health Research Authority; an aligned/simplified approach for companies across the devolved nations; facilitating improved links between patient communities, healthcare professionals and companies; addressing delays in budget review and approval by individual hospitals; and the ability to use electronic records in the UK. Clinical research skills should continue to be developed in the NHS to support clinical research leadership as well as the operational running of clinical trials.

 

E15.  The commitment in the NHS plan to “Work in partnership with DH and the Health Research Authority to create a more fertile environment for clinical trials...” is welcome and supports the research environment and the recommendations in paragraph 57. At present Industry is not listed as a partner in the NHS England plan; including industry as a partner in research would promote an understanding of the importance of collaboration between NHS, industry, regulators, charities and others. The commitment in the plan to providing an environment where technologies can be developed and tested is welcome; this needs to be operationalised in a way that is reliable and predictable so it can be built into commercial development plans.

 

E16.  Points on how the NHS can better adopt new technology are addressed earlier in this section of questions.

 

  1. Responsibility and accountability

 

Question 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?

 

F1.        To ensure implementation of the strategy, based on our assessment of the previous strategy the following steps would be beneficial[32]

 

F2.        A Cabinet Minister should hold ultimate responsibility for implementation of the Strategy. The Strategy should also be integrated into departmental plans for the Department for Business, Energy and Industrial Strategy and the Department of Health.

 

F3.        Our understanding is that the Government will work with industry to respond to the Strategy with a Sector Deal and we look forward to more details on this process of engagement.

 

F4.        In the inter-connected life sciences ecosystem, it is vital that the Strategy (and its implementation through a Sector Deal) is a joint endeavour with government, NHS, business and the charity and research sectors as partners holding each other to account.

 

Question 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?

 

F5.        As the largest segment within the sector, biopharmaceutical development and manufacturing companies account for 52% of UK GVA in life sciences[33] (life sciences account for 6.8% of UK GVA), and 65% of jobs. They are the UK sector that invests the most in R&D and has the highest productivity in the manufacturing sector. Larger companies are partners and investors for smaller companies, they provide a pool of talented people and crucial commercialisation, manufacturing, regulatory and adoption expertise that is not easily found in other parts of the sector.

 

F6.        Success of the strategy can be measured by how far it encourages these companies to invest and employ more in the UK; that is not something that companies can be accountable for in isolation but is rather a natural consequence and indicator of success.

 

F7.        By arriving at a strong sector deal, the Government can confirm its support for the recommendations of the Life Sciences Industrial Strategy whilst securing short, medium and long term investment from the industry. This is a way in which all parties can hold each other to account for the implementation of the Strategy.

 

Question 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?

 

F8.        For a holistic strategy to be effective and for a sector like life sciences to be supported across the product lifecycle, it is crucial that government is able to muster the various arms and agencies of the state together behind a clear, commonly held objective. This requires a strong and clear agenda as well as a lot of work to align different departments and agencies that are pursuing other objectives of their own. It also requires a high degree of expertise and connectedness with the industry so that the risks and unintended consequences of policy decisions can be understood and anticipated; for a complex and unique sector it is not realistic to expect all those who impact it to have this level of understanding. The ABPI is therefore of the view that a well-funded, expert Office for Life Sciences and clear sponsorship for the industry at Cabinet level are vital. These are also an important signal to the global pharmaceutical industry of life science’s importance to the UK Government.

 

F9.        The government has at various times had a single Life Sciences Minister sitting in both the Department of Health and the business department through its various incarnations, or lead Ministers in each Department working with colleagues in the usual way. The ABPI does not have sufficient information to rigorously assess the benefits of either model compared to the other, however the loss of a single Life Sciences Minister almost concurrently with the restructuring of the Department of Health which saw the Directorate for Innovation, Growth and Technology disbanded, we feel has had an impact on the sponsorship of our sector.

 

F10.   We note there are some difficulties in creating a UK-wide Minister given the different levels of decentralisation of different departments’ responsibilities to the devolved nations.

 

F11.   We have been privileged to work with Ministers over several years all of whom have had a desire to understand this complex sector and engage with businesses. What has seemed to us most important in supporting the industry has been a desire to improve the lives of patients, an understanding of business and the bringing together of the Department of Health, Department of Business, Energy and Industrial Strategy, the Department for International Trade and HM Treasury with NHS leadership, in particular NHS England and NICE, for dialogue on medicines and industrial policy.

 

  1. Brexit

 

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

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

 

G1.      The ABPI has opted to answer all three questions together.

 

G2.      The UK’s membership of the EU has provided much of the scientific, regulatory and trade infrastructure for the pharmaceutical industry in the UK. As such, the negotiations that determine Britain’s new relationship with the European Union (EU) will be critical to how medicines are delivered to patients in the UK and in Europe, and the future success of the pharmaceutical industry.

 

G3.      Following the result of the referendum on the UK’s membership of the European Union in June 2016, the ABPI welcomed the creation of the UK EU Life Sciences Steering Group to determine how to create a world-leading Life Sciences environment in the UK outside of the EU. Policy analysis produced by the ABPI and BIA and submitted to this group identified four key priority policy areas for the pharmaceutical industry:

 

Scientific research and collaboration

G4.      The UK is one of the largest recipients of research funding in the EU. The EU Horizon 2020 framework, has a total budget of €75bn (2014-20) for all EU member states[34]. Between 2007 and 2013, the UK received a total of €8.8bn, including €1.9bn in ESIF funding, €1.7bn from the ERC and €1.1bn from Marie-Curie[35].

 

G5.      The ABPI welcomed the Government’s commitment to underwrite funding for Horizon 2020 projects secured while the UK is an EU member. However, access to EU research funding beyond the existing Horizon 2020 round of funding is unknown. The UK’s eligibility for EU-wide research collaborations also enhances the UK’s position as a global research leader, for example leading the highest number of IMI projects[36], which speed up the development of new medicines in Europe.

 

G6.      As such, the UK should seek to negotiate continued access to long-term European funding and collaboration programmes for science, through:

 

Medicines regulation

G7.      The ABPI has warmly welcomed the recent statements by the Secretary of State for Health and the Secretary of State for Business indicating that achieving cooperation between the UK and EU is an objective of the UK Government through the negotiations. We also welcome the intention of the European Union (Withdrawal) Bill to provide businesses with continuity and certainty as the UK leaves the EU.

 

G8.      Medicines regulation here includes licensing processes and approvals, manufacturing inspections, clinical trial regulation and pharmacovigilance. The MHRA was Rapporteur on 15% of all centralised procedures[37] and performed 23% of GMP inspections[38] coordinated by the EMA. There are currently 978 medicinal products which received a marketing authorisation via the centralised procedure between 1995 and July 2017[39]. Many of these will be held by a UK-based legal entity and would need to be transferred to an EU-based legal entity in the event of the UK not agreeing cooperation with the EU on the regulation of medicines. Additionally, regulatory procedures for which the UK MHRA is the lead assessment agency (Rapporteur or Reference Member State) will need to be reassigned to an EU Member State agency.

 

G9.      The processes for making these changes, particularly if all changes are to be made the short time before the date the UK leaves the EU, will add significant burden which might impact companies’ and regulators’ capacity to progress other changes more directly related to medicine quality, safety and efficacy.

 

G10. In order to deliver further certainty for the pharmaceutical industry, we would welcome a formal Ministerial statement and further policy detail on the Government’s negotiating position in seeking regulatory cooperation between the UK and the EU on the regulation of medicines.

 

G11. 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:

 

Trade and supply

G12. Medical technologies for UK patients are sourced from around the world, with the UK also a significant contributor to global supply. In 2015, the UK imported approximately £29.7bn in Life Sciences goods, and exported £29.5bn, of which 44% went to the EU[40]. As such, European and UK supply chains are profoundly integrated in terms of both finished medicinal products as well as component parts.

 

G13. Should trade between the UK and EU be subject to customs duties, import VAT and border controls (import/export declarations and inspections/goods’ testing), this would cause significant disruption to the supply chain for medicines.

 

G14. Currently, the UK is a WTO member in its own right. However, as a member of the EU Customs Union, terms of trade between the UK and the rest of the world (e.g. general customs duty rates assessed against imports into the UK) are agreed by the EU. Separate to the EU Customs Union, is the World Trade Organisation Pharmaceutical Tariff Elimination Agreement. The agreement enables exports to signatory countries for many pharmaceutical products at 0% tariff. However, the agreement does not cover all finished products or component products. The list is generally reviewed every five years although the last review of included products was in 2010. Should the UK rely on WTO arrangements, it will be critical that the specific pharmaceutical agreement reflects all completed and component pharmaceutical products.

 

G15. Due to the complexity of import/export declarations and inspections, and the existing integrated nature of supply chains, the UK should seek to negotiate the ability to trade and move goods and capital across borders with the EU for pharmaceuticals and medical supplies, through:

 

G16. Border delays and other pressures on the medicines supply chain have the potential to further impact on the availability of medicines for patients. This is particularly relevant for medicines that are time and temperature sensitive, such as cutting-edge cell and gene therapies. Given the importance of such medicines to patients, the Government should take into account the specific requirements of pharmaceutical products when negotiating new customs and trade arrangements with the EU and look to further support existing supply chain arrangements.

 

G17. We have argued for transition arrangements, given the scale and complexity of our supply chains for medicines across Europe and the considerable investment and disruption any change to these supply chains necessarily requires. The UK Government has proposed that an interim phase be considered, and that any transition be a single transition from the current trading arrangements (including non-tariff, regulatory requirements) to the future arrangements. We are sharing with the UK and EU Negotiating Teams (in continued partnership with the BioIndustries Association, other UK life science associations and our European trade bodies) our need for the right process, timing, duration and legal clarity about a transition period and the urgency of having this defined and communicated as soon as possible.

 

Access to talent

G18. The UK’s position as a leader in Life Sciences is underpinned by the ability to attract, develop and retain a highly skilled workforce. This is particularly crucial in skills gap areas such as clinical pharmacology and bioinformatics. The ability to attract top talent will be critical if the UK is to become a leader in emerging skills areas e.g. device technologies, digital health, physiological modelling, genomics and advanced manufacturing.

 

G19. Currently, non-UK EU nationals make up around 17% of Science, Technology, Engineering and Mathematics (STEM) academics at UK research institutions[41].

 

G20. The UK should seek to negotiate an agreement with the EU that facilitates the ease of movement for highly-skilled talent in Life Sciences, through:

 

G21. The Life Sciences Industrial Strategy would have been beneficial to the UK with or without Brexit. However, leaving the EU creates business uncertainty which puts a focus on the UK’s economic competitiveness. This context for the Strategy makes it all the more important that it is taken forward and this is done comprehensively rather than selecting the easiest or quickest elements, in order to make the biggest impact.

 

G22. The Strategy most directly complements the sector’s science and talent priorities for leaving the EU, by looking at how the UK Government can further support the sector through research and innovation funding and collaboration, and in seeking to address current and emerging skills gaps.

 

  1. Health Data

 

H1.      In addition to the questions posed, the ABPI recommends that the Committee should specifically consider the role and opportunity of health data to the Life Sciences Industrial Strategy.

 

H2.      After the EU referendum, we identified that the data potential of the NHS as the single most powerful opportunity for the UK to attract life sciences investment. The advantage of the NHS is in its population coverage which, if the right steps are taken quickly, could provide a competitive advantage to the UK. This needs significant investment from government to enable the NHS to get the best from its data and enable the life sciences sector to operate clinical trials with the resulting data sets.

 

H3.      The use of health data can transform the provision of health care, by both improving the quality and reducing the cost of health care services, and driving research and innovation in the life sciences.

 

H4.      Healthcare decisions could be better informed if based on good quality data throughout a medicine’s lifecycle and the patient treatment pathway. Therefore, further development should be expected in improving the quality of data collection, the consistent implementation of data standards and the linkage of health data throughout the patient pathway, from primary care into secondary and specialised care. The ABPI has outlined the key actions that need to be undertaken to establish a competitive health information and data informatics service in the UK which will serve the life sciences industry effectively into the future[42].

 

H5.      The Salford Lung Study shows the power of health data. The study involved collaboration between GSK, academics and health services. The study compared GSK's Relovair against current treatments, using electronic data collated in Salford's innovative e-Health database to keep track of patient's progress outside a clinical trial setting. The e-Health database enabled patients to be identified and followed through the process far more easily than in other trials. It also provided researchers with a breadth of clinical data about how patients use their medicines. Building on this the pharmaceutical industry signed a Memorandum of Understanding with Greater Manchester Health and Social Care Partnership. This collaboration will improve the use and safety of medicines and use the unique data and information capabilities of the NHS to discover, develop, and deliver new medicines and treatments for patients[43].

 

H6.      Building on the National Data Guardian and Care Quality Commission’s standards, we would like to see an improvement in routine recording of patient information. Currently, we observe data silos between the patient information recorded between primary, secondary and specialist care. Integrating or linking these data sources will allow for better measurement of the longer term value of medicines and more informed discussions based on patient outcomes. In the current model the value of some of the information is lost due to lack of linkage data.

 

H7.      For many years, the UK has led the way in infectious disease surveillance and routine collation of vaccine coverage data, allowing the impact of NHS immunisation programmes to be assessed on a regular basis and programmes to be changed where necessary. This research has influenced decisions in both the UK and overseas. However, outside of immunisation, the benefits of research based on routinely collected health care data are still not well disseminated and understood. There is need to showcase benefits that can be realised with the use of routinely collected health data. For example, the analysis of anonymised data has a great potential to increase the understanding of disease, outcomes, as well as treatments and treatments pathways. This would enable assessment of the value of treatments and services based on actual health outcomes and the total cost of care.

             

H8.      There is a need to unify and simplify the application processes for data access, as the complex procedures and high costs are likely to affect the numbers of potential users. We think that a single application process, ethics, and a single licence for the use of all NHS data will help to unlock the potential of this resource for UK innovation and research. Such harmonisation would enable data users to make the best informed decisions based on the quality and content of the data, and would help build and sustain public trust in the way their information is used and protected. The Government should continue to support the Department of Health led “Maximising research through health data programme” to deliver a single entry point to access catalogued, linkage-ready, routinely collected health and social care data, within a clear and proportionate governance framework.

 

H9.      With a single healthcare system in the UK, the national and regional data sets are highly beneficial and, if developed well and quickly, could be a significant differentiation for the UK, helping to attract inward investment. For example, the use of data sets can increase speed and efficiency of clinical research by allowing quicker and more accurate feasibility and delivery of clinical trials. Dialogue is beginning in local health economies in Manchester and Scotland to pilot this exciting data-driven healthcare transformation and partnership with industry, but it would benefit from greater Government support and investment into the appropriate agencies and data repositories, and greater engagement with industry.

 

H10. In order to facilitate this transformation of the health care environment it is important to effectively communicate the benefits of health data use appropriately amongst all stakeholders and in particular engaging with and involving patients. As part of this, there is a need to discuss the governance principles, purpose and risks of using health data.

 

20 September 2017

 

[1] PhRMA (2016) Chart Pack Biopharmaceuticals in Perspective. Washington DC: Pharmaceutical Research and Manufacturers of America, p 22. http://phrma.org/sites/default/files/pdf/chart-pack-biopharmaceuticals-in-perspective.pdf This was the correct figure in 2015.

[2] The ABPI, through its Innovation Board, held a roundtable to explore how the AAR can define “transformative technologies” to support Government in launching the pathway - Defining “transformative” technology in life sciences” ABPI Reflection Paper, forthcoming.

[3] http://www.abpi.org.uk/our-work/policy-parliamentary/documents/lsuk_twoyearon.pdf

[4] The 2015 EU Industrial R&D Investment Scoreboard, European Commission, JRC/DG RTD

[5] “Open for Innovation: UK Biopharma R&D Sourcebook 2016”, ABPI, www.abpi.org.uk.

[6] “Bridging the Valley of Death” https://publications.parliament.uk/pa/cm201213/cmselect/cmsctech/348/348.pdf

[7] Op. Cit., p. 31.

[8] Page 8, https://www.ucl.ac.uk/pharmacy/departments/practice-policy/affording-the-future.pdf

[9] http://www.ukcrc.org/research-coordination/health-researchanalysis/uk-health-research-analysis/

[10] http://www.abpi.org.uk/our-work/library/industry/Documents/Open_for_innovation_ABPI_Sourcebook_2016.pdf

[11] EvaluatePharma World Preview 2016, Outlook to 2022, published September 2016. P 27 based on exchange rate at 31 December 2015.

[12] http://www.abpi.org.uk/our-work/mmip/Pages/default.aspx

[13] http://www.abpi.org.uk/our-work/mmip/documents/advanced-therapies-manufacturing-taskforce-report.pdf

[14] Science, the State and the City: Britain’s Struggle to Success in Biotechnology. Geoffrey Owen and Michael Hopkins. OUP, 2016.

[15] Buiilding Something Great: UK’s Global Bioscience Cluster 2016, BioIndustries Association (BIA) and Informa Pharma.

[16] CMOs and CROs Have Different Trajectories CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate. May 02, 201.Jim Miller Pharmaceutical Technology Volume 41, Issue 5, pg 72–73

[17] ABPI research, forthcoming.

[18] The Changing Drug Discovery Landscape, ABPI, 2015, http://www.abpi.org.uk/our-work/library/industry/Documents/the-changing-UK-drug-discovery-landscape.pdf,

[19] ABPI LINC https://linc.abpi.org.uk/

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

[21] ‘Pact for the Future’ see summary at http://www.tforg.com/how-we-think/sweetspot-blog/2015/08/14/how-to-foster-pharma-innovation-belgiums-pact-for-the-future-2015/

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

[23] This includes Pfizer, Lilley, J&J and Medtronic-Covidien

[24] http://www.abpi.org.uk/our-work/policy-parliamentary/documents/lsuk_twoyearon.pdf

[25]https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/597467/spring_budget_2017_web.pdf

[26] https://www.gov.uk/government/news/sir-john-bell-to-unveil-industry-led-proposals-to-build-uks-status-as-world-leader-in-life-sciences

[27] http://www.assembly.wales/deposited%20papers/dp-1631-16-21.pdf/dp-1631-16-21.pdf

[28] NHS Mandate 2017-18 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/601188/NHS_Mandate_2017-18_A.pdf

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

[30] Thomson Reuters, CMR 2016 International R&D Factbook, August 2016 ISBN: 978-0-9573843-4-7 Version 1.0, Figure 2.1.

[31] Office for National Statistics. 2016. "Business enterprise research and development, UK: 2015." In, 42. London: ONS.

[32] http://www.abpi.org.uk/our-work/policy-parliamentary/documents/lsuk_twoyearon.pdf

[33] http://www.abpi.org.uk/our-work/library/industry/Documents/The_economic_contribution_of_the_UK_Life_Sciences_industry.pdf

[34] The Royal Society, “UK research and the European Union: The role of the EU in funding UK research” (December 2015),p.5

[35] The Royal Society, “UK research and the European Union: The role of the EU in funding UK research” (December 2015), pp. 5, 12-13

[36] ABPI, “UK Participation in the Innovative Medicines Initiative”, p.4

[37] European Medicines Agency, Annual Report 2015. MHRA was also Co-Rapporteur on 15% of centralised procedures.

[38] Number of inspections identified in EudraGMP for 2015; EFPIA data compiled from EFPIA member companies.

[39] Office of Health Economics, analysis for ABPI on data provided by the European Medicines Agency. ABPI and its sister association, EFPIA, are currently completing survey work to determine the share of medicinal product licenses held by a UK-based legal entity more precisely and these data will be available shortly.

[40] ONS Balance of Payments data, (2015)

[41] CaSE, “Immigration: Keeping the UK at the heart of global science and engineering” (January 2016), p. 25

[42] http://www.abpi.org.uk/our-work/library/industry/Documents/ABPI%20eHealth%20and%20health%20information.pdf

[43] http://www.abpi.org.uk/media-centre/newsreleases/2017/Pages/New-partnership-set-to-help-%E2%80%98transform%E2%80%99-access-to-medicines-for-patients-in-Greater-Manchester-24.02.17.aspx