AbbVie – Written evidence (LSI0068)

 

Summary

 

 

 

 

 

 

 

About AbbVie and background

 

  1. AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com.

 

  1. The Committee’s inquiry is welcome and can play an important role in ensuring momentum in implementing the Life Sciences Industrial Strategy (hereafter the Strategy)[1] and the Accelerated Access Review (AAR)[2] is maintained. The Committee has also particularly identified aspects relating to governance and accountability which are also critical to the success of industrial policy, particularly when aspects touch many different Governmental Departments and Non-Departmental Public Bodies (NDPBs).

 

  1. AbbVie operates across the research and development paradigm. Examples of AbbVie’s UK footprint include:

 

 

  1. AbbVie therefore has a strong interest in seeing supportive policies brought forward and implemented to sustain and enhance the UK’s competitiveness as a location for life sciences activity, particularly in the context of Brexit.

 

  1. In line with guidance issued by the Committee, we have only answered those questions where we believe we have a particular expertise and / or relevance and have attempted to keep our comments brief. We would of course be happy to provide any further information or clarification to the Committee, either verbally or written, should that be helpful.

 

Answers to specific questions

 

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 Strategy was welcomed by the sector and a number of its recommendations made a tangible positive impact on the environment. For example, the BioMedical Catalyst is largely viewed as being a successful Government intervention to support non-dilutive sources of capital for promising research and the 1000,000 Genomes Project and creation of Genomics England also came as a result of the 2011 Strategy and. AbbVie has been an active industrial partner in this endeavour and continues to be so.

 

  1. Likewise, the Early Access to Medicines Scheme (EAMS) demonstrated an ambition to use regulatory flexibilities to allow for earlier patient access to medicine in areas of unmet need. A number of medicines have now passed through the EAMS and while improvements can and should be made, particularly engagement around the effective communication of EAMS into the NHS and the gap between the regulatory and payer view of clinical datasets and resulting uncertainty in small patient populations, the involvement of industry provides a solid blueprint upon which to build. AbbVie has put two medicines into the EAMS process for example in the areas of hepatitis C and Chronic Lymphocytic Lymphoma.

 

  1. However, beyond this, analysis of the 2011 Strategy by sector representative bodies demonstrated a mixed record of delivery, impact and success[4]. AbbVie agrees with the conclusions of this analysis that greater focus and clear accountability is required across departments and government agencies. The 2011 Strategy may have suffered from too broad a range and number of recommendations which served to dilute such focus.

 

  1. In addition, alongside the Strategy and incorporated within it was the Innovation, Health and Wealth[5] report containing additional recommendations focused towards the NHS. It was not always clear which department or officials were responsible for implementing the joint aspects of both reports and there was a failure to address the systemic issues with the patient access environment.

 

  1. In AbbVie’s view, this demonstrates the need for a holistic strategy with clear lines of accountability, regular touchpoints with the sector to identify any barriers or challenges to implementation and a focus on the key recommendations that will make a meaningful impact. In particular, the interest and engagement of the NHS is critical to success given the fundamentally important role of adoption of innovation to any industrial policy focused on the life sciences sector.

 

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

 

  1. Professor Sir John Bell has engaged thoroughly and outlined an ambitious vision for the life sciences sector in the UK. This includes a complimentary mix of long term, strategic and aspirational goals and short term recommendations to address ongoing areas of concern in the adoption environment. In particular, AbbVie agrees with the potential for the UK to harness, and play an important role in, genomic medicine, its potential to be an important location for the placement of novel and complex clinical trials and Professor Bell’s recommendations to implement the AAR (further comment provided below). The Strategy document usefully contains a Strategic Goal for its recommendations that can act as a measure of success and AbbVie specifically notes the Strategic Goals to support a 50% increase in the number of clinical trials in the UK and to place the UK in the top quartile of comparator countries for the speed of adoption and overall uptake of innovation.

 

  1. It is important to note however that this is an independent, expert led report and does not give an indication as to the Government’s approach to life sciences. AbbVie is particularly keen to see a Government response to the proposals, whether as part of a proposed Sector Deal or otherwise, and clear indication of the commitment of the NHS. An early government response will allow for implementation to begin which will be a crucial part to the success of the Strategy. This will also allow for a clear direction from Government to have been signaled to the sector ahead of the settlement of the next Pharmaceutical Price Regulation Scheme (PPRS) that will set the reimbursement environment for medicines from 2019 onwards.

 

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

 

  1. It is AbbVie’s contention that significant progress can be made in the implementation of the Strategy by delivering improved and more robust accountability and communication structures both within governmental departments and between the sector and government. This requires organisational drive and commitment rather than significant new funds.

 

  1. In a number of areas that are a focus of the Strategy there will naturally be the potential for industry funding to support its delivery. As outlined above, AbbVie invests in the UK in a number of ways including through academic partnerships, collaborations and investments into UK companies and funding of clinical trials that provides a source of revenue to hospitals. Such investment allows for the objectives of the Strategy to be delivered and can be a natural consequence of it.

 

  1. In addition, AbbVie facilitates, supports and funds a number of pilot projects across the country, often in partnership with patient organisations, to improve the patient pathway in a number of disease areas. Such projects aim to enhance and improve patient outcomes and patient experience of care in a timely and convenient manner whilst optimising the use of NHS resources. Examples include support peer to peer support services within hepatitis C and optimising care closer to home and reducing clinical variation in Inflammatory Bowel Disease pathways across the UK. Such activities also provide funding and headroom for the objectives of the Strategy.

 

  1. In relation to those aspects focused upon improving the slow and low adoption of medicines and innovation in the UK, it must be pointed out that the current PPRS, in operation from 2014 to 2018, is designed to cap the overall medicines budget within agreed levels[6]. Any overspend by the NHS above these levels are then paid back to Government by industry (this is estimated to be in the region of £3 billion over the lifetime of the current PPRS). This should provide the headroom for the NHS to ensure patient access to medicines and is a recognition by the sector of the financial pressures the NHS is under. It is therefore a source of frustration that this has not led to a uniform improvement in the adoption of innovation in the NHS but rather continued cost-containment measures are being implemented that, in AbbVie’s view, further erode the ability of patients to access medicines in a timely fashion.

 

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

 

  1. For the Strategy to be as effective as possible it would be beneficial for the devolved nations to be fully engaged in taking its recommendations forward, even if specific application of those recommendations may be tailored to the local environment. For a global biopharmaceutical company that operates across the UK, with clinical trial activity in all four home nations, the benefits of a coordinated and streamlined offer are significant and reduce variation and complexity.

 

  1. The EAMS is one example of a policy that has a single point of entry through the Medicines and Healthcare Regulatory Agency (MHRA). However, the implementation of a product that has progressed through EAMS is variable across the UK, in both administrative procedure and in patient access, highlighting the need for effective devolved nation engagement.

 

  1. It is also important to recognise, as the Committee highlights in its question, the devolved nations have their own proposals and industrial policies in place at varying stages of development. The Scottish strategy was published in Spring 2017 and in Wales initiatives such as the three year pilot for a “Wales Life Sciences Bridging Fund”, which aims to accelerate life sciences technologies on the path to commercialisation, is in place. Devolved nations will naturally wish to build upon those areas where they have a particular strength. However, in those broader scientific and research endeavours where larger collaborations are beneficial to progress, such as genomics, it is important to maintain as harmonised a position and “offer” as possible.

 

  1. A similar rationale and approach should be applied to the devolved regions of England and clearly the Academic Health Science Networks have a critical role to play here in ensuring that local and regional efforts can be translated into national benefits. However, it is even more critical within devolved English regions, operating within the same legal and health structures, to maintain alignment and ensure unwarranted variation is avoided.

 

  1. This should include a clear and concise approach to communicating with global organisations and companies, such as AbbVie, when outlining the many benefits of research and development in England and the UK. It is AbbVie’s view that it is important not to fragment or confuse the environment with multiple and misaligned initiatives that do not speak to the national picture.

 

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?

 

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. These questions are taken together. The AAR has been a thorough exercise with a number of independently researched components and widespread engagement exercises. Momentum behind the AAR has been affected by the significant political events of the European Union Referendum and the 2017 General Election but it is important that the recommendations are fully considered and taken forward. This is even more critical given that during the intervening period the adoption environment, with which the AAR is primarily concerned, has changed significantly most notably with the introduction of the new “budget impact test” by NICE and NHS England. AbbVie is therefore encouraged to see these recommendations reinforced within the Strategy.

 

  1. The AAR outlines a number of recommendations that represent a positive step towards closer cross-agency working, such as the Accelerated Access Partnership (AAP). It is hoped this will address the urgent need to provide greater certainty over the uptake of cost-effective medicines which is one of the most effective public procurement stimulus the NHS could offer to encourage continued innovation.

 

  1. The UK environment is viewed as one of the most complex in Europe and increasingly one driven by cost containment measures. 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[7]. This is particularly frustrating when considering the overall medicines bill is largely secured by the provisions of the current PPRS. AbbVie therefore welcomes specific and measurable Strategic Goals recommended by the Strategy that includes moving the UK to the top quartile of comparator countries for adoption and uptake of innovation.

 

  1. In measuring such a goal, and considering how to take forward the AAP and new access routes for medicines, it is important to agree an appropriate definition of innovation whilst ensuring clear routes to patient access for varying types of medicines are available. There should not be too narrow a definition of innovation recognising there remain continued areas of unmet medical need even in disease areas with multiple existing therapeutic interventions, such as some inflammatory conditions for example. Definitions of innovation and unmet medical need related to existing regulatory schemes globally provide a useful starting point but it should be noted within the EAMS it has been shown that areas of unmet need exist even in therapy areas where products are approved, such as AbbVie’s recent experience of the EAMS designation for a hepatitis C medicine demonstrates.

 

  1. Increased predictability in this area could be achieved via some of the aspects below, which are familiar themes in the debate around adoption in the UK and are referenced in the AAR and the Strategy:

 

 

  1. The AAR, and in particular proposals around new policies such as the AAP, will need to learn from, and build on, experiences from previous strategies such as the EAMS. This will be vital if UK patients are to benefit from the science and innovation that is being supported by the UK Government. For example, senior government and NHS figures, such as the Chief Medical Officer in her Annual Report[8], have clearly identified genomics as a current and future field of technology. Genomics will lead to, and is already delivering, targeted precision medicines that are tailored to specific and smaller patient populations. The development of medicines in this field will be based around such smaller patient populations, naturally resulting in smaller clinical trials and less available clinical data. Payers and health technology assessors need to engage with industry on how to approach the uncertainty of more immature datasets, often based on Phase II data, otherwise we risk not benefiting from the very science the UK is seeking to promote. Tensions between the flexibility of the regulatory approach to such data and the payer approach are already being seen, in oncology for example, and this gap risks widening further in future leaving a situation where medicines are approved but not accessible routinely by patients.

 

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. A number of comments made above in relation to the previous 2011 Strategy are relevant here. In particular, it is important that in its response or Sector Deal the Government clearly outlines how it will implement the recommendations with clear lines of accountability and mechanisms of engagements between the sector and Ministers / officials to measure progress and course correct where necessary. It is understood that implementation can take time but it is important to have confidence in the direction of travel.

 

  1. As outlined above, the involvement and commitment of the NHS to delivering the Strategy and AAR is critical. One way of addressing this could be for NHS England and NHS Improvement to appoint accountable board members for delivering improved rates of innovation and implementing the recommendations for example.

 

  1. The AAP is another vehicle that may be well placed to deliver and encourage cross-agency working, given the representation of key stakeholder groups, and a clear and transparent line of communication between the AAP and industry would bring added value.

 

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. For the life sciences to thrive there needs to be a robust ecosystem with different elements of the interrelated sector all present from a strong scientific base, high performing academic institutions and accessible early stage finance, through an engaged healthcare system with the necessary infrastructure, to medical research charities and industry, both global biopharmaceutical and UK based companies.

 

  1. The benefit of global biopharmaceutical companies within this value chain are many and varied including the in-house expertise we can bring to scientific exploration, as AbbVie demonstrates through our consortia membership for example, and the investment into the NHS through the placement of clinical trials which has the additional benefit of bringing medicines to patients earlier than they would otherwise expect to access to it, free of charge. In the UK, this is also further underpinned by industry through the medicines bill cap covered by the existing PPRS.

 

  1. Industry can also support the successful implementation of the recommendations of the Strategy by engaging in the resulting initiatives, as AbbVie has done with Genomics England the EAMS for example. This must be based, however, on a spirit of ongoing and continuous improvement to those initiatives with a forum where each stakeholder can bring forward ideas for improvement.

 

  1. At its core, the Strategy and AAR seek to create a more favourable environment for the research and development of new medicines and technologies for patient benefit. Global pharmaceutical companies have a significant part to play in developing these medicines.

 

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. A number of points outlined above are relevant to this question and we can restate the AbbVie view that it is critical to ensure momentum is maintained in the implementation of the recommendations of the AAR and Strategy.

 

  1. The Office for Life Sciences has shown that it can be well placed to co-ordinate the many strands of government to deliver cross-departmental policies. This is an essential element of the life sciences strategy and Government departments must respond and engage with the OLS meaningfully for that organisation to make a success of its objectives.

 

  1. Similarly, the dedicated Life Sciences Minister acted as a champion for the sector within government and engaged widely with the various parts of the sector in a sustained way. Reinstating that Ministerial position would be beneficial, particularly as the sector works closely across multiple government departments around Brexit issues.

 

  1. In whatever structure that is decided upon, the ability to bring in meaningful engagement from NHS England and other NDPBs is critical. This may include ensuring the structures are in place to enable appropriate challenge to those organisations if delivery is slow or not taken forward.

 

  1. Likewise, it is also important that as well as implementing the recommendations designed to bring forward positive change, the OLS, Life Sciences Minister or other accountable delivery partners are able to ensure policies that would serve to undermine the direction of travel are properly explored, their impact assessed and the proposals amended or withdrawn should they be of an order that will severely impact the sector. The recently introduced ‘budget impact test’ brought forward by NHS England and NICE is one such example of a policy that does not resonate with the positive message from Government regarding the importance of the life sciences sector to the UK economy and patient outcomes.

 

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. AbbVie recognises there are a number of highly complex regulatory, trade, legal and other issues which must be resolved during this process and support efforts to conclude these in a satisfactory manner. Our primary aim is to ensure resulting necessary changes do not impact public health or patient access to medicines.

 

  1. Given AbbVie’s footprint in the UK and our global reach there are some specific topics that require our particular focus which we are engaging with government and sector representative bodies on. We are confident that there is strong dialogue taking place between the sector and governmental departments at present which will lead to a better appreciation and understanding of these issues, many of which are unique to medicines development and our sector.

 

  1. Irrespective of the need to address the issues that Brexit gives rise to and independent of that process, it is right to continually analyse and assess the UK’s competitive position in the life sciences sector and address barriers or issues as they arise. It is important not to “stand still” particularly given that the adoption of medicines is a retained Member State issue that is unaffected by Brexit. Many of the access challenges have been well known for a number of years and addressing these requires focus and in a timely fashion and will need to proceed concurrently with Brexit negotiations.

 

15 September 2017

 

 

[1] Life Sciences Industrial Strategy, Professor Sir John Bell, August 2017. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/640696/life-sciences-industrial-strategy.pdf

[2] Accelerated Access Review, UK Government, October 2016. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/565072/AAR_final.pdf

[3] AbbVie Data on File,AXAXDoF170210, February 2017

[4] From vision to action: delivery of the Strategy for UK Life Sciences, LifeSciencesUK, January 2014. Available at: http://www.abpi.org.uk/our-work/library/industry/PublishingImages/Life%20Sciences%20UK%20From%20vision%20to%20action%20delivery%20of%20the%20Strategy%20for%20UK%20Life%20Sciences%20(2).pdf

[5] Innovation, Health and Wealth, Department of Health, December 2011. Available at: http://webarchive.nationalarchives.gov.uk/20130107013731/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_131299

[6] Understanding the 2014 Pharmaceutical Price Regulation Scheme, the ABPI, 2014. Available at: http://www.abpi.org.uk/our-work/policy-parliamentary/Documents/understanding_pprs2014.pdf

[7] Life Sciences Competitiveness Indicators Report, Office for Life Sciences, April 2017. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/606651/life-science-competitiveness-indicators-report-2017.pdf

[8] Annual Report of the Chief Medical Officer, 2016, Generation Genome, Department of Health, July 2017. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/631043/CMO_annual_report_generation_genome.pdf