QuintilesIMS – Written evidence (LSI0104)

QuintilesIMS (QI) provides integrated information and technology solutions to improve real-world patient outcomes. We are the UK’s 4th largest life sciences employer, with a team of 3,800 people located across the UK, generating £650mn in revenue. QI conduct 30% of all commercial clinical trials in the NHS. With our knowledge and expertise we are well placed to support the Government and industry in maintaining the position of life sciences as the “jewel in the crown” of the UK economy.

We welcome the opportunity to respond to this Call for Evidence. Our vision is to improve NHS patient quality and quantity of life. We do this by enabling UK patients to access clinical trials of innovative medicines and capturing the real world patient experience of such medicines once licensed. QuintilesIMS aspires to become a trusted partner to the Government by providing the market evidence on the current and future attractiveness of the UK for inward investment by global pharma, informed by unique insights provided by our clinical research, real world evidence (RWE), and medicines trends data.

QuintilesIMS provides market insights on the uptake of innovation to the global pharmaceutical industry and governments. In the UK, we work with hospitals and community pharmacy to monitor all medicines access and usage, including the tracking of new medicines uptake and benchmarking with the rest of the world using our proprietary global data assets. In the UK, complete coverage is achieved by 99% of all NHS Hospitals and 85% of UK Retail Pharmacies contributing to QuintilesIMS anonymized prescription audits. QI is working with the ABPI who, in conjunction with NHS England, identifying innovation and novel drug uptake across regional and geographies.

Summary

We welcome the opportunity to respond to this Call for Evidence. As the Committee’s Call for Evidence points out, the UK life sciences sector is an integral part of the economy, contributing over £30bn in 2015 and employing 482,000 people. It is therefore vital that the Industrial Strategy the Government puts forward in due course contains a number of provisions for enhancing the UK’s competitive advantage, increasing productivity within the sector, and improving links between public and private healthcare actors.

Science and innovation

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

The pharmaceutical manufacturing alone contributes around £13bn to UK Gross Value Added (GVA), more than in any other European country aside from Germany, and the UK is the third highest beneficiary of foreign direct investment in pharmaceuticals after Germany and the United States. However, current medicines’ spending sits at one per cent of GDP in the UK, behind spending in Germany, France and the US. That equates to medicines expenditure (at list price) per head of just £231 in Britain, in comparison the USA, Germany and France spend £648, £343 and £341 per head.

The UK is currently ranks third in the world for new medicine launch (NCE) numbers, by global pharma, as the table below demonstrates:

However, whilst the UK performs well in terms of being a preferred country for new medicines launches, uptake by the NHS is the lowest in the EU 5 at years 1 and 5. Combined with Brexit uncertainty about the future of the EMA this must be addressed in order for global pharma to maintain confidence in the UK as a priority country for clinical trials and launches in the future – as can be seen in the table below.

In order to take the opportunities offered by Brexit, as well as ensure continued trade with the Single Market, the UK should prioritise understanding which regulatory structures will work and which requirements we propose to change. This is crucial to develop the argument that the UK could become a more attractive as a location for investment by global pharma and to understand how the new UK will relate to the regimes which apply elsewhere in the world, and in particular in the United States, the rest of the EU and Japan.

QuintilesIMS strongly believes that policy makers need to focus on the UK’s future relationship with the US, the EU and Japan-three blocs which together account for over 90% of world sales of new hi-tech medicines. Future trading relationships with BRICT (Brazil, Russia, India, China and Turkey) countries are important to the wider interests of the UK, but their demand for medicines is focussed on primary care and generic manufacturers; they are not significant markets for the hi-tech, speciality patented medicines that are the lifeblood of innovation for the industry and which are pushing forward boundaries in cancer and other devastating diseases.

Industrial Strategy

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’?

QuintilesIMS strongly welcomes the publication of the Life Sciences Industrial Strategy report by Professor Sir John Bell. In particular, we welcome actions to significantly accelerate clinical and real-world studies through the adoption of recommendations from the Accelerated Access Review, as well as recommendations concerning access to data. However, there are a number of areas where we believe it could be further strengthened.

Firstly, whilst access to anonymised patient level data (APLD) is important for researchers, we strongly recommend that the Government also commit to making APLD available for appropriate commercial research. Specifically, on page 7 the report recommends, “Building on the standards set out by the National Data Guardian and Care Quality Commission, the health and care system should set out a vision and a plan to deliver a national approach with the capability to rapidly and effectively establish studies for the generation of real world data, which can be appropriately accessed by researchers.” We would urge the Government to include, “and for commercial purposes”, at the end of this recommendation.

Secondly, we believe there is scope to simplify and streamline the approvals process for clinical trials. The recommendations concerning ‘Translational Science’ on page 5 are particularly welcomed, including, “Government should improve the UK’s clinical trial capabilities so that the UK can best compete globally in our support for industry and academic studies at all phases.”

However, we believe that clinical trials processes could be further enhanced by creating a single agency to oversee them, rather than having responsibility spread between 4 national bodies – as is currently the case.

In addition, action must be taken to standardise clinical trial contracts, as well as the rates that are charged, to provide greater industry certainty and clarity – something that already exists in Scotland. The Government should therefore review how clinical trial contracts in Scotland currently function, and identify the benefits that this system could have if applied in England.

We also believe that performance management of commercial trials conducted in the NHS will improve recruitment. The UK is a slow recruitment country which compromises patient outcomes; it is well documented that patients in clinical trials have better outcomes than those not enrolled and to improve the UKs attractiveness for research investment. Performance metrics should be aligned with global gold standards, such as the US, to improve trial success rate and predictability. In particular the UK should look to benchmark clinical trial NHS patient recruitment speed with the USA standard (90 days), rather than the EU standard.

Finally, to improve the environment for clinical research in the UK, we believe there should be an automatic opt-in for use of NHS patients’ data for appropriate research. Greater efforts should be made to support identification of patients for clinical trial participation, including promoting clinical trials as a routine part of patient care. Doctors should also be able to directly contact patients who could benefit from participation in clinical trials, the so-called ‘right to write’ provision.

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?

QuintilesIMS is the largest life sciences employer in Scotland and so we have a vested interest in the both the UK and Scottish life sciences strategies working collaboratively. As previously mentioned, we believe that there are significant benefits to the Scottish system of clinical trials contracts, which are standardised in format and in payment terms. This provides greater certainty and clarity to commercial enterprises and improves efficiency.

NHS procurement and collaboration

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?

How can the recommendations of the Accelerated Access Review be taken forward alongside the strategy?

QuintilesIMS welcomed the 2016 AAR report and its recommendations. However, its publication has not translated into visible and tangible outcomes in respect of accelerating access to transformative medicines. The strategy should be seized as an opportunity to re-energise the AAR and mobilise those charged with implementation to align with Professor Bell’s report and the future Government response paper.

Whilst the AAR is ambitious, it restricts its acceleration priorities to transformative medicines and devices. Transformative medicines and devices come along once in a life time and include medicines such as Glivec for Chronic myeloid leukaemia, Kalydeco for cystic fibrosis, and Sovaldi a cure for Hepatitis C. Pharmaceutical innovation is built on a history of incremental innovation, so treatments such as Herceptin for breast cancer, Everolimus for a number of different tumours both common and rare, and Lucentis for preventing blindness in people with wet AMD are examples of how patient outcomes have been improved incrementally. The AAR will do nothing to accelerate medicines such as these and we recommend that the life sciences industrial strategy implementation should find ways to expand the ambition of the AAR to include incremental medicines.

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?

The NHS England Prioritisation Framework 2016 has delayed access to many specialised medicines, mainly in the rare diseases space, and continues to do so because of its slow work programme. For example, there are six programmes in the NHS England Clinical Commissioning Programme that have been paused and three that have been stopped altogether. The CCP work programme shows how many drugs are in its existing work programme, many have been in discussion with NHS England for more than 2 years and may still not get a reimbursement decision and access to patients within the next financial year. This system needs to be aligned to the principles of the life sciences industrial strategy and the AAR. Critically, NHS England should sign-up to being a catalyst for access not a barrier. Many of the drugs are developed by emerging biopharma firms, who simply cannot afford delays of such length, sometimes 2-3 years, in accessing the UK market, leading to companies deciding not to continue to purse access in the UK, whilst continuing to gain access in Europe.

How can quick access to new treatments and the need to provide value for money be reconciled?

The best way to achieve this goal is through improved transparency and open collaboration between NHS England, NICE and the industry. NICE has an established track record of engaging with NICE - but recent changes influenced by NHS England threaten this established relationship. Importantly, we would recommend the removal of the new NICE Budget Impact Threshold, set at £20m. QI undertook research on behalf of the industry body, the Association of British Pharmaceutical Industry (ABPI), which demonstrated that, had the BIT existed 3 years ago, up to 24 innovative medicines would have had difficulty in reaching patients (see the table below).

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?

As previously mentioned, we believe it is important to improve the support available to patients in order to access clinical trials, making the promotion of relevant trials a standard part of patient care. The ‘right to write’ provision, whereby doctors can directly contact patients who could benefit from participation in clinical trials, should be introduced to improve participation.

Responsibility and accountability?

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?

We were disappointed when the Government chose to end the post of Life Sciences Minister when the new Prime Minister took office in July 2016. We would strongly recommend that the Government correct this decision by appointing a Minister that can focus on delivering many of the recommendations made in Professor Bell’s life sciences industry strategy report, as well as harnessing efforts across Whitehall to better support this crucial economic sector.

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?

Along with a majority of the business community, key figures in the life sciences sector made clear that remaining in the EU was their preference. Our analysis suggests that Brexit could decelerate UK Pharma growth over next 3 years, which the table below demonstrates.

The potential upside of Brexit is driven by ring-fencing PPRS rebates for spending on new innovative drugs, accelerating NHS access and uptake of new drugs.

Our baseline case suggests that, although funding gaps will be plugged, there will be a squeeze on public sector resources. In addition, we have assumed that the UK’s MHRA will align itself with the EMA and that the new UK-EU relationship will cause minimal disruption to industry in general.

On the downside, we expect more significant curtailing of pharmaceutical spending growth than in our baseline case. There is also an increased risk of product shortages due to the depreciation of the sterling and the emergence of possible new trade barriers. The UK’s regulatory pathway could diverge which, when coupled with the UK’s tough pricing and reimbursement environment, would lead commercial decisions to delay new product launches in the UK.

Nonetheless, as negotiations continue QuintilesIMS are keen to offer advice and support to the Government in order to secure the best outcome for the country and for the healthcare industry. The nature of our business relies on market certainty, strong regulatory standards, and close international collaboration. We are therefore calling on the Government to prioritise a number of critical issues, including:

• The UK should continue to implement EU rules as we leave the bloc, including the Clinical Trials Harmonisation Regulation and the General Data Protection Regulation;
• In the future relationship, the Government and the EU should ensure close regulatory alignment on authorisation and licensing, assuring patient access to innovative medicines and maintaining the standard of care;
• Of particular concern is the status of the UK’s membership of the European Medicines Agency (EMA). The UK should prioritise negotiating membership or associated status in this critical agency to avoid any delays to licensing applications and the recognition of qualified persons;
• Ensure the continued free movement of biological samples across borders within the European Union to allow continuing operations of our laboratory in Edinburgh; and
• Being able to access the best talent from across the global scientific community is critical for the sector. Importantly, the rights of EU nationals (10% of our workforce in the UK) currently living and working in the UK should be protected and their status secured – as should be the case for UK nationals living and working in the EU.

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

The life sciences industry relies on close international collaboration, which is enhanced when regulatory standards are recognised as equivalent and as closely aligned as possible. To support this, we would recommend that the Government review the clinical trial standards in other jurisdictions around the world, in particular in the United States. This would enable us identify whether the UK’s standards could be adjusted to make them closer aligned to these global systems in order to develop closer international science links and improve bilateral trade.

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

As previously stated, the UK’s membership or association with the EMA will be important if we are to avoid issues arising in applications for licenses or to recognise qualified persons. The Government should prioritise this issue as part of the negotiations on the transitional arrangements, as well as the future relationship.

15 September 2017