Drivers of medical innovation in Europe have called on policy makers to consider a more collaborative approach, one that puts patients first and helps avoid stifling economic growth.
In 2009, the European Union (EU) spent 1.8 percent of its GDP – the value of all products and services that it produces – on research and development (R&D), and plans to further bolster this investment with the introduction of an ambitious growth strategy (Europe 2020) to help drive R&D investments up to 3 percent of the GDP by 2020.1-2 The commission estimated that this plan will create 3.7 million jobs and increase annual GDP by €795 billion.3 However, there is still some room for improvement.4
Bureaucracy is one of the greatest challenges faced by the pharmaceutical industry in R&D. For example, initiatives such as ‘The 100,000 Genome Project’ in the UK – a £300 million collaboration with universities, the Department of Health, the Wellcome Trust, Great Ormond Street Hospital and the Medical Research Council, to sequence genomes to map the genetic profile of thousands of rare diseases and cancers, has been somewhat affected by strict legislation.5 However, the European Commission has recognised the need for reform and has already implemented measures to review and adapt policy to ease the process for R&D. This has been evident in the review of the Clinical Trials Directive of 2001 – a policy which resulted in time increases and greater expenses in conducting clinical trials, contributing to a 22 percent drop in clinical trial applications in the UK from 2007 to 2011.,6-7 A new version was adopted in 2014 (to be applied from 2016) that prioritises the EU’s competitiveness in clinical research and the development of new and innovative treatments and medicines, with an aim to bring patient-oriented research back to Europe.8
Also, there has been a growing debate on the need for greater transparency in clinical trial reporting, led by the Association of the British Pharmaceutical Industry (ABPI) who states that this could provide greater health benefits to patients, and that the pharmaceutical industry should not be immune from wider social trends towards openness and collaboration. 9 In fact, the ABPI explains that, with the breadth and complexity of treatment options increasing as more personalised and precise options are introduced, transparency remains crucial for an efficient and effective development process of appropriate and timely treatments.9
The Pharmaceutical Pricing Regulation Scheme (PPRS) agreement that was reached in 2014 was intended to help support the adoption of innovative medicines and allow for more flexibility in the NHS budget.10 To date, the PPRS rebate paid by Celgene and other companies does not seem to be directly reinvested in NHS England or Clinical Commissioning Groups to increase patient access to innovative medicines. Equally, the PPRS agreement is not currently taken into account during Health Technology Appraisals and therefore does not impact the overall cost-effectiveness of the drug.
It is therefore important to put in place safeguards that the money from the industry used to underwrite growth in NHS spending on medicines is reinvested by the Department of Health into NHS England and Clinical Commissioning Groups to increase access for medicines for patients. Without greater investment and access to innovative medicines it will be more and more difficult for companies like Celgene to maintain high levels of investment in the UK.
In addition, there have been suggestions that greater investment in programmes which support collaborations between public and private sectors could help provide wider treatment options for patients whilst supporting innovation and competition. For example, the Innovative Medicines Initiative, Europe’s largest public-private initiative aimed at speeding the development of better and safer medicines for patients, examined new development approaches for medicines to ensure expedited market access.11 New approaches included how to get better data and quicker analysis for shorter assessment times, how to ensure opportunities for charities and patient groups to play an increased role in market access, and strategies to promote quicker adoption of significant medical advances into clinical practice.12
In the UK, the Government launched a ten-year Strategy for UK Life Sciences in 2011, setting out a long-term vision to re-establish the UK’s global leadership in life sciences, and support the growth of British small and medium-sized enterprises in this industry.13 Under this strategy the UK is seeking to develop an integrated healthcare economy in which universities, the NHS and the commercial life sciences sectors can work together in the interests of patients and the wider economy.13
Furthermore, the London Mayor, Boris Johnson, has introduced a strategy to help re-establish Britain’s reputation for bioscience innovation. The idea is to create a ‘MedCity’ together with the Cambridge and Oxford institutions to form a ‘golden triangle’ in medical and life science research. This institution will help attract investment into the life sciences and ensure that any advances are better exploited to boost the economy.14
This approach is similar to that taken by Sweden, who has ensured the provision of clear technology transfer policies. As one of the biggest investors in R&D in the EU (3.40 percent of its GDP in 2014), realising the importance of commercialising research findings, the Swedish Government established technology transfer offices to promote innovation and to facilitate the transfer of academic knowledge to the private sector.15
However, the pharmaceutical industry also plays a major part in re-establishing the UK’s global leadership in life sciences. Celgene is committed to supporting advancements in medical innovation and has provided grants for research in health services research programs all over the country, and in UK institutes including the Kings College Hospital Charity Haematology Laboratory Services and University College London, to drive research in areas of unmet need.16
In conclusion, some great work is being done in Europe, with the landscape for medical innovation improving and continually evolving, as companies like Celgene seek to foster innovation. Some have argued that healthcare in the UK is undergoing a ‘quiet revolution’, which could help establish the country as a world leader in healthcare and a pioneer in clinical research. So, as national and international policies begin to take shape and more collaborations across industry and academia come to fruition, research and development is set for an exciting future, which is sure to benefit both healthcare providers and patients alike.
2European Commission. EUROPE 2020 A strategy for smart, sustainable and inclusive growth [online]
[Last accessed: June 2015]
3European Commission. Why do we need an Innovation Union? [online] Available from: http://ec.europa.eu/research/innovation-union/index_en.cfm?pg=why [Last accessed: June 2015]
4Science is Vital. UK investment in science drops below 0.5% of GDP [online] Available from: http://scienceisvital.org.uk/2015/03/13/press-release-uk-science-funding-gdp/ [Last accessed: June 2015]
5Sarah Knapton. ‘Hostile’ Europe risks derailing medical innovation, warns minister. Daily Telegraph. [online] Available from: http://www.telegraph.co.uk/news/science/science-news/11077912/Hostile-Europe-risks-derailing-medical-innovation-warns-minister.html. [Last accessed: June 2015]
6The European Parliament and the Council of the European Union. 2001 Clinical Trials Directive [online] Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. [Last accessed: June 2015]
7House of Commons. Clinical Trials – Science and Technology Committee publication [online] Available from: http://www.publications.parliament.uk/pa/cm201314/cmselect/cmsctech/104/10406.htm [Last accessed: June 2015]
8European Commission. Clinical trials – Regulation EU No 536/2014 [online] Available from: http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm [Last accessed: June 2015]
9ABPI. Clinical Trial Reporting [online] Available from: http://www.abpi.org.uk/our-work/library/industry/Documents/Clinical%20trial%20reporting%20-%20Definitions%20and%20guiding%20principles.pdf#search=transparency [Last accessed: June 2015]
10Suzanne Elvidge. Germany caps drug prices. Nature Biotechnology (2010):28,539. Available from: http://www.nature.com/nbt/journal/v28/n6/full/nbt0610-539c.htm [Last accessed: June 2015]
11Department of Health. The Pharmaceutical Price Regulation Scheme 2014 [online] Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/282523/Pharmaceutical_Price_Regulation.pdf [Last accessed: June 2015]
12Innovative Medicines Initiative. Introducing IMI [online] Available from: http://www.imi.europa.eu/content/mission. [Last accessed: June 2015]
13Department of Health and Department for Business, Innovation & Skills, Office for Life Sciences. Major Investments in Life Sciences [online] Available from: https://www.gov.uk/government/news/major-investment-in-life-sciences [Last accessed: June 2015]
14Department for Business, Innovation & Skills, Office for Life Sciences. Strategy for UK Life Sciences [online] Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/32457/11-1429-strategy-for-uk-life-sciences.pdf [Last accessed: June 2015]
15Denise Roland. London to complete ‘golden triangle’ of UK bioscience. Daily Telegraph [online] Available from: http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10746343/London-to-complete-golden-triangle-of-UK-bioscience.html [Last accessed: June 2015]
16European Commission. Sweden [online] Available from: http://ec.europa.eu/research/fp7/pdf/country-profiles/sweden/country_profile_and_featured_projects.pdf [Last accessed: June 2015]
Date Preparation: May 2015