Europeans are facing decreased access to new medicines and the ability to take part in ground-breaking clinical trials, as research and development of new treatments increasingly moves to more ambitious life science sectors in the US and Asia.
A new report published today by Charles River Associates for EFPIA paints a challenging picture of falling competitiveness in Europe, with the global share of pharmaceutical R&D investment, clinical trials and manufacturing output all decreasing. The situation is most acute for Advanced Therapies Medicinal Products (ATMPs) – tissue, gene and cell therapies - used to prevent, treat and cure rare conditions including some cancers, where the US and China dominate.
A snapshot of the research shows:
- R&D investment: In 2002 the US spent $2billion more than Europe on R&D; today that figure is $25billion - a rise of 1000%. Of the total R&D investments made in the US, Europe, China and Japan, only 31% of this occurs in Europe. This has declined steadily from 41% in 2001. China has meanwhile grown its share from 1% to 8%.
- ATMPs: Clinical trial activity is twice as high in the US and almost three times as high in China than in Europe. The number of ATMP trials conducted in the US and Asia-Pacific region grew by 70% and 67%, respectively from 2014-21, while Europe remained stagnant.
- Clinical trials: Europe accounted for a 19.3% share of global clinical trials activity in 2020, a decrease of 6.3%, compared with a 25.6% average over the last ten-years.
The report highlights a number of challenging areas and makes policy recommendations – which could be implemented at National Government level – or EU level through the revision of the pharmaceutical legislation. EFPIA is warning that the options being discussed by policy makers in the context of the European Pharma Strategy fall well short of addressing concerns, improving Europe’s attractiveness for life sciences and supporting companies already invested in Europe. The report is launched alongside a European footprint report – an interactive map detailing the locations of all pharmaceutical manufacturing plants throughout Europe.
Recommendations to address areas of concern include:
- Incentivising the development of truly world class innovation hubs in the EU.
While global R&D is expected to grow at a rate of 4.2% per year to reach $233 billion in 2026, it is moving out of the EU. While world-leading hubs like Boston, San Francisco and the UK’s Golden Triangle receive significant policy focus and strategic funding, European research funding is more uniform, prioritising equality over quality. The countries with the highest EU research spend per population are not the centres of innovation. This is a weak strategy: The EU should consider sponsoring a review of existing life science and industrial policies across Member States to identify success factors and opportunities for replication. A focus on life-science hubs is currently missing from the policy framework.
- Enhance end-to-end capabilities and funding of disruptive innovation
Europe’s share of emerging biopharma companies has been in decline for ten years. The location of existing R&D sites is a key driver of new investments; while companies emerging in the US and China may invest in Europe as they grow, they will continue to invest where they originate. The contribution of emerging Chinese biopharma companies to the global pipeline has grown rapidly at a rate of 456% between 2016 and 2021. The EU Pharmaceutical Strategy acknowledges the importance of EU-level funding and national schemes to support SMEs but this should go further. There are signs of positive trends in some Member States – for example Denmark - in supporting growth of around 200 new life sciences companies in the Eastern Denmark cluster between 2017 and 2022 – also supported by the government-led ‘Innovation Centre Denmark’ located in Boston, which aims to accelerate cooperation between the clusters. Identifying and adopting successful initiatives should be prioritised in the European Pharma strategy.
- Rethink supply chain policies to attract ATMP investment in Europe
ATMPs are the therapies of the future - with 804 next generation biotherapeutics (including cell and gene therapies and mRNA technology) in a global pipeline of over 8,000 new medicines. The US has 50% of the world’s ATMP manufacturing facilities. Asia is fast becoming the most competitive region for attracting ATMP clinical trials (255 in 2021), with Europe in decline (89 in 2021).
For Europe to start competing more effectively it must recognise the complexity of these new technologies and build the interconnected ecosystem required to develop them. While Europe performs strongly in academic research for ATMPs – European institutions authored 48,000 more publications than the US between 2017 and 2019, and 20,000 more than China - it is not turning the research into therapies for patients.
Europe’s competitiveness is hindered by a siloed approach to policymaking and missed opportunities. The EU should take a more proactive role in fostering the growth of emerging ATMP clusters providing support across the entire eco-system of R&D, manufacturing and clinical trials.
- Supporting innovation by implementing early access mechanisms, including generation and use of real-world evidence
The traditional lifecycle of medicine development is changing. Medicines increasingly need to gain conditional approval to reach patients earlier to generate real-world evidence. Company research investment will increasingly be influenced by regulatory agility and flexibility and a supportive clinical trial environment, which ensures patients can benefit from new therapies.
The Commission’s proposals for a revised pharmaceutical legislation shares some of these objectives; supporting innovative trial designs and new methods of evidence generation and assessment. However, the Commission strategy seems not to take into account the link between the early patient access to new medicines and the attractiveness of Europe as a location for companies to locate their research, clinical trials and manufacturing, particularly for new technologies.
- Boost EU digital transformation and support development of digital capabilities
Countries offering an effective digital ecosystem is a major driver of investment for global companies. The US is far ahead of Europe in digital infrastructure and interconnectedness. Despite five EU countries ranked in the world’s top ten for digitisation, Europe’s leading hubs for R&D and manufacturing – Germany, Belgium and Ireland – rank poorly in digital competitiveness (19th, 23rd and 24th out of 52, respectively). An EU-led effort to increase the interconnectedness of hubs, upskill the scientific workforce in digital technologies and accelerate the digitalisation of health systems will help boost innovation. The EU’s Pharmaceutical Strategy shares a focus on preparing for the digital transformation. but lacks emphasis on supporting Member States in modernising their digital infrastructure to support development and access to new medicines.
- Foster adoption of sustainable procurement and pricing policies
Global supply chains for new medicines held up remarkably well in the pandemic. Europe’s increased focus on onshoring and manufacturing older, generic medicines is a strategy at odds with the EU’s long term industrial policy goals and together with a lack of a sustainable market for innovative products, will damage future innovation unless re-thought in the proposed revision of the EU pharmaceutical legislation.
- Develop longer term (15-20-year) European policies and collaborations to create stability for attracting biopharmaceutical investments
Decisions regarding investment in research hubs and manufacturing are long-term decisions, while clinical trials are often carried out over many years. For Europe to be strategically autonomous from the rest of the world it requires a vibrant R&D ecosystem. The policy decisions taken today will impact on Europe’s attractiveness for investment for decades to come.
Given the long-term focus on investment decisions, regions that offer long-term stable environments coupled with growing markets will benefit from decreased perceived risk. A long-term outlook requires the EU Pharma Strategy to be implemented through a forward-looking partnership with industry, with tangible and relevant key performance indicators co-created to ensure the revised legislation is having its intended impact and enables benchmarking of Europe’s long-term competitiveness for attracting R&D, clinical trials and manufacturing investments.
Director General, EFPIA, Nathalie Moll said:
“Today’s report should provide a wake-up call to all of us. It could not be more important to patients - and to the future of medicines development in Europe - that the Commission and National Governments work with Industry to retain – and grow – the sector here in Europe.
To achieve this, the focus should be on adopting best practice across the life science eco-system to emulate the successes of ambitious, world-leading regions in the US and Asia.
While the Commission’s ambition of balancing affordability for member states and future innovation is the right one, the current thinking is set to have a negative impact on patient care and further erode Europe’s competitiveness.”
R&D and manufacturing sites in Europe