Recent crises have highlighted the critical need for Europe to secure and strengthen its position as leader in medical innovation. As the European Commission works on the next Pharmaceutical Strategy, we need to ensure Europe has the right environment to bring the next generation of treatments to patients. The challenge for the coming decades is not if medical innovation will happen but where it will happen. This article is part of a series explaining that where innovation happens matters for patients, health care systems, the research community, jobs and the economy.
Ilya Yuffa, Senior Vice President, Eli Lilly and Company and President, Lilly International | via EFPIAToday, as we emerge from COVID-19 restrictions in most countries, we face a new crisis in Europe. A humanitarian one affecting our communities in Ukraine, Russia and across the Continent. Like many companies, Lilly is donating essential medicines, donating to nongovernmental organizations, and supporting a coordinated industry response to help those in urgent need. We hope for an end to the hostilities and a resolution to this crisis as soon as possible.
The crisis has increased pressure on global supply chains and health care systems. It is a stark reminder of the importance of access to treatment and medical care, and the never-ending need for innovative solutions. We are on the cusp of a wave of medical breakthroughs developing at an unprecedented pace that will offer ever greater benefit to everyone. How can this potential be realized for patients in Europe?
We are on the cusp of a wave of medical breakthroughs developing at an unprecedented pace.
The European Commission has acknowledged the value of our industry and the need for the right incentives to create the best environment for innovation. These are crucial to encourage research into new medicines and investment in research and development (R&D). But innovation takes many forms. Europe needs innovation in its approach to its regulatory environment, in how to deliver equitable access to patients across Europe, and in driving R&D — including clinical trials, which can offer patients life-saving early access to innovative treatments.
We will have our own experiences, personally or through family members or friends, of the transformative impact medical innovation can have and there’s a greater chance of new medicines being discovered today than ever before. We have never had as many medicines in development in our industry as we do now: 8,000 at the latest count. At Lilly we committed to launch 20 new medicines in just 10 years between 2014 and 2024. And the promise of ever-more personalized medicines to improve outcomes for patients is quite remarkable. Between 2000 and 2020, the number of people diagnosed with cancer rose around 50 percent in Europe, however more people are surviving than ever before as mortality rates decline sharply.1 The opportunities are coming — at this point, it is no longer a case of whether the next breakthroughs will happen, but more a case of when, and equally importantly across Europe, where.
Europe has a strong legacy in health care, but it has fallen behind.
Europe has a strong legacy in health care, but it has fallen behind. Of all new medical discoveries between 2014-18, just 22 percent were of European origin versus 48 percent from the United States.3 This is an almost exact reversal of figures from 25 years earlier. There is also increasing competition for clinical trials, for example the number of clinical trials conducted in Asia grew from 14 percent in the years 2009-2013 to 34 percent in 2020 (IQVIA)4, offering patients greater opportunity to access innovative treatments. While I would not bet against a next great breakthrough happening in Europe, there are challenges.
How can we revive innovation in Europe, and why does it matter?
Innovation in R&D
The innovations we see coming through pipelines today are the result of many years’ work, underpinned by strong and predictable intellectual property (IP) rights. Lilly alone has invested $6 billion into Alzheimer’s disease research over the past three decades, yet it is still one of the most challenging unmet needs in health care.
IP is one element of a supportive life sciences ecosystem that leads to results and there are many excellent examples across Europe. In Spain, scientists at Lilly’s R&D site in Alcobendas, Madrid, discovered a molecule that has now been developed into an approved treatment for breast cancer. Spain has an environment that strongly supports collaboration between researchers in industry, academics and the medical community, speeding up the iterative testing of molecules from lab to live cancer cells and clinical trials. On clinical trials, historically, under 5 percent of eligible patients participate in trials, and across a number of disease areas, racial minorities are under-represented. We need to look at how to make it easier for patients to participate, for example through increased use of digital interactions and improving outreach to diverse groups.
Innovation for patients in our regulatory systems
The EU needs flexible, well-resourced policies to ensure its regulatory system is efficient, effective and globally competitive. It should allow for cutting-edge approaches like innovative clinical trial designs, real-world data evidence and cloud-based submissions. We can learn from the COVID-19 crisis, which has shown how initiatives like rolling reviews can speed up access without compromising safety. And learn from other regions — it currently takes an additional 150 days on average for the European Medicines Agency (EMA) to review a new medicine compared to the Food and Drug Administration (FDA) in the U.S.
Innovation means nothing though without access for patients.
Innovating patient access
Innovation means nothing though without access for patients. We know there are opportunities to improve this. After marketing authorization, there are vastly different speeds of access to new medicines across Europe — in some countries patients wait up to six times as long as in neighboring countries. The average time to reimbursement for innovative treatments across EU and European Economic Area (EEA) countries is 511 days, ranging from 133 days in Germany to over 899 days in Romania.5 And within individual countries there can be even more delay at a local level.6 We can work together to address this.
Opportunity to act
The EU’s Industrial and Pharmaceutical strategies present a golden opportunity to help European scientists lead the next wave of discoveries that will once again change the world of medicine. We have the opportunity to create a futureproof regulatory system to suit the demands of sophisticated new diagnostics, treatments and technologies; to maintain strong and predictable intellectual property rights that drive R&D and future innovations for patients; and to create more nimble, faster and equitable patient access to deliver on a globally competitive life sciences ecosystem in Europe.
It’s been 20 years since European pharmaceutical legislation was last reviewed, and the pace of innovation across all related sectors — technology, R&D, development of genomics — has been so fast, we need to ensure our legislative framework is updated to meet these demands and make the most of the innovation we see. Will Europe step up to the challenge? We hope so.
References:
1 Comparator Report on Cancer in Europe 2019 — Disease Burden, Costs and Access to Medicines IHE Report 2019:7 (efpia.eu)
2 IDF Diabetes Atlas Europe.pdf (worlddiabetesfoundation.org)
3 The Pharmaceutical Industry in Figures, Key data 2021, Pharmaprojects & SCRIP, March 2021
4 EFPIA Pipeline Review 2021 Update IQVIA/EFPIA Pipeline Review 2021
5 EFPIA Charles River Associates The Root Causes of Unavailability & Delay to Innovative Medicines, April 2022 Root Cause Unavailability Delays CRA Report April 2022 Final.docx (efpia.eu)
6 The Patients W.A.I.T indicator Survey, shows the average time to patient access to treatments across EU and European Economic Area (EEA) countries April, 2022 Patient WAIT Indicator Data 2022 (efpia.eu)
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