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Why is innovation in Europe important for patients? – POLITICS

Recent crises have highlighted the importance of Europe securing and strengthening its position as a leader in medical innovation. As the European Commission works on the next medicines strategy, we need to ensure Europe has the right environment to bring the next generation of treatments to patients. The challenge of the coming decades is not whether medical innovations will take place, but where they will take place. This article is part of a series explaining how where innovation happens matters to patients, healthcare systems, the research community, jobs and the economy.

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Ilya Yuffa, Senior Vice President, Eli Lilly and Company and President, Lilly International | via EFPIA

Today, as we emerge from the COVID-19 restrictions in most countries, we face a new crisis in Europe. A humanitarian one that affects our communities in Ukraine, Russia and across the continent. Like many companies, Lilly donates essential medicines, donates to non-governmental organizations and supports a coordinated industry response to help people in dire need. We hope for an early end to hostilities and a resolution to this crisis.

The crisis has increased the pressure on global supply chains and healthcare systems. It’s a stark reminder of the importance of access to treatment and healthcare, and the never-ending need for innovative solutions. We are on the cusp of a wave of medical breakthroughs that are unfolding at an unprecedented pace and will bring ever greater benefits to all. How can this potential be realized for patients in Europe?

We are on the cusp of a wave of medical breakthroughs that are unfolding at an unprecedented pace.

The European Commission has recognized the value of our industry and the need for the right incentives to create the best environment for innovation. These are vital 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 providing equitable access for patients across Europe, and in fostering research and development – ​​including clinical trials that 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 that medical innovation can have, and the likelihood of new medicines being discovered is greater now than ever. We’ve never had as many drugs in development in our industry as we have now: 8,000 at last count. At Lilly, we have committed to bringing 20 new medicines to market in just 10 years, between 2014 and 2024. And the promise of more and more personalized medicines to improve patient outcomes is quite remarkable. Between 2000 and 2020, the number of people diagnosed with cancer in Europe increased by about 50 percent, but more people are surviving than ever as mortality rates plummet.1 The opportunities are coming – at this point it is no longer a question of whether the next breakthroughs will come, but rather of when and, just as important across Europe, where.

Europe has a strong heritage in healthcare but has fallen behind.

Europe has a strong heritage in healthcare but has fallen behind. Of all new medical discoveries between 2014 and 2018, only 22 percent were of European origin versus 48 percent from the United States.3 This is an almost exact reversal of the numbers from 25 years ago. There is also increasing competition for clinical trials, for example the number of clinical trials conducted in Asia increased from 14 percent in 2009-2013 to 34 percent in 2020 (IQVIA).4, giving patients a greater chance of accessing innovative treatments. While I wouldn’t bet against the next big break in Europe, there are challenges.

How can we revitalize innovation in Europe and why is this important??

Innovation in R&D

The innovations we see coming down pipelines today are the result of many years of work, underpinned by strong and predictable intellectual property (IP) rights. Lilly alone has invested $6 billion in research into Alzheimer’s disease over the past three decades, but it still remains one of the biggest public health challenges.

IP is one element of a supportive life sciences ecosystem that drives 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 is now being developed into an approved treatment for breast cancer. Spain has an environment that strongly supports collaborations between researchers in industry, academics and the medical community, accelerating the iterative testing of molecules from the laboratory to live cancer cells and clinical trials. In clinical trials, fewer than 5 percent of eligible patients have historically participated in trials, and ethnic minorities are underrepresented in a number of disease areas. We need to look at how we can make it easier for patients to participate, for example by increasing the use of digital interactions and improving outreach to different groups.

Innovation for patients in our regulatory systems

The EU needs flexible, well-resourced strategies to ensure that its regulatory system is efficient, effective and globally competitive. It should enable innovative approaches such as 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 access without compromising security. And learn from other regions—currently, it takes the European Medicines Agency (EMA) an average of 150 days longer to review a new drug, compared to the Food and Drug Administration (FDA) in the US

However, innovation means nothing without patient access.

Innovative patient access

However, innovation means nothing without patient access. We know there are ways to improve this. Once on the market, access to new medicines varies greatly 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 in 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 may be even more delays at the local level.6 We can work together to fix this.

opportunity to act

The EU’s industrial and pharmaceutical strategies represent a unique 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 future-proof regulatory regime that meets the needs of challenging new diagnostics, treatments and technologies; to maintain strong and predictable intellectual property rights that drive research and development and future innovation for patients; and to provide more flexible, faster and fairer patient access to create a globally competitive life sciences ecosystem in Europe.

It has been 20 years since Europe’s medicines legislation was last reviewed and the pace of innovation in all related sectors – technology, R&D, genomics development – has been so fast that we need to ensure our regulatory framework is updated to reflect these needs to meet most of the innovations that we see. Will Europe be up to the challenge? We hope so.


References:

1 Cancer in Europe 2019 Comparative Report – Burden of disease, 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 figures 2021, Pharmaprojects & SCRIP, March 2021

4 2021 EFPIA pipeline review update IQVIA/EFPIA Pipeline Review 2021

5 EFPIA Charles River Associates The Root Causes of Nonavailability & Delay to Innovative Medicines, April 2022 Cause unavailability delayed CRA report April 2022 Final.docx (efpia.eu)

6 The Patients WAIT Indicator Survey shows the average time to patient access to treatment in EU and European Economic Area (EEA) countries, April 2022 Patient WAIT Indicator Data 2022 (efpia.eu)

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Fry Electronics Team

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