Europe needs to act now to ensure its patients are not left behind

An estimated one-third of people in the European Union will be over the age of 65 by 2050 . Add in lifestyle risk factors and socio-economic differences, and it is clear Europe needs to act fast to upgrade its health systems to improve life for patients.

To achieve this, Europe needs to improve the global competitiveness of its regulatory framework in order to get medical innovation to patients faster.

Europe should be commended for the speed, transparency and efficiency of its regulators in responding to the Covid-19 pandemic. However, these efficiencies have not endured. The European regulatory system takes about 120 days longer than regulatory systems in the United States and Japan.[1] Such delays, combined with complex country-level market access systems, mean patients in Europe are waiting an average of 20 months longer than people living in the United States to benefit from scientific innovation.

The data means large numbers of Europeans living with cancer, cardiovascular conditions and other difficult-to-treat conditions may be missing out on medicines that could help them.  Furthermore, they have far less opportunities to access much-needed care.

Alzheimer’s disease — a progressive, fatal condition — is just the latest example. After more than three decades of dedicated research investment, two new breakthrough treatments were recently approved in a number of countries, including the United States, Japan and China, the first that can delay the progression of early symptomatic Alzheimer’s disease. This makes it possible for patients to have more time to live independently, relieving some of the tremendous financial and emotional burden on families and caregivers. These new medicines have comparable efficacy, safety and costs to other biologic medicines already approved for cancer and autoimmune conditions.

The millions of people across Europe are suffering from this relentless and fatal disease and will have to keep waiting.

Yet in Europe there is little evidence that these breakthrough medicines are even available. European regulators have been reviewing one of these medicines for a staggering 26 months — and market authorization is still pending. In sharp contrast, regulators in Japan completed their review in eight months, and China and the United States each took about 13 months to issue full marketing approval for the same medicine. In the case of a second medicine, made by my company, Lilly, after 20 months from submission the scientific committee of the European Medicines Agency (EMA) recommended against approving it at all — even though regulators in 10 other countries already have. The millions of people across Europe are suffering from this relentless and fatal disease and will have to keep waiting.

These delays undermine the European Commission’s goal to improve Europe’s competitiveness. Europe is at a crossroads on whether it can deliver on the recommendations of the Commission’s Draghi report, which calls out the “slow and complex EU regulatory framework” as one of the factors underpinning the EU’s competitive gap.

The pharmaceutical industry spends more than four times as much on research and development in the United States than in Europe, despite our much larger population.[2] Europe’s fragmented system for clinical trial approvals has also cut the region’s share of clinical trials by nearly half over the past decade, depriving at least 60,000 Europeans of the opportunity to benefit from groundbreaking clinical studies.[3]

One way to change this is to expand the use of expedited approval pathways for new medicines. In 2023, only 3 percent of reviews by the EMA used an expedited pathway, compared with 62 percent in the United States and 33 percent in Japan.

Europe is at a crossroads on whether it can deliver on the recommendations of the Commission’s Draghi report, which calls out the “slow and complex EU regulatory framework” as one of the factors underpinning the EU’s competitive gap.

The voice of patients is also woefully missing from the regulatory process, which needs to introduce additional ways to incorporate their perspectives in weighing benefits and risks.

When medicines show clinically meaningful effects and have well-characterized, manageable and monitorable safety profiles, EU regulators should enable physicians and patients to decide whether these medicines are the right choice for them.

If EU policymakers desire to encourage more companies to invest in Europe, they need a modernized regulatory framework with sufficient resources to deliver approvals for clinical trials and new medicines at pace and on a consistent scientific basis with regulators in the United States and Asia.

Europe can either strengthen its competitiveness by creating a regulatory environment that improves patient access to innovative treatments for diseases like Alzheimer’s or it can continue to see declining investment in the health of its citizens. Which path will EU leaders choose?

[1] Centre for Innovation in Regulatory Science (2024) R&D Briefing 93: New drug approvals in six major authorities 2014-2023: Changing regulatory landscape and facilitated regulatory pathways. Centre for Innovation in Regulatory Science (CIRS), London, UK: https://cirsci.org/wp-content/uploads/dlm_uploads/2024/07/CIRS-RD-Briefing-93-six-agency-briefing-v2.0.pdf.

[2] Organisation for Economic Co-operation and Development, Figure 10.12 in “Health at a Glance 2019: OECD Indicators”: https://www.oecd-ilibrary.org/docserver/4dd50c09-en.pdf?expires=1598376941&id=id&accname=guest&checksum=ACAEE105A158161FA44800557714694B.

[3] IQVIA, Assessing the clinical trial ecosystem in Europe, Final Report, October 2024: efpia_ve_iqvia_assessing-the-clinical-trial-ct-ecosystem.pdf.