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.
