Europe must act now to ensure that its patients are not left behind – politico

Data means that a large number of Europeans living with cancer, cardiovascular conditions and other conditions that are difficult to deal with may lack drugs that could help them. In addition, they have much fewer possibilities to access the essential care.

Alzheimer’s disease – a progressive fatal condition – is only the last example. After more than three decades of dedicated research investment, two new revolutionary treatments have recently been approved in a number of countries, including the United States, Japan and China, the first which can delay the progression of early symptomatic Alzheimer’s disease. This allows patients to have more time to live independently, relieving part of the huge financial and emotional burden for families and caregivers. These new drugs have efficiency, safety and costs comparable to other organic drugs already approved for cancer and autoimmune conditions.

However, in Europe, there is little evidence that these revolutionary drugs are even available. European regulators have examined one of these drugs for 26 months – and market authorization is still pending. On the other hand, regulators in Japan have completed their examination in eight months, and China and the United States all took about 13 months to issue complete marketing approval for the same drug. In the case of a second medication, carried out by my company, Lilly, after 20 months after the submission, the Scientific Committee of the European Agency for Medicines (EMA) recommended that it is at all – even if the regulators in 10 other countries have already done so. The millions of people through Europe suffer from this relentless and fatal disease and will have to continue to wait.

These delays undermine the European Commission’s objective to improve the competitiveness of Europe. Europe is at the crossroads to find out if it can make recommendations from the Draghi report of the Commission, which calls for the “slow and complex regulatory framework” as one of the factors underlying the competitive gap of the EU.

The pharmaceutical industry spends more than four times more in research and development in the United States than in Europe, despite our much greater population. (2) The fragmented system in Europe for clinical trial approvals has also reduced the share of the region of clinical trials by almost half of clinical studies.

One way of modifying this is to extend the use of accelerated approval routes for new drugs. In 2023, only 3% of EMA exams used an accelerated route, compared to 62% in the United States and 33% in Japan.