Wait Times for New Medicines in Europe Lengthen, Reopening Cracks in Patient Access

Approval of a new drug does not mean patients can use it the next day. For patients with cancer, rare diseases, or chronic immune diseases, what often matters most is the next gate: whether the medicine enters reimbursement, whether physicians can prescribe it, and whether hospitals and local systems are ready to absorb it. The European Federation of Pharmaceutical Industries and Associations recently cited the latest survey as saying that the speed at which European patients gain access to innovative medicines has not only failed to improve, but has instead regressed.

According to EFPIA and IQVIA’s 2025 Patients W.A.I.T. Indicator survey, the study covered 168 innovative medicines approved through the EU centralized review process between 2021 and 2024, with medicine availability data current as of January 5, 2026. The average availability rate across EU27 countries was 45%, lower than the 46% in the previous year’s survey; the average time from marketing authorization to patient availability lengthened from 578 days to 597 days.

This average masks sharper disparities. Country-level differences listed in the report show that Germany can make medicines available in an average of about 158 days, while Romania reaches 1,110 days. EFPIA also stressed in related notes that the time European patients wait for the same medicine in some countries may be several times that of neighboring countries; from marketing authorization to actual availability, the period can range from about 4 months to more than two and a half years.

Delays do not arise only from whether pharmaceutical companies submit applications. A root-cause analysis released simultaneously by EFPIA and Charles River Associates breaks the issue into 10 interlinked factors, from the speed of regulatory processes, pricing and reimbursement review, value-assessment methods, and budget pressure to healthcare infrastructure, local-level decision-making, and duplicative evidence requirements. Although the report’s tone clearly represents an industry position, it also points to a reality that is harder to solve through a single reform: access is not one administrative procedure, but a whole chain of institutional handoffs.

Another set of fourth-year data from Europe’s Access Hurdles Portal adds a picture of action on the pharmaceutical-company side. The data cover 91 products whose first indications were approved between January 2022 and June 2025, and EFPIA said all eligible member companies had participated. Across European countries, 61% of products had submitted pricing and reimbursement applications; when alternative access schemes are included, the proportion rises to 69%. Among reimbursed products, 64% of the total time from marketing authorization to availability was attributed to the stage after pricing and reimbursement applications had been submitted, while awaiting decisions by individual countries.

These figures also appear against the backdrop of EU pharmaceutical legislation reform and the proposed Biotech Act. Industry argues that if Europe hopes to retain biomedical innovation, it cannot look only at whether medicines can be approved, but must also address post-approval market-access friction. However, drug-price negotiations and healthcare budgets are inherently core matters of each country’s public finances and health policy, and shortening wait times does not mean all countries can accept the cost of new medicines on the same terms and at the same speed.

The most meaningful aspect of this survey, therefore, is not simply that it declares Europe has “slowed down,” but that it brings patient access back from an abstract slogan to concrete time. 597 days is an average, and 45% is a coverage rate; behind them are different answers from national systems about the value of new medicines, fiscal capacity, and healthcare equity. For patients, these answers ultimately become the same question: the medicine already exists, but when will it be my turn?