1. Úvod
  2. Médiá a verejnosť
  3. Patients in Europe waiting longer for new medicines as inequality grows between Member States

Patients in Europe waiting longer for new medicines as inequality grows between Member States

EFPIA’s annual WAIT Indicator provides an analysis of the access and availability of 168 new medicines across 36 countries. The report shows a picture of widening inequality with no indication of an improvement in the future. The situation looks likely to be compounded by the introduction of the US Most Favoured Nation Policy (MFN), which aims to provide balance in how global medicines research and development (R&D) is funded, and which would see the US pay the same price as comparable countries for the same medicines (International Reference Pricing).

 


Overview of the 2026 WAIT indicator

This year’s data provides an analysis of 168 innovative medicines that received central marketing authorisation between 2021 and 2024. The figures show:
➢ The median time to availability is 532 days, ranging from 56 days in Germany to 1 201 days in Romania.
➢ An 88% access disparity between the highest and lowest European countries.

 

00063_1746604202_255

 

This year’s report takes a deep dive into the availability of medicines in different countries, as well as the restrictions and conditions placed on their use. Historically, full availability was the primary route of access; however, restrictions are now commonplace.


➢ In 2025, close to half (49%) are not available to patients in Europe – up from 46% in 2019.
➢ In 2025, 17% are only available under restricted conditions (6% in 2019).
➢ In 2025, the share of medicines fully available on public reimbursement lists has declined substantially to 28%, down from 42% in 2019.


As in previous years, the root causes of unavailability and delay in accessing new medicines are multifactorial, ranging from the speed of regulatory processes to misalignment of evidence requirements to insufficient budgets in Member States. Industry continues to stress that these barriers can be addressed through collaborative work among Member States, the European Commission, and all relevant stakeholders, on proposals to improve availability and reduce delays.


Overview of regulatory landscape

As part of the access package, EFPIA has also published new regulatory data: A regulatory quarterly tracker analyses to what extent new medicines approved by the US FDA were, or will be, approved by other global regulatory agencies, including the European Medicines Agency and the Chinese NMPA.

Approvals data for the past 18 months suggest a declining trend in the number of FDA-approved medicines that are subsequently approved by the EMA, with a particularly steep drop since October 2025. Over the coming months, the tracker is expected to provide analysis of the impact of the US Most-Favoured-Nation Policy (MFN) on countries around the world. While it is too early to make assumptions, an uncertain EU market, poor patient access and companies prioritising the US (which accounts for 74.1% of global pharmaceutical sales of new active substances vs 15,6% in Europe(1) would all negatively impact Europe’s patient access disparities. If trends persist, China will soon surpass the EU for approving and launching FDA-approved medicines.


How can access and availability be improved

  1. Faster access: Improving patient access in Europe will require a step change to processes, allowing patients to benefit from a medicine as soon as it is approved (Day 1 access). This would mean patients would have access to the latest treatments while national HTA value assessment and reimbursement processes take place, within an agreed 180-day time frame. Day 1 access could eliminate months or even years of delays while national pricing and reimbursement discussions are concluded.
  2. Improved availability requires an increase in spending on new medicines across the EU:
    Global R&D has been disproportionately paid for by the US for decades. Europe spends around 1% of GDP on pharmaceuticals compared with 2% in the US and 1.8% in China. A more balanced approach to pricing and a renewed focus on investment attractiveness are essential to improving Europe's attractiveness for new medicines research and reducing the significantly longer timeframe that patients in Europe wait for medicines.


Nathalie Moll, EFPIA Director General, said: "Europe has had medicines access problems for 25 years, and global pricing reforms are set to exacerbate these issues. It is unrealistic to expect greater investment in Europe and faster access to new treatments for Europeans if Member States also demand the lowest possible prices and the highest government clawback rates. We need to make a choice.”

(1) Geographical breakdown (by main markets) of sales of new medicines launched during the. Period 2020-2024, IQVIA (MIDAS April 2026).

Download the new reports


« Späť