EFPIA’s annual WAIT Indicator provides analysis of 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 the same medicines (International Reference Pricing). 

Overview of 2026 WAIT indicator  

This year’s data provides 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 country.

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, now restrictions are 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 to accessing new medicines are multifactorial, ranging from the speed of regulatory processes to misalignment on evidence requirements to insufficient budgets in Member States. Industry continues to stress that these barriers can be addressed through collaborative work between 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 suggests a declining trend in the number of FDA approved medicines that are subsequently approved by the EMA, with a particularly steeply drop since October 2025.

Over the coming months, the tracker is expected to provide analysis on the impact of the US Most Favoured Nation Policy (MFN) on countries around the world. While 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 Europe¹) would all negatively impact Europe’s patient access disparities. If trends persist, China will soon surpass 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 getting access to the latest treatments while national HTA value assessment and reimbursement processes take place - within an agreed time frame of 180 days. Day 1 access could remove months, or even years of delays waiting for national pricing and reimbursement discussion to be concluded. 
2. Improved availability requires an increased in spending on new medicines across the EU: Global R&D has been disproportionality 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 is essential to improving Europe attractiveness for new medicines research and reduce 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 into Europe and faster access to new treatments for Europeans if Member States also demand the lowest possible prices and highest government clawback rates. We need to make a choice.”  

Ends 

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

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