New data from two reports, published today by EFPIA, highlight the ongoing challenges of providing equal access to medicines for all Europeans.  

Part of EFPIA’s ongoing commitment to build data on access and availability of medicines in Europe, the Patients W.A.I.T. Indicator shows persistent, significant variation in access to new medicines between countries across the EU, while the CRA Report on the Root Causes of Unavailability and Delay to Innovative Medicines identifies the numerous interlinked reasons behind the delays and barriers that patients face.  

The W.A.I.T. Indicator provides a comprehensive analysis of 173 new medicines approved between 2020 and 2023. In 2024, using the EU average across 27 member states, the data show: 

• Less than half (46%) of centrally approved innovative medicines were available to patients – down from 48% in 2019.  
• Only 29% of medicines were fully available through public reimbursement, declining from 42% in 2019. 
• Additionally, 17% of medicines were only available with restrictions, increasing from 6% in 2019.

The average time from approval to patient access has now reached 578 days – more than a month longer than 2023.

There remain significant and enduring variations between countries; the fastest is Germany at 128 days, with Portuguese patients now facing the longest wait, at 840 days. Across all therapy areas, cancer, orphan medicines and combination therapies, the average wait time has increased. The average time to availability for oncology products continues to increase: 33 days slower than last year’s report and 66 days slower than the 2022 cohort.  

The CRA Report on root causes of unavailability and delays delves deeper into the underlying causes of these disparities, often due to a combination of factors. They include a slow regulatory process, late initiation of market access assessment, duplicative evidence requirements, reimbursement delays, and local formulary decisions. These factors are rooted in medicines access systems and processes in the EU member states and the corresponding impact on commercial decision-making. The report underlines that not only are the issues multi-faceted but that real solutions requires all parties around the table to cocreate solutions that work for patients.

Several concrete examples illustrate how these factors play out in practice. In Greece, companies can only file for reimbursement once a medicine is reimbursed in at least five of 11 designated EU countries, delaying filing due to the external reference pricing (ERP) system. This structural condition adds to other delays, including those linked to limited healthcare funding and launch decisions.  

Bulgaria follows a similar ERP approach: companies can only enter the Positive Drug List once the medicine is reimbursed in at least five of 17 designated EU countries. Additionally, a fixed annual schedule for updating the reimbursement list each January can mean that if a P&R decision is not finalised by December, reimbursement is automatically postponed by another year.

Regional fragmentation further complicates access: in Italy, for example, the average time to regional access following the national decision is 65 days, ranging from 1 to 773 days. Patients in northern regions usually have faster access to new medicines than those in southern regions. 

Beyond regulatory and administrative hurdles, limitations in health system infrastructure also play a significant role. Even after a medicine is reimbursed, patients may face barriers to use a new therapy due to insufficient diagnostic capacity, specialised personnel, or facility readiness – particularly in the case of highly specialised treatments such as advanced therapy medicinal products (ATMPs) or orphan medicines. 

Ensuring that medicines reach citizens regardless of where they live in Europe is a shared ambition and a shared responsibility. However, the lack of consensus on how best to achieve this means that patients in one European country can wait more than 7 times as long as patients in a neighbouring country for the same medicine. EFPIA is seeking to create partnerships to tackle these issues in the countries where patients face some of the most pressing access challenges. On the 14 May 2025, EFPIA will publish results from the European Access Hurdles Portal as well as a new report looking at the specific access issues faced by smaller countries.  

Nathalie Moll, EFPIA Director General, said:  

"The EFPIA W.A.I.T. indicators have been published for two decades, and in that time, across Europe, there has been a collective failure to move the needle for millions of patients. It has long been recognised that there is no one-size-fits-all solution and no one actor can fix the problem: It requires strong will, country-specific solutions and real alliance between EU policy makers, Member States and the pharmaceutical industry to cut red tape, reduce duplicative processes, and ensure swift and pragmatic pricing and reimbursement decisions that truly value and reward innovation.” 

Ends.

* Learn more about EFPIA's concrete proposals to improve patient access to innovative medicines. *