EFPIA also publishes first report aimed specifically as a catalyst for action to tackle inequalities faced by smaller countries.   

EFPIA has today published new data from two reports, which provide granular detail about why new medicines are available in some countries but not in others.  

The third European Access Hurdles Portal report is part of an industry-led initiative to increase visibility regarding the root causes of unavailability of innovative medicines in Europe.  

With 100% participation from EFPIA members and covering 94 medicines approved between January 2021 and June 2024, the data clearly shows that that the majority of delays (69%) occur after companies have filed and are awaiting a decision from a Member State. 

On average, companies filed for pricing and reimbursement in 16 out of 27 Members States. In the remaining cases, the primary reasons for not filing were a lack of health system infrastructure, economic viability or issues with the pricing and reimbursement processes and value assessments, the vast majority of which are outside of the company’s control. 

The WAIT indicator report published last week by EFPIA, highlighted the significant variations in access, with some patients waiting 7 times longer than others to receive a new medicine.  The core purpose of the portal is to help identify and co-create pragmatic, evidence-based solutions that reduce the disparities faced by patients across Europe. 

Nathalie Moll, Director General, EFPIA, said  

“We now have three years of compelling data that clearly demonstrates the systematic barriers preventing new medicines from reaching patients – and how the solutions lie with health systems, governments and industry working together.  

Blinkered legislative proposals like obligating companies to launch and continuously supply products in all Member States would fail entirely to address the real, evidence-based root causes of delays, not improving access to medicines while at the same time, proving to be highly damaging to the sector’s presence in the EU. It takes two to launch, we cannot solve such a complex issue with a one-size-fits-all approach in the legislation.” 

The second report published today, "The root causes of unavailability and delay to innovative medicines in smaller EU markets" looks specifically at the challenges faced by smaller countries.  Smaller countries often experience the longest delays and the fewest medicine launches, with average wait times exceeding 550 days and filing rates as low as 9%.   

Recognising the pressing need to take action to improve access in these countries, the analysis focuses on nine countries: seven EU countries that follow the EU regulatory process (Croatia, Cyprus, Estonia, Latvia, Lithuania, Malta, and Slovenia) and two non-EU countries with their own national systems (Montenegro and North Macedonia). All have populations under 4 million and below-average levels of medicine availability.   

Key challenges include long and unpredictable approval timelines, limited regulatory capacity, budget constraints, and inadequate infrastructure — particularly for cancer and rare diseases. The report shows several country specific dynamics and conditions which directly impact the time it takes for medicines to become available:   

Malta: The Maltese P&R system is under-resourced, leading to delays in decision making, budgetary constraints see specific therapy areas prioritised for procurement. There is a significant lack of transparency as to a product's status after filing, and a significant backlog which discourages filing. Tenders are largely single winner, price only and lasting 3-4 year, meaning innovative medicines can be frozen out of the public reimbursement market. 

Cyprus: A major barrier is the country’s reliance on Greece as a reference market for pricing. Since Greece faces delays in reimbursement due to its own external reference reimbursement requirements [1], Cyprus cannot finalise prices until Greece has done so — creating indirect but significant delays for patients.  

Croatia: While pricing decisions are generally made within 30 days, reimbursement can take anywhere from six months to three years. Low transparency, minimal communication with manufacturers, and inconsistent application of assessment criteria all contribute to delayed access and discourage new submissions.  

Different situations require different approaches in a collaborative manner. EFPIA is actively engaging with these countries to explore practical, tailored solutions. The findings in this report provide a solid foundation for strategic dialogue aimed at improving access for patients in smaller European markets.  

Nathalie Moll, EFPIA Director General, said:  

"It’s clear that smaller countries face some of the biggest challenges: The publication of the small markets report can help stimulate conversations in those countries and help us find tailored solutions for patients. We must address the underlying structural, procedural, and economic barriers if we are to achieve timely and equal access to medicines."

Notes to editors  

The reports follow back up the findings of two separate reports launched on May 7. EFPIA’s WAIT Indicators and the CRA Root Causes. Taken together these reports provide full transparency on the availability of medicines in Europe.   

References:

1. 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. See EFPIA Patients W.A.I.T. Indicator 2025.