欧洲障碍门户2026

Results from thefourthyear of data collection May2026Final report Executivesummary In April 2022, EFPIA and its members committed to a series of actions designed to reducedisparities in access across Europe.TheEuropean Access HurdlesPortal(the “Portal”) waslaunched then as an industry-led initiative toincreasetransparency regarding the root causes ofunavailabilityof innovative medicines in Europe—a key issue affecting patient access toinnovative medicines. It is intended to identifyand report onthemultifactorialroot causes ofdelays in pricing and reimbursement (P&R) filing or the reimbursement decision-making processfor European Union (EU) centrally approved medicinesin their first indication. This allows dataondelay and lack of availability to be put into context and thereby supports a sharedunderstanding oftheseroot causesandthecollective responsibility to address theseissues. ThePortal can be used to support a multi-stakeholder dialogue to devise solutions that can addressthese challenges holistically. This is thefourthreport using evidence from the Portal. The Portal now includes data collectedon medicines that received marketing authorisation in their first indication between January 2022and June 2025. The data continue to mature over each iteration of the Portal, allowing us tovalidate results from previous reports,undertake more granular analysisand begin to assesstrends in accessibility of innovative medicines over time. Transparency:There is a commitment to providing more transparency on the root causes ofunavailability and delay, with 100%participation fromEFPIA member companieswith eligibleproducts. As a result, the Portal now contains a total of 91products that were approved betweenJanuary 2022and June 2025in their first indication(representingnearlyone-half of all productsapproved by the European Medicines Agency (EMA) in this period).The Portalis similar in sizeto last year (reflecting that21 new products have been included in the database butthe firstcohorthas now been removed). Filing, availability and accessibility:As we gain more data in the Portal, the complexinteraction between filing, availability and accessibilityis becoming more apparent. There is adistinction between products being available (included in the national reimbursement list) andpatients having access to them.We find the following: •To understand if products are accessible to patients,we need to consider filing,availability(inclusion of a centrallyapproved medicine on the public reimbursement listin a country)andwhetherpatientshavethe possibility toaccess products through alternative access schemes (AAS).1On average across European countries, 69% ofproducts have either been filed for P&R(includingfiled andalreadyreimbursed)or madeaccessible to patients through anAAS. •Focusing on the formal price and reimbursement channel,taking an average acrossEuropean countries,61% of products have already been filed for P&R.Therefore, thePortal shows that in most instances of product unavailability, the products have beenfiled for reimbursement but have not yet been reimbursed. Looking at all products in thisperiod (which are onaverage 27months post-marketing authorisation(MA)), we find thefollowing: oOf filed products,53% have been reimbursed o41% are pending a reimbursement decision,and othe remaining6% have had a negative reimbursement decision or been withdrawnby the manufacturer •Given we havecollected data over a number of years, we can observe if delays andunavailability are changing over time.When comparing how rates of filing for P&R andaccessibility have changed over time for the41products included in the 2025Portalreport,2we find that there has been a14% increaseover the last year. This has beenprimarily driven by an increase in the proportion of products filed for P&R. •Although there are delays in P&R filing for some products across European countries,this is not a key driver of low availability of medicines in all countries. Across productsthat have been successfully reimbursed, 36% of the total time between MA andavailability can be attributed to the time between MA and P&R filing, while 64% isattributable to the time between P&R filing and P&R decisions at the country level. Variation across countries and the role of AAS:The percentage of products that have beenfiled for P&R or made accessible to patients through anAASvaries significantly across Europeanmarkets; the percentage is higher in larger markets than in smaller markets, particularly in CentralEastern Europe.In several smaller markets,such as Austria, Greece and Cyprus,a highproportion(over20%)ofproductshave been madeaccessiblethrough AAS. Root causes:The Portal also provides granular data on the reasons why products have not yetbeen filed for P&R across different countries. As set out in the CRA root causes analysis,evidence from the Portalcontinues tosupport that delays in both P&R filing and P&R decision-making are multifactorial. We find the