Only 46% of innovative medicines approved centrally in the period 2020-2023 (173 in total) were found to be available to European patients in 2024, according to data from the latest Patients W.A.I.T. Indicator report published by EFPIA. This figure is slightly lower than the previous survey (48%), which dates back to 2019. Much more pronounced than the same comparison period is the gap in medicines fully available under public reimbursement, which stood at 29% in 2004 vs 42% in 2019. On the other hand, the number of medicines available with restrictions increased from 6% in 2019 to 17% last year.
‘The EFPIA W.A.I.T. indicators have been published for more than two decades, and during this period there has been a collective failure across Europe to tip the balance for millions of patients,’said Nathalie Moll, Director General of EFPIA. It has long been recognised that there is no one-size-fits-all solution and that no single actor can solve the problem: strong will, country-specific solutions and a true alliance between EU policymakers, Member States and the pharmaceutical industry are needed to streamline bureaucracy, reduce duplication and ensure swift and pragmatic decisions on pricing and reimbursement that truly value and reward innovation‘.
Some more data on access to innovative medicines
The Patients W.A.I.T. Indicator study, conducted by Iqvia on behalf of EFPIA, was first published in 2004 and this year examined 36 different European countries.
The data showed an increase of about one month in the time needed to make innovative medicines available to European patients, from 531 days in the 2023 report to 578 in the latest release. High disparities in access (87%) between different European countries were also confirmed. From this point of view, Germany has the shortest time (128 days), while at the other end of the scale is Portugal (840 days). Significantly, the waiting time for access to cancer treatments also continues to increase, rising by 33 days since the last edition of the report.
The causes of unavailability
EFPIA has also published a second report, prepared by Charles River Associates, which explores the causes of the unavailability of innovative medicines in European countries, complementing the Patients W.A.I.T. Indicator.
There is no single cause at the root of the problem, but rather a mix of factors that can come into play at different points in the authorisation process. These include, for example, possible regulatory issues that slow down the MA granting process, delays in health technology assessment decisions or in price and reimbursement negotiations. Duplicate requests for evidence and the need to include products in different local formularies are other possible factors causing delays. These factors are particularly relevant in Italy, given the fragmentation of regional healthcare systems, which, according to the report, results in an average delay in access of 65 days (min 1 day – max 773 days) compared to the timing of decisions at national level.
Other points raised by the EFPIA document concern possible infrastructural difficulties in accessing new medicines, for example due to insufficient diagnostic capacity or staff specialisation, particularly for more complex products such as orphan medicines or advanced therapies.