Coalition of European partners urgently needed to fix tenfold variation in access to medicines across the EU

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is today publishing a series of reports that paint the clearest picture yet about the availability of new medicines throughout Europe. The reports provide detailed information on delays and barriers to care, the root causes, and offer pragmatic recommendations to end Europe’s medicines lottery. 

EFPIA’s 2022 Patient WAIT Indicator tracks the availability of new medicines and length of time it takes patients to get them in 37 countries in the EU and EEA. Figures show that, on average, a new medicine will reach patients fastest in Germany in 128 days; this compares with 918 days in Romania and 1351 days in Malta, with a European average of 517 days. 

In Europe, the average rate of availability of medicines across all therapy areas has dropped to 47% - down 2% on last year’s figures. Disparities persist between Northern and Western Europe and Southern and Eastern Europe - with an 80% average variance in availability. 

Today’s reports include the first ever data set from the European Access Portal, an industry-led initiative to increase the visibility of the root causes of patients being unable to access new medicines. The portal allows monitoring of progress against the industry commitment, launched in spring 2022, to file for pricing and reimbursement in all member states within 2 years of marketing authorisation. The comprehensive data relates to 32 EU medicines belonging to EFPIA members approved between January 2021 and June 2022. 90% of eligible companies provided information on 82% of their new medicines. 

Of these, 56% had already filed for pricing and reimbursement in the first year of the commitment and 41% had been reimbursed; 59% are pending a decision – with figures expected to rise in the coming year. That six out of ten medicines have been filed for pricing and reimbursement in just 14 months demonstrates industry’s commitment to filing for pricing and reimbursement across the EU27 within two years, authors say.  

A clear picture is also emerging about the exact points of delay. For medicines that have completed the reimbursement process, early trends from the Portal suggest that about a quarter of the delays to patient availability are due to delays in company filing and the rest (75%) occur as the product goes through national pricing and reimbursement processes.  

The Portal data supports EFPIA’s Root Causes Analysis also published today and finds the reasons for delays in P&R filing and P&R decision making to be multi-factorial, with 10 root causes identified. The reasons vary between regions of Europe: delays in filing in Western Europe are largely due to the value assessment process and evidence requirements; delays in Eastern Europe are due to health system constraints and the corresponding impact on companies’ decision-making and resource allocation. This shows that there is no one-size-fits-all-solution to fix access issues, and regional or country-specific solutions are needed.  

The combined data provides irrefutable evidence that the approach set out in the pharmaceutical legislation - penalising companies by removing intellectual property rights if a medicine is not available in all Member States within two years of getting marketing authorisation will only damage innovation and not improve access, given that the vast majority of delays are out with the control of companies. Rather than improve access to medicines across Europe, the legislation will add unpredictability for companies and investors and will further disincentives research in the EU. 

What is abundantly clear from the series of reports published today is that a ten-fold difference in time to patient access and an 80% difference in availability across Europe is untenable. Industry is keen to play a pivotal role in improving access and committed in April 2022 to series of actions including: 

  • Filing for pricing and reimbursement applications in all EU countries no later than 2 years after EU market authorisation, provided that local systems allow it.  
  • The European Access Portal to improve visibility of medicines access across the EU.
  • A conceptual framework for Equity-Based Tiered Pricing (EBTP), to ensure that ability to pay across countries is considered in the prices of medicines. 
  • Novel payment and pricing models, to help payers to manage clinical uncertainty, budget impact and sustainability of healthcare systems. 

The data shows that that no one sector, organisation or legislation can address medicines access issues in isolation. To make real progress in providing equal access to treatments across Europe, a coalition of willing partners prepared to co-create evidence-based solutions is urgently required: EFPIA is asking its European partners to step up. 

Nathalie Moll, Director General, EFPIA, said: If we are serious about equal access to medicines and vaccines for all Europeans, we need all partners around the table, building a shared understanding of the issues, a joint commitment to resolving them and taking action now. 

Cancer patients facing delays of more than two years for new medicines in countries like Malta and Bulgaria do not have the luxury of waiting around for lengthy and unpredictable legislative developments that will ultimately make no difference to their treatment options. 

The draft legislation published this week is not only bad news for patients, but also damaging for companies operating in Europe. Absolving responsibility for delays to medicines from the very partners required to fix the problem simply means we will be having the same conversations about healthcare inequalities for years to come.”