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.”