New data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) reveals multiple factors leading to unequal medicine access across Europe. On average, European patients wait 531 days for access, with disparities ranging from 126 days in Germany to 804 days in Poland. This discrepancy highlights the urgent need for a more equitable distribution of healthcare resources. The EFPIA reports highlight the significant delays and barriers European patients face in accessing new medicines. Ensuring equal medicine access across Europe is not only a shared goal but also a shared responsibility. However, patients in some countries wait over six times longer than those in neighboring countries, a situation that demands immediate attention and action.
Several factors contribute to these delays. Slow regulatory processes can lengthen the time it takes for new medicines to reach patients even before approval in Europe. Additionally, varying speeds of health technology assessments, different reimbursement processes, and regional decision-making layers add to the delays. Inconsistent evidence requirements also cause delays or lack of availability, with different countries and payers demanding varying endpoints or types of evidence. The use of external reference pricing (ERP) further complicates access. Many countries wait for reimbursement decisions from other European countries before starting their national pricing and reimbursement processes.
This practice delays the availability of new medicines to patients who need them the most. The European Access Hurdles Portal offers detailed insights into these delays, covering 66 medicines authorized between January 2021 and June 2023. The Patient W.A.I.T. Indicator tracks the time from EU marketing authorization to reimbursement in the Member States. The Portal reveals that 71% of the delay occurs after filing for pricing and reimbursement (P&R), with the remaining 29% happening before filing. This data highlights the need for streamlined processes to reduce delays.
Portal Highlights Regional Disparities in Medicine Access Across Europe
The Portal also identifies issues across various categories: health system infrastructure, economic viability, P&R process, and value assessment. Delays in Western Europe are mainly due to value assessment processes and evidence requirements, while in Eastern and Southern Europe, health system constraints and economic viability issues for manufacturers cause significant delays. In countries with low filing rates for P&R, such as Greece, Latvia, Lithuania, Cyprus, and Malta, specific challenges arise. For instance, Greece requires medicines to be reimbursed in at least five of 11 Western European countries before being considered for HTA, contributing to low filing rates. This regulatory hurdle further delays patient access to necessary treatments.
The Portal provides a detailed analysis of regional disparities in medicine access. In Western Europe, delays are largely due to the value assessment process and evidence requirements, whereas in Eastern and Southern Europe, the primary issues are health system constraints and economic viability. These disparities highlight the need for tailored solutions that address the specific challenges faced by different regions. Moreover, the granularity of the information demonstrates the value of the Portal in increasing transparency regarding the root causes of delays. By understanding these root causes, stakeholders can move towards pragmatic solutions that work for patients and help address Europe’s health inequalities.
EFPIA’s Nathalie Moll Highlights Industry Commitment to Reducing Medicine Access Delays
Nathalie Moll, representing EFPIA, emphasized the industry’s commitment to addressing medicine access issues. Every EFPIA member submitted data on all medicines launched during the reporting period, reflecting a collective effort to understand and overcome access barriers. This level of engagement underscores the industry’s dedication to finding solutions that benefit patients across Europe. The EFPIA’s efforts are geared towards building an evidence-based, shared understanding of barriers and delays to medicine access. This comprehensive approach aims to facilitate collaborative solutions that address the long-standing issues affecting patient new medicine access.
Addressing access issues requires collaboration among multiple actors, including Member States. The EFPIA report suggests that solving these problems goes beyond EU innovation legislation and calls for targeted actions to reduce the time it takes for patients to access new medicines.
Nathalie Moll concluded that the reasons behind access delays are multifactorial and vary across countries and therapy areas. The EFPIA stands ready to play its part in reducing these delays and ensuring equitable medicine access to innovative medicines for all European patients. By working together, stakeholders can make significant progress in reducing health disparities and improving patient outcomes.
Resource: European Federation of Pharmaceutical Industries and Associations, June 12, 2024
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