New research-based pharmaceutical industry proposals set to reduce inequalities in patient access to medicines across Europe

BRUSSELS, April 10, 2022–(BUSINESS WIRE)–Europe’s pharmaceutical industry is stepping up action to help deliver faster and fairer access to medicines for millions of patients across the EU.

The new commitment of member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA) is expected to significantly increase the availability of innovative medicines in EU countries and decrease the time patients have to wait for new drugs by several months.

From today, EFPIA member companies commit to filing a pricing and reimbursement request in all EU countries as soon as possible and no later than 2 years after marketing authorization. in the central EU market, provided that local systems allow it. The pledge is designed to help provide faster and fairer access to medicines for patients across Europe.

Published data by the EFPIA last week showed that disparities in the time needed for patients to access new medicines in different EU Member States are widening. German patients wait about 133 days to access new drugs, compared to 899 days for Romanian patients. Significant disparities have also occurred in terms of the availability of innovative medicines, as less than 30% of centrally approved products are available in the smaller and Eastern European Member States, compared to 92% in Germany and 46 % on average in the European Union.

Modeling by IQVIA predicts that file commitment would increase drug availability from 18% to 64% in several countries depending on the country’s resource payer for assessing the increased number of claims. Critically, the modeling also estimates that the commitment would reduce patient waiting time for new medicines by 4-5 months in several countries such as Bulgaria (-179 days), Poland (-129 days) and Romania (-155 days).

However, the time that elapses between obtaining marketing authorization and companies filing for pricing and reimbursement in a country is only part of the story. According to analysis by Charles River Associates, there are 10 interrelated factors that hinder and delay patient access to new medicines. These causes are rooted in Member States’ access systems and processes and their corresponding impact on business decision-making.

That’s why the commitment to file is supported by the launch of an online portal where Marketing Authorization Holders can provide timely information regarding the timing and processing of pricing and reimbursement applications in EU-27 countries. Greater transparency on obstacles and delays in access will facilitate the search for solutions in partnership. Further details of the Undertaking to File and the online portal are included in Tackling patient inequalities in Europeposition paper published today by the EFPIA.

In addition to a fairer system for patients, EFPIA is opening discussions on a fairer system for EU Member States where the price of innovative medicines may vary between countries depending on their economic level and their ability to pay. Also released today is a discussion paper titled ‘A shared approach to support equity-based tiered pricing” defines the main features of a differentiated charging system based on fairness, anchored in the principle of solidarity between Member States and enshrined in the EU Treaties. To put in place a fairer and equity-based system, the Commission and Member States need to change external reference price systems and put in place mechanisms to prevent unintended consequences of internal trade in medicines.

Speaking about the launch of the new commitments, EFPIA Chief Executive Nathalie Moll said. “By reducing the time it takes to apply for pricing and reimbursement in all 27 EU Member States, providing greater transparency on barriers and timeframes to access, co-creating a system of equity-based pricing, by adopting an effective system of EU relative efficiency assessments and by sharing information on the implementation of new pricing mechanisms, we believe that together we can create change radical change in the patient access landscape across Europe.

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Melanie Wahl, Acumen Public Affairs
[email protected]
+32 492 288717

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