Background and policy context

The Pharmaceutical Strategy for Europe mentions that the Commission will engage with Member States to foster transparency of price information to help them take better pricing and reimbursement decisions. Prices and pricing decisions influence access to cost-effective and affordable medicines. The 2019 report on the Competition enforcement in the pharmaceutical sector (2009-2017) revealed that the distortion of the price competition in the Union can affect the functioning of internal market. Voluntary collaborations on pricing, like the EURIPID database, can support early identification and warning for such practices through exchanges of relevant information at Union level.

This action will contribute to the policy priority to implement the Pharmaceutical Strategy for Europe as it concerns the support of Member States in national pricing and reimbursement policies. It implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and of supporting innovation regarding such products (Article 3, point (c)) through the specific objectives defined in Article 4, points (c) and (h), of Regulation (EU) 2021/522

Objectives pursued

The scope of this action is to develop early warning mechanisms and guidance in the area of pricing through the EURIPID database, based on lessons from competition cases, in particular on excessive pricing.

Description of the activities to be funded under this topic

This action will create common approaches to verify claims on price information and to provide appropriate guidance to adjust pricing methodologies.

The activities will include the monitoring of strategic sequencing of price increases of threats to de-list reimbursable medicines or withdraw of medicines. These activities may prevent price increases based on unfounded claims to recover investments and increased costs.

Expected results and impact

This action will:

a) strengthen the cooperation between national authorities to address the challenges due to certain commercial practices;

b) extend the EURIPID database to develop warning features;

c) develop relevant and related technical guidance;

d) provide an updated guidance document on External Reference Pricing.

Specific mandatory deliverables and/or milestones

The activities will include the monitoring of strategic sequencing of price increases meant to game the External Reference Pricing system and monitoring.

The extension of the EURIPID database to develop warning features is meant to identify strategic price increases and threats to de-list or withdraw medicines. As part of the activities, it would be necessary to explore synergies with other databases to complement early warning information (like verification of shortages and/or market withdrawals).

The following deliverables should be included:

• Project Leaflet 1: A leaflet (1-2 pages maximum) to promote the project must be produced at the beginning of the project;
• Leaflet 2: A leaflet in A4 format (1-2 pages maximum) in a layman language (EN) to promote the output and the results of the project;
• Layman version of the Executive Summary of the Final Report: This is a short (maximum 10 pages) version of the final report, written for the interested public as a target group;
• Public Website Expanded Project’s website with the new features at https://www.euripid.eu;
• eLeaflets on country background information on national pricing and reimbursement policies;
• Notification feature on the updates of the list prices, price increases, updates on list of the products covered by their health insurance system etc;
• Webinars for the users to strengthen cooperation to address certain commercial practices and to implement the guidance on pricing methods and ERP;
• User guides: updated user guides information, standardisation manual;
• Fact sheets: analyses following the format ‘EURIPID quick check’ on specific products with data from the EURIPID database;
• Dissemination activities: meetings with EURIPID members and dedicated workshops with key stakeholders;
• Final report.

Specific action-level indicators for reporting purposes

Applicants shall collect data on the following specific action-level indicators in their regular reporting activities in case of award:

• Number of leaflets, factsheets, user guide and other communication materials disseminated
• Number of notifications received by type (e.g. list prices, price increases, updates on list of the products covered by their health insurance system, etc)
• Number of webinar and workshops and other dissemination activities organised
• Number of participants to the webinar and workshop
• Satisfaction rate of participants to the webinar and workshop
• Number of additional warning integrated in the database
• Number of countries uptaking ERP guidance document in their national processes
• Number of countries declaring that Euripid has impacted their national pricing and reimbursement system of medicines
• Number of countries providing information (on prices and reimbursement products; on sales data; on MEAs)

The applicants are required to include in their proposals additional specific action-level indicators which will be agreed with the Commission during the grant agreement preparation.

The Commission may require the awardees to collect data for additional specific action-level indicators, where needed to complement the above indicators.