Bringing AMR medical countermeasures to the market – new study

HERA plays an important role in bringing medical countermeasures to the market in the fight against Antimicrobial Resistance (AMR), as outlined in a new study published by HaDEA.

Findings and results indicated that stakeholders expect HERA to play the following roles:

• Coordinate and support the implementation of pull incentives
• Improve coordination and contribute to financial push incentives
• Ensure coordination, knowledge sharing and provision of non-financial support, including

the dissemination of best practices and capacity building for Member States.

One of the core deliverables of the study is a pre-feasibility assessment for the implementation of EU multi-country pull incentives for the development and access to antimicrobials.

Pull incentives encompass all the measures that reward R&D by increasing future revenue expectations; their primary aim is to make the completion of antimicrobial R&D projects financially attractive, and thereby help tackle market failures for antimicrobials. The four schemes assessed in the study are: revenue guarantee, market entry rewards combined with revenue guarantee, lump-sum market entry rewards and milestone payments.

Next Steps

The study will help HERA to prepare for the drafting of the upcoming action “Support innovation and access to antimicrobials” under the work programme EU4Health 2023. This €22 million action will support the implementation of the chosen scheme through (i) the establishment of a network supporting HERA for preparation and implementation of procurement(s) of medical countermeasures or reservation contracts; and (ii) the purchase of reserve capacities for antimicrobials.

The network to be implemented under the present call should support the Commission and Member States to pool resources, take collaborative actions, and financially contribute to the implementation of EU multi-country pull incentives based on procurement mechanisms.

The network should be established for three years and provide analyses, recommendations and other information to the Commission and Member States representatives through the HERA Board, as well as prepare the concrete implementation of the proposed schemes, including, where needed, procurement documents and template contracts.

Background

The coming years will be of high importance to ensure global awareness and preparedness for the fight against AMR. It is estimated that between 3.62 to 6.57 million deaths associated with antibiotic resistant bacteria in 2019, including 1.27 million deaths directly attributable. In the EU, AMR is associated to more than 35 000 deaths annually according to ECDC.

Despite this public health threat, the number of Medical Countermeasures (MCMs) available on the market is insufficient. Consequently, HERA has included AMR in its top 3 priority threats and aims to support the development of and access to preventive, diagnostic and therapeutic medical countermeasures against AMR (AMR MCM).

The need for innovative approaches at EU level for supporting research, development and public procurement of antimicrobials to address the issue of antimicrobial resistance was already mentioned in the 2020 Pharmaceutical Strategy for Europe.

On 26 April 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation, as well as a proposal for a Council Recommendation to step up the fight against AMR.

As stated in the communication on this reform, the EU needs both push incentives (i.e. funding for antimicrobial research and innovation, primarily via research grants and partnerships) and pull incentives (both regulatory and financial) to reward successful development and secure access to effective antimicrobials. The Commission is proposing two types of pull incentives:

• Temporary mechanism consisting of transferable data exclusivity vouchers, for the development of novel antimicrobials to be granted and used under strict conditions.
• Procurement mechanisms for access to new and existing antimicrobials that would guarantee revenue for antimicrobials marketing authorisation holders, regardless of sales volumes.

The HERA study identified and analysed options for implementing this second type of pull incentives, in complementary manner to the transferable exclusivity extension vouchers proposed in the EU pharma legislation.

These actions will help to bring more AMR MCMs to market through incentivising the R&D pipeline, and ensuring accessibility once launched with a specific focus on antimicrobial treatments for bacterial infection.