![]() ![]() 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.Īs stated in the communication on this reform, the EU needs both push incentives (i.e. 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. 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). In the EU, AMR is associated to more than 35 000 deaths annually according to ECDC.ĭespite this public health threat, the number of Medical Countermeasures (MCMs) available on the market is insufficient. 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. The coming years will be of high importance to ensure global awareness and preparedness for the fight against AMR. 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. 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. 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 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. 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. 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. 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. The dissemination of best practices and capacity building for Member States. Ensure coordination, knowledge sharing and provision of non-financial support, including.Improve coordination and contribute to financial push incentives.Coordinate and support the implementation of pull incentives.HERA was launched as a new European Commission Directorate-General on 16 September 2021.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.įindings and results indicated that stakeholders expect HERA to play the following roles: HERA is a key pillar of the European Health Union announced by President von der Leyen in her 2021 State of the Union address and will fill a gap in the EU's health emergency response and preparedness. When an emergency hits, HERA will ensure the development, production and distribution of medicines, vaccines and other medical countermeasures – such as gloves and masks – that were often lacking during the first phase of the response to the COVID-19 pandemic. HERA, created in the aftermath of the COVID-19 pandemic, will anticipate threats and potential health crises, through intelligence gathering and building the necessary response capacities. The Health Emergency Preparedness and Response (HERA) department’s mission is to prevent, detect, and rapidly respond to health emergencies. ![]()
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