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The EU is offering some $13 million for advice on bringing to the market medicines that combat antimicrobial resistance—and there's only one month to claim the grant...and then nine to do the work.
The European Union is offering some $13 million for advice on bringing to the market medicines that combat antimicrobial resistance—and there is just a month to claim the grant, and then just nine months to do the work.
The formal title of the offer is “A study on bringing AMR medical countermeasures to market” and is intended as a rapid preparation to collect evidence and provide options for action. The EU defines medical-countermeasures (MCMs) as "regulated products that are used for medical diagnosis, treatment or prevention and can also be used in the event of a public health emergency. These products may include medicines (e.g., antibiotics, antivirals), biologic products (e.g., vaccines, blood products and antibodies) and devices (e.g., diagnostic tests, personal protective equipment, surgical-site medical devices)."
It's one of the first concrete tenders from the EU's new Health Emergency Preparedness and Response Authority (HERA), and the tasks involved include a technological review of the latest AMR medicines, medical devices and vaccines, a gap analysis and assessment of needs amongst the EU member states and key stakeholders, and a check on how useful EU support mechanisms are in bringing safe and effective products rapidly to market.
The driver for the initiative is the EU's vulnerability to viruses, as exposed by the Covid pandemic. "We must not allow other microbes to get to this stage," says the EU in its tender documents, warning that AMR is at "serious risk of reaching a tipping point" and leading to a Covid-like outbreak. Despite EU research and development support, "innovative new medical countermeasures obtaining regulatory approval and reaching the EU market remains limited," and the antimicrobials are victims of "the broken market economy".
The EU's (also new) pharmaceutical strategy "highlights the need for new business models and incentives to develop antimicrobials, with a pull incentive to be devised with member states that would couple funding of late-stage research on novel antimicrobials with public procurement of the successful developments."
The tenderer will have to propose a methodology for assessing the added value of a new MCM compared to existing ones. Areas of particular interest include novel diagnostics (e.g., point of care diagnostics, rapid tests, or screening tools) that can more rapidly, reliably, and cheaply distinguish whether and which antibiotics are required, determine resistance mechanisms or screen for carriage of key pathogens/resistance mechanisms. Vaccines and other alternatives with direct impact in reducing the need for use of antibiotics in both human and agricultural settings is also a priority ask. And countermeasures are also to be proposed to encourage novel or last line antibiotics to be used prudently, and to reduce inappropriate use of other antimicrobials—such as increasing narrow spectrum use and reducing the use of broad-spectrum antimicrobials in humans.
The chosen contractor will explore approaches used in different countries (e.g., US-BARDA) and provide a cost estimation for rolling-out different scenarios at EU level. Support structures will be considered (e.g., BARDA has multi-disciplinary teams that accompany supported projects). The chosen contractor is expected to summarize information available to date and propose appropriate methodologies/approaches for primary data collection and to formulate comprehensive conclusions.
The tender is being managed by (yet) another new EU health agency, known as HaDEA—the acronym for the European Health and Digital Executive Agency, launched in February this year as a management tool for the proliferating EU programs on health, research and digital transformation. I mention it here only to draw the distinction with HERA, whose role is to engage in actual research, rather than administration. If the pace of European innovation in health comes anywhere close to matching the pace of the announcement of new EU initiatives, everyone in this part of the world can look forward to living virtually forever, disease-free.