In the 2021 Queen’s Speech, the UK government announced its program to establish an Advanced Research and Invention Agency (“ARIA”), which will fund high-risk, high-reward research and development. On February 24, 2022, the bill to create the ARIA received Royal Assent and became law.1 Similarly, the European Commission recently launched the European Health Emergency Preparedness and Response Authority (“HERA”).2The Biomedical Advanced Research and Development Authority (“BARDA”) in the United States performs a similar function for both entities and can provide a useful framework for ARIA and HERA as they get started. This Customer Alert discusses the proposed role of ARIA and HERA in drug development and compares ARIA, HERA and BARDA.
UK Agency for Advanced Research and Invention (“ARIA”)
By creating ARIA, the British government is trying to “consolidate the UK’s position as a scientific superpower”.3The government plans to invest £14.6 billion in research and development (‘R&D’) in ARIA’s first year, with a view to meeting the government’s target of spending 2.4% of R&D GDP across the UK economy by 2027.
ARIA aims to “focus exclusively on projects that have the potential to produce transformative technological change”. The agency will have autonomy over its own research and choice of projects, and it will recruit researchers from the public and private spheres. ARIA will tolerate a high level of failure to encourage investment in high-stakes, high-reward research areas. It will work throughout the R&D life cycle. The agency’s funding approaches will include incentive prizes, hybrid grants/prizes, seed grants, equity investments, attraction of private co-funding, and academic and entrepreneurial scholarships.
European Health Emergency Preparedness and Response Authority (“HERA”)
On September 16, 2021, the European Commission launched HERA, an internal service within the European Commission, aimed at preventing, detecting and rapidly responding to health emergencies. Inspired by BARDA, the main objective of HERA is to ensure that medicines, vaccines and other medical countermeasures are rapidly developed, manufactured and made available to EU citizens. By working closely with European and national partners, HERA aims to fill a gap in the European Union’s health emergency response and preparedness. HERA will focus on threat assessment, research and innovation support, responding to market changes and building industrial capacity. Its total budget is 6 billion euros over the next six years.
The development of ARIA and HERA by the UK and EU suggests that these key jurisdictions intend to better prepare for the next public emergency, rather than react to issues as they arise. they arise, which was often their approach to the coronavirus pandemic.
U.S. Biomedical Advanced Research and Development Authority (“BARDA”)
Established in 2006, BARDA is a U.S. government department that prepares and maintains an integrated system of medical countermeasures for known, unknown, re-emerging, and new types of public health emergencies.4 Some consider BARDA to be the “biomedical DARPA”. DARPA is the Defense Advanced Research Projects Agency, housed within the US Department of Defense; BARDA is a similar agency, but with the directive to procure and develop countermeasures against bioterrorism, pandemics, and emerging diseases. A UK government guidance document published on March 19, 2021 highlights many similarities between DARPA and ARIA.5 Along the same lines, BARDA and ARIA are also analogous in many ways.
BARDA offers an integrated and systematic approach to the development of vaccines, drugs, therapies and diagnostic tools needed for public health medical emergencies. It does not fund basic science research. BARDA instead focuses on the following program areas: chemical, biological, radiological and nuclear accidents, incidents and attacks; antimicrobial resistance; pandemic influenza and emerging infectious diseases. BARDA relies on public-private partnerships to drive innovation, collaborating with private partners to develop promising technologies. In response to COVID-19, BARDA has entered into a series of expanded public-private partnerships to develop medical countermeasures and has established a single entry point for product developers to submit their research on these COVID-19 countermeasures. 19.
President Biden has also proposed the creation of a biomedical research agency called the Advanced Research Projects Agency for Health (“ARPA-H”) within the National Institutes of Health. Unlike BARDA, which focuses on public health emergencies, ARPA-H would fund research into non-communicable diseases, such as Alzheimer’s disease, diabetes and cancer.
BARDA’s impact and lessons learned
BARDA is the only national agency that actively targets and funds late-stage development of high-risk medical countermeasures. The agency’s funding bridges the “valley of death” – the high costs characterizing the later stages of product development and clinical trials.6The US Congress has granted $6.5 billion in additional COVID-19 funding to BARDA for the development of vaccines and countermeasures under Operation Warp Speed. This funding has led to the development of several effective vaccines: Johnson & Johnson, AstraZeneca, Pfizer-BioNTech and Moderna.
On the other hand, BARDA is not without its critics. BARDA ensures that certain requirements are included in the terms and conditions for funding grants, contracts and cooperative agreements; some see it as an obstacle to progress.
Further fueling its critics, BARDA has also faced longstanding management issues since its inception in 2006. Additionally, a 2018 whistleblower complaint alleged that funds intended for vaccine development had been misappropriated for the removal of office furniture and administrative expenses.7 A May 2020 report, released by the Office of Special Counsel, found that the Department of Health and Human Services diverted millions of dollars intended for BARDA to other government activities and failed to inform Congress. .8 As the UK and EU governments move forward with the development of ARIA and HERA, they may want to keep in mind the successes and failures of BARDA, as well as the possibility of funds being misappropriated.
The fate of ARIA and HERA remains to be determined, but the two entities could soon pave the way for biomedical breakthroughs. If the COVID-19 pandemic is any indication, preparing for global biomedical threats will remain a key priority shared by the UK, EU, US and the international community, and there is much to be gained by encouraging innovation in emerging biomedical fields. research areas.
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