references
STRATEGY
GARD: A new partnership to fill critical gaps in antibiotic R&D
“Antimicrobial resistance threatens the very core of modern medicine and the sustainability
of an effective, global public health response to the enduring threat from infectious diseases. Without harmonized and immediate action on a global scale, the world is heading towards a post-antibiotic era in which common infections could once again kill.”
Global Action Plan on Antimicrobial Resistance, World Health Organization, 2015
A joint initiative by WHO and DNDi, the vision of the Global Antibiotic Research and Development (GARD) Partnership is to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all, with a focus on global health needs. The initiative ties in with the Global Action Plan on Antimicrobial Resistance adopted in 2015, which required the WHO Secretariat to propose options for the establishment of new partnerships to identify priorities for new treatments, diagnostics, and vaccines to fight resistant pathogens. In November 2015, WHO and DNDi jointly organized a technical consultation that reaffirmed the initiative, with participants from pharmaceutical and biotechnology companies, other product development partnerships, academia, civil society, and health authorities from countries of all income levels, including Brazil, Canada, Chile, China, Egypt, India, Japan, Malaysia, Qatar, South Africa, Thailand, the US, Zambia, and seven European countries and the European Commission. In December 2015, the DNDi Board of Directors approved the hosting of the incubation of the GARD Partnership, which was formally launched in May 2016. New incentive mechanisms A critical issue is the failure of current incentive mechanisms to replenish the empty antibiotic R&D pipeline. GARD will provide an important alternative to the traditional market-driven approach, by focusing on products that the pharmaceutical industry has not and will not develop for lack of profitability. To overcome this hurdle, alternative business models and incentives need to be tested, including ‘delinkage’ of the cost of R&D from volume-based sales and price of treatments. Learning from DNDi’s experience of the partnership model for product development in the field
of neglected diseases, GARD will test new incentive mechanisms that stimulate R&D but also contribute to responsible use, while facilitating equitable access to new antibiotic treatments. Political and financial support from governments At the time of its launch, GARD secured seed funding commitments from the Federal Ministry of Health of Germany, the Netherlands’ Ministry of Health Welfare and Sports, the South African Medical Research Council, and the United Kingdom Department for International Development as well as from Médecins Sans Frontières, totalling over EUR 2 million of the projected EUR 3 million required for the incubation phase. Hosted by DNDi, the GARD team is responsible for building the scientific strategy and a product pipeline, developing the GARD business plan, setting up a scientific working group and steering committee, and establishing the operational structure. GARD’s governance is de facto embedded into DNDi’s during this start-up phase. WHO will provide support in priority setting, stewardship, and access; report back to its Member States; secure close collaboration with the AMR Secretariat, relevant WHO departments, the Essential Medicines List team, and the Global Health R&D Observatory; and provide other technical input where needed.
Staphylococcus Aureus bacteria culture.
DNDi Annual Report 2015 › 9
