POLICY & ADVOCACY
New medicines to treat antimicrobial resistant infections that are critical to our national health are in short supply. To address this crisis, we need to create a sustainable ecosystem and marketplace for antimicrobial R&D. And to achieve this, we must change the way antibiotics are prescribed, accessed, consumed, monitored and paid for. This will involve leadership and collaboration from private industry working alongside government and academia to focus on solving complex problems through a comprehensive set of policy solutions.
The inadequacy of the pipeline for new antimicrobial products has two main causes. First, development of new and novel products to treat AMR infections is very scientifically challenging and significantly risky. Second, the market for new antimicrobial products is generally not commercially attractive due to several important factors. First, stewardship programs seek to limit the use of novel products to appropriate patients, therefore limiting uptake. Second, demonstrating clinical superiority is challenging due to ethical and practical issues in clinical trials, limiting the ability of manufacturers to charge prices reflective of value. And third, bundled payment systems for inpatient services drive hospital use of low-cost generics which may not be clinically appropriate. These problems are exacerbated by a lack of point-of-care diagnostic tools and clinical guidelines.
Policymakers must support the development of new antimicrobial products by creating strong financial market incentives that will create a return on investment that is competitive enough to create a sustainable product pipeline and commercial market. Numerous independent reports and economic models have concluded that incentive mechanisms of between $1 billion and $3 billion would be impactful. Incentive policies must be paired with policies that address stewardship and surveillance, stabilize the current market through payment and reimbursement reforms, and address barriers that prevent patients from getting access to the appropriate medicines.
Everyone can make a difference – from patients taking their full course of their medicines, to physicians using diagnostics and following clinical guidelines, to insurers providing access to clinically appropriate medicines without barriers, to policy makers helping to shape the environment for new medicines so researchers can continue their efforts to discover new antimicrobial medicines.