Global discussions are ongoing on how to stimulate antibiotic research and development in order to provide patients with new antibiotics able to address the challenges of antimicrobial resistance. In this supplement, we present nine articles derived from the research performed as part of the Innovative Medicine Initiative-funded DRIVE-AB project and others. These publications provide new evidence and arguments in the debate around economic incentives to stimulate antibiotic innovation, including characteristics, implementation and governance.

Antibiotic research and development (R&D) has failed to produce innovative antibiotics in the past two decades, which is due to both scientific and economic factors. We reviewed national and international funding agencies and critically assessed current grant funding mechanisms. Finally, we propose four complementary grant-funding incentives aimed to help developers along the R&D pipeline. Equally important objective of these incentives is to address some of the known R&D risks and bottlenecks.

The medicalization model of poverty leads us to devote considerable resources to treating the healthcare problems caused by poverty while neglecting the root cause of those problems — the poverty itself. Treating symptoms rather than causes is far less effective than treating causes. When correctly understood, poverty is a major public health problem that needs to be addressed directly with effective anti-poverty programs. Only then can we properly serve the healthcare needs of the poor.

The incredible complexity of the United States health care system can be connected to three simple outcomes: access, affordability, and quality. We should measure our progress against these three measures. While historic progress on access was made through implementation of the Affordable Care Act, the next area of focus for more results across all three measures is delivery system reform.

The scope and severity of the opioid epidemic in the United States has prompted significant legislative intrusion into the patient-physician relationship. These proscriptive regulatory regimes mirror earlier legislation in other politically-charged domains like abortion and gun regulation. We draw on lessons from those contexts to argue that states should consider integrating their responses to the epidemic with existing medical regulatory structures, making physicians partners rather than adversaries in addressing this public health crisis.

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

The World Health Organization (WHO) has published a global priority list of antibiotic-resistant bacteria to guide research and development (R&D) of new antibiotics. Every pathogen on this list requires R&D activity, but some are more attractive for private sector investments, as evidenced by the current antibacterial pipeline. A “pipeline coordinator” is a governmental/non-profit organization that closely tracks the antibacterial pipeline and actively supports R&D across all priority pathogens employing new financing tools.

American society tends to medicalize or criminalize social problems. Criminal justice reformers have made arguments for a positive role in the relief of poverty that are similar to those aired in healthcare today. The consequences of criminalizing poverty caution against its continued medicalization.

Although the importance of including vulnerable populations in medical research is widely accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the language of informed consent is comprehensible to this group is no less of a challenge. Although a variety of interventions show promise for increasing the comprehensibility of informed consent and increasing a climate of exchange, consensus is lacking on which interventions should be used in which situations and current regulations provide little guidance. We argue that the notion of individual autonomy — a foundational principle of informed consent — may be too narrow for some vulnerable populations by virtue of its failure to acknowledge their unique histories and current circumstances. It has a different meaning for members of structured groups like American Indians than for unstructured groups, such as African Americans, whose complicated histories foster group identity. Ensuring broad participation in research and selecting appropriate methods for obtaining informed consent — namely, methods aligned with the source of vulnerability and level of risk — require new ways of thinking that might produce guidelines for matching informed consent models and processes with subpopulations.

The author, a health insurance industry leader and a prominent voice in the national reform debate, shares his perspective on attempts to transform health care over nearly a decade. He advocates for a bipartisan solution to stabilize the health insurance market in the near term, and for private sector innovation in partnership with government to create sustainable long-term change. He encourages ASLME members to continue to lend their expertise to the process of transformation.

Specialists and primary care physicians play an integral role in treating the twin epidemics of pain and addiction. But inadequate access to specialists causes much of the treatment burden to fall on primary physicians. This article chronicles the differences between treatment contexts for both pain and addiction — in the specialty and primary care contexts — and derives a series of reforms that would empower primary care physicians and better leverage specialists.