Ever-evolving bacteria have left doctors desperate for new drugs, and a new report commissioned by the government of the United Kingdom lays out a plan for how to get them: Global governments should unite to offer multibillion-dollar incentives for drug developers, and pharmaceutical companies should pool their billions in support of early-stage research. The analysis—the third in a series from a commission established by U.K. Prime Minister David Cameron and chaired by former Goldman Sachs economist Jim O’Neill—is the most specific and prescriptive yet, laying out what it calls “a bold set of interventions” to get new drugs to market.
The problem of antimicrobial resistance has received a global spotlight lately as cases of highly resistant infections mount. The White House rolled out a new antibiotic resistance budget initiative in January, following the creation of an interagency task force last year.
Unfortunately, the development of new drugs has stalled, partially for economic reasons: New therapies are costly and risky to develop, but when they reach the market, they compete with cheap generic drugs that doctors prefer to use for all but the more dire resistant infections. The new report starts with the premise that the world needs 15 new antibiotics per decade, at least four of which should have new mechanisms of action to target the most harmful pathogens, such as Klebsiella pneumoniae and Escherichia coli.
As a “pump-priming” measure, the report suggests a $2 billion “global innovation fund,” bankrolled by pharmaceutical companies, to conduct fundamental research on bacterial resistance, improve diagnostics to identify resistant strains, and revisit old antibiotics the development of which has stalled.
To incentivize drug development without encouraging overuse, the report promotes an idea gaining popularity in antibiotics: “de-linking” a drugmaker’s profits from the drug’s sales. Such strategies aim to give companies assurance that they will make money if they bring valuable new antibiotics to market, regardless of the number of pills prescribed right away. The report suggests two strategies: A “designated global body” could buy the rights to a drug from a pharmaceutical company—for a suggested $2 billion to $3 billion per antibiotic—and carefully control its supply. Or, a company would retain the rights to sell its drug, but receive an additional lump sum reward—a suggested $1 billion to $1.3 billion—for introducing it.
“This is a happy moment,” wrote Boston University health law professor Kevin Outterson in a blog post in response to the report. Outterson, who has long promoted de-linkage, says its publication “marks a watershed event as an authoritative endorsement of the principle.”
Meanwhile, a public-private partnership between the European Union and the European pharmaceutical industry is already exploring how to implement de-linkage strategies through a project called “driving reinvestment in research and development and responsible antibiotic use” (DRIVE-AB), which held its first meeting in October.