MedCity Influencers

The Antibiotics Exist —The System Cannot Deliver Them

This is not a discovery problem. It is a market entry and access problem, and it is far more tractable than the pipeline crisis we spend most of our attention on.

The dominant story about antimicrobial resistance is a story about scarcity. We are told there are not enough new antibiotics, that the pipeline is broken, that the economics of antibiotic development have collapsed. All of this is true, and all of it is well documented. Pull incentives, subscription models, and the PASTEUR Act have absorbed most of the policy oxygen for a decade.

But there is a second failure, quieter and less examined, that kills people even when the science has already succeeded. Existing treatments, approved somewhere, sit on a shelf in one country, and routinely cannot reach a patient dying of a resistant infection in another. This is not a discovery problem. It is a market entry and access problem, and it is far more tractable than the pipeline crisis we spend most of our attention on.

Consider what actually happens between a working therapy and a patient who needs it. A drug or a phage preparation may be authorized in one jurisdiction and unavailable in the next. Regulatory pathways are fragmented and rarely recognize one another. There is often no pricing precedent for a novel antimicrobial, so payers have no reference point and procurement stalls. Emergency import mechanisms exist on paper but move on timelines measured in weeks, while a resistant bloodstream infection progresses in days. Each of these barriers is individually surmountable. Together, they turn a solvable clinical situation into a fatal delay.

One of us has spent a career inside that gap, after losing a daughter to a pan-resistant infection when the systems meant to reach an alternative therapy in time could not move fast enough. That experience is not an argument; it is a data point that thousands of families could supply. It reframes the question. The urgent issue is not only whether we can make new antimicrobials. It is whether the infrastructure exists to deliver the ones we already have, to the specific patient, in the specific market, within the window that matters.

The other of us has spent more than a decade in global health, working inside multilateral agencies on precisely the machinery that governs whether an approved product reaches the people it was made for. The pattern is consistent across therapeutic areas and across income levels. The binding constraint is rarely the molecule. It is the sequence of regulatory, pricing, procurement, and distribution decisions that determine whether the molecule ever arrives.

For antimicrobials, this delivery failure is uniquely severe, for reasons that are structural rather than accidental. Novel antibiotics are, by design, held in reserve. Stewardship requirements restrict their use, which suppresses volume, which weakens the commercial case for entering any individual market. A manufacturer that has cleared the scientific and regulatory hurdles may still decline to launch in dozens of countries because the addressable volume cannot justify the cost and complexity of entry. The result is a map of availability that tracks commercial viability, not clinical need. Resistance, meanwhile, does not respect that map. It emerges fastest in precisely the settings where new agents are least likely to be commercially launched.

This is why AMR should be understood, in part, as a market design failure. We have built a system in which the treatments most important to preserve are also the least likely to be made broadly available, because the ordinary economics of market entry work against them. Policy has concentrated almost entirely on the front of that pipeline, on pulling new products into existence. It has paid far less attention to the back of the pipeline, where existing products fail to move.

The good news is that the back of the pipeline is more amenable to intervention than the front. Fixing the economics of antibiotic discovery requires sustained, multibillion-dollar commitments over many years. Fixing delivery requires coordination, standardization, and speed, which are within reach of existing institutions if they choose to prioritize them.

Several directions are worth serious consideration by senior policymakers and industry leaders alike.

  • First, regulatory reliance and recognition. Where a novel antimicrobial has been rigorously assessed by a stringent authority, other jurisdictions should be able to rely on that assessment rather than repeat it. Reliance pathways already exist in principle across several regions. For reserve antimicrobials, they should be the default, not the exception.
  • Second, pre-negotiated access and pricing frameworks for reserve agents. If the commercial volume for a new antibiotic is inherently small, the entry decision cannot be left to market-by-market calculation each time. Delinked models, in which access is decoupled from unit sales, need to extend beyond the country of first launch and be built into procurement from the outset.
  • Third, standing emergency access mechanisms with response times matched to clinical reality. A pathway that takes weeks to deliver a therapy for an infection that kills in days is not, in any meaningful sense, an access pathway. These mechanisms exist; their timelines do not yet reflect the biology.
  • Fourth, treating antimicrobial availability as infrastructure. National security and pandemic preparedness planning increasingly recognize AMR as a systemic threat. That recognition should extend to the logistics of delivery, including regional stockpiles, distribution agreements, and clear lines of procurement responsibility, so that availability does not depend on whether a given market happened to be commercially attractive.

None of this diminishes the importance of the pipeline. New antimicrobials are essential, and the incentives to develop them remain inadequate. But a therapy that cannot reach the patient is, from that patient’s perspective, indistinguishable from a therapy that was never invented. We have spent a decade debating how to make more. We have spent far less time ensuring that what already exists can move.

The measure of an AMR strategy is not only how many new agents it produces. It is whether a person with a resistant infection can obtain an effective treatment in time, regardless of where they happen to live. On that measure, the system we have built is failing, and it is failing for reasons we know how to fix.

Photo: porcorex, Getty Images

Mallika Auplish has worked in global health market access at the World Health Organization, the World Bank, and UNICEF, and is the founder of Vantro Health.

Diane Shader Smith is an antimicrobial resistance advocate who brought her late daughter Mallory's best-selling memoir, Salt in My Soul, to publication. She speaks worldwide on the human cost of drug-resistant infection, including at the White House and NATO.

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