Breakout Track #3

–Innovation and access to health technologies, including the role of industry incentives

The exit of Big Pharma from antibiotic innovation has received considerable attention in recent years, and this has prompted the call, from the UK Review on AMR and DRIVE-AB to the BCG’s report for the German government and the OECD, for greater pull incentives. These have ranged from extended market exclusivity (U.S. GAIN Act) and transferrable IP exclusivity (the failed REVAMP bill in US Congress last session) to the calls for billion dollar, late stage market entry rewards. The failure of Achaogen in bringing forward a new, second generation amino glycoside, Plazomicin, has heightened concerns and renewed the call for pull incentives by funders (CARB-X and Wellcome Trust) as well as industry.

We face several key, near term challenges

  1. Proposals for incentives that exacerbate AMR (e.g., higher drug prices and extended market exclusivity) rather than follow the principle of delinkage

  2. Proposals for incentives that provide outsized prizes, which would not ensure sustainable access and which may further distort the need for closer-to-marginal cost pricing among essential medicines

  3. Zero-sum trade-offs against other priorities, from complementary technologies like diagnostics and vaccines to innovation of clinical practice to improve antimicrobial stewardship

  4. Growing conflict of interest concerns have emerged on multiple fronts: AMR Industry Alliance self-monitoring report card; Pfizer-Indian Council of Medical Research joint initiative on antimicrobial stewardship; potential bias in industry-funded surveillance systems; problems in the determination of antibiotic resistance breakpoints in the Clinical Laboratory Standards Institute process.

Several opportunities also are on the horizon

  1. New grants from CARB-X and other funders that could place conditions for access and stewardship

  2. New efforts to ensure global governance and coordination, from the Global Leadership Group to the R&D Coordination Hub

  3. Alternative payment proposals, from former FDA Commissioner Scott Gottlieb licensing proposal to the UK Review on AMR to Lord O’Neill’s “pay or play” proposal

  4. Alternative production, from government-owned production and PDPs like GARDP to CivicaRx

  5. Pooled procurement facility, as noted in the IACG recommendations, that could build on the experience of the Global Drug Facility.

Participants

  • Steve Knievel

  • Sebastian Schonherr

  • Jyotsna Singh

  • Elizabeth Lovinger

  • Viviana Galli

  • Rohit Malpani

  • Maarten van der Heijden

  • Mengying Ren

  • Sebastian Schonherr

  • Viviana Munoz

  • Anthony So

Resources