Monday, November 22, 2021

Pull Incentives at ASM/ESCMID


On a personal note, as I grow older, I find I am likely to be more dependent on physicians and caregivers.  I am grateful to have a truly talented, kind and smart team of physicians, nurses, family and friends to provide care and support if needed.  As I contemplate this universal issue of aging, given my training and history, I can’t help but reflect on the state of antimicrobial resistance and the antibiotic pipeline designed to meet this challenge. I hope, that should the need arise, my care team will have access to antibiotics that are both safe and effective against whatever resistant pathogen I might encounter. 


Those of us following this field for any length of time understand the critical importance of pull incentives designed to correct the disastrous state of the antibiotic market such that companies and investors risking it all do not have to face bankruptcy after having finally obtained market approval for their precious new antibiotic. The US is apparently seriously considering a generous pull incentive in the form of the Pasteur Act and the 21stCentury Cures Act 2.0. Europe has requested public comments on a proposal to provide pull incentives of some sort as well. 

This year, the ASM/ESCMID meeting (held virtually) will spend an entire morning devoted to thinking around how such pull incentives can be implemented.  The base assumption here is that without such pull incentives we are all, ultimately, doomed.  In an optimistic mode, ASM/ESCMID is posing questions around implementation of these incentives.  I have been asked to moderate one of these sessions.  

The experts presenting the morning of December 8 include, 

Christine Ardal (Institute of Public Health, Norway),

Louise Norton-Smith, M.A., (Head of Global AMR Strategy, U.K. Department of Health and Social Care), 

Kevin Outterson, J.D., (Boston University, School of Law, Boston, Mass), 

Beth Woods, MSc., (Centre for Health Economics, University of York, U.K.),

Colm Leonard, M.D., (National Institute for Health and Care Excellence UK), 

Nick Crabb Ph.D., (National Institute for Health and Care Excellence UK),

Emily Wheeler, (Biotechnology Innovation Organization), 

Helen Boucher, M.D., FACP, FIDSA, (Interim Dean Tufts School of Medicine, IDSA Officer).


Clearly the speakers and panel could hardly be of greater quality.  


I am laser-focused on the questions of “who and how?” We may not get to all the questions I pose here – but I think all are worthy of further consideration. 


Since any pull incentive, to be effective, must be large ($2-4 billion), who should bear the financial burden of such pull incentives? 


Companies will need to understand how products will be chosen to receive these incentives.  What will the criteria be?  In this regard, how do considerations of clinical utility and innovation come into these criteria?  Do we even have agreed definitions for these two concepts?


If countries/regions pay their "fair share" will all providers of pull incentives have to agree not only on the criteria, but on the ultimate choice of products to receive such an award?  The discrepancy between the approaches of the UK and Sweden (where different products were ultimately chosen for subscriptions by the two countries) are instructive in this regard. 


Are there regulatory implications for pull incentives? Should regulatory authorities be involved or at least be required to consider that compounds have been chosen for such incentives? Does this also have implications for access? 


I am sure that we will have a lively discussion. And - there are other very important discussions with key experts to follow this first session.  I highly recommend attending the ASM/ESCMID meeting.