Today we have the next in the excellent series of Antimicrobial Resistance (AMR) Review Team publications, and the report has some critical messages about point of care diagnostics to ensure that patients get the right antibiotic treatment if they need it.
To reach that aim, the diagnostics have to be available, accurate and fast. The last of these qualities remains scientifically challenging, and has been recognised in a number of recent reports on AMR 1-3. The innovative biopharma industry would welcome better tests, as illustrated by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) recent report which highlighted, "The ability to identify targeted pathogens with rapid diagnostic tests (RDTs) could greatly improve appropriate treatment involving the use of antibiotics"4.
Given that shared view on the critical importance of rapid diagnostics to address AMR, and specifically biopharma's explicit support on that measure, it's disappointing to read in the AMR report, Rapid Diagnostics: Stopping Unnecessary Use of Antibiotics, their conclusion that "[m]any drug companies, meanwhile, including those producing affordable generic antibiotics, have no commercial interest in the advent of rapid diagnostics, which would act to limit the number of antibiotics prescribed."5: 3 I recall the same guesswork being applied when targeted therapies first came to the fore. We now have nearly half of the pipeline dedicated to targeted treatments 6, which also narrow the relevant patient population. The value of a medicine lies in its appropriate use, and our members are continuously investing to improve that accuracy of approach. Industry has called for a new commercial that is better aligned with minimising the use of a new antibiotic, by de-linking the payments from the volume of the product used.
The report follows this statement about biopharma disincentives with the conclusion, "[s]o it is not hard to see why diagnostic innovation has been so slow, with limited financial incentives to sell or buy these innovative products."5: 3 This is a non sequitur, just as it is for targeted therapies. Our colleagues at the British In Vitro Diagnostics Association, BIVDA, have tirelessly made the arguments for a sustainable business model for diagnostics and critically their uptake and incorporation in healthcare systems, which remains a challenge as recent research by CRUK has demonstrated. What little progress there has been made with diagnostics in targeted therapies has largely happened because biopharma has invested when no one else would.
And therein lies the real question for biopharma in this report: Are we expected to be the funder of Last Resort? The Review Team concludes the solution for new rapid diagnostics is best achieved through early-stage R&D funding through the Global Innovation Fund announced in the previous report 7, which it proposes to be funded by biopharma. Today also brings the next piece of news about the establishment of the Global AMR Research Innovation Fund by the Governments of UK and China. We know from this announcement that the intention is to "attract £1 billion", but how much public money is already in the hat is guesswork.
If we've learned one thing about the integration of diagnostics into care, it's that asking biopharma – or any funder - to cover the costs isn't enough. There needs to be a commissioning process that means that diagnostic companies can gain a good return on their investment and deliver technology that meets the needs of patients and their healthcare services. The AMR Review report recognises that additional market incentives are needed to improve this commercial environment for diagnostics, just as they are for antibiotics. Diagnostics are core infrastructure to any healthcare system. As the AMR Review Team argue very well, they are a public good for AMR. If we are globally to solve AMR, we need all parties to engage in the solution, including the costs.
The AMR Review Team has delivered another excellent report to advance our conversation around AMR and hopefully to provide the basis for a well-considered plan by the Review Team in 2016. The global urgency for this kind of international leadership is clear. Let's just make sure that the solutions proposed can deliver for the long run and with solutions that are self-sustaining.
1 Clift, C. et al. Towards a New Global Business Model for Antibiotics: Delinking Revenues from Sales. 34 (London, 2015).
2 Bax, R. & Green, S. Antibiotics: the changing regulatory and pharmaceutical industry paradigm. Journal of Antimicrobial Chemotherapy, dku572 (2015).
3 Shallcross, L. J. & Davies, S. C. The World Health Assembly resolution on antimicrobial resistance. Journal of Antimicrobial Chemotherapy 69, 2883-2885 (2014).
4 International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Rethinking the Way We Fight Bacteria. 26 (Geneva, 2015).
5 Review on Antimicrobial Resistance. Rapid Diagnostics: Stopping Unnecessary Use of Antibiotics. 36 (London, 2015).
6 Pharmaceutical Research and Manufacturers of America (PhRMA). in Chart Pack (PhRMA, Washington DC, 2015).
7 Review on Antimicrobial Resistance. Securing New Drugs for Future Generations: The Pipeline of Antibiotics. 41 (London, 2015).