Currently, there is little market incentive to invest in the discovery and development of new antibiotics, even though the rise of antimicrobial resistance means there is huge medical need – it is estimated that drug-resistant infections currently cause 25,000 deaths per annum in Europe
The main reason for the mismatch is that the commercial returns are uncertain until resistance has emerged to a previous generation of drugs. By the time a new drug becomes standard of care its patent life will be shortened and the developer may not get a return on investment.
Even if a new antibiotic treats an infection that is already resistant to the current therapies, the market potential is hampered by the need to use it sparingly to delay the development of resistance.
“I strongly believe we need to re-think payments to pharma,” said Moore. “At the moment, to use a small analogy, you go into a supermarket and fill your trolley up with potatoes. You then pay based on how many potatoes you’ve bought,” he said.
“It works the same for buying antibiotics, meaning there is an obvious incentive for pharma to keep us buying more,” he said.
Along with several co-authors, Moore raises the possibility of de-linking company profits from the sales volume for antimicrobials in a paper published today in medical journal The Lancet. The paper is one of a series examining how antimicrobial resistance is being tackled worldwide, and outlining future priorities for researchers and policymakers.
“Of course, we need to keep pharma interested in finding new drugs,” said Moore. “So we could say we will reimburse their R&D and their capital costs and pay a premium on top of that, but we’re not going to keep paying for volume.”
Moore acknowledges the proposal is radical, but says, “It’s so important that we make this break.”The idea of using lump-sum payments to redress perverse incentives has been around for a while and has gained the support of a number of academics and economists. The money would be paid to a pharma company once a product received regulatory approval.
This would de-link profit from the volume of sales and make development financially sustainable. It would also enable stewardship of an new antibiotic in order to preserve its effect for longer.
The proposal was made in a report published in May by the UK’s Antimicrobial Review committee, which was formed to come up with solutions to the global antibiotic crisis. The review, headed by economist and former chair of Goldman Sachs Asset Management Jim O’Neill, says a new reward scheme would, “reflect[] better the benefit that the drug is likely to offer society in the long term instead of looking at the narrow period during which they are ‘on patent’.”
Moore’s paper in the Lancet says complete global action is not necessarily required in order for the de-linkage proposal to work. “The actions of a few high-income countries can have a disproportionately large global effect, and additional countries will join the effort in due course.”
“Therefore, a pledge from a group such as the G20 to increase their investment in R&D tied to responsible use and global access stipulations could have a substantial effect on the antimicrobial R&D landscape,” the paper says.
Some major pharma companies, including GlaxoSmithKline, have publicly supported the concept.
“I don’t know how many pharma companies are on board with the idea,” said Moore. “They’re not overtly against it though, as far as I can see. I think it’s worth exploring further with their chief financial officers.”Increasing awareness
While international attention is more easily drawn to the development of new antibiotics, there are signs both the medical profession and policymakers are beginning to take the issue of their overuse just as seriously.
There have been recent worldwide attempts to increase public awareness about the rising tide of drug-resistant infections.
On Monday, the World Health Organisation launched a global campaign ‘Antibiotics: Handle with Care’ which aims to preserve the effectiveness of existing antibiotics by limiting their use. In 2009 the EU announced the annual European Antimicrobial Awareness Day, with the message, “Everyone’s responsible.”
“In the past few years people are certainly talking about it more,” said Moore. “But whether or not it’s percolated down to action is unclear in my mind. Internationally, I’m still unclear on whether there’s tangible outcomes we can point to.”