How can we encourage drug companies to invest in research which might combat bacterial resistance to our drugs?by Kevin Outterson / July 17, 2014 / Leave a comment
David Cameron issued a dire warning on 2nd July about antibiotic resistance, calling for global action to preserve antibiotic effectiveness. The Prime Minister highlighted the urgent need to develop new antibiotics to replace those being rendered ineffective by resistance. He has appointed the economist Jim O’Neill to lead an expert panel to look at how new antibiotic development can be encouraged.
This is to be welcomed, but the problem we face is a shortage of global collective action. There has been no shortage of expert review panels.
Antibiotics are undoubtedly important to human health. While better sanitation, housing and food and other public health measures have been the most important factors in extending human life, antibiotics have played a critical role over the past seven decades, adding several years to average life expectancy.
They are also critical to many medical treatments. Chemotherapy and hip replacements would become much more dangerous in the absence of effective antibiotics. Procedures like dialysis or endoscopy would no longer be as safe. Entire branches of medicine would be at risk.
So the world clearly needs a continuing stream of new antibiotics, vaccines and diagnostic tools to fight infection, together with every possible technique to delay resistance. But many large drug companies have lost interest in the field over the past 20 years. The primary problem is the business model, which is perhaps why an economist was appointed to lead the UK process.
For any other industry, success comes when millions of people buy your product, and new drugs are therefore widely promoted and marketed. But indiscriminate global sales of a powerful new antibiotic are a formula for a public health disaster, as we are learning with NDM-1—an enzyme produced by some bacteria that make them resistant to some of the most commonly-used antibiotics.
Physicians and public health experts work hard to restrict antibiotics to only appropriate situations, but when they do, this is dismal news for the companies’ bottom line. Imagine a smartphone company that brought an innovative model to the market and all of the key players clubbed together to limit demand for the product. Little wonder companies aren’t eager to invest in antibiotic research and development (R&D).
Drug company leaders such as Andrew Witty at GlaxoSmithKline acknowledge that the business model for antibiotics is broken. The question is how to fix it.
A promising approach is to make antibiotics available at low prices under tight medical control while rewarding drug developers in ways that do not depend on sales volume or prices. Companies would not depend on high sales volumes to finance R&D and health authorities would decide on the most appropriate use in the absence of commercial pressure.
Several major drug companies agree that delinkage is an idea worth pursuing. It rewards companies for the social value or health impact of new antibiotics, vaccines and diagnostics, instead of just unit sales supported by marketing.
The reward could take the form of enhanced reimbursement. The recently announced Longitude Prize has put £10m towards research in this area—the global antibiotics market needs a similar inducement, but on a scale many times greater.
Indeed, a report to the US government issued last month suggests global antibiotic prizes will need to be in the range of €1bn or more per year. While that number seems large, the global market for antibiotics is currently more than 20 times that.
We should also view this as an insurance policy. What would we pay to protect the gains in human flourishing made possible by antibiotics? A couple of billion euros seems a bargain.
To do this effectively a global framework will be needed, which requires international cooperation through an existing or new organisation. Given the diversity of ways in which countries manage their health systems, in the developing as well as the developed world, this will be a major challenge, requiring flexibility within broad targets. But the work can proceed in stages.
To boost supplies of important new antibiotics, we only need the agreement of the major antibiotic market countries. For example, G7 members could commit to long-term funding targets (based on GDP) for basic science grants and R&D tax credits, but leave the implementation details to each government. Their combined market power would be sufficient to jump start innovation again.
On the demand side, a global agreement will be needed to carefully steward these precious global resources, which are currently wasted through inappropriate use in both animals and humans. Many countries, particularly the Brics—Brazil, Russia, India, China and South Africa—must be a part of this agenda, which will include making life-saving antibiotics available to even the poorest.
It is encouraging to see the UK government engaged at the highest level on this critical issue. One can only hope the process will be short on reports and long on global collective action.