Superbugs Require New Weapons: Strong, Effective Intellectual Property Rights May Be Our Best, Last Hope

The virus that could spark the next global disease pandemic is already circulating – and the world is not ready to respond.  In a recent Time Magazine cover story, Brian Walsh highlights the growing risk of killer germs and superbugs such as bird flu H7N9 Ebola, Zika and MERS, across an increasingly interconnected and densely populated planet. He reports that “[t]he number of new diseases per decade has increased nearly fourfold over the past 60 years, and since 1980, the number of outbreaks per year has more than tripled”.[1]  As the threat grows, our efforts to prepare for the consequences are clearly falling short.

The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the Middle East.  The impact is being felt much closer to home as well.  According to the Centers for Disease Control and Prevention (CDC), in September 2016, a 70-year-old Nevada woman died from an infection that was “resistant to all available antimicrobial drugs”.  Analysis of the superbug, Klebsiella pneumonia, established that it was resistant to all 26 antibiotics available in the United States, including the “drug of last resort”, colistin.[2]  The event is a frightening wake up call to the perils of what the CDC terms untreatable “nightmare bacteria”.[3]

Unfortunately, this is not an isolated incident.  In 2011, doctors at the Providence Alaska Medical Center because seeing highly drug-resistant infections.  As in the 2016 case, eventually they turned to colistin, finding that even it was ineffective against the bacterial strain.  By early 2013, 19 patients had been infected and five died from the bacteria that were both highly resistant to drugs and highly virulent, an uncommon and very danger combination.[4]

Across the globe, scientists are acutely aware that we are losing the battle against pathogens and that our arsenal of antibiotics is nearly empty.  Our response should be engagement!  Our response should be to expand the incentives that will encourage greater research into the treatments and cures we will need!  Our response should be stronger intellectual property rights for the biopharmaceutical sector to attract the best of the best to take on these challenges!  Our response should be recognizing the fight ahead of us and doing everything possible to set us up for victory!  Tragically, we have stumbled and we are ill-prepared for what lies ahead.  The reality is that “microbes evolve about 40 million times as fast as humans do, and we are losing ground”.[5]

Our short-sighted approach is nothing new, but the tide may be turning.  It has been 30 years since a new class of antibiotics was discovered, for many reasons.  The graphic below depicts the development of antibiotics over the past century, with a notable “discovery void” dating from the 1980s.  It has been a combination of scientific as well as commercial barriers that have impeded antibiotic development.  The Review on Antimicrobial Resistance (AMR), and the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance, recognize the substantial challenges surrounding antibiotic development.  Notably, the scientific difficulties are formidable and the value assigned to antibiotics and diagnostics often fail to reflect the benefits they bring to society, nor the investment required for their creation.

An effective response will require strong leadership, at the national level and from global institutions like the World Health Organization (WHO).  Given greater awareness and the increasing prevalence of new diseases and outbreaks, it would seem that pandemic preparedness should dominate the agenda as the WHO convenes officials from more than 190 countries in Geneva, Switzerland this week for the annual World Health Assembly.  It would seem that the WHO should champion the incentives that encourage research on new medicines and vaccines.   a global effort to discover and develop new antibiotics would be called for.  Unfortunately, the WHO is moving in the opposite direction.

Instead of acknowledging that the incentives provided by intellectual property rights have provided humanity with an impressive selection of treatments and cures, efforts are underway in the WHO to weaken those protections, threatening the ability of health technology innovators to bring new products to patients.  Late last year, the United Nations High-Level Panel on Access to Medicines (HLP) released a deeply flawed and troubling report, making damaging recommendations that would ultimately undermine the laws and policies that foster biopharmaceutical innovation.  The United Nations report was a missed opportunity to build consensus and facilitate cooperation to springboard innovation in the areas in which it is most needed. Instead the report advocates a dismantling of the system that has brought us so many breakthrough medicines.

If we are to have a fighting chance against superbugs and pandemics, we must invest in innovation and safeguard the property rights that incentivize these discoveries.  Short-sighted efforts to enervate existing intellectual property rights laws and policies will not only damage incentives to innovate, they may hand a victory to the superbugs.  “‘Of all the things that can kill millions of people in very short order,’ says Dr.Ashish Jha, director of the Harvard Global Health Institute, ‘the one that is most likely to occur over the next 10 years is a pandemic.’”[6] If we are to avoid these dire predictions, we must invest in what will save us.  We must embrace and encourage the process of discovery and make sure that it is rewarding enough to attract the best and brightest minds.  We must strengthen – not eviscerate – our IP regimes.

_______________

[1] Walsh, Bryan. The World is Not Ready for the Next Pandemic, Time Magazine, online edition, 4 May 2017.
[2] “This powerful antibiotic was largely abandoned in the 1960s for its toxic side effects.  Out of necessity, it has become in recent years a weapon of last resort against the worsening superbug scourge.”  (Chung, Andrew, Yasmeen Abutaleb and Deborah J. Nelson, “As ‘superbugs’ strengthen, an alarming lack of new weapons to fight them,” webpost, www.Reuters.com, 15 December 2016.
[3] Gallager, James. Bug resistant to all antibiotics kills woman, webpost, BBC.com, 13 January 2017.
[4] Chung, Andrew, Yasmeen Abutaleb and Deborah J. Nelson, “As ‘superbugs’ strengthen, an alarming lack of new weapons to fight them,” webpost, www.Reuters.com, 15 December 2016.
[5] Walsh, Bryan. “The World is Not Ready for the Next Pandemic,” Time Magazine, online edition, 4 May 2017.  Available at:  http://time.com/magazine/us/4766607/may-15th-2017-vol-189-no-18-u-s/
[6] Walsh, Bryan. The World is Not Ready for the Next Pandemic, Time Magazine, online edition, 4 May 2017.

The Author

Dr. Kristina Lybecker

Dr. Kristina Lybecker is an Associate Professor of Economics at Colorado College in Colorado Springs. She earned a B.A. from Macalester College, with a double major in Economics and Latin American Studies, and received her Ph.D. in Economics in 2000 from the University of California, Berkeley.

Dr. Lybecker's research analyzes the challenges surrounding intellectual property rights protection in innovative industries: incentivizing pharmaceutical research and development especially on neglected diseases, addressing the difficulties of strengthening intellectual property rights protection in developing countries, battling the problems related to pharmaceutical counterfeiting and the unique nature of protection for biotech therapies. Recent publications have also addressed alternatives to the existing patent system, the balance between pharmaceutical patent protection and access to essential medicines, and the markets for jointly produced goods such as blood and blood products. Kristina has testified in more than a dozen states on the economics of pharmaceutical counterfeiting. She has also worked with US Food and Drug Administration, Reconnaissance International, PhRMA, the National Peace Foundation, the OECD, the Fraser Institute, the Macdonald Laurier Institute, and the World Bank, on issues of innovation, international trade, and corruption.

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Discuss this

There are currently 3 Comments comments.

  1. Paul Cole May 22, 2017 11:42 am

    Congratulations on your interesting and timely article. The only solution is to recognise that these life-saving drugs which are typically administered for relatively short periods (weeks as opposed to years or decades e.g. for drugs intended to combat high cholesterol, diabetes, high blood pressure and asthma) are prima facie less profitable to pharma, and that the price mechanisms need to recognise their value.

    The regulatory burden for a new antibiotic is precisely the same as for a new cholesterol-reducing drug, but the potential financial return is likely to be significantly less.

    In 1940 penicillin was found to be effective for the treatment in mice, and tested on the first patient Albert Alexander only a short time later. What chance anything similar happening today with the present necessary but vastly bureaucratic regulatory regimes?

  2. Bob Hodges May 22, 2017 1:33 pm

    As a practitioner, I have have worked on many antibiotic and antimicrobial inventions. My sense is that it is the lack of investment in development of new antibiotic ideas rather than a lack of new antibiotic ideas that is holding back new antibiotics in clinical use. The word is that, because antibiotics are administered for only a short time, the market is not large enough to support the cost of development and clinical trials for a new antibiotic.

  3. Chris Gallagher May 23, 2017 9:38 am

    Bob Hodges @ 2 makes an important point. Those who wonder whether investment is as important as invention or that price controls adversely affect the commercialization and development of promising life science discoveries need look no further than his comment above complementing Dr. Lybecker’s post. Where the time for a microbiology cure is short reasons to invest in the cure is subject to inherently limited ROI. Incentives to invest in developing an effective response are thus diminished. Price controls have the same effect as cure duration. When pricing is subject to political pressure, as will surely be the case when this pandemic hits, the investment deterrents are even greater. Pricing power directly affect private sector commercialization.