1

Hot Topics for Advanced Instruction:

The Economics of Developing Emergency Medical Countermeasures

Development of vaccines and therapeutics to address the ongoing 2014-2015

outbreak of Ebola Virus Disease in West Africa illustrate some of the legal and
economic principles that influence the development of medical countermeasures
against public health threats.

 There is no approved vaccine to prevent Ebola. Unlike for measles, influenza, and
polio, there is no vaccine for Ebola Virus Disease, despite the fact that Ebola Virus
Disease was first discovered in 1976 and has a very high mortality rate.

 Developing a vaccine against Ebola is very complex. A key difficulty in proving

the effectiveness of a vaccine against Ebola is the limited human data available to
assess the effectiveness of the vaccine. Until the latest major outbreak, the number
of people infected in typical Ebola outbreaks is so small that clinical trials are
infeasible. Therefore, drug developers are required to show that their product is
effective by using studies conducted in animals that model the human disease,
which can be technically challenging.

 Generally and relatively speaking, there is not a strong economic case for a
company to develop a vaccine against Ebola. Like any other commercial
enterprise, pharmaceutical companies must make business decisions that support
the sustainability, security, and growth of the company. Therefore, when a company
decides where to invest, they assess the potential market for a drug candidate. The
market for other medical products, particularly those that treat chronic diseases
that affect wealthy consumers, dwarfs the market for Ebola vaccine.

 However, national governments provide support to companies to develop a

vaccine and other similar products, called medical countermeasures.
Recognizing the public health and security interest in having a vaccine against Ebola
and other dangerous agents, many countries support the development of products
to treat chemical, biological, and radio-nuclear threats, pandemic influenza, and
emerging infectious diseases by investing in product development and building
manufacturing infrastructure.

 After medical countermeasures are successfully developed, countries and

other international response organizations (e.g., the World Health
Organization) stockpile them until they are needed. For example, the United
States Centers for Disease Control and Prevention (CDC) has large quantities of
medicine and medical supplies available if there is a public health emergency severe
enough to cause local supplies to run out.

These resources will help you explore more about the development and stockpiling
of emergency medical countermeasures.
 2

(1) The economics driving the development of Ebola vaccine and other medical
countermeasures

 Read this popular article, Ebolanomics, which was published in The New Yorker in
August of 2014, http://www.newyorker.com/magazine/2014/08/25/ebolanomics,
and this similar article from NBC News, 'No Market': Scientists Struggle to Make
Ebola Vaccines, Treatments, http://www.nbcnews.com/storyline/ebola-virus-
outbreak/no-market-scientists-struggle-make-ebola-vaccines-treatments-n167871

 Also see, Ebola Vaccine, Ready for Test, Sat on the Shelf from The New York Times,
http://www.nytimes.com/2014/10/24/health/without-lucrative-market-potential-
ebola-vaccine-was-shelved-for-years.html?_r=1 , which alludes to the necessity to
prove effectiveness using animal models.

(2) Understand the important role of proving medical countermeasure effectiveness

using animal models.
 Learn about the “Animal Rule” from the U.S. Food and Drug Administration by
reading these Q&A’s:
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCounterm
easures/ucm282547.htm

(3) Discover The Project BioShield Act, and the United States’ approach to expanding
its stockpile of medical countermeasures.
 Read this policy brief from the Center for New American Security on Project
BioShield, written by Robert Kadlec, former Special Assistant to the President
and Senior Director for Biodefense Policy during the George W. Bush
Administration.
https://www.bio.org/sites/default/files/CNAS_RenewingTheProjectBioShieldA
ct_Kadlec.pdf
 Learn about the Biomedical Advanced Research and Development Authority
(BARDA), within the U.S. Department of Health and Human Services. BARDA
provides an integrated, systematic approach to the development and purchase
of the necessary vaccines, drugs, therapies, and diagnostic tools for public health
medical emergencies. https://www.medicalcountermeasures.gov/barda.aspx

(4) The Strategic National Stockpile

 Learn more about the Strategic National Stockpile maintained by the Centers for
Disease Control by reading their article, The Strategic National Stockpile: What it
Means to You, http://www.cdc.gov/phpr/stockpile/stockpile.htm

(5) Post in the Discussion Forum. Based on what you’ve learned above about the
economic conditions surrounding the development of emergency medical
countermeasures, what are some approaches that you think governments and
companies could take to help inspire the development of new drugs? For inspiration,
visit this site: http://www.xprize.org/prizes/future-prizes/bioterrorism