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countermeasures against emerging infectious disease threats faces several unique challenges. Pharmaceutical companies, both publicly traded and privately owned, generally make investment decisions based on potential market size and revenue potential, as well as the ease of the regulatory approval pathway. Emerging infectious disease outbreaks lack predictability in terms of their nature, size, location, frequency, and duration. The revenue streams a company may realize from an emerging infectious disease countermeasure are uncertain, as many of these events occur in low-resource settings in which there is little to no ability to purchase such products, increasing the risk that a firm may not achieve a return on investment. In addition, there are opportunity costs incurred for not pursuing more lucrative activities that compete for the same financial, personnel, and manufacturing resources. In essence, there is no commercial market for the majority of emerging infectious disease countermeasures. It is also important to understand that the global pharmaceutical industry as a whole is represented by fewer players (as companies have increasingly relied on mergers to acquire new research), and fewer new drugs are in development (as research and development costs have risen along with competition from generic drugs). Development of novel drugs that serve previously unmet needs is particularly sluggish. In the United States, which has the largest pharmaceutical market in the world, only 13% of new drugs approved between 2005 and 2016 were novel drug products.120 In light of these realities, it is necessary to consider different avenues for promoting research and development of medical countermeasures for respiratory transmissible diseases with pandemic potential. Regulatory, policy, tax, and direct financial incentives have all been used at various times and could be pursued further to encourage R&D investment by industry. When structured appropriately, tax incentives can entice companies to develop drugs eligible for these inducements. For example, as a consequence of the Orphan Drug Designation program, which provided federal tax incentives to encourage development of drugs for rare diseases affecting fewer than 200,000 people annually, the number of claims by companies for this tax credit increased 5-fold between 2005 and 2014 in the United States.120 The promise of expedited regulatory review can also positively influence industry R&D investment, especially if companies are permitted to apply expedited review “vouchers” to any drug in their development pipeline or sell the vouchers to other companies. Direct incentives, such as milestone payments given to a company at various designated stages when the company develops a needed MCM, can also be effective. Direct incentives have been used successfully both at the national and now international levels. CEPI, a global partnership among public, private, philanthropic, and civil society organizations, has created financial pull incentives to bring multiple candidate vaccines for certain emerging infectious diseases through an intermediate (phase IIb) level of development. By stopping at a specific development level and pursuing further development as threat analyses change, a layered-security approach to threats could be pursued in a less costly manner versus full-development through licensure. Policy and regulatory approaches of countries, especially those relating to intellectual property rights, can be tremendously influential on investment decisions by the private sector. Regulations that predictably protect the intellectual property rights of companies provide an incentive for investments in innovation, facilitate exports to other countries in need, and can lead to technology transfer to importing countries. Research and development of MCMs is a long-term, uncertain, and extremely expensive endeavor. (Some estimate an average of 15 years and US$1.4 billion.120) Robust and transparent regulatory and policy regimes, as well as political stability, can help to minimize investment risk for the private sector. Nonpharmaceutical Interventions As has been demonstrated in recent events such as Ebola and 2009 H1N1 pandemic, national governments and responding agencies may seek to employ nonpharmaceutical interventions (NPIs) in disease outbreaks, either in coordination with available medical countermeasures or, in the absence of developed vaccines and therapeutics, as the primary measure to prevent or slow down disease spread. NPIs principally aim to limit the degree to which exposure to ongoing infectious disease threats can occur, both at the individual and community levels. The degree to which NPI measures will be effective at preventing or limiting transmission of high-impact respiratory pathogens is uncertain and will largely depend on the context, timing, and epidemiology of the outbreak. In addition, the range of NPIs that might be called for in response to a high-impact respiratory pandemic (see Box 8 for the most commonly considered) all differ considerably in terms of objectives, feasibility, costs, downside consequence, and evidence. In determining whether and how to implement NPIs, countries must assess each proposed measure on the following dimensions:121 1. Epidemiologic assessment: Do available data or experience suggest a specific NPI will work to prevent or slow transmission in a meaningful way? 2. Logistical assessment: Is the particular NPI measure feasible given available resources? 3. Social, economic, and political assessment: What are the possible unintended adverse societal consequences of a particular NPI? Box 8: Definitions of NPI While NPIs cover a variety of measures, those that might be most likely to be considered or called for in the setting of a pandemic caused by a high-impact respiratory pathogen include: travel restrictions, movement restrictions, quarantine, and social distancing. Travel restrictions refer to enforceable limitations on travel but should not be confused with travel alerts or notices, which provide information for travelers on ongoing health events. Movement restrictions are measures implemented to prevent or limit contact between infectious individuals and susceptible
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