Kenneth A. Oye

Explaining Cooperation Under Anarchy: Hypotheses and Strategies

What circumstances favor the realization of mutual interests in the absence of centralized authority? And through what strategies can nations foster the emergence of cooperation by altering the circumstances that they confront? Elementary game theory suggests three sets of conditions that serve as proximate explanations of the incidence of cooperation and discord: (i) Payoff Structure: Mutual and Conflicting Preferences; (2) The Shadow of the Future: Single-play and Iterated Games; and (3) Number of Players: Two-Person and N-Person Games. Each of these three attributes of context may be subject to willful modification. Nations may create the preconditions for cooperation through strategies to alter payoffs, lengthen the shadow of the future, and reduce the number of actors required to realize limited mutual interests.

adaptive Licensing: Taking the Next Step in the Evolution of Drug approval

Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The concept of AL embraces a range of perspectives. Some see AL as an evolutionary step, extending elements that are now in place. Others envision a transformative framework that may require legislative action before implementation. This article summarizes recent AL proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.

Co-benefits of climate policy--lessons learned from a study in Shanxi, China

We analyse health benefits and socio-economic costs of CO2-abating options related to coal consumption in Shanxi, China. Emission reductions are estimated for SO2 and particles in addition to CO2. Co-benefits of each option are estimated in terms of how effectively it improves local air quality and thereby reduces health damage from pollution. The population-weighted exposure level for particles and SO2 is estimated using air quality monitoring data, and a simplified methodology is applied to estimate the reduced exposure to the population that may result from implementing the abatement measures. Exposure–response functions from Chinese and international epidemiological studies are used to estimate the ensuing health effects. A method for estimating the impact of chronic PM10 exposure on life expectancy in the affected population is developed and applied. An economic evaluation of the reduced health effect is made by determining unit prices of health impacts based partly on damage costs and partly on the willingness-to-pay approach. Our assessment of CO2-reducing abatement options in Shanxi demonstrates that these measures entail large co-benefits and are highly profitable in a socio-economic sense.

Regulating gene drives

Regulatory gaps must be filled before gene drives could be used in the wild Genes in sexually reproducing organisms normally have, on average, a 50% chance of being inherited, but some genes have a higher chance of being inherited. These genes can increase in relative frequency in a population even if they reduce the odds that each organism will reproduce. Aided by technological advances, scientists are investigating how populations might be altered by adding, disrupting, or editing genes or suppressed by propagating traits that reduce reproductive capacity (1, 2). Potential beneficial uses of such “gene drives” include reprogramming mosquito genomes to eliminate malaria, reversing the development of pesticide and herbicide resistance, and locally eradicating invasive species. However, drives may present environmental and security challenges as well as benefits.

From Adaptive Licensing to Adaptive Pathways: Delivering a Flexible Life-Span Approach to Bring New Drugs to Patients

The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life‐span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade‐off, help de‐risk drug development, and lead to better outcomes for patients.

8. Self-Interest and Environmental Management

Based upon an empirical analysis of environmental cases, we argue that regulations work most effectively when they confer tangible benefits on the regulated. In what could be termed Stiglerian situations, the convergence of self-interest and the publics desire to improve the environment occurs almost naturally. Because those who are regulated lobby for and benefit from regulation and the costs are widely dispersed, these situations tend to be characterized by regulatory stability. In what could be termed Olsonian situations, regulatory benefits are diffused across the many, while regulatory costs are concentrated on the few. In these situations the relatively few clear losers will tend to mobilize against regulation with greater effectiveness than the many weakly motivated beneficiaries, resulting in a high degree of regulatory instability. Compensation can be used in Olsonian situations to create incentives that approximate those that occur naturally in Stiglerian situations.

What Rough Beast: Synthetic Biology, Uncertainty, and the Future of Biosecurity

Abstract Synthetic biology seeks to create modular biological parts that can be assembled into useful devices, allowing the modification of biological systems with greater reliability, at lower cost, with greater speed, and by a larger pool of people than has been the case with traditional genetic engineering. We assess the offensive and defensive security implications of synthetic biology based on the insights of leading synthetic biologists into how the technology may develop, the projections of practicing biosecurity authorities on changes in the security context and potential security applications of synthetic biology, and joint appraisals of policy relevant sources of uncertainty. Synthetic biology appears to have minimal security implications in the near term, create modest offensive advantages in the medium term, and strengthen defensive capabilities against natural and engineered biological threats and enable novel potential offensive uses in the long term. To maximize defensive and minimize offensive effects of synthetic biology despite uncertainty, this essay suggests a combination of policy approaches, including community-based efforts, regulation and surveillance, further research, and the deliberate design of security and safety features into the technology.

Coal utilization in industrial boilers in China --a prospect for mitigating CO2 emissions

It is estimated from GEF statistical data for 1991 that more than 500,000 industrial boilers (mostly stoker-fired) in China consume over 400 million tons of coal per year. Each year, because of low boiler efficiency, 75 million tons of coal is wasted and 130 million tons of excess CO2 are emitted. An analysis of 250 boiler thermal-balance test certificates and 6 field visits in three provinces have shown that: (1) boilers with efficiencies of less than 70% account for 75% of the total boiler-population; (2) the main causes of the low efficiencies are high excess air and unburned carbon in the slag and fly ash. The effect of unburned carbon on CO2 emission is a balance of positive and negative contributions: while the unburned carbon does not produce CO2 emissions, its replacement carbon, burned at a low efficiency, contributes to a net increase in CO2 emissions. It seems from the analysis that the average boiler efficiency can be raised to 73% by relatively simple means, such as the size grading of the coal, improved boiler operating practice and some inexpensive equipment modifications. This could then result in savings each year of 34 million tons of coal and a reduction in CO2 emissions of 63 million tons at an estimated cost of

The Intellectual Commons and Property in Synthetic Biology

10 per ton of CO2.

Drugs: Regulate 'home-brew' opiates

Is the development of synthetic biology threatened by sharing and ownership issues? What measures are synthetic biologists taking to address intellectual property and commons issues that may threaten development of the field? Part I presents a conceptual framework for the analysis of ownership and sharing in emerging technologies, organized around two dimensions – a private ownership vs commons axis and a clarity vs ambiguity axis. It then uses the framework to assess the fit between conventions governing intellectual property and elements of synthetic biology. Part II describes internal positions on ownership and sharing within the community of synthetic biologists, highlighting areas of agreement on common ownership of registries of parts for basic research and education, standards for performance and interoperability, and design and testing methods; and agreement on private ownership of designs of devices ripe for commercialization. Part II also discusses the varied views of synthetic biologists on precisely where to draw the line on public vs private ownership of biological parts and design principles. The conclusions examine domestic and international forces that may shape the evolution of formal legal conventions and informal practices in synthetic biology.