How do proprietary interests affect science policy and/or the availability of data or tools for society?
At the height of its outbreak in 2014, Ebola claimed the lives of over 11,000 with a mortality rate viciously indiscriminate as more than two-thirds of affected patients were killed by the disease. In response, government and industry players across the globe mobilized resources and funding to stop the spread of Ebola and develop a vaccine. Unfortunately, drug development is a risky business. Large operating costs, lengthy time-frames, and low margins of returns for diseases in the developing world routinely leave the research pipeline bare. While such threats to global health, like Ebola, may be imminent, the path to future treatment is routinely unclear as the financial incentives can be as difficult to discover as the cures we need.
Who or what should have access to the rewards of scientific research and development? To the extent that science policy is the means of promoting science and technology development while also balancing the values of the country and its members, this question is incredibly important but difficult to answer. On one hand, scientists, developers, and their employers have argued that the fruits of their labor should be theirs to control, otherwise why would they invest their resources? Meanwhile, many outside of the laboratory and boardroom feel entitled to their fair share as taxpayer-patrons of the nation’s research infrastructure and funding. When assessing science policy, it’s important to consider how the policy navigates this tension as well as the availability of proprietary data or tools for policy makers.
In the case of vaccine development, for example, sometimes the more impeding aspect of drug development is the pervasive uncertainty plaguing potential drug developers’ decision making. Prior to any developer’s decision to begin the lengthy and costly process of attempting to develop a drug is assessing whether those costs will be worthwhile to the developer. Key to that assessment is resolving the uncertainties depicted in the chart below to ensure the successful development of a profitable vaccine.
Many of these same principles remain constant throughout research and technology. However, critics of this perspective believe that the high degree of control that is believed to be necessary for incentivizing research and development is detrimental to the free exchange of ideas and fair competition in the Market.
In the case of patenting technology, these tensions have become more prevalent in academic research since Congress passed the Bayh-Dole Act. This Act, signed into law in 1980, permitted the private patenting for federally funded research. In particular, there has been growing interest in patenting discoveries made from basic research with the hopes of also owning or licensing whatever products or services those discoveries contribute to.
Whereas patents for technology developments or applied scientific discoveries grant more limited privileges, patents more “upstream” in the development and discovery processes, increase incentives for research and development investment but blur the lines between traditional distinctions of what has traditionally been proprietary knowledge and public knowledge.
The best example of this was evident in 2013 when the Supreme Court had to consider the patenting of naturally occurring genes found in human breast cells, known as BRCA1. In response to the medical diagnostic company, Myriad Genetics’, proprietary claim for the gene and related knowledge the company had gained about it, the court ruled that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” invalidating Myriad’s patents on the gene.
Open Science
Another paradigm of information ownership that has been growing traction in research and development has been the concept of Open Science. In this alternative paradigm, enabled by advancements in digital communications and data storage, scientists pursuing Open Science can publish their hypotheses, data, analysis tools, and findings on websites that provide free and unfettered access to the rest of the scientific community; a stark contrast to traditional research efforts sheltered within siloed individual labs until findings were published behind paywalls. Besides providing a means for publicly funded research to be accessible by the public, the Open Science paradigm is also touted as a means of increasing transparency as scientists can be held accountable to their initial research aims, their data and tools can be scrutinized, and findings can be publicly verified.
Detractors of the Open Science paradigm have raised several concerns, however, as they claim that while more transparent, Open Science may create a deluge of data and publications that will overwhelm the scientific community’s ability to review everything published to the web. Another concern raised against the Open Science paradigm are the uncertain consequences of removing the proprietary incentives highlighted earlier on this page.
As a matter of policy, ideas from the Open Science paradigm have begun making headway in Federal rules and regulations. Most notably, in 2013, the Office of Science and Technology Policy published a memorandum to the federal science funding agencies requiring their developing plans to support public access to the findings of Federally funded research. As a result of this, there have been significant increases in federal support of the database infrastructure needed to support Open Science. Further, scientists themselves have begun to face changes in their own responsibilities as more funding is being allocated with the stipulation that research data become more publicly available and standardized to support interoperability among different research efforts.
A final and significant consideration are the challenges that arise as society straddles between these two paradigms. Recently, in an attempt to increase transparency in the research used by the Environmental Protection Agency, a rule was proposed to limit the agency to rely only on publicly available research and data. While ostensibly fulfilling the values of Open Science, this rule was widely criticized throughout the scientific community and the very same Open Source advocates the rule was allegedly inspired by. For one, the rule would eliminate troves of proprietary data and research collected throughout the past century thus skewing the available research consensus. Further, the strict requirements of openness were antithetical to many forms of critical health data that required preserving the privacy of the participants included in the study. For this and the other tensions discussed on this topic, science policy makers must remain vigilant and aware of the necessary questions to ask regarding the appropriate roles of proprietary and open science.
References and Further Reading
- Eisenberg, R. S., & Nelson, R. R. (2002). Public vs. proprietary science: a fruitful tension?. Daedalus, 131(2), 89-101.
- National Academies of Sciences, Engineering, and Medicine. (2018). Open science by design: Realizing a vision for 21st century research. National Academies Press.
- Nelkin, D. (1984). Science as Intellectual Property: Who Controls Research? AAAS Series on Issues in Science and Technology. Macmillan Publishing Co., 866 Third Ave., New York, NY 10022.