In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies’ “foundational” nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents (...) to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing. (shrink)
If climate change represents a severe threat to humankind, why then is response to it characterized by inaction at all levels? The authors argue there are two complementary explanations for the lack of motivation. First, our moral judgment system appears to be unable to identify climate change as an important moral problem and there are pervasive doubts about the agency of individuals. This explanation, however, is incomplete: Individual emitters can effectively be held morally responsible for their luxury emissions. Second, doubts (...) about individual agency have become overly emphasized and fail to convincingly exonerate individuals from responsibility. This book extends the second explanation for the motivational gap, namely that the arguments for the lack of individual agency do in fact correspond to mechanisms of moral disengagement. The use of these mechanisms enables consumption elites to maintain their consumptive lifestyles without having to accept moral responsibility for their luxury emissions. (shrink)
Although climate change jeopardizes the fundamental human rights of current as well as future people, current actions and ambitions to tackle it are inadequate. There are two prominent explanations for this motivational gap in the climate ethics literature. The first maintains that our conventional moral judgement system is not well equipped to identify a complex problem such as climate change as an important moral problem. The second explanation refers to people’s reluctance to change their behaviour and the temptation to shirk (...) responsibility. We argue that both factors are at play in the motivational gap and that they are complemented by crucial moral psychological insights regarding moral disengagement, which enables emitters to dissociate self-condemnation from harmful conduct. In this way, emitters are able to maintain their profligate, consumptive lifestyle, even though this conflicts with their moral standards with respect to climate change. We provide some illustrations of how strategies of moral disengagement are deployed in climate change and discuss the relationship between the explanations for the motivational gap and moral disengagement. On the basis of this explanatory framework, we submit that there are three pathways to tackle the motivational gap and moral disengagement in climate change: making climate change more salient to emitters and affirming their self-efficacy; reconsidering the self-interested motives that necessitate moral disengagement; and tackling moral disengagement directly. (shrink)
Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the (...) regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)
Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as “biosimilars.”Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise (...) problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist.This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologic's cell line at the stage of the regulatory approval as the most effective remedy. (shrink)
Mandating Data Exclusivity for Pharmaceuticals Through International Agreements: A Fair Idea?Lisa Diependaele & Sigrid Sterckx - 2018 - In David Boonin, Katrina L. Sifferd, Tyler K. Fagan, Valerie Gray Hardcastle, Michael Huemer, Daniel Wodak, Derk Pereboom, Stephen J. Morse, Sarah Tyson, Mark Zelcer, Garrett VanPelt, Devin Casey, Philip E. Devine, David K. Chan, Maarten Boudry, Christopher Freiman, Hrishikesh Joshi, Shelley Wilcox, Jason Brennan, Eric Wiland, Ryan Muldoon, Mark Alfano, Philip Robichaud, Kevin Timpe, David Livingstone Smith, Francis J. Beckwith, Dan Hooley, Russell Blackford, John Corvino, Corey McCall, Dan Demetriou, Ajume Wingo, Michael Shermer, Ole Martin Moen, Aksel Braanen Sterri, Teresa Blankmeyer Burke, Jeppe von Platz, John Thrasher, Mary Hawkesworth, William MacAskill, Daniel Halliday, Janine O’Flynn, Yoaav Isaacs, Jason Iuliano, Claire Pickard, Arvin M. Gouw, Tina Rulli, Justin Caouette, Allen Habib, Brian D. Earp, Andrew Vierra, Subrena E. Smith, Danielle M. Wenner, Lisa Diependaele, Sigrid Sterckx, G. Owen Schaefer, Markus K. Labude, Harisan Unais Nasir, Udo Schuklenk, Benjamin Zolf & Woolwine (eds.), The Palgrave Handbook of Philosophy and Public Policy. Springer Verlag. pp. 575-591.details
Data exclusivity is a temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the normative legitimacy of the industry’s demand (...) to include minimum standards for data exclusivity in international agreements, this chapter evaluates the three justifications that have frequently been advanced, depicting data exclusivity as an essential policy tool to promote innovation, a mechanism to prevent the generic industry from ‘free-riding,’ and a legal instrument to protect the industry’s property rights in clinical data. (shrink)
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