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The influence of the precautionary principle in the civil litigation of off-label uses
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
It follows that the precautionary principle aims to establish a seamless interaction between the development of scientific knowledge and the measures to be taken to protect the public against potential risks of severe harm, without waiting for them to turn into actual ones.21 Thus, precaution does not require to take steps against purely theoretical dangerous effects. This is because potential risks, although not formally established, must have a scientific basis.22 Indeed, the first step of the implementation of the precautionary principle should always be a scientific evaluation, as complete as possible. Then, depending on the level of the potential risk, agents may decide to intervene in precaution.23 Under these circumstances, the banning of an activity is an option, but is a means of last resort.24 Importantly, the communication clarifies that the requirements for regulatory action may be fleshed out both by regulators and courts.25
Healthy People / Immuno-enhancement
Published in Jonathan Anomaly, Creating Future People, 2020
Some philosophers and social scientists invoke the ‘precautionary principle’ in cases of deep uncertainty. There are different versions of the principle, but in its strong (and original) form – developed in the context of environmental pollution – it says that if there are serious but unquantifiable risks associated with a new technology that alters the environment we should not use it. A weaker form of the precautionary principle holds that we should balance potential risks against likely benefits, and reject using the technology unless the benefits are demonstrable and large. The weak version is just a common-sense call for caution in the face of uncertainty. The strong version is implausible, since the risks of nearly all innovations are imperfectly understood. Abiding by the strong version of the precautionary principle would halt virtually all technological innovation (Sunstein, 2005).
Hazard Characterization and Dose–Response Assessment
Published in Ted W. Simon, Environmental Risk Assessment, 2019
The story of Hermann Muller is a cautionary tale about the importance of scientific integrity. If Muller’s deception was indeed based on precautionary thinking, this story highlights the wrongness of the backwards thinking embodied in the precautionary principle. The precautionary principle was first stated at the Rio Declaration of 1992: when an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.(www.unesco.org/education/pdf/RIO_E.PDF) The precautionary principle was given voice with the best of intentions—to encourage policies that protect human health and the environment in the face of uncertain risks. However, the desire for protection in the face of incomplete knowledge also has its perils—that an action taken without sufficient understanding may have unintended consequences that actually make matters worse.285
Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance
Published in The American Journal of Bioethics, 2019
Nora Hutchinson, Alexander Capron, Adélaïde Doussau
Although clinical guidelines for either reversing gadolinium accumulation or treating its effects do not yet exist, a finding of gadolinium deposition is nevertheless actionable, namely, by potentially refraining from participating in future studies that involve GBCAs. Thus, healthy participants in this study who wish to adhere to the precautionary principle could benefit by responding to their study results and reducing a potential future health risk. Although this unknowable future risk is certainly in a lesser category than a life-threatening but treatable brain tumor uncovered by chance in a research MRI study, preserving patient choice and the opportunity to avoid amassing potential risk is compelling.
Anticipatory Governance and Foresight in Regulating for Uncertainty
Published in The American Journal of Bioethics, 2022
The most philosophically substantiated account of the precautionary principle has multiple versions, rules and conditions to trigger proportionally cautious responses in the presence of scientific uncertainty (Steel 2014). While sophisticated, the scope of this account is arguably too broad and impractical. It is also embedded within a definition of scientific uncertainty that, surprisingly, does not account for well-established principles in science philosophy or the complexities of socially important but morally contentious research. According to this account:
E-cigarettes and the obsolescence of combustion
Published in Expert Review of Respiratory Medicine, 2018
A precautionary principle should be applied, which implies that a risk evaluation should be performed, assessing the consequences of adopting new technologies and the consequences of rejecting them. The precautionary principle does not imply that new technologies should be blocked until full information is available, but it implies that regulations should be proportional and should not discriminate against innovative products in favor of status quo.