Abstract
There is no doubt that the introduction of quality system principles and regulation to blood and tissue services in the 1990’s has brought about significant improvements in the control of processes and the quality of products being released for patient care. But, as regulation extends into new areas of cellular and tissue therapy, it is perhaps time to review the regulatory paradigm within which we work, and the principles that underpin it. At what point do the costs of regulation exceed the benefits to be gained? At what point to regulations cease to yield measurable benefits to patient care and safety at all, but instead become simply a burden on service providers and businesses, and ultimately the community as a whole? And is there a point at which regulation actually compromises patient care and safety, or the development of new technologies? In the early stages of regulation, there is demonstrable cost-benefit as assessed by product quality and patient outcomes. However, there is inevitably a “law of diminishing returns”, whereby the degree of improvement that can be achieved decreases and the cost of achieving that benefit increases. What has not yet been determined is whether, as regulations and regulators become more precise and more demanding, there remains a measurable net cost benefit over time, or whether there is a point at which the cost of further improvement matches, or even exceeds, the benefits to be gained. A key underpinning of the regulatory philosophy is the “Precautionary Principle”. This paper will focus on the application of the Precautionary Principle in the area of blood and tissues, which encompasses the burgeoning field of cellular therapies.
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a suggestion posed by the French philosopher Blaise Pascal that even though the existence of God cannot be determined through reason, a person should "wager" as though God exists, because by doing so the individual has potentially everything to gain, and certainly nothing to lose.
“Adversarial rulemaking deprives the affected parties and the public of the benefits of face-to-face negotiations and cooperation in developing and reaching agreement on a rule. It also deprives them of the benefits of shared information, knowledge, expertise, and technical abilities possessed by the affected parties.” 5 U.S. Code §§ 561 et seq.
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Decision theory http://en.wikipedia.org/wiki/Decision_theory
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This is an awarded paper of the ATBF conference in Perth, Australia, May 4–8, 2009.
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Kirkland, M. The precautionary principle: a double edged sword?. Cell Tissue Bank 11, 217–224 (2010). https://doi.org/10.1007/s10561-010-9182-8
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DOI: https://doi.org/10.1007/s10561-010-9182-8