The document discusses the precautionary principle and its application to managing risks related to plasma protein therapies. It provides guidelines for how risk management measures based on the precautionary principle should be proportional, non-discriminatory, consistent with similar past measures, based on risk-benefit analysis, and subject to review with new scientific findings. Responsibility for producing more information to improve risk assessment is also addressed.

1. Precautionism and plasma protein therapies PPTA Workshop International Plasma Protein Congress Paris March 2, 2009

2. “ The frequency of major crashes of Western-built jetliners in Europe jumped by more than one-third last year compared with 2007, according to the latest statistics released by the International Air Transport Association, or IATA. The rate climbed to almost one accident per two million flights in 2008, compared with one in roughly three million flights throughout the preceding three years.”

4. Good turning bad Examples of blood safety measures having deleterious outcomes (challengeable) HCV antibody testing HCV transmission by IVIG Heat treatment of FVIII Development of FVIII antibodies Plasma depletion of RCCs Y Enterocolitica infections Use of RCCs rather than whole blood Association with increase in deaths from maternal haemorrhage

9. Applications of the precautionary principle Shared concepts (1) advocating anticipatory action to prevent harm (2) shifting some of the burden of proof to the proponents of new technologies to show safety (3) advocating a consideration of all alternatives to a new technology including doing nothing (4) incorporating all affected parties in the decision-making process concerning adopting a new technology

10. Guidelines for Application of the Precautionary Principle* Proportionality "Measures...must not be disproportionate to the desired level of protection and must not aim at zero risk" Nondiscrimination "comparable situations should not be treated differently and... different situations should not be treated in the same way, unless there are objective grounds for doing so." Consistency "measures...should be comparable in nature and scope with measures already taken in equivalent areas in which all the scientific data are available." Examination of the benefits and costs of action or lack of action "This examination should include an economic cost/benefit analysis when this is appropriate and feasible. However, other analysis methods...may also be relevant" Examination of scientific developments "The measures must be of a provisional nature pending the availability of more reliable scientific data"... "scientific research shall be continued with a view to obtaining more complete data." *EC Commentary, 2 February 2000

11. "Preventive action should be taken when there is evidence that a potentially disease-causing agent is or may be blood borne, even when there is no evidence that recipients have been affected. If harm can occur, it should be assumed that it will occur. If there are no measures that will entirely prevent the harm, measures that may only partially prevent transmission should be taken" You said it Judge

14. Philosophy of Risk 1. We can tell the future from the past : linear analysis 2. We can’t tell the future from the past: non-linear, non-deterministic, chaotic WG Murphy 2003