1. innovation, public health & the precautionary principle Dr Alexandra McConnell BIICL Conference “Innovation in Lifesciences” 25 September 2008

2. 1 centrality: environment & public health “Community policy on the environment […] shall be based on the precautionary principle” (Art. 174 EC Treaty) “We reaffirm the importance of the precautionary principle as a risk management tool” (WHO Regional Office for Europe Declaration June 2004) Vorsorgeprinzip: foresight principle i.e. a proactive, anticipatory and imaginative attitude to decision-making in uncertainty

3. 2 a few definitions 1992 Rio Declaration, principle 15 “In order to protect the environment, the precautionary approach should be widely applied by States…where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation” 1998 Wingspread Declaration “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” simplest: “better safe than sorry”

4. 3 functionality justifies acting in the face of uncertainty shifts burden of proof from the public/regulator’s need to prove substance is harmful to the duty for the manufacturer to demonstrate safety stresses the fundamental importance of participation, openness and transparency in decision-making under uncertainty potential to stimulate the generation of scientific evidence about risk critics: paralysing effect since leads to a narrow viewscreen of risk (e.g. Sunstein)

5. 4 status quo: the reactionary principle burden on the public/regulator to show that the substance/activity is harmful industry reliance on uncertainty: no consideration of full range of potential health impacts of new technologies discouraging public participation in decision- making about hazard control corrupting influence of economic interests on the evidentiary base through intentional manufacturing of uncertainty paralysis of potential liability for getting it wrong

6. 5 risk v uncertainty Luhmann’s risk society quantifiable risk v uncertain scientific evidence prevention applies to known causes precaution applies to uncertain determinants, complex scenarios, suspected risk factors Giddens’ “manufactured risk” traditional drug-making: manufactured uncertainty technological advances outpace the accumulation of data, knowledge and evidence

7. 6 a political tool “As we know, There are known knowns. There are things we know we know. We also know There are known unknowns. That is to say We know there are some things We do not know. But there are also unknown unknowns, The ones we don’t know We don’t know”

8. 7 innovative risk regulation is the pp applied in regulatory decision- making about conventional drugs? Vioxx, Seroxat are innovative drugs/therapies inherently any more uncertain? who is responsible for that uncertainty/lack of scientific data? how can regulatory decision-making, using the pp, stimulate the generation of scientific evidence by industry?

9. innovation, public health & the precautionary principle Dr Alexandra McConnell BIICL Conference “Innovation in Lifesciences” 25 September 2008