Journal of Risk Research Vol. 9, No. 4, 297–311, June 2006
ARTICLE
Precaution, Science and Jurisprudence: a Test Case I. FORRESTER & J . C. HANEKAMP1
ABSTRACT This article discusses scientific, regulatory and social problems presented when there is a lack of scientific knowledge with regard to a risk. This question arises following the European Union’s recent decision to ban virginiamycin, and the ruling on that decision by the European Court of First Instance in the Pfizer Animal Health case. The authors suggest that while policy-makers ostensibly pay due deference to scientific opinion, their final assessment of risk and application of the precautionary principle will be policy-driven rather than based on science. When in doubt, they may prefer to eliminate risk by imposing a ban, rather than conduct a proper risk/benefit analysis that includes the damage caused by banning a potentially useful product. KEY WORDS: Precautionary principle, science, jurisprudence, Virginiamycin
1. Introduction The subject of this article, written by a lawyer (specialising in European Community law) and a natural scientist (specialising in chemistry), is the application of the precautionary principle in the European Union (EU). This principle presents challenging problems in several disciplines. It is variously presented by scientists and regulators as blandly normal and uncontroversial, or as muddled and even cowardly. Whatever one’s view, it is of evident 1
Ian Forrester QC practises law in Brussels and is Visiting Professor at Glasgow University. He has represented a number of pharmaceutical companies in litigation concerning the precautionary principle. Jaap C. Hanekamp PhD was a cofounder and CEO of the scientific institute of the HAN Foundation, a body dedicated to the neutral exposition of scientific data. Dr Hanekamp supervised and was co-author of the HAN publication on antibiotic growth promoters, one of the controversies examined in this article. Correspondence Address: J. C. Hanekamp, Runderweide 2, 2727 HV Zoetermeer, The Netherlands. Tel.: +31(0)793560304; Email:
[email protected] 1366-9877 Print/1466-4461 Online/06/040297–15 # 2006 Taylor & Francis DOI: 10.1080/13669870500042974
298 I. Forrester & J. C. Hanekamp significance in an increasingly regulated world whose inhabitants are becoming more aware that scientific progress may involve negative consequences, and where it is increasingly difficult to resolve controversies about safety in a manner that satisfies all interested parties. The Institutions of the EU have for a number of years regarded the precautionary principle as a crucial element in policy and legislation on the protection of human health and the environment. The European Commission, which considers the principle to be ‘‘a full-fledged and general principle of international law’’, set out to provide guidance on its use in a Communication (EC, 2000) adopted at the Nice European Council Meeting in December 2000 (see Annex III, Council Resolution on the Precautionary Principle, attached to the Presidency Conclusions of the Nice European Council meeting, 7, 8 and 9 December 2000). The Communication deserves careful scrutiny, particularly with regard to its advice on how decisions with a scientific element should be made, and its implications for the examination by the Community Courts of legislation influenced by the application of the precautionary principle. The principle tells us that precautionary action may be necessary to prevent the materialising of dangers which society chooses to deem unacceptable. Although ‘‘precaution’’ and ‘‘prevention’’ may seem almost synonymous, they should be distinguished for the purposes of applying the precautionary principle. ‘‘Prevention’’ means avoiding damage rather than remedying it after the event. The damage to be avoided is clearly defined as resulting from a specific process or product in a causal chain of events: cutting a finger in a food processor, injury caused by a car crash, foodpoisoning as a result of consuming food-borne pathogens such as Salmonella, and so forth. Thus, prevention entails putting in place measures to ensure that an already identified danger cannot materialise, or to reduce its likelihood: requiring food processors to be designed so they will not function if fingers are touching the blades, prohibiting travel at more than a specified speed, forbidding the selling of canned meats containing pathogenic micro-organisms. Precaution essentially takes prevention a step further, by deciding not to postpone legal or political intervention to prevent potential damage merely on the grounds that full scientific evidence of the causal hazard chain is lacking. Thus, application of the precautionary principle means that regulation will be introduced at an earlier stage, or that more stringent regulation will be introduced, or that an existing regulation will be applied to ban a product even before it is certain that a potential danger will indeed materialise (Wiener, 2001). The precautionary principle emerged as a doctrine cognisable by international policy-making (if not international law) at the Rio Summit in 1992. The definition of the precautionary principle drawn up at Rio, and inserted in the Declaration on Environment and Development issued at the end of the conference, is regarded as the most
Precaution, Science and Jurisprudence 299 authoritative definition of the precautionary principle. It reads as follows (Sandin, 1995): ‘‘In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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.’’
In this perspective, the precautionary principle is viewed as the core principle for achieving a ‘‘sustainable’’ society where the risks which illconsidered scientific and technological developments may present for present and future generations are curbed. (Perhaps the most notable example of sustainable development is the worldwide attempt, governed mainly by the Kyoto Protocol, to limit damage to the environment by cutting greenhouse gas emissions). The signatories to the Rio Declaration were convinced that prudence was desirable to prevent damage to the world’s climate systems, in order to ensure that the environment did indeed have a good future and that it should not be further shaken by recourse to technologies whose effects were controversial or uncertain. A technology that might be inimical to sustainable development should perhaps not be used, or used only moderately, or subject to certain safeguards. Now, ‘‘sustainability’’ is not an easy goal to define or understand; nor is it a useful criterion for considering whether to prohibit a controversial chemical. Many societies have been sustainable only by regular adaptation. Refraining from technical or political reform because of doubts about sustainability could be a prescription for never trying anything new. In this context, the environmental historian McNeill (2000) notes that history offers many examples of apparently unsustainable societies that nevertheless survived for long periods of time: ‘‘Imperial China, for all its apparent conservatism, was more rat than shark, adopting new food crops, new technologies, shifting its trade relations with its neighbours, constantly adapting—and surviving several crises.’’
In the past, though, the impact of human societies on the physical world was relatively limited. The unprecedented scientific and technological developments of the last two centuries have made it possible for man to damage not only large sections of the globe we inhabit, but the globe itself. However, the negative effects of these developments on human health or the environment are not always apparent at once. Few would have predicted a century ago what the motorcar has done to change the world, or that asbestos might have fatal effects on factory workers. (When King James the Sixth of Scotland (and First of England) published his ‘‘Counterblaste to
300 I. Forrester & J. C. Hanekamp Tobacco’’, his was probably a minority opinion; now the medical profession worldwide, not to mention the WHO, would echo his condemnation of smoking as ‘‘a custom loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lungs, and in the black stinking fume thereof nearest resembling the horrible stygian smoke of the pit that is bottomless.’’) Moreover, those who foresee dire consequences from innovation may be mistaken. It was asserted during the 1920s that frozen food could be harmful to health, but that genuine controversy on regulatory behaviour had a far less significant impact than the debate over, say, mobile telephones or microwave ovens today. The consequences of human activities for human health or the environment will continue to be unclear and uncertain, in part because science cannot always give comprehensible or reliable information on the effects of newly implemented technologies. There are several reasons for this: lack of data (knowledge), indeterminacy (non-causal random events or poorly understood non-linear interactions), measurement errors, variability (observed or predicted variation of individual responses to an identical stimulus) or a combination of these (Klinke and Renn, 2003). The last problem is well known in the medical field, where a well-defined and properly dosed pharmaceutical product may lead to widely varying side effects in different patients. This problem of diverse toxicity responses to one specific chemical compound is dealt with effectively through safety rules on how the compound may be used (for example, by warning doctors and patients of the possible side effects). The precautionary principle has been developed as a means of responding to these uncertain situations by steering society towards costeffective measures to prevent environmental degradation and protect human health. Douma’s (2003) thesis on the precautionary principle describes how it is used: ‘‘… The default rule applied in both the EC and the WTO that the burden of proof rests with the regulating authorities, obliging them to demonstrate the existence of a risk, should be applied in a precautionary manner. The threshold of producing such proof should not be set too high. …’’
Douma goes on to note: ‘‘The basic shortcoming of the way in which the precautionary principle has developed over the course of the last two decades is thus that the legislature and the executive indeed promise to abide by the principle time and time again, but at the same time no legal assurances are developed that would ensure that they actually stick to these promises. Again, if the state of the environment and the threats to human health would be diminishing, this would not be such a problem. But, since this is not the case, action is necessary to ensure that the precautionary principle takes effect and is applied in
Precaution, Science and Jurisprudence 301 practice. It needs to be applied in such a way that environmental and health interests are protected, and, at the same time, in a way that prevents unwarranted recourse as far as possible.’’
We challenge some of these assertions. Our contention is that more attention must be paid to identifying the situations where recourse to the precautionary principle would be wise, and the criteria by which decisions should be guided; and that scientific knowledge and scientific method should play a crucial role throughout the decision-making process. In other words, there must be a clear distinction between recourse to precaution on scientific grounds, and recourse to precaution on public policy grounds, if the precautionary principle is to function properly as a principle of law. 2. The EU and the precautionary principle It is interesting in this context to examine the role envisaged for science in the Commission’s Communication on the Precautionary Principle, which states that when an element of risk arises, a ‘‘scientific evaluation of the potential adverse effects should be undertaken based on the available data when considering whether measures are necessary to protect the environment, the human, animal or plant health.’’ This scientific evaluation should be ‘‘as complete as possible’’, although the final decision as to what is an acceptable risk to society is ‘‘an eminently political responsibility’’. It is obviously desirable that the scientific evaluation should indeed be as complete as possible, and this at first suggests that science is centre-stage in the EU debate on risk. However, the Commission continues: ‘‘An assessment of risk should be considered where feasible when deciding whether or not to invoke the precautionary principle. This requires reliable scientific data and logical reasoning, leading to a conclusion which expresses the possibility of occurrence and the severity of a hazard’s impact on the environment, or health of a given population including the extent of possible damage, persistency, reversibility and delayed effect. However it is not possible in all cases to complete a comprehensive assessment of risk, but all effort should be made to evaluate the available scientific information. Where possible, a report should be made which indicates the assessment of the existing knowledge and the available information, providing the views of the scientists on the reliability of the assessment as well as on the remaining uncertainties. If necessary, it should also contain the identification of topics for further scientific research’’ (emphasis added).
The Commission does not attempt to indicate when a risk assessment would or would not be ‘‘feasible’’. And while every effort should be made to evaluate whatever scientific information is available, there is no need to wait for additional information, as the process ‘‘is bound up with a less theoretical and more concrete perception of risk.’’ Indeed, the precautionary
302 I. Forrester & J. C. Hanekamp principle can be invoked ‘‘even if this [potential] risk cannot be fully demonstrated.’’ Thus, while we are told that the scientific enquiry ought to be as complete as possible, the underlined phrases in the above quotations from the Communication, and its general tenor, indicate that in a variety of circumstances the need for a thorough examination may be considered to be impracticable or unnecessary. This precautionary vagueness opens the door to a certain arbitrary element in decision-making on alleged risks. Presumably a risk assessment is likely to be dispensed with when those identifying the risk hold the view that a risk assessment is not necessary because the answer will be obvious. All of which suggests that risk management—including decisions on acceptable risks—is eminently political. In other words, invoking the precautionary principle is actually a political decision about what risk is acceptable in light of the high level of protection deemed necessary. The Communication suggests that the scientific basis for that decision may be very thin indeed, as the provisional nature of precautionary measures ‘‘is not bound up with a time limit but with the development of scientific knowledge’’. These words may mean that it will take too long to become fully informed about all aspects of the risk; or that the wisdom of a ban today may be confirmed by science tomorrow; or that the scientific material generated is not deemed to guarantee full insight into the problem; or that precautionary measures could well have a permanent temporary status. The Communication also stresses that a precautionary measure may be based on a less objective appraisal than a comprehensive risk assessment, and that the EU is entitled to prescribe whatever level of protection it deems appropriate. Finally, it is important to note what kind of precautionary measures the Commission considers appropriate. The Communication observes that a wide range of initiatives is available, from a legally binding measure to a research project or recommendation. However, although the measure chosen must be proportional, its proportionality seems to relate not to the risk in question, but to the chosen level of protection; it should not be more severe than is necessary for the level of security chosen as being appropriate. In this context, the Commission adds that a total ban may not be a proportional response to a potential risk in all cases. This raises the question of what is a proportional response when there is a lack of scientific knowledge with regard to the potential risk under scrutiny. One possible answer to this question may be found through an examination of the ruling by the Court of First Instance of the European Communities in the Pfizer Animal Health case (case T-13/99, Pfizer Animal Health v Council of the European Union). The Regulation containing the ban that gave rise to this litigation was adopted before the Communication on the Precautionary Principle was published. However, the Communication itself notes that ‘‘[t]he Community has already relied on the precautionary principle. Abundant experience has been gained over many years in the environmental field, where many measures have been inspired by the precautionary principle, such as
Precaution, Science and Jurisprudence 303 measures to protect the ozone layer or concerning climate change’’ (communication on the Precautionary Principle, Section 2, The Goals of the Communication, final paragraph). The Commission also specifies that the Communication seeks to ‘‘outline the Commission’s approach to using the precautionary principle’’ (summary of the Communication, point 2) and that its aim ‘‘is to inform all interested parties, in particular the European Parliament, the Council and the Member States, of the manner in which the Commission applies or intends to apply the precautionary principle when faced with taking decisions relating to the containment of risk’’ (emphasis and punctuation added) (section 2, The Goals of the Communication, first paragraph). Thus, it may be assumed that the approach explained in the Communication is the approach that the Commission followed when it proposed the Regulation that gave rise to the Pfizer case. 3. Virginiamycin: the Pfizer Animal Health case In human medicine, the resistance of bacteria to antibiotics, meaning that particular antibiotics do not have their normal bactericidal or bacteriostatic effect due to the increased or inherent capability of bacteria to withstand the antibiotics in question, can present a serious public health risk. For many years, antibiotics were used in the veterinary field, as growth promoters (Antimicrobial Growth Promoters or AGPs). They were added in very low doses to certain types of animal feedstuffs, a practice known to result in improved growth and weight gain in the animal, so that it needed less time and less food to attain its required weight for slaughter and excreted less manure, thus benefiting the environment. There were other beneficial effects, such as prevention of diseases in animals confined in small spaces. Farmers favoured AGPs because they enhanced animal health and prepared the livestock earlier for slaughter. On December 17, 1998, however, the EC adopted a Regulation that banned the use of four antibiotics as AGP additives in animal feedstuffs: virginiamycin, bacitracin zinc, spiramycin and tylosin phosphate. At the time the ban was adopted, no link had been proved between use of the antibiotics concerned and the development of resistance to those antibiotics in humans (Bezoen et al., 1999). A recent publication (Cox and Popken, 2004) on Virginiamycin and the health-benefits of banning its use in chicken presents the following figures: ‘‘The model shows that the theoretical statistical human health benefits of a VM ban range from zero to less than one statistical life saved in both Australia and the United States over the next five years and are rapidly decreasing.’’ It was against that background that the Council of Ministers, on the recommendation of the EC, had recourse to the precautionary principle (see further Phillips et al., 2004). It has been shown unequivocally that the use of antibiotics as growth promoters selects for (that is, tends to encourage the development of) resistant bacteria in animals (as does any other type of use of antibiotics).
304 I. Forrester & J. C. Hanekamp The risk of the transfer of resistance from animals to humans is, however, difficult if not impossible to assess, owing to lack of data. The risk assessment revolves round the extent to which the use of AGPs in animal rearing contributes to bacterial antibiotic resistance already present in humans. It has not to date been demonstrated that the use of AGPs in animal rearing has led to any deterioration in human health as a result of infectious diseases caused by resistant bacteria. Had such a deterioration been demonstrated with regard to the AGPs concerned here, we are confident the products would have been withdrawn voluntarily, before any formal ban was introduced. Indeed, although these AGPs had been used for decades, no human health problems had been attributed to them. One of the producers asserted that in thirty years of use, the product had never once been reported as compromising the treatment of a patient. However, no producer could prove this would never happen, or could never happen. Indeed, bacterial resistance that does, or might, or could, originate from use of AGPs in animal feedstuffs, has become a subject of extensive political and scientific debate in the EC. That debate opposes scientists who state that the practice of systematically giving antibiotics to animals is intrinsically undesirable and scientists who state that any decision should be based on accurately analysed evidence. When the Council Regulation was adopted, Pfizer Animal Health SA (‘‘Pfizer’’) was the only producer of virginiamycin in the world, with one factory in Belgium devoted solely to production of virginiamycin. Pfizer brought an action for annulment of the Regulation before the Court of First Instance of the European Communities (CFI). At the time when the contested Regulation was adopted, scientific views on whether virginiamycin constituted a risk to human health varied; some scientists and specialist bodies (WHO, Netherlands Health Council) considered that it did, while others (SCAN—the Scientific Committee on Animal Nutrition, the official scientific advisers to the European institutions, which reported that the evidence said to justify a ban was not convincing—and the experts called by Pfizer) did not. More specifically, the former group of scientists held the view that it was desirable to phase out a practice that could contribute to the growth of antibiotic resistance in humans. The latter group held the view that there was no evidence that such a contribution had ever occurred, and that epidemiological indicators, after decades of use, offered no support for the proposition. However, although both sides explained their respective scientific argumentation at length and in detail during the proceedings, the ruling by the CFI makes no reference to the quality or the content of those arguments. The CFI referred to the conclusions of these different specialist bodies and experts only in order to show the difference of opinion within the scientific community. The CFI noted the existence of the controversy, but held that it was not for the Court to decide whether one side or the other’s views were more plausible. Concerning the scientific debate, the Court stated the following (the full text of the ruling may be found on the website of the European Courts: http://curia.eu.int/):
Precaution, Science and Jurisprudence 305 ‘‘391 Relying on the SCAN opinion and the advice of Professor Casewell and Professor Pugh, Pfizer has, admittedly, put forward a number of factors which could be advanced to counter the argument that there is a link between the use of virginiamycin as an additive in feedingstuffs and the development of streptogramin resistance in humans. In particular, Pfizer has drawn attention to research in France and in the United States which shows that in those countries streptogramins continued to be very effective although virginiamycin had been used there as an additive in feedingstuffs for many years. Similarly, Pfizer maintained that some bacteria had a certain level of natural resistance, which was one plausible explanation for the level of streptogramin resistance observed. 392 However, Pfizer does not claim that those arguments prove conclusively that there is no link between the use of virginiamycin as an additive in feedingstuffs and the development of streptogramin resistance in humans. They merely demonstrate that the existence of such a link is ‘very unlikely’ and that other ‘plausible explanations’ existed. Furthermore, the Council and the interveners challenged the merits of Pfizer’s arguments relying, in their turn, on experts.’’
Despite these remarks, the Court continued: ‘‘393 It is not for the Court to assess the merits of either of the scientific points of view argued before it and to substitute its assessment for that of the Community institutions, on which the Treaty confers sole responsibility in that regard. In the light of the foregoing, the Court nevertheless finds that the parties’ arguments, supported in each case by the opinions of eminent scientists, show that there was great uncertainty, at the time of adoption of the contested regulation, about the link between the use of virginiamycin as an additive in feedingstuffs and the development of streptogramin resistance in humans. Since the Community institutions could reasonably take the view that they had a proper scientific basis for a possible link, the mere fact that there were scientific indications to the contrary does not establish that they exceeded the bounds of their discretion in finding that there was a risk to human health.’’
The Court (press release No 71/02, 2002. Judgments of the Court of First Instance in Cases T-13/99 and T-70/99 Pfizer Animal Health SA v Council and Alpharma Inc. v Council) ruled on the basis of precaution, the essence of its conclusions being as follows: ‘‘Despite uncertainty as to whether there is a link between the use of certain antibiotics as additives and increased resistance to those antibiotics in humans, the ban on the products is not a disproportionate measure given the need to protect public health.’’
The Court made the following analysis:
306 I. Forrester & J. C. Hanekamp – The precautionary principle as defined by the EC is confirmed – The precautionary principle has already been implemented in certain foodsafety issues (e.g. in the case of BSE, where certain beef products were banned for fear of bovine spinal encephalopathy) – Prevention, however, should be related to genuine risks, not just conjecture – The degree of risk politically established as acceptable cannot be set at zero – The decision to ban a product is political, a policy matter, and the decisionmakers need not follow scientific advice when setting it. Thus, the Court followed the same line of reasoning as that which had led the Commission to propose banning the products, and which was subsequently explained in detail in the Communication on the precautionary principle. The ruling is helpful in that it views zero risk as an unattainable goal, and seems to accept that whatever precautionary policy is adopted, total elimination of risk is impossible. However, by referring to the notion of zero risk at all, if only to exclude it, the ruling also implies that precautionary policies do reduce risk, albeit not to zero. In other words, the principle is regarded as ‘‘directional’’ in terms of risk reduction; it may not be a panacea, but it helps. This is, we submit, an erroneous assumption. Thus, although confident knowledge on which to base the taking of decisions on issues of risks such as these could only come from scientific research and its findings, the Court, like the Commission, found that such decision-making is an essentially political prerogative. This effectively obscures, and indeed devalues, the role of science in such cases. The Court relied on the fact that there was a scientific debate, and on the weight of authority of the specialist (governmental) bodies, as a basis for upholding the ban on the use of virginiamycin. It did not review the actual contents of the scientific dispute—the quality of each side’s scientific arguments or the evidence invoked. It may be argued that the judges of the European Courts are not equipped academically to evaluate a scientific debate as they would be equipped to consider a legal debate. However, judges are deemed competent to decide questions of medical negligence, the performance of marine engines, pensions, competition and many other complex issues, so examining the merits of the controversy would surely not be beyond them. Nevertheless, in administrative law the courts rarely substitute their own policy opinions for the opinions of the administration. Thus, though they would be capable of reaching a view on the merits, they commonly do not get to the merits. The inevitable result, as the Pfizer case showed, is that the line between real risk and conjecture can become very thin, since the merits of specific scientific controversies on degrees of risk are by their nature inappropriate to the decision of a Court; and the opponents of prohibition can never show the absence of risk, only its low probability. By contrast, the proponents of a ban can describe the dire consequences that might otherwise occur.
Precaution, Science and Jurisprudence 307 Moreover, in Pfizer the Court considered only the direct relation between the use of antibiotics and the risks potentially ensuing to public health. It paid little attention to Pfizer’s evidence of the risks that might arise if virginiamycin was not added to animal feedstuffs. This is one of the major flaws resulting from the current application of the precautionary principle, where bans are adopted without a thorough risk assessment. We live in a multi-risk world where any decision has a myriad of consequences, both positive and negative (Wiener, 2001; Graham and Wiener, 1995; Cross, 1996; Tengs et al., 1995; Wildavsky, 1997). Obviously, in the Pfizer case, the alleged risk of virginiamycin to human health might have evolved if use of the product had continued. Science could not answer the straightforward question of whether there was a risk of transfer of resistance, now or in the future. So the Court relied on the precautionary principle to uphold the ban, as human health was said to be at stake. Human health was perceived by the Court ‘‘through the lens’’ of the upheld ban. That the ban could result in countervailing risks—growing curative use of antibiotics in animal rearing, an increase in imports of animal products from other countries where growth promoters are allowed and so on—was barely considered by the Court. Thus, although science was involved, the Court’s final decision was based on constitutional, not legal, grounds. The ban on virginiamycin and the other AGPs was regarded as proportionate in relation to the objective pursued, namely public health. The Court based its decision not on an examination of the scientific merits, but on the fact that a controversy existed between scientists. Indeed, since according to the CFI it was ‘‘not for the Court to assess the merits of either of the scientific points of view argued before it’’; paragraph 393) it could have made its decision without any scientific input at all, by concluding that as there was a scientific dispute, and as a certain weight of authority seemed to be in favour of a ban, a ban would be justified on the grounds of the precautionary principle, irrespective of the respective merits of the scientific arguments advanced by the two sides. 4. Observations and conclusions The virginiamycin case shows that the true scientific value of the precautionary principle remains as elusive as ever. Although the scientific community is specifically invited to contribute to assessments of risk, since science is considered the best possible source of guidance on these matters, other mechanisms more imprecise and familiar than scientific evidence seem to form the basis for the way in which decision-makers and legal experts apply the precautionary principle. The Pfizer case suggests that for the CFI it is axiomatic that implementation of the precautionary principle is only risk-reductive, and that there is no need for any serious empirical scrutiny of this assumption. It was assumed that a ban on AGPs would benefit human health, or at least that the health benefits of a ban outweighed the modest drawbacks (whose
308 I. Forrester & J. C. Hanekamp potential risks to human health had not been seriously weighed). This assumption in turn was based on the supposition of resistance being transferred from animals to humans. Yet that highly undesirable phenomenon, if it has occurred, has never been shown to have hindered the treatment of any patient over many years. Moreover, it was assumed that should resistance transfer eventually be proved to take place, it would by definition pose a health risk. The existence of a scientific dispute between the adherents of this thesis and those scholars less convinced of it was noted, but the CFI did not feel free to attempt a proper analysis of the contents of the dispute itself. However, the CFI was prepared to find that the weight of authority, in the form of the positions held by those adhering to the thesis, added to the credibility of that thesis. Throughout this process of administrative and constitutional reasoning, science per se was ignored. Indeed, a profound ambiguity towards scientific knowledge is inherent in the precautionary culture. By its nature, scientific knowledge is never complete and certain, which would be the best criteria for the implementation of the precautionary principle. (In a decade or two, science unquestionably will have developed new and surprising insights.) Moreover, although the scientific knowledge which exists at any time is itself objective, scientists and government science departments are not objective, however much they may wish to be; like lawyers and regulators, they are swayed by personal prejudices, hidden agendas and similar unscientific factors, as well as the need to protect or to reassure the public. They may pursue causes, which are driven by policy agendas (‘‘pro-business’’, ‘‘Green’’, ‘‘environmentally friendly’’). On the other hand, one of the fundamental effects of the precautionary principle is to reverse the burden of proof by requiring those responsible for new scientific discoveries or new technologies to prove their achievements are not a potential source of risk, instead of requiring proof from those who allege they are. Paragraph 392 of the Pfizer judgement, cited above, is a clear example of this. Even when this demand is not stated explicitly, invoking the precautionary principle is considered to be synonymous with ‘‘securing a safe future’’. Thus, a very high level of scepticism as to what science cannot deliver goes hand in hand with a very optimistic level of confidence regarding what science should be able to deliver. In this situation, the line between real risk and mere conjecture may be practically imperceptible. Although the aid of science is enlisted, science is deemed insufficient to deliver discerning criteria. In Europe, the decisive factor for determining whether the risk is serious enough is not a scientist’s choice, but the EU Institutions’ political judgment of what risks society should accept. Although the Institutions must not base their decision on zero risk, they must take account of their obligation to ensure a level of human health protection that ‘‘does not necessarily have to be the highest that is technically possible’’. While setting zero risk as a target would be unacceptable, even the lowest imaginable level of risk from a product—or the technical inadequacies of the Member States in handling its
Precaution, Science and Jurisprudence 309 problems—would justify banning it. The ban might be necessary to pursue the highest technically feasible levels of safety. Thus, considerations labelled ‘‘scientific’’ (not religious, not humanitarian, not trade-related) and based on some assertions in the scientific literature can justify a prohibition on precautionary grounds. No distinction need be made between such a prohibition as an emergency step or as a longterm legislative choice. Whether it is temporary or permanent elimination of a product that is contemplated, the same levels of hypothesis or anxiety based on scientific opinions may suffice. The scientific risk assessment must merely allow the politicians to conclude that there is a risk to human health, even if it is small. The politicians can then determine that as a matter of public policy this level of risk is too high to be acceptable, and ban the product—with no recourse to any statistical data that may have been produced. Much depends on how the public authority assesses the acceptable level of risk in a complex scientific matter where it clearly lacks scientific expertise. The Institutions have created new scientific committees to assist the Commission in assessing the quality, safety and efficacy of pharmaceutical and veterinary products, yet they themselves do not treat those committees’ opinions and findings as a priori reliable, and do not always even take advantage of their expertise. Instead, the scientifically demonstrated (or alleged, or suggested) existence of not fanciful risks is enough. Then it is a policy, and a political, decision whether this level of risk is acceptable or not. When there is scientific uncertainty, decision-makers will inevitably be tempted to apply the precautionary principle. Judges are thought to have neither the means nor the specialised knowledge to analyse the disputed scientific issues, and they will therefore tend to put their trust in the weight of scientific authority and the desirability of the goal sought by the measure before them, i.e., protection of human health or the environment (Forrester, 2003). Moreover, the target-risk approach of the precautionary principle is inherently exclusionary; it ignores the complexity of the real multi-risk world (to exaggerate: ‘‘We are addressing the risk we have targeted for attention, and other consequences of that attention can be discarded for now’’). The assumptive nature of the precautionary principle makes it an ideal tool in the political arena, where science is not heeded or not properly heard (Hanekamp and Kwakman, 2004). Wildavsky (1997) observed this some years ago: ‘‘The precautionary principle is a marvellous piece of rhetoric. It places the speaker on the side of the citizen - I am acting for your health - and portrays opponents of the contemplated ban or regulation as indifferent or hostile to the public’s health. The rhetoric works in part because it assumes what actually should be proven, namely, that the health effects of the actions in view will be superior to the alternative. And this comparison is made favourable in
310 I. Forrester & J. C. Hanekamp the only possible way -by assuming also that there are no health detriments from the proposed regulation. The rhetoric seems to present a choice between health and money or even suggests health with no loss whatsoever, for a tangential presumption is that industry will find a better and a cheaper as well as safe way.’ Something (health) is gained with nothing lost (no adverse health effects from the bans or regulations).’’
In other words: when in doubt, it is not a bad thing to prohibit. So long as we assume the precautionary principle is risk-reductive, science will not be required (or able) to deliver the rigorous evidence sought by the courts in other spheres. The precautionary principle therefore confines legal experts to considering issues of procedural tidiness, instead of examining the empirical question of whether or not specific regulation will in fact lead to the soughtafter risk reduction. Science is of limited help, owing to the ambiguous attitude of the precautionary culture to scientific data. Science is, sadly, only one reading of the world. It would be most helpful if the level of scientific scrutiny required were to be set much higher than is now the case. Moreover, logic requires that those who insist on invoking the precautionary principle should be under the obligation to adhere to it themselves. If this requirement of ‘‘symmetry’’ were met, the outcome might very well be a return to the more classic cost-benefit analysis, probably with more factors taken into account, including risk-risk and health-health analysis. This would fit into the long-term trend in economic affairs of internalising external costs. This is why, as the United States National Research Council remarked, the policymakers’ maxim should be ‘‘science first’’ (Stern and Fineberg, 1996): ‘‘Reliable technical and scientific input is essential to making sound decisions about risk. Scientific and technical experts bring indispensable substantive knowledge, methodological skills, experience, and judgement to the task of understanding risk. … Good scientific analysis is neutral in the sense that it does not seek to support or refute the claims of any party in a dispute, and it is objective in a sense that any scientist who knows the rules of observation of the particular field of study can in principle obtain the same results’’.
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