The Precautionary Principle: Is it Safe
Identifieur interne : 000322 ( Istex/Corpus ); précédent : 000321; suivant : 000323The Precautionary Principle: Is it Safe
Auteurs : Maxime Gignon ; Olivier Ganry ; Olivier Jardé ; Cécile ManaouilSource :
- European Journal of Health Law [ 0929-0273 ] ; 2013.
English descriptors
- Teeft :
- Aids epidemic, Amiens university hospital, Biomedical, Biomedical research, Blood products, Blood system, Clinical investigation, Critical analysis, Educational work, Environmental issues, Environmental protection, European communities, European court reports, European journal, European union, First instance, Future drug development, Gignon, Health protection, Health risks, Human rights, Influenza pandemic, Irreversible damage, Medical context, Medical research, Nuremberg code, Official journal, Pandemic, Policy makers, Powerful tool, Precautionary, Precautionary principle, Pregnant women, Protective measures, Public health, Public health policy, Public opinion, Regulatory texts, Risk assessment, Risk management, Scientific data, Scientific evidence, Scientific uncertainty, Substantive version, Unknown areas.
Abstract
Abstract The precautionary principle is generally acknowledged to be a powerful tool for protecting health but it was originally invoked by policy makers for dealing with environmental issues. In the 1990s, the principle was incorporated into many legislative and regulatory texts in international law. One can consider that the precautionary principle has turned into “precautionism” necessary to prove to the people, taking account of risk in decisions. There is now a risk that these abuses will deprive the principle of its meaning and value. When pushed to its limits, the precautionary principle can even be dangerous when applied to the healthcare field. This is why a critical analysis of the principle is necessary. Through the literature, it sometimes seems to deviate somehow from the essence of the precautionary principle as it is commonly used in relation to health. We believe that educational work is necessary to familiarize professionals, policy makers and public opinion of the precautionary principle and avoid confusion. We propose a critical analysis of the use and misuse of the precautionary principle.
Url:
DOI: 10.1163/15718093-12341272
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ISTEX:FDD8BBCBA44B37BB3EF1F56E14DE5203815D0CECLe document en format XML
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We propose a critical analysis of the use and misuse of the precautionary principle.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>precautionary principle</term></item><item><term>public health policy</term></item><item><term>ethic</term></item><item><term>biomedical research</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2013">Created</change><change when="2013">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/JKT-0LTVPQM8-8/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus brill-journals not found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="http://dtd.nlm.nih.gov/publishing/2.3/journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article">
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<name>
<surname>Gignon</surname>
<given-names>Maxime</given-names>
</name>
<xref ref-type="aff"><sup>a</sup></xref>
<xref ref-type="aff"><sup>b</sup></xref>
<xref ref-type="aff"><sup>c</sup></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ganry</surname>
<given-names>Olivier</given-names>
</name>
<xref ref-type="aff"><sup>a</sup></xref>
<xref ref-type="aff"><sup>b</sup></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Jardé</surname>
<given-names>Olivier</given-names>
</name>
<xref ref-type="aff"><sup>b</sup></xref>
<xref ref-type="aff"><sup>d</sup></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Manaouil</surname>
<given-names>Cécile</given-names>
</name>
<xref ref-type="aff"><sup>b</sup></xref>
<xref ref-type="aff"><sup>d</sup></xref>
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<aff>
<sup>a</sup> 1 Public Health Department, Amiens University Hospital, place Victor Pauchet, F-80054 Amiens cedex 1, France
<sup>b</sup> Medical School — Jules Verne University of Picardy, Amiens, France
<sup>c</sup> University Paris 13, Sorbonne Paris Cité, Laboratory of Health Pedagogy, Bobigny, France
<sup>d</sup> Forensic Medicine and Medical Law Unit, Amiens University Hospital, Amiens, France
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<abstract>
<sec>
<title><bold>Abstract</bold></title>
<p>The precautionary principle is generally acknowledged to be a powerful tool for protecting health but it was originally invoked by policy makers for dealing with environmental issues. In the 1990s, the principle was incorporated into many legislative and regulatory texts in international law. One can consider that the precautionary principle has turned into “precautionism” necessary to prove to the people, taking account of risk in decisions. There is now a risk that these abuses will deprive the principle of its meaning and value. When pushed to its limits, the precautionary principle can even be dangerous when applied to the healthcare field. This is why a critical analysis of the principle is necessary. Through the literature, it sometimes seems to deviate somehow from the essence of the precautionary principle as it is commonly used in relation to health. We believe that educational work is necessary to familiarize professionals, policy makers and public opinion of the precautionary principle and avoid confusion. We propose a critical analysis of the use and misuse of the precautionary principle.</p>
</sec>
</abstract>
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<kwd>precautionary principle</kwd>
<kwd>public health policy</kwd>
<kwd>ethic</kwd>
<kwd>biomedical research</kwd>
</kwd-group>
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<body>
<sec id="B10.1163_15718093-12341272_001" sec-type="head1">
<title><bold>1. Introduction</bold></title> <p>The precautionary principle was originally invoked by policy makers for dealing with environmental issues, such as global warming. It was then suggested that the principle could also be applied to medical issues. The present paper seeks to clarify what the precautionary principle may reasonably be taken to mean in a medical context. The Rio Declaration on Environment and Development stated that “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”.<xref ref-type="fn" rid="FN1"><sup>1</sup></xref></p>
<p>The precautionary principle is generally acknowledged to be a powerful tool for protecting health.<xref ref-type="fn" rid="FN2"><sup>2</sup></xref> It is reported that “public health advocates around the world have increasingly invoked the precautionary principle as a basis for preventive actions”<xref ref-type="fn" rid="FN3"><sup>3</sup></xref> and that the latter will contribute to better public health decisions.<xref ref-type="fn" rid="FN4"><sup>4</sup></xref> In a society concerned about risks and prevention,<xref ref-type="fn" rid="FN5"><sup>5</sup></xref> it is not surprising that the precautionary principle has been successful. The precautionary principle is the flip side of “risk assessment”. However, a variety of stakeholders have used and abused the precautionary principle in the name of public health protection; there is now a risk that these abuses will deprive the principle of its meaning and value. Through the literature, it sometimes seems to deviate somehow from the essence of the precautionary principle as it is commonly used in relation to health.</p>
</sec>
<sec id="B10.1163_15718093-12341272_002" sec-type="head1">
<title><bold>2. How the Precautionary Principle Arose</bold></title> <p>The precautionary principle was created in the mid-1970s as part of Germany’s environmental protection policy. It consists in taking protective measures against unidentified or poorly identified risks. It goes beyond the notion of prevention, which seeks solely to minimize the impact of identified risks.</p>
<p>In 1992, the United Nations organized a Conference on Environment and Development in Rio de Janeiro, Brazil.<sup>1</sup> The resulting Rio Declaration asserts that when there is suspected harm and the scientific evidence is inconclusive, the prescribed course is precautionary action: “Nations shall use the precautionary principle to protect the environment. Where there are threats of serious or irreversible damage, scientific uncertainty shall not be used to postpone cost-effective measures to prevent environmental degradation”. The Conference’s goal was to advance the concept of nations’ rights and responsibilities in the environmental field. Although the Declaration is not legally binding, it constitutes a moral commitment. The precautionary principle is now increasingly accepted in relation to environmental safety. In the 1990s, the principle was incorporated into many legislative and regulatory texts in international law.</p>
<p>The European Union also refers to the precautionary principle.<xref ref-type="fn" rid="FN6"><sup>6</sup></xref> The Treaty on European Union, signed on 1992 in Maastricht, states that EU policy on the environment shall contribute to the protection of human health.<xref ref-type="fn" rid="FN7"><sup>7</sup></xref> The link between environmental protection and health protection is clear and the precautionary principle has shifted from one to the other. The Community authorities’ practical experience and its judicial review make it possible to get an ever-better handle on the precautionary principle.</p>
<p>The precautionary principle spread rapidly into the field of food safety,<xref ref-type="fn" rid="FN8"><sup>8</sup></xref> following a ruling by the European Court on the beef embargo during the “mad cow disease” crisis. The Court considered that “where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent”.<xref ref-type="fn" rid="FN9"><sup>9</sup></xref> This case law was mentioned by the Court of First Instance in a judgement concerning protection of consumer health.<xref ref-type="fn" rid="FN10"><sup>10</sup></xref> A year later, the President of the Court of First Instance explicitly mentions the precautionary principle and affirms that “requirements linked to the protection of public health should undoubtedly be given greater weight that economic considerations.”<xref ref-type="fn" rid="FN11"><sup>11</sup></xref></p>
<p>The Court explicitly extended the precautionary principle to the field of public health in 2002 by making it a general principle of EU law.<xref ref-type="fn" rid="FN12"><sup>12</sup></xref> In fact, the Court justified its decision by stating that “therefore, although the precautionary principle is mentioned in the Treaty only in connection with environmental policy, it is broader in scope. It is intended to be applied in order to ensure a high level of protection of health”. Thus, the precautionary principle places an obligation on Member States when they legislate in the field of public health.</p>
<p>Hence the Commission considers that the precautionary principle is a general one which should in particular be taken into consideration in the fields of environmental protection and human, animal and plant health.</p>
<p>In 2000, the Commission established guidelines for applying the precaution principle.<xref ref-type="fn" rid="FN13"><sup>13</sup></xref> First, the precautionary principle should be considered within a structured approach to the analysis of risk, based on risk assessment, risk management, and risk communication. Decision-makers should use the precautionary principle in the management of risk. If it should not be confused with the element of caution that scientists apply in their assessment of scientific data, but we note that sometimes it is not so clear. The Commission notes that “the implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty”. So, before the precautionary principle is invoked, the scientific data relevant to the risks must first be evaluated. The scientific data analysis should provide the extent of possible damage, persistency, reversibility and delayed effect. Unfortunately it is not always possible in all cases to complete a comprehensive assessment of risk. Risk assessment consists of four components — namely hazard identification, hazard characterisation, appraisal of exposure and risk characterisation. However, there are limits of scientific knowledge and scientific uncertainty is linked to the scientific method. The concept of risk and the scientific uncertainty, are complex concepts to understand for the public opinion and sometimes also for policymakers. However, the appropriate response in a given situation is thus an eminently political decision. There is a whole range of actions available to decision-makers under the head of the precautionary principle: law and regulation texts to produce legal but also the decision to fund a research programme or even the decision to inform the public.</p>
<p>At the outset, the philosophical concept of “precaution” was related to forecasting and anticipating the consequences of human activity. The Commission’s guidelines are provides concrete guidance for applying the precautionary principle. However, the social extension of this concept has gradually prompted an inappropriate use of the “precautionary principle” by policy makers faced with risks and uncertainties. Media coverage of health issues causes a growing concern about health risks in public opinion. However, the field of health and medical research creates new uncertainties and new risks, real, potential or virtual.</p>
<p>The precautionary principle is commonly used as a principle that applies to public health/safety in general; as such it is not related to the individual doctor-patient relationship, to the patient’s bedside or to medical research. However, several authors have also suggested that the precautionary principle may as well be applied to medical issues.<xref ref-type="fn" rid="FN14"><sup>14,</sup></xref><xref ref-type="fn" rid="FN15"><sup>15,</sup></xref><xref ref-type="fn" rid="FN16"><sup>16,</sup></xref> <xref ref-type="fn" rid="FN17"><sup>17</sup></xref>In 2007, Peterson seeks to clarify what the precautionary principle may reasonably be taken to mean in a medical context.<xref ref-type="fn" rid="FN18"><sup>18</sup></xref> We note that there is a “misuse” of the precautionary principle. At the risk of trivializing, one can consider that the inappropriate use of the precautionary principle has turned into “precautionism”. A critical analysis of this inappropriate use of the precautionary principle in the field of health is necessary.</p>
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<title><bold>3. A Critical Analysis of the Inappropriate Use of the Precautionary Principle in the Field of Health</bold></title> <p>The “extension” of the precautionary principle now brings many health and political actors to invoke so inadequate, confusing caution, prevention and precaution. Some authors have improperly extended the precautionary principle to the individual doctor-patient relationship or to medical research.</p>
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<title>3.1. <italic>Are too Many Precautions Being Taken in Public Health Policies</italic></title> <p>At first glance, extension of the precautionary principle appears to be a powerful tool for protecting public health. It enables the development of <italic>a priori</italic> checks on subjects such as nanotechnology.<xref ref-type="fn" rid="FN19"><sup>19</sup></xref> It is also invoked in the implementation of plans to prepare the population for potential health crises (an influenza pandemic, for example).<xref ref-type="fn" rid="FN20"><sup>20</sup></xref> Political leaders consider the precautionary principle when building organization structures and deploying resources to prepare for a potential health crisis. Although this anticipatory approach may appear to be reasonable and wise, it is subject to much debate.<xref ref-type="fn" rid="FN21"><sup>21</sup></xref><xref ref-type="fn" rid="FN22"><sup>22</sup></xref></p>
<p>The unexpected emergence and rapid worldwide spread of swine flu triggered national and international efforts to provide citizens with information on this topic; although there was uncertainty about how the virus would behave. Furthermore, the social and cultural context was marked by increasing use of social media as a means of communication. It also generated problems for stakeholders having to communicate about the risks posed by the disease and the corresponding responses and treatment, as traditional, well-controlled channels of communication channels were bypassed.<xref ref-type="fn" rid="FN23"><sup>23</sup></xref> Thus, the precautionary principle has been used widely to reassure citizens.</p>
<p>When considering the notion of risk, one can distinguish between prudence (for known events with a known likelihood of occurrence), prevention (for known events whose likelihood of occurrence cannot be assessed) and precaution (for ill-defined events, the scope of which cannot be assessed by current scientific and technical knowledge). In the influenza pandemic, the risk was known but ill-defined at the outset. So, should the response to the pandemic be prevention and not precaution?</p>
<p>Here, the notion of risk is central. Even though the influenza risk has since been proven, it was not clear at the time which decisions would protect public health. Although the virus was likely to be highly contagious, its virulence, attack rate and mutation rate were not known. The first set of consolidated scientific data was published a year after the start of the pandemic.<xref ref-type="fn" rid="FN24"><sup>24</sup></xref></p>
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<title>3.2. <italic>Precaution at the Patient’s Bedside, an Inappropriate Use of the Principle</italic></title> <p>Some authors seem to have an inappropriate use the precautionary principle in the context of care practice.<xref ref-type="fn" rid="FN25"><sup>25</sup></xref> The caregiver-patient relationship is characterized by a choice between risks generated by the disease and those inherently related to the treatment. With advice from the physician, the patient chooses the most appropriate treatment option. This choice requires the patient to make an assessment of the risk-benefit balance, which in turn requires high-quality information. Discussion of the risk-benefit balance is especially important in surgery. The risks associated with anaesthesia and surgical procedures must be weighed against the expected benefits of each treatment option — including the postponement or absence of treatment.</p>
<p>The “hijacking” of the precautionary principle in a medical context can be used as a pretext for changes in medical practice.<xref ref-type="fn" rid="FN26"><sup>26</sup></xref> Some physicians strictly enforce their patients’ rights because they believe that this approach will reduce their liability. “I gave you all the information, now you choose!” Once information is disclosed, it may highlight doubts and fears; the patient is then faced with making the decision. In case of dispute, research discussion benefit / risk, is also one of the bases of the law of medical malpractice.<xref ref-type="fn" rid="FN27"><sup>27</sup></xref></p>
<p>When there is uncertainty concerning the diagnostic process, the deviation of the “precautionary principle at the bedside” requires one consider the most serious consequences — even if the latter are rare. In this approach (which is intended to be beneficial), the practitioner is then prompted to prescribe a broad range of diagnostic and therapeutic procedures, with the risk of harm to the patient and expense for society in general. This “you never know” approach has evolved into an obligation to provide care with no guarantee of a positive outcome for the patient. There is a risk of conflict with the principles of medical reasoning and evidence-based medicine.</p>
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<title>3.3. <italic>Precaution in Biomedical Research</italic></title> <p>Risks are inherent to biomedical research and because of the physical integrity of the trial subject should be kept to the minimum. However, biomedical research was subject to ethical and legislative frameworks long before consecration of the precautionary principle. The right of biomedical research, is influenced by several international conventions to which the European Convention on Human Rights<xref ref-type="fn" rid="FN28"><sup>28</sup></xref> or the Convention of Oviedo.<xref ref-type="fn" rid="FN29"><sup>29</sup></xref></p>
<p>In essence, biomedical research seeks to test a hypothesis that is supported by scientific evidence but which may be ineffective or even harmful for some of the study participants. This approach is justified by the potential benefits for individual patients and for society as a whole. Life science research can open the door to advances that are as fascinating as they are frightening.</p>
<p>In 1947, the Nuremberg Code laid the foundations of today’s national and international legislations and ethical guidelines.<xref ref-type="fn" rid="FN30"><sup>30</sup></xref> It laid down the principle of the consent to participation, stated the obligation to limit the risks to which participants were exposed and emphasized the need for highly qualified investigators. Since then, various revisions of the Declaration of Helsinki (first signed in 1964) have covered most fields of biomedical research.</p>
<p>Given the risks that are inherent to biomedical research, it might be tempting to invoke the precautionary principle as a means of protection. Some authors have explored the “potential role of the precautionary principle in providing greater safety in clinical trials”.<xref ref-type="fn" rid="FN31"><sup>31</sup></xref> If the right of biomedical research is not commonly related to the precautionary principle which is about decision making at a more general level, it seems have some confusions. These distinct situations should not be mixed up.</p>
<p>It is important to distinguish a “substantive version” of the precautionary principle from a “procedural version”. The “substantive version” is an extreme approach that seeks to suspend any research in which risks are present. In contrast, the “procedural approach” involves a risk assessment process. The latter interpretation does not block biomedical research but strengthens the risk assessment for participants. Under a substantive approach, the first face allograft would not have been allowed.<xref ref-type="fn" rid="FN32"><sup>32</sup></xref> The ethical foundations of biomedical research relate to benefit for the community (which includes the participant), rather than for individual him/herself. There is no need to favour the individual over the community; from an ethical standpoint, biomedical research is founded on sharing risk. However, researchers are faced with limitations through application of the precautionary principle. Research involves the production of new knowledge and thus necessarily requires unknown areas to be explored. In contrast, researchers may sometimes have the impression that the precautionary principle is sometimes experienced by as the lack of exploration of unknown areas. One example is drug trials in pregnant women. Research is usually forbidden in this population but there is also a particular risk of depriving pregnant women of a certain number of active drugs. Hence, some interpretations of the precautionary principle may hamper the development of knowledge.</p>
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<title><bold>4. The Influence of the Precautionary Principle in the EU Health Regulations</bold></title> <p>It is evident that in relation to health, European Union regulations are imbued with the precautionary principle. This in particular when it concerns the use of human organs or tissues in healthcare. The consequence of the precautionary principle is visible in testing and traceability requirements. Emerging health risks from the products of the human body are very difficult to quantify. For example, it is difficult to estimate with sufficient precision the risks for the patients who are need of blood and blood products. In the 80’s, we assisted at the AIDS epidemic in the haemophilia population after the administering of blood products. Evatt reminds us that the use of heat-treated clotting factors in patients with haemophilia effectively stopped AIDS transmission; however, all licensed technologies were not equally effective at inactivating HIV. Lacking clinical data and robust validated methods of testing inactivating technology, these seroconversions could not be predicted in advance.<xref ref-type="fn" rid="FN33"><sup>33</sup></xref> During the 2000s, several Directives have regulated security measures. However the Directive does not establish a uniform European safety policy for blood and blood products. It achieves harmonisation at a minimum level. According to Derckx, a maximum level would include measures to eliminate beforehand all risks one could think of, based on the precautionnary principle, an optimal level aims at the introduction of safety measures that are based upon the scientific state of the art.<xref ref-type="fn" rid="FN34"><sup>34</sup></xref> However, there is difficulty in balancing the risk prevented by applying a precautionary measure against the risk for shortages of blood. That is why Wilson suggests developing a precautionary principle specifically for the blood system to prevent such a situation from occurring.<xref ref-type="fn" rid="FN35"><sup>35</sup></xref> The more human bodily material will be used in healthcare, the more the precautionary principle will be of interest. A major field of concern of precautionary measures are medicinal products and devices of human or animal origin because of their potential risks by contamination with pathogens.<xref ref-type="fn" rid="FN36"><sup>36</sup></xref></p>
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<title><bold>5. Conclusion</bold></title> <p>Some authors argue that the precautionary principle is ingrained in law and in our minds and thus affects our entire society.<xref ref-type="fn" rid="FN37"><sup>37</sup></xref> This could explain the confusion between the precautionary principle as previously described in international and misuse in health care or biomedical research. The principle sometimes tends to be used as justification for doing nothing.<xref ref-type="fn" rid="FN38"><sup>38</sup></xref> Some authors are worried about this trend because they believe that “the radical application of the precautionary principle in medicine may cause a first irrational safety and create serious obstacles to technological innovation”.<xref ref-type="fn" rid="FN39"><sup>39</sup></xref> Thus, it seems necessary to apply the precautionary principle as a method of risk management to make progress in fields where lack of knowledge is inevitable, rather than a refusal to explore the new, unknown realms created by technological progress. The precautionary principle has grown in response to a profoundly felt societal need. The impressive scientific advances of the twentieth century have created hope, revolutionized our lives and opened up fascinating but sometimes frightening opportunities with new associated risks. When medical science had only a few therapeutic options at its disposal, the inevitability of sickness and death was accepted. At that time, divine nature was considered to be more powerful than humankind. Medical progress has challenged this view but risk has now become unacceptable.</p>
<p>The more our knowledge progresses, the more readily we identify the risks that we face and that might threaten us. In terms of healthcare, our society has never been so safe and we have never had so many means of preserving health — yet the perception of danger persists and grows.</p>
<p>Using the precautionary principle does not necessarily lead to wiser decisions in public health policy. It is the role of governments and their public health authorities to seek and protect the common good. That is at the core of the precautionary principle and at the heart of democracy. The wrong interpretation and confusion around the precautionary principle fuels controversy. The controversy over the precautionary principle is nevertheless instructive and fascinating and has been instrumental in stimulating critical debate on public health and health policy. Some authors propose a framework for applying the precautionary principle to potential public health risks, based on adequacy of the evidence of causation, severity of harm and acceptability of the precautionary measures.<xref ref-type="fn" rid="FN40"><sup>40</sup></xref> We believe that educational work is necessary to familiarize professionals, policy makers and public opinion of the precautionary principle and avoid confusion. The precautionary principle in relation to health is an important issue and it even may become more important in future.</p>
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<fn id="FN1"><p><sup>1)</sup> United Nations General Assembly. 1992. “Rio Declaration on Environment and Development.” Report of the United Nations Conference on Environment and Development, Rio de Janeiro, June 3-14, 1992. A/CONF.151/26 (Vol. I). New York: UN. Retrieved 15 January 2013 <ext-link ext-link-type="url" xlink:href="http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm">http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm</ext-link>.</p></fn>
<fn id="FN2"><p><sup>2)</sup> I.B. Pless, “Expanding the precautionary principle”, <italic>Injury Prevention</italic> 9(1) (2003) 1-2.</p></fn>
<fn id="FN3"><p><sup>3)</sup> B.D. Goldstein, ‘The precautionary principle also applies to public health actions’, <italic>American Journal of Public Health</italic> 91(9) (2001) 1358-62.</p></fn>
<fn id="FN4"><p><sup>4)</sup> B.D. Goldstein, “Problems in applying the precautionary principle to public health”, <italic>Occupational & Environmental Medicine</italic> 64(9) (2007) 71-4.</p></fn>
<fn id="FN5"><p><sup>5)</sup> P. Fugelli, “The Zero-vision: potential side effects of communicating health perfection and zero risk”, <italic>Patient Education & Counselling</italic> 60(3) (2006) 267-71.</p></fn>
<fn id="FN6"><p><sup>6)</sup> Art. 174. Treaty establishing the European Community. Official Journal C 325, 24 December 2002 pp. 0107-0108.</p></fn>
<fn id="FN7"><p><sup>7)</sup> Art. 130 R. Treaty on European Union, Official Journal C 191, 29 July 1992.</p></fn>
<fn id="FN8"><p><sup>8)</sup> Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Official Journal of the European Communities, L 31, 1 February 2002.</p></fn>
<fn id="FN9"><p><sup>9)</sup> Judgment of the Court of 5 May 1998. — <italic>United Kingdom of Great Britain and Northern Ireland v. Commission of the European Communities</italic> [1998]. Case C-180/96. European Court reports 1998 Page I-02265.</p></fn>
<fn id="FN10"><p><sup>10)</sup> Judgement of the Court of First Instance (Third Chamber) of 16 July 1998, case T-199/96. <italic>Laboratoires pharmaceutiques Bergaderm SA and Jean-Jacques Goupil v. Commission of the European Communities</italic> [1998] — European Court reports 1998 Page II-02805.</p></fn>
<fn id="FN11"><p><sup>11)</sup> Order of the President of the Court of First Instance of 30 June 1999, case T-70/99 <italic>R. Alpharma Inc. v. Council of the European Union</italic>. [1999] — European Court reports 1999 Page II-02027.</p></fn>
<fn id="FN12"><p><sup>12)</sup> Judgment of the Court of First Instance (Second Chamber, extended composition) of 26 November 2002. <italic>Artegodan GmbH and Others v. Commission of the European Communities</italic> [2002] — European Court reports Page II-04945.</p></fn>
<fn id="FN13"><p><sup>13)</sup> Communication from the Commission on the precautionary principle /* COM/2000/0001 final */ Retrieved 27 February 2013. <ext-link ext-link-type="url" xlink:href="http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52000DC0001:EN:HTML">http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52000DC0001:EN:HTML</ext-link></p></fn>
<fn id="FN14"><p><sup>14)</sup> D. Resnik, “The precautionary principle and medical decision making”, <italic>The Journal of Medicine and Philosophy</italic> 29(3) (2004) 281-99.</p></fn>
<fn id="FN15"><p><sup>15)</sup> D. Resnik, “Is the precautionary principle unscientific?”, <italic>Studies in History and Philosophy of Science Part C. Studies in History and Philosophy of Biological and Biomedical Sciences</italic> 34 (2003) 329-44.</p></fn>
<fn id="FN16"><p><sup>16)</sup> D.L. Weed, “Precaution, prevention, and public health ethics”, <italic>The Journal of Medicine and Philosophy</italic> 29(3) (2004) 313-32.</p></fn>
<fn id="FN17"><p><sup>17)</sup> S. Alban, “The ‘precautionary principle’ as a guide for future drug development”, <italic>European Journal of Clinical Investigation</italic> 35 (2005) 33-44.</p></fn>
<fn id="FN18"><p><sup>18)</sup> M. Peterson, “Should the precautionary principle guide our actions or our beliefs?” <italic>Journal of Medical Ethics</italic> 33(1) (2007) 5-10.</p></fn>
<fn id="FN19"><p><sup>19)</sup> S. Lacour, “A legal version of the nanoworld”, <italic>Comptes Rendus Physique</italic> 12(7) (2011) 693-701.</p></fn>
<fn id="FN20"><p><sup>20)</sup> M. Basili, M. Franzini, “Understanding the risk of an avian flu pandemic: rational waiting or precautionary failure?”, <italic>Risk Analysis</italic> 26(3) (2006) 617-30.</p></fn>
<fn id="FN21"><p><sup>21)</sup> J. Zarocostas, “Swine flu pandemic review panel seeks access to confidential documents between WHO and drug companies”, <italic>BMJ</italic> 340 (2010) 2792.</p></fn>
<fn id="FN22"><p><sup>22)</sup> D. Cohen and P. Carter, “Conflicts of interest. WHO and the pandemic flu ‘conspiracies’ ”, <italic>BMJ</italic> 340 (2010) 2912.</p></fn>
<fn id="FN23"><p><sup>23)</sup> B. Nerlich and N. Koteyko, “Crying wolf? Biosecurity and metacommunication in the context of the 2009 swine flu pandemic”, <italic>Health & Place</italic> 18(4) (2012) 710-717.</p></fn>
<fn id="FN24"><p><sup>24)</sup> C. Viboud, M. Miller, D. Olson, M. Osterholm and L. Simonsen, “Preliminary Estimates of Mortality and Years of Life Lost Associated with the 2009 A/H1N1 Pandemic in the US and Comparison with Past Influenza Seasons”, <italic>PLoS currents</italic>. (2010) RRN1153.</p></fn>
<fn id="FN25"><p><sup>25)</sup> J. Tickner and J.M. Coffin, “What does the precautionary principle mean for evidence-based dentistry?”, <italic>Journal of Evidence-Based Dental Practice</italic> 6(1) (2006) 6-15.</p></fn>
<fn id="FN26"><p><sup>26)</sup> A.C. Masquelet, “Le principe de précaution en médecine clinique” In D. Lecourt. <italic>La santé face au principe de précaution</italic>. (Paris: Presses Universitaires de France, 2010).</p></fn>
<fn id="FN27"><p><sup>27)</sup> M. Gignon, C. Manaouil and O. Jardé, “La discussion bénéfices/risques en pratique chirurgicale: Pourquoi? Comment?” <italic>Journal de Chirurgie</italic> 144(1) (2007) 19-24.</p></fn>
<fn id="FN28"><p><sup>28)</sup> Convention for the Protection of Human Rights and Fundamental Freedoms. Retrieved 19 March 2013 <ext-link ext-link-type="url" xlink:href="http://www.echr.coe.int/NR/rdonlyres/D5CC24A7-DC13-4318-B457-5C9014916D7A/0/Convention_ENG.pdf">http://www.echr.coe.int/NR/rdonlyres/D5CC24A7-DC13-4318-B457-5C9014916D7A/0/Convention_ENG.pdf</ext-link>.</p></fn>
<fn id="FN29"><p><sup>29)</sup> Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Retrieved 19 March 2013 <ext-link ext-link-type="url" xlink:href="http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm">http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm</ext-link>.</p></fn>
<fn id="FN30"><p><sup>30)</sup> The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946-April 1949. Washington D.C.: U.S. G.P.O, 1949-1953.</p></fn>
<fn id="FN31"><p><sup>31)</sup> G.E. Marchant, R.A. Lindor, “Prudent precaution in clinical trials of nanomedicines”, <italic>The Journal of Law, Medicine & Ethics</italic> 40(4) (2012) 831-40.</p></fn>
<fn id="FN32"><p><sup>32)</sup> B. Devauchelle, L. Badet, B. Lengelé, E. Morelon, S. Testelin, M. Michallet, C. D’Hauthuille and J.M. Dubernard, “First human face allograft: early report”, <italic>Lancet</italic> 368(9531) (2006) 203-9.</p></fn>
<fn id="FN33"><p><sup>33)</sup> B.L. Evatt, “The AIDS epidemic in haemophilia patients II: pursuing absolute viral safety of clotting factor concentrates 1985-1988”, <italic>Haemophilia</italic> 18(5) (2012) 649-54.</p></fn>
<fn id="FN34"><p><sup>34)</sup> V. Derckx and H. Roscam Abbing, “Patients rights to health protection and quality and safety of blood (products)”, <italic>European Journal of Health Law</italic> 12(2) (2005) 158-159.</p></fn>
<fn id="FN35"><p><sup>35)</sup> K. Wilson, M. Wilson, P.C. Hébert, I. Graham, “The application of the precautionary principle to the blood system: the Canadian blood system’s vCJD donor deferral policy”, <italic>Transfusion medicine reviews</italic> 17(2) (2003) 89-94.</p></fn>
<fn id="FN36"><p><sup>36)</sup> S. Alban, “The ‘precautionary principle’ as a guide for future drug development”, <italic>European Journal of Clinical Investigation</italic>, 35(suppl 1) (2005) 33-44.</p></fn>
<fn id="FN37"><p><sup>37)</sup> G. David, “La Médecine saisie par le principe de précaution”, <italic>Bulletin de l’Académie Nationale de Médecine</italic> 182(6) (1998) 1219-28.</p></fn>
<fn id="FN38"><p><sup>38)</sup> F. Demichel, “Le droit malade de la peste: les ravages du principe de précaution” <italic>Revue Générale de Droit Médical</italic> 37 (2010) 303-320.</p></fn>
<fn id="FN39"><p><sup>39)</sup> L. Picard, S. Bracard, M. Braun, R. Anxionnat, C. Moret, A. Lebedinsky, S. Finitsis, E. Schmitt and S. Kremer, “Risques et responsabilités en radiologie diagnostique et interventionnelle. Aspects éthiques et médico-légaux”, <italic>Journal de Radiologie</italic> 86 (2005) 579-85.</p></fn>
<fn id="FN40"><p><sup>40)</sup> E. Weir, R. Schabas, K. Wilson and C. Mackie, “A Canadian framework for applying the precautionary principle to public health issues”, <italic>Canadian Journal of Public Health</italic>, 101(5) (2010) 396-8.</p></fn>
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</istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>The Precautionary Principle: Is it Safe</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>The Precautionary Principle: Is it Safe</title></titleInfo><name type="personal"><namePart type="given">Maxime</namePart><namePart type="family">Gignon</namePart><affiliation> 1 Public Health Department, Amiens University Hospital, place Victor Pauchet, F-80054 Amiens cedex 1, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Ganry</namePart><affiliation> 1 Public Health Department, Amiens University Hospital, place Victor Pauchet, F-80054 Amiens cedex 1, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Jardé</namePart><affiliation> Medical School — Jules Verne University of Picardy, Amiens, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cécile</namePart><namePart type="family">Manaouil</namePart><affiliation> Medical School — Jules Verne University of Picardy, Amiens, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>Martinus Nijhoff Publishers</publisher><place><placeTerm type="text">Netherlands</placeTerm></place><dateIssued encoding="w3cdtf">2013</dateIssued><dateCreated encoding="w3cdtf">2013</dateCreated><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract>Abstract The precautionary principle is generally acknowledged to be a powerful tool for protecting health but it was originally invoked by policy makers for dealing with environmental issues. In the 1990s, the principle was incorporated into many legislative and regulatory texts in international law. One can consider that the precautionary principle has turned into “precautionism” necessary to prove to the people, taking account of risk in decisions. There is now a risk that these abuses will deprive the principle of its meaning and value. When pushed to its limits, the precautionary principle can even be dangerous when applied to the healthcare field. This is why a critical analysis of the principle is necessary. Through the literature, it sometimes seems to deviate somehow from the essence of the precautionary principle as it is commonly used in relation to health. We believe that educational work is necessary to familiarize professionals, policy makers and public opinion of the precautionary principle and avoid confusion. We propose a critical analysis of the use and misuse of the precautionary principle.</abstract><subject><genre>keywords</genre><topic>precautionary principle</topic><topic>public health policy</topic><topic>ethic</topic><topic>biomedical research</topic></subject><relatedItem type="host"><titleInfo><title>European Journal of Health Law</title></titleInfo><titleInfo type="abbreviated"><title>EJHL</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">0929-0273</identifier><identifier type="eISSN">1571-8093</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>20</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>261</start><end>270</end></extent></part></relatedItem><identifier type="istex">FDD8BBCBA44B37BB3EF1F56E14DE5203815D0CEC</identifier><identifier type="ark">ark:/67375/JKT-0LTVPQM8-8</identifier><identifier type="DOI">10.1163/15718093-12341272</identifier><identifier type="href">15718093_020_03_S02_text.pdf</identifier><accessCondition type="use and reproduction" contentType="copyright">© Koninklijke Brill NV, Leiden, The Netherlands</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-56W3KPD5-3">brill-journals</recordContentSource><recordOrigin>© Koninklijke Brill NV, Leiden, The Netherlands</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/JKT-0LTVPQM8-8/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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