Mad Cows and Variant Creutzfeldt-Jakob Disease - The New Stature of the Precautionary Principle in European Law and Health Practice

(This is page 5)  Page 1Page 2Page3Page 4

Page 6Page 7AppendixFootnotes

 

© April 2001 Peter Free

The Inquiry Committee recommended precautionary ideas for the future

            In order to be effectively implemented, the Precautionary Principle requires more than a simple bias toward protecting health and environment.  The BSE/vCJD epidemics illustrated what happens when the need for action is obvious, but the responding institutional framework is only partially adequate.  The Inquiry's report illustrated what is practically required to make application of the Principle a reality, rather than well-intentioned but relatively useless idea.

            The Phillips panel made recommendations with a strong precautionary tone for future governmental action in the face of health risk:

(a) Precaution:

Even where the risk to human life appears remote, all reasonably practicable precautions should be taken. [119]  Uncertainty itself can justify action. [120]  Precautionary measures should be strictly enforced, even if the risk they address appears to be remote. [121]

(b) Scientific advice:

Scientific advice should come from the best source. [122]  Lead responsibility for coordinating the scientific response should be clearly assigned. [123]  Veterinarians should be trained in epidemiology. [124]  Scientific judgments should be separated from value judgments. [125]

(c) Scientific research:

Research coordination requires that gaps in research and the sources of expertise should be identified. [126]  Research priorities and funding should be established. [127]  Competition, peer review, and efficient arrangements for the provision of clinical material are also necessary in coordinating scientific effort. [128]  Review should be continuous and public. [129]

(d) Reality:

When precautionary measures are introduced, all real-world aspects of implementation must be considered. [130]  Knowledge of practical working conditions is essential. [131]  It is not always appropriate to depend on trade associations to communicate the importance of precautionary measures within that trade. [132]

(e) Clarity:

Advisory committees should explain their reasoning, assumptions, principles of risk management, and speak without shading the results. [133]  Advice should be written, clearly stated, and understandable by lay people. [134]  Policy options and consequences should be set out. [135]

(f) Administrative:

Administrative chains of responsibility should be clearly laid out. [136]  In-house expertise is preferred so as to reduce delays. [137]  Contingency planning is essential. [138]  Central regulatory monitoring is necessary. [139]  Successful control of animal diseases requires effective disease surveillance. [140]

(g) Openness:

Openness is necessary. [141]  It requires recognition of the public's capacity for rationality in the face of uncertainty. [142]  Committee advice should normally be made public. [143]

(h) Law:

Statutes cognizant of the need for precautionary action or regulation should be enacted. [144]  Government should have the power to destroy animals and animal materials that might carry infection when disease transmission is possible rather than probable. [145]

The European Court of Justice implements the Precautionary Principle

            In May 1998's Case 180/96, the European Court of Justice found against the United Kingdom, [146] after the Kingdom challenged a Commission-imposed trade embargo [147] that prohibited the U.K. from exporting cattle and cattle products.  The embargo was overtly precautionary, coming a week after the United Kingdom's Spongiform Encephalopathy Advisory Committee announced the likely cause of vCJD was BSE. [148]

            The United Kingdom argued that the Commission had (i) exceeded its powers, (ii) disregarded the principle of free trade, (iii) breached proportionality, (iv) infringed the Treaty on European Union, (v) disregarded the principle of legal certainty, and (vi) founded the action on an inappropriate Treaty article. [149]

            In partial support of these claims, the United Kingdom stated that there had been no new outbreak of a zoonosis that would fall within the meaning of the directives upon which the Commission had founded its action. [150]  BSE was not new, nor were the UK's control measures ineffective.  The threat of inter-species transmission was based on conjecture, and the threat to human health was negligible.  Consequently, the ban could be seen as economically inspired and therefore without legal foundation. [151]

            The Court reduced the trade and powers issue to a precautionary one, asking "whether the announcements by SEAC that BSE was the most likely explanation for the outbreak of the new variant of Creutzfeldt-Jakob disease justified the adoption of safeguard measures, given that BSE had already existed for a number of years, that measures had been adopted both by the United Kingdom and by the Community and that the risk posed to humans had already been taken into consideration." [152]  It found that the directives the British had cited empowered the Commission to act rapidly to prevent propagation of animal or human disease. [153]  Directives 90/425 and 89/662 gave the Commission wide powers over live animals, animal products, and products derived from them. [154]  Only animals and animal products fulfilling Commission requirements can be exported. [155]  If a zoonosis or disease is discovered, a member state can order the animals or products quarantined or destroyed. [156]  Logically, this means that containment is an appropriate measure. [157]  If containment is to be effective, a total ban may be necessary, including one on exports to third countries. [158]

            The Commission had not, therefore, clearly exceeded its bounds of discretion in imposing the embargo. [159]  It would make no sense to prevent the Commission from acting when significant new information emerged about the disease's transmissibility, merely because the disease had existed for a long time. [160]  The SEAC announcement had elevated the risk to humans from theory to possibility. [161]  That alteration in perceived risk therefore authorized the Commission embargo under the authority of Directives 90/425 and 89/662. [162]

            In regard to proportionality, the British argued that BSE was in decline in the United Kingdom, demonstrating that existing measures were sufficient. [163]  Additionally, it made no sense to ban live animals never exposed to infected feed, [164] meat not likely to be infected, [165] and byproducts from certified BSE-free herds destined for cosmetics and pharmaceuticals. [166]  The ban on third country export was disproportional, since the risk of re-importation back into the European Union was non-existent. [167]  The ban was discriminatory because BSE had emerged in other member states, but no embargoes had been imposed upon them. [168]  And the ban was excessive; alternative, less restrictive, measures had been available. [169]  For example, the Commission might have imposed the UK's own ban (against the human consumption of beef from cattle older than thirty months throughout the Union).

            In reply, the Court agreed that proportionality is a general principle of Community law. [170]  It requires that measures not exceed the limits of what is necessary and appropriate in achieving legislative goals.  The least burdensome alternative must be chosen, and the disadvantages caused must not be disproportionate to the aims. [171]  However, the Community legislature has discretionary power in common agricultural policy, and the legality of measures taken can only be challenged when the measure is manifestly inappropriate to the accomplishment of its objective. [172]  Article 130r of the Treaty on European Union requires that Union environmental policy provide human health with a high level of protection based on principles of preventive action. [173]  Consequently, "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." [174]

 

(This is page 5)  Page 1Page 2Page3Page 4

Page 6Page 7AppendixFootnotes