The Precautionary Principle in EU Risk Regulation
A Matter of Priorities
©2014
Academic Paper
85 Pages
Summary
The precautionary principle provides a justification to act where scientific uncertainty about the nature and extent of detected indications of harm would otherwise possibly impede regulatory interventions. The highly controversial and often misunderstood principle plays a central role in European risk regulation. The present volume should allow readers to gain an overview of all essential points linked with the role of the principle in the risk regulation framework of the European Union. Based on an outline of the precautionary principle’s main characteristics and its conception by the European Commission, common allegations brought against the principle are illuminated and critically assessed. The second part of the book is then devoted to the actual implementation of the principle in the EU – from early applications to ongoing disputes. Three case studies from the agrochemical, pharmaceutical and food packaging sector reflect current applications as well as the relevant institutional and procedural framework. Insights from the theoretical part and the case studies are melted in the final discussion section that also includes recommendations for EU risk regulators.
Excerpt
Table Of Contents
8
Introduction
The precautionary principle (hereinafter PP) provides a justification to act where scientific
uncertainty about the nature and extent of detected indications of harm would otherwise possibly
impede regulatory interventions. The PP is considered to be one of the most controversial
principles and attracted much scholarly attention. Despite the vast array of books and shorter
articles about the topic, less documents are available that are not limited to a single aspect of the
principle or í if discussing several aspects í do not amount to a weighty tome. While the
present volume will also not be able to cover all aspects on a limited amount of pages, it
nevertheless should allow readers to gain an overview of all essential points linked with the role
of the PP in the framework of risk regulation in the European Union (EU). To begin with the
most important, the principle is introduced by describing its main characteristics. As these are
heavily dependent on those who breathe life into the principle, the characteristics the EU
assigned to it shall form the centerpiece of the first part of this book. Based on this clarification,
allegations brought against the PP are critically assessed. In the second part of the book, the
focus is shifted to the actual application of the PP in EU risk regulation. After shedding light on
the origins of the principle in EU risk regulation, three case studies from the agrochemical,
pharmaceutical and food packaging sector reflect current applications as well as the relevant
institutional and procedural framework. Insights from the theoretical part and the case studies
are melted in the final discussion section that also includes recommendations for EU risk
regulators. The study concludes with a general summary of main findings.
The established systematic approach as applied in the case studies would allow to be extended to
further cases or could be adapted to other countries or international settings. However, in this
volume international aspects are only treated to a limited extend and not all sectors where the PP
is applied can be presented.
9
I.
The Precautionary Principle
A.
Approaching the PP's Meanings
Most risk regulators might agree that the PP is in action where restrictive measures are imposed
on activities that are assumed to harm but where the scientific evidence is not sufficient to prove
causality between the activity and the harm or where the extent of harm is unknown. However,
the consent ends when it comes to a broader discussion concerning the details of what condi-
tions have to be met to trigger the PP and what kind of actions are really adequate in such cases.
Obviously, this sketchiness did not hinder the PP to find its way from its origins in German
environmental law of the 1970s into national laws of various countries but also into international
conventions and treaties from the 1980s on, reflecting the variance of conceptions by differing
wordings from one agreement to the other.
1
It is thus understandable that many scholars approach the definition of the PP by taking refer-
ence to the history of the principle. At least, almost all of them mention the Rio Declaration
from 1992. Furthermore, comparing the wordings used in early international agreements reveals
that they often resemble those used in the Rio Declaration.
2
The Rio Declaration shall therefore
be introduced as a merited starting point in approaching the PP's meaning.
1.
The Rio Declaration
Taking place in Rio, the United Nations Conference on Environment and Development aimed at
promoting sustainable development facing a more and more globalised world. Principle 15 of
the resulting Declaration states that:
"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."
3
Knowing the above definition is not only interesting from a historical perspective but also helps
to understand the ongoing controversy that surrounds the PP. Indeed, a recent empirical analy-
1
See e.g. SPREP, Report in Relation to the Noumea Convention, 9; see also Arndt, Vorsorgeprinzip im EU-Recht, 11 ff.
2
SPREP, Report in Relation to the Noumea Convention, 10 ff.
3
UNCED, Rio Declaration, Principle 15.
10
sis
4
found that this definition best approximates the prevailing interpretation in scientific debate
about the principle. Before addressing this debate, the focus shall now first be turned to the EU
and its conception of the PP.
2.
The Communication from the Commission on the PP
In the same year that the Rio Declaration was concluded, the EU integrated the PP in the
Maastricht Treaty, stating that in EU environmental policy a high level of protection shall be
aspired by taking recourse to preventive action, as well as the precautionary and polluter-pays
principle.
5
Besides the renumbering of the article, the codification of the PP in EU primary law
has not been changed or extended since then nor has a definition been provided. Yet realising
the resulting confusion and criticism in debates about the proper interpretation of the PP, the
European Commission (EC) issued a Communication in 2000 (hereinafter: COM(2000) 1)
6
,
which aimed to clarify when and how the principle shall be applied. Rather than to provide a
definition, it simply tried to contribute to the debate and promote the EU's interpretation of the
PP.
However, in order to compare it with the predominant Rio Declaration, a distillation of the
relevant terminology that represents the Commission's view becomes necessary. This shall be
done in the next chapter.
3.
Synthesis of Common Elements
Describing the PP by its common elements is another widespread approach applied by scholars.
7
Yet these approaches bear potential for amendments. Firstly, to be more precise, the term
`element' shall be replaced by the term `variable', as variables clearly imply that they can be
filled with values. Such values are able to represent the different interpretations of one specific
variable or aspect of the PP. Summing up used values in an abstract formula consisting of such
variables would result in a specific overall interpretation of the PP. Secondly, additional
variables will be introduced in order to strive for completeness.
4
Pereira Di Salvo/Raymond, Defining the Precautionary Principle.
5
Maastricht TEU of 29 July 1992, art. 130r(2).
6
Commission Communication, COM(2000) 1.
7
See e.g. Holdway, Reducing Uncertainty; see also Manson, Formulating the Precautionary Principle.
11
The following listing of the variables shall also present the values assigned to them according to
the description of the PP by the Rio Declaration and the COM(2000) 1, which where appropriate
shall be contrasted with dominant complementary or divergent views.
a)
Scope
As first variable, a topical scope can be identified. While originating in an environmental
context as also reflected in the Rio Declaration and Article 130r(2) of the Maastricht Treaty (that
now has become Article 191(2) TFEU)
8
, the COM(2000) 1 clearly states that the application is
not limited to the environmental field and adds that the scope of the PP "also depends on trends
in case law, which to some degree are influenced by prevailing social and political values"
9
. In
addition, there is no explicit limitation of the scope relating to the type of risk in any of them.
The notion of "effects resulting from a phenomenon, product or procedure"
10
in the COM(2000)
1 leaves it unanswered whether natural phenomena are included. Therefore, natural as well as
man-made disasters seem both to be within the scope of the PP.
This broad scope of the PP is however contrasted by Trouwborst's opinion that the main arena
for the PP in the international context remains the environmental field and health issues result-
ing from environmental pollution. According to him, it reflects precautionary logic but should
not be intermingled with the PP when for example the US Bush administration tries to justify its
anti-terror missions by using terms associated with precautionary action.
11
Furthermore, a possible explanation why the PP is still only mentioned in the environmental
section of the TFEU might lay in the fact that the PP mainly applies to situations where human
activity manipulates nature by changing naturally occurring characteristics or compositions, for
example by means of chemical and biotechnical engineering, in short, wherever ordinary people
lack traditional experience. Complementary, it also applies when it comes to fears of novel and
threatening outcomes resulting from collectively and cumulatively overstressing planetary
ecosystems whose stress tolerance are relatively unknown.
12
A good example for that are fears
regarding outcomes of a global climate change.
8
Maastricht TEU of 29 July 1992, art. 130r(2); Consolidated Version of the TFEU post-Lisbon, art. 191(2).
9
Commission Communication, COM(2000) 1, 9.
10
Commission Communication, COM(2000) 1, 14.
11
Trouwborst, Prevention, Precaution, Logic and Law, 113 ff.
12
Randall, Risk and Precaution, 40 f.
12
b)
Goal
Second and narrowly linked to the first, there is a pursued goal. While the Rio Declaration
simply talks about preventing environmental degradation, the COM(2000) 1 introduces the
concept of a pre-determined protection level recognising the fact that a zero-risk approach
would most likely be neither feasible nor reasonable. It clearly assigns the responsibility for this
determination to the politicians.
13
Unfortunately it does not further specify the `high protection
level' the EU aspires pursuant to the Treaties of the EU, thus inviting confusion and debates.
c)
Trigger Conditions
The third variable is represented by the triggering conditions. As first triggering condition the
Rio Declaration mentions the existence of `threats of serious or irreversible damage' while the
COM(2000) 1 speaks about "indications that the possible effects on the environment, or human,
animal or plant health may be potentially dangerous and inconsistent with the chosen level of
protection."
14
While the Rio Declaration does not indicate who shall determine what constitutes
a `threat of serious or irreversible damage', the COM(2000) 1 provides some hints that indica-
tions of possible harmful effects might only be taken into account if arising in the context of
scientific studies, even if performed by a scientific minority. It further assigns it to the experts to
assess if a certain action might jeopardise the level of protection determined by the Communi-
ty.
15
As second triggering condition both the Rio Declaration and the COM(2000) 1 refer to the
concept of scientific uncertainty. However, the COM(2000) 1 is more deliberate not to name it
`lack of full scientific certainty'. `Full scientific certainty' is by the very nature of science an
oxymoron and therefore not achievable.
16
Instead, it talks about a lack of sufficient certainty to
determine the risk in question due to "insufficient, inconclusive, or uncertain"
17
scientific data.
18
The insufficient determination of the risk is further specified as "absence of scientific proof of
the existence of a cause-effect relationship, a quantifiable dose/response relationship or a
quantitative evaluation of the probability of the emergence of adverse effects following expo-
sure".
19
13
Commission Communication, COM(2000) 1, 3.
14
Commission Communication, COM(2000) 1, 7.
15
Commission Communication, COM(2000) 1, 16.
16
See e.g. Koning, The Scientific Method; See also Like, Scientifically Proven is an Oxymoron.
17
Commission Communication, COM(2000) 1, 7.
18
Commission Communication, COM(2000) 1, 14.
19
Commission Communication, COM(2000) 1, 16.
13
Put it another way, the preventative principle covers the handling of sufficiently determinable
risks or known adverse effects, while the PP calls for actions during the period of a proceeding
risk assessment.
d)
Measures
The fourth variable stands for the measures. The Rio Declaration omits to describe them further
and only provides three criteria such measures should meet: being cost-effective, preventive and
match the capabilities of the state. In contrast, the COM(2000) 1 mentions a range of possible
precautionary responses from `no action' at one end to `soft' measures such as recommenda-
tions, funding a research program or informing the public about the possible adverse effects to
more restrictive legally binding measures which may at the opposite end also entail a
reversal of the burden of proof or a ban of the activity.
20
The choice for an appropriate measure
shall be facilitated by information derived from a scientific evaluation which should be as
complete as possible, at best identifying at each stage the degree of scientific uncertainty.
21
In addition, such measures have to respect the general principles of risk management which are
those of proportionality, non-discrimination, consistency, examination of the benefits and cost
of action or lack of inaction and examination of scientific developments.
22
The latest is directly
linked to the temporary character precautionary measures should have, meaning that the
situation should be reassessed as soon as new scientific evidence becomes available.
e)
Legal Status
The fifth variable refers to the legal status attributable to the principle. The analysis of the
wording hardly allows drawing many conclusions on that. While the notion of `approach' as in
the Rio Declaration is often used by those denying precaution any legally binding status, the
notion of `principle' as in the COM(2000) 1 does not indicate whether it generates legally
binding obligations. Academic investigation was devoted to determine the general traits of the
term `principle'. Most seem to see principles as guiding tools representing values that are
applied in legislative and judicial interpretation.
23
In the words of one of them, principles "guide
processes of interpretation and application, as well as processes of norm formation [and in
20
Commission Communication, COM(2000) 1, 3, 4,15 and 17.
21
Commission Communication, COM(2000) 1, 16.
22
Commission Communication, COM(2000) 1, 17 ff.
23
See e.g. Daci, Legal Principles; see also Lang, UN-Principles; and Ellis, Overexploitation; and Zander, Application of the
Precautionary Principle.
14
contrast to rules, their] main function is not to impose obligations directly, although it is
possible for them to do so."
24
Another author adds that a rule generally exists in situations where
a defined situation invokes a predefined reaction, with minor deviations, whereas a principle is
more of a flexible tool helping to reach fair, just and ethical decisions.
25
He furthermore notes
that the PP is no ideal candidate to apply for the status of a legal rule as it still comes with too
much ambiguity.
26
The pivotal question in the international context is whether the PP has become a general
principle of international law or a principle of customary law. While the COM(2000) 1 does not
call it a `principle of customary law' it clearly states that it considers the PP as "a full-fledged
and general principle of international law."
27
The reasoning behind this statement is the PP's
widespread incorporation into international environmental law. Interestingly, the EC seems to
see no need to stick to the notion of `environmental'. This attitude is underpinned by settled EU
case law, in particular the Artegodan Case.
28
In the Artegodan Case, the Court of First Instance
(CFI) ruled that the PP based on the relevant Treaty provisions "can be defined as a general
principle of Community law requiring the competent authorities to take appropriate measures to
prevent specific potential risks to public health, safety and the environment, by giving prece-
dence to the requirements related to the protection of those interests over economic interests."
29
In a nutshell, this broadly interpreted and self-imposed PP as enshrined in Art 191 of the TFEU
forces EU institutions to follow it in their legislative activities, while the resulting secondary law
possibly containing provision based on the PP further binds EU Member States.
30
Besides, supporting voices that argue for an international legally binding status of the PP persist
or even become louder, as the PP further evolved not only from the inclusion into non-binding
conventions towards its incorporation in many national and international legally binding
24
Ellis, Overexploitation, 458.
25
Zander, Application of the Precautionary Principle, 30.
26
Zander, Application of the Precautionary Principle, 31.
27
Commission Communication, COM(2000) 1, 10.
28
See De Sadeeler, Implementing the Precautionary Principle, 12 ff.
29
CFI, Joined cases T-74/00, T-76/00, T-83/00, T-84/00, T-85/00, T-132/00, T-137/00 and T-141/00, Artegodan GmbH and
Others v Commission, [2002] ECR II-04945, par. 184.
30
Marti, Vorsorgeprinzip im Umweltrecht, 133.
15
instruments but also gains force as it tends to appear more and more in the operational provi-
sions rather than only in the preambles or among the general principles.
31
In contrast, the WTO Appellate Body repeatedly noted that the PP's acceptance in international
law is widely confined to environmental law.
32
Furthermore, the EC Biotech case
33
is a good
example for the clash of the all-embracing concept of the PP promoted by the EU with that of
the US. The view of the US at the time of the case was that the PP is far from being a rule of
international law and even does not deserve the name `principle' but with respect to its lack of
common understanding may better be called `precautionary approach'.
34
In particular, it lists the
following arguments why precautionary action does not belong to the rules of customary
international law:
"(i) it cannot be considered a "rule" because it has no clear content and therefore cannot be said to
provide any authoritative guide for a State's conduct;
(ii) it cannot be said to reflect the practice of States, as it cannot even be uniformly defined by
those who espouse it; and
(iii) given that precaution cannot be defined and, therefore, could not possibly be a legal norm, one
could not argue that States follow it from a sense of legal obligation"
35
While the WTO panel acknowledged the fact that the US, Argentina and Canada have not
ratified the Biosafety Protocol
36
and therefore defeated the reliance of the EC on it to defend its
delays in the approval of GMOs (resulting in a de facto moratorium), the outcome if this
Protocol would have been applicable remains unclear.
37
In addition, the WTO panel refused to
answer the question whether in its view the PP is a principle of general or customary interna-
tional law.
38
The question about the legal status of the PP cannot come without the question of the content of
such a PP. To the best knowledge of the author, there is only an attempt stemming from 2006
31
Marti, Vorsorgeprinzip im Umweltrecht, 68.
32
Trouwborst, Prevention, Precaution, Logic and Law, 115.
33
WTO Panel, European Communities - Measures Affecting the Approval and Marketing of Biotech Products, Reports of the
Panel from 29 September 2006, WT/DS291/R, WT/DS292/R, WT/DS291/R.
34
WTO Panel, EC Biotech Report, par. 7.81 and 4.541.
35
WTO Panel, EC Biotech Report, par. 7.82.
36
Cartagena Protocol on Biosafety.
37
Peel, Science and Risk Regulation, 304.
38
WTO Panel, EC Biotech Report, par. 7.89.
16
drawing from the state of the law a definition of a PP representing a widely accepted duty of
states. This duty resembles both Principle 15 of the Rio Declaration and the conception of the
EU and incorporates the notions of `reasonable grounds for concern' as well as `serious and/or
irreversible harm' and `effective and proportional action'.
39
It would be interesting to know if
such binding obligations are more on the procedural side (determining steps that have to be
followed in decision-making) or on the substantive side (determining outcomes that have to be
achieved) and how capacity limits of states, as mentioned in the Rio Declaration, are taken into
account.
It is however questionable if a global definition of the PP is desirable. While the PP's ambiguity
weakens its legally binding force it comes with the advantage of an enhanced flexibility able to
represent different cultural understandings.
40
Besides, it is assumable that the PP gains impetus
when it is invoked together with similar principles such as the preventative principle or the
concept of sustainability.
B.
Debates
The PP attracted massive criticism from its beginnings. Such critique often addresses an extreme
interpretation of a PP that is assumed not to be embedded in an overall elaborated decision-
making framework and that pursues very high protective goals and hence comes with a low
threshold as regards conditions that when met trigger harsh protective countermeasures.
41
Although some statements of critics
42
lack objective evidence and resemble sheer propaganda, it
is nevertheless worth to draw some valuable inputs from them. The following sections therefore
discuss the most prominent allegations the PP has to face.
1.
The PP Stifles Innovation and is thus Bad for Economy and Social Welfare
43
The most extreme goal that might be pursued by the application of the PP would be that of a
zero risk level. Such intentions more likely arise when vulnerable groups of society are affected,
in particular children. Although such calls are usually not all-embracing but limited to a particu-
lar product group, they are sufficient to provoke allegations that the PP stifles innovation and
39
Trouwborst, Prevention, Precaution, Logic and Law, 109 f.
40
See e.g. SPREP, Report in Relation to the Noumea Convention.
41
See e.g. More, Perils of Precaution.
42
For the maybe largest collection of anti-precautionary statements see the Paralyzing Precautionary Principle Website.
43
See e.g. Guldberg, Challenging the precautionary principle.
17
harms the economy since "[t]echnological innovation occurs through a process of trial-and-error
and refinement"
44
and hence cannot develop if the risk of erring is barred. To add to this, zero
risk is not achievable anyway, even without any innovation, as misuse or accidents are able to
render almost any product dangerous while nature definitively has inherent devastating powers.
Risk acceptance is therefore a must and not an option. This of course does not mean that risk
reduction is not reasonable.
Criticism that attacks the zero risk approach is often tied to the extreme maxim of `banned until
proven harmless' which imposes the burden of proof of harmlessness on those who intend to
market an innovative product or technology. This is rightly not only seen as an offence of the
standard `innocent until proven guilty' paradigm best known from criminal law, but it also
demands the maybe impossible proof of inexistence of something.
45
While again the extreme form is not a viable option, there are established systems designed to
allot the burden in a way that respects the affected parties' possibilities to defend their interests.
Furthermore, instead of talking of the burden of proof, the obligations that are meant with it can
be shaped stricter or more moderate
46
, as the burden could for example be limited to simply
perform predefined tests, such as laboratory or field experiments, bioassays and clinical trials.
A known burden of proof that is embedded in any kind of approval system and is also referred
to as `administrative' burden of proof increases the legal certainty and predictability for compa-
nies. This is a big advantage compared to the application of so-called `adjudicatory' burden of
proofs that might be reversed on an ad-hoc basis while demanding either full or only prima facie
evidence.
47
Unfortunately the COM(2000) 1 at some points uses expressions that come close to
the `banned until proven harmless' maxim and does not conclusively reject the zero risk
approach
48
, while the issue is even worse in case of certain market approval descriptions that
clearly manifest a `no harm' approach.
49
Proponents of the PP usually see no conflict between reasonable risk reduction and economic
prosperity. Moreover, allegations that the PP stifles innovation have been countered recently by
44
Graham, Facing the Unknown, 5.
45
The issue whether it is possible to prove a negative or not is highly controversial.
46
See e.g. Van den Belt, Debating the Precautionary Principle, 1124 f.
47
Foster, Science and Precautionary Principle, 245; see also Commission Communication, COM(2000) 1, 4.
48
See Commission Communication, COM(2000) 1, in particular 3, 4 and 7.
49
See e.g. EC, EU Action on Pesticides.
18
a report of the European Environmental Agency (EEA), stating that "there is growing evidence
that precautionary measures do not stifle innovation, but instead can encourage it, in particular
when supported by smart regulation or well-designed tax changes"
50
. For example, the search
for less risky alternatives may simply shift innovation rather than eliminate it. For all those not
trusting this symbiotic relationship, risk reduction still has to be balanced against incentivising
innovations. In fact, risk reduction not only has to be balanced against economic concerns, but
also against any resulting costs as well as so-called `risk-risk trade-offs'.
2.
The PP Ignores Cost-benefit Ratios and Neglects Risk-risk Trade-offs
51
In order to assess whether the reproaches that the PP ignores cost-benefits and neglects risk-risk
trade-offs are substantiated, the problems surrounding this issues shall be illuminated first.
a)
Pre-defined Protection Level versus Traditional Cost-benefit Analysis
The traditional Cost-Benefit Analysis (CBA) first defines the intended project, then it identifies
the potential impacts of that project, sorts out those deemed to be (economically) irrelevant,
quantifies the relevant ones and finally translates them into monetary units thereby assuring that
the time value of money is taken into account by applying discount rates. This done, by applica-
tion of the net-present value test it becomes visible whether the sum of discounted gains exceeds
the sum of discounted losses, in other words whether the project would result in an efficient shift
in resource allocation. Acknowledging that this result only holds true for the estimations
actually taken, sensitivity analysis is applied to see to what point a change of estimations
sustains this result.
52
Cost-benefit analysis is mentioned in the Rio Declaration as well as the COM(2000) 1 when it
comes to potential measures. However, the one promoted in the later resembles an incomplete
CBA that is restricted to those costs and benefits that do not alter one particular benefit that is
treated as an inviolable given, namely a pre-determined protection level and not a complete
CBA where all variables are balanced against each other. As has been confirmed in the Pfizer
case of 2002 such an incomplete CBA in principle mirrors the proportionality principle.
53
Insofar, the allegation that the PP leads to an ignorance of CBA ratios is therefore partially
justified.
50
EEA, Late lessons from early warnings, 38.
51
See e.g. Wiener, Precaution in a multirisk world; see also Kysar, It might have been.
52
Hanley/Spash, Cost-benefit analysis, 8 ff.
53
CFI, T-13/99 Pfizer Animal Hearth v Council of the European Union [2002] ECR II-3305.
19
Nevertheless, the predefined protection level seems to be variable and dependent on overall
costs and benefits as well as scientific uncertainties in some areas, such as pesticides approval,
and more obvious drug approval. Here the acceptable harm, namely adverse health effects, is
dependent on the benefit such risk acceptance would bring.
54
Instead of a pre-defined protection
level and an arsenal of potential measures that might be evaluated by their costs and benefits but
have to meet the target level, there is a pre-defined measure (denial of market approval) and a
flexible level of protection.
Since 2002, the European Commission follows an integrated impact assessment system, and
since 2005 prepares combined economic, social and environmental impact assessments for all
legislative and policy proposals coming along with the Commission Legislative and Work
Programme (CLWP)
55
and Annual Policy Strategy (APS).
56
Roadmaps that announce such
initiatives and already contain preliminary impact assessments shall allow stakeholders to
provide early inputs. While impact assessments shall assess the feasibility of the proposed
interventions to meet the set objectives in an effective and efficient way while being consistent
with existent policies and respect the principles of proportionality and subsidiarity, they do not
encompass a duty to prepare a full CBA.
57
It is thus true that the EU in its policy-making does
not really regard CBA as top priority, but also does not completely ignore such considerations.
b)
Single-policy and Cross-policy Issues
The balancing of risks against benefits is easier if they fall into the same policy regime. In the
case of medication, health risks and benefits of used drugs usually devolve only to the treated
humans. In fact, patients have a certain choice whether or not they want to take a particular
drug. To help them finding a decision, they are provided with a description of adverse health
effects that might occur. This also reflects the situation we have in the realm of lifestyle risks,
where people voluntary accept risks as their perceived individual benefit is bigger than their
perceived individual harm.
However, patients are patronised regarding certain drugs deemed too risky which are not
granted market approval or regarding drugs that are not yet granted approval as not yet thor-
54
See e.g. EC, EU Action on Pesticides; see also e.g. Deutscher Bundestag, Arzneimittelgesetz, par. 5.
55
Meanwhile, the CLWP was renamed to Commission Work Programme (CWP).
56
Robertson, Impact Assessment, 17 f.
57
Robertson, Impact Assessment, 18; for an overview of historic and current provisions regarding EU impact assessments, see
EC, Impact Assessment.
20
oughly tested. Here, the risk of adverse health effects of a medicine has to be balanced against
the ongoing harm generated by an untreated disease. The withholding of a possible life-saving
drug because of unfinished assessments of all adverse health effects is often used as an example
to illustrate a risk-risk trade-off respective an omission of CBA that comes with the PP which
may in the end lead to more harm than if no precautionary approach would have been applied.
58
Less apparent than the balancing of risks and benefits for patients is the weighting up of factors
that belong to different policy areas and affect various stakeholders. For example, there is an
economic benefit for drug manufactures resulting from product sale and it is a valid argument
that the withholding of drugs based on a precautionary approach harms such companies finan-
cially. On the other hand, a too lax approval system might cause them long-term financial costs
arising from recalls and a reputational damage. Indeed, public outrage about harm caused by
pharmaceuticals is often pushed by the media, something that hardly occurs when it comes to
less visible harm due to a denied medicine.
59
Furthermore, economic benefits arising out of industrial activities often lead to so-called
`external costs' meaning that they negatively impact parties that had no say when the decision
for the action causing the impacts had been taken.
60
Situations where benefits and costs do not
fall to the same group of persons raise issues of fairness and renders it more difficult to find an
accepted risk level, as those who benefit from an activity call for a lower or more flexible target
line, while those affected negatively request better protection and are more in a fixed protection
level.
The weighting up of costs and benefits is further complicated as they first have to be translated
into a common measure in order to make them comparable. As money is already well-
established as a symbol for value and as the translation of risks into monetary terms is routine in
the insurance business, its use for comparing costs and benefits is obvious. The monetary value
of something can be derived from the price someone is willing to pay for it which in turn
depends on the supply and demand, and the resulting extent of scarcity.
Nevertheless, the monetisation of human health and ecosystems is strictly rejected by some
people who consider human life as priceless and argue that this value might be underestimated
when the willingness-to-pay method is applied for poor people. As an alternative, they suggest
58
Randall, Risk and Precaution, 18.
59
See e.g. MacGuill, Medication kills.
60
Heijman, Regional Externalities, 1.
21
to use cost-utility analysis while the utility on the benefit side is expressed in non-monetary
terms, for example as `quality-adjusted life year' in the health policy area.
61
In the environmental field, for example with regard to biodiversity, irreversibility is something
that immensely escalates the value.
62
Irreversibility comes at the cost of lost options. It also
relates to the interests of future generations to have an intact ecosystem providing for good or at
least viable living conditions. The well-being of future generations is explicitly mentioned in the
COM(2000)1.
63
Sustainable development generally acknowledges the scarcity of natural
resources while scarcity is a known cost driver. The value of ecosystems is usually not seen as
an inherent value but determined according to its value for human beings, for example consist-
ing of goods that can be harvested or of income from attracted tourism.
64
Not only may industrial activities have impacts affecting various stakeholders and spheres, the
same is true for regulatory decisions. For example, the use of MTBE as a fuel additive was
promoted in the course of a Clean Air Act Amendment to reduce air emissions. Unfortunately
MTBE turned out to be a problem itself, especially as water pollutant.
65
Regulatory actions
targeted to reduce one risk run the risk to cause unintended risks in other areas, however they
may not only have unintended negative impacts but also positive side effects. In the EU, the
review of preliminary impact assessments contained in roadmaps for new policy initiatives by
other Directorate General's (DG's) of the Commission might mitigate negative regulatory
spillovers.
66
It is fair to say that decision-makers are confronted with the same general problems of balancing
benefits and costs, including risks, whether or not they apply the PP. This is also true for the
assessment of risk-risk trade-offs, the valuation problems and the need to find a solution on how
to take into account scientific uncertainty in any calculations.
What distinguishes approaches driven by the PP from the traditional CBA is essentially the
different prioritisation. While the traditional CBA aims at finding the optimum outcome in
economic terms and usually ignores non-economic aspects, the PP leads to a prioritisation of
61
See e.g. Robinson, Cost-utility analysis, 859 ff.
62
Veinla, Environmental Protection and Proportionality, 96.
63
Commission Communication, COM(2000) 1, 7.
64
See e.g. Burke et al., Reefs at Risk, 52.
65
See U.S. EPA, Overview on MTBE.
66
Robertson, Impact Assessment, 18.
22
environmental protection, plant and animal health over economic benefits.
67
It is therefore clear
that those whose perceived individual benefit in a particular situation is more on the economic
side do not like the PP.
3.
The PP Ignores Sound Science and Invites Biased, Suboptimal Decisions
68
a)
Sound Science versus the Perils of Public Risk Perception
It is hard to find a definition of sound science, but it is sufficient here to say that basing deci-
sions on sound science usually means that only the existence of a high degree of well-founded
scientific studies able to prove causation is sufficient to justify restrictive measures.
69
Scientific
proven causation is usually deemed achieved if scientists believe that their established hypothe-
sis holds true with a 95% probability and see only a 5% chance that their hypothesis will be
rejected.
70
On the other hand, sound science is also used as counterpart to junk science, which
does not comply with established scientific standards.
71
Calls for sound science traditionally
could be traced back to the U.S., becoming particularly evident during the era of the second
Bush administration when the rejection of international conventions containing precautionary
elements affirmed the perceived transformation of the U.S. from a precautionary friendly to a
precautionary hostile country.
72
Not only governments dominated by industry representatives
but also industry groups themselves use(d) sound science as an instrument to combat burden-
some regulatory restrictions, typically by challenging the scientific legitimacy of agency actions
in front of the courts.
73
The debate about the role of sound science is furthermore linked to the dilemma that lies in the
prevention of false positives and false negatives. The PP is alleged to produce too many false
positives, meaning false alarms that would not have occurred if decisions would have been taken
based on sound science.
74
67
Commission Communication, COM(2000) 1, 4.
68
See e.g. Sunstein, Laws of Fear.
69
See Ray, Producers argue for Sound Science.
70
Randall, Risk and Precaution, 93 f.
71
SETAC, Sound Science Technical Issue Paper.
72
Peel, Science and Risk Regulation, 117 ff.
73
Peel, Science and Risk Regulation, 119 ff.
74
Tickner/Kriebel/Wright, A compass for health, 490 f.
23
In particular, opponents of the PP argue that the PP, while trying to prevent false negatives
(ignored risks that result in injuries or catastrophes), not only generates a lot of false positives,
but also false negatives as the regulatory focus is diverted by public concerns from `real' risks
pointed to by scientific studies to unimportant issues or `phantom' risks.
75
In addition, the
stigmatisation of a particular product by the public may lead to the acceptance of alternatives
whose risks might not be smaller but that have not (yet) received much media attention.
Countering such allegations, the EPA report on late lessons from early warnings concludes that:
"Overall, the analysis shows that fear of false positives is misplaced and should not be a
rationale for avoiding precautionary actions".
76
As the EU is committed to democracy, it has to respect the opinions of its citizens. But are they
really able to properly assess risks or do they hinder reasonable risk decisions? According to
academic research, people aim to be rational, but are affected in several ways, highly depending
on their actual situation as well as past experiences.
77
To add to this another psychological
peculiarity, the Nocebo effect should be mentioned. While the Placebo effect leads to positive
reactions or improved health despite an agent-free treatment, the Nocebo effect leads to negative
effects despite the lack of exposure to any harmful agent.
78
b)
Sound Science versus a Clash of Interests
(1)
Biased Media
Taking the fear of cancer caused by the use of mobile phones as an example, a media repre-
sentative himself complains about the involved huge costs in producing scientific studies that
proved the safety of mobile phones but have ended in headlines that long-term harm from
mobile phones cannot be ruled out.
79
While one cannot see a big effect of such headlines on mobile phone users, misrepresentation by
media is a known problem that is mainly caused by their need to produce selling headlines to
stay commercially viable.
80
Apart from traditional media, social media play an important role,
75
Sunstein, Laws of Fear, 56.
76
EEA, Late lessons from early warnings, 12.
77
Princeton University, Psychology Lecture.
78
Cook, The Nocebo Effect.
79
O'Neil, Mobile phones.
80
For a list of factors that increase media attention in relation to risks, see ERF, The Precautionary Principle, 30.
24
too. They are especially prone to unintentional misrepresentation as well as intentional misuse
by interest groups.
81
(2)
Industry Interests and Interests of NGOs
Industry representatives form a particular interest group whose goals often conflict with the
PP.
82
In order to pursue their goals they might attempt to influence the public and political
opinion. For example, they could misuse the media by manufacturing the impression of safety
83
or by manufacturing uncertainty where scientific facts reveal causalities that are bad for busi-
ness.
84
Manufacturing uncertainty ranges from attempts to draw the attention to remaining
uncertainties up to manipulating scientific studies which starts with incomplete publication of
results.
85
Industry groups are frequently in dispute with NGOs, who often use the web to disperse their
mission, thus usually supporting precautionary measures.
86
As other interest groups, they are
able to manufacture uncertainty, too.
(3)
Biased Politicians
Policy making that is required to be transparent might be biased by politicians' fear to be
blamed for errors, in particular false negatives.
87
They might tell themselves: We want to be sure
that we have done everything in our power so we cannot blame ourselves if a catastrophe
occurs. While success underpins the legitimacy of regulatory institutions, regulatory failures
lead to a loss of public trust and acceptance.
c)
The EU's Perspective on the Role of Science
It was a major concern of the EC to counter accusations that the PP is a means to justify arbi-
trary decisions or to disguise protectionist measures.
88
The COM(2000) 1 highlights that
decision-making under the PP presupposes a structured risk analysis process thoroughly
informed by available scientific data. Risk analysis according to the EC is composed of three
81
WEF, Global Risks 2013, 23 ff.
82
See e.g. ERF, The Precautionary Principle, 28.
83
See e.g. Schnurr, Leere Versprechen; see also Hertwig, Pestizid-Hersteller wollte Forscher ruhig stellen.
84
OECD, Risk and Regulatory Policy, 57.
85
See e.g. Peel, Science and Risk Regulation, 127.
86
See e.g. ERF, The Precautionary Principle, 29.
87
OECD, Risk and Regulatory Policy, 30.
88
Commission Communication, COM(2000) 1, 2 and 13.
25
separate stages, namely risk assessment performed by scientific experts, risk management
performed by political decision-makers and serving as main venue for the PP, and risk commu-
nication.
89
Besides, measures that have been adopted based on precautionary reasons shall be
temporary and revised as soon as (mandatory) further research provides new scientific evidence
or as soon as the particular trigger conditions are not fulfilled anymore.
90
Nevertheless, the
accumulation of the word `should' instead of `have to' in relation to the described application of
science reduces the credibility of the pro-scientific statements contained in the COM(2000) 1.
Moreover, the Communication alludes to the importance of public perception already in its first
section: "Decision-makers have to take account of the fears generated by these perceptions and
to put in place preventive measures to eliminate the risk or at least reduce it to the minimum
acceptable level."
91
As the implications of this sentence are not further specified in the Commu-
nication, this statement is not helpful to counter accusations that the PP leads to decisions
resting upon public paranoia instead of sound science. The commitment to the democratic
element of public participation (already at the earliest possible stage)
92
may increase the conflict
with the less cogent commitment to scientifically based decisions.
While the EU had a hard time to defend precautionary measures in international disputes
93
, the
European courts have been reluctant to limit the discretion of Community institutions and
Member States in applying precautionary measures. Judicial review was generally limited to
detect manifest errors or a misuse of institutional powers
94
as well as the compliance with the
proportionality principle.
95
Although a hypothetical risk is not accepted as trigger for precau-
tionary measures, it is sufficient if the alleged risk is adequately backed up by scientific data
96
or
solid evidence
97
and that the risk assessment fulfils some scientific standards.
98
Actual appear-
89
Commission Communication, COM(2000) 1, 2.
90
Commission Communication, COM(2000) 1, 19.
91
Commission Communication, COM(2000) 1, 7.
92
Commission Communication, COM(2000) 1, 16.
93
See e.g. Peel, Science and Risk Regulation; see also Foster, Science and Precautionary Principle.
94
See e.g. ECJ, C-120/97, Upjohn Ltd v Licensing Authority and others [1999] ECR 223, par. 34; see also CFI, Pfizer, par.166-
170 and par. 201.
95
See CFI, Pfizer, par. 407 and 411; see also ECJ, C-192/01, Commission v Denmark [2003] ECR I-09693, par. 55-56; and
ECJ, C-79/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute [2010] ECR I-13533, par. 83.
96
CFI, Pfizer, par.144.
97
CFI, T-229/04, Sweden v Commission [2007] ECR II-2437, par.161.
98
CFI, Pfizer, par.172.
Details
- Pages
- Type of Edition
- Erstauflage
- Year
- 2014
- ISBN (eBook)
- 9783954897209
- ISBN (Softcover)
- 9783954892204
- File size
- 397 KB
- Language
- English
- Publication date
- 2014 (July)
