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A Defining Moment for

Precaution?

An Analysis of Post-Pfizer Case Law

Anne-May JanssenID i426474ajp.janssen@student.unimaas.nl

Master ThesisSupervisor: Marjolein van Asselt

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When wealth is lost, nothing is lost; When health is lost, something is lost;

When character is lost, all is lost.

- Billy Graham

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Abstract

The application of the precautionary principle by the European Courts has given riseto a series of debates. The Pfizer case, in specific, has been a landmark case in the

development of the precautionary principle. It was in this case that the CFI discussedat length the interpretation and the correct application of the principle for the first

time. It was also in this case that the Court applied a remarkable justification for itsruling. The Court constructed its own definition of uncertainty to validate the use of

the precautionary principle. Uncertainty was defined as differences in scientificopinions. This has lead some authors to argue that such an interpretation ofuncertainty could erode the precautionary principle. This paper investigates whether,and if so, how the application of the precautionary principle in the Pfizer case

influenced its application in subsequent case law. The analysis consists of three casestudies of case law. These are cases that were brought before the CFI after the Pfizer

case in 1999 and in which the precautionary principle was extensively discussed. Thefindings are twofold. First, the case studies demonstrate a partial precedent.

Although the Court has not applied the same kind of ruling in all cases, similaritiesare noticeable. Second, the research revealed other developments. The inconsistencyin which the Court deals with scientific evidence is reason for concern as it has failed

to set a high standard for the precautionary principle.

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Table of Content

Introduction .............................................................................................................................1

Old vs. New Risks ...................................................................................................................4Uncertain risks ......................................................................................................................6

The Precautionary Principle.................................................................................................8Legal Framing of the Precautionary Principle....................................................................9Pros and Cons .................................................................................................................... 11Uncertainty Paradox .......................................................................................................... 12

Risk Assessment and the Precautionary Principle......................................................... 13Risk Assessment in EU law .............................................................................................. 14Elements of Risk Assessment ........................................................................................... 14A Troublesome Relationship ............................................................................................ 16

The Pfizer Case .................................................................................................................... 18Antibiotics in Animal Feedstuffs ..................................................................................... 18Regulation 2821/98 ........................................................................................................... 19The Ruling of the Court .................................................................................................... 20

Methodology ......................................................................................................................... 22

Analysis: Uncertainty Interpretations............................................................................. 24Alpharma Inc. v. Council of the European Union........................................................... 26

Facts and Background ................................................................................................... 26The Courts Ruling........................................................................................................ 28Back to Pfizer ................................................................................................................ 31

Solvay Pharmaceuticals BV v. Council of the European Union .................................... 32Facts and Background ................................................................................................... 32The Courts Ruling........................................................................................................ 34Back to Pfizer ................................................................................................................ 36

Artegodan GmbH and Others v. Commission of the European Communities.............. 38Facts and Background ................................................................................................... 38The Courts Ruling........................................................................................................ 41Back to Pfizer ................................................................................................................ 43

A Broader Perspective ........................................................................................................ 44Analogy as Solid Scientific Evidence ........................................................................... 44Lack of Scientific Evidence .............................................................................................. 46Old Data ............................................................................................................................. 48Where to Go From Here?.................................................................................................. 49

Conclusion ............................................................................................................................ 51References .............................................................................................................................. 57

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Table of Figure(s)

Figure 1: Timeline Case Law........................................................................................... 25

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Introduction

It is a popular notion that the concepts of science and technology go hand in hand with

the idea of progress (Ravetz, 2006). Scientific research and technological developments

are responsible for many positive changes. Life has become more facilitated. One

may even say that it has become easier to live in certain parts of todays world. Distances

are smaller as travelling has become a common good. Staying in touch with family and

friends, regardless of their location on earth, has never been easier. The handwritten letter

that took days - if not weeks - to reach the other party has been replaced by e-mail, text

messaging, and Skype with which contact is instantaneous. Many more examples could

be given which illustrate how technological and scientific progress has influenced our

every day life.

With all these technologies that assist our daily activities it could be easily

forgotten that scientific progress is not always benign. The opportunities which are

created through scientific progress are accompanied by hazards that could pose a threat to

society. Although these hazards are a side effect of science, the remarkable thing is that

science often cannot provide the evidence required to assure that these hazards will not

occur. In other word, [s]cientific of historic proofs of harmful consequences are lacking,but suspicions cannot be fully refuted either (van Asselt & Vos, 2008, p. 281).

ORiordan et. al. (2001) argued that in such situations science is ignorant. It simply

cannot predict the outcomes of the risk. These risks are known as uncertain risks and

scientific uncertainty is thecharacteristic of these risks. What is more, in such instance

the risk in question is often the subject of great public concern. The question becomes

then how policy makers and judicial institutions should handle these situations.

When science cannot give us certainty about the likelihood of an adverse event

occurring in the future, what can be done? In light of the severity of possible outcomes

and public fears concerning these outcomes, the risk cannot be ignored. In such situations

the precautionary principle comes into play. It is a tool that policy makers can use in

circumstances where it is not possible to foresee the consequences of a development. A

precaution approach allows for action to be taken to deal with complex situations (van

Asselt & Vos, 2006). Application of the principle is aimed at addressing the cause of the

threat and, thus, not the symptoms (Sandin, 1999). The preventive measures that follow

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must be appropriate for the specific threat. They aim to protect human health and the

environment (ORiordan et.al, 2001). Such regulatory measures can range from

informing the public about the potential adverse effects of a certain product, to a compete

ban of that product (Europa, 2005).

The Pfizer case was a landmark case in the development of the precautionary

principle. In this case the Court of First Instance (CFI) discussed the main elements of the

principle and the conditions for its application (da Cruz Vilaa, 2004). The case

concerned the use of virginiamycin - which is an antibiotic - as growth promoter in

animal feed. The use of antibiotics as growth promoters stimulates the development of

resistant bacteria in animals. However, it has proven to be extremely difficult todetermine whether antibiotic resistance is transferrable from animals to humans

(Forrester & Hanekamp, 2006). The question before the Court was whether the use of this

antibiotic constituted a risk for public health in the future (da Cruz Vilaa, 2004; van

Asselt & Vos, 2006). It is the task of the Court to determine the degree of scientific

uncertainty necessary to trigger intervention based on the precautionary principle (da

Cruz Vilaa, 2004). In its ruling, the CFI forbade the use of virginiamycin as a growth

promoter based on the precautionary principle, attesting that there was indeed enough

scientific evidence that there could be a link between animal and human bacterial

resistance (van Asselt & Vos, 2006). In the Courts rationale for applying the

precautionary principle it constructed its own definition of the core of the principle,

namely uncertainty. By doing so, it created a justification for using the principle. More

specifically, in the Pfizer case the CFI equated uncertainty with differing scientific

opinions. In other words, the decision to ban virginiamycin was based on establishing

scientific controversy (Forrester & Hanekamp, 2006). The ruling raised the question

whether the Court has eroded the precautionary principle of its use (van Asselt & Vos,

2006). Two approaches are important in this matter. First, if the Court upheld the

definition of uncertainty as it was established in the Pfizer case, then the principle runs

the risk of becoming eroded. Since the CFI interpreted uncertainty as contrasting

scientific opinions, it can be argued that the precautionary principle can henceforth be

applied whenever one scientist does not agree. In view of the fact that this is the case in

virtually all scientific disciplines, one can argue that the conditions that trigger the

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application of the principle are very slim. Second, a broader approach demonstrates that

not only the specific definition which the Court gave uncertainty in the Pfizer case which

is relevant here. Also, the realisation that the Court constructed its own definition of

uncertainty to justify the use of the precautionary principle. This illustrates that the lack

of a clear and established definition of uncertainty may jeopardise the principle. Different

definitions of uncertainty lead to an incoherent application of the precautionary principle.

The objective of this paper is to investigate, in view of the above expressed

concerns, whether and how the application of the precautionary principle in the Pfizer

case influenced its application in subsequent cases. This can be achieved by researching

whether the interpretation of uncertainty as established in the Pfizer case has been upheldin other cases. Moreover, it is important to establish whether uncertainty continues to be

defined in an incoherent manner. The aim is, thus, to establish whether or not the Pfizer

case has set a precedent. If it has, then the Pfizer interpretation of uncertainty will be

upheld in other cases as well. The implications of this situation on public policy could be

significant. For example, too much emphasis on a precautionary approach could lead to a

risk adverse society and hinder technological development and economic growth. Also,

precautionary measures could then be used as protectionist trade barriers. As a result, the

research question is as follows: Whether, and if so, how has the application of the

precautionary principle by the CFI in the Pfizer case influenced its subsequent use in

case law?

In order to illustrate the position of the precautionary principle in todays society

it is important to commence with an explanation of the background of the principle.

Therefore, this paper starts with a discussion on old risks and new risks. In particular,

uncertain risks are extensively covered as they are specific to the precautionary context.

Hereafter, the precautionary principle will be explained. The legal framework of the

principle and the pros and cons are presented. Following this, the complex relationship

between the principle and risk assessments is discussed. Then, the Pfizer case will be

discussed elaborately. The background of the case will be presented and the ruling of the

Court. This section then concludes the background information leading up to the analysis.

The methodology section explains the decision making process of choosing case law and

how these cases were examined. Hereafter, the analysis of the cases commences. Three

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cases are investigated. These are Alpharma Inc. v. Council of the European Union,

Solvay Pharmaceuticals BV. v. Commission of the European Union, and Artegodan

GmbH and Others v. Commission of the European Communities. After the analysis and

the effects of the Pfizer case are discussed, a wider perspective will be given on the

developments in the Courts behaviour in its rulings. Last, the main points will be

summarised in the conclusion.

Old vs. New Risks

Ulrich Beck argued that modernity and the industrial revolution have created new risksthat differ from past or old dangers. These risks are larger in scope and experts are

needed to detect them. He stated that [i]n advanced modernity the social production of

wealthis systematically accompanied by the social production of risks (as quoted in

Adams, 1995, p. 179). Thus, in his view, people are no longer concerned with the

accumulation of wealth, or to a lesser extent. Now they are more concerned with the

pursuit of safety and trying to prevent the worst. Some of the fears of pre-industrial

society still exist today, since we cannot control natural disasters for example. However,

there are many anxieties the modern world has about risks that did not exist in pre-

modern times (Adams, 1995). According to Beck (1992a), thedefining feature of our age

is risk. These unprecedented dangers are the consequences of industrial and scientific

development. Nowadays we live in a risk society in which people are exposed to

different risks than before (Beck, 1992b).

In other words, there are differences between old risks and new risks. Pre-

industrial risks are natural disasters such as famines and plagues. These human dramas

were stokes of fate that could be attributed to God or nature. The accountability is

placed outside the realm of human responsibility. Modern risks, however, have their

origin in decision making in which issues such as utility and economic considerations are

considered (Beck, 1992a). The idea that we can master risks constitutes the dividing line

between the past and modern times. The future is no longer dependent on the whim of the

gods. Human beings have a say in it. The future is now influenced by the present. Risks

are defined, measured, and their consequences weighed. These factors are translated into

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a decision-making process that allows people to weigh the risks they are willing to take.

Now this rational process of risk-taking guides a wide variety of decision-making topics.

Such issues range from family planning to waging a war and from reallocation of wealth

to wearing a seatbelt (Bernstein, 1996). However, the origin of risk in human decision-

making creates the problem of social accountability. Who is responsible? It is no longer

possible to attribute an industrial disaster to an other. Instead, firms, politicians, and

people are now responsible. This makes industrial hazards a political issue (Beck, 1992a).

In addition, previously the state needed to protect its citizens from external threats such

as other powerful states. These days, however, through the industrial character of society

we have created internal threats. The political agenda is now concerned with thequestions of how to deal with these risks. Moreover, these risks are no longer only a

concern of a single state. They transcend national borders and states cannot deal with

them alone. They must work together (de Vries, 2010).

New risks arise out of developments in, for example, nuclear power,

nanotechnology, artificial intelligence, and genetic engineering. These threats have a

rather abstract and elusive character (ibid.). It is very difficult, if not impossible, to

predict the likelihood of any disastrous events occurring, or their costs (Clarke, 2005).

Early on, the industrial system created insurance as a way to deal with the unforeseeable

future. Insurance offers protection against modern risks. People invest now to feel secure

in the future. However, the irony is that current chemical, nuclear, ecological, and genetic

hazards could result in catastrophes with such unimaginable devastating effects that there

is no institution which is prepared for - or ever could be prepared for - a worst case

scenario. These mega-hazards abolish the foundation for calculating hazards and with it

the purpose of insurance. Thus, according to Beck (1992a), as danger grows protection

reduces. The insurance industry must acknowledge its limitations. In situations

concerning these kinds of threats, insurance companies find themselves relying more and

more on states (de Vries, 2010).

For many modern risks, such as those arising from nuclear technology or

chemical technology, it is not possible to test their safety by way of trail and error. It is

not an option to blow up a nuclear reactor to test how safe it is. Reactors must first be

build before their safety can be tested. It seems that science has turned technological

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development upside down, allowing technologies to be manufactured without any

knowledge about what kind of harm they could do (ibid.). The extent of the risk cannot

be calculated. Therefore, any statements on these risks are extremely speculative. In other

words, there is uncertainty about the risk (de Vries, 2010). This has lead to a situation in

which science can only guess as to where the limits lie (Beck, 1992a).

To summarise, modern risks differ from pre-industrial risks due to their origin in

decision-making and, hence, the problem of social accountability. It is not possible to test

their safety before their creation. Yet, people create a false sense of security by insuring

themselves against these risks. The preceding demonstrates that modernity, though these

risks, has brought a great deal of uncertainty to the world (Beck, 1992a). The next sectionwill discuss uncertain risks and their implications.

Uncertain risks

Uncertainty and risk are two different - yet related - concepts. There is no universal

definition of risk, but originally it has always had a negative undertone. Beck defined risk

as ... the perception of the probability and magnitude of some future adverse event

(1992a). The debate on its definition is still ongoing (van Asselt, 2000), and it is outside

the scope of this paper to present a detailed description of the arguments of this

discussion. For a more detailed representation of this debate see van Asselt (2000),

Douglas and Wildavski (1982), Hendrickx (1991), Adams (1995), Vlek (1990),

Jungermann (1993), Swart (1994), and Kmper (1998). There are, nonetheless, a few

elements that are worth mentioning for the purpose of clarifying the concept. Risk assigns

the possibility of a negative adverse event to an unknown future (van Asselt, 2000).

There is no certainty that the damage will manifest, but there is a degree of probability

that it could occur (WRR, 2009). It is only afterwards that we can determine what the

actual danger was. A part of the debate focuses on the difference between objective risks

and perceived risks. Objective risks are the real, actual, objective, measurable risks that

obey the formal laws of statistical theory. [S]ubjective risks inaccurately perceived by

non-experts are perceived risks (as quoted in van Asselt, 2000, p. 152). The first

definition of objective risks implies that all risks can be measured. This is, however, not

the case. An inherent characteristic of risk is uncertainty. Vercelli states that

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[u]ncertainty refers to the impossibility of exact predictions and [r]isk refers to the

possible negative consequences of uncertainty (as quoted in van Asselt & Vos, 2006, p.

314). Uncertain risks are situations in which there are serious reasons to believe that there

may be danger, but scientific evidence to prove it is lacking. However, science cannot

refute the suspicions of danger either. Uncertain risks are the product of their

unpredictability. Uncertainty, and therefore also uncertain risks, are both produced by

change, by societys pursuit of innovation (van Asselt & Vos, 2006; van Asselt & Vos,

2008). Uncertain risk problems emerge when activities are undertaken with

consequences that can be anticipates only partially, if at all (WRR, 2009, p. 102). A brief

remark is required here to emphasise that it is false to equate risk with uncertainty. Notall uncertainties pose threats and not all risks are uncertain (van Asselt & Vos, 2008). A

differentiation must be made between uncertain risks and safe uncertainties. Not knowing

what time it is, is in many situations a safe uncertainty and does not affect society in such

a way that societal actors regard it as unacceptable. Risky uncertainties are those which

pose a threat. Examples include a new development in nanotechnology, or manufacturing

a chemical substance. These are all situations in which it is very difficult to establish on

beforehand what the possible consequences are (van Asselt & Vos, 2006). Thus, [t]he

notion of uncertain risks refers to possible, new, imaginable hazards, with which society

has no or limited experience (van Asselt & Vos, 2008, p. 281).

Uncertainty can be viewed as limited knowledge. The cause of this limitation can

vary widely. The limitation may be a result of inexactness due to statistical errors,

validity and/or reliability problems, or just ignorance (WRR, 2009). A logical response to

all this uncertainty would be to call for more research, more knowledge. It is a natural

reaction to try and remove as much uncertainty as possible. However, gathering more

knowledge does not necessarily mean that uncertainty will decrease (McGarvin, 2001). In

fact, new information could very well increase uncertainty as it may become clear that

there is still much more that is unknown. Thus, uncertainty cannot be equated to a lack of

knowledge (van Asselt & Vos, 2006). It is important to add that experts and scientist can

give information and insights on the background of uncertainties, how they come about,

and whether uncertainty can be reduced. This is also known as uncertainty information

(ibid; van Asselt & Vos, 2008). However, they cannot provide certainty about

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uncertain risks (van Asselt & Vos, 2006, p. 317). When attempting to predict the

consequences and impact of technological developments on society, even experts

grope in the dark (WRR, 2009, p. 103). According to Beck, scientist and engineers have

a monopoly in diagnosing hazards. However, he argues that in case of predicting hazards

no one is an expert - particularly not the experts (1992, p. 106).

The Precautionary Principle

It has probably become clear that the development of new technologies not only results in

positive outcomes for society. There are many examples one can think of in which a new

technology leads to unexpected and unwanted consequences. Such as a computer error

that causes the government to collect too much taxes, or a telephone network crash which

leaves millions of people without service. In many situations these errors are

inconvenient, but not dangerous for the environment or individuals. There are, however,

technologies that could result in serious harm to human health if something goes wrong.

The most famous example being the nuclear disaster in Chernobyl. In hindsight it is

always easy to see where the mistakes were made and where more caution would havebeen required (Clarke, 2005). Unfortunately, insight after the fact could be too little too

late. As a means of dealing with the possible negative side effects of new technologies,

the precautionary principle enables policy makers to act.

In the areas of environment and human health and safety, the precautionary

principle has come to play an important role in the decision-making process. In policy

situations where the possible consequences of the subject matter are uncertain, the

principle legitimates precautionary action. The principle allows institutions to take

protective measures without having to wait until the reality and seriousness of those risks

become fully apparent (da Cruz Vilaa, 2004, p. 381). According to de Sadeleer (2007)

and van Asselt and Vos (2006), [i]t is generally agreed that uncertainty is the essence of

the precautionary principle (p. 314). Thereby risk and uncertainty are linked as the

fundamental elements of the principle. The principle covers significant and serious risks

that could cause irrevocable damage (de Sadeleer, 2007). It is not correct, however, to

view the precautionary principle as an all-inclusive risk principle (ibid.). The

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application of the principle is only logical when risk and uncertainty interact (ibid.). It

follows that the principle does not apply to risks that are certain risks. Such as the risks of

smoking on human health. Nor does it apply to speculative or hypothetical risks which

have no foundation in science (de Sadeleer, 2007).

Legal Framing of the Precautionary Principle

There are several accounts as to how the precautionary principle developed and when it

was first recognised by the international community. This paper will not bring forward a

lengthy discussion of these different reports as such a review is outside the scope of this

paper. Instead, a few landmark developments of the principles are highlighted.

The principle was recognised in the UNs World Charter for Nature in 1982, and

enshrined in the Rio Declaration of 1992 during the Rio Conference on the Environment

and Development. Having its roots in environmental law the principles application soon

extended into fields such as public health and food safety (European Commission, 2000;

Victor, 2001; WRR, 2009). Article 15 of the Rio Declaration states the following;

[i]n order to protect the environment, the precautionary approach shall be widelyapplied by States according to their capabilities. Where there are threats of seriousor irreversible damage, lack of full scientific certainty shall not be used as areason for postponing cost-effective measures to prevent environmentaldegradation.

There is not one clear definition of the precautionary principle. However, the different

versions do have several elements in common: the willingness we must posses to act in

such a way as to avoid any possible negative circumstances or consequences, even when

science cannot give conclusive evidence on whether or not the outcome is possible

(ibid.). The principle is designed to address the existence of scientific uncertainty in

areas where our failure to anticipate future harm may lead to disaster (Kaiser, 1997, p.

202). Thus, we have to be ready to take precautionary action even if our fears prove to be

unwarranted (ibid.). Precaution thus entails that regulation to prevent the potential danger

will be enforced before it is certain whether or not it will materialise. Forrester and

Hanekamp point out that full scientific evidence of the causal hazard chain is lacking

(2006, p. 298). The European Commission (2000) confirmed this, declaring that [t]he

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absence of scientific proof of the existence of a cause-effect relationship should not be

used to justify inaction (p. 17). The remarkable thing is that although the EU recognises

the precautionary principle as a full-fledged principle of international law, the principle

requires no objective relationship between source and harm. This link has disappeared in

scientific uncertainty.

Within the European Union, the precautionary principle is an important policy

tool. It was introduced in 1993 into the Treaty on European Union, also known as the

Maastricht Treaty. In the environmental section of the treaty the principle was placed

under Article 174 (European Commission, 2000; Gezondheidsraad, 2008; Jordan, 2001).

Even though the treaty only refers to it in the environmental context, in practice the EUapplies it as a general principle of law (European Commission, 2000). This is affirmed by

Article 7(1) of EC Regulation 178/2002, which states that

[i]n specific circumstances where, following an assessment of availableinformation, the possibility of harmful effects on health is identified but scientificuncertainty persists, provisional risk management measures necessary to ensurethe high level of health protection chosen in the Community may be adopted,pending further scientific information for a more comprehensive risk assessment

(European Parliament, 2002, p. 9).

This entails that in situations where there are serious reasons to believe that harm to

human health could manifest, even though there is not enough scientific evidence to

prove it, the EU is entitled to take precautionary measures to protect the health of its

citizens. Additionally, case law has confirmed the position of the principle. In the

Artegodan case, for example, the CFI ruled that the precautionary principle is a

general principle of Community law1.

In 2000, the European Commission issued the Communication from the

Commission on the precautionary principle. This Communication represents the

Commissions own views on the principle and its implementation. None of the Members

States or any of the EU institutions are legally bound to adhere to the Communication.

Rather, it is meant to serve as a general guideline (Jordan, 2001).

1Judgment of the Court of First Instance of 26 November 2002 in Case T-74/00. Artegodan GmbH v.Commission of the European Communities, para. 184.

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Pros and Cons

The lack of a fixed and clear definition has given the precautionary principle a certain

vagueness which can be seen as a vice and as well as a virtue. On the one hand, it is

argued that the lack of a clear definition inhibits a sound application of the principle. The

vagueness of the principle has generated the view with some authors that it is incoherent

(Percival, 2005; Peterson, 2006; Sunstein, 2005). It is flexible and compliant, opening the

door for an element of arbitrariness in decision-making concerning possible risks. This

could lead to a situation where it could be used in any situation to restrict or ban products

(Forrester & Hanekamp, 2006; Gezondheidsraad, 2008; Sandin, 2006). Then the principle

would become a tool for arbitrary discrimination of trade. Also, the principle does not

prescribe how large the harm must be, or what kind of measures should be implemented

(Grandjean, 2004; Percival, 2005). Article 7(2) of Regulation 178/2002 states that any

measures taken in the spirit of the precautionary principle must be proportional, no more

restrictive to trade than is necessary, and should be reviewed in reasonable time

(European Parliament, 2002). However, the decision to act is in itself a political decision

(European Commission, 2000). The social acceptability of a risk depends on the level of

protection that is deemed necessary. This, again, is a political decision (Forrester &

Hanekamp, 2006). In a situation where it is not clear what the consequences may be, it is

difficult to determine what constitutes a proportional and necessary measure. Since there

are only a few guidelines guiding the implementation of the principle, its implementation

can be viewed as arbitrary and incoherent (Forrester & Hanekamp, 2006; Percival, 2005;

WRR, 2009). The European Commission itself acknowledges that the EU reserves the

right to impose whatever level of protection it considers to be necessary (Forrester &

Hanekamp, 2006). On the other hand, Clarke argued that the vagueness can be seen as a

positive characteristic of the principle. It is not just applicable to one specific case, but

can be used as a guide for policy making. Hence, policy-makers will become more

cautious and more aware of the consequences of technological development (2006). It is

also argued that in circumstances dealing with potential catastrophic risks, the principle

can be useful (Sunstein, 2005). In addition, although the precautionary principle entails a

(subjective) value judgement this holds true for most decision making rules (Grandjean.

2004).

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Another argument voiced against the precautionary principle is that it has the

possibility to obstruct the development of new technologies and that it is hostile to

science (Grandjean, 2004). When suspicions are sufficient motivation for precautionary

measures, then there will be no more need for further research. Thereby, depriving

science of its place in policy-making (WRR, 2009). The argument holds that relying on

the principle too extensively might bring innovation to a halt and incite risk aversion.

Imagine that the principle had prevailed in the past, then we would not have any

antibiotics, bicycles, biotechnology, or airplanes for example. However, it is unlikely that

innovation will come to a complete stop. In all cases concerning uncertain risks, not only

the risks and uncertainties are weighed. Also the available knowledge and otherconsiderations, thereby creating a broad illustration of the situation at hand. For that

reason, the principle is argued not to be hostile to science. In addition, the application of

the precautionary itself calls for new research. Instead of viewing scientific research as

being crippled under the precautionary principle, it can be seen as a new approach to

research responding to new needs (Gezondheidsraad, 2008; Grandjean, 2004; WRR,

2009).

Uncertainty Paradox

The understanding that science cannot provide well-founded scientific certainty that

proves whether or not a particular disastrous event will occur stood at the cradle of the

precautionary principle. It is striking, therefore, that in order to apply the precautionary

principle a knowledge condition must be fulfilled. This entails that experts and scientist

are asked to deliver a statement of proof about the possibility on whether or not there is a

risk, also known as plausibility proofs (van Asselt & Vos, 2006). It seems that this is

difficult to reconcile with the core of the precautionary principle, which is uncertainty

(van Asselt & Vos, 2006). This situation is referred to as the uncertainty paradox, in

which a very high level of scepticism as to what science cannot deliver goes hand in

hand with a very optimistic level of confidence regarding what science should be able to

deliver (Forrester & Hanekamp, 2006, p. 308). Thus, although it is accepted that there is

uncertainty and that science cannot offer decisive evidence, science is placed in the

position of having to provide certainty. The inability of properly dealing with uncertainty

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and not truly appreciating its meaning have led to this paradox which endangers decision-

making to become deadlocked in a vicious circle (van Asselt & Vos, 2006).

Even in the Commissions Communication on the Precautionary Principle the

uncertainty paradox is visible. The Communication states that when potential adverse

effects could occur a scientific evaluation must be conducted to determine whether

measures must be taken to protect the environment, the human, animal or plant

health (European Commission, 2000, p. 14). It continues to state that where it is feasible,

an assessment of risk should be undertaken to determine if there is cause to apply the

precautionary principle. Hereafter, it recognises that it is not possible in all cases to

complete a comprehensive assessment of risk, but all efforts should be made to evaluatethe available scientific information (ibid.). The paradox is visible in the Commissions

call for a comprehensive risk assessment, while at the same time acknowledging that this

might not be possible. However, no effort must be spared to evaluate the scientific

evidence.

The role of risk assessment within the precautionary principle is complex. Risk

assessments are a prerequisite for the application of the principle. However, it is difficult

to establish how in depth these assessments should be executed. How much evidence is

enough? In the following section the relationship between risk assessment and the

precautionary principle will be discussed in order to illustrate the intricacy of their

interaction.

Risk Assessment and the Precautionary Principle

The precautionary principle has a somewhat difficult relationship with risk assessments.

The definitional ambiguity of the principle has left it up to the Courts to define the role of

risk assessment in the application of the principle. Early cases dealing with precaution

were ambiguous concerning the necessary specifications to trigger its application.

Throughout the years, however, the role of scientific risk assessment to determine the

appropriateness of a precautionary approach has gained prominence in case law (Stokes,

2008).

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Risk Assessment in EU law

Article 174 of the EC Treaty does not mention a direct relationship between the

precautionary principle and risk assessments. Even so, Article 174(3) does require

Community policy must take into consideration available and scientific information

(Stokes, 2008). The Communication on the precautionary principle states that in order to

trigger the precautionary principle, an objective and complete as possible scientific

evaluation is required (European Commission, 2000). In the Pfizer case, the CFI defined

a scientific risk assessment as a scientific process consisting in the identification and

characterisation of a hazard, the assessment of exposure to the hazard and the

characterisation of the risk2. In case law the Courts confirmed that after uncertainty is

recognised, a de minimis level of scientific evidence is required to trigger precaution.

This prerequisite can be achieved by performing a risk assessment. For instance, in the

Pfizer case the CFI ruled that a preventive measure may only be taken if the risk

appears to be adequately backed up by scientific data available3. In addition, the

Court declared that the precautionary principle requires a scientific assessment of

risks as exhaustive as possible on the basis of scientific opinions based on principles of

excellence, transparency and independence4. In a similar fashion, the Court was

unambiguous in the Monsanto case that precautionary measures had to be based on as

complete a risk assessment as possible5. In short, the Courts have confirmed that

precautionary measures must have a solid scientific basis (Stokes, 2008).

Elements of Risk Assessment

When assessing suspected risks, there are two complementary tasks that need to be

performed. First, the level of risk that is deemed unacceptable must be established. This

is done by the competent authority and, therefore, the decision to apply the precautionary

principle is also taken at that level. This is a political decision, since the scientific experts

2Case Y-13/99, para., 156.3Judgement of the Court of First Instance of 11 September 2002 in Case T-13/99. Pfizer Animal Health SA

v Council of the European Union, para. 143.4Order of the Court of First Instance, 14 December, 2005. Arizona Chemical and Others v. Commission.Case T-369/03, para. 85.5Judgement of the Court, 9 September 2003, in Case C-236/01. Monsanto Agriocultura Italia SpA v. Presidenzadel Consiglio dei Ministri, para. 131.

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have no political responsibilities or democratic legitimacy. However, since science is a

necessary, but not sufficient condition, political players have a significant degree of

discretion in determining what level of risk is acceptable and how to achieve this. It

follows from case law that the opinions from scientific committees are not binding. For

that reason, EU institutions can choose to disregard the scientific opinion offered.

Second, a scientific assessment of the risk must be performed (de Sadeleer, 2007). The

scientific assessment is preferably a quantitative estimation of the risk. The quantitative

assessment is at the heart of risk assessment (WRR, 2009). At a minimum, the process

has the following elements;

1) identification and, if possible, estimation of a particular hazard; 2) anassessment of exposure and/or vulnerability; 3) an estimation of risk, combiningthe likelihood and the severity of the targeted consequences based on theidentified hazardous characteristics and the exposure/vulnerability assessment(IRGC, 2005, p. 27).

By placing such emphasis on risk assessment, some have argued that performing a risk

assessment has become a condition sine qua non for the implementation of

precautionary measures (ibid., p. 22). This could be seen as an attempt to construct acause-and-effect relationship to justify the application of the precautionary principle.

When performing a scientific risk assessment, prevailing and dissident opinions

become apparent. Science, it seems, does not speak with one voice. Drawing a line

between the scientific majority opinion and the minority opinion is, again, a political

issue. Science in itself does not require a majority rule, politicians do (de Sadeleer, 2007).

With this in mind, it is important to note that political judgements are about trade-offs.

Do the advantages of the technology outweigh the risk (Millstone, 2010)? The role of

scientific dissidents has not been clarified by the EU law-makers or by the Courts.

Hereby, there is room in the precautionary principle debate on marginal and differing

opinions (de Sadeleer, 2007).

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A Troublesome Relationship

Scientific research provides the data on which the decision whether or not the estimated

risk is acceptable is taken. Risk assessment will be the most helpful when scientific data

is almost complete. Unproblematic evaluations of risks are those based on hard data

(WRR, 2009). However, in case of uncertain risks, science cannot provide this hard data.

Nevertheless, governing institutions still insist on executing risk assessments with regard

to uncertain risks, while uncertainty is the main problem in standard risk assessments

(Grandjean, 2004). In situations where risks are characterised by uncertainty, it is

unlikely that a comprehensive risk assessment can be executed at all (European

Commission, 2000; de Sadeleer, 2007; Stoker, 2008). This is also acknowledged by the

Commissions Communication. Nevertheless, the Commission declares that all

efforts should be made to evaluate the scientific information (2000, p. 14). This

dichotomy can also be found in the Courts ruling of the Pfizer case, where the Court

held that a precautionary measure may only be taken when there is enough scientific data

to belief the seriousness of potential adverse effects6. The Court continued to state that

the purpose of a risk assessment is to assess the degree of probability of acertain product or procedure having adverse effects on human health and theseriousness of any such effects

7.

A risk assessment must then perform a scientific assessment of the risk. At the same time

though, the Court asserted that

a risk assessment cannot be required to provide the community institutionswith conclusive scientific evidence of the reality of the risk and the seriousness ofthe potential adverse effects were that risk to become a reality

8.

Again, the Court stated that when the precautionary principle is applied, it may prove

impossible to carry out a full risk assessment () because of the inadequate nature of the

available scientific data9. Yet,

6Pfizer, Para. 144.7Pfizer, Para. 148

8Pfizer, Para. 1429Pfizer, Para. 160

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[n]otwithstanding the existing scientific uncertainty, the scientific risk

assessment must enable the competent public authority to ascertain, on the basisof the best available scientific data and the most recent results of internationalresearch, whether matters have gone beyond the level of risk that it deemsacceptable for society10.

Then, the questions arise as to what a less than comprehensive risk assessment should

consist of and how much scientific evidence is enough evidence (de Sadeleer, 2007). The

risk assessment must determine the proportionality of a precautionary measure. This

means that the Courts need to know the level of protection sought in order to determine

whether the measure was adequately founded in scientific data (Alemanno, 2008). Again,

this is unlikely to be discovered with regard to uncertain risks. In addition, the

Communication states that a risk assessment must be performed where feasible. Yet, no

mention is made of the conditions under which the Commission believes a risk

assessment to be feasible (Forrester & Hanekamp, 2006; Stokes, 2008).

It seems that although scientific uncertainty is acknowledged, the experts are still

expected to provide certainty. This can lead to a situation of uncertainty intolerance. In

such circumstances, uncertainties are evaded instead of investigated (van Asselt & Vos,2008). In case of a risk intolerant risk assessment, application of the precautionary

principle is not possible, since its core - uncertainty - is not acknowledged. Hence, the

definition of uncertainty is politically very important. It decides whether precaution can

be used or not (van Asselt, 2010).

10Pfizer, para. 162

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The Pfizer Case

The Pfizer case was an important case in the development of the precautionary principle.

It was in this case that the CFI discussed at length the interpretation and the correct

application of the precautionary principle for the first time (Case Law Analysis, 2003; da

Cruz Vilaa, 2004). Pfizer Animal Health is a pharmaceutical company that produced and

marketed virginiamycin, an antibiotic. At the time when Regulation 2821/98 was adopted

- thereby banning the use of virginiamycin as additive to feedstuffs - Pfizer was the only

producer in the world of that substance. Pfizer, in turn, brought proceedings before the

CFI seeking annulment of that regulation11

. In this section the specifics of the case and

the interpretation of the case by - amongst others - van Asselt and Vos (2006) will be

discussed.

Antibiotics in Animal Feedstuffs

An antibiotic is a substance that acts at the level of the metabolism of bacteria. They are

used to treat bacterial infections, both in humans as well as in animals. Resistance of

bacteria to antibiotics can present a serious risk for public health since these bacteria can

no longer be treated with the respective antibiotic. Bacteria are resistant to antibiotics

when they have an increased capability to resist the effects of the antibiotics at hand. For

many years antibiotics have served as growth promoters and were added in low doses to

animal feedstuffs. This practice causes animals to grow faster and gain more weight. As a

result, they need less time and less food to reach the desired weight for slaughter12

.

It has been indisputably demonstrated that using antibiotics as growth promoters

tends to encourage the development of resistant bacteria in animals. It is very difficult,

however, to assess the risk of transferring antibiotic resistance from animals to humans. It

is assumed that antibiotic resistance is transferrable from animals to humans. Though at

present, no human health problems have been attributed to antibiotic resistant bacteria as

a result of using growth promoters (Case Law Analysis, 2003; Forrester & Hanekamp,

2006). However, no producer could ever prove this would never happen, or could never

happen (Forrester & HaneKamp, 2006, p. 304).

11Pfizer, para. 42.12Pfizer, para. 29 - 31.

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Regulation 2821/98

In January 1998 Denmark notified the Commission of its decision to ban the use of the

antibiotic virginiamycin as growth promoter. This decision was based on a report from

the Danish National Veterinarian Laboratory which considered it to be probable that

virginiamycin could be transferred from animals to humans. The Commission submitted

the Danish report to the Scientific Committee on Animal Nutrition (SCAN) (van Asselt

& Vos, 2006). SCAN is an advisory body attached to the Commission. It carries out risk

assessments and provides the Commission with scientific advice at its request. Due to

SCANs advisory role, the Commission is not obliged to accept the conclusions provided

in its opinion (da Cruz Vilaa, 2004). SCAN was asked by the Commission

to give an opinion on whether the conclusions in the Danish report arescientifically justified and on the question whether or not the use of thevirginiamycin as a growth promoter constitutes a public health risk of could

constitute such a risk in the future (van Asselt & Vos, 2006, p. 320; in terms ofreference: SCAN 1998).

The conclusion of SCAN was that the use of virginiamycin as a growth promote does

not constitute an immediate risk to public health (1998). Nonetheless, Commission did

not agree with the SCAN conclusions and did not follow SCANs opinion (Calster &

Lee, 2003). The Commission still proposed a ban of the antibiotic and appealed to the

precautionary principle to do so. The draft-decision of the Commission was then sent to

the Council to decide on the issue. Where after it agreed with the position of the

Commission (van Asselt & Vos, 2006). Subsequently, on December 17th,1998, the

European Council adopted Regulation 2821/98 which prohibited the use of four

antibiotics in animal feedstuffs. These were bacitracin zinc, tylosin phosphate,

spiramicin, and virginiamycin. At the time of adoption, there was no scientific proof that

established a link between any of the four mentioned antibiotics and development of

human resistance to these antibiotics13. In addition, scientific views on whether

virginiamycin was a human health risk differed significantly (Case Law Analysis, 2003;

Forrester & Hanekamp, 2006). When Regulation 2821/98 was adopted, Pfizer Animal

13Pfizer, para. 41.

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Health SA (from hereon Pfizer), was the sole producer of virginiamycin. Faced with the

ban that the regulation had brought about, Pfizer challenged this decision and brought an

action for annulment of the regulation before the CFI (Forrester & Hanekamp. 2006; van

Asselt & Vos, 2006).

The Ruling of the Court

The risk to be assessed in the Pfizer case was the possibility that adding virginiamycin as

a growth promoter to animal feedstuffs would lead to adverse effects on human health.

More specifically, the transfer of bacterial resistance to antibiotics from animals to

humans thereby reducing the effectiveness of certain medical products designed for

humans (da Cruz Vilaa, 2004). Pfizers grounds in their request for annulment were

related to faulty application of the precautionary principle, and errors made in the risk

assessment and management. This forced the Court to investigate the scientific arguments

made by both parties (van Asselt & Vos, 2006). The Court eventually upheld the ban in

its ruling. It is the argumentation for the application of the precautionary principle that

has given rise to much debate.

Van Asselt and Vos (2006) argued that the Court found itself in a deadlock

struggling with its role in the scientific debate. The Court stated that [i]t is not for the

Court to assess the merits of either of the scientific points of view argued before it 14. It

continued, however, to state that

the Court nevertheless finds that the parties arguments, supported in each

case by the opinions of eminent scientists, show that there was great uncertainty,at the time of the adoption of the contested regulation, about the link between theuse of virginiamycin () and the development of () resistance in humans

15

(italics added by author).

Hereafter, the Court stated that it is apparent that at the time when the contested

regulation was adopted, other scientists and specialist bodies had taken a different view

14Pfizer, para. 393.15Pfizer, para. 393.

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from that of SCAN and the experts called by Pfizer16

. However, at the same time the

Court stated that there was

sufficient reliable and cogent scientific evidence() to conclude that therewas a proper scientific basis for a possible linkbetween the use of virginiamycin

() and the development of () resistance in humans17

(italics added byauthor).

Moreover, the Court concluded that

the Community institutions had a scientific basis on which to reach a decision,since they could draw on some results of the most recent scientific research on the

matter18

.

These statements of the Court have lead Van Asselt and Vos (2006) to assert that the

precautionary paradox was visibly at work in the Pfizer case. They argued that while

on the one hand great uncertaintyis emphasised, at the same time, it is suggested that

sufficient reliable and cogent scientific evidenceand a proper scientific basiswere

available (p. 326). Consequently, the Court found itself in a deadlock. In an attempt to

overcome this deadlock and to come to a ruling, the Court constructed uncertainty to

justify the application of the precautionary principle. In doing so it equated scientific

uncertainty - the core element of the precautionary principle - with diverging opinions

between experts. Thus, the Court interpreted uncertainty as contrasting scientific

opinions (van Asselt & Vos, 2006, p. 329). It seems that contrasting scientific opinions

are enough evidence for the Court to conclude that uncertainty is present. In a way the

Court created its own version or interpretation of uncertainty to legitimise the use of the

precautionary principle (ibid.). This view is also held by Forrester and Hanekamp (2006),

who state that [t]he CFI referred to the conclusions of different specialist bodies andexperts only in order to show the difference of opinion within the scientific community

(p. 304). They conclude by declaring that [t]he Court based its decision not on an

examination of the scientific merits, but on the fact that a controversy existed between

scientists (p. 307).

16Pfizer, para. 394.

17Pfizer, para. 389.18Pfizer, para. 369.

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Based on the preceding analysis, van Asselt and Vos (2006) posed the question

whether such an interpretation of uncertainty erodes the precautionary principle.

According to the Courts interpretation of uncertainty in the Pfizer case it all comes down

to contrasting scientific opinions. Van Asselt and Vos (2006) continued by asserting

[s]ince nearly in all uncertain risk cases a qualified dissident can be found, this

interpretation and application of the precautionary principle would in practice deprive the

ambition of precaution of any meaning (p. 329). The line of reasoning applied by the

CFI in the Pfizer case has subsequently left the institutions with a very wide margin of

discretion (Case Law Analysis, 2003).

Methodology

In order to ascertain whether the interpretation of the precautionary principle as

established in the Pfizer case has been held up in other cases, it is necessary to examine

post-Pfizer case law that deals with the precautionary principle. The analysis of these

cases consists of several steps starting with a broad approach where after the analysis will

become more focussed. The first phase is intended to create an impression of the case

itself. This requires a close reading of the case law in question (Maxwell, 2005). The

second phase narrows its focus through the application of the qualitative research

technique of content analysis to analyse the texts. Content analysis allows for the in-depth

exploration of the texts. Krippendorf (2004) defines content analysis as a research

technique for making replicable and valid inferences from texts (or other meaningful

matter) to the contexts of their use (p. 18). The relevance of content analysis as research

technique lies in its acknowledgement that text has meaning for the reader. It is produced

to mean something to someone (ibid.). It is precisely this meaning that is vital, as it can

give indications concerning the Courts intentions. Not only the meaning of the text, but

also how these texts are used is of importance in content analysis. Texts do not have a

single meaning and opinions concerning texts may not be shared (ibid.). Studying a text

through content analysis does not constitute a true reading of the text. It must be viewed

in the context of the theory of the researcher and the research purpose. When approached

in a different manner and with a different goal, alternate readings of the same text can

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come to the fore (Bauer, 2000). This characteristic demonstrates its relevance for the

Pfizer case and subsequent cases, as it will shed light on the interpretation of uncertainty

and, subsequently, the precautionary principle.

Case law is selected according to the relevance sampling technique. This

sampling technique aims at selecting all textual units that contribute to answering

given research questions (ibid, p. 119). The chosen texts for analysis in this method are

not intended to be representative of a larger population of texts. They should be regarded

as the relevant population of texts, whereby texts with less relevant information are

excluded (ibid.). It may have become clear that the selection criteria for the cases are

twofold, namely that they were handled by either the ECJ or CFI after 1999 and that theydeal with the precautionary principle. A qualitative strategy is categorical coding

(Kippendorf, 2004; Maxwell, 2005). The case law texts are coded according to

categorical distinctions. These allow for classification of textual units according to their

commonality and for comparison within the defined categories (Maxwell, 2005). Thereby

uncovering different interpretations of uncertainty for example. The coding categories are

set up to permit argumentation analysis of the case law texts since the analysis focuses on

the argumentation and justifications given by the courts. Thus, the coding categories are

then the parts of the argumentation data, claim, warrant, backing, and rebuttal

(Liakopoulos, 2000). Within these categories, the following words and concepts are of

importance; the precautionary principle, Pfizer, risk(s), (scientific) uncertainty, uncertain

risk(s), scientific evidence, and contrasting scientific opinions. The coding will enable the

search for patterns, differences, and references to the Pfizer case. Some categories were

established ex ante and others were informed by the analysis itself.

One disadvantage of using coding schemes for text analysis is that the categories

become a controlling conceptual grid which is difficult to break away from (Silverman,

2003). However, the close reading approach that takes place before the categorical

coding aims to diminish this disadvantage. It is important to note, again, that the chosen

categories are context specific for this analysis and are used for this specific research

angle. Naturally, the examined cases can be studied for other purposes and the categories

can be applied in different settings as well. They are then used to accomplish different

goals (ibid, 2003). It is important to ask for what purpose the texts are used before any

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analogies can be founded. In addition to the study of Post-Pfizer case law, the analysis

will be complemented by reviews done on the selected cases by other authors. Reviewing

these will provide insights into the development of the precautionary principle. Both the

case law review performed in this paper and those done by other authors reflects the

interpretation of uncertainty and the precautionary principle. They enable conclusions to

be drawn as to whether the interpretation of the principle established in the Pfizer case is

continued in subsequent case law.

Analysis: Uncertainty InterpretationsIn spite of its prevalence in regulatory schemes that aim at protecting the environment

and human health, it has been the Courts who are largely responsible for clarifying the

operation of the precautionary principle. Due to its litigious character, the interpretation

of the principle has been thedefining aspect that determines its jurisprudence. The Court

is not always consistent in defining uncertainty and in its application of the precautionary

principle. These shifts in the judicial interpretation of precaution have also been observed

by other authors, such as Stokes (2008). Her viewpoint is that the debatable nature of theprinciple functions as the facilitator of the shifts (ibid.).

In this section of the paper some of these shifts in the interpretation of precaution

are examined. Three case studies of case law are presented in which the CFI dealt with

the precautionary principle extensively. Each case starts with a description of the

background facts. Then, an examination of the argumentation of the Court is carried out.

Last, the case in question will be linked back to the Pfizer case to determine precedence.

Hereafter, the findings are placed in a wider context. Thereby enabling a reflection of the

consequences and implications of the results. Before the discussion of the cases starts,

however, a timeline of the proceedings within these cases is presented on the next page.

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1995 1996 1997 1998 1999 2000 2001 2002 2003

Alpharma

February 2nd

Swedensubmitsrequest towithdrawmarketauthorisationfor bacitracinzinc

June 6th:

Alpharmaapplied forrenewalmarket

authorisation

December17th

CounciladoptedRegulation2821/98:withdrawalmarketauthorisation

Nifursolwassubject of newmarketauthorisationunder Article 9hof Directive70/524

July 18th:

AssessmentreportCPMP

March 9th:

CommissionadoptedDecisionC(2000) 453,DecisionC(2000) 452,and DecisionC(2000) 608.

October21st:

JudgmentCFI inSolvay

Artegodan

May17th:

ReferralGermany toCPMPconcerningcentrally-actinganorectics

Regulation2377/90:

Nitrofuransbanned asveterinarymedicinalproducts

Solvay

1990 - 1995:

Examinationsubstances byCommittee forVeterinary

MedicinalProducts

November16th:

ProvisionalauthorisationNifursolreplaced

May22nd:

VMDforwardedexpert opinion toSCAN

October11th:

SCANadoptsopinion onNifursol

September23rd:

CounciladoptedRegulation1756/2002:withdrawalmarketauthorisationNifursol

September11th:

JudgmentCFIin Alpharma

November26th:

JudgmentCFI inArtegodan

CommissionDecision ofDecember 9th

June 4th:

Picon/AbadieReport

April:

NewsupplementPicon/AbadieReport

August 31st:

CPMPopinion:recommendation forwithdrawal marketauthorisationamfepramone,phentermine,clobenzorex,fenproporex, andnorpseudoephedrine

November 5th:

Alpharmawas informedthat the Commissionwanted to banbacitracinzinc

Figure 1: Timeline Case Law

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Alpharma Inc. v. Council of the European Union

Alpharma is a company that focuses on producing medicated feed additive products for

animals. It develops, manufactures, and markets pharmaceutical and nutritional products

for food producing animals (Alpharma, 2010). After the EU institutions implemented

Regulation 2821/98 - with which the market authorisation of one of Alpharmas products

was withdrawn - Alpharma brought proceedings before the CFI seeking the annulment of

that regulation.

Facts and Background

At the time of adoption of the contested regulation, Alpharma was the only manufacturer

of bacitracin zinc in the EU. Bacitracin zinc is an antibiotic which is used as an additive

in feedstuffs. Added to the feedstuffs of poultry, calves, and pigs in very low

concentrations, it improves growth and weight gain of these animals19

. The use of

antibiotics in feedstuffs has given rise to the question whether this could lead to increased

resistance of bacteria to antibiotics in humans. The causes for antibiotic resistance in

humans have not been completely clarified yet. However, the scientific community

largely recognises the existence of a link between the practice of using antibiotics asgrowth promoters in animals and development of resistance to those antibiotics in

humans. Resistance in humans to antibiotics could have major implications for human

medicine. It results in treatment complications as certain diseases become more and more

difficult to treat, and in increased mortality risks arising from those diseases20.

Bacitracin zinc was an authorised feedstuffs additive under Directive 70/524. In

some cases the authorisation was without time limitations, and for others it was for a

specific period of time. On February 2nd1998, Sweden submitted a request to amend that

directive seeking to withdraw market authorisation of bacitracin zinc. Sweden also

attached a report to the request in which it addressed the risk of the use of bacitracin zinc

in both human and animal treatment. It reported cases of humans undergoing bacitracin

treatment which have allergic reactions to the substance. Also, it claimed that people who

use bacitracin on a daily basis may be sensitised. However, the report acknowledges that

19Case T-70/99. Judgment of the CFI of September 2002.Alpharma Inc. v. Council of the European

Union, para. 30 42.20Alpharma, para. 34 35.

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there is not enough information to assess the possible risk of the antibiotic to human and

animal health. This report was discussed at a SCAN meeting, but no SCAN opinion was

requested by the Commission21. According to Calster and Lee (2003), the Courts ruling

in Alpharma means that

nothing precludes the reliance, in the absence of a SCAN opinion or a

scientific report from the SSC, on SCAN opinions relating to other antibiotics andthe reports of various international, Community and national bodies (p. 110).

On June 6th1998, Alpharma applied for renewal of market authorisation of bacitracin

zinc. On November 5th

1998, Alpharma was informed that the Commission had drawn upa draft proposal that would add bacitracin zinc to the list of banned additives for

feedstuffs. Hereafter, on December 17th1998, the Council adopted the contested

Regulation 2821/98, thereby banning bacitracin zinc22. Hereafter, Alpharma brought

proceedings before the CFI.

The parties were in accordance concerning their call for more research on this

matter. The point on which they disagreed was whether, and if so, to what extent

bacitracin zinc influences human medicine23. The Court acknowledged that [t]he

possibility and the probability of such transfer and the risk it may entail for public health

continue to give rise to argument in scientific circles24(italics added by author). The

Court asserted that

[i]t is common ground between the parties that at the time when the measurewas adopted, the transfer and development of such resistance had not yet beenscientifically established in respect of bacitracin zinc25.

It continued to state that the available data is too scarce to conduct a risk assessment of

the possible risks to human health as a result of using bacitracin zinc26. The Court ruled

in favour of the EU institutions, declaring that they did not make manifest errors of

21Alpharma, para. 43 44.

22Alpharma, para. 45 53.23Alpharma, para. 30 42.24

Alpharma, para. 37.25Alpharma, para. 41.26Alpharma, para. 44.

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assessment in concluding that the use of that additive as a growth promoter constituted

a risk for human health27

.

The Courts Ruling

Early on, the Court stated that the judicial review of the scientific risk assessment must be

limited, as it is not entitled to substitute the EUs risk managers assessment - meaning

that of the Commission - with its own interpretation of the risk assessment28

. The

Commission has discretionary powers when determining the level of acceptability of a

risk29. The Courts review, though, is only marginal. It examines whether the procedures

were adhered to properly. However, due to the Alpharmas claim that the EU institutions

did not rightly assess the risks, the Court had little choice but to go into the discussion on

the available scientific information.

When considering the risk assessment the Court started by stressing that in

applying the precautionary principle

[i]t is sufficient that the risk exists, that serious concerns have been expressed inscientific literature and in the reports of various conferences and bodies and that

it could have serious consequences for human health.It does not matter that there are differences of opinion between scientists

30(italics added by author).

This quote brings forward two interesting points. First, the Court held that it is enough for

a risk to exist. This statement is not consistent with the kind of risk that is under scrutiny

here. By stating that the risk exists, the Court implied that the risks in this case are

simple, calculable, and objective (Hansson, 2010; Van Asselt & Renn, n.d.). With simple

risks the causes and consequences are known. There is hardly any uncertainty and past

experiences have left us with ample of statistical data that enables meaningful riskassessment (Van Asselt & Renn, n.d.). If this were the case in Alpharma, there would

have been no need for the EU institutions or the Court to discuss the precautionary

principle at all. As exemplified by Van Asselt and Renn (n.d.) risks associated with

agro-biotechnology are best characterized as risks that are uncertain, complex and

27Alpharma, para. 12.28

Alpharma, para. 180.29Alpharma, para. 8.30Alpharma, para. 150

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ambiguous (p. 12). These systemic risks are inherently complex as it is very difficult to

discover the cause and effect relationships. There are often many causal agents and even

more effects which are the result of their non-linear interactions. In addition, risks that

involve future consequences are unavoidably surrounded with uncertainty (ibid.). For

these risks no facts about the future are present (De Jouvenel, 1967). Ambiguity is the

last component and it means that there are multiple varying viewpoints on risks which are

all legitimate. There are several values at play which means that on a single treat

diverging views on how to assess the risk exist and they challenge each other (Van Asselt

& Renn, n.d.). Therefore, ... whether risks are acceptable, tolerable or not could be

subject of considerable debate and intense controversy (ibid., p. 11). Viewing risks inthis light, one can see that risks are in part social constructs. How risks are experienced is

to some extent a result of the values held by - for example - political and religious groups.

Risks are not only comprised of objective facts (Hansson, 2010). By stating that the

existence of a risk is enough, the Court ignored the uncertainty of the situation by trying

to narrow the risk down to a calculable issue. This behaviour of the Court then enables it

to justify seeking concrete scientific evidence on the possibility of whether or not there is

a risk, also known as plausibility proofs. However, these cannot be provided with regard

to uncertain risks.

Second, a double standard appears to have manifested in the Courts reasoning

and ruling. When stating that [i]t does not matter that there are differences of opinion

between scientists31

, the Court stringently stated that the Alpharma cannot use existing

differences in scientific opinions as a way to conclude that there is no risk. Thus, the

Court does not allow Alpharma to use this argument. Yet, in the Pfizer case the Court

does exactly that.

The application of the precautionary principle cannot be based on diverging

views. However, the Court recognised that the withdrawal of the authorisation to market

bacitracin zinc was established on extremely complex scientific and technical

assessments over which scientists have widely diverging views32

. On the question

whether bacteria are naturally resistant to bacitracin zinc, the Court held that

31Alpharma, para. 15032Alpharma, para. 167

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it is clear from the documents before the Court that, at the time when the

contested regulation was adopted, scientific opinion was sharply dividedon thequestion of natural resistance in the particular case of bacitracin33(italics addedby author).

Hereafter, when addressing the lack of an opinion of SCAN in issue of using bacitracin

zinc in human medicine to treat VRE, the Court asserted that

the Community institutions could properly find that, at the time the contestedregulation was adopted, there were significant differences of opinion between

scientistsas to whether bacitracin zinc could be used then of in the future to treatVRE

34(italics added by author).

The SCAN opinion was pending. However, the Commission wanted to move forward in

the proceedings for banning the substance. Therefore, the ban was adopted before SCAN

could complete its work (Marchant & Mossman, 2004). The Courts behaviour

demonstrates the significant differences between scientific evidence used to establish

uncertainty and subsequently as justification of the precautionary principle. The Court

then continued,

Alpharma has therefore failed to show that the Community institutions erredin concluding that bacitracin zinc might possibly be used to treat VRE35.

Thus, according to the Court, Alpharma had to prove that the substance was safe.

Thereby the Court expected Alpharma to produce plausibility proofs. Even though the

Court tried to avoid using diverging scientific views in its ruling, the argument still finds

its way into the justification for the precautionary principle. In a similar fashion as in thePfizer case, the Court constructed its own definition of uncertainty. Uncertainty in the

Alpharma case is based on three components; scientific evidence based on reports

produced by other bodies than SCAN, analogy with other antibiotics, and contradictory

scientific opinions. The latter became a large influence on the uncertainty definition in

33Alpharma, para. 299

34Alpharma, para. 26435Alpharma, para. 264

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this case. Hence, bacitranic zinc could be a treat becausethere are different opinions of

scientists.

Back to Pfizer

It is striking that the Court only made a few direct references to Pfizer in Alpharma and

none of them were in relation to the argumentation of different scientific opinions it

applied in Pfizer. However, the Court did on various occasions refer to the SCAN opinion

on virginiamycin that was used for the Pfizer case as well. Since there was no opinion

present on bacitracin zinc, the SCAN opinion on virginiamycin served as a justification

for the Courts ruling in Alpharma. In order to strengthen its argumentation, the Court

also reviewed the other materials that the EU institutions had weighed in on the decision

to withdraw the authorisation. In the scientific opinion of SCAN of 5 February and 10

July 1998 about, amongst others virginiamycin, it concluded that there was not sufficient

evidence to establish a possible risk associated with that antibiotic. As a result, SCAN

also concluded that the authorisation of virginiamycin did not need to be withdrawn

(SCAN, 1998). The Commission and the Court took a completely different reading of the

same conclusions and upheld the ban of virginiamycin based on the precautionary

principle36

. Since there were no specific assessments done on the effects of bacitracin

zinc, the Court accepted that the transfer mechanisms were similarfor all antibiotics

and that the transfer of resistance to bacitracin zinc was therefore highly probable37

(italics added by author). In Alpharma, the Court then used SCANs scientific opinion on

virginiamycin and argued that they supported the conclusion of the EU institutions

that there was a risk associated with those products38. Thus, the Court relied on previous

analyses of other antibiotics to come to the conclusion for bacitracin zinc that a risk was

found. In addition, the Court relied on the similar ruling and rationale applied in Pfizer. In

that case the Court established different scientific opinions as the basis for using the

precautionary principle. As Laduer (2003) also observes,

36Council Regulation No 2821/98 12; Pfizer, para. 401

37Alpharma, para. 30738Alpharma, para. 306

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[d]espite the fact that, in Alpharma, SCAN had not even been consulted at all,the Court was of the opinion that the Council and Commission had been

sufficiently informed by the opinion given in the other procedure concerning

Pfizer (p. 1456).

The behaviour of the Court in Alpharma shows that it has indeed set a precedent

with Pfizer. Although the Court does not explicitly refer to the line or reasoning it applied

in Pfizer, it nevertheless argued in a similar fashion in Alpharma as it did in Pfizer. This

becomes apparent as a result of two choices the Court made. First, the Court upheld the

Commissions choice to base its decision on the SCAN opinion also utilised in Pfizer, and

second, despite its attempt to avoid the argument of diverging scientific opinions, it still

crept into its ruling as a justification of uncertainty. At this point the leverage of the

Courts and their discretion becomes apparent. It seems that the Courts have no objection

to such different scientific bases. There are systematic differences in the level of

scientific evidence that are regarded sufficient. Thus, as they have room to manoeuvre in

the realm of risk assessments they subsequently also have room in defining uncertainty.

Solvay Pharmaceuticals BV v. Council of the European Union

Whereas Pfizer and Alpharma concerned antibiotics as growth promoters, this case is

about a substance called Nifursol. Nifursol is an additive that is used in feedstuffs which

belongs to the group of nitrofurans, which is a class of antibiotic drugs. Nifursol is used

to prevent the occurrence of a parasitic disease in turkeys39. When the EU institutions

wanted to withdraw market authorisation, Solvay Pharmaceuticals - who produced and

marketed the substance - brought proceedings before the CFI to prevent this.

Facts and Background

Originally Nifursol was authorised in 1988. In 1995 Regulation No 2377/90 decreed that

it was no longer permitted to administer nitrofurans as veterinary medicinal products to

food-producing animals Nifursol was not covered by this ban. The ban was based on an

examination by the Committee for Veterinary Medicinal Products of four substances

which belonged to the nitrofurans group, namely nitrofurazone, nitrofurantoine,

39Solvay, para. 27 - 28.

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furaltadone, and furazolidone. The report held that nitrofurazone and furazolidone

presented a risk of carcinogenicity and genotoxicity40

. There was not enough information

available to determine the safety of the other two substances. It is important to address

that the Committee for Veterinary Medicinal Products did not examine Nifursol. In 1999,

Nifursol was subject of new authorisation under Article 9h of Directive 70/524 for which

Solvay applied. The United Kongdom Veterimary Medicines Directorate (VMD) made

clear to Solvay that Nifursol would not be re-evaluated for the purpose of retaining its

market authorisation. The Commission subsequently pointed out that Nifursol belongs to

the nitrofurans group and that there needs to be consistency in the rules for the substances

belonging to that group. By request of the Commission, Solvay sent the VMD additionalinformation concerning the carcinogenicity and safety of Nifursol. The VMD then sent

this report to the SCAN members and the Standing Committee. The provisional

authorisation for Nifursol was replaced on November 16th1999, with an authorisation

linked to the manufacturer, Solvay Pharmaceuticals, through Regulation 2430/1999. The

VMD forwarded to Solvay an expert opinion on May 22nd

2000. The findings of that

report held that it is proven that certain nitrofurans are genotoxic and that that risk is

thought to be associated with the presence in the molecule of a group 5-nitro41. Based

on these conclusions, the VMD held that since Nifursol has the same molecular

structure, it is ... also likely to present a risk of genotoxicity42. The VMD acknowledged

that the available data concerning Nifursol are incomplete. However, it cannot rule out

that it could pose a risk. On October 11th

2001, SCAN adopted an opinion on Nifursol43

.

It concluded that there was not enough data available, but that the safety of Nifursol

could not be guaranteed. Hereafter, Solvay provided additional information. However,

SCAN concluded that this data only confirmed the lack of evidence. Hence, SCAN

argued that doubts persisted and the safety of Nifursol still was not