Applying precautionary principle to veterinary pharmaceuticals, CFI upholds ban on antibiotic additives to animal feed: two judgments (with press release)

Luxembourg, 11 September 2002

T-13/99, Pfizer Animal Health SA v v Council of the European Union

Judgment of the Court of First Instance (Third Chamber) on 11 September 2002 (link to English version when available). Full text

Transfer of resistance to antibiotics from animals to humans - Directive 70/524/EEC - Regulation concerning the withdrawal of the authorisation of an additive in feedingstuffs - Admissibility - Article 11 of Directive 70/524/EEC - Manifest error of assessment - Precautionary principle - Risk assessment and risk management - Consultation of a scientific committee - Principle of proportionality - Legitimate expectations - Obligation to state reasons - Right to property - Misuse of powers

The Court:

1. Dismissed the application;

2. Ordered Pfizer to bear its own costs and to pay those incurred by the Council, including those relating to the proceedings for interim relief;

3. Ordered the Asociación nacional de productores de ganado porcino, the Asociación española de criadores de vacuno de carne, the Fédération européenne de la santé animale and the Fédération européenne des fabricants d'adjuvants pour la nutrition animale to bear their own costs and to pay those incurred by the Council in respect of their intervention in the main proceedings and the proceedings for interim relief;

4. Ordered the Asociación española de productores de huevos and the Pig Veterinary Society to bear their own costs and to pay those incurred by the Council in respect of their applications for leave to intervene;

5. Ordered the Commission, the Kingdom of Denmark, the Kingdom of Sweden, the Republic of Finland and the United Kingdom of Great Britain and Northern Ireland to bear their own costs, both in the main proceedings and in the proceedings for interim relief.

**********

T-70/99, Alpharma Inc. v Council of the European Union

Judgment of the Court of First Instance (Third Chamber) on 11 September 2002 (link to English version when available). Full text

Transfer of resistance to antibiotics from animals to humans - Directive 70/524/EEC - Regulation withdrawing authorisation of an additive in feedingstuffs - Admissibility - Breach of essential procedural requirements - Manifest error of assessment - Precautionary principle - Risk assessment and risk management - Consultation of a scientific committee - Principle of proportionality - Legitimate expectations - Obligation to state reasons - Rights of the defence

The Court:

1. Dismissed the application;

2. Ordered Alpharma to bear its own costs and to pay those incurred by the Council, including those relating to the proceedings for interim relief;

3. Ordered the Commission, the Kingdom of Sweden, the Republic of Finland and the United Kingdom of Great Britain and Northern Ireland to bear their own costs, both in the main proceedings and in the proceedings for interim relief.

**********

Press release:

Despite uncertainty as to whether there is a link between the use of certain antibiotics as additives and increased resistance to those antibiotics in humans, the ban on the products is not a disproportionate measure given the need to protect public health

A Council regulation adopted on 17 December 1998 banned the use of four antibiotics as additives in animal feedingstuffs: virginiamycin, bacitracin zinc, spiramycin and tylosin phosphate. The Council decided, however, that four other antibiotics could remain on the market. Safeguard measures had been introduced prior to the regulation by various Member States, in particular Denmark, and Sweden had requested that Community legislation should be amended.

For many years the antibiotics referred to had been added in very low doses to the feedingstuffs of certain animals as growth promoters. That practice is known to result in improved growth in the animal and in improved weight gain, so that an animal needs less time and less food to attain its required weight for slaughter. The practice is also said to have certain beneficial side effects, in particular it prevents certain diseases in animals.

Since the 1970s many scientists have claimed that the practice entails a risk of resistance to those antibiotics developing in animals and being transferred to humans, notably via the food chain, with the result that those and certain other related antibiotics could no longer be used effectively in human medicine for the treatment of certain dangerous diseases. In particular, in 1997 and 1998, various specialist international, Community and national bodies, such as the World Health Organisation (WHO), recommended the immediate or gradual discontinuance of the practice.

At the time when the regulation at issue was adopted, it had not been proved that there was a link between use of the antibiotics concerned and the development of resistance to those antibiotics in humans. It was against that background that the Council had recourse to the precautionary principle in the contested regulation.

When the regulation was adopted, Pfizer Animal Health SA was the only producer of virginiamycin in the world and Alpharma Inc. was the only manufacturer and the largest supplierof bacitracin zinc in Europe. They brought actions for annulment of the Council regulation before the Court of First Instance. Pfizer Animal Health was supported by several agricultural associations. The Council was supported by the Commission and also by Denmark, Sweden, Finland and the United Kingdom. In 1999 applications for suspension of operation of the regulation were dismissed by two orders of the President of the Court of First Instance. One of those orders was upheld on appeal by the President of the Court of Justice.

Before the Court of First Instance, Pfizer and Alpharma claim that, instead of undertaking a thorough assessment of the risks associated with those products, the Council and the Commission attempted to exclude any risk, taking an unrealistic approach referred to as "zero risk" and basing their decision on political expediency rather than on an objective scientific analysis.

The Court of First Instance sets out in this case the conditions on which the precautionary principle is to apply in Community law. It reaffirms to a large extent the principles stated by the Commission in 2000 in its communication on the precautionary principle.

The Court starts by observing that in other cases dealing with food safety (in particular the "mad cow" crisis), the Community Courts have already held that it is possible to take preventive measures without having to wait until the reality and seriousness of the risks perceived become fully apparent.

However, it points out that a preventive measure cannot be founded on mere conjecture which has not been scientifically verified but may be taken only where there is a real risk. In the Court's view, the concept of risk entails some probability that the negative effects which the measure is specifically designed to prevent will occur. The degree of risk cannot be set at "zero risk".

Before taking any preventive measure, a public authority must therefore carry out a risk assessment, which involves two components: a scientific component, i.e. as thorough a scientific risk assessment as possible account being taken of how urgent the matter is, and a political component ("risk management") in the context of which the public authority must decide on the measure it deems appropriate given the degree of risk set by it.

In its judgment, the Court lays great stress on the conditions with which the public authority must comply in its risk assessment. It places particular emphasis on the essential role of scientists in this context and concludes that the view of the competent scientific committees must be obtained even if this is not specifically provided for by legislation, unless the public authority can ensure that it is acting on an equivalent scientific basis. However, the Court points out that the decision to ban a product is not a matter for the scientists but rather for the public authority to whom political responsibility has been entrusted.

Virginiamycin

Having been consulted about the scientific material submitted by the Danish authorities with regard to their safeguard measures, the competent Community scientific committee took the view that there was insufficient scientific evidence to find that virginiamycin entailed a risk and it did not advise the competent Community institutions to withdraw it from the market. The Council none the less decided to ban it.

The Court upholds this decision pointing out the role of expert scientific advice, which must ensure that the measure in question is taken on an objective scientific basis. However, it holds that, unless the legislation provides otherwise, a public authority is not bound by that advice. In the present case, which concerns a measure whose objective is the protection of human health, the view taken by the institutions, which differs from that expressed in the scientific advice, must be founded on that objective alone. Thus, if the institutions are to depart from the findings in the opinion of the competent scientific committee, they must be able to rely on
- a proper examination
- carefully and impartially carried out
- of all the relevant aspects of the individual case,
- which include the reasoning on which the committee concerned based the findings in its opinion.

The Court finds that in this case the decision of the institutions not to accept the scientific opinion is justified in the interest of the protection of human health.

Bacitracin zinc

The view of the scientific committee on this particular product was not sought before the contested regulation was adopted. The institutions nevertheless found that the product belonged to one of the classes of antibiotics in respect of which, according to available research, the risk of transfer was highest.

The Court finds that, given the scientific knowledge already available to them concerning the various other antibiotics of the same class, the institutions were entitled to take a horizontal approach to that entire class of antibiotics by systematically excluding the use as additives in feedingstuffs of products also used in human medicine (the exclusion of "dual-use" products). The Court accepts that horizontal approach and holds that the institutions were able to ban bacitracin zinc without first obtaining an opinion specific to that product from the competent scientific committee.

The Court concludes that, despite uncertainty as to whether there is a link between the use of those antibiotics as additives and the development of resistance to them in humans, the ban on the products is not a disproportionate measure by comparison with the objective pursued, namely the protection of human health.

Reminder: an appeal, limited to points of law, may be brought before the Court of Justice of the European Communities against the decision of the Court of First Instance within two months of its notification.

Unofficial document for media use only; not binding on the Court of First Instance. Available in Dutch, English, French, German, Italian and Spanish. For further information please contact Reinier van Winden: Tel: (00 352) 4303 3355; Fax: (00 352) 4303 31

European Court of First Instance, judgment 11 September 2002. Press and Information Division Press Release No 71/02