52000AC0081

Opinion of the Economic and Social Committee on the "Proposal for a European Parliament and Council Directive on the Community code relating to veterinary medicinal products (codified version)"

(2000/C 75/03)

On 4 October 1999, the Council decided to consult the Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 17 December 1999. The rapporteur was Mr Braghin.

At its 369th plenary session of 26 and 27 January 2000 (meeting of 26 January) the Economic and Social Committee adopted the following opinion by 119 votes in favour and two abstentions.

1. Introduction

1.1. The proposed directive aims to codify, and thus supersede, the various directives that have been issued to harmonise the Member States' legislation on veterinary medicinal products, from Council Directives 81/851/EEC and 81/852/EEC of 28 September 1981 onwards.

1.1.1. Codification is a means of simplifying and clarifying Community legislation so as to ensure transparency and correct interpretation, in accordance with the Commission decision of 1 April 1987 and the Presidency Conclusions of the Edinburgh European Council in December 1992.

1.2. The new directive, which will codify the laws expressly mentioned in Part A of Annex II in a list of repealed directives, must be adopted in full compliance with the normal Community legislative procedures as laid down in Article 251 of the Treaty.

1.3. This legislative codification proposal has been drawn up on the basis of the texts of the acts published in the Official Journal, to which no substantive changes may be made. The Commission's consolidated text brings together the above mentioned directives and makes only such formal amendments as are required.

1.4. The Commission has taken account of the fact that Council Regulation (EEC) No 2309/93(1) has since laid down Community procedures for the authorisation and supervision of medicinal products for veterinary use and established the European Agency for the Evaluation of Medicinal Products(2).

1.5. The codification proposal regarding veterinary medicinal products was drafted in parallel with the codification proposal for the directives on medicinal products for human use, on which the Committee has already given its opinion(3).

2. General comments

2.1. The Committee welcomes this codification, as it provides an essential reference point for the relevant authorities of the Member States. The proposed codification, reflecting a long-felt need, was finally included in the Commission's 1998 work programme and has now reached the proposal stage. The Committee hopes that accelerated procedure, endorsed by the interinstitutional agreement of 20 December 1994, will enable the rapid adoption of the codified legislation, enabling the directive to enter into force at least during the first half of 2000, if not on 1 January 2000 as stated in Article 99.

2.2. The codification is complete inasmuch as it covers Directive 90/677/EEC on immunological veterinary medicinal products and Directive 92/74/EEC on homeopathic veterinary medicinal products. The text is concluded by Annex I on "Requirements and analytical protocol, safety tests, pre-clinical and clinical, for tests of veterinary medicinal products".

2.3. The codified text retains the terminology used in the original directives and does not reflect more recent developments, for instance the guidelines published by the Committee for Veterinary Medicinal Products(4). As the more recent versions of the repealed directives have applied more up-to-date terminology, the result is that differing terms are sometimes used in the various languages to express the same concept. The Committee would therefore recommend that all the languages use the up-to-date and now universally-used terms. This would be a change in form rather than content.

2.3.1. For the purposes of the smooth functioning of the pharmacovigilance system, the Committee particularly advocates applying the above suggestion in order to favour the term "adverse reaction" over "side-effect" or "undesired effect", as the latter terms are no longer commonly used at international level. Incorporating such developments in the transposition of directives into national laws is a way of ensuring that the legislative framework is truly uniform.

2.3.2. Furthermore, the Committee would like to see single terms applied consistently and exclusively to single concepts, such as for instance: "marketing authorisation", "authorisation holder", "summary of the product characteristics", "public health".

2.3.3. There are a number of discrepancies in the terminology used in Annex I, owing to problems with the translation from the original language. This sometimes makes it difficult to understand how the Directive is to be applied. In view of the technical nature of the points and their importance for the correct preparation of the registration dossier, it would be helpful to check the consistency of the translations and point out and explain the resulting changes to the initial version in specific notes or a special annex.

2.3.4. The various language versions do not always match up, possibly owing to imperfect translation from the original document. The Committee suggests that the Commission could make use of the present codification exercise to amend any articles that were incorrectly translated from the reference language in the first instance, while taking account of recent terminological developments.

2.4. The Committee, while aware of the importance of this codification for the purposes of harmonising the rules governing the sector and transposing the directive into national legislation as rapidly as possible, recommends that the Commission verify that technical terms are used in a consistent and uniform way, possibly by setting up a team of experts representing all the official EU languages. Particular attention should be given to the following terms:

- adverse reactions / negative side effects

- veterinary medicinal product / medicinal product / proprietary medicinal product

- holder of marketing authorisation / authorisation holder / applicant

- public health / human health / animal health.

2.5. Chapter VII tackles pharmacovigilance, a field in which Community rules do not appear to be uniformly or fully applied. In the Committee's view, the content and practical methodology should be clarified. Furthermore, given its importance for protection of public health, pharmacovigilance should be made a priority in the implementation of current legislation.

2.6. In the veterinary pharmaceuticals sector, there are still diverging interpretations by national administrations, a certain reluctance to trust scientific assessments from other Member States and lengthy national administrative procedures - all factors which have prevented full use of the advantages of the new authorisation procedures(5). The Committee asks the Commission, when planning new measures in the light of experience gained, to ensure that risk/benefit analysis is the point of reference in every scientific evaluation of the data accompanying marketing authorisation requests.

2.7. The Committee hopes that new measures will be proposed for medicated foodstuffs (not covered as such in the current directive), in order to guarantee the purity of the active ingredients, quality standards, production procedures and checks and that the balance of medicinal, veterinary and food products meets specific qualitative criteria to protect human health and animal welfare.

2.8. The Committee hopes that when it conducts its overall review of the registration system for veterinary and, in parallel, human drugs in 2001, the Commission, helped by the major codification work currently under way, will focus on simplifying the definition of specifications relating to quality, safety and efficiency, applying the guidelines drawn up by the Committee for Veterinary Medicinal Products (CVMP) properly, making them an integral part of the new legislation when necessary, and guaranteeing a free choice of authorisation procedures (centralised system or mutual recognition) so as to ensure adequate availability of products for the various well- and lesser-known animal species, bearing in mind the absolute priority which is to protect public health and develop the concept of animal welfare.

Brussels, 26 January 2000.

The President

of the Economic and Social Committee

Beatrice Rangoni Machiavelli

(1) OJ L 214, 24.8.1993.

(2) Above-mentioned regulation and Directive 93/40/EC on which the Committee has already issued an opinion - OJ C 269, 14.10.1991.

(3) OJ C 368, 20.12.1999, p. 3.

(4) Committee set up as part of the European Agency for the Evaluation of Medicinal Products, ex Regulation (EEC) No 2309/93, with tasks specified by Directive 93/40/EEC, Article 1, point 10.

(5) Communication from the Commission on the Commission communication on the Community marketing authorisation procedures for medicinal products - OJ C 229, 22.7.1998.