WRITTEN QUESTION E-2094/00

by Gianfranco Dell'Alba (TDI) to the Commission

(28 June 2000)

Subject: Community rules on plant protection products

Articles 84 and 85 of the Treaty of Rome establishing the European Economic Community explicitly prohibit abuse of dominant positions, which could have a negative impact on product prices and on the free movement of goods and encourage practices liable to prevent other operators from entering or staying on the market.

However, this is precisely the effect produced by Article 13 of Council Directive 91/414(1) of 15 July 1991 concerning the placing of plant protection products on the market. The article in question gives data holders who also produce active substances the right to deny access to that data to formulating companies, notably small and medium-sized firms; as a result, the competent authorities of the Member States may cancel authorisations to manufacture and sell plant protection products.

In the light of this, can the Commission say:

- what, if any, measures can be taken to safeguard European small and medium-sized firms in the event that, upon completion of the review process, data holders deny applicant companies access to data on active substances included in Annex I, or demand an exorbitant sum of money for such access;

- what could be considered a fair, reasonable payment for the use of data, sustainable by small and medium-sized firms, in accordance with their market share;

- whether it would not perhaps be advisable to amend Directive 91/414, completely eliminating the entire data protection mechanism with regard to existing active substances, in view of the investments made to include such substances in Annex I one element of manufacturing costs investments which could be recouped by adjusting selling prices;

- what impact Directive 98/8/EC(2), concerning the placing of biocidal products on the market and very similar to Directive 91/414, would have on small and medium-sized firms involved in the formulation of such products.

(1) OJ L 230, 19.8.1991, p. 1.

(2) OJ L 123, 24.4.1998, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(19 September 2000)

Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market provides for detailed, but very complex, rules on data protection. These provisions have to be applied by Member States when they grant authorisations for plant protection products at national level. The rules for data protection have to serve two interests: those of the research-based companies which invest considerable resources in the development of active substances and have a legitimate expectation of a return on their investment and those of the smaller companies which apply for authorisations after the period of data protection has expired. Whereas the research-based companies ensure innovation, the presence of smaller companies in the marketplace ensures that prices remain reasonable for users.

The Commission is currently developing a guidance document on the interpretation of the rules on data protection. This document is not yet finalised, partly because of the contentiousness of the issues involved. Discussions are being held with the Member States as well as with trade associations representing the major and the smaller companies with a view to reaching an agreement on the subject.

Council Directive 91/414/EEC does not provide for an obligatory system of data sharing.

As indicated in its white paper on food safety(1), the Commission intends to make a proposal for an amendment of Directive 91/414/EEC by mid-2002. Such an amendment could take the issue of data protection and sharing into account. However, the Commission recognises that any proposal to amend the provisions on data protection or data sharing would again be very contentious and would engender considerable discussion, mainly because industry and Member States are divided on the subject.

Regarding Directive 98/8/EC of the Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, the provisions on data protection are very similar to those contained in Directive 91/414/EEC and therefore also their impact on small and medium-sized enterprises involved in the formulation of biocidal products will be very similar, even if the biocides Directive contains provisions that allow Member States to take action under certain circumstances.

Directive 98/8/EC does not provide for a general obligatory system of data sharing. However Article 13(2) provides that Member States should encourage the holders of former authorisations and applicants to co-operate and they shall take all reasonable steps to reach agreement on the sharing of information, so as to avoid, if possible, the duplication of testing on vertebrate animals.

If it is not possible for applicants and holders of former authorisations of the same product to reach an agreement on the sharing of data, Member States may introduce national measures obliging applicants and holders of former authorisations located within their territory to share the data with a view to avoiding duplication of testing on vertebrate animals as well as to determine both the procedure for utilising information, and the reasonable balance of the interests of the parties concerned.

Besides, it follows from the above explanation that the Directives 91/414/EEC and 98/8/EC cannot be considered as encouraging abuses of dominant positions within the meaning of Article 82 (ex Article 86) of the EC Treaty.

(1) COM(1999) 719 final.