EU lawyers debate ethofumesate

Dutch company AgriChem should be allowed to continue to market the sugar beet herbicide, ethofumesate, in the EU without having to resubmit a full dossier of registration data, says an adviser to the European Court of Justice (ECJ). UK advocate general Eleanor Sharpston issued her opinion in a case brought by German company Feinchemie Schwebda and Bayer CropScience, which supported the active ingredient through the EU review. They argue that, once ethofumesate was re-registered, any company that had not participated in the review should have to submit a full registration dossier if it wished to continue marketing its existing products.

 

Feinchemie Schwebda (now part of Makhteshim-Agan Industries) and the Bayer forerunner, Aventis CropScience, formed a task force to support ethofumesate through the first round of the review. The ai gained re-registration in 2003. AgriChem already held approvals for seven ethofumesate-based products, but did not act as a co-supporter nor submit an ai dossier for the review. The company's ethofumesate registrations were initially withdrawn by the Dutch regulatory authority, the CTB, in January 2004. However, the CTB revoked this decision in November 2004 after deciding that AgriChem was not required to resubmit a dossier to support these existing approvals.

 

Feinchemie Schwebda and Bayer appealed against the CTB's action, supported by the Belgium and Netherlands governments and the European Commission. They argued that the review rules under the EU agrochemical registration Directive (91/414) required products containing first-round review ais to be withdrawn by September 2003, unless the approval holder was either supporting the ai through the review or had access to the full registration data dossier.

 

AgriChem contests that interpretation and argues that the rules do not oblige an EU member state to withdraw an existing registration from a company not in possession of a dossier by September 2003. It also points out that the re-registration of ethofumesate implies that there are no health reasons for the withdrawal of existing products.

 

The Dutch administrative court for trade and industry has referred the issue to the ECJ. Ms Sharpston points out that the Dutch court appears to be in agreement with the CTB and AgriChem.

 

Ms Sharpston dismisses the appellants' argument that the purpose of the legislation is to protect intellectual property. -It is clear" that its primary purpose is to regulate the placement of agrochemicals on the market, rather than to ensure data protection, she says.

 

The Commission argues that the aim is to protect data provided by companies for the review by granting future authorisations on the basis of a full ai dossier. However, Ms Sharpston says that this is not a -convincing" explanation of why an existing approval holder should have to behave in the same way as a new applicant. She agrees with the Dutch court that such an interpretation may give companies supporting ais in the review an unjustified competitive advantage. It would amount to a -lock-out" that would prohibit other existing approval holders from continuing to market ais once they have been re-registered, she adds.

 

Ms Sharpston's advice will be considered by the ECJ in formulating its ruling on the case.