The High Court has upheld a central challenge by Dutch agrochemical company Agrichem BV to the withdrawal of Irish authorisations for three weed-control products used in sugar beet farming.
Agrichem had distributed three products in Ireland containing the active substance ethofumesate. One had been sold here since 1996 and two since 2001. Their existing national authorisations came under review after ethofumesate was added to the EU list of approved active substances in 2003.
The Department of Agriculture required Agrichem to demonstrate access to protected scientific data used to secure ethofumesate’s EU approval, or to supply equivalent studies. It warned that failure to do so would result in the products’ authorisations being withdrawn. The Department subsequently revoked the authorisations in October 2003.
Agrichem challenged that decision on several grounds.
High Court President Mr Justice Finnegan accepted the company’s principal EU-law argument. He held that the first-stage review required under Article 4.1 of the 2002 Directive was narrower than the later, more detailed re-evaluation process due by February 2007.
At that initial stage, the Minister was confined to checking whether the specific conditions attached to ethofumesate’s inclusion on the EU list were satisfied. The Department was not entitled to insist that Agrichem establish access to Annex II data protected under the earlier Directive, provide equivalent information or obtain letters of access from the original data owners.
The judge rejected Agrichem’s remaining grounds. He held that departmental officials could make the decision under the established principle allowing ministerial functions to be exercised by authorised officials. He also found no irrationality in refusing incomplete studies and rejected claims that the Department had acted arbitrarily over deadlines, scientific reports or earlier communications suggesting the application looked favourable.
Agrichem therefore succeeded on the core data-requirement issue only. The court did not specify the final remedy in this judgment and invited submissions on the appropriate order.