The Plant Protection Products Directive 91/414, which currently governs the regulatory framework for agricultural chemicals in the EU, will be replaced as from June 2011 by Regulation 1107/2009. One of the many areas in which the new Regulation differs from the current Directive is in mandating, in Article 62, a derogation from the general principles of regulatory data protection which will, in effect, oblige the first applicant for an authorisation to share with subsequent applicants’ data as to tests and studies involving vertebrate animals. As observed in Recital 13 to the Regulation, there should be no deliberate human testing and, by Recital 40, animal testing for the purposes of the Regulation should be minimised and tests on vertebrates should be undertaken as a last resort. In pursuance of this aim Article 62 provides that where the regulator has relied on such data, as it is entitled to do, the first applicant, absent any agreement on costsharing, which is to be determined in a fair, transparent and non-discriminatory way, has a claim, enforceable nationally, against the second applicant for a fair share of such costs.
The current Directive also addresses this issue, permitting Member States to mandate the sharing of such vertebrate test data, but not obliging them to do so. Thus Article 13(7) provides that, absent agreement, “Member States may introduce national measures obliging the applicant and holders of previous authorisations located within their territory to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilising information, and the reasonable balance of the interests of the parties concerned.” In both the current Directive and the new Regulation however the derogation is limited to data as to tests and studies involving vertebrate animals and does not extend to other data that the regulators require be filed. The Biocidal Products Directive 98/8/EC (also in the process of being amended and replaced by a Regulation) and Regulation 1831/2003 on animal feed additives also contain limited derogations for vertebrate test data to the respective regulatory data protection regimes they establish. However the derogation from regulatory data protection in the REACH Regulation 1907/2006 on chemicals generally is more widely expressed, and the Regulation provides for a more developed data sharing regime.
The Court of Justice of the EU, in its Judgment of 1 July 2010 in Case C-363/09 Commission v Spain has held that Spain had failed to fulfil its obligations under the Plant Protection Products Directive 91/414, by including in its national implementation of the Directive a provision which went wider than that permitted by Article 13(7) in not being limited to vertebrate test data, and which instead permitted data sharing in all circumstances. This Judgment thus confirms that the only derogations from the respective regulatory data protection regimes established under EU legislation for various different types of regulated product are those expressly provided for in such legislation, and that Member States when implementing such legislation are not free to expand on such derogations.