A Court of Appeal decision (27 February) will give agrochemical companies greater protection in relation to commercially sensitive field monitoring data which would otherwise allow competitors to bring their products to market without first having to conduct their own such studies.
The case – Chiltern Farm Chemicals Limited -v- Health and Safety Executive – relates to the re-authorisation of Chiltern’s popular slug pellets used by commercial farmers and gardeners and data collected in field monitoring studies involving the tagging of birds.
The Court of Appeal was asked to determine what constitutes a ‘vertebrate study’ under the relevant EU legislation, says Chiltern’s lawyers Boodle Hatfield. It is the first case of its kind and the decision is important as it now provides agrochemical companies with the confidence that the costs they incur in generating specific data that support the authorisation and re-authorisation of their products belong to them and are protected.
Philip Tavener, director of Chiltern, said: “This case is important to us and our business. These studies are time consuming and costly, and the distinction between what constitutes a vertebrate study or not has considerable commercial implications.
“The data we generate are commercially sensitive and it is right and fair that in non-vertebrate studies we are allowed to properly negotiate our competitors’ access to those data.”
Simon Fitzpatrick, a partner in the Commercial Litigation team at Boodle Hatfield, who led the case with support from Associate Sarah Latham, adds: “This is a complicated and technical area of law relating to what is and what isn’t a vertebrate study and subsequently what happens to data submitted in support of authorisation of agrochemicals.
“Quite rightly, the Health and Safety Executive’s (HSE) Chemicals Regulation Division (CRD) wishes to minimise the impact on wildlife of all studies and it does this by requiring agrochemical companies to share data from certain studies involving vertebrates. The regulations also grant businesses protection to commercially sensitive data, and this case has for the first time provided valuable clarification of where the line should be drawn.”
The CRD is responsible for regulating plant protection products in the UK. Pesticide producers are required to apply to the CRD for authorisation prior to marketing their products in the UK. Once authorised, products are periodically required to be reviewed and re-authorised.
Chiltern, a producer of slug pellets, applied for the re-authorisation of its products in the UK. The extensive data submitted by Chiltern in support of its applications included a bird field monitoring study, involving the standard application of Chiltern’s slug pellets to agricultural sites followed by the monitoring of radio tagged birds which happened to be present at those sites. No effects on any birds were observed.
Studies submitted to the CRD are generally afforded data protection and cannot be used for the benefit of other companies without the data owner’s consent, subject to specific exceptions. One such exception is vertebrate studies, where the regulations seek to avoid duplication of studies that may cause harm to vertebrates. Tagging for identification purposes is excluded from the definition of a vertebrate study as is “recognised agricultural practice”.
Vertebrate studies can be used by the CRD for other applicants if they have requested access from the data owner but have not received the data owner’s consent. The data owner then has a claim for “a fair share of the costs” from the applicant.
The CRD considered that Chiltern’s bird field monitoring study was a vertebrate study and that it could be used for the benefit of other applicants without Chiltern’s consent. CRD’s reasoning for the decision was, they alleged, that the study’s overall purpose was to determine if metaldehyde (the active substance in Chiltern’s slug pellets) kills birds or results in clinical or behavioural effects.
Chiltern brought proceedings for judicial review of this decision. It was common ground between the parties that the radio tagging of the birds did not cause the study to be a vertebrate study.
Court of Appeal’s decision
The Court of Appeal unanimously held that Chiltern’s study was not a vertebrate study.
In coming to its conclusion, the Court considered that the study was excluded from the definition because of the express exclusion for recognised agricultural practice. It was common ground between the parties that the use to which Chiltern’s slug pellets were put in the study was recognised agricultural practice. The pellets had been applied by farmers to agricultural fields at the authorised application rate.
The Court further considered that it would be curious if the monitoring of an authorised plant protection product used in accordance with its authorised directions was prohibited if similar monitoring had been performed before, or if it required a licence to be performed (vertebrate studies are required to be licensed prior to the work being carried out).
Finally, the Court concluded that the study did not increase the risk to birds over and above that inherent in the use of the product during the course of authorised and recognised agricultural practice, given the modest size of the experimental area compared with the area over which authorised metaldehyde products were used in farming. Therefore, the interference with Chiltern’s property and confidentiality rights in the study would have been disproportionate.
This case is an important decision, being the first time the English courts have considered the definition of a vertebrate study. Its remit will extend across the whole range of plant protection products and monitoring studies in the context of re-authorisation applications to secure the data protection rights of data owners in these studies.
It was considered and accepted that if the study had involved monitoring the effects of a new unauthorised product or the new use of an existing product, that would have been experimental and within the definition of a vertebrate study. A trials permit from CRD would have been required for such a study in any event.
The decision clarifies that monitoring studies, where the form of monitoring does not itself cross the threshold for a vertebrate study, may be duplicated. This can only increase the protection of vertebrate wildlife, with numerous studies able to be carried out.