UK rules for first time on protection over field monitoring data for agrochemical companies
A Court of Appeal decision will give agro-chemical companies greater protection in relation to commercially sensitive field monitoring data. The decision 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 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.
This case is seen as 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.
The decision is important as it now provides agro-chemical 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.
‘Time consuming’
Philip Tavener, director of Chiltern, said the case is «important» to the business.
He said: “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 at Boodle Hatfield, said: “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.”
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.
Source: www.agropages.com
