Data Protection

Date: 12 May 2020

Data protection for plant protection products is specified in Regulation (EC) No 1107/2009, Article 59. It is defined as „the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant”. Data protection is always granted on Member State level and therefore applies to the data submitted for the authorisation of a product in one specific Member State. As underlying data for the active substance is also submitted for product authorisation, this data can also be protected. To make sure that studies used in the approval of active substances on EU level gain data protection later on Member state level, a list of claims is included in the application for the approval of the active substance.

Data protection can be claimed for test and study reports, if they fulfil the following requirements: The underlying studies have to have been performed according to good laboratory praxis (GLP) or good experimental practice (GEP) and the reports have to be considered necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop. Therefore, a GLP-study submitted, but not considered necessary by evaluators, is not eligible for data protection, as the authorisation is possible without this study.

For new active substances and products, the period of data protection is 10 years in general, starting at the date of first authorisation of the product in a Member State. There are only a few exceptions, where other applicants may be allowed to refer to protected data for their product authorisations during that time (see also the next online academy article on data sharing and vertebrate studies). Data protection can be extended for each minor use by three month (if the extension of authorisation is not based on extrapolation and if the application is made within the first five years after first authorisation), but never exceeding 13 years in total. 

If new studies are submitted for the renewal of an active substance or review of an existing product authorisation, the new studies will be protected for 2.5 years. Studies from the first authorisation will no longer be protected as the protection time span has elapsed. 

As an incentive to promote low risk plant protection products, the data protection period granted is a maximum of 15 years.

The fact that data protection is based on the authorisation date of the product in a specific Member State even for active substance approval or renewal studies might lead to some confusion as the protection time can vary between different countries. It is possible that a certain study is protected in one country, but not or no longer protected in another one, starting already with the different evaluation times between zonal Rapporteur Member State and concerned Member States. Also considering delays in evaluations, handling and determination of data protection is often a challenge. This should be taken into account for product registration strategies.

Sarah-Madeleine Hönig