Data Sharing and vertebrate studies

Date: 13 May 2020

Usually, data protection is granted for submitted studies on Member State level and it is not possible for other applicants to refer to this data in the respective Member State without approval from the data owner. At the same time, applicants are asked to avoid duplicate testing as stated in Article 61 of Regulation (EC) No 1107/2009, and therefore studies can be shared by a letter of authorisation from the data owner, granting prospective applicants the right to use the protected data for a product registration. Interestingly, there is no limit to which studies this applies as set out in Article 61. The use of protected data can be restricted to reference only, where the prospective applicant is not allowed to have insight into the study reports and can only use the results, or full access to the study reports can be granted.

A data owner is not obliged to share protected data with other applicants – with one major exception. For data generated using vertebrates (referred to as vertebrate studies), Article 62 of Regulation (EC) No. 1107/2009 specifies that such studies must not be repeated and authorities will not accept a duplicate vertebrate test. It is the responsibility of the applicant to verify that those test and studies have not already been performed or initiated. This includes active substance data such as livestock metabolism studies as well as product data such as acute toxicity studies. The reason behind this clause is that animal welfare weighs heavier than data protection claims.

For vertebrate studies, the data owner and a prospective applicant should make every effort to ensure that they come to an agreement to share such data. Compensation for the data owner should be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only requested to share the costs of information required for the intended authorisation.

In the event, where the prospective applicant and the data holder cannot come to an agreement, the respective Member state authority should be informed. However, the failure to reach an agreement does not prevent the Member State authority to make use of the vertebrate studies for the purpose of the application of the prospective applicant.

Sarah-Madeleine Hönig