EU Regulatory Bulletin contents
On 1 February 2013 the European Commission (EC) issued new guidance on a number of aspects concerning data protection for plant protection products. The aim of the guidance is to provide member states and applications with information to assist them in understanding and applying the legislation.
The guidance document explains the complexity generated by the coexistence of three data protection systems, namely, national legislation in place prior to the entry into force of Annex I listings under Directive 91/414, national legislation transposing Directive 91/414 and the new provisions under Regulation 1107/2009. The document concludes that it is critical that Member States consider carefully the context in which data have been submitted in order to correctly apply the periods of protection in relation to the relevant data protection system. A summary table is provided with a series of examples of data protection.
In general, active substance confirmatory data submitted for post-approval assessment under Directive 91/414 will not receive any protection from the data protection provisions of the directive unless the approval is formally amended following the submission of confirmatory data or critical end points change as a result. In that case data protection will be 5 years from the date of the amended approval.
In the case confirmatory data is necessary for the authorisation under Regulation 1107/2009, it will be protected for 30 months from the date of amended authorisation or from the date of decision to maintain the authorisation in each Member State.
However, the revised version of the Commission's guidance document states that protection would only apply to data which was considered 'essential' to amend the authorisation. This assessment has two steps:
1. Was the decisions amended following submission and consideration of the confirmatory data;
2. if so, was the data essential to amending that decision.
Under Regulation 1107/2009 there is a trade off between the length of protection and the scope of protection available. Under the previous regime confirmatory data which satisfied the two stage test was protected for five years. Under the new regime confirmatory information can be protected for up to 30 months from the date the decision to amend the authorisation or the decision to maintain the authorisation in each member state was taken. By doing away with the requirement for confirmatory information to have caused a change in the decision this means that applicants will receive protection for potentially commercially sensitive information in a wider range of circumstances.
Active substance data submitted with an application under Article 15 of the Regulation (renewal of approval) and with the application for renewal of authorisation of the corresponding product are protected for 30 months from date of first renewal of authorisation of product containing that active substance in each Member State. Data protection periods therefore may start to run and expire at different times in each Member State. However, according to the guidance document the protection applies only to new data used to support the renewal of approval of the active substance, where the data concerned are also necessary to support the renewal of authorisation of a product containing it.
No data protection for a change of GAP
The guidance document also clarifies the data protection regime for data submitted for an amendment to an existing authorisation. Specifically, under Article 59(1)(a) of Regulation 1107/2009, where an applicant seeks to amend and existing authorisation to include a new good agricultural practice (GAP) for an existing crop, the data submitted in support of that application will not receive protection. By contrast, data submitted to secure an amendment to include a new crop for the existing GAP/s will be protected for a period of 10 years. In this case the period of protection commences from the date the original authorisation was made and not from the date of amendment.
The Commission's guidance document is intended to assist Member States in interpreting data protection provisions but is not legally binding. Data protection periods remain a complex area of law. Please do not hesitate to contact us for further advice.
Sign up to our email digest