EU Promotion of Non-Animal Tests Methods: Mandatory Vertebrate Data Sharing
Regulation 1107/2009 of the European Parliament and Council of 21 October 2009 concerning the placing of plant protection products on the market entered into force on 14 December 2009 and has been applied since 14 June 2011. It replaced the legislation on plant protection products (laid down in Council Directive 91/414/EEC and several implementing Regulations) and in particular put in place new rules for the avoidance of duplicate testing and sharing of tests and studies involving vertebrate data.
Broadly speaking, the harmonized authorisation system for active substances used in plant protection products, as originally set out in Directive 91/414/EEC, is maintained. The placing on the market of plant protection products is still subject to a two step process whereby active substances are approved at EU level (with the inclusion into a "positive list" – Annex 1 to the new Regulation) while formulated products are authorised at the national level based on "Uniform Principles" laid down in a new implementing Regulation 546/2011. However, the criteria laid down by Regulation 1107/2009 ("the Regulation") concerning the data that may be submitted to enable evaluation of the substance has been amended radically where vertebrate studies are involved. (For an explanation of the full authorisation procedure please see ….> EU Bulletin of 18 July 2011).
The changes are twofold. Firstly, the Regulation clearly states that tests on vertebrates should be undertaken as a last resort. Indeed, testing on vertebrate animals for the purposes of the Regulation is only permitted where no other methods are available. Furthermore, for each vertebrate test or study that is conducted and submitted by the applicant as part of the dossier to be evaluated, the applicant is obliged to provide a justification detailing the steps taken to avoid these vertebrate tests in the first place. (Article 8 (c)). This applies equally whether the applicant is seeking an authorisation or an amendment of an authorisation (Article 33 (c)).
Secondly, where the substance has already been tested on vertebrates and thus the data required in support of the application for authorisation already exists but perhaps, crucially, it is owned by someone else, the Regulation continues in the same vein by severely restricting the applicant's right to duplicate these studies in the following ways.
At the outset, the Regulation imposes on any person intending to perform tests involving vertebrates to verify that those tests or studies have not already been performed or initiated. This information can be found online as under Article 57, Member States are obliged to make electronically available to the public information on the plant protections products which have been authorised and withdrawn. Once the applicant identifies through this online system that an authorisation for a plant protection product containing the same active substance as his own application, the applicant may request the Member state authority to provide a list of all the tests and study reports prepared for that product (Article 61(1)).
Next, Member States are forbidden to accept duplication where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used instead (Article 62(2)).
Lastly, to ensure that the applicant is able to obtain the data necessitated to meet the authorisation requirements, the Regulation imposes mandatory data sharing with regards to vertebrate studies only, without which the related restrictions on duplication could amount to an insurmountable barrier to entry to the market.
Obligatory Vertebrate Data Sharing Provisions – Article 62
The mandatory sharing provisions dictate that the prospective applicant and the holder of the relevant authorisations make "every effort" to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the data is to be determined in a "fair, transparent and non-discriminatory way". The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.
Therefore, it is key to understand what specifically is meant by "every effort", "fair", "transparent", and "non-discriminatory" in this context. However, the Commission has not provided any guidance on data sharing leaving the matter of interpretation to the Member States and ultimately the courts. The UK CRd has issued a guidance document in this respect, considering that "every effort" will be at a minimum an exchange of letters between data owner and subsequent applicants. No indication on what constitutes a "fair" share of the data cost is given though.
Where agreement between the applicant and the data owner cannot be reached, the prospective applicant is to inform the Member State authority and it may nonetheless use the vertebrate data it is in possession of as a result of another authorisation, for the purposes of the application of the prospective applicant. This ability to use the date without the data owner's approval is a radical departure from the previous legislation which may prove contentious.
By 14 December 2016, the Commission shall report on the effects of the provisions discussed and accompanied, if necessary, by an appropriate legislative proposal. If a severe amount of litigation ensues demonstrating that legislative intervention is needed, we may see the Commission submitting its report much earlier.
