Guidance on data sharing in the UK for the Biocidal Products Directive / Biocidal Products Regulations

This guidance document provides suggestions for applicants on some steps they can take to achieve data sharing when submitting information to the HSE in support of active substances under the Biocidal Products Directive (BPD) or biocidal products under the Biocidal Products Regulations (BPR).

General points

HSE encourages co-operation in the use of data to ensure that unnecessary duplicate experiments are not carried out. In order to achieve data sharing, the BPR/BPD actually puts a duty on the data holder and subsequent applicants for product authorisation to take all reasonable steps to share data.

The primary reason for this is to minimise animal testing, however, there are many other advantages to sharing data, such as reducing costs for the companies involved, both in relation to the generation of the data themselves, and for the assessment of the data when they are submitted to the HSE.

A reduced number of studies being submitted for assessment will also help to reduce the amount of work that needs to be carried out by HSE, and help to improve the efficiency of the assessment programme.

Active substances

• Before deciding whether they need to carry out testing on vertebrate animals for the purpose of supporting an active substance under the BPD review programme, applicants should check whether or not the active substance they intend to apply for has already been notified for review or is undergoing review. They can do this by checking the European Commission’s website which lists all those substances for which a notification for review has been made and gives details of the companies involved.
• If it is found that the active substance of interest has already been notified, the prospective applicant should contact the notifier and try to reach an agreement on data sharing. The intention is that if the substance is sufficiently similar to one for which supporting data already exist, then further animal testing could be minimised by sharing the data. When negotiating an agreement, all parties involved in the discussions should keep in mind the other major advantages to data sharing as mentioned above, such as shared costs and improved efficiency of the review process.
• If the applicant finds that the substance is not already being supported under the review programme, they should check with HSE as to whether the substance has been assessed previously under national rules (The Control of Pesticides Regulations 1986). If it has, HSE will provide details of the companies involved and the applicant should contact those companies and try to reach an agreement on data sharing. The applicant should carry out an evaluation into the adequacy of existing data and make a decision on the need to conduct tests, taking into account, among other things, the requirement to minimise testing on animals.
• Before starting a testing programme and submitting an application, prospective applicants should try to find other parties who may also be interested in supporting the same active substance. Applicants should consider forming a task force in which members can work together and agree what data can be shared and where further data will need to be generated.

Biocidal products

• Before deciding on the need to carry out testing on vertebrate animals for the purpose of applying for authorisation or registration of a biocidal product under the BPR, applicants should contact HSE and give details, as required, on the proposed product. HSE will check whether similar products have already been authorised or registered, and will put the applicant in touch with the authorisation holder for those products.
• If it is found that a similar product has already been authorised, the prospective applicant should contact the authorisation holder and try to reach an agreement on data sharing. The intention is that if the new product is sufficiently similar to one for which supporting data already exist, then further animal testing could be minimised by sharing the data. When negotiating an agreement, all parties involved in the discussions should keep in mind the other major advantages to data sharing such as shared costs and improved efficiency. For example, if HSE has already assessed the data, less resource is likely to be required to authorise the new product, which may then result in reduced costs being charged to industry.

Reaching agreement on data sharing

The Regulations/Directive place an obligation on all parties to take all reasonable steps to reach an agreement on the sharing of data for the Inclusion of an active substance and/or the authorisation of biocidal products. Therefore applicants may be required to demonstrate to HSE all the efforts they have made to find existing data and in trying to reach an agreement with other data owners.

Situations in which data sharing may be possible, but an agreement between parties has not been possible, should be reported to HSE who will investigate each dispute on a case-by-case basis, and may also refer certain disputes to the Home Office, the UK Government department that licenses animal tests.