Data sharing and GB BPR

Owners of existing data and prospective applicants are obliged to share certain data from tests and studies on biocidal active substances and products submitted under the GB Biocidal Products Regulation (GB BPR).

Sharing of vertebrate animal studies in exchange for reasonable compensation is mandatory under GB BPR. This is expected to save costs and animal lives by prohibiting the duplication of these studies.

Identifying data gaps

As a prospective applicant, you need to determine what data you require both in terms of actual data missing and possible improvements that could be made to the quality/robustness of the data you already have. The data required will vary depending on the type of application you intend to submit, for example, active substance approval, biocidal product authorisation, inclusion on the GB Article 95 List.

Identifying data owners/submitters

As a prospective applicant, you:

• must, for data involving tests on vertebrates
• may, for data not involving tests on vertebrates

check whether such tests have already been submitted to HSE in connection with a previous application under GB BPR.

If relevant tests have already been submitted to HSE, we will provide you with the contact details of the data submitter and data owner.

If vertebrate tests have not been submitted to HSE, you should consider whether other options are available for generating the required data before you begin any vertebrate tests - we recommend you contact us with your proposed justification for carrying out such tests before you begin new tests involving vertebrates^[67].

If non-vertebrate tests have not been submitted to HSE, you may carry them out (please note this is only applicable for non-vertebrate testing).

Sharing the data - data owner agreement

The data submitter will facilitate contact between the prospective applicant and the data owner, where applicable.

If the data are still under data protection, the prospective applicant:

• must, for data involving tests on vertebrates
• may, for data not involving tests on vertebrates

request from the data owner, all the technical and scientific data related to the tests as well as the right to refer to these data when submitting an application under GB BPR.

If such a request is made, you and the data owner should make every effort to reach an agreement, including financial compensation to the data owner, on the sharing of the results of the tests or studies you've requested. The data owner may make all the technical and scientific data related to the tests available to the applicant, or may grant the applicant permission to refer to the data owner's tests or studies when submitting applications under GB BPR.

You may agree with the data owner to jointly refer the matter to an arbitration body and make a commitment to accept the arbitration order.

The negotiations and compensation for accessing data is between you and the data owner.

Sharing the data - no agreement

If the prospective applicant cannot reach agreement with the data owner on data involving tests on vertebrates, as a last resort, the prospective applicant can ask HSE for permission to refer to the data.

What you must do

You must provide HSE with

• details of the steps you have taken to try to reach agreement with the data owner
• evidence you paid the data owner a share of the costs involved in generating the data

Note: The request for permission cannot be submitted to HSE within one calendar month after you have received the name and address of the data owner from HSE. The one-month limit is to allow an attempt at negotiations to be made. It is not the maximum amount of time for negotiation. Your negotiations can go on for as long as necessary and the request to HSE should be made only once substantive negotiations have concluded and no agreement can be reached.

What HSE will do

HSE has 60 days to consider your request.

If you have demonstrated that you've:

• made every effort to reach an agreement with the data owner; and
• paid them a share of the costs involved in generating the data

HSE will grant you permission to refer to data involving tests on vertebrates in your GB BPR application.

If you have not demonstrated you've made every effort to reach agreement with the data owner or have not paid them a share of the costs, HSE will not grant you permission to refer to the data.

Write to HSE

To enquire about tests that may have already been submitted to HSE in connection with a previous application under GB BPR, the prospective applicant or company acting on their behalf should submit, in English, a completed data sharing request form (.docx) ^[68] to biocidesapplications@hse.gov.uk - companies may wish to mark emails as appropriate eg confidential. Please note that your form may be returned if it is incomplete.

To request permission to refer to data after failing to reach an agreement with the data owner, the prospective applicant or company acting on their behalf should submit, in English, a completed data access request form (.docx) ^[69] to biocidesapplications@hse.gov.uk - companies may wish to mark emails as appropriate eg confidential. Please note that your form may be returned if it is incomplete.

Only the request form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:

• evidence that you have contacted HSE to determine whether we already hold such studies
• evidence that you have made every effort to reach an agreement with the data owner
• evidence that you have paid the data owner a share of the cost incurred

Using the HSE Secure File Sharing Service

• Once we have received and processed your request form, you will be sent a link to upload the files associated with the relevant request - please do not use the link to upload files related to other requests/applications.
• Links will be sent out Monday - Friday and are valid for 5 working days - if the link expires before you are able to upload your files, please email biocidesapplications@hse.gov.uk to request a new link.
• Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service - these will be included in the email alongside the link.
• Please check the spam settings on your email account to ensure our emails are not going to your junk folder.

Article 95 data

Article 95 (3) of GB BPR extends the mandatory data sharing obligation to toxicological, ecotoxicological and environmental fate and behaviour data, including those not involving vertebrate animals (as described in Sections 8, 9 and 10 of Annex II of GB BPR).

This extension only applies to accessing data for the purposes Article 95 of the GB BPR. It also only applies to active substances in the GB Review Programme and does not apply to new active substances.

The processes described above can also be followed to identify data owners and to arrange for data to be shared.

Data owners

If you own data that have been submitted for any purpose under GB BPR you may receive a request for data sharing. These requests could be for access to individual studies (vertebrate and non-vertebrate) or access to complete dossiers.

It is up to you to agree what data to share, although under GB BPR you must share data involving tests on vertebrates. You must also share toxicological, ecotoxicological and environmental fate and behaviour data, including those not involving vertebrate animals, where the prospective applicant is applying to be included on the GB Article 95 List.

You are entitled to compensation from the prospective applicant to refer to the data you own which still has protection under GB BPR. You should only request compensation in relation to the requested data.

HSE recommend that data owners have a process in place to deal with requests for data sharing.

Upon a request to share data, both you and the prospective applicant have the duty to make every effort to reach an agreement - it is not a one-way obligation.

You may agree with the prospective applicant to jointly refer the matter to an arbitration body and make a commitment to accept the arbitration order.

The negotiations and compensation for accessing data is between you and the data owner.

Where agreement cannot be reached and when the prospective applicant submits a request to HSE for access to the data, they will pay you what they consider to be compensation. You have to accept this payment. You can pursue additional financial compensation via national courts if you wish to do so.