Introduction
This update provides advice on the procedure to be followed to resolve disputes between the owner(s) of vertebrate animal test data and an applicant wishing to have access to that data, in order to gain an approval under the Plant Protection Products Regulations, as amended (PPPR).
PPPR requires companies to request information on vertebrate test data when they seek to include an old active substance on Annex 1 (Regulation 16(3)); or when a company intends to apply for the approval of a product following Annex I inclusion (Regulation 16(1)).
Background
As part of the application process applicants may need to demonstrate access to certain data, including vertebrate animal test data, which they do not hold themselves, in order to gain an authorisation or approval under PPPR for a plant protection product.
PSD, in common with other Regulatory Authorities supports a reduction in the number of animals used for testing and has already taken steps to encourage companies to share data where appropriate. In addition to this, Article 13 of Directive 91/414/EC requires existing holders, or holders of previous approvals and applicants to take all reasonable steps to share data on experiments involving vertebrate animals.
Therefore, to ensure that tests involving vertebrate animals are not repeated unnecessarily, PSD expects:
- companies seeking approval always to enquire about previous or existing approval holders and any vertebrate study data they may already hold. If satisfied that the company intends to make an application, PSD will supply these details and inform the previous or existing approval holder that they have done so.
- approval holders should then respond positively to any reasonable request to share data.
What Vertebrate Test Data Is Covered?
The most common vertebrates on which test data are generated are rabbits, rats, mice, dogs, guinea pigs, hamsters, fish and birds. Therefore if you think your data package needs to include studies on any of these vertebrates, you should talk to PSD before carrying out any work because studies may already exist. Similarly if you believe that studies involving other vertebrates are required talk to PSD.
What If Companies Cannot Agree Terms?
PSD is not in a position to adjudicate in commercial disputes of this nature. However, where companies are unable to reach agreement voluntarily, the Directive allows the regulatory authorities to introduce national measures obliging the companies involved to share data using procedures specified by the authorities. The Secretary of State has agreed that where companies fail to resolve such an issue voluntarily both parties may be directed to participate in an independent Alternative Dispute Resolution procedure (ADR) to resolve the terms of any vertebrate data share arrangement. PSD has agreed the terms of a disputes procedure with Dispute Resolution Services Chartered Institute of Arbitrators (DRS-CIArb), a division of the Chartered Institute of Arbitrators for this purpose. http://www.ciarb.org/dispute-resolution/
How Will The Disputes Procedure Work?
As a first step, the applicant should enquire to the PSD Information Services branch:
- whether vertebrate studies are required in support of such an application and if so;
- if there are previous or existing approval holders that may hold some or all of the relevant data.
This information will be confirmed in writing (including e-mail) by PSD and any future enquiries, or matters of clarification on the data requirements should be directed through that PSD contact.
Initially, PSD would expect all parties to act within the spirit of Directive 91/414/EC and take all reasonable steps to reach an amicable solution on data sharing. In this respect PSD does not expect any reasonable request to be refused. However, should a data holder refuse access or both sides fail to reach agreement for any reason PSD would suggest that, in the first instance, the matter is referred to DRS-CIArb for mediation. This stage is entirely voluntary and referral by the Secretary of State is not necessary.
If following voluntary mediation parties still cannot agree or either party does not agree to enter the mediation process, PSD, acting on behalf of the Secretary of State will consider whether the matter could best be settled by referral to a formal and binding arbitration mechanism under the Arbitration Act 1996. Both parties can of course enter the arbitration process voluntarily but there may be situations where a direction from the Secretary of State to enter arbitration may be necessary. Such a ‘direction’ will be legally binding on both parties.
If either party believes a direction to enter arbitration is necessary they should write to their PSD contact setting out the area of dispute. They should also set out the reasons why voluntary mediation or arbitration have not been followed.
If PSD accept that a direction to enter arbitration is appropriate:
- PSD will respond giving both sides 21 working days in which to resolve the issue. This letter will also explain that if agreement is not reached both companies will be directed to apply to DRS-CIArb and enter the formal arbitration arrangement www.idrs.ltd.uk.
- Either party must inform PSD as to whether agreement has been reached within the initial 21 days.
- If after the 21 days period agreement had not been reached, both parties have 7 working days within which to mutually agree an arbitrator to determine the matter. Should the parties fail to agree then, as part of the agreement, DRS-CIArb will automatically appoint an arbitrator.
- Once appointed the arbitrator will handle the timetable and request statements and evidence.
The arbitrator’s award will be binding on both parties in respect of approvals granted under PPPR in the United Kingdom.
An approval may be refused in circumstances where relevant vertebrate animal test data exists and this process has not been followed.
Update Reference
Regulatory Update: 19/2005
Issued: 31 August 2005
