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ACVM Group Information Paper: Business Rules for Data Protection

July 2000

BACKGROUND

The Hazardous Substances and New Organisms (HSNO) Act 1996 and the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 provide for the continuation of CSI provisions (data protection) for animal remedies and pesticides. The ACVM Group have been approached recently with requests to access data held by the Pesticides Board in support of an animal remedy application (where the active ingredient is still under data protection) or vice versa. In the past it has been the practice for both Boards not to access data held by the other. However, in a recent policy approved by the Boards there is the opportunity for an applicant to request the sourcing of information held by other organisations such as the Ministry of Health (MoH) or the National Registration Authority (NRA) in Australia. It could be seen to be inconsistent if each of the Boards did not have a similar ability to request information of each other.

Previously, even if data is being presented by the same company that holds the CSI protection on an active ingredient under one Act, it has been Board policy to request the full data package for a separate CSI application under the other Act. There have been differing standards for information required and accepted.

Under the ACVM Act, for new active ingredients, it will only be possible to have a single period of data protection covering both plant compounds and veterinary medicines, as opposed to the current situation where the same active ingredient can have separate data protection periods under the Animal Remedies Act to that under the Pesticides Act. The change from the current situation with two periods, to a single period under the ACVM Act, will need to be managed.

This issue needs to be resolved in the short term, in the transition period to the ACVM Act and beyond it as the CSI periods will extend past the end of the transition period in a number of instances. The following proposals were considered and accepted by the Animal Remedies and Pesticides Boards.

1. The Boards will not attempt to source data from other bodies where there is a data protection period in existence for an active ingredient under their own Act. Complete data packages in this instance must be supplied by the applicant.

2. The Boards will only supply protected data where required (for instance to ERMA under HSNO Act for transitional activity) on the undertaking that it will be given the same protection (for the same period) by the recipient agency.

3. The Boards will not supply data to each other as a means of avoiding the data protection provisions in other Acts.

4. In the transition period, and for the time remaining for any data protection period under the ACVM Act, MAF will continue to act as if the Animal Remedies and Pesticides Acts were still in existence.

5. The Boards will accept a letter of consent from the owner of data which is under CSI, rather than request new data in future. It is understood that the data being cross-referenced should meet the relevant standards.