Regulation Robs Vets, Producers of Animal Meds

Over Regulation Robs Vets And Primary Producers of Innovative Animal Medicines

Joint Press Release

MONDAY 10 MAY, 2010

Farmers, vets, and manufacturers of animal medicines are calling for vet medicines to be exempted from the Hazardous Substance and New Organisms Act (HSNO), currently under review.

“The double regulation of animal medicines is over the top and adds unnecessary compliance costs, which in turn is limiting innovation and the range of treatments available in New Zealand,” said Dr Wayne Ricketts, Veterinary Resource Manager, New Zealand Veterinary Association.

“Human medicines have been exempt from the hazardous substance rules for nine years. It’s now time animal medicines were granted the same exemption,” Dr Ricketts said.

“It makes no sense at all for animal medicines to be more rigorously regulated than human medicines, especially when many are identical. Take the Quinolone antibiotic family. The 15mg enrofloxacin vet medicine requires Environmental Risk Management Authority (ERMA) approval while the similar 400 mg moxifloxacin human medicine does not, despite the level of active ingredient being over 20 times greater,” Dr Ricketts said.

Animal medicines are already well regulated under the Agricultural Compounds and Veterinary Medicines Act (ACVM). In addition to having concern for risks to animal welfare, market access and agricultural security, and domestic food residue standards, the New Zealand Food Safety Authority (NZFSA) must take into account any risks to public health when assessing veterinary medicines. The NZFSA has a robust system, which includes compliance audits. These responsibilities are sufficient to cover any concerns about the effects of animal medicines on people.

“We have felt for a long time now that the requirement for ERMA approval is over-regulation,” said Dr Ricketts

In response to this, Federated Farmers, the New Zealand Veterinary Association, and manufacturer associations Agcarm and Animal Remedy and Plant Protection Association (ARPPA) have put forward a joint case for an exemption.

“An exemption would be in line with the Government’s desire to remove regulatory requirements that are unnecessary and costly to both industry and users,” said Mr Phil York, National Board Member and HSNO spokesperson, Federated Farmers of New Zealand.

“An exemption would also allow ERMA to cut costs or divert resources into the areas that pose real risks to people and the environment,” Mr York said. “And to enter its transition into an Environmental Protection Authority without the unnecessary burden of regulating animal medicines,” said Mr Graeme Peters of Agcarm, which represents manufacturers of veterinary medicines.

“We are seeking an exemption across the vast bulk of medicines such as antibiotics, vaccines, surgical drugs, management of internal parasites, and flea treatments for cats and dogs,” said Mr Peters.

“However, we recognize that some products used on farm animals could be hazardous if used improperly. These are mainly drench insecticides used in a dispersive manner and we will not be seeking an exemption across these products,” he said.

New Zealand’s hazardous substance rules are based on the United Nations classification and labeling framework, the Globally Harmonised System (GHS).

The GHS was written to cover the use, transport, and disposal of chemicals such as sulfuric acid, pesticides, and 1080. It was not intended to cover human and animal medicines.

“With the government updating its nine-year-old hazardous substance regime to match the latest version of the GHS, we have the opportunity to remove this anomaly,” said Mr Graeme Peters of Agcarm.

ENDS

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