Industry Applauds Government for Cutting Red Tape

A three-year effort by industry to reduce super-cautious rules constricting the availability of animal medicines has succeeded.

Animal health companies say that the resulting streamlined process for approving treatments will reduce cost and remove a roadblock which had curtailed access to some medicines.

“Agcarm would like to thank the Environmental Protection Authority for fulfilling the government’s mandate to cut red tape and ease the regulatory burden,” said Graeme Peters, the chief executive of Agcarm, the industry association for manufacturers of veterinary medicines.

“This sends the clear message that if industry can make a sound case for the removal of red tape, the government will listen and act.”

Mr Peters said the problem first flared 10 years ago when veterinary medicines were captured under the then new Hazardous Substances and New Organisms Act, which manages risks for hazardous substances such as industrial chemicals, fuel, and explosives. By contrast, human medicines were exempted from the environmental safety law because they were seen as low risk, were regulated elsewhere, and HSNO added unnecessary cost for little gain.

Being captured by HSNO meant that veterinary medicines had to be regulated by the Environmental Protection Authority – even though they were already regulated by the Ministry for Primary Industries.

Double-headed regulation not only added cost, it also meant that small amounts of product that contained low concentrations of mildly hazardous substances were required to carry unnecessary label warnings in New Zealand.

“Animal medicines are produced for a worldwide market, but New Zealand is only one per cent of that market. The problem was that label warnings were not required in other countries so had to be added to New Zealand labels. On small product lines, and even some larger ones, this was not economically viable or possible, so the medicines were not available here,” Peters said.

Some warnings were statements of the obvious and therefore clogged up tiny labels. “For example, a product that was designed to target organs was required to carry a warning that it could affect organs – a meaningless statement.”

“Others carried warnings that the product was flammable when the cardboard box surrounding them was more of a fire risk.”

In 2010 Agcarm, the New Zealand Veterinary Association, and Federated Farmers sought an exemption for animal health products from the HSNO Act, but after consultation with the EPA it emerged that a ‘group standard’ could achieve a similar result in less time because it did not require an amendment to law.

A group standard is an approval method for a wide range of similar products with certain properties. Developed by Agcarm, the group standard for veterinary medicines includes a set of conditions that enable low-risk substances in pack sizes under 500 grams or 500 millilitres to be managed to minimise adverse effects.

Key benefits of the group standard, which comes into effect on November 29, include better alignment with overseas labelling and a reduction in superfluous labelling requirements.

The group standard also allows manufacturers to ‘self-assess’ their products which fit under the scope of the group standard. Self-assessment means that a manufacturer does not need to apply – and pay - for regulatory approval from the EPA.

ENDS

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