Export NZ says new regulations covering the production and importation of medicines and therapeutic products should be revised to remove unnecessary compliance costs for exporters.
Export NZ advocacy director Catherine Beard said the Therapeutic Products Bill was something the industry wanted, but it had gone too far in requiring exporters to relabel and re-register products which were destined for overseas markets and already complied with international best practices.
She said the domestic regulation of therapeutic products should be more aligned with that of international trading partners, which often had much higher standards, such as the United States Food & Drug Administration (FDA).
"Certainly, the companies that are interested in exporting were keen to have a better regulatory framework that lifted the bar to give more credibility in overseas markets," Beard said.
"But the actual way that the bill came out of the woodwork had a few fishhooks for exporters, as it turns out."
She said big and small exporters would be caught up in the new regulation, which would add to the cost of production.
"I think the domestic regulators here have to look at whether their regulation helps exporters or hinders them."
Beard said the law would cover large companies, such as Fisher & Paykel Healthcare, that manufacture high-tech therapeutic medical devices to the highest international standards.
"So if another country has a regulatory regime, which is obviously exemplary, you would just recognise that and give that a tick, essentially.
"So they just need to have a provision that recognises that, rather than have everything re-registered in a slow and expensive regime in New Zealand."
Beard said domestic regulators here should look at whether their regulation was helping exporters or hindering them, with the cost of compliance already accounting for about 10% of production.
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