$15,000 Fine For Selling Non-Approved Medicine
Company Fined More Than $15,000 For Selling Non-Approved Medicine
THE Ministry of Health welcomes the penalty of more than $15,000 imposed on Lyprinol (NZ) Ltd in North Shore District Court today for selling a product derived from green lipped mussels as a cure for cancer.
The company was sentenced on two charges relating to the sale and advertising of Lyprinol as a new medicine without consent, after the Ministry of Health brought about a prosecution last year.
Medsafe Compliance Team Leader Peter Pratt said, "The Ministry of Health is pleased with the outcome of the case and the penalty."
"It sends a strong deterrent message to the industry that making therapeutic claims for products that aren't registered as medicines will not be tolerated.''
Lyprinol (NZ) Ltd admitted it breached section 20 of the Medicines Act 1981, which states it is an offence to sell, distribute or advertise the availability of a new medicine before the Minister of Health has consented to such distribution. It was fined $15,000 on this charge and $130 court costs.
It also admitted causing, or permitting, the publication of a medical advertisement that directly, and/or by implication, claimed the medicine of the description advertised, namely Lyprinol, would prevent, alleviate, or cure cancer or arthritis. This is in breach of section 58 of the Act and the company was fined $150 plus court costs of $130 on this count.
Sentencing for Lyprinol (NZ) Ltd was adjourned after last year's finding pending the outcome of an appeal by the Ministry against the sentence handed down to lyprinol distributors Pacific Pharmaceuticals.
In February this year, Auckland High Court Justices J Priestley and J Anderson quashed the original $5000 fine imposed on Pacific Pharmaceuticals as "manifestly inadequate" and increased it to $15,000.
"Today's result and the consistent fine shows the level of culpability between the two companies is similar," Mr Pratt said.
Lyprinol came to the attention of the Ministry of Health in July 1999 when there was significant coverage in television and newsprint of a story about the product being a possible cure for cancer.
The product was originally sold as a dietary supplement and, under these regulations, the distributor of the product is not permitted to make claims that the product may treat or cure any diseases or medical conditions.
To be able to market a product as a medicine, it must first be assessed as to its safety, quality and effectiveness by Medsafe, the medicines regulatory branch of the Ministry of Health, to be registered on the schedule of permitted medicines.