Lyprinol Sentence increased
19 February 2001
Lyprinol Sentence increased
THE Ministry of Health is delighted at a High Court decision which increases the sentence imposed on Lyprinol distributors Pacific Pharmaceuticals.
"This sends an important message about how seriously we take the law about medicines, and our vigilance in respect of products which do not meet the quality and safety criteria the Medicines Act demands," Director-General of Health Dr Karen Poutasi said.
In the 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.
Dr Poutasi said the Ministry of Health was legally required to ensure New Zealanders had access to safe and effective medicines, registered under the Medicines Act.
"This means making sure that we protect the public against therapeutic claims for products which have not had the appropriate clinical trials and testing," Dr Poutasi said.
"We lodged an appeal against the original sentence because we believed the fine imposed on Pacific Pharmaceuticals in September was inadequate. Bearing in mind that this has always been something of a test case - acknowledged in this latest judgement - we asked for more."
Pacific Pharmaceuticals had admitted in an earlier court appearance that it breached section 20 of the Medicines Act 1981 which states that 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 also admitted causing, or permitting to be published a medical advertisement that directly and/or by implication, claimed that the medicine of the description advertised, namely lyprinol, would prevent, alleviate, or cure cancer and/or arthritis. This breached section 58 of the Act. A small fine imposed for this breach ($150) is unchanged by today's decision.
Lyprinol's appearance on the New Zealand market in 1999 was marked by what the latest Court ruling called "extensive and in part inaccurate media attention....The end result was the deliberate sale of a product for which therapeutic claims had been made in the absence of the consents required."
Although the brief time the product was on the market meant profits were not great, the Court noted that "substantial profits" were built into the distribution chain for Lyprinol.
For further information contact: Angus Barclay Media advisor Tel: 04 496 2067
Pacific Pharmaceuticals was the New Zealand distributor of Lyprinol - a green-lipped mussel extract. Lyprinol was claimed to be effective in the treatment of arthritis and asthma and touted as a possible cure for cancer.
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.
The media hype was generated at the same time as the product became available in pharmacies.
The Ministry's submission was that Pacific Pharmaceuticals Ltd was part of a cynical marketing campaign aimed to generate an instant profile for the product and to target it at a vulnerable audience - those suffering from cancer.