Source: New Zealand Ministry of Health
Medsafe has withdrawn its prosecution of Promisia Integrative Ltd in relation to its product Arthrem, in return for an agreement that will see the product removed from supply.
The settlement means Promisia accepts it breached the Medicines Act and will now cease manufacturing, advertising and selling Arthrem which has been linked to serious cases of liver harm.
In turn, Medsafe has agreed to withdraw the nine charges laid in the District Court against the company last year.
The prosecution of Promisia Integrative Limited, began in January 2019, followed Medsafe’s earlier warnings to the company about the sale, supply and advertising of Arthrem.
The company was warned that its advertising of Arthrem breached the Medicines Act.
Promotional claims made by the Company about Arthrem’s use for arthritis effectively made the product a medicine, which was unapproved, and was in breach of the Act.
In 2018 Medsafe published two privileged statements made by the Director-General of Health warning of the possible link between the Artemisia annua extract contained in Arthrem and reports of liver harm in people using it.
Despite the warnings, Promisia continued to supply Arthrem both within New Zealand and overseas, resulting in Medsafe laying charges.
Medsafe Group Manager Chris James says a settlement was seen as preferable given the length of time likely to be involved in pursuing a prosecution.
Under the Medicines Act, a substance that is supplied for a therapeutic purpose and that is to be administered to human beings is (with some exceptions) a medicine and, except in closely limited circumstances, cannot be sold, supplied, distributed, or advertised unless first approved by Medsafe on behalf of the Minister of Health. Promisia was supplying Arthrem for a therapeutic purpose without the necessary approvals.
Medsafe contends that Arthrem was intended to be taken for a therapeutic purpose but was being marketed under the guise of a dietary supplement.
Mr James emphasised that this is an example where a potentially harmful product was illegally marketed to the public as a dietary supplement, with fewer safety controls, when it should have been subjected to the more rigorous controls required for medicines.
- Promisia was first warned in 2016 that its advertising of Arthrem breached the Medicines Act because a therapeutic purpose was being claimed for the product.
- Information on the safety issues relating to Arthrem can be found in the following links to the section 98 privileged statements: 15 Feb 2018; 27 Nov 2018.
- The New Zealand Pharmacovigilance Centre reported that up till 28 February 2020 it had received reports of 46 cases relating to adverse reactions reported in association with the use of Arthrem.
- Medsafe operates an approval system for medicines that ensures they are safe, effective and of an acceptable quality.
- The nine charges related to breaches of section 20 of the Medicines Act 1981; specifically, sections 20(2)(a) (selling) and 20(2)(c) (advertising).
- The penalty, on successful prosecution, for a breach of section 20 is, for a body corporate, a fine not exceeding $100,000.
- A product is a medicine if it comes within the definition of ‘medicine’ in the Medicines Act 1981. Sections 3 and 4 of the Act are relevant.
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