Australian meds placed illegally on government register though direct order

Malta’s central procurement unit (CPSU) for medicines has been acquiring an imported Australian product that could have been illegally placed on the Maltese market.

Novartis agents V.J.Salomone Pharma believes the health ministry’s CPSU has been acquiring illegally-imported versions of their Novartis product, Cosentyx.

The matter was considered serious enough for top brass from the Novartis pharmaceutical company in Switzerland to file a complaint directly with Prime Minister Robert Abela about illegal procurement practices in 2020.

The CPSU is accused of acquiring Cosentyx from a third party that is neither the authorised Novartis agent in Malta, nor does it have readily-available stocks of the medicine in Malta, contrary to EU law on such out-of-stock medicinals.

Instead it is sourcing Cosentyx from Target Healthcare Ltd, a Żebbug company owned by Scottish national Lewis Campbell – despite the CPSU having previously sourced the product from Novartis agent VJS since 2016.

The €98,000 direct order for Target Healthcare was made in April 2020. Target was only incorporated in March 2019.

Cosentyx is a prescription medication that is used for treating plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. It is one of the most prescribed treatments of its kind.

In a complaint filed against Target in the Maltese courts, VJS said Target’s product could have been imported from an unidentified Australian exporter, which Novartis Pharmaceuticals Australia Pty think has illegally resold them to the Maltese company.

VJS insisted that the Cosentyx products imported by the company were specifically manufactured for commercial distribution in Australia, and not the European Economic Area, with a 24-month shelf life that was longer than equivalent European products.

The product also lacks security features designed for the EEA such as unique identifiers and anti-tampering devices, whilst the information leaflet inside the medicinal’s box is not in conformity with EU rules.

“At worst these medicinals could be counterfeit products, with packaging cloned from genuine products manufactured for the Australian market,” a VJS representative said in an affidavit to the court.

“Whether authentic or not, these products do not have the security guarantees for use of such medicinals in the EEA, and this is a grave concern in the use of a pharmaceutical for humans, both for those who prescribe or administer them, as well as for patients.”

Jason Melbourne, Novartis Australia’s head of supply chain, testified in an affidavit that the product procured by the CPSU from Target was only for sale in the Australia market region. “NPA’s direct customers – wholesalers – are well aware of their legal and contractual obligations, and after I queried matters with them I can quite positively confirm that none of our direct customers would be exporting these goods. It is thus most likely that the exportation is being effected by a customer of one of our customers, or perhaps an operator even further down the line of trade.”

Letter to PM

In a strongly worded letter to Prime Minister Robert Abela dated 2 December, Novartis AG accused the Maltese government of not following EU rules on the way it procures its medicines.

The matter has been ongoing since January 2020, but Novartis has complained that it has been ignored by the health minister, deputy Prime Minister Chris Fearne, in previous correspondence.

Novartis contends that the CPSU is bypassing its Malta agent when it is legally obliged to tap into local sources of stocked medicinals before seeking out other importers to provide any medicines that are out-of-stock, as happened in late 2019.

“Novartis had Cosentyx stock in Malta at the relevant time, and continues to do so, and such stock could have been and can still be supplied to the CPSU at short notice,” the company told Abela.

Novartis warned Abela that the Australian imports of Cosentyx are contrary to EU laws “which require medicinal products distributed in the EU to bear safety features consisting of a unique identified and an anti-tampering device, and poses a risk to public health due to the unregulated distribution channels involved in their importation into Malta.”

Novartis also told Abela that under both EU and Maltese legislation, importation of medicinal products from outside the EU is restricted to situations of public health reasons or non-availability of medicinal products locally “and must comply with the strict conditions under the specific legislation. These conditions are not met in this particular case with Cosentyx.”