Pharma giant Novartis tells Abela that Malta is breaching EU medicines law

Top brass from the Swiss pharmaceutical giant Novartis have accused the Maltese government of breaking EU rules on medicine procurement.

In a strongly worded letter to Prime Minister Robert Abela dated 2 December, the company 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 is based in Basel, Switzerland, and is the world’s second largest pharmaceutical company based on prescription drug sales

Novartis contends that the Central Procurement Supplies Unit, which is responsible for all government procurement of medicinals, is bypassing local agents who already supply Novartis products and have readily-available stocks of required medicines.

Instead, the CPSU was ignoring established importers who had stocks of required medicines, and procuring the same medicines from other importers with stocks from outside the EU.

Novartis received no explanation as to why the CPSU has ignored the established procedure to tap into local stocks of medicinals, before seeking stocks elsewhere.

Novartis medicine Cosentyx - a prescription medication that is used for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis

The complaint concerns the supply of the Novartis medicine Cosentyx, a prescription medication that is used for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. The medication is especially important, being one of the most prescribed treatments of its kind as well as a biologic: a protein-based medication made from living sources, unlike so-called biosimilars.

CPSU is obliged to tap into local sources of stocked medicinals before seeking out other importers to provide any medicines that are out-of-stock.

In Malta, Novartis has been supplying the CPSU through a local distributor with Cosentyx since 2016 until August 2019. But in November 2019, when the CPSU ran out of its Cosentyx supplies, it did not open negotiations with the Novartis distributor, which has regular stocks of the medicinal.

Instead, it turned out that the CPSU was supplying patients with Cosentyx imported into Malta from outside the EU, more specifically from Australia by a company called Target Healthcare Limited, owned by Lewis Campbell. The latest direct order was last published on 29 September, with Target selected to provide the Cosentyx medication.

“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.

“This unauthorised circulation of Cosentyx in Malta by the CPSU may violate the EU legal framework relating to medicinal products and the intellectual property rights of Novartis…”

Novartis took issue with CPSU’s direction, telling Robert Abela in its letter that the CPSU’s acquisition of 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.”

“We believe that the procurement of medicines must always follow the established legal framework of the European Union, aimed at safeguarding the safety of medicinal products and patients’ health and protecting intellectual property rights.”

Novartis also said it had already informed the CPSU and the minister of health of its complaint back in February 2020, but said that both parties had declined the company’s invitation to discuss the issue.