Counterfeit Viread also on market, says MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that counterfeit versions of Gilead Sciences' HIV medication Viread have been discovered on the UK market alongside the earlier-reported Truvada fakes.

An MHRA spokesperson told SecuringPharma: “We have become aware that one batch of Truvada and three batches of Viread...have entered the EU supply chain in suspected counterfeit packaging."  

Last week, a Danish supplier of parallel-imported and generic pharmaceuticals, Orifarm, was forced to withdraw its stocks of Truvada (emtricitabine and tenofovir disoproxil fumarate) from the market because the product had been compromised by the presence of counterfeits (see Counterfeits cause parallel importer to withdraw product in Denmark).

Orifarm did not report any issues with Viread (tenofovir disoproxil fumarate), and said it took the decision to withdraw supplies of Truvada in consultation with the Danish Medicines Agency.

"In the UK, current evidence suggests that this is at wholesale level only and affected batches have not reached UK patients," said the MHRA.

Tests conducted by the MHRA and Gilead "confirm that all affected batches contain genuine Truvada and Viread medicines, and investigations are underway to determine the source and supply of the affected batches."

“Our priority is to establish what has happened here. We are inspecting various UK wholesalers to investigate the cause,” added the spokesperson.

The incident appears to be a case of diversion, as the product appears to be genuine Gilead medicine destined for the Turkish market while the packaging is counterfeit, according to Heinz Kobelt of the European Association of Euro-Pharmaceutical Companies (EAEPC), which represents the parallel trade industry.

"It has happened before that medicines originally shipped to Turkey have been diverted to the EU, which is a case of trademark infringement," he said. In the EU, medicines can legally be purchased from a low-priced member state and re-sold into a higher-priced market, but it is illegal for non-EU products to be redistributed in this way.

An EAEPC member brought the suspect products to the attention of Gilead and the MHRA, said Kobelt, who noted that the organisation recently set up an information sharing and alert system to allow cases of counterfeiting and diversion to be disseminated rapidly to its members, affected brand owners and the regulatory authorities.