Couple arrested over fake Harvoni in Japan

A Japanese couple have been arrested for a second time over allegations of selling fake Harvoni-branded hepatitis C drugs.

Yoshimi Kase, 49, and her husband Takayuki Kase, 43, are accused of selling the counterfeit copies of Gilead Sciences' Harvoni (sofosbuvir and ledipasvir) pills to a wholesaler, with the intention that the knock-offs enter Japan’s legitimate drug supply chain.

They have been charged with violating the pharmaceuticals and medical devices law and have already been indicted for the use of illegal drugs.

According to police, the couple are suspected of selling two bottles of fake Harvoni tablets back in January 2017 to a Tokyo-based wholesaler that is no longer operating, The Japan Times reported.

They allegedly sought Y1.6m-2m ($14,600-$18,300) for the drugs, which equates to a discount of around 50-70 per cent of the government-set price tag, the newspaper says.

The pair have also been charged for allegedly twice selling a second hepatitis C drug Sovaldi (sofosbuvir) to another wholesaler in 2016, profiting Y1m ($9160) from the transactions.

The couple have denied any wrongdoing and have claimed their products were genuine. 

Harvoni has been targeted by counterfeiters because of its hefty price tag - the US list price is around $95,000 a year. Demand for the drug, which sometimes cannot receive reimbursement cover because of its cost, means patients will look to seek out cheaper sources of the drug, increasing their chances of stumbling across counterfeits.   

The recent case of counterfeit Harvoni was discovered when fakes turned up at the Kansai Medico pharmacy chain in Nara Prefecture. Bottles of fake Harvoni were also found at two wholesalers and a further nine pharmacies have been caught up in the circulation of the counterfeits.

Since January last year, at least 15 bottles have been seized.

The fake drugs, in genuine Harvoni bottles, were found to contain vitamins, herbal ingredients and other pills, instead of the active ingredients sofosbuvir and ledipasvir. Although more than 60 people were dispensed the fake drugs, it is believed none were taken.

Authorities believe the Kase couple were supplying the Tokyo wholesaler with counterfeits, although they have not ruled out that others may be involved in the illicit supply and distribution of fake Harvoni in Japan, The Japan Times claimed.

Previous reports suggest that fake Harvoni has been able to enter the legitimate drug supply chain in Japan through small “back-channel, cash-only” wholesale firms, which have sourced the meds from unreliable suppliers. There are no laws in Japan that ban purchasing drugs from an unlicensed company.