Cash-Only Wholesalers Sell Counterfeit Harvoni Pills

In the first month of 2017, officials say fake Harvoni drugs are being sold for the treatment of hepatitis C virus (HCV) through back-channel, cash-only wholesalers in Japan, according to The Mainichi.

Gilead’s lifesaving drug Harvoni changed the HCV landscape after its release in October 2014. Although it has a cure rate of more than 95%, it comes with a big sticker price. For a 12-week regimen the treatment costs approximately $94,000, or $1125 per pill.

These predominantly small to mid-size wholesalers have a reputation for selling pharmaceuticals from unreliable sources. According to The Mainichi, sources believe that at this point in the supply chain, genuine Harvoni pills were removed from their bottles and replaced with counterfeit tablets.

Although there are no laws in Japan that ban purchasing drugs from an unlicensed company, these suppliers are usually responsible for distributing fake medications, according to the report.

Normally, drug manufacturers will sell their drugs to pharmacies and medical institutions via a distributor, according to The Mainichi. However, back-channel wholesalers differ from the norm when purchasing the drugs, as they buy leftover medication from medical institutions, pharmacies, and sometimes even patients, according to the report. The wholesalers will then resell the drugs at slightly lower costs than those paid in the normal distribution system.

The counterfeit Harvoni pills were being distributed through several cash-only wholesalers, a senior official from the Ministry of Health, Labor, and Welfare, told The Mainichi.

In Japan, the official pricing for a bottle of Harvoni costs approximately 1.53 million yen. Beginning last autumn, 1 of several wholesalers allegedly bought approximately 10 bottles of the HCV drug from individual persons for between 900,000 yen and 1 million yen per bottle, the report noted.

Five of the counterfeit Harvoni bottles appeared in the Kansai Medico pharmaceutical chain, according to The Mainichi. The pharmacy told authorities it purchased some of the medication through non-standard channels because it was cheaper.

“It’s very surprising that even a major pharmacy would procure stock this way,” a former pharmaceutical executive told The Mainichi.

Although there are laws that prohibit non-licensed dealers from selling prescription drugs, there are no regulations in Japan that prevent unlicensed businesses from buying the medication.

Unfortunately, pinpointing who introduced the fake Harvoni pills into the distribution network is nearly impossible, according to The Mainichi. This is because buyers record the names of the seller, but are prohibited from recording their contact information.