'Dallas Buyers' Club' for Hep C treatments under investigation

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'Dallas Buyers' Club' for Hep C treatments under investigation

By Jane Lee
Updated

A "Dallas Buyers Club" of doctors and patients importing potentially life-saving Hepatitis C medication from countries like China is being investigated by the Therapeutic Goods Administration.

Australians suffering Hepatitis C have been waiting for about six months for the Pharmaceutical Benefits Scheme to negotiate with US companies on a subsidised Australian price on new drugs for the virus. The drugs are far more effective and fast-acting than existing interferon therapies for Hepatitis C, which carry debilitating side effects. Four new drugs were recommended to be listed on the Scheme by its advisory council earlier this year.

It is unknown how much the drugs sell for privately in Australia, but the US prices for some of the drugs are reportedly more than $A100,000.

The FixHepC Buyers Club, established in September, helps patients with a doctor's prescription import and test the drugs for their personal use for cheaper rates from China and India. Visits to the group's website soared from 5000 to more than 217,000 in its first week after a Fairfax Media report.

Labor Senator Jan McLucas asked Department of Health representatives about the practice at a senate estimates hearing on Wednesday night: "What is the TGA's position on doctors establishing a so-called Dallas Buyers' Club to bypass the Pharmaceutical Benefits' Scheme and import drugs such as Harvoni and Sovaldi from China?"

Adjunct Professor John Skerritt, a deputy secretary of the Department, said that the TGA was investigating the lawfulness of the importation and the advertising of such drugs.

"There are still a range of investigations in progress. We are aware of groups doing this and there are analogies to a Dallas Buyers Club but this does not make this whole package necessarily illegal," he said.

Fairfax Media has reported that most of Australia's 233,000 hepatitis C sufferers are deferring interferon treatment, often on advice from their doctors, to wait for the more effective drugs to be listed on the Pharmaceutical Benefits Scheme, at the risk the virus would become life-threatening. A study published in the Journal of Gastroenterology and Hepatology has found that some patients, who were unable to receive interferon treatment, had experienced liver failure in that time.

Dr Skerritt said there were cases where finished medicines were being imported into Australia. Under the "personal import scheme" people could legally import medicines for up to three months for personal use, with a prescription from an Australian registered medical practitioner.

There were other cases where only the "active pharmaceutical ingredient" or the "starting material" of the drugs were being imported. If people were importing compounded forms of these ingredients with a prescription, the states and territories, not the federal authority, had regulatory powers to act.

Dr Skerritt said they were also investigating whether buyers' clubs had breached laws that prevented advertising prescribed medicines directly to Australians. Using the analogy of botox treatments, he said "You can advertise a service saying 'I'm doing wrinkle reduction surgery' but you can't advertise the substance (to be used.)"

Twenty-seven health advocacy groups including Hepatitis Australia wrote an open letter to Health Minister Sussan Ley last month urging her to intervene to speed up the negotiations, so that the drugs can be listed before the end of the year.

The Department's Andriana Platona said negotiations were particularly difficult because they involved three different companies and drugs that covered the entire Hepatitis C spectrum: "What we are trying to achieve during these negotiations (is) treatment for most people …as many as we can at the lowest possible price."

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