Should Generic DAAs Be More Widely Imported?

Even in high-income countries, patients can have problems getting the new but expensive direct acting antivirals that are so effective in treating hepatitis C.

A recent article written by Narcyz Ghinea, BSc, of the Center for Values, Ethics, and the Law in Medicine at the University of Sydney in Australia, and several colleagues, and published in The Lancet, suggests that importing generics could be the answer.

The authors begin by describing the incredible recent advancements in therapies for treatment of HCV, saying, “Simple, highly tolerable, short-duration regimens with extremely high efficacy have been developed and registered internationally.” They go on to say that broad implementation of these therapies could “dramatically affect the burden of HCV-related disease globally.”

However, the cost of the drugs is prohibitive: as much as $93,000 per 12-week course in the US. The authors say that other factors also limit access, adding, “Even in high-income countries, there is a considerable diversity in access to and pricing of new HCV therapies.”

Both the UK and Australia have increased funding for HCV treatment, however, in the UK “access has generally been restricted to those with advanced liver disease,” due to limited funds, according to the authors. In Australia, thanks to a volume-based pricing deal, no such restrictions exist.

“Patients who live in countries that do not have universal government funding schemes, or who do not fit specific criteria for subsidisation, must wait until these medicines are funded by their public or private insurers, or find other ways to access medicines such as through clinical trials, industry access schemes, or personal fundraising,” say the authors. Some patients are unable to get treatment, limiting the potential public health benefits of the new therapies.

To address the problem in lower-income countries, pharmaceutical companies have, in some instances, issued voluntary licenses, allowing generic versions of HCV treatments to be manufactured. The authors point out, however, that part of such agreements is an explicit prohibition against exporting the generic drugs to middle- or high-income countries.

There are some ways for patients in high-income countries to take advantage, though such as medical tourism. In Australia patients can “import up to 12 weeks of unlicensed medicines at their own risk,” say the authors. In fact, before the funding in Australia was increased to meet the need for more HCV treatments, “an estimated 1400 Australia patients received treatment with the assistance of FixHepC, a web-based platform for the importation of HCV therapies,” say the authors.

The success of such importation schemes raises the question of why more don’t exist. Regulations, limitations on what physicians can prescribe, and other policies -- many related to safety -- are all cited as reasons. Additionally, the authors say there are “unresolved legal, political, and operational complexities when it comes to large-scale importation.” They specifically discuss Australia, but the same is true in other high-income countries.

One argument against importation schemes as those discussed the authors say is “that patients in high-income countries should not have access to cheaper medicines available in low-income countries because price discrepancies are legitimate responses to the ability of different markets to pay for medicines.” However, the authors go on to point out that “the fact that medicines can be sold at massive discounts in many parts of the world (and presumably not at a loss) calls into question the legitimacy of prices charged in many high-income countries.”

The authors conclude with “The generic importation of HCV medication thus highlights the problems of drug cost, regulation, and access in both high-income and low-income countries,” along with the suggestion that “we need to have legal frameworks and mechanisms in place that allow patients to access these treatments … without fear of personal or societal repercussions.”

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