Two interesting things were announced by WHO over the last week: first, the recommendation to extend the Essential Drugs List (EDL) to a few anticancer biologicals and to many of the latest generation of antivirals to treat hepatitis C; and second, the publication of research commissioned by WHO on the patent status of those new-generation antivirals.
Why is this interesting? Well, there used to be an informal code that WHO did not include on-patent or expensive treatments on the EDL. This was breached first in HIV, but it appears other therapeutic classes are following. Of the three biologicals listed, only one (Glivec) is still on patent – in Europe until 2016 – and generic biosimilars are in the pipeline for all three. However, large molecule drugs such as these are not cheap to produce even if off-patent, and require all sorts of complex imaging and diagnostic equipment to be used properly. All of the new antivirals are still on patent, most with many years to run.
The reaction of some of the access to medicines activists has been near-ecstatic – one commenting in a KEI blog piece that this is a “watershed moment for the global NCD community, including patients and front-line providers … [this] helps re-define essentiality based on clinical need — and not cost or cost-effectiveness alone.” However, shifting from cost-effectiveness as the leading criterion is a slippery slope – while the three anticancer drugs selected are genuine milestones, could there not be a similar clinical need for other treatments which extend the life of advanced cancer patients for a few weeks, or few months? This can prove a difficult dilemma, as the UK’s troubled Cancer Drugs Fund found out.
The hepatitis C situation is more revealing. In the space of a couple of years, the emergence of well-tolerated oral drugs that cure after only a few weeks’ treatment makes hepatitis C look like a disease that can be eradicated.
Here, WHO have commissioned that well-known activist organisation Thomson Reuters to look at the patent status of the new generation of hepatitis C treatments across a range of middle-income countries (MICs). This is not the first such survey that WHO have done, but it appears to be the largest. So, for instance, the review appears to show that there have been no patent submissions on behalf of sofosbuvir – Gilead’s Solvadi, the infamous treatment supposedly costing ‘$1,000 a pill’ – in Tunisia, which presumably means that the Tunisian government can import from an Indian generic manufacturer as soon as they start producing the drug (although the Indian producer would be breaking Gilead’s licence conditions for Indian manufacturers, which specify they cannot export to MICs).
It is unclear why WHO has commissioned this research or who is likely to benefit from it. However, the tone of the accompanying release stating that “WHO works closely with Member State governments to assess and promote policy options for increasing access to these medicines, which remain unaffordable to many of those who need them and put an enormous financial strain even on the health systems of high-income countries” seems to a ramping up of rhetoric that the scrupulously neutral WHO of previous years would not recognise. Again, a slippery slope – how soon before WHO becomes co-opted into an ideological battle against the whole edifice of patent and IP law? They need to be careful – nearly four-fifth’s of WHO’s money comes from voluntary contributions, which can easily be withdrawn, and its two biggest funders remain the U.S. government and the Bill & Melinda Gates Foundation.