Worldwide 80 million people are chronically infected with hepatitis C virus (HCV) 1, of whom 80% live in low‐ and middle‐income countries (LMICs). Analogous to the introduction of HAART in HIV/AIDS, new interferon‐free direct‐acting antiviral (DAA) treatment combinations have transformed the HCV treatment options 2, 3 with their potential to cure patients and stop the pandemic.
However, the high prices set by innovator manufacturers keep these novel medicines out of reach of most patients in LMICs 4, 5, because they prevent countries from integrating DAAs into treatment policies, and funding and implementing agencies from launching large‐scale treatment programmes. Prices have been pushed so high – sofosbuvir may cost up to US$ 85 000–110 000 per treatment course – that access has become a challenge even in high‐income countries, where in the majority, strict eligibility criteria are in place for allocating patients to these treatments 6, 7. The access strategies voluntarily put in place for LMICs by some pharmaceutical companies, although laudable, appear insufficient to achieve the goal of universal access 8, 9. Conversely, generic competition coupled to economies of scale could dramatically lower prices: a generic version of sofosbuvir is already available at less than US$ 500 per treatment course, and scaled‐up manufacturing is projected to achieve target prices of US$ 100–250 for a full generic treatment course within the next 15 years 10, 11, or potentially earlier. There is broad consensus among stakeholders that competition among quality‐assured generics is now urgently needed to enable the launch of large‐scale public treatment programmes and to change HCV treatment patterns worldwide 9.
An important step towards universal access to DAAs was the inclusion in 2015 of sofosbuvir, simeprevir, daclatasvir, dasabuvir, ledipasvir/sofosbuvir and ombitasvir/paritaprevir/ritonavir in the WHO Essential Medicines List (EML) 12, 13. This was accompanied by the expansion of the WHO Prequalification Programme to include medicines for hepatitis 14, 15. In the field of HIV/AIDS, the WHO Prequalification Programme has been a key element for the launch of large‐scale treatment programmes 16, by assessing the quality of generic antiretrovirals and building the capacity of medicines regulatory agencies (MRAs). But in that case, manufacturers of pre‐qualified generic products were benefiting from market rewards, as major stakeholders such as the Global Fund, UNITAID, PEPFAR etc. only purchase products pre‐qualified by the WHO or approved by SRAs 16, 17, thus creating an important market incentive for quality assurance. Such funding mechanisms do not exist for HCV today, thus there is no equivalent ‘market push’ for DAAs’ quality assurance. However, differently from HIV/AIDS, HCV treatment is not lifelong but for a limited time. Thus national governments might be less dependent on external funders and able to play this role themselves, if fairly‐priced, quality‐assured medicines were available.