Kazakhstan has one of the lowest prices for sofosbuvir (SOF) – based regimens in the region: $ 78 for a three-month treatment course of SOF and daclatasvir (DCV). Since the beginning of the national elimination programme in 2018, 26,000 patients have received life-saving DAA-based Hepatitis C treatment. But there is much more to be done.
Answer Foundation and Antihepatitis C Foundation, MMA’s partners in Kazakhstan, with technical support from ITPC-Ru, recently launched a comprehensive Annual Report on access to antiretrovirals (ARVs) and direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV). Their report focuses on procurement issues that occurred during 2020 – and the lessons learned from them.
One key recommendation, the effort to continue improving access to HIV integrase inhibitors, specifically dolutegravir (DTG) and bictegravir (BIC), is particularly important. DTG is WHO-recommended as part of first- and second-line antiretroviral therapy (ART), because of its potency, tolerability and high resistance barrier. Despite a recent agreement between the Medicines Patent Pool (MPP) and patent holder ViiV, Kazakhstan is still without generic DTG – this needs to change.
The report makes several recommendations to improve access to medicines, including simplifying the registration process for medicines and improving access to unregistered drugs. New rules for the Common Medicines Market within the Eurasian Economic Union countries will make drug registration more lengthy and complicated than those in place before, according to a recent study from MMA’s consortium partner, Partnership Network.
Another recommendation – adding a provision enabling Kazakhstan’s government to use compulsory licenses (CL) and pre-grant oppositions to its national regulatory intellectual property (IP) framework – would improve access to medicines. Pre-grant oppositions give Kazakhstan an opportunity to oppose patents immediately after applications are submitted, rather than having to pursue lengthy and costly legal procedures for opposing granted patents in court.
“A provision about government use of inventions is absolutely crucial, so that more pressure to lower prices for essential medicines – such as dolutegravir – can be applied to pharmaceutical companies,” says Sergey Golovin, IP and Access Lead at ITPC-Ru.
The procedure for patent oppositions could be optimized by clearly identifying parties involved with the opposition process, namely whether it is the patent holder or the Chamber for intellectual Property.
The report also highlighted the importance of giving preference to domestic manufacturers, to foster local production and diminish its costs – with the ultimate goals of making drugs more accessible and affordable, reducing public spending on these medicines.
Another important recommendation is the call for more transparency and information on drug prices, since only 13% of the total government expenses on ARVs was open to public monitoring.
“This work shows the importance of community monitoring in the field of drug procurement and IP issues; it builds a solid platform for successful advocacy to improve access to life-saving treatment. I am sure we will soon have more exciting stories from Kazakhstan; compulsory licensing, reducing prices for dolutegravir, HCV elimination and much more. The community there have really come a long way in their efforts to make the system work better for people living with HIV, HCV, TB and other diseases.”, says Sergey Golovin.