Belarus: Civil society pushes for compulsory license as dolutegravir remains overpriced

  • Positive Movement (PMPlus) in Belarus, one of our partner organizations, is an NGO representing people living with HIV, advocating for access to high-quality HIV treatment at an affordable price.
  • ViiV Healthcare continues to block access to generic versions of the HIV drug, dolutegravir, while simultaneously charging 22 times the price compared to other countries in Eastern Europe and Central Asia (EECA) when there are no barriers to generics.
  • PMPlus believes, after years of negotiating and prices remaining prohibitive, that it is time for the government to issue a compulsory license.

The main barrier to affordable, optimal antiretroviral treatment for the estimated 18,000 people living with HIV in Belarus, is the high price of several branded drugs protected by patents, including dolutegravir (DTG).

PMPlus has monitored spending on HIV drugs in the country and found that between 46% to 75% of the total budget for ARVs is being spent on just three brand drugs – DTG, lopinavir/ritonavir and ritonavir.

The current price charged for branded DTG in Belarus is $1,319 (USD) per person per year.

  • This is 34 times higher than the cost of generic efavirenz (a drug commonly used in first-line regimens in Belarus);
  • and 22 times higher than the cost of DTG in other EECA countries as Armenia, Georgia, Kyrgyzstan and Ukraine, where there are no patent barriers to purchasing generics.

The high price of branded drugs impedes their widespread use: If Belarus was reflecting the World Health Organization’s (WHO) 2019 recommendation to include DTG in preferred first-line regimens, that would equate to more than 13,000 people receiving a DTG-based treatment. As it stands, at the start of 2020 only 267 people were receiving DTG in Belarus.

Years of negotiations between ViiV Healthcare and the patient community and health authorities of Belarus have not yet resulted in a decreased price for DTG, which needs to be at a level comparable to the price of generics, which would still yield profits for the company.

Insufficient use

The national legislation of Belarus includes a mechanism for issuing a compulsory license in the case of insufficient use of the invention by the patent holder, three years from the date the patent was issued. Dolutegravir has been registered in Belarus since 2015 and is still not not widely used. It is used only in third-line treatment regimens, which is a much narrower use than what is recommended by WHO (2019) and Belarus’ own national treatment protocol (2017).

If there was sufficient use of dolutegravir in Belarus, there were be 13,000+ people receiving it. As it stands, there’s only 267.

In 2018, twenty countries from EECA signed the Minsk Statement of the Ministries of Health of Eastern Europe and Central Asia Countries on Expanding Access to Affordable and Quality Assured Medicines and Diagnostic Technologies.

Ready to use
all available tools
to lower medicine prices

The statement emphasizes that countries must ensure timely access to affordable, optimal treatments, and are ready to use all available tools to lower medicine prices, including overcoming barriers related to intellectual property.

Our partner, with support from ITPC-Ru, will continue to consult with national health authorities and national pharmaceutical companies on the use of a compulsory licensing mechanism to access DTG.

Additionally, the organization has released two reports (in Russian), both of which are also available via the website:

  • The latest edition of its annual report: Access to HIV and Hepatitis C Treatment in Belarus.
  • Plus: A Review of International Mechanisms for Access to Antiretroviral Medicines and Direct Antiviral Drugs for Hepatitis C.