Russian patient organizations ask Gilead to disclaim patents for Truvada

  • On 3 September 2020, 25 patient organizations working within the HIV response in Russia published an open letter to Gilead Sciences. 
  • They directly ask the pharmaceutical company to disclaim patent rights for the combination of tenofovir and emtricitabine (TDF/FTC), marketed as Truvada.
  • The price barrier is such that in 2019, only 10 people could access TDF/FTC within the government HIV treatment programme.

Prior to the action this week, Humanitarian Action, a St. Petersburg-based NGO, with the technical support of ITPCru, filed an opposition against a patent for this drug. The next hearing in the Chamber for Patent Disputes is scheduled for 9 September 2020.

The combination of TDF/FTC is part of a key regimen recommended by the World Health Organization (WHO) and the Russian Association of Specialists in HIV Prevention, Diagnostics and Treatment. Currently, it is the only regimen approved in Russia for pre-exposure prophylaxis (PrEP).

The drug is not included in Russia’s Essential Medicines List (EML), and during a meeting with patient organizations, Gilead stated explicitly that it was not planning to re-submit the dossier for inclusion of TDF/FTC into the EML. 

This is important, as due to the absence of TDF/FTC in the EML, the price of TDF/FTC in Russia is not regulated. The current price, which is in the range of $200 (USD) per month, places the drug out of reach for most patients, either as HIV pre-exposure prophylaxis (PrEP) or as treatment. In 2019, only 10 people could access it within the government HIV treatment programme in Russia.

PrEP is not yet provided by the government, so people must purchase the drug themselves. According to a study carried out by one of the Russian patient organizations (Phoenix-PLUS), only 6% of the respondents are willing and able to buy the original version of TDF/FTC at the current price.

There are currently several generic versions of TDF/FTC registered in Russia, which could be marketed at considerably lower prices if there were no patent protection (registration in itself is not a patent violation). 

The price of PrEP: From $3 to $300+

The global prices for generic TDF/FTC can be as low as $3 per month; and in some EU countries the price of generic TDF/FTC is below €50. In the Netherlands, for example, the price of TDF/FTC has dropped from €344.28 (Gilead’s Truvada) for a 30 day supply, to €47.95 for the generic version.

Activists believe that the availability of generic versions of tenofovir and emtricitabine in Russia will result in a significant decrease in the price of PrEP and expand its availability, as well as improve access to recommended fixed-dose combinations of antiretroviral drugs. This, in turn, will increase the effectiveness of therapy and the HIV response.

Read the letter in full.