MSF refuses to sign ViiV NDA for access to lifesaving HIV drug

NEW YORK/GENEVA, AUGUST 17, 2023—Doctors Without Borders/Médecins Sans Frontières (MSF) is asking today for the removal of last-minute terms that ViiV Healthcare has added to an agreement to procure the injectable HIV prevention drug long-acting cabotegravir (CAB-LA) for use in MSF projects. These unacceptable conditions include a confidentiality clause akin to a Non-Disclosure Agreement (NDA) on the drug’s price and supply terms, and give ViiV the right to terminate the contract or refuse a purchase without just reasons.

“MSF has been trying to access CAB-LA since January 2022 and has been stuck in an infuriating situation,” said Dr. Helen Bygrave, chronic disease advisor for MSF’s Access Campaign. “There’s a lifesaving HIV prevention drug at our fingertips, but ViiV—the only pharmaceutical corporation producing CAB-LA for at least the next three to four years—is deliberately putting up red tape to delay access for people in our care.”

CAB-LA is currently the most effective form of pre-exposure prophylaxis (PrEP) for people at high risk of contracting HIV and is recommended for HIV prevention by the World Health Organization. This medicine, which is administered by injection every two months, is more discreet than the once-daily oral PrEP pill and could be key to turning the tide against new HIV infections, as the latter can be a burden that undermines adherence. Discretion can be especially important for key and vulnerable populations at risk of HIV, like girls and women, sex workers, and men who have sex with men.

“We are ready to start offering CAB-LA to people for the prevention of HIV in Mozambique and other countries, but signing a purchase agreement that lacks supply assurance and does not allow us to disclose the prices we pay is untenable,” Dr. Bygrave said. “Signing this agreement would perpetuate a system that continues to undermine transparency, limit civil society activism for lower drug prices, and restrict supply to low- and middle-income countries. NDA agreements like this essentially blindfold governments and procurers during future price negotiations.”

In May 2022, an access price for the drug set by ViiV was published by a civil society organization, and the new access price is not expected to be significantly different. Regardless, ViiV continues to undermine established good practices for transparency of HIV drug prices and supply terms in its ongoing negotiations with procurers. It is doing so by attempting to reinstate confidentiality clauses concerning the price and supply terms of CAB-LA. Such clauses in procurement agreements for COVID-19 vaccines and therapeutics were heavily criticized during the pandemic for diminishing the right to information, transparency, and accountability in purchases funded by the public, and for hampering governments and procurers' ability to negotiate lower prices with manufacturers.

“ViiV must stop stalling, immediately withdraw the confidentiality clause, and amend the restrictive supply-related terms so that we can make sure people in our care are offered the most effective HIV prevention treatment as quickly as possible,” Dr. Bygrave said. “While we anxiously wait to access this drug, vulnerable people continue to be at risk of HIV infection. MSF remains open to finding an immediate solution and awaits the response from ViiV.”

Since MSF first began responding to HIV more than 20 years ago, the organization has consistently refrained from signing any confidentiality agreement or NDA that would block the disclosure of the prices it pays for HIV antiretroviral medicines (ARVs) to donors or to the public. In fact, MSF has remained committed to monitoring the patent barriers, prices, and availability of ARVs through its Untangling the Web report series, as well as transparently reporting ARV prices and pushing for the uptake of policies that promote access to affordable, quality-assured treatments.