MSF refuses to sign ViiV’s last-minute NDA for access to most-effective HIV prevention drug CAB-LA

MSF refuses to sign ViiV’s last-minute NDA for access to most-effective HIV prevention drug CAB-LA

Signing confidentiality clauses on supply & pricing blocks transparency and accountability

Geneva, 17 August 2023 – Today, Médecins Sans Frontières/Doctors Without Borders (MSF) asked ViiV Healthcare to withdraw conditions in negotiations for a purchase agreement that are holding up procurement of the preventative HIV drug cabotegravir long-acting (CAB-LA) for key and vulnerable populations*, due to the pharmaceutical corporation’s last-minute insertion of terms that are not acceptable in MSF purchase agreements. This includes conditions that undermine supply security for patients because ViiV retains the power to terminate the contract or refuse the purchase order without just reasons, and a confidentiality clause, akin to a Non-Disclosure Agreement (NDA), on the drug’s price and supply terms.

CAB-LA is the most effective form of HIV prevention (pre-exposure prophylaxis [PrEP]) available today, and involves an injection of the drug every two months, which is more long-lasting and discreet than daily oral PrEP pills, so may facilitate better adherence and help turn the tide against new HIV infections globally.

In May 2022, an access price for the drug set by ViiV was published by a civil society organisation, and the new access price is not expected to be significantly different. Regardless, ViiV continues to undermine the established good practices of transparency on HIV drug prices and supply terms in its ongoing negotiations with procurers, by attempting to reinstate confidentiality clauses around the price and supply terms of CAB-LA. Such clauses in procurement agreements for COVID vaccines and therapeutics were heavily criticised 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. The constitutionality of these NDAs within COVID vaccines purchase agreements is being contested through a legal challenge in South Africa.

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

MSF requested ViiV to immediately withdraw the confidentiality clause on pricing and amend the terms that undermine timely availability and supply security of CAB-LA. MSF is eagerly waiting to start offering CAB-LA to key and vulnerable populations in our care in Mozambique and beyond, as soon as ViiV returns with an agreement that guarantees transparency, ensures supply security and facilitates timely access to this critical drug.

Dr Helen Bygrave, Chronic Disease Advisor, MSF Access Campaign:

“MSF has been trying to access CAB-LA since January 2022 and are stuck in an infuriating situation: there’s a lifesaving HIV prevention drug at our fingertips, but ViiV, the only 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.

“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 – it 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. These agreements essentially blindfold governments and procurers during future price negotiations.

“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 as quickly as possible. 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.”

*Includes sex workers, men who have sex with men, people who inject drugs, people in prisons and transgender people, and their sexual partners, as well as people in general populations, such as women and girls.