Open letter to Johnson & Johnson requesting clarification on the recent deal on generic bedaquiline supply

Advocates call for clarity on the terms of the Johnson & Johnson's deal with the Stop TB Partnership’s Global Drug Facility to supply generic bedaquiline.

On 1 August 2023, Médecins Sans Frontières, Partners In Health and Treatment Action Group sent an open letter to Johnson & Johnson (J&J) requesting detailed responses to questions and concerns regarding the deal with the Stop TB Partnership’s Global Drug Facility (GDF) to supply generic bedaquiline to low- and middle-income countries that excludes South Africa, 10 Eastern European and Central Asian countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, and Ukraine), and China.

The J&J/GDF deal was announced on 13 July 2023. GDF issued frequently asked questions (FAQs), which provides some helpful information on the deal but leaves a number of questions unanswered.

The open letter to J&J seeks clarity on a number of issues and unanswered questions, such as:

• whether the deal is a license or distribution agreement;
• an exhaustive list of countries covered by the deal;
• the rationale / criteria used to determine country exclusions from the deal;
• the ability of countries included in the deal to procure generic bedaquiline through UN agencies (other than the GDF); and
• whether excluded countries that nullify the secondary patents or issue compulsory licenses can procure generic bedaquiline through the GDF.

These questions and more listed in the open letter to J&J were inspired by feedback received from contact persons in countries potentially impacted by the J&J/GDF deal.

In addition to seeking clarity on these unanswered questions, signatories of the letter continue to call on J&J to publicly commit to non-enforcement of secondary patents on bedaquiline and to withdraw any pending secondary patent applications so that all low- and middle-income countries can access affordable generic bedaquiline.