J&J allows nonprofit to distribute generic TB drug in low, middle-income countries

The agreement, signed with Global Drug Facility, an arm of Stop TB Partnership, allows the non-profit organisation to tender, procure, and supply generic versions of bedaquiline to 44 low- and middle-income countries.

The global patent of the drug ends today, but in a number of countries Johnson & Johnson continues to control the market with secondary patents.

In a statement, Stop TB Partnership announced the agreement and called for tenders. The statement read:

“Following lengthy negotiations, Johnson & Johnson has granted Stop TB Partnership’s Global Drug Facility’s licenses that enable Global Drug Facility (GDF) to tender, procure, and supply generic versions of SIRTURO (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect.”

The “important agreement” will support the goal of ending TB, the Stop TB Partnership said adding that the tender for bedaquiline will be launched by end-July.

The MSF Access Campaign, which advocates for affordable and available medical treatments, said that while it welcomed the move, it was only a “stopgap” solution, and that the full terms of the agreement needed to be made public, reported The Guardian.

“We remain concerned that J&J retains the global authority to determine access to lifesaving generic versions of bedaquiline in countries with a high burden of TB, even after the expiration of the main patent,” The Guardian reported quoting Christophe Perrin, TB advocacy pharmacist for MSF Access Campaign.

MSF Access said J&J’s bedaquiline is the most expensive component of the multi-drug regimen for people with drug-resistant TB, but this could be reduced from $1.50 (£1.15) a day to $0.50.

J&J should not enforce its existing secondary patents and withdraw any pending applications for more. If it does not, governments should override the patents and seek to buy the drug from generic manufacturers, Perrin said.

“Only by taking these actions will J&J truly demonstrate a commitment to improving global access to bedaquiline and prioritising the health needs of people most affected by this deadly disease over profits accrued through secondary patents,” The Guardian quoted Perrin.

The US based nonprofit organisation Treatment Action Group (TAG) said the deal “falls short” of demands made by TB patients and that it was using “patent evergreening … to extend monopoly rights over publicly funded innovations”.

“J&J is dodging accountability for how their patenting practices have harmed people with TB and taken advantage of the governments whose investments made this drug possible and those which have purchased bedaquiline at unjustifiably high prices,” the TAG said in a statement.

A J&J spokesperson said it uses money made through patents to pay for other drugs to be developed, which generic manufacturers do not usually do.

“More and faster innovation is needed, and IP [intellectual property] protections make it possible for companies to make the sustained financial commitments to discover and develop new and improved medicines needed to end diseases like TB that primarily affect people in low- and middle-income countries and protect the effectiveness of existing ones” the spokesperson added.

Updated: 18 Jul 2023, 06:22 PM IST

The agreement, signed with Global Drug Facility, an arm of Stop TB Partnership, allows the non-profit organisation to tender, procure, and supply generic versions of bedaquiline to 44 low- and middle-income countries.

The global patent of the drug ends today, but in a number of countries Johnson & Johnson continues to control the market with secondary patents.

In a statement, Stop TB Partnership announced the agreement and called for tenders. The statement read:

“Following lengthy negotiations, Johnson & Johnson has granted Stop TB Partnership’s Global Drug Facility’s licenses that enable Global Drug Facility (GDF) to tender, procure, and supply generic versions of SIRTURO (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect.”

The “important agreement” will support the goal of ending TB, the Stop TB Partnership said adding that the tender for bedaquiline will be launched by end-July.

The MSF Access Campaign, which advocates for affordable and available medical treatments, said that while it welcomed the move, it was only a “stopgap” solution, and that the full terms of the agreement needed to be made public, reported The Guardian.

“We remain concerned that J&J retains the global authority to determine access to lifesaving generic versions of bedaquiline in countries with a high burden of TB, even after the expiration of the main patent,” The Guardian reported quoting Christophe Perrin, TB advocacy pharmacist for MSF Access Campaign.

MSF Access said J&J’s bedaquiline is the most expensive component of the multi-drug regimen for people with drug-resistant TB, but this could be reduced from $1.50 (£1.15) a day to $0.50.

J&J should not enforce its existing secondary patents and withdraw any pending applications for more. If it does not, governments should override the patents and seek to buy the drug from generic manufacturers, Perrin said.

“Only by taking these actions will J&J truly demonstrate a commitment to improving global access to bedaquiline and prioritising the health needs of people most affected by this deadly disease over profits accrued through secondary patents,” The Guardian quoted Perrin.

The US based nonprofit organisation Treatment Action Group (TAG) said the deal “falls short” of demands made by TB patients and that it was using “patent evergreening … to extend monopoly rights over publicly funded innovations”.

“J&J is dodging accountability for how their patenting practices have harmed people with TB and taken advantage of the governments whose investments made this drug possible and those which have purchased bedaquiline at unjustifiably high prices,” the TAG said in a statement.

A J&J spokesperson said it uses money made through patents to pay for other drugs to be developed, which generic manufacturers do not usually do.

“More and faster innovation is needed, and IP [intellectual property] protections make it possible for companies to make the sustained financial commitments to discover and develop new and improved medicines needed to end diseases like TB that primarily affect people in low- and middle-income countries and protect the effectiveness of existing ones” the spokesperson added.

Updated: 18 Jul 2023, 06:22 PM IST