Johnson & Johnson has struck a deal to allow generic versions of its TB drug to be supplied to low-income countries – but critics say it does not go far to end the company’s monopoly on global supplies of bedaquiline.
The pill was initially approved in 2012 as the first new TB drug in more than 40 years and revolutionised treatment for drug-resistant infections.
But its relatively high cost limited access in many low- and middle-income countries hit hardest by an epidemic that still kills around 1.5m people every year, most of them among the world’s poorest, according to STAT News.
The global patent of the drug ended on 18 July, however, the company continues to control the market with secondary patents in various countries – for which small modifications are made to a product to extend a patent.
The new deal, which has been in the works for months and was signed in June, will allow the Stop TB Partnership coalition to procure and supply generic bedaquiline to 44 low- and middle-income countries through its Global Drug Facility (GDF), reports The Guardian.
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.
“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,” said Christophe Perrin, TB advocacy pharmacist for MSF Access Campaign.
According to MSF Access, J&J’s bedaquiline is the most expensive component of the multi-drug regimen for people with drug-resistant TB.
Perrin said the company 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.
He said nine countries in Eastern Europe and Central Asia, which have some of the world’s highest burden of drug-resistant TB, are excluded from the deal, and will not be able to access a potentially lower price for a generic through the STOP TB global drug facility, or purchase directly from generic manufacturers, because J&J holds a secondary patent in each of those countries.
“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 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 its 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.
“While it’s a start in that it will allow countries buying through the STOP TB facility (to) gain access to generics and lower prices, it doesn’t remove the larger structural barrier the secondary patents present,” Lindsay McKenna, co-director of the TB Project at TAG, told STAT News. “Countries that don’t buy from (STOP TB), like South Africa, won’t be able to access generics.”
The GDF’s chief, Brenda Waning, said that the deal would allow them to supply low- and middle-income countries with generic bedaquiline even where secondary patents – active until 2027 – are in place. “From our perspective, the end point is the same. We can supply to all the countries (under the deal) regardless of patents,” she said.
A J&J spokesperson said it used money made through patents to pay for other drugs to be developed, which generic manufacturers do not usually do.
“IP (intellectual property) protections make it possible for companies to make the sustained financial commitments to discover and develop new medicines needed to end diseases like TB that primarily affect people in low- and middle-income countries and protect the effectiveness of existing ones.”
See more from MedicalBrief archives:
TB drug costs to drop after J&J loses patent extension bid
WHO may promote bedaquiline after SA brokers deal with J&J
Bedaquiline-delamanid combo for resistant TB — SA and Peru trial