Recent deal offering controlled generics access in limited countries does not go far enough
Delhi/Cape Town/ Geneva, 18 July 2023—As Johnson & Johnson’s (J&J) 20-year primary patent on the critical, lifesaving drug-resistant tuberculosis (DR-TB) drug bedaquiline expires in majority of countries including India today, Médecins Sans Frontières/Doctors Without Borders (MSF) reiterated its call for the US pharmaceutical corporation to publicly announce it will not enforce any ‘secondary’ patents for the drug in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this critical drug everywhere. MSF also called for a commitment from J&J to not take any legal action against any generic manufacturer that exports generic versions of bedaquiline to or from TB high-burden countries where secondary patents on the drug exist. The corporation should make this announcement public by the UN TB Summit taking place in New York this September.
Last week’s announcement by the Stop TB Partnership/Global Drug Facility (GDF) about a deal with J&J to increase access to affordable generic versions of bedaquiline offers only a partial solution to the access problem, because the deal excludes many countries that have a high burden of people living with TB, primarily in Eastern Europe and Central Asia (EECA).
“Being able to offer bedaquiline to people with drug-resistant TB has been a revolution in the treatment of this deadly disease, contributing to a significant reduction in treatment duration, pill burden and side effects, with improved adherence and treatment response,” said Dr Zulfiya Dusmatova who treats people with TB for MSF in Tajikistan. “It would be infuriating if countries in Eastern Europe and Central Asia, which have some of the highest burdens of drug-resistant TB, are unjustly left out of this deal, effectively denying access to generics for people who may urgently need treatment. Instead of offering a partial solution, we call on J&J to immediately announce it will abandon, withdraw and not enforce any secondary patents on bedaquiline in all countries with high burden of TB, so that more lives can be saved right now.”
J&J holds secondary patents in at least 34 of the 49 countries with a high burden of TB, TB-HIV and/or DR-TB, for which bedaquiline is an essential part of treatment regimens. Several of these countries are in the EECA region. While J&J had attempted to extend its patent by 4 years in India by filing for a secondary patent, this request was rejected by the Indian Patent Office in March 2023. With the primary patent expiring in India today, multiple manufacturers will now be able to produce and sell generic versions of the drug freely in India and export them to any other country where patents do not stand in the way. Enforcing the secondary patent in countries excluded from the deal would delay access to more affordable generic bedaquiline by at least 4 years, resulting in higher treatment costs that would not only limit access for people who urgently need it, but would also mean less funding to cover other crucial TB care costs.
Bedaquiline tablets are now the backbone of TB treatment regimens, recommended by the World Health Organization (WHO) for a far-improved, shorter, better-tolerated and more-effective treatment for people affected by DR-TB. The current recommended treatment, containing bedaquiline, is all oral, 6 months long and can achieve cure rates as high as 89%. This is a vast improvement over the older treatments that had to be administered for 18 months and included daily painful injections.
J&J currently prices the drug at US$1.50/day for an adult treatment ($272/six months). But with scale-up and unrestricted generic competition, the price of bedaquiline would be expected to drop, bringing it closer to its estimated target price of $0.50 per day.
“I wouldn’t wish the old drug-resistant TB treatment I had to suffer through on my worst enemy,” said Phumeza Tisile, a TB treatment activist from Khayelitsha, South Africa, who along with fellow TB survivor Nandita Venkatesan from India won the legal challenge in India in March against J&J’s attempt to extend its monopoly on bedaquiline in the country. Tisile also became permanently deaf from the older treatments. “We took on pharma corporation Johnson & Johnson because we want everyone who needs bedaquiline to have immediate access to the treatment. There’s no excuse when much better treatment exists, so it must be affordable and available to everyone. J&J, do the right thing now and commit to not enforcing extended patents on bedaquiline.”
MSF also urged any country where J&J has patents on bedaquiline, and is excluded from the GDF deal, to exercise its rights under World Trade Organization (WTO) rules, outlined in the ‘TRIPS’ Agreement and Doha declaration, to overcome these barriers that stand in the way of being able to provide people with the more affordable treatment they need to stay alive and healthy. They can do so, for example, by issuing ‘compulsory licenses,’ which allow producers other than the patent holder to make and sell the drug, or for more affordable generic versions of the drug to be imported even if a patent is in place.
“If J&J won’t do what’s right, we are urging governments of all countries with a high burden of TB to take matters into their own hands so that more lives can be saved,” said Christophe Perrin, TB advocacy pharmacist with MSF’s Access Campaign. “Waiting years after primary patent expiry to finally be able to access affordable bedaquiline should not be seen by any country as an option.”
Editor’s note: Previously recommended regimens did not achieve cure in a vast proportion of people having DR-TB who had to be treated for as long as 2 years, with regimens that included daily injections and older drugs, causing intolerable side effects, ranging from psychosis to irreversible deafness and persistent nausea. Moreover, adherence to longer regimens posed a significant challenge.