Johnson & Johnson’s Patenting & Pricing Strategy for TB Medicine Bedaquiline: A Cautionary Tale for New TB Medicines [GUEST ESSAY]
Newsletter Edition #200 [The Curated Primer]
Hi,
When companies take strategic decisions such as to not enforce patents, there are many factors that contribute to such an outcome - economic, political, legal and temporal. Our guest essay today tries to unpack some of these considerations.
Last month, Johnson and Johnson (J&J) announced that it will not enforce patents for its brand name drug Sirturo (Bedaquiline) used for treating Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries. (Also see: TWN on Under pressure J&J announces non-enforcement of Bedaquiline patents in low and middle income countries)
In today’s edition, we bring you an op-ed from activists from Médecins sans Frontières (MSF) who have been at the forefront of a sustained advocacy campaign pushing for access to this critical drug. The authors chart out the many twists and turns in this saga, bringing our readers up to speed on this rather riveting case in the access to medicines.
These developments add fuel to critical discussions in Geneva on the access to countermeasures not just in the context of pandemics, but also more broadly for health emergencies. (Also read Peter Sands on TB as a key pandemic that the world has been facing for decades.)
And of course, consequences from, and implications of, Colombia’s recent decision to pursue the Compulsory Licensing approach for a HIV drug, will also prove to be a live case study for negotiators here.
We are tracking the evolving big picture for you, and bringing together the nuts and bolts of global health policy-making. Support our work!
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Until later.
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. GUEST ESSAY
Johnson & Johnson’s Patenting & Pricing Strategy for TB Medicine Bedaquiline: A Cautionary Tale for New TB Medicines [GUEST ESSAY]
Christophe Perrin, TB Advocacy Pharmacist; Shailly Gupta, Communications Advisor; Roshan Joseph, Trade and Intellectual Property Analyst, Médecins Sans Frontières Access Campaign
In August 2023, Johnson & Johnson (J&J) reduced the price of the lifesaving tuberculosis (TB) medicine, Bedaquiline, from US$272 to $130 per treatment course of six months for many low- and middle-income countries (LMICs). This price reduction was the result of a competitive tender by the Stop TB Partnership’s Global Drug Facility (GDF), an international pooled procurement mechanism for procurement of TB health products, and represents a watershed moment in the decade-long struggle for expanding access to Bedaquiline.
The high prices J&J charged in the decade prior to the August 2023 price reduction were entirely unjustified, especially as the development of Bedaquiline was funded predominantly through public money: the US government’s investments exceeded J&J’s by up to five times. Had J&J offered a significantly lower price closer to $130 when Bedaquiline was launched, hundreds of thousands more people with drug-resistant TB (DR-TB) would have had an opportunity to access this revolutionary medicine. However, the story of Bedaquiline played out very differently and it is worth revisiting it from the start for the lessons it holds for access to lifesaving medicines.
Market entry and exorbitant prices
Launched in 2012, Bedaquiline is now the backbone of all short and long regimens recommended by the World Health Organization (WHO) to treat DR-TB. It was the first TB drug from a new class of TB medicines that received regulatory approval after a gap of nearly half a century. This groundbreaking medicine has offered hope for people with DR-TB, facilitating DR-TB treatment regimens that are all-oral, shorter, less toxic and much more effective. Previous regimens were longer, consisted of painful injections and caused intolerable and damaging side effects such as psychosis and loss of hearing. Despite the clear benefits of Bedaquiline over previous regimens, people with DR-TB struggled for many years to access Bedaquiline due to J&J’s patenting and pricing strategy.
In 2014, J&J set the exorbitant prices of $3,000 per treatment course of 6 months in middle-income countries, and $900 in low-income countries, making it difficult for governments to scale up the use of this medicine.
In response to protests against high prices and the slow uptake of the medicine in countries with a high burden of TB, J&J established a donation programme through the GDF between 2015 and 2018 but did not drop the price of the medicine.
In 2017, researchers estimated the cost-based generic price of Bedaquiline to be in the range of $48-102 for a treatment course of six months. J&J announced a drop in price to $272 per treatment course of six months in 2019 for LMICs amid strong pressure from the TB community, civil society organisations and treatment providers, including Médecins Sans Frontières (MSF).
Primary and secondary patents
The high prices J&J has charged over the years are the result of the 20-year patent monopoly enjoyed by the corporation in line with international trade rules. While the corporation's primary patent on Bedaquiline expired in July 2023, it has extended its monopoly until at least 2027 in many countries, including at least 35 out of 43 countries with a high burden of TB, DR-TB, and TB/HIV, through an aggressive patenting strategy consisting of patent term extensions and secondary patents.
In a landmark decision in March 2023, the Indian Patent Office rejected J&J’s attempt to secure a secondary patent in the country that would have extended its monopoly for four more years, until 2027. The ruling reasoned that the secondary patent application did not encompass any justified follow-on innovation, and therefore, it should not be granted to J&J. The case and subsequent rejection resulted from two ‘pre-grant oppositions’ filed by the Network of Maharashtra People Living with HIV (NMP+), and two TB survivors—Nandita Venkatesan from India and Phumeza Tisile from South Africa—who were both forced to endure the older, more toxic DR-TB treatments that lasted up to two years and caused excruciating side effects: they both lost their hearing.
As a result of the ruling, Indian generic manufacturers could start producing and supplying affordable, quality-assured generic versions of Bedaquiline in India from July 2023. However, they could not export the medicine to countries where secondary patents were granted until recently.
Johnson & Johnson’s deal with the Global Drug Facility
The price drop to $130 announced by the GDF this past August followed a deal signed in July 2023 wherein J&J allowed the GDF to supply generic Bedaquiline to a list of countries, including some where the corporation still holds a monopoly through patents. This deal – the full terms and conditions of which were never disclosed by J&J or the GDF despite repeated calls –, was a stop-gap solution as it left out several high DR-TB burden countries, including Russia and China, two of three countries with the highest burden of DR-TB. As per the terms of the deal, these countries were unable to access the lowest-priced generic in the longer term until the corporation’s additional patents expired.
The system to review patent applications that can extend a corporation’s monopoly beyond the internationally accepted term of 20 years does not exist in a majority of countries with a high burden of TB. However, many countries have now started to realise the impact of secondary patents on the accessibility and scalability of this medicine that is urgently needed for all people with DR-TB.
Ukraine and Belarus, which were also excluded from the J&J/GDF deal, wrote to the corporation appealing to them to drop these secondary patents in their countries to allow generic competition.
Although South Africa was part of the J&J/GDF deal, the South African government could not purchase directly from the GDF due to its national procurement rules set out in the Public Finance Management Act that do not allow the government to use pooled procurement mechanisms. In addition, the government signed an agreement with J&J earlier this year for a price that is more than double the price now being offered through the GDF. Although the agreement allows room for negotiation, J&J hasn’t yet proactively offered the $130 price to South Africa. In a welcome move in September 2023, the South African Competition Commission initiated an investigation into J&J’s patenting and pricing strategy for Bedaquiline in the country.
Last week, UNITAID, the international organisation dedicated to finding innovative solutions for tackling infectious diseases including tuberculosis, also called on J&J to drop its secondary patents on this drug and clearly highlighted that the corporation’s deal with GDF still unfairly restricts access in the countries where the need is greatest.
J&J attempted to use its deal with the GDF as a smokescreen to conceal its prolonged patent monopoly on this critical drug through extended and secondary patents. In a classic move of deflecting responsibility, J&J issued a statement pointing to underdiagnosis as a barrier to treatment and argued that generic versions of Bedaquiline will not solve the problem of DR-TB. However, the corporation failed to acknowledge the fact that unrestricted access to Bedaquiline could make a difference in the lives of the 500,000 people who are newly affected by DR-TB every year.
Amid massive public pressure, J&J finally announced last week its intent to not enforce patents for Bedaquiline for the treatment of multi-drug resistant TB (MDR-TB) in 134 LMICs . This will pave the way for generic competition and ensure access for everyone who needs it. J&J must now withdraw all existing patents and pending patent applications related to Bedaquiline to ensure legal assurance for manufacturers exporting generic versions of this drug from or to countries where patents still exist.
Way forward
In the early 2000s, patent monopolies kept the price of HIV medicines at $10,000 per person per year. Then competition among multiple producers paved the way for affordable treatment for all people living with HIV in all LMICs. Thanks to generic competition, the price of the triple cocktail of HIV medicines is now less than $70 per person per year.
Once the absence of J&J’s patent monopoly on Bedaquiline is confirmed in all 134 LMICs, quality-assured generics are expected to be available at a price lower than the $130 currently offered by J&J, meaning this lifesaving drug will be more accessible to everyone, everywhere, who needs it.
The journey of access to Bedaquiline highlights the lessons we must learn to ensure that newer medicines for TB, expected in the coming years, are available and affordable. Governments need to step up and start holding pharmaceutical corporations accountable by attaching conditions of affordability and accessibility to all public investments that go towards the development of medicines. And, if unmerited patents act as barriers to access, governments should consider using public health safeguards such as compulsory licensing to ensure affordable access to medicines. At the end of the day, lifesaving medicines shouldn’t be a luxury.
Get in touch with the authors, reach out to Shailly.GUPTA@geneva.msf.org
II. PODCAST CORNER
The health journey of refugees and migrants is global health
For this episode Global Health Matters brings you a topic that rarely reaches the top of the global health agenda, that is the subject of the health of refugees and migrants. This podcast episode lays out the key issues for the listener and through our guests it builds an awareness to ensure this topic gets better attention in the future.
Host Garry Aslanyan speaks with the following guests:
Eugen Ghita, Human Rights Monitor and President from Roma Lawyers Association, Romania RomaJust, who was a migrant and he is now working as a human rights monitor on behalf of the Roma community in Europe. Eugen identified that there is a lack of information dedicated to the refugees and many language barriers.
Reem Mussa, Humanitarian Advisor and Coordinator of the Forced Migration Team at Médecins Sans Frontières (MSF), is able to give us context in relation to the policies of the different types of refugees and migrants, including the repercussions for the health of the newcomers may encounter on their journey such as mental health needs or respiratory conditions for those subjected to detention. These preventable health conditions and lack of primary health care provision may possibly have a long-term impact on the individual's health which may lead to an additional burden on their host country in the future.
Garry Aslanyan is the host and executive producer of the Global Health Matters podcast. You can contact him at: aslanyang@who.int
[This is a sponsored advertisement: Get in touch with us if you want to promote books, webinars, job postings. Write to patnaik.reporting@gmail.com.]
III. WHAT WE ARE READING
AN UNHEALTHY CLIMATE: Science Special Issue
The Secret Plot Against the Head of the World Health Organization: Bloomberg
How a Big Pharma Company Stalled a Potentially Lifesaving Vaccine in Pursuit of Bigger Profits: ProPublica
Colombia set to issue a compulsory license for an HIV medicine sold by GSK’s ViiV: STAT
Global Health Equity and the Role of Trade: Remarks by DG Okonjo-Iweala [WTO]
German Ministers Call For Investment in Pandemic Prevention, Suggest Cutting Fossil Fuel Subsidies to Pay for Healthcare: Health Policy Watch
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