he United Nations “high-level meeting” on tuberculosis will take place in less than a month and the political declaration that emerges from it will, for better or worse, shape the global response to the world’s deadliest infectious disease for years, perhaps decades, to come. There is a very real risk that the declaration could undermine, rather than improve, access to medicines for the more than 10 million people who fall ill with tuberculosis every year. To prevent this from happening, we must distinguish disagreements that are honest from those that are dishonest.
The content of the political declaration was supposed to have been agreed upon a few months ago, but that didn’t happen. Here’s why: The United States government and pharmaceutical companies are driving efforts to strip language from the declaration that reminds countries they can use international legal mechanisms to lower the prices of tuberculosis drugs to make them accessible to all people who need them. But countries from the global South with high burdens of tuberculosis, civil society, and people affected by tuberculosis are fighting back.
At issue are certain “flexibilities” that come from the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as clarified in the Doha Declaration on the TRIPS agreement and public health. As a part of international law, among other things, TRIPS flexibilities allow countries to set their own standards for what can be patented — taking public health into account — and to use compulsory licenses to permit generic manufacturers or the government to produce and sell patented drugs, thus lowering their prices.
Thanks to TRIPS flexibilities, millions of people living with HIV have been able to take lifesaving drugs that would otherwise have been inaccessible because of exorbitantly high prices.
The U.N. and its institutions have consistently endorsed the full use of TRIPS flexibilities. Until now. Just as we are on the cusp of charting a coordinated global commitment to fighting the world’s oldest, most neglected, and most dangerous infectious disease, the United States and pharmaceutical companies have dug in their heels.
At a civil society hearing in New York City in June 2018 held by the U.N. in the run-up to high-level meeting on tuberculosis, Laurie Phipps, who is part of the U.S. Mission to the U.N., spoke from the floor to warn the delegates against being “distracted” by TRIPS flexibilities. Pursuing these sirens, she cautioned, would be folly in light of the desperate need for new treatments.
Dr. Adrian Thomas, vice president for global public health and access at Johnson & Johnson, occupies the private sector constituency seat on the board of the Stop TB Partnership, an international collective of nearly 1,000 organizations. He recently published a First Opinion arguing that mentioning TRIPS flexibilities in the political declaration emerging from the U.N. high-level meeting would cost lives.
His impassioned article opens with the story of Prisha (not her real name) and her battle with drug-resistant tuberculosis. Like most stories that involve drug-resistant TB, Prisha’s is full of suffering, heartbreak, and injustice. As Thomas rightly notes, the drugs currently used to treat the disease are torturous and largely ineffective, causing psychosis and permanent disabilities, and rendering many people who take them deaf, as they did for Prisha. Thomas argues, as did Phipps, that the mere mention of TRIPS flexibilities in the political declaration will place people like Prisha at risk.
This is simply not true. And everyone knows it isn’t true, including those who claim otherwise. The debate, in short, is dishonest. We shouldn’t be having it.
The main argument against TRIPS flexibilities is that their use undermines incentives to innovate and thereby stifles research and development that could lead to new treatments, diagnostics, and vaccines. This argument is especially disingenuous in the context of tuberculosis.
Let’s look at some of the numbers. Only 11 percent of funding for tuberculosis research and development comes from private sources. Of the rest, 66 percent comes from public sources, 20 percent comes from philanthropic sources, and the remaining 3 percent comes from multilateral sources. Private spending on tuberculosis research and development has been declining for years. The level of private investment in 2016 was the lowest since 2008. During that eight-year period, TRIPS flexibilities were not used on any treatment or technology related to tuberculosis.
Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, holds the patent to bedaquiline, one of only two new drugs for tuberculosis to come out in 50 years. The World Health Organization recently issued new guidelines recommending the use of bedaquiline in the first line of treatment for drug-resistant tuberculosis. There’s no question that Janssen invested in the research and development of bedaquiline. But it also benefited handsomely from funding from U.S. taxpayers via the National Institutes of Health and other partners who invested more than $40 million in helping develop the drug.
In addition, as a reward for developing bedaquiline, Janssen received a priority review voucher from the Food and Drug Administration. Other companies have sold such vouchers for as much as $350 million. Janssen used its voucher to get an expedited FDA review of a biologic, guselkumab (Tremfya) that is expected to generate the company $1.56 billion in 2020 sales.
Last month, Janssen announced a significant reduction in the price of a six-month course of bedaquiline, from $750 to $400, when purchased through the Stop TB Partnership’s Global Drug Facility, an innovative global procurement mechanism. That’s still too much. Research published in the Journal of Antimicrobial Chemotherapy estimates that bedaquiline could be produced and sold for a profit at between $48 and $102 a course.
The only other new tuberculosis drug on the market, delamanid, made by Japanese manufacturer Otsuka, is priced at $1,700 per treatment course. It’s no surprise that fewer than 7,500 treatment courses of delamanid have been ordered by TB programs around the world since the drug’s release. Compare that with the 600,000 people who develop drug-resistant tuberculosis each year.
The development and distribution of drugs to fight tuberculosis raise two questions: How much profit is enough? And at what cost?
The first question is one of the most pressing moral and political questions of our time, for which there is no easy answer. The second is easier to answer: the cost of excessive pharmaceutical industry profits is unnecessary human suffering and death at a staggering scale.
But what about innovation? Thomas writes that “we need to think creatively if we want major innovator companies to develop” new TB drugs. This is absolutely true. But continuing with a broken system that gives companies a 20-year monopoly on their new drugs during which they can price them as high as the market will bear — regardless of whether people who need them can access them — is not creative thinking. It is extremely uncreative thinking, the kind that has driven drug development for decades and played a central role in the utter failure of the global response to tuberculosis.
Insanity has been defined as doing the same thing over and over again but expecting different results. How can we expect an innovation ecosystem that has failed so terribly — producing only two new tuberculosis drugs in 50 years while millions die from the disease each year — to suddenly produce better results? It can’t, and it won’t.
Instead, we should listen to the recommendations of the U.N. secretary-general’s High-Level Panel on Access to Medicines and the U.N.’s Special Rapporteur on the Right to Health. In addition to reaffirming the legal right of World Trade Organization member states to use TRIPS flexibilities, the panel and the special rapporteur call on governments, the private sector, and institutional funders to “delink” the cost of new drugs from the often exaggerated cost of research and development. The outcome of doing that would be new kinds of incentives for individuals and companies to develop innovative drugs and health technologies, incentives other than the right to sell your patent-protected drug at the highest price possible for 20 years.
There are several examples of these new, innovative approaches to creating incentives for tuberculosis research and development. Doctors without Borders (Médecins Sans Frontières) champions one such framework, the 3P Project. The three P’s — push, pull, and pool — constitute an “open collaborative approach to conducting drug development, using novel approaches to financing and coordinating R&D.” That is creative thinking.
It’s one thing to seek profit, even by means that enrich so few by hurting so many. But it is an entirely different evil to appropriate the pain of real people like Prisha in order to do so — to disguise greed in the garments of compassion. This deserves our repugnance and condemnation.
Prisha and millions of other people with tuberculosis and drug-resistant tuberculosis do not need more patents for drugs they can’t afford. Instead, they need a better system with new incentives. They need real innovation. And right now they need a political declaration from the U.N.’s high-level meeting on tuberculosis that reaffirms countries’ legal right to use TRIPS flexibilities when they cannot otherwise afford the lifesaving treatments that Prisha and millions like her desperately need.
John Stephens is a human rights activist and lawyer and an associate at the O’Neill Institute for National and Global Health Law at the Georgetown University Law Center. Prabha Mahesh is a tuberculosis survivor, a member of Touched by TB, and an advocate and mentor for communities affected by tuberculosis in India. Brian Citro is a clinical professor of law at Northwestern Pritzker School of Law and an architect of the Nairobi Strategy of Tuberculosis and Human Rights.