Fran Quigley

The long list of complaints about the current system of medicine access and pharmacological research is well-known and well-documented, including in the Health and Human Rights Journal.

Those complaints start with patients facing significant—often deadly—pricing barriers, in low-income and high-income countries alike. The pharmaceutical companies that set those prices have been fiercely criticized for benefitting from publicly-funded research and then leveraging resulting patent monopolies to achieve profit margins that are the envy of other industries.

At the same time, medicines research and development is not nearly as robust as most would hope. That is especially true for new medicines that may be enormously impactful in the lives of the global poor, but do not promise significant profitability for private companies. Multiple studies have shown that the pursuit of patent revenue can negatively impact the research process, leading to hidden data, wasted efforts in pursuit of “me too” versions of existing lucrative drugs, and patent thickets that block follow-on research.

In September 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines issued its much-anticipated final report on this dismal state of affairs. The Panel’s membership was as impressive as its formidable title suggests, including representatives from the private pharmaceutical industry, former heads of state, researchers, and public health activists.

As I wrote previously in the Health and Human Rights Journal, the High-Level Panel’s existence demonstrates that concern about the current system has spread far beyond the realm of researchers and care providers to become the subject of political debates, proposed global treaties, and voter referenda. The uber-capitalist US President-elect Donald Trump tapped into this populist frustration, pledging to rein in what he and others criticize as a runaway pharma industry and medicine prices.

But even if there is consensus that the current model is deeply flawed, what is the alternative? The Panel’s report lists several options, including broader government use of compulsory licenses to manufacture generic versions of over-priced patented medicines. For medicines whose discovery was funded by government grants, there already exists strong legal and popular support for government-issued licenses for generic production. The Panel also outlined proposals for more effective use of government dollars to improve access while at the same time incentivizing the most impactful medicines research.

The Panel necessarily had to summarize these options, sometimes bundled under the heading of “delinkage” of medicine price from research costs. But the deep concerns of patients, advocates, and researchers suggest that some may want to go beyond the broad Panel overview and envision what a better system may look like. If so, they would do well to read Good Pharma: The Public-Health Model of the Mario Negri Institute (Palgrave Macmillan 2015) by medical sociologists Donald Light and Antonio Maturo.

As Light and Maturo write, the Italy-based pharmacological research institution prides itself on “patient-oriented” research rather than a “patent-oriented” model. In some ways the Mario Negri approach is not revolutionary: the institute competes for the same grants and contracts as other research organizations. It studies the same types of diseases as other researchers, including breast cancer, epilepsy, and dementia. But it departs from the norm by refusing to pursue patents on the drugs and methods it develops and by pledging open-source sharing of its research data.

The institute has also made a commitment not to drop a drug candidate because its profit potential is too low. It is an approach that would have prevented the tragedy of the vaccine for Ebola being unavailable because it sat undeveloped for 10 years due to its perceived unprofitability. The Institute won’t allow industry representatives to ghost-write journal articles for its researchers, and it structures clinical trials to include practicing physicians on the research team, an approach it believes will ensure its research has treatment relevancy.

The Mario Negri Institute manages to adhere to its noble philosophy while still competing effectively for funding—it is consistently in the top 10 of National Institutes of Health list of most-funded foreign institutions—and producing valuable science. Its researchers have published over 12,000 oft-cited articles in scientific journals. It averages 80 clinical trials being conducted at any one time, with over 70,000 patients enrolled.

Before writing this book, Light was known for his withering and detailed critiques of what he describes as the private industry’s corrupting influence on medicines research and access. In Good Pharma, he and Maturo shine a light on a rare example of pharmacological research that escapes that influence, and offers hope for a better approach. They write of the overall medicines system, “It’s worse than you think, but could be much better than you imagine.”

Good Pharma is not a neutral analysis—the authors don’t hide their admiration for the Mario Negri Institute, calling it an “oasis of classic science” and even “a utopia” for clinical trials. It doesn’t aspire to draw precise contours of a new global research paradigm. But Light and Maturo do allow readers to see in detail one concrete model of the improved system that the UN High-Level Panel and others are calling for. And that makes the book a significant contribution to one of the most pressing health, science, and human rights challenges of our time.

Fran Quigley is a clinical professor and director of the Health and Human Rights Clinic at Indiana University McKinney School of Law and coordinator of People of Faith for Access to Medicines. His book, A Prescription for Change: 22 Reasons Why Our Medicines System is Sick and How We Can Cure It, will be published by Cornell University Press in 2017.

 
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