Aug 20, 2020
Far too many people have suffered and died because our medicines and medical products system was not prepared to respond to the COVID-19 pandemic with prompt and universal access to reliable tests, treatments, and vaccines. Governments, non-profits, and industry in the U.S. and around the world are working furiously to catch up. But their efforts have been hampered by fundamental flaws in our profit-driven pharmaceutical industry.
"We must transform the U.S. pharmaceutical sector so that our nation can successfully combat this crisis, prepare for the next one, and ensure that millions of people have access to the essential medications they need to live healthy lives."
For Americans with diabetes, cancer, asthma, infectious diseases, mental illnesses, and a myriad of other health issues, those flaws have been causing suffering and even death for decades. From growing shortages in essential medicines, to lagging innovation, dangerous mislabeling and misbranding, and the highest prices in the world, America's pharmaceutical sector is clearly not meeting the needs of our society. The current crisis has brought these problems into even sharper focus.
Now is the time to redesign our medicines system to effectively, equitably, and rapidly address and anticipate crises like the current pandemic. This can and must be done while also providing a safe, consistent, and affordable supply of essential medicines to all, including persons with health challenges beyond COVID-19.
Medicines were long considered a public good, off-limits to corporate profiteering, price-gouging, and monopolizing. It is time for us to reclaim them as such. We must transform the U.S. pharmaceutical sector so that our nation can successfully combat this crisis, prepare for the next one, and ensure that millions of people have access to the essential medications they need to live healthy lives, and participate in society and the economy.
To do so, we must take these four steps:
1. Codify open science practices that accelerate innovation, reduce costs, and strengthen the evidence base on which our medicines system rests.
"Open science"--broad, ready, equitable access to scientific knowledge, and to the data that generates that knowledge, across a drug's entire lifecycle--is essential to focusing research and development activity on the most crucial health needs, accelerating R&D, expanding competition and preventing monopolization, and reducing costs. We must provide access to the "means, methods, and materials" of biomedical innovation, including various preclinical, clinical, and financial data that is currently kept mostly hidden by industry, government, and academia.
This could be done in two phases. In phase one, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and other public agencies--including the public sector vaccine and pharmaceutical agencies we describe below--would begin discretionary sharing of preclinical and clinical data they hold. Government-held results of experiments and clinical trials, and information on the costs of this research, can and should be shared regardless of if the results are generated by government, industry, or academia. Such data sharing would make it easier for researchers to replicate research findings, reduce redundancy and other inefficiency, and speed the development of new therapies.
Phase one could be achieved immediately, through agency discretion, without changes to existing law. However, Congress could maximize public benefit by making this data sharing mandatory.
Phase two would extend open science to manufacturing. Sharing data and know-how on manufacturing processes would accelerate development of new drugs, especially biologics and biosimilars. This would break monopolies and lower sky-high prices.
To achieve this, Congress should amend federal statute (such as the Food, Drug, and Cosmetic Act or the Biologics Price Competition and Innovation Act) to require manufacturers and the FDA to share information that is currently protected as trade secrets once the appropriate exclusivity period has passed. Congress should also provide the FDA and Department of Health and Human Services (HHS) discretion to share manufacturing information--and clinical data, too--sooner, before the exclusivity period expires, to accelerate competition in the event of anticompetitive conduct or pressing public health needs. The Patent Act should also be reformed to raise the bar to patentability, require patent owners to disclose more useful information, and discourage dense patent "thickets" that overprotect drugs' manufacturing processes.
2. Create public sector capacity for full-cycle pharmaceutical innovation and production of essential medicines.
The U.S. should establish a public full-cycle pharmaceutical research and development institute and one or more public sector pharmaceutical manufacturers. These institutions would work together based on a new bottom line: the public good. The American public already funds many breakthroughs in the discovery and development of new drugs--far more than even the largest drug companies. But we currently depend on those companies, and the profit motive, to get those breakthroughs to patients.
Public sector institutions could work together to reimagine the innovation cycle from beginning to end. They could direct discovery efforts at the disease areas most important to public health, and lead the world on open science, embracing and expanding on the data sharing asked of industry. Additionally, as public sector actors, these institutions would benefit from the "patient capital"--investment not expected to turn a quick profit--needed to engage in the long-term, uncertain process of discovering and developing truly revolutionary science.
Public pharmaceuticals would lower prices, return revenues to public balance sheets and reduce inefficiencies while building in surge capacity for crises. They would foster a more resilient supply chain and ensure broad, equitable access to new drugs through public-interest management of its inventions. These institutions would be a source of stable, public sector jobs (themselves an upstream investment in health).
By breaking Big Pharma's monopoly on our medicines supply, public sector institutions would also begin to erode its capture of our political system. The U.S. public sector has a long tradition of path-breaking innovation, from development of the internet to HIV prevention therapy to putting people on the moon. It is incumbent upon us to also wield the full power of that public sector innovation-engine to develop the medicines our society most needs, and assure equitable access to them.
3. Use the full power of compulsory licensing to ensure access to essential medicines.
The federal government should use its existing compulsory licensing power to either directly manufacture essential medicines or allow others to do so. This will ensure adequate supplies and equitable, affordable access. Under two different U.S. statutes, we already possess full legal rights to bypass the barriers of privately-held medicine patents.
There is a long history of the U.S. government issuing compulsory licenses to respond to crises like the one we face today, ensuring affordable access to medicines and technologies in the medical, energy, and other sectors.
In response to the COVID-19 pandemic, several nations are already taking steps to issue compulsory licenses for medicines (and other medical technologies). Beyond the present pandemic, we must also recognize the everyday crises of lack of access to many essential medicines--whether driven by shortages or prohibitive costs--and use compulsory licensing any time access issues jeopardize public health.
Extending the U.S. government's compulsory licensing power beyond patents to trade secret manufacturing information and regulatory exclusivities (as described above) will ensure that these barriers do not jeopardize public health either. Compulsory licenses call for a reasonable royalty to be paid to the holder of the patent instead of the typical massive monopoly mark-up. Therefore, prescription drugs manufactured through compulsory licensing can be much cheaper, while innovators are nonetheless compensated for their work.
4. Take the vaccine industry into public ownership to assure its products are available to all.
Vaccines are not an effective market good; in fact, they are an essential public good. Only a robust, public program of vaccine development and production can meet our public health challenges. In a profit-driven pharmaceutical industry, vaccines for infectious diseases simply do not offer the kind of return on investment that owners believe they deserve.
This has led most major pharmaceutical companies to pull out of vaccine development altogether, leaving us with a highly consolidated and non-competitive oligopoly of producers-none with the capacity to alone produce a coronavirus vaccine at scale. Yet, current U.S. policy is built on the presumption that these same disinterested corporate actors are the only ones capable of bringing vaccines to market, despite many historical examples to the contrary. De-privatizing the vaccine industry would be a major step towards establishing the full public sector capacity needed to assure essential medicines are accessible to all.
Such de-privatizations in times of emergency are commonplace, and the U.S. has specific experience with public sector mobilization of vaccine development and production, including our highly successful vaccine program during World War II. A public laboratory in Canada recently led the development of the Ebola vaccine. And the U.S. public has already invested billions in vaccine development through federal agencies.
By taking the vaccine industry into full public ownership, we can provide an internationalized response to this and future pandemics that properly recognizes vaccines as a global public good. Vaccines developed in the public sector could be licensed through a global pool--or developed and marketed without patents altogether--so that they are available to all, ensuring the prompt and equitable access necessary for coherent public health interventions. A federal vaccine development agency could break with industry's tradition of secrecy and commit itself to data sharing, accelerating innovation around the world.
The COVID-19 pandemic has revealed shocking deficiencies in our country's commitment to the health of all Americans. The choice to prioritize corporate profits over the research, development, and distribution of effective, affordable medicines has proven deadly, just as it has for Americans who have been facing dire access challenges for decades. We are confronting the challenge of our lifetimes without the tests, treatments and vaccines we need. Yet, more and more public money is being pumped into a system best placed to produce duplicative "me-too" drugs that generate excessive profits but have little to no impact on public health.
The pandemic has taught us a brutal lesson: it is time to reclaim our medicines system for the public good. These four steps are the way to begin.
Action Center on Race and the Economy
AIDS Foundation of Chicago
Albuquerque Center for Peace and Justice
American Family Voices
Black AIDS Institute
Center for Open Science
Center for Popular Democracy
Columbia University Students for a National Health Program
Congregation of Our Lady of Charity of the Good Shepherd, U.S. Provinces
Democratic Socialists of America Health Workers Collective
Faith in Healthcare
Health Global Access Project
Iowa Citizens for Community Improvement
Just Care USA
Latino Commission on AIDS
Maine People's Alliance
National Advocacy Center of the Sisters of the Good Shepherd
NETWORK Lobby for Catholic Social Justice
Physicians for a National Health Program
Right Care Alliance
Rights & Democracy
Rights & Democracy NH & VT
The Democracy Collaborative
The Zero Hour with RJ Eskow
Treatment Action Group
United Vision for Idaho
Universal Health Care Action Network
Universities Allied for Essential Medicines (UAEM)
Dana Brown, Director of the Next System Project, the Democracy Collaborative
Alex Lawson, Executive Director, Social Security Works
Christopher Morten, Fellow and Supervising Attorney, NYU School of Law
Fran Quigley, Clinical Professor of Law, Health and Human Rights Clinic, Indiana University Robert H. McKinney School of Law
Adam Hege, Associate Professor and Program Director, Appalachian State University
Alexandra Greenberg, Medical Student, SUNY Downstate
Alexandra Sundell Human
Alison Case, MD
Amanda Ramsdell, M.D., Physician in New York City
Ameet Sarpatwari, Assistant Professor, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital/Harvard Medical School
Amy Picone, MD
Andrea Jacobo, UC Berkeley
Andrew Goldstein, NYU School of Medicine
Anna Kaplan, Epidemiologist, Tufts University
ATimothy Lunceford-Stevens, JD, End AIDS Now
Barbara McCormack, Social Justice
Brendan Parent, Assistant Professor of Bioethics, New York University Grossman School of Medicine
Brinda Raval, New York Medical College
Caitlyn Passaretti, Social Worker
Catherine Jones, LPC, ACA
Catherine Lowenthal, Columbia University Vagelos College of Physicians & Surgeons
Christele Felix, LupusChat
Christopher Noble, Harvard Medical School Department of Global Health and Social Medicine
Daniel Alohan, Masters of Public Health candidate, Columbia University Mailman School of Public Health
Darcy Cherlin, MPH
David Himmelstein, Distinguished Professor of Public Health and Lecturer in Medicine, City University of New York and Harvard Medical School
Deborah Passey, Research Associate, University of Utah
Deborah Socolar, UHCAN
Denice Arnold, Columbia University VP&S
Dr. Linda Settle, Children's Healthcare of Atlanta
Dr. Yusra Hussain, Independent
Dr. Abraham Young, Community Health Center
Dr. Alan Wartenberg, Brown Center for Alcohol and Addiction Studies
Dr. Arthur Rourke, Retired
Dr. Bruce Trigg, Public Health and Addiction Medicine Consultant
Dr. Bryan Terrazas, Harvard University
Dr. Carol Kessler
Dr. Elizabeth Brown, Emergency Physician
Dr. Hussain Lalani, Internal Medicine Resident Physician, UT Southwestern Medical Center
Dr. Jessica Goodkind, University of New Mexico
Dr. Juliana Morris, University of California San Francisco
Dr. Laura Kaplan-Weisman, MD
Dr. Maureen Miller
Dr. Nathaniel Robinson, Case Western Reserve University
Dr. Reshma Ramachandran, National Clinician Scholars Program, Yale School of Medicine
Dr. Roni Diamant-Wilson, UIC
Dr. Virginia Adams OConnell, Moravian College
Dr. Zinzi Bailey ScD, MSPH
Duncan Maru Icahn, Physician and Faculty, School of Medicine at Mount Sinai & NYC H&H / Elmhurst Hospital Center
Emily Hops, University of Washington
Emilyn Cahn, Charles R. Drew University of Medicine and Science
Erin Kohout, SPT, CUMC
Reverend Fred Kinsey, Unity Lutheran Church, Chicago
Gloria Tavera Case, PhD, MD Candidate, Western Reserve University
Hannah Mesa, University of Michigan
Harry Hochheiser, Associate Professor, University of Pittsburgh
Heather Booth, Organizer
Helen Zhou, NYU School of Medicine
Henry Kahn, Emeritus Professor, Emory University School of Medicine
Irwin Abraham, MD, Private Practice
Jacquolyn Duerr, Public Health Advocate
James Elliott, T1International
Jan Torpy, Concerned Citizen
Jason Schultz, Professor, NYU School of Law
Jeff Taylor, HIV+Aging Research Project-Palm Springs
Jennifer Arbuckle, Seniors Consultant, Kaiser Permanente
Jennifer Flynn Walker, Senior Director of Mobilization and Advocacy, Center for Popular Democracy
Jessica Ho, MPH, Columbia University Vagelos College of Physicians & Surgeons
Jonathan Michels, Health Care for All North Carolina
Jonathan Shaffer, PhD Candidate, Boston University
Joshua Prasad, Individual
Karyn Pomerantz, Retired, GWU SPH
Kate Crawford, Distinguished Research Professor, NYU
Kathie Piccagli, Mothers Out Front San Francisco
Kelly Dougherty, MPH, Injury Prevention Coordinator
Kim Westrick, Contract Compliance Officer, University of Pittsburgh Masters of Public Health
Kylah Le, Student
Leah Carnine, PA-C, Family Medicine
Linda van der Wal, Retired Educator
Liz Salomon, Constituent, Cambridge, MA
Marcus Hill, Clinical Trial Recruitment Strategist, US Solidarity Economy Network
Matt Musselman, DO, MPH, Physician
Matthew Bosley, MD, MPH-Candidate, University of Nebraska College of Public Health
Matthew Flynn, Associate Professor, Georgia Southern University
Matthew Herder, JSM LLM, Director, Health Law Institute, Associate Professor, Department of Pharmacology, Faculties of Medicine and Law, Dalhousie University
Matthew Kavanagh, Director, Global Health Policy & Politics Initiative, O'Neill Institute for National and Global Health Law & Assistant Professor of Global Health, Georgetown University
Megan Mueller Johnson, Behavioral Health Researcher
Merith Basey, Executive Director, Universities Allied for Essential Medicines (UAEM) North America
Michael Zingman, Psychiatry Resident, NYU Langone/HHC Bellevue
Michelle Glathe, Registered Nurse, University of California
Norty Kalishman, Physician
Paul Ehrlich, Student Doctor, Member
Peter Sherman, Chair of Pediatrics, Icahn School of Medicine
Priti Krishtel, Co-Founder and Co-Executive Director, I-MAK
Rael Slavensky, RN, MPH, MSN, Retired
Ravi Gupta, MD, NCSP
Sanjeev Sriram, MD, MPH, Social Security Works
Sanna Alas, Medical Student, Columbia Vagelos College of Physicians & Surgeons
Sivateja Mandava, MD, Independent Contractor
Siyu Xiao, MD, Montefiore Medical Center
Stephanie Caldwell, Public Health Awakened
Susan Reverby, Professor Emerita, Wellesley College
Tahir Amin, Co-Executive Director, I-MAK
Tanya Azarani M.D., Psychiatrist
Thomas McInerny, MD
Titilayo Arowolo, Intern, Families USA
Uma Tadepalli, MD, Democratic Socialists of America Health Workers Collective
Vanessa Martinez, Professor, MotherWoman
Vicki Fitch, Public health student
Yanglu Chen, Columbia University
Yuri Cartier, Social Interventions Research and Evaluation Network, UCSF
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