by Susan Crowley
The innovative pharmaceutical industry is under attack from critics around the world for failing to develop new antibiotics to treat emerging infections. The charge has been furthered by statements from World Health Organization (WHO) director Margaret Chan. In 2012, she warned that bacteria were starting to become so resistant to common antibiotics that it could bring about “the end of modern medicine as we know it” and earlier this year, she asserted that the world is entering a “post antibiotic era.” The health agency notes that antibiotics are losing effectiveness in every country. Marie-Paule Kieny, WHO assistant director-general who heads the program responsible for intellectual property policy-making, together with other programs that include research, has been quoted asserting that there is “no market” for antibiotics.
Dire warnings from the WHO and others have prompted calls for new innovation models that would provide alternatives to the patent-based intellectual property system – models that would apply beyond antibiotics and extend to cutting-edge therapies for cancer, hepatitis and other categories that fuel the research enterprise of innovative firms.
Garance Upham, president of Safe Observer and administrative board member of the World Alliance Against Antibiotic Resistance, was quoted at a recent meeting saying that John-Arne Røttingen, chair of the Advisory Panel for the WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), told her that “delinking between innovation and product prices applies to neglected diseases and is also relevant to the problem of antibiotic resistance.”
Knowledge Ecology International, led by James Love, put forward a proposal to WHO, further to demonstration projects called for by the CEWG, that proposed “new open innovation business model for the development of antibiotic drugs.” The proposal suggested financial innovation incentives such as the use of grants and prizes to delink the cost of innovation from product prices. It also proposed incentives for “open source development of new antibiotics” and sharing of technology, as well as competitive production of generic supplies of products.**
Additionally, a well-known critic of the current IP system, Kevin Outterson, professor at the Boston University School of Law, where he co-directs the Health Law Program, wrote a paper titled, “New Business Models for Sustainable Antibiotics,” that was published by Chatham House in February, 2014. The paper explores all the antibiotic delinkage models in the existing literature, as the author believes, “Antibiotic delinkage may offer the most promising avenue for a sustainable, global approach.” The South Center’s Martin Khor, anticipating discussion of this topic on the agenda of the May, 2014 World Health Assembly, called for “Promoting the development of new antibiotics and in ways (including financing) that do not make the new drugs the exclusive property of drug companies.”
Rather than allowing anti-IP activists to use the trough in antibiotic research as a cudgel to attack the IP system, the R&D industry could take steps along the lines it took in decades past to tackle HIV/AIDs. In the mid-1980’s, then President of Pfizer, Dr. Gerald Laubach, convened a group of competitor pharmaceutical firms at Pfizer headquarters in NY to float the idea of industry collaboration to develop treatments to address HIV/AIDS, and called for mounting a new “Manhattan Project” (the research and development project that produced the first atomic bombs during World War II). Discussions continued at a 1987 session of an Institute of Medicine meeting. A series of negotiations ensued until, in 1993, the Inter-Company Collaboration for AIDS Drug Development (ICC) was launched, despite skepticism about the business wisdom of sharing scientific data with competitors—even for the goal of addressing a pressing global health need.
The sharing of substantive scientific information began immediately at the Collaboration’s first formal meeting. Three companies presented data on antivirals then in development: Bristol-Myers Squibb, Hoffmann-La Roche, and Merck & Co., Inc. At the second meeting, several months later, six more companies came forward with data: Astra AB, Boehringer Ingelheim, Burroughs Wellcome, Eli Lilly, Glaxo, and Hoechst AG.
Though the prospect for addressing the HIV/AIDS pandemic in the mid-1980’s looked bleak, given the enormous challenges posed by the ever-mutating virus, innovative drug companies have successfully rolled out successful HIV/AIDS medicines over the past 25 years, innovated a range of access initiatives, and provided compounds that enabled generic firms to subsequently manufacture in high volumes. As a result, in developed countries, HIV/AIDS has become a manageable chronic condition. According to WHO, at the end of 2012, close to million people living with HIV were receiving antiretroviral therapy (ART) in low- and middle-income countries. Of this, about 640,000 were children. This is more than a 30-fold increase in the number of people receiving ART in developing countries between 2003 and 2012, and almost a 20% increase in just one year (from 8 million in 2011 to 9.7 million in 2012).
Given the industry’s record of success, and the need to withhold ammunition from anti-IP activists, innovative pharmaceutical companies ought to consider mounting a new “Manhattan Project” to develop critically-needed new antibiotics.
Susan Crowley is president of Multilateral Consulting, LLC. She can be reached at email@example.com
**Note: PharmExec spoke with Novartis’s Paul Herrling in May 2012 about his role on the CEWG, and his delinking proposal, here.