Veta Obazenu, M.S.
The World Health Organization (WHO) estimates that more than 1 billion people – one sixth of the world’s population — suffer from one or more neglected diseases. In 2019, the organization also compiled a list of the top 10 threats to global health and more than half of the list was made up of infectious diseases including influenza, antimicrobial resistance, Dengue, HIV, Ebola and Disease X.1 More broadly, infectious disease rarely garners the attention of big pharma where central-nervous-system disorders or cancer have a greater chance of being brought to market than an antiviral. Treatment options for diseases such as malaria and tuberculosis are hugely dismissed because they are not high-profit products. 2 The NIH program Therapeutics for Rare and Neglected Diseases (TRND) asserts that diseases are “neglected” because they are overlooked by drug developers or by others instrumental in drug access.3 Thirty-nine percent of new chemical entities in clinical development are abandoned because profit prospects are poor.”2
The pharmaceutical industry reasonably argues that their stake in research and development is too costly and risky to invest in low-return neglected diseases. The NIH acknowledges the industry perspective and also once declared that this category of disease does not affect developed nations, and they “lack visibility” due to the low likelihood of “dramatic outbreaks that kill large populations of people.”3 However, factors such as global urbanization, climate change, and travel create opportunities for these pathogenic infectious agents to spread.4 Just what exactly are we up against? Five major infectious agents – bacteria, viruses, fungi, protozoa, and parasitic worms- invade human and animal hosts and pose a constant threat to society. To exist in a world where transcontinental travel for businesses or leisure is executed at a moment’s notice, the idea that rare or neglected disease would not trigger a pandemic has clearly been debunked by COVID-19.
In the US, prior to COVID-19, 80% of CDC funding was cut14, “Predict”, The program behind the discovery of more than 1,000 viruses, including an Ebola strain5, was discontinued and the National Security’s Council’s global pandemic team disbanded in 2018. These actions ominously left the US with a vulnerable health infrastructure, which ultimately impacts both global health and economies. One could argue, that without the establishment of an international pharmaceutical policy for all neglected diseases2, we are left defenseless when public sector capacity is arbitrarily demoted.
In efforts to stop the coronavirus, all hands were on deck as industry rallied towards the common goal of saving lives. This coronavirus pandemic may be the opportunity for private-sector research obligations to be explored more vigorously. However, the current architecture of the pharmaceutical markets6 reflects a perceivable misalignment of financial incentives that contributes to the gap in public health strategies. Public and private initiatives have tried to overcome market and financial limitations through incentive packages and public-private partnerships.7 Realistically, however, the lack of drug research and development for “non-profitable” infectious diseases will require a new blueprint.
A look into public benefit corporation structure may present an equitable solution to the sustainability required for the industry to position patients above profits. Public benefit companies are not the same as non-profit companies. Similar to a traditional corporation, public benefit corporations have shareholders. These shareholders expect the company to profit and produce dividends just as traditional shareholders would anticipate8. The underlying commitment to serve the public good is the true differentiator9. Public benefit corporations utilize profits and resources to support that benefit8. Under this model, pharmaceutical companies are able to develop drugs based on need—and successfully so.
These types of pharmaceutical companies are more prevalent outside of the United States. Successful public options from Sweden, Brazil, and Thailand can be modeled within our own borders. China and India also boast successful models as each country has a state-owned company that produces active pharmaceutical ingredients.10 Independent of an emergency health crisis, some advocates for the current pharmaceutical structure claim that the public benefit model would stifle innovation. An argument against that belief looks at CimaVax, a lung cancer vaccine, was developed by Cuba’s state-owned pharmaceutical company and is currently being tested in U.S. clinical trials10. Beta Bionics, a benefit corporation in the biomedical space, is dedicated to developing a bionic pancreas for patients with type 1 diabetes11.
It is not likely that innovation will throttle, but investors will likely be different from the profit-driven shareholders driving most pharmaceutical companies. Public benefit companies need to find investors that support the company’s vision. In some cases, these investors may even come from a crowd-funding source. Beta Bionics raised $1 million from 700 donors through Wefunder11. Socially responsible organizations like the Bill & Melinda Gates Foundation also contribute integral funding to global health research organizations and governments collaborating with companies addressing neglected diseases.
Public benefit pharmaceutical companies, like Audacity Therapeutics12, want to see our industry “be practical, efficient, rigorous and lean” and even allow open collaboration to repurpose approved drugs for different indications. The objective is for these types of companies to share data and continually build on advancements in molecular technology and diagnostics to aid in the development of effective medicines. This level of transparency facilitates production of more therapeutics and removes exorbitant costs and redundancy from R&D pipelines.
Can we be hopeful that broad adoption of public benefit pharmaceutical ideology will emerge out of the coronavirus pandemic? Already, we see many of the components in action during this crisis that includes heightened, cross-industry collaboration made possible by a mix of public, corporate and private funding. These efforts are driving the industry closer to delivery of accessible therapeutics to our global communities.
We, as consumers, are now expecting the “first to market” race to be truly driven by the interest of the public. This aspect, however, remains to be seen given the challenges that still exist in the detail of access and affordability protections built into the coronavirus spending bill13.
Nonetheless, this pandemic has created opportunity for the private sector to restructure the pharmaceutical business model to deliver public benefit while sustaining a collaborative response to the persistent, unpredictable nature of infectious disease.
- Patrice Trouiller, Piero Olliaro, Els Torreele,James Orbinski, Richard Laing, Nathan Ford
“Drug development for neglected diseases: a deficient market and a public-health policy failure” The Lancet Vol 359 22 June 2002.
- Gagnon, Marc-André. “Corruption of pharmaceutical markets: addressing the misalignment of financial incentives and public health.” The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics 41,3 (2013): 571-80. doi:10.1111/jlme.12066