We study history for many reasons — one is to learn how to avoid making the same mistakes of the past. In recent months, the Biden Administration has expressed support for waiving intellectual property rights for Covid vaccines at the World Trade Organization. Although a well-intentioned idea aiming to increase vaccine access worldwide, critics have cited concerns for both safety and the fear of stifling future innovation. These are not theoretical concerns. One need not look any further than our own country’s current critical shortage of the vaccine for Tuberculosis, Bacillus Calmette-Guerin (BCG).
A century ago, tuberculosis was arguably a greater threat to public health than Covid is today. In response with hopes of increasing access to the vaccine, in 1921 the Pasteur Institute generously gave the formula for BCG to different laboratories around the world, without claiming intellectual property rights. In 1930, with access to the Pasteur Institute’s vaccine formula, physicians in the German city of Lubeck vaccinated 250 newborns with BCG prepared in a local laboratory. Unfortunately, many of these patients suffered greatly from these vaccines and 72 children died from TB within their first year of life. An investigation demonstrated that the local laboratory lacked the technical expertise and proper quality and safety standards, resulting in product contamination.
Handing over the recipe for the vaccine to laboratories and scientists ill-prepared to develop and manufacture it, is equivalent to handing them the blueprints for an airplane: They might have the instructions, but lack the experience, infrastructure, and training to fly the plane.
While BCG is no longer in widespread use as a vaccine to prevent tuberculosis in the United States, it has become important in the treatment of non-invasive bladder cancer. It has saved many patients from life-altering surgeries and prevented countless deaths. However, in 2011, one of only two North American producers struggled with manufacturing challenges and, without an incentive to invest further, they stopped producing BCG. With limited manufacturers remaining, the vaccine has been rationed for years, leaving many patients without access. The sole remaining manufacturer is working to increase supply, but sufficient access for bladder cancer patients remains difficult. Development and manufacturing of complex medicines, like vaccines, is costly and requires specialized knowledge to avoid these kinds of problems.
Simply put, vaccines are some of the greatest medical innovations the world has ever seen. Intellectual property protection creates economic incentives to discover and produce safe and effective vaccines. When those incentives are removed, it becomes the wild West for vaccine production, leaving patients at risk and, potentially without access at all. A century ago, when BCG was discovered as a vaccine for a life-threatening disease, no one could have foreseen that one day it would be useful in treating bladder cancer.
In current times, the enormity of the Covid pandemic justified the tremendous investment of both private and public resources. The desired scaling-up of production and mass distribution can be safely and quickly achieved through cooperative contracts and collaboration between governments and manufacturers. Intellectual property protections are the foundation for ongoing efforts to provide timely and essential Covid protection. The BCG story illustrates that once intellectual property rights are off the table, safety and access become real threats to patients around the world. The future of the public health demands we learn from our past, especially if we hope to be able to meet the next innovation challenge.
Murray S. Feldstein M.D. is a retired Assistant Professor of Urology/ Mayo Clinic College of Medicine and Science and Mark Tyson, M.D., M.P.H. is Associate Professor of Urology | Mayo Clinic College of Medicine and Science.