The Covid-19 pandemic has upended the normal ways of doing everything from going to school to making sure countries have the medications their citizens need. It has also exposed vulnerabilities in the global medicine supply chain, leading to uncertainty, drug shortages, quality issues, and price volatility.
Strengthening the supply chain to ensure an uninterrupted supply of essential medicines that are safe, meet standards for quality, and are beneficial to health — something the U.S. Senate’s Finance Committee will be discussing at a hearing Tuesday afternoon — should be seen as a public health priority.
The dependence of Americans on medicines and their active ingredients mostly made in a handful of countries outside the U.S. raises concerns about supply-chain disruptions and our ability to ensure the availability of essential medicines. This was evident earlier this year when cities in China shut down and the production of some medicines was halted as India was restricting the export of certain medicines.
The vulnerabilities can be addressed by increasing the geographic diversity of production around the world (including more, but not exclusively, domestic manufacturing), investing in advanced manufacturing, strengthening international regulatory cooperation, and creating additional transparency in the supply chain. Now is the time to address these vulnerabilities and enhance our ability to respond to pandemics and other public health crises.
Increase geographic diversity in manufacturing
Today, too much of the U.S. medicine supply is sourced from too few areas of the world. Over 70% of manufacturing sites that make active ingredients for our medicines are overseas, with almost one-third of them in India or China. When crises such as natural disasters, geopolitical strife, and pandemics like Covid-19 arise, major interruptions in the supply of quality medicines would have a global impact.
While some have suggested that the U.S. should bring a significant amount of manufacturing back to the country, that will be difficult due to complex pricing dynamics, the availability of raw materials at the volume required, and increased operating costs for low-margin generic medicines. Moreover, this strategy presents the same risk of disruption when a natural disaster or disease outbreak shuts down plants on American soil. Manufacturing that is more evenly distributed globally will mitigate the risk of supply disruptions so that when a crisis affects supply in one part of the world, the rest of the world can scale up production.
Ensure supply of critical medicines
It is unrealistic for any country to manufacture all of its own medicines. Yet all countries should be able to make the most essential ones. Many, such as Brazil, Ethiopia, Korea, and Pakistan are already investing in developing their pharmaceutical sectors. Investing in advanced technologies and ensuring an adequate supply of these essential medicines can buffer against disruptions in supply during a global crisis.
Advanced manufacturing technologies like continuous pharmaceutical manufacturing provide more streamlined, consistent, and efficient production of medicines than traditional approaches. Devoting resources to these technologies would help enable more efficient and nimble production of critical medicines. The U.S. should also expand investments to ensure an appropriate supply of the medicines and vaccines needed to address the most urgent public health concerns. That effort should include making the national stockpile more comprehensive.
Increase transparency and enhance global cooperation
To maintain a strong and safe supply chain, regulators need to know where medicines and ingredients are manufactured and how they pass through the supply chain. Today, that information is limited and inconsistent. Increasing transparency across the supply chain can help make sure the supply of quality medicines isn’t put at risk by sudden disruptions. The CARES Act took important steps to add “sunshine” to the supply chain, but more can be done, including expanding global reporting requirements for indicators of drug shortages, requiring drug manufacturers and ingredient suppliers to monitor and report on their capacity and ingredient quality, and providing incentives to manufacturers for developing shortage mitigation plans.
Enhanced global cooperation can also help countries secure critical medicines, especially in light of challenges caused by border closures. During past drug shortages and public health emergencies, information sharing by regulatory authorities around the world has expedited the approval of essential vaccines and medicines, prevented the distribution of substandard and falsified medicines, and quickly mobilized resources.
Strengthen regulatory systems and quality assurance
During times of crisis, aggressive enforcement action against counterfeit products, unverified or false claims of treatments or cures, and price gouging is vital to prevent further harm. Stronger regulatory systems are needed to efficiently review applications for therapeutics and vaccines and enforce existing regulations that protect patient safety, including adherence to quality standards. This could be done through greater enforcement of regulations, reliance between robust regulatory agencies, and investments in drug quality control laboratories and workforce training.
During a global crisis, maintaining the quality of medicines is paramount to ensure that patients receive the treatments they need. When faced with a shortage, countries have sometimes resorted to purchasing medicines from untested suppliers. But the urgency to secure and develop new therapeutics and vaccines must be coupled with safety and quality.
As a stress test on our global medicine supply chain, Covid-19 has revealed gaps and cracks that must be addressed. As the world comes together in a collective effort to combat this pandemic, drug manufacturers, regulators, and other stakeholders in health care must work together to support and secure the medicine supply chain. Patients around the world deserve a supply chain that can withstand wide-scale disruptions, and our policymakers should take steps to ensure it has this resilience, now and in the future.
Anthony Lakavage is the senior vice president for global external affairs for U.S. Pharmacopeia, an independent, scientific organization that helps ensure the quality of medicines.