Kris Soyoung Lee
Unlike flu epidemics, which are regional, the coronavirus disease 2019 (COVID-19) is a pandemic that crosses international boundaries and affects a very large number of people. While many companies are in lockdown, pharmaceutical companies are identifying methods of ensuring supply continuity so that patients taking regular medication can continue to receive the treatments they need. Without the maintenance of medicine supply chains, lifesaving medicines could become unavailable, with the health of many unwell people being compromised.
Some European Union (EU) member states have indicated that they expect shortages to occur soon or are starting to experience shortages of certain medicines being used to treat patients with COVID-19. In April 2020, the European Medicines Agency organized the first meeting of the EU Executive Steering Group to address the impact of COVID-19 on the supply of medicines in Europe. The group aims to supply strategic leadership for urgent action and will identify and coordinate EU-wide actions to protect patients who may be affected. The FDA is working closely with manufacturers to mitigate shortages and has recommended that, should the need arise, alternative medications be used by patients.
Samsung Bioepis is a biopharmaceutical company that supplies medicines to many countries around the world. COVID-19 affects our business, as it does many others in the pharma industry. Six months ago, there were about 100,000 planes flying globally every day. Now, there are fewer than 60,000 flying each day, and many flights are cancelled or delayed depending on infection rates in different regions. Our freights are examined and re-examined according to newly implemented processes due to COVID-19, adding additional transit days to already lengthened supply chain lead-times; and our raw material suppliers and manufacturing partners are working nonstop to support our strained supply chain with limited resources and limited capacities. We have implemented mitigation plans and changed our working patterns to minimize the impact COVID-19 has on medicine supply.
For Samsung Bioepis, our supply chain is geographically diversified. To ensure supply continuity and flexibility to swiftly respond to market changes, we have regionalized supply chain activities to provide near-market manufacturing. And under the current situation, this has been beneficial for our supply chain. However, based on recent lessons learned about COVID-19 challenges for logistics, we spend more time with our logistics vendors or internally develop freight-routing possibilities to ensure the supply of medicine is not diminished. Based on the latest flight schedules, we review and update, on a weekly or sometimes daily basis, routes, shipping solutions, and modes of transport. We are also working to build and diversify our current modes of transport, shipping solutions, and routes to provide more flexibility when moving our biosimilar products around world during this challenging time. Fortunately, with these reviews and actions put in place, we have not experienced any disruptions to the supply of our biosimilars.
Recently, there has been a debate about whether manufacturing of “critical” prescription drugs should become more US-based to ensure the availability of medicines to patients in the United States. Many times, supply chains are globalized not just because of cost benefits but also due to advancements in technological know-how. Yes, it may be cost-effective to manufacture active pharmaceutical ingredients (APIs) or specific raw materials in certain parts of the world, but these countries may have a technological advantage for making critical APIs and raw materials at a much larger scale for global supply. Therefore, the use of incentives to spur in-country manufacturing of critical APIs and raw materials may not be sustainable in the long run, especially as the critical prescription drug list becomes longer.
Currently, many biopharmaceutical companies are rushing to develop a COVID-19 vaccine. Once a vaccine is developed and approved, what are the next steps to bring production to commercial scale and make this vaccine available to everyone in need?
In a time when the global supply chain is essential, we need to work together to remove the roadblocks to ensure that all “critical drugs” are provided to patients who need them. Globalization of the supply chain provides value for the efficient manufacture and distribution of these critical APIs and raw materials. It takes into consideration the technology and the global resources necessary to do so. By harmonizing these supply efforts and providing guidelines that all countries can follow, these critical APIs and raw materials can be supplied globally during the pandemic, ensuring that medicines are provided to patients in a timely manner. COVID-19 is changing the current supply chain every day and, to ensure critical drugs are provided to patients who desperately need them, industry and regulatory agencies should come together to stabilize a supply chain that is sustainable in the long-run.
Kris Soyoung Lee is the vice president of the Supply Chain Management team at Samsung Bioepis. She has more than 20 years of experience in supply chain management across various industries including chemical, pharmaceutical, and biopharmaceutical.