The COVID-19 pandemic has tested Europe’s medicine supply chains like never before. It has affected manufacturing, trade and logistics. Matching the supply of medicines to fluctuating demand can be a challenge at the best of times. So, what have we learned?
It is vital that we understand what drives medicine shortages in parts of Europe, how the pandemic has affected supply, and what can be done to make systems more resilient. With this in mind, EFPIA hosted two online discussions entitled Everything you always wanted to know about drug shortages (but were afraid to ask) in October and November this year. The events explored the issue in depth, with insights from industry experts, before focusing on solutions that the research-based pharmaceutical industry believe will help to safeguard this key asset of the health system.
Medicines supply chains are complex, with many stakeholders involved. Their design is a long-term enterprise that begins long before a medicine is even approved. Once established, supply chains must be maintained and upgraded to keep pace with advances in technology and rising environmental standards. The products available in our hospitals and pharmacies today typically began their journey up to 24 months ago. For biological products, including vaccines, the process of production and distribution can be even more complex. Production of this winter’s flu vaccines, for example, began more than a year ago.
Despite the planning and forecasting that goes into this work, delays and shortages can still occur. The reasons behind this fall into two broad categories: factors that companies can control, and those that are out of their hands such as issues around economic policy, geopolitical developments or unexpected increase in demand.
The ultimate test
The COVID-19 outbreak fits squarely under the heading of ‘unforeseen events’. If you cast your mind back to Spring this year, concerns about widespread shortages of medicines were headline news. Companies made changes to work practices to keep employees safe while increasing production, export restrictions were a major concern, and worried patients stocked up on the medicines they need.
Despite this, manufacturing sites and distribution centres proved nimble enough to maintain supply. It was a real-world test of global supply chain resilience and robustness in the face of a dramatic surge in patient need and demand. For the most part, Europe’s pharmaceutical sector rose to the occasion. In fact, in some cases, operations were scaled up to 800% normal volume to meet rising demand for specific products.
However, there is always an opportunity to learn from experience and explore ways to make our systems stronger still. Where the system worked well, it was thanks to supply readiness and proactive (pandemic preparedness) planning. Business continuity plans – devised for precisely this kind of eventuality – were ready to go.
Diversification of supply, the use of predictive analytics to forecast demand, and in some particular cases close cooperation with health authorities on stockpiling, were key elements of our collective response to the pandemic. Indeed, dialogue between stakeholders and institutions, and consultation with health authorities and regulators at national and European level, helped industry to play its part in getting medicines to patients, but there remains significant room for improvement.
Dialogue indeed has been the cornerstone of the resilience of the system, as it allowed in-time adjustment as needed. It allowed well-informed authorities to take the necessary decisions to ensure the continuity of supply, such as ensuring that workers reach their manufacturing sites (sometimes across locked down borders), implementing green lanes at borders or agreeing on regulatory flexibilities to fast-track certain administrative procedures. Dialogue is important and needs to be accompanied by the right set of epidemiological forecasting and patient data underlying country needs in order to ensure the right allocation of supply at the right place at the right time.
This spirit of cooperation was evident across the supply chain, with manufactures, governments, health authorities, freight companies and other supply chain actors working closer than ever before. These partnerships are also at the foundation of developing and distributing new vaccines against COVID-19.
The events highlighted that the preventive measures research-based pharmaceutical companies have established, were shown to be successful in enabling continuous medicine supply. Furthermore, the discussions pointed to several measures that would further strengthen supply chains and build resilience to future shocks. Regulatory harmonisation by the relevant authorities would help to make medicines distribution easier and less costly by, for example, introducing common definitions of key concepts, which could lay the basis for harmonised reporting requirements.
Practical measures, such as flexible labelling requirements would reduce the logistical burden on industry. Specifically, making multi-language labelling information downloadable, would add greater flexibility to the system.
Transparency and cooperation between national authorities, and with manufacturers and other supply chain actors, would help to make forecasting more accurate and help to prevent shortages. Better and more detailed epidemiological data, based on foreseen clinical usage, and greater transparency on downstream inventories, would have informed detailed industry supply planning and helped the distribution of much needed medicines during wave 1 of the COVID-19 crisis. It is paramount to set up such a transparency and cooperation on data in the future, to improve the planning of production and supply. The data in the European Medicines Verification System on how medicines are consumed by patients is already available, and could easily be exploited to precisely monitor stocks, trigger alerts and shed further light on roots of shortages.
By nature, some sudden demand surges cannot be predicted. When they strike, panic can prompt stockpiling across Europe – by patients, by hospitals, by distributors, by governments. Maintaining a reserve supply of targeted critical medicines at European level, for instance at semi-finished product level, would offer a much more efficient and resilient mechanism than non-coordinated national stockpiling requirements, and would be more responsive to demand across Europe.
An underrated asset
Fortunately, our medicines supply chain has proven resilient enough to pass the stress test of wave 1 of the COVID-19 crisis and is proving stable in wave 2, without major mass-scaled patient incidents that the extreme surge of global demand could have triggered in Spring 2020. This resilience is based on careful risk management, planning and anticipation, and on the collaborative dialogue that led to flexibility left to manufacturers to increase the production and allocate medicines where they were needed. To improve the resilience of the system and make sure we are even better prepared, we should bet on strengthening these two assets, and be careful not to hamper its capacity to react and adapt by adding-on rigidity. What we need is a harmonised definition and a common reporting framework for shortages, better data to anticipate demand, and an agile, unconstrained distribution system able to react quickly.
Risk of medicines shortages existed long before the pandemic was declared. The lessons learned in 2020, including successful measures introduced by the industry, provide a sound starting point for a structured dialogue with all supply chain actors and public authorities and can be used to refine our system further, ensuring it serves patients well in good times and in moments of crisis.