On Thursday, 25th April 2024, Charles Young and David Holland from Solidsoft Reply attended the inaugural meeting of the European Commission HERA Critical Medicines Alliance (CMA) in Brussels. The CMA is a consultative forum open to all relevant industry, research, regulatory and other stakeholders. Its mandate is to propose solutions to strengthen the supply of critical medicines in the EU, providing a more resilient supply chain with effective detection, prevention, and management of medicine shortages.
The meeting was a great start to what we all hope will be a new chapter in tackling the problems that increasingly affect the supply of medicines in Europe. A series of shocks to the international system in recent years and increasing global instability due to conflict and climate change, threaten the reliable supply of essential medicines across the continent. The meeting emphasised the need for sustainable approaches, placing greater emphasis on sourcing of ingredients and finished products within Europe, the reappraisal of global supply chain practices such as just-in-time delivery, avoidance of national stockpiling and better detection of emerging issues, both in supply and demand.
The two issues that most caught my attention were the need to comprehensively trace the supply of active pharmaceutical ingredients (APIs), many of which cannot be sourced within the EU, and the need to detect changes in demand at the local and clinical level more effectively. The reliance on API production outside of Europe, and the increased concentration of production amongst a small number of suppliers leads to inherent instability. We need to diversify API pro duction, increase local sourcing, implement better traceability, and improve the visibility of API production in relation to finished products. This will support better early-warning detection of emerging issues and allow the industry and government to identify risks and take early action to tackle shortages.
Several other members of the CMA commented on the apparent emphasis on supply rather than demand in the presentations. A comprehensive approach to securing the supply of critical medicines requires better monitoring and forecasting of demand for medicines at the pharmacy and clinical level. I personally experienced the effect of medicine shortages last year due to the combination of a localised issue in the UK that increased demand for certain medicines, followed by an unrelated and significant rise in the cost of APIs used in those medicines which impacted manufacture. Despite the UK's recent exit from the EU it faces very similar problems to the European Union. For a time, the affected medicines became almost impossible to obtain in the UK. In this case, these were not critical medicines. Although widely reported, the issue was not regarded as major. Nevertheless, the problem illustrated the fragility of the supply chain. Better forecasting and earlier detection of demand issues would have allowed suppliers to purchase more stock before API price increases affected the global supply chain.
Solidsoft Reply supports medicine verification and traceability both at the European and the global levels. I was interested to see how the European-centric debate at the meeting closely mirrors the international debate concerning secure supply of medicines. I was glad to hear mention of the commitment of the EU to promoting local manufacture of APIs and finished products in low- and middle-income countries. The concept of protecting and ensuring supplies of critical medicines within and across borders should not be restricted to the EU. For example, the African Medicines Agency, the African Union and supporting agencies should also build a robust and sustainable approach to critical medicines resilience within the African continent’s supply chains.
The pharmaceutical industry is global in nature, and the stability and sustainability of the European supply chain depends on the adoption of policies that lead to improved security and diversity of the supply of critical medicines across the globe.
The world faces many challenges. We must rise to the occasion and do all in our power to improve the situation.
Critical Medicines Alliance - European Commission