As discussions intensify around the Critical Medicines Act (CMA), its implications for medicine supply, patient access, and Europe’s pharmaceutical competitiveness are coming under scrutiny. The act aims to strengthen the availability of critical medicines while enhancing access to a broader range of pharmaceuticals. Stakeholders in the industry are emphasizing the need to maintain focus on crucial areas to support a resilient pharmaceutical ecosystem in Europe.
Focusing on Critical Medicines
The ongoing debate about the CMA highlights its commitment to ensuring the security of supply for critical medicines within the European Union (EU). A significant aspect of the proposal involves conducting vulnerability assessments to identify medicines at risk of supply disruption. However, a new definition proposed for ‘medicinal products of common interest’ raises concerns. This definition could encompass any medicine unavailable in at least three member states, which may dilute the focus of the act and lead to confusion between supply and access issues.
The pharmaceutical industry argues that these two challenges require distinct policy tools. A broad application of the CMA could stretch healthcare budgets and place unnecessary administrative burdens on industry players, ultimately failing to deliver tangible benefits for patients. To be effective, the act should concentrate on ‘medicinal products of common interest’ that demonstrate a clear market failure and address only those critical medicines with a genuine risk of supply disruption.
Joint Procurement: A Complex Solution
The CMA proposes joint procurement as a central strategy to tackle supply and access challenges. While joint procurement can improve availability, it needs to be carefully designed to address the root causes of medicine shortages and access delays. The experience from the Covid-19 pandemic illustrates that coordinated purchasing can be beneficial in specific contexts, particularly for medicines with fragile supply chains.
However, for medicines facing access delays, joint procurement may not be the best solution, especially in countries where products are already available. In these scenarios, improving national pricing and reimbursement systems could be more effective. To ensure that joint procurement does not inadvertently hinder access, several safeguards must be put in place. These include rewarding quality in tenders, maintaining price confidentiality, and allowing national procurement processes to run concurrently to avoid delays.
Addressing the broader causes of shortages and access delays requires a multifaceted approach. This includes reducing dependencies on specific suppliers, enhancing transparency within supply chains, and avoiding rigid national stockpiling rules. Moreover, tackling national pricing and reimbursement challenges is crucial to improving access to innovative medicines.
Rethinking Protectionism in Medicine Production
The CMA debate has also brought attention to the notion of prioritizing EU-made medicines to enhance supply security and reduce reliance on non-EU countries. While this perspective is well-intentioned, it risks oversimplifying the complexities of global pharmaceutical supply chains. Europe already maintains a robust pharmaceutical manufacturing base, with 71 percent of its production exported globally.
Implementing local-content requirements or preferential treatment for EU-made products could disrupt established supply networks, increase costs, and potentially weaken Europe’s trade relationships. Such measures could lead to reduced diversity and greater concentration in supply chains, counteracting the resilience the CMA aims to achieve. Any procurement criteria related to resilience should be justified by clear evidence of dependencies or supply risks.
Ultimately, protectionist measures cannot replace the need for a broader policy environment that fosters investment in research, development, and manufacturing. A competitive European pharmaceutical ecosystem relies on predictable intellectual-property rules, efficient regulatory processes, access to capital, and a strong technical workforce.
Future Directions for the CMA
The CMA presents a crucial opportunity for Europe to refine its approach to medicine supply and access. With the European Parliament proposing more consistent stock rules, there is potential for the act to effectively focus on medicines genuinely at risk of shortage. Policymakers are encouraged to streamline reporting by utilizing existing systems rather than creating new ones.
A cohesive policy framework is essential to bolster resilience in Europe’s pharmaceutical sector. The EU must prioritize an environment conducive to innovation and production, recognizing that supply security is intrinsically linked to the strength of the industry that provides it. Engagement between the industry and EU policymakers is vital for successful implementation of the CMA. A high-level forum involving all stakeholders could facilitate discussions aimed at enhancing supply security and improving patient access, positioning Europe as a key player in the global life sciences arena.
