As discussions advance on the Critical Medicines Act (CMA), the implications for medicine supply, patient access, and Europe’s competitive standing are coming under scrutiny. Industry stakeholders are particularly concerned about how the act can fulfill its objectives while fostering a robust pharmaceutical ecosystem across the continent.
Focusing on Critical Needs
The core of the CMA debate revolves around its promise to enhance the availability and security of essential medicines within the European Union. The European Commission aims to zero in on critical medicines, incorporating a vulnerability assessment to pinpoint products at risk of supply disruption and tailor solutions effectively.
A key point of contention is the proposed definition of “medicinal products of common interest.” Currently, this encompasses any medicine unavailable in at least three member states, which risks transforming a focused framework into an overly broad mechanism covering nearly all medicines on the market. This could obscure the distinction between supply challenges and access issues, which require different policy approaches.
If the CMA applies its measures universally, it could dilute priorities, stretch healthcare budgets, and create additional administrative burdens for the industry, ultimately failing to deliver substantial benefits for patients. A more effective approach would be to restrict the definition to cases of clear market failure, directing resources toward genuinely critical medicines that are demonstrably at risk of supply disruptions.
Joint Procurement: A Double-Edged Sword
Central to the CMA’s strategy is the concept of joint procurement to tackle supply and access challenges. While this method could improve availability under certain conditions, it must address the root causes of access delays and shortages, which differ based on geography and product types.
For medicines impacted by fragile supply chains, joint procurement can be advantageous, particularly when it enhances predictability and economic viability for suppliers. Lessons learned from the Covid-19 pandemic have highlighted the effectiveness of coordinated purchasing in specific instances. However, the benefits diminish in countries where products are already accessible or where access barriers could be resolved through improved national pricing and reimbursement systems.
For joint procurement to be beneficial, necessary safeguards must be in place. Tenders should prioritize quality and stimulate innovation, acknowledging the societal value of innovative medicines. Price confidentiality is vital to prevent unintended consequences, such as reference pricing impacts. Furthermore, once joint procurement agreements are established, additional national negotiations or expenditure controls should not complicate matters. Allowing national procurement processes to proceed concurrently will be crucial for maintaining flexibility and avoiding delays.
Addressing broader supply fragility requires reducing strategic dependencies, enhancing transparency across supply chains, and avoiding rigid national stockpiling regulations. Tackling access issues necessitates a reevaluation of national pricing and reimbursement practices, alongside a more proactive governmental stance on rewarding the value of innovative medicines.
Rethinking Protectionism
One of the most debated aspects of the CMA is the push to prioritize medicines produced within the EU. The rationale suggests that increasing local production will diminish reliance on non-EU countries, bolster strategic autonomy, and ultimately enhance supply security. While this perspective is understandable, it risks oversimplifying the complexities of modern pharmaceutical manufacturing.
Currently, Europe boasts one of the most substantial pharmaceutical manufacturing sectors globally, with an impressive 71 percent of its production exported. This output relies on intricate global supply networks for active ingredients, raw materials, and specialized technologies. Implementing local-content requirements or preferential treatment for EU-produced medicines could disrupt these networks, fragment supply chains, and inflate costs, without necessarily bolstering resilience.
Moreover, such protectionist measures could jeopardize Europe’s trade relationships and weaken its industrial base over the long term. They may also distort competition within the single market, undermining the competitiveness of both European and international companies operating in the region. The result could be less diversity and greater concentration in supply chains, which runs counter to the goal of a resilient pharmaceutical ecosystem.
If procurement criteria referencing resilience or strategic autonomy are introduced, they must be proportionate and tied to clear supply risks. Well-intentioned protectionist policies cannot replace the broader framework needed to maintain Europe’s attractiveness for investment in research, development, and manufacturing.
Looking Ahead: A Call for Collaboration
The CMA presents a significant opportunity to reshape Europe’s pharmaceutical landscape. The European Parliament has proposed more consistent contingency stock rules, which could prove beneficial if they focus solely on medicines genuinely at risk of shortage. Additionally, the act could streamline reporting processes by leveraging existing systems rather than establishing new ones.
Policymakers must recognize that broader regulatory initiatives directly influence Europe’s ability to manufacture and supply medicines. A cohesive policy framework is crucial for fortifying resilience within the industry.
Ultimately, Europe must realize that achieving supply security cannot come at the expense of the industry that guarantees it. The CMA’s success hinges on addressing the right challenges with appropriate solutions while keeping competitiveness at the forefront. The pharmaceutical industry stands ready to engage with EU and national policymakers to facilitate this process. A high-level forum including all stakeholders could be instrumental in guiding the CMA’s implementation, enhancing supply security, and expediting patient access, while reinforcing Europe’s status as a global leader in life sciences.
