As trilogue discussions on the Critical Medicines Act (CMA) advance, critical assessments regarding its potential impact on medicine supply, patient access, and Europe’s global competitiveness have emerged. The pharmaceutical industry is closely examining how this legislation can effectively support a robust healthcare ecosystem across the European Union.
Focus on Essential Medicines
Much of the dialogue surrounding the CMA emphasizes its role in enhancing the availability and security of critical medicines within the EU, as well as improving access to a broader range of pharmaceuticals. These objectives are widely supported by the industry. The European Commission has proposed a framework that targets critical medicines through a vulnerability assessment designed to identify products at risk of supply disruption.
However, the proposal also introduces a new classification of “medicinal products of common interest.” Under the current definition, any medicine unavailable in at least three member states would fall under this category, regardless of the reasons behind its unavailability. Critics argue that such a broad definition could dilute the effectiveness of the CMA, transforming a focused resilience strategy into an all-encompassing mechanism that addresses nearly every medicine on the market. This would blur the lines between supply and access challenges, which require distinct policy approaches.
The act’s effectiveness would be significantly enhanced if it concentrates on genuine market failures and directs measures towards medicines that face proven supply disruptions.
Joint Procurement: A Complex Solution
Central to the CMA’s strategy is the concept of joint procurement, intended to address both supply and access challenges. While this approach has the potential to improve availability in targeted situations, it must be carefully designed to tackle the root causes of access delays and shortages, which vary based on geography and specific products.
During the Covid-19 pandemic, coordinated purchasing demonstrated its effectiveness in certain contexts. For medicines where supply chain fragility is the primary concern, joint procurement could enhance predictability and economic viability for suppliers. In cases of access delays, it may also improve availability in regions suffering from market failures.
Yet, in countries where products are already accessible, the value of joint procurement diminishes. To prevent hindering access, several safeguards are necessary. Tenders should prioritize quality and innovation, ensuring that the value of new medicines is recognized. Additionally, protecting price confidentiality is crucial to avoid unintended consequences, such as reference pricing.
Once joint procurement agreements are in place, national renegotiations and expenditure control measures should be avoided to maintain commercial predictability. Allowing national procurement processes to function simultaneously will also be essential to preventing delays and preserving flexibility.
To effectively address the broader issues of shortages and access delays, a comprehensive strategy is required. This entails reducing strategic dependencies in supply chains, enhancing transparency, and adopting more flexible national stockpiling regulations. Furthermore, addressing national pricing and reimbursement challenges is vital for overcoming access delays.
Avoiding Protectionist Policies
The debate surrounding the CMA has also spotlighted the notion of prioritizing EU-made medicines. Proponents argue that increasing local production would reduce reliance on external sources and bolster strategic autonomy, ultimately improving supply security. However, experts warn that such a simplistic view overlooks the complexities of modern pharmaceutical manufacturing.
Europe maintains one of the strongest pharmaceutical manufacturing sectors globally, exporting 71 percent of its production. This success relies heavily on global supply networks for active ingredients and specialized technologies. Implementing local-content requirements or preferential treatment for EU products could disrupt these networks, fragment supply chains, and inflate costs, without necessarily enhancing resilience.
Protectionist measures may also adversely affect Europe’s trade relationships and weaken its industrial base in the long term. Such policies risk distorting competition within the single market and could lead to reduced diversity in supply chains, contrary to the goals of resilience.
If procurement criteria emphasizing resilience or strategic autonomy are employed, they must be proportionate and based on clearly identified dependencies or supply risks. Well-intentioned protectionist strategies cannot replace the broader policy framework necessary for fostering investment in research, development, and manufacturing.
The Path Forward for the CMA
The CMA presents a pivotal opportunity for European policymakers to address these pressing issues effectively. The European Parliament has proposed more consistent contingency stock rules, which could enhance the framework if focused on medicines genuinely at risk of shortage. Moreover, streamlining reporting processes by utilizing existing systems could increase efficiency.
Policymakers must remain mindful that broader regulatory initiatives directly influence Europe’s capacity to manufacture and supply medicines. A cohesive policy environment will be essential for strengthening resilience in the pharmaceutical sector.
Ultimately, Europe’s ability to achieve supply security is contingent upon empowering the industry that underpins it. The CMA will succeed only if it addresses the most pressing challenges with appropriate tools while prioritizing competitiveness. Engaging with stakeholders through high-level forums could facilitate the act’s implementation, ensuring it enhances supply security and accelerates patient access while reinforcing Europe’s status as a key player in the life sciences sector.
