Egualia
EGUALIA è l'organo di rappresentanza ufficiale dell’industria dei farmaci generici equivalenti, dei biosimilari (rappresentati dall'Italian Biosimilars Group - IBG) e delle Value Added Medicines (rappresentate dal Gruppo VAM) in Italia.
ID: 856838295034-76
Lobbying Activity
Response to Critical Medicines Act
19 Jun 2025
Egualia, the Italian association representing the manufacturers of generic, biosimilar, shares the ECs objective of ensuring security of supply for critical medicines and strengthening Europe's pharmaceutical resilience. However, we believe that the current proposal does not go far enough in addressing the structural vulnerabilities of the off-patent medicines sector. The CMA must go beyond a consolidation of existing tools and provide new, robust, and targeted industrial policy instruments to safeguard the production of essential medicines in Europe. The off-patent sector provides a large share of critical and essential medicines at affordable prices. Yet, despite this essential role, the current market framework has led to excessive supplier consolidation and increasing fragility in supply chains. The CMAs budget of 80 million is insufficient when compared to international competitors. The CMA currently relies on existing incentive mechanisms that have proven ineffective in fostering EU-based production: The EU State Aid Map excludes industrialized areas, where many pharmaceutical manufacturers are located. Minimum investment thresholds (e.g. 20 million in Italy) exclude most SMEs in the off-patent sector, which represent around 70% of Egualias members. High administrative burdens, unequal Member State fiscal capacities, and incentives skewed towards R&D rather than large-scale manufacturing have all contributed to failed reshoring attempts post-COVID. Egualia recommends the establishment of new financial instruments that: Are funded through a dedicated EU budget line and do not burden national finances. Include light incentives for mid-size investments (between 5M and 20M). Support large-scale production and not only innovation or pilot projects. Eliminate geographical eligibility restrictions for industrial incentives. Streamline administrative procedures, e.g. fast-track authorisation for plant upgrades. Allow equitable access for SMEs. While the EU Critical Medicines List is a welcome step, the current version includes over 280 products, diluting the focus and reducing the effectiveness of targeted policy actions. Egualia recommends that: The list be reduced to cover medicines with real and current vulnerabilities in supply chains. Inclusion criteria should go beyond therapeutic importance to consider market structure and supplier concentration. National lists should be abolished in favor of a single, coordinated EU approach. Procurement practices remain a major driver of supply shortages. The use of single-winner tenders based solely on price has contributed to supplier exit, market concentration, and vulnerability to disruptions. Egualia urges the inclusion in the CMA of: Binding rules for Member States and regional agencies to conduct preliminary assessments of abnormally low bids. Obligations to apply MEAT (Most Economically Advantageous Tender) criteria, including supply security and ESG factors. A formal preference or bonus system for EU-based manufacturers where aligned with international trade obligations. The use of multi-winner tenders to reduce supply risk and improve resilience. We also caution against expanding joint procurement mechanisms beyond very specific use cases. Joint procurement should remain exceptional, and always be based on MEAT criteria. Stockpiling obligations, when imposed unilaterally by Member States, create internal market fragmentation and exacerbate shortages. Egualia recommends that: National stockpiling be avoided. A limited, EU-managed strategic reserve be created, focusing on critical antibiotics and emergency medicines. Industry contributions to such reserves be adequately compensated. The EC act as a coordinator to prevent national divergences and ensure solidarity-based redistribution of stocks during crises.
Read full responseResponse to Critical Medicines Act
27 Feb 2025
The Critical Medicines Act must lead to a resilient, competitive, and sustainable off-patent pharmaceutical industry. It must ensure secure supply chains, reward investment and strengthen Europes autonomy in critical medicines. 1. Invest in Resilient Manufacturing The EU must reverse the dangerous decline in local FDF and API production for off-patent medicines, including critical medicines, biosimilars and other products of essential interest. A secure off-patent sector requires: A reformed State Aid & IPCEI framework: Current policies fail to support essential off-patent medicines, which make up 90% of Europes critical medicine list. The Act must broaden the definition of innovation to include advanced manufacturing, automation, and sustainability, ensuring vital investment into this sector. Support for "First-of-a-Kind" Manufacturing: Europe cannot afford to lose its production sites for critical medicines. The Act must incentivize cutting-edge production facilities, enabling automation, continuous manufacturing, and environmental compliance while ensuring long-term security. Targeted Regional & Financial Aid: The EU should unlock regional funding for industrial parks and embed health security criteria into financial mechanisms like EU4Health. Dedicated funding for Critical Medicines Act via the MFF. 2. Stop Market Failures Driving Medicine Shortages Europes medicine shortages are due to pricing and procurement policies that prioritize cost-cutting over security. The Critical Medicines Act must: Mandate Secure & Strategic Procurement: Nearly 40% of all medicines in Europe are purchased through tenders. Current procurement models focusing on price-only undermine supply security. The Act must enforce MEAT criteria, ensuring that supply chain resilience, sustainability, and reliability become mandatory procurement criteria. Fix Broken Pricing Models: Inflexible pricing regulations cripple manufacturers during inflation and rising costs. The EU must: o Implement dynamic pricing mechanisms to prevent critical medicines from disappearing. o Encourage national pricing reforms that allow for inflation adjustments. o Enforce the Transparency Directive to align medicine pricing with long-term supply security. 3. Establish a European Solidarity Stock System National stockpiling rules are disrupting supply chains and worsening medicine shortages. Instead of uncoordinated national hoarding, the EU must: Foster the European Solidarity Mechanism that allows efficient medicine redistribution between member states during crises. Improve monitoring and stock allocation through existing tools such as EMVS. Foster reallocation of products through regulatory simplification tools such as e-leaflet, muti-country and EU packs. Allow for the same level of flexibility for MAHs in stock reallocation as it granted to parallel traders. 4. Strengthen Global Partnerships & Open Trade Protectionism and export bans worsen medicine supply chains in times of crisis. The Critical Medicines Act must: Prevent trade restrictions that threaten Europes access to essential medicines. Strengthen cooperation with international partners to ensure stable supply chains and coordinated crisis responses. 5. Tackle the Workforce Shortage in Pharmaceutical Manufacturing The EU must establish competence centres and fund large-scale upskilling and reskilling programs, ensuring that workers adapt to the industrys increasing digitalization and automation. The Critical Medicines Act must deliver bold, systemic reforms to prevent medicine shortages, reduce Europes reliance on fragile supply chains, and restore pharmaceutical resilience. Without immediate action, Europe will remain exposed to crises, losing its ability to provide secure and affordable medicines to its citizens.
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