{"id":25866,"date":"2026-01-21T17:28:03","date_gmt":"2026-01-21T15:28:03","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/critical-medicines-act-forte-segnale-politico-per-lindustria\/"},"modified":"2026-01-26T14:53:50","modified_gmt":"2026-01-26T12:53:50","slug":"critical-medicines-act-forte-segnale-politico-per-lindustria","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/regulatory\/legislation\/critical-medicines-act-forte-segnale-politico-per-lindustria\/","title":{"rendered":"Critical Medicines Act sends a strong political signal to industry"},"content":{"rendered":"

On 20 January 2026, the European Parliament approved the Critical Medicines Act <\/a><\/strong>by a broad, cross-party majority.
A politically significant outcome, to be read not only as a response to the medicine shortages that have emerged in recent years, but also as a clear message to the pharmaceutical industry and the European manufacturing value chain.<\/p>\n

The issue is no longer merely a matter of public health.<\/strong>
It is industrial, strategic, and geopolitical.<\/p>\n

From shortages to an industrial policy<\/h2>\n

Over the past five years, the European Union has experienced a structural vulnerability: recurring shortages of essential medicines, dependence on extra-EU supplies, and fragile supply chains.<\/p>\n

The Critical Medicines Act was conceived to turn emergency-driven management into a structured policy framework<\/strong>, integrated with the broader reform of European pharmaceutical legislation.<\/p>\n

The stated objective is twofold:<\/p>\n

    \n
  • \n

    to ensure continuity of access to critical medicines<\/strong><\/p>\n<\/li>\n

  • \n

    to strengthen Europe\u2019s manufacturing capacity<\/strong><\/p>\n<\/li>\n<\/ul>\n

    European manufacturing and procurement as strategic levers<\/h2>\n

    One of the most relevant elements for the sector is the strengthened role of public procurement as an instrument of industrial policy.<\/p>\n

    The text explicitly opens the door to:<\/p>\n

      \n
    • \n

      tender criteria that value EU-based production<\/strong><\/p>\n<\/li>\n

    • \n

      joint procurement mechanisms<\/strong><\/p>\n<\/li>\n

    • \n

      tools designed to support local manufacturing capacity in the most vulnerable segments<\/p>\n<\/li>\n<\/ul>\n

      For many companies\u2014particularly those operating in the mature, low-margin medicines segment<\/strong>\u2014this represents a potential shift in perspective: from the risk of disinvestment to renewed strategic centrality.<\/p>\n

      Supply chain: resilience over efficiency<\/h2>\n

      The CMA also marks a cultural shift. Resilience<\/strong>\u2014understood as the system\u2019s ability to withstand shocks, crises, and disruptions without interrupting access to medicines\u2014formally enters the regulatory objectives<\/strong>, alongside quality, safety, and cost efficiency.<\/p>\n

      For the value chain, this translates into:<\/p>\n

        \n
      • \n

        greater focus on the localisation of APIs<\/strong><\/p>\n<\/li>\n

      • \n

        reduced dependence on single countries or suppliers<\/strong><\/p>\n<\/li>\n

      • \n

        a possible rethinking of just-in-time models<\/strong><\/p>\n<\/li>\n<\/ul>\n

        This is not yet an explicit reshoring policy, but the direction is clear.<\/p>\n

        Expected impacts on the pharmaceutical industry<\/h2>\n

        From an industrial perspective, the Critical Medicines Act raises several key questions:<\/p>\n

          \n
        • \n

          which manufacturing segments will be deemed \u201ccritical\u201d?<\/p>\n<\/li>\n

        • \n

          what concrete incentives will accompany the new requirements?<\/p>\n<\/li>\n

        • \n

          how will costs, economic sustainability, and supply obligations be balanced?<\/p>\n<\/li>\n<\/ul>\n

          The Parliament\u2019s vote does not close the debate, but it raises the political bar ahead of the trilogue negotiations with the Council and the Commission.<\/p>\n

          A building block of the European Health Union<\/h2>\n

          The CMA fits into the vision of a more integrated European Health Union, where access to medicines is treated as a matter of collective security.<\/p>\n

          Within this framework, industry is not merely a supplier, but a systemic actor\u2014called upon to engage on production, stockpiling, planning, and risk.<\/p>\n

          What happens next<\/h2>\n

          The text now enters the interinstitutional negotiation phase. The coming months will be decisive in determining:<\/p>\n

            \n
          • \n

            the degree of flexibility for companies<\/p>\n<\/li>\n

          • \n

            the concrete impact on manufacturing models<\/p>\n<\/li>\n

          • \n

            the level of coordination among Member States<\/p>\n<\/li>\n<\/ul>\n

            One thing is certain: critical medicines are now firmly embedded in the European industrial agenda.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

            With broad cross-party support, the European Parliament has approved the Critical Medicines Act.
            \nThe proposal aims to strengthen the production, supply, and resilience of critical medicines, directly affecting the industrial and procurement strategies of the European pharmaceutical sector.<\/p>\n","protected":false},"author":35,"featured_media":25845,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1101,822],"tags":[],"class_list":{"0":"post-25866","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-highlights-en","8":"category-legislation"},"yoast_head":"\nCritical Medicines Act: che cosa cambia per l\u2019industria pharma - MakingPharmaIndustry<\/title>\n<meta name=\"description\" content=\"The EU Parliament approves the Critical Medicines Act.Access to medicines, production, and supply chain resilience become strategic priorities for the pharmaceutical industry.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/makingpharmaindustry.it\/en\/regulatory\/legislation\/critical-medicines-act-forte-segnale-politico-per-lindustria\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Critical Medicines Act: che cosa cambia per l\u2019industria pharma - 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