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Executive Summary
The European Union is entering a new era of strategic public procurement. Through the Critical Medicines Act (CMA) and the forthcoming Public Procurement Act, the EU is deliberately transforming how public money is spent: shifting from a rules-based, lowest-price model to one that actively advances industrial competitiveness, supply chain resilience, the green transition, and European strategic autonomy. Healthcare and Life Sciences sit at the heart of this transformation.
For Life Sciences companies, these reforms create both significant risks and substantial opportunities. Companies that proactively adapt their supply chains, manufacturing footprints, sustainability performance, and tender capabilities will gain competitive advantages in public procurement and tenders across Europe. Those that treat the changes as a compliance exercise risk losing market share to more agile competitors.
At a Glance: Timeline & Headline Impacts
May 2026
CMA Political Agreement
!High: Immediate preparation needed
September 2026
Public Procurement Act Proposal
!Medium–High: Monitor & engage now
2027 (Phased)
CMA Application
!Very High: Operational changes required
2030–2031
Full General Act + Green Public Procurement (GPP) Mainstreaming
!High: Strategic positioning critical now
Key Takeaways for Life Sciences Leaders
- The Critical Medicines Act introduces near-term mandatory resilience criteria and EU preference mechanisms for critical medicines, with application expected from 2027.
- The general Public Procurement Act (proposal expected September 2026) will mainstream sustainability, resilience, and “Made in Europe” criteria across all health procurement, with full effect around 2030–2031.
- Green Public Procurement (GPP) criteria will become significantly more prominent and, in many cases, mandatory or heavily weighted in healthcare tenders.
- Winners will be companies that treat these reforms as a strategic transformation: investing in EU manufacturing, supply chain transparency, carbon reduction, and value-based tender capabilities.
- Marbls recommends immediate portfolio and supply chain assessments, combined with green procurement readiness reviews for all clients with material EU public sector exposure.
1. The Paradigm Shift: From Price to Strategic Value
The 2026 reforms represent one of the most significant shifts in EU public procurement policy in over a decade. The European Commission is explicitly repositioning public procurement as a tool of industrial policy, green transition, and strategic autonomy, rather than purely as a mechanism to ensure competition and value for money in the narrowest sense.
This evolution builds on the evaluation of the 2014 EU Public Procurement Directives, which found that while transparency had improved, the use of strategic and qualitative criteria remained uneven and the rules had become overly complex. The new framework aims to correct these shortcomings while aligning procurement more closely with the EU’s broader priorities under the Clean Industrial Deal and Single Market Strategy.
Lowest price
Limited
Generally restricted
Voluntary / patchy
Administrative / compliance function
2. Key Changes: What Is Coming
The Critical Medicines Act (CMA): Near-Term & High Impact
The CMA is the more immediate and sector-specific instrument. It was designed to address the growing problem of medicine shortages in Europe by combining supply-side measures (support for EU manufacturing) with demand-side measures (new public procurement rules). A political agreement was reached in May 2026, with formal adoption expected later in 2026 and phased application from 2027.
Core procurement provisions
- Mandatory resilience and non-price criteria: Contracting and Tendering Authorities must incorporate factors such as supply chain diversification, monitoring and traceability, stock obligations, and environmental sustainability when awarding contracts for critical medicines.
- EU preference mechanism: For medicines with confirmed high dependence on third-country suppliers, authorities are required to favour suppliers that manufacture a significant proportion of the product or active ingredients in the EU.
- Facilitated collaborative and joint procurement: Lower thresholds for Member States to request Commission support for joint purchasing, enabling larger-scale contracts and better negotiating power.
Critical Medicines, Supply Chain Transparency & Resilience Requirements
The CMA introduces the most concrete and near-term obligations regarding supply chain transparency and resilience. These obligations are primarily triggered by medicines included on the Union list of critical medicines.
What are the critical medicines subject to mandatory resilience criteria?
Mandatory resilience criteria (including MEAT evaluation with resilience weighting and EU preference mechanisms) apply to medicines on the “Union list of critical medicines”. This list currently contains over 270 medicines (Version 2.1, updated January 2026) and is maintained by the European Commission, EMA, and Heads of Medicines Agencies.
A medicine is generally included on the “Union list” if it meets the following three cumulative criteria:
| Inclusion criterion | Description & examples |
|---|---|
| Serious harm potential | Shortages can cause serious harm to patients or public health (e.g., life-saving antibiotics, insulin, oncology medicines, anesthetics, certain vaccines) |
| Limited alternatives | There are no or very limited therapeutic alternatives available |
| Supply chain vulnerability | Identified vulnerabilities such as high concentration of production in one or two third countries, single-source API dependency, or limited manufacturing redundancy |
The majority of medicines on the list are older, off-patent generic products. The list is dynamic and is reviewed and updated periodically based on shortage data and vulnerability assessments conducted by EMA and Member States.
Critical categories for supply chain transparency
The highest mandatory transparency and resilience obligations currently apply to medicines on the Union list of critical medicines. However, the broader public procurement reform is extending similar expectations to other high-risk areas in healthcare.
| Critical category | Key transparency focus | Primary legal basis |
|---|---|---|
| Union list (Critical Medicines) | Full supply chain mapping (API to finished product), supplier diversification, geographic concentration, traceability | Critical Medicines Act (CMA) |
| APIs & Key Starting Materials | Origin of API, number of qualified suppliers, single-source risks, manufacturing site transparency | CMA + General Procurement Reform |
| Sterile injectables, antibiotics, insulin, oncology, anesthetics | Stock levels, contingency capacity, manufacturing redundancy, supply disruption early warning | CMA (primary) |
| Critical components in Medical Devices | Semiconductors, microelectronics, specialty chemicals, batteries, contrast media components — high import dependency mapping | General Public Procurement Reform + Critical Raw Materials Act |
| Critical Raw Materials used in Life Sciences | Rare earths, lithium, cobalt, specific excipients — diversification away from single third countries | Critical Raw Materials Act + Procurement Reform |
Resilience Requirements for Critical Components and Technologies
Beyond medicines, the general Public Procurement Act reform is introducing resilience criteria for “critical components and technologies” across strategic sectors, including healthcare. These requirements are less prescriptive than those in the CMA but are becoming increasingly important in public procurement and tender design.
Definition of critical components and technologies
In the context of the procurement reform, “critical components and technologies” generally refers to items where the EU has high strategic dependency and where supply disruption would have significant economic, security, or health impacts. They are primarily defined by reference to:
- The EU list of Critical Raw Materials (updated regularly)
- Strategic technologies under the Net-Zero Industry Act, Chips Act, and Clean Industrial Deal
- High-dependency healthcare inputs (e.g., semiconductors for connected medical devices, specialty polymers, contrast agents, certain excipients and starting materials)
We are seeing public buyers increasingly incorporate resilience criteria even before the new legislation is fully transposed. In our advisory work, clients who can provide clear, auditable supply chain maps, evidence of diversification efforts, and credible EU manufacturing optionality are gaining measurable advantages in both medicine and medical device tenders. Conversely, suppliers with opaque or highly concentrated supply chains are facing growing challenges in winning or retaining framework agreements.
Sources: European Commission roadmap on public procurement reform (Clean Industrial Deal context); Net-Zero Industry Act; Critical Raw Materials Act; Council position on Critical Medicines Act (December 2025).
Green Public Procurement (GPP): Key Updates and Impacts for Life Sciences
“Green Public Procurement (GPP)” is the European Union’s approach to encouraging public authorities to procure goods, services, and works with a reduced environmental impact throughout their lifecycle. While GPP has existed as a voluntary policy for many years, the 2026 Public Procurement reform is expected to significantly strengthen and mainstream it, moving environmental criteria from “nice-to-have” to a core part of tender evaluation in many sectors, including healthcare.
What is changing with GPP in the new framework?
The evaluation of the 2014 directives showed that while many contracting and tendering authorities wanted to apply green criteria, they often lacked clear guidance, standardised criteria, and legal certainty. The new framework addresses these barriers by:
- Mainstreaming lifecycle costing and environmental performance criteria as standard elements of MEAT evaluation
- Providing clearer, more harmonised definitions and verification methods (aligned with the Ecodesign for Sustainable Products Regulation “ESPR” and other horizontal legislation)
- Encouraging or requiring sector-specific green criteria, including for healthcare products and services
- Linking GPP more explicitly to the EU’s broader climate, circular economy, and net-zero objectives
Key impacts for Life Sciences manufacturers
The strengthening of GPP will have differentiated but significant impacts across the Life Sciences sector:
| Segment | Key GPP-related impacts & expectations |
|---|---|
| Pharmaceuticals |
|
| Medical Devices & Diagnostics |
|
| Hospital & Health System Procurement |
|
Sources: European Commission GPP criteria and strategy documents; Ecodesign for Sustainable Products Regulation (ESPR); evaluation of the 2014 Public Procurement Directives; national green procurement pilots in healthcare (Nordics, Netherlands, Germany).
We are seeing a clear acceleration in buyer expectations around sustainability in healthcare tenders, even before the new legislation is finalised. Clients who have invested in robust environmental data, including lifecycle assessments, carbon accounting aligned with the requirements from the Corporate Sustainability Reporting Directive (CSRD), and credible circularity strategies, are already able to differentiate themselves in tenders. Conversely, companies that treat GPP as a future compliance issue rather than a current competitive factor are losing ground. We strongly advise Life Sciences companies to treat green procurement readiness as a strategic priority alongside resilience and EU manufacturing considerations.
Risks & Opportunities Matrix
Key risks
- Loss of tenders due to inability to meet new resilience, EU content, or green criteria
- Margin pressure from localisation, dual-sourcing, or environmental compliance costs
- Increased compliance and documentation burden across multiple regulatory streams
- Competitive disadvantage versus more agile or EU-centric peers
Key opportunities
- Higher win rates and improved margins through value-based and green differentiation
- Access to larger collaborative/joint procurement contracts and strategic project support
- Strengthened competitive position through transparent, resilient, and lower-carbon supply chains
- Long-term moat via integrated resilience + sustainability capabilities
3. Implications for Life Sciences Companies
The combined effect of the CMA, the general procurement reform, and the mainstreaming of Green Public Procurement is a clear strategic signal: public buyers will increasingly reward companies that can demonstrate resilient and transparent supply chains, meaningful European manufacturing content where it matters, and strong environmental performance across the product lifecycle.
For Pharmaceutical & Biotech Companies
- Highest immediate exposure through the CMA on the critical medicines portfolio
- Need to develop verifiable data on EU manufacturing share and supply chain resilience for public procurement and tender responses
- Growing importance of environmental footprint data (manufacturing emissions, packaging, transport) as GPP criteria strengthen
- Opportunity to engage in collaborative procurement mechanisms and strategic project support
For MedTech & Diagnostics Companies
- Primary impact through the general reform and strengthened GPP criteria
- Lifecycle costing, circular design, and material sustainability becoming more prominent in hospital procurement and framework tenders
- Supply chain resilience requirements likely to expand to critical components and raw materials
- Opportunity to leverage innovation procurement procedures for advanced and digital health solutions
4. Immediate Actions and Recommended Roadmap for Life Sciences Manufacturers (2026–2030)
Drawing on our client engagements, we recommend the following priority actions for Life Sciences companies with significant EU public sector exposure:
For Pharmaceutical & Biotech Companies
- Map current portfolio against the “Union list of critical medicines” and identify exposure levels
- Conduct integrated supply chain resilience and environmental footprint audit
- Assess current EU manufacturing footprint and develop options for increasing “significant proportion” manufactured in the EU where strategically relevant
- Develop or enhance capabilities to generate lifecycle assessment data and environmental product declarations aligned with emerging GPP requirements
- Build internal tender response frameworks that address resilience, EU content, and green criteria in an integrated manner
For MedTech & Diagnostics Companies
- Review major hospital framework agreements and identify emerging lifecycle costing, circularity, and carbon criteria
- Develop or enhance lifecycle cost and environmental impact modelling capabilities for priority product lines
- Map supply chain vulnerabilities for critical components and raw materials, including environmental risks
- Train market access, tender, and sustainability teams on integrated value-based and green procurement responses
- Monitor national green procurement pilots and early adopters in healthcare to anticipate criteria evolution
Companies that begin this journey in 2026 with a structured, integrated programme covering resilience, EU manufacturing optionality, and green capabilities will be significantly better positioned than those that address these issues reactively or in isolation. Early movers consistently achieve better risk mitigation and competitive outcomes.
To ensure full readiness for the evolving EU public procurement landscape, Marbls recommends that Life Sciences manufacturers adopt a structured, phased approach spanning from immediate actions in 2026 through to full operational readiness by 2030. The roadmap below integrates resilience, EU manufacturing considerations, and Green Public Procurement requirements.
| Phase | Key actions & focus areas | Recommended Marbls support |
|---|---|---|
| 2026 Immediate – Q3/Q4 |
|
|
| 2027 CMA Application Phase |
|
|
| 2028–2029 Preparation for General Reform |
|
|
| 2030 Full Operational Readiness |
|
This roadmap is indicative and should be tailored to each company’s specific portfolio, geographic footprint, and risk exposure. Marbls recommends starting with a comprehensive readiness assessment in 2026 to prioritise actions and allocate resources effectively.
5. Looking Ahead: The 2030 Procurement Landscape
By 2030, we anticipate that public procurement and tenders in the Life Sciences sector will be characterised by the following features:
- Widespread, often mandatory use of resilience, sustainability, and innovation scoring in virtually all significant healthcare public procurement and especially tenders
- Material European preference mechanisms in place for critical medicines and designated strategic health technologies
- Lifecycle costing and carbon footprint evaluation as standard elements of tender assessment in hospital and framework procurement
- Larger-scale collaborative and joint procurement becoming the norm for high-volume or strategically important categories
- A clear competitive divide between companies that built integrated resilience, European optionality, and green capabilities; and those that did not
The companies that will thrive in the 2030 landscape are those that view public procurement not merely as a sales channel, but as a strategic arena in which to compete on resilience, European value creation, and environmental performance. The regulatory changes simply accelerate and formalise a shift that leading buyers were already beginning to make. The winners will be those who treat this as a multi-year capability-building journey that starts immediately.
How Marbls Can Help
At Marbls, we combine deep expertise in EU public procurement policy with extensive practical experience advising Life Sciences companies on market access strategy, tender excellence, supply chain transformation, and sustainability integration. We help clients convert regulatory change into sustainable competitive advantage.
Our relevant services
- Integrated CMA & Green Procurement Readiness Assessments: Portfolio mapping, gap analysis, and prioritised action plans covering resilience, EU content, and environmental criteria
- Supply Chain Resilience & EU Footprint Strategy: Comprehensive audits, scenario modelling, and implementation support for localisation and diversification decisions
- Green Public Procurement & Lifecycle Excellence: Development of lifecycle costing tools, environmental data infrastructure, and GPP-compliant tender response capabilities & tools
- Value-Based Tender Capability Building: MEAT response frameworks, team training, and process redesign for complex healthcare tenders
- Strategic Project & Collaborative Procurement Advisory: Guidance on navigating joint procurement mechanisms, and engaging with public buyers for stakeholder engagement
- Ongoing Regulatory Monitoring & Tender Intelligence: Keeping clients ahead of national implementation, emerging buyer practices, and GPP criteria evolution
Appendix: Sources & Further Reading
This article is based on official EU documents, legislative tracking, stakeholder positions, and Marbls’ proprietary analysis and client work as of July 2026.
- European Parliament Legislative Train Schedule: Public Procurement Act
- European Commission: Public Procurement Portal, Evaluation of the Directives (SWD(2025)332), and 2026 Work Programme
- Critical Medicines Act: Commission documentation and May 2026 political agreement texts
- EMA: Union list of critical medicines (Version 2.1, January 2026) and related Q&A documents
- Euractiv and other reporting on reform timelines and political developments (2025–2026)
- Stakeholder positions from E3G, IISD, Orgalim, and industry associations on strategic procurement, GPP, and resilience criteria
- Council of the EU position on Critical Medicines Act (December 2025) and related trilogue outcomes
- European Commission GPP criteria, strategy documents, and Ecodesign for Sustainable Products Regulation (ESPR)