Critical Medicines Act: Parliament ambition versus Council revision
The Critical Medicines Act receives over a thousand proposed amendments from MEPs - while the Council is determined to weaken its provisions
The EU’s Critical Medicines Act (CMA) is becoming the latest battleground between the European Parliament and the Council, as lawmakers clash over how ambitious Europe should be.
The European Parliament’s Public Health Committee (SANT) presented the feedback on Tomislav Sokol’s (EPP, Croatia) report on critical medicines today (6 November). In total the SANT committee tabled 1,313 amendments, with additional amendments from the Environment Committee (ENVI) - 119, Research and Industry Committee (ITRA) - 414, and the Internal Market Committee (IMCO) - 221.
Sokol said that there were six scheduled technical meetings in the coming weeks and that he still hoped that it would be possible to have a vote on 2 December.
Pharma package alignment
Some MEPs want a broader definition of medicinal products of common interest, Sokol wants to include orphan medicines and novel antimicrobials. But German MEP Tiemo Wölken, whose views were presented by fellow S&D member Nikos Papandreou, said that these medicines would probably be defined as ‘medicinal products of common interest’ (MPCIs) under the General Pharmaceutical Legislation (GPL).
Wölken said that MPCIs should be seen as areas suitable for joint procurement and should not be the focus of any limited resources foreseen under the Critical Medicines Act, Green MEP Tilly Metz was also realistic about the available resources and said a targeted approach was required.
While there are potential benefits of parallel negotiations on the Pharma Package and Critical Medicines Act, Wölken said that it was important that they were properly aligned; a view shared by other committees. This might be difficult with separate negotiations and separate trilogues.
Another concern - echoed by other committees - was the need to make the authorization of production facilities as straight forward as possible. ENVI, wants fast-tracked permits for EU manufacturing, simplified environmental assessments and support for strategic projects.
In general MEPs wanted a more centralized one-stop-shop portal for real time alerts and information sharing to better manage shortages.
Council will reign in parliament’s ambitions
While the European Parliament - and the SANT Committee, in particular - want to strengthen common European action, the Council’s proposed amendments replace many binding obligations with discretionary ones. The threshold for triggering Commission-led joint procurement rises from six to nine member states - other than in exceptional circumstances - making coordinated purchasing slower and less likely.
It was thought that the CMA could be a way to address the problems of access to medicines that the Pharma Package is seeking to address, but this is now looking less likely. The use of joint procurement was proposed by the Cypriot government as a potential way forward and received wide support, but by raising the number of states needed for EU coordination it means that it faces greater barriers to success.
Provisions on stockpiling are softened too, from a firm obligation not to harm other countries’ supplies to “shall aim at avoiding negative impact.” These are not imagined problems; when Germany imposed a six-month stockpiling requirement on pharmaceutical companies, it had knock-on effects in neighbouring countries. Czechia was particularly vocal about how this measure had hit the supply of medicines.
Whereas the parliament wants stronger wording to address resilience factors in procurement, the Council allows broad exceptions allowing price-only awards in cases of cost or urgency, undermining the drive to favour diversified and EU-based production. Likewise, the requirement that at least 25% of a medicine’s value be manufactured in the EU can now be met partly in trade-partner countries, diluting the reshoring goal.
Parliament’s push for stronger, more coordinated action contrasts sharply with the Council’s preference for flexibility and national discretion. The urgency of medicines during the COVID pandemic is fading, but the problems have not gone away. The provisions on shortages in the GPL may go some way to addressing the problems, but geopolitical pressures - especially from across the Atlantic - are a reminder that Europe could once again find itself dependent on others.
The Commission and Council compared
| Theme / Article | Commission Proposal | Council (Presidency) Compromise | Effect / Weakening |
|---|---|---|---|
| Scope & Definitions | “Critical medicinal product” defined by objective harm criterion (serious public-health risk from shortage). Tools apply to “critical” and “common-interest” medicines. | Makes “critical” status list-dependent; Chapter III (investment support) excluded for “common-interest” products. | Narrows scope; fewer medicines benefit from resilience and investment tools. |
| Strategic Projects (Ch. III) | Commission/EMA recognises projects directly; clear eligibility & fast-track support. | Member States designate authorities to “verify” if a project may be recognised; support granted upon request. | Moves power to MS; turns automatic EU recognition into optional, slower process. |
| Permitting & Inspections | Obligatory prioritisation of administrative and GMP steps for strategic projects. | “May prioritise… upon request.” | Removes obligation; weakens guaranteed acceleration. |
| Financial Support / Obligations (Arts 15-17) | Beneficiaries must supply EU market first; MS shall require prioritisation to avoid shortages. | “Best efforts” wording; MS may impose conditions or “request” supplies. | Turns binding EU supply duty into voluntary cooperation. |
| EU Funding | EU programmes and HERA instruments explicitly mobilised. | “Subject to annual budget procedure.” | Removes ring-fenced funding; reduces predictability. |
| Procurement – General (Art 18) | Contracting authorities shall use criteria beyond price; resilience factors mandatory. | Authorities must use “requirements other than price-only” but can choose form; many exceptions (urgency, cost, competition). | Keeps flexibility so wide that most can still award on price only. |
| Procurement – EU Manufacturing (Art 18 §2-3) | For vulnerable supply chains, preference for EU/EEA manufacturing mandatory. | Preference permitted, not required; allows suppliers from GPA/FTA countries; contract clause only needs low threshold (≈ 25 %). | Weakens on-shoring incentive; EU-production preference easily bypassed. |
| Medicines of Common Interest (Art 18 §4) | Must apply resilience-based requirements. | “May apply” such requirements. | Optional instead of mandatory. |
| National Programmes (Art 19) | MS to establish resilience procurement programmes within 6 months; coordinated via CMCG. | Deadline stretched to 12 months; CMCG only “discusses” coherence. | Slower and less binding implementation. |
| Stockpiles (Art 20) | MS stockpiling “shall not compromise supply in other MS.” | “Shall aim at avoiding negative impact.” | Converts hard non-harm rule into best-effort goal. |
| Cross-Border Procurement (Art 21) | Commission may coordinate joint actions; optional but strong facilitation role. | Commission purely facilitator, non-liable; voluntary participation; deadlines relaxed. | Weakens EU steering capacity. |
| Commission Procurement on behalf of MS (Art 22) | Triggered by ≥ 6 MS request; Commission may negotiate EU-wide. | Threshold raised to ≥ 9 MS (6 only “exceptionally”); extra proportionality & competition tests. | Harder to activate; more bureaucracy. |
| True Joint Procurement (Art 23) | ≥ 6 MS sufficient; Commission leads. | ≥ 9 MS; extra “necessity” & “non-distortion” checks; fully voluntary. | Makes EU-level joint buying less likely and slower. |
| Governance – CMCG (Arts 25-26) | Strong coordination role; may issue binding opinions. | Purely advisory; decisions by consensus; EMA only observer. | Limits central oversight; weak collective direction. |
| Transparency & Info-sharing (Arts 29-29a) | Commission access to data; public reporting with protection of genuine trade secrets. | Adds broad confidentiality shields; MS may object to disclosure for security reasons. | Reduces transparency; restricts market-monitoring. |