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Critical Medicines Act

Public health

The initiative will address supply chain vulnerabilities of critical medicines and reduce Europe’s dependencies to strengthen the supply of critical medicines. It will aim to improve availability of other medicines of common interest. The proposal will complement the reform of the EU pharmaceutical legislation and will build on the work of the Executive Steering Group on Shortages of Medicines, Structured Dialogue on security of medicines supply, Critical Medicines Alliance, and a supporting study.

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Public consultation

ID: 14486

Lobbying Activity

131 responses

BEUC urges public health priority in new Critical Medicines Act

Bureau Européen des Unions de Consommateurs, 27 Feb 2025

BEUC calls for financial aid to pharmaceutical companies to be tied to rules on medicine affordability. They recommend expanding joint purchasing across Europe for expensive treatments. They also advocate for supporting non-profit drug manufacturing to address shortages.
This would lower costs for the millions of households currently facing medicine shortages.
Pharmaceutical companies would face stricter obligations and mechanisms to return excess profits to states.

AmCham EU warns against protectionism in medicine supply chains

American Chamber of Commerce to the European Union, 26 Feb 2025

The group urges the EU to avoid protectionist localisation and maintain open trade. They request expanded mutual recognition agreements and harmonised regulatory requirements for packaging.
Avoiding local production mandates reduces manufacturing inefficiencies and lowers overall compliance costs.
National stockpiling policies harm other Member States by undermining access to critical medicines.

Chemical industry urges EU support for medicine manufacturing base

European Chemical Industry Council, 27 Feb 2025

The group demands financial support and simplified funding to strengthen Europe's pharmaceutical manufacturing base. They want public procurement to prioritize local production instead of just the lowest price. The organization requests a reduction in administrative red tape and compensation for high energy costs.
These measures would reduce operational costs and help European firms compete against cheaper Asian imports.
Asian medicine producers would lose their competitive price advantage in the European procurement market.

Consultation response

European farmers, 4 Jul 2025

Copa-Cogeca welcomes the European Commissions initiative to strengthen the resilience of the supply chain for critical medicinal products, and its alignment with the EUs One Health approach. The proposal rightly recognises the interdependence of human, animal, and environmental health and the need…

Consultation response

European Federation of Pharmaceutical Industries and Associations, 4 Jul 2025

EFPIA welcomes the objectives of the Critical Medicines Act (CMA) to reinforce supply chain resilience and improve the availability of medicines for patients across Europe. To achieve these goals effectively and without unintended consequences, the Acts implementation should be targeted,…

EFPIA urges innovation-focused Critical Medicines Act with streamlined rules

European Federation of Pharmaceutical Industries and Associations, 26 Feb 2025

EFPIA calls for an act that promotes innovation and avoids rigid targets for local production. They recommend replacing national stockpiling with EU-level coordination and streamlining regulatory processes using digital data.
The industry would avoid fragmented regulations and reduce costs through streamlined manufacturing authorizations.
Smaller EU countries lose medicine access if large markets implement separate stockpiling requirements.

Bayer Urges Thorough Impact Assessment Before Critical Medicines Act

Bayer AG, 27 Feb 2025

Bayer requests a thorough impact assessment before publication and streamlined administrative requirements. They want the Act to avoid duplication between national and EU systems. Any incentives for EU manufacturing should consider existing regulations and prioritize existing facilities with competitive advantages.
This would reduce administrative costs and protect existing European manufacturing investments.
Generic medicine suppliers face stricter requirements while innovative medicines experience fewer disruptions.

Consultation response

MEDICINES FOR EUROPE, 4 Jul 2025

Medicines for Europe welcomes the proposal for a Critical Medicines Act and its objectives. Building on the proposal and the growing need for health security, we underline the importance of market reforms, a partnership for investment in manufacturing and the need for EU solidarity. Demand-side…

Medicines for Europe Demands Bold Reforms to Secure Critical Medicine Supply

MEDICINES FOR EUROPE, 26 Feb 2025

The organization demands reformed State Aid frameworks to support off-patent medicines, mandatory procurement criteria prioritizing supply security over price, and dynamic pricing mechanisms that adjust for inflation. They call for a European solidarity stock system and strengthened global partnerships.
This would unlock investment for their manufacturing facilities and prevent pricing pressures that make products unprofitable.
Member states pursuing lowest-price procurement lose flexibility to national healthcare cost-containment strategies.

Union demands social conditionalities for EU medicine manufacturing

industriAll European Trade Union, 27 Feb 2025

The union calls for mandatory social conditionalities on public investments and a Buy European approach to foster domestic production. They advocate for tying state aid to the protection of quality employment, collective bargaining, and cost-free training programs.
This strategy would secure higher quality jobs and better protections for industrial workers.
Foreign producers with lower labor or environmental standards could lose access to contracts.

MedTech Europe Urges Exclusion From Critical Medicines Act

MedTech Europe, 27 Feb 2025

MedTech Europe recommends that medical technologies remain excluded from the Critical Medicines Act. They argue that solutions effective for pharmaceuticals are not applicable for medical devices.
This would prevent the imposition of unsuitable pharmaceutical regulations on their complex supply chains.

Consultation response

The Danish Chamber of Commerce, 5 May 2025

The Danish Chamber of Commerce/Dansk Erhverv representing appr. 500 Danish and international life science companies located in Denmark, defined by biotech, medtech and pharma companies, welcomes the European Commissions initiative on Critical Medicines Act. The new geopolitical reality requires…

Consultation response

EuropaBio, 4 Jul 2025

EuropaBio supports the goal of the Critical Medicines Act (CMA) to strengthen the security of supply for medicines in the EU. Medicine shortages have various causes and require tailored solutions. Addressing long-standing external dependencies and rebuilding manufacturing capacity will require…

EuropaBio advocates for targeted rules in Critical Medicines Act

EuropaBio, 26 Feb 2025

EuropaBio recommends focusing new requirements on companies with a history of medicine shortages. They suggest excluding rare disease medicines and prioritizing strategic partnerships over new legislation.
This would minimize administrative expenses and prevent unnecessary regulatory pressure on biotech manufacturers.
Organizations that have failed to prevent medicine shortages would be subject to stricter oversight.

Johnson & Johnson calls for harmonized EU medicine supply rules

Johnson Johnson, 27 Feb 2025

J&J urges the EU to harmonize national measures and avoid additional complexity. They request a risk-based approach that differentiates between critical and vulnerable medicines. Finally, stockpiling should be coordinated at the EU level to ensure solidarity.
These changes would lower compliance costs and protect their international manufacturing networks.
Member States lose individual control over national stockpiling and local procurement criteria.

Danish Agriculture and Food Council urges veterinary medicine focus

Landbrug Fødevarer - Danish Agriculture and Food Council, 26 Feb 2025

The council highlights that penicillin supply for production animals is limited due to few production sites. They call for new medicines to treat prevalent animal diseases.
Securing medicine supplies would help Danish farmers maintain healthy livestock and production levels.

Consultation response

Affordable Medicines Europe, 1 Jul 2025

Affordable Medicines Europe welcomes the opportunity to contribute to this public consultation on the Critical Medicines Act (CMA). Our association represents the independent distribution of medicines across the EEA. By moving medicines between countries at lower prices than standard local rates,…

Consultation response

Affordable Medicines Europe, 21 Feb 2025

Affordable Medicines Europe welcomes the opportunity to contribute to this consultation. We represent the independent distribution of medicine across the EEA. By moving medicines between countries at prices lower than standard local rates, parallel trade boosts competition, generates savings for…

Pfizer Warns EU Critical Medicines Act Risks Undermining Innovation

Pfizer Inc., 4 Jul 2025

Pfizer requests risk-based measures and comprehensive impact assessment before implementation. They advocate for strategic partnerships and diversified trade rather than local production requirements. The company opposes expanding joint procurement beyond health emergencies and seeks narrower focus on Union List medicines.
This would preserve their global supply chain flexibility and prevent costly localization requirements.
European manufacturers lose advantage as rules favor Pfizer's global production model over local supply.

Pfizer advocates for global partnerships to secure medicine supplies

Pfizer Inc., 27 Feb 2025

Pfizer requests that the EU prioritize international trade agreements and global manufacturing diversity over local production requirements. They also advocate for harmonized stockpiling rules and procurement processes that reward supply continuity.
Pfizer avoids the high costs of localizing production by maintaining its existing global manufacturing network.
Supporters of European strategic autonomy lose if policies favor global networks over local manufacturing.

DSW urges gender-sensitive policies for EU Critical Medicines Act

DSW (Deutsche Stiftung Weltbevoelkerung), 27 Feb 2025

DSW recommends that contraceptives and maternal medications be included in critical lists. They advocate for leveraging EU-Africa partnerships to support local pharmaceutical manufacturing. The organization also suggests formal advisory mechanisms for civil society participation.
These measures would contribute to a healthier and more equitable world.
Suppliers focusing on lowest costs may lose out to ethical procurement models.

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 4 Jul 2025

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges the European Commission's proposal for the Critical Medicines Act (CMA). Initially expected to focus solely on shortages of critical medicines (also in light of the work within the Critical Medicines Alliance), the…

EUCOPE demands impact assessment for Critical Medicines Act

European Confederation of Pharmaceutical Entrepreneurs, 27 Feb 2025

EUCOPE urges the Commission to conduct a proper impact assessment before publishing. They argue measures should focus strictly on the Union List of Critical Medicines. Financial incentives are requested to help small companies diversify their manufacturing capacity.
Small firms would gain financial support and lower administrative costs for production.
Patients risk shortages of non-critical drugs if procurement rules are extended too widely.

Orano urges EU to include nuclear medicine in critical list

Orano, 21 Feb 2025

Orano requests expanding the EU's critical medicines list to include emerging radioelement treatments. They also call for an ambitious budget for the European Radioisotope Valley Initiative. Finally, they advocate for stronger financial incentives through state aid frameworks.
This framework would secure subsidies and market support for Orano's radioisotope production.

Consultation response

Association of the European Self-Care Industry, 6 Jul 2025

In response to the ECs Proposal for Critical Medicines Act, AESGP would like to draw attention to the specific case of Non-Prescription Medicines (NPMs). There are more than 200 APIs, available without prescription in Europe, and over 4.000 different products. With a high number of NPM…

AESGP warns against mandatory onshoring of non-prescription medicines

Association of the European Self-Care Industry, 27 Feb 2025

The association requests that non-prescription drugs remain exempt from aggressive onshoring requirements due to their low shortage risk. They recommend prioritizing global supply chains and trade agreements over localizing production within Europe. They also call for mandatory impact assessments on any other laws affecting pharmaceutical production costs.
Avoiding mandatory onshoring prevents significant industrial expenses and maintains current medicine affordability.
Patients may suffer from reduced access and higher prices if production shifts occur prematurely.

Consultation response

Standing Committee of European Doctors, 20 Jun 2025

CPME Statement on the European Commission proposal for a Critical Medicines Act.

European doctors demand mandatory stocks to solve medicine shortages

Standing Committee of European Doctors, 17 Feb 2025

CPME calls for mandatory safety stocks of finished medicinal products at the producer level. They also request that doctors receive up-to-date information on shortages and available alternatives.
Better availability and information would help doctors protect patient safety during systemic medicine shortages.
Pharmaceutical producers would face higher operational costs from new mandatory requirements to maintain stocks.

Consultation response

Boehringer Ingelheim, 6 Jul 2025

Boehringer Ingelheim is a leading research-driven biopharmaceutical company dedicated to improving human and animal health. As one of the industrys top global investors in R&D, we focus on creating innovative therapies that address areas of significant unmet medical need, enhancing and extending…

Consultation response

AnimalhealthEurope, 4 Jul 2025

AnimalhealthEurope represents manufacturers of animal medicines, vaccines, and other animal health products across Europe. Our membership includes corporate and national animal health associations, innovators, generics, and companies of all sizes, covering 90% of the European market for animal…

AnimalhealthEurope urges One Health approach for critical medicine supplies

AnimalhealthEurope, 27 Feb 2025

The organization calls for the inclusion of veterinary medicine supply chains in the Critical Medicines Act. They advocate for a One Health approach that recognizes the shared raw materials between human and animal drugs.
This would protect the animal health sector from supply shortages caused by human-centric regulations.
Public health is at risk if neglected animal health leads to zoonotic disease outbreaks.

Feed industry urges EU support for domestic additive production

Fédération Européenne des Fabricants d'Aliments Composés, 25 Feb 2025

FEFAC requests that availability of medicines be considered simultaneously for human and animal care. They call for an ambitious plan to support investments in manufacturing capacity.
Boosting internal production would protect the livestock chain from dramatic consequences of supply ruptures.
Third-country exporters would lose market dominance as Europe reduces its dependency on foreign substances.

Ecolab Urges Modernization of Pharmaceutical Manufacturing Quality Standards

ECOLAB, 25 Feb 2025

Ecolab advocates updating regulatory guidelines to adopt international quality standards and modernize production. They suggest standardizing cleaning requirements to reduce the validation burden on manufacturers.
Modernizing standards would increase demand for Ecolab's specialized manufacturing solutions and digital tools.

Consultation response

Teva Pharmaceuticals Europe BV, 4 Jul 2025

Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar, and innovative portfolio in plants across 13 European countries. In 2024 alone, Teva saved healthcare systems more than 3.4 billion USD across 17 European countries, supporting over 104,000…

Consultation response

Teva Pharmaceuticals Europe BV, 27 Feb 2025

Teva is a strategic partner of Europes healthcare systems, producing 96% of its generic, biosimilar and innovative portfolio in 13 member states in which we support more than 120,000 jobs. Our portfolio covers 42% of the medicines on the Union List of Critical Medicine, of which 70% are still…

Reproductive rights group urges inclusion of contraception

Center for Reproductive Rights, Inc., 27 Feb 2025

Include contraception and abortion medication in the upcoming Critical Medicines Act. Align the European Union list with World Health Organization standards.
This would protect medicine supplies from shortages and political interference.
Anti-rights governments lose the ability to restrict access by stopping production.

Consultation response

Deutsche Sozialversicherung Europavertretung, 30 Jun 2025

With the proposal for a Regulation on a Critical Medicines Act (CMA), the European Commission aims to strengthen the security of supply of critical medicinal products and reduce geopolitical dependencies in pharmaceutical production and supply. The German Social Insurance (DSV) expressly welcomes…

German Social Insurance urges EU to fund drug production

Deutsche Sozialversicherung Europavertretung, 25 Feb 2025

The group argues that diversifying production is an industrial policy task that must be funded by the EU rather than health insurance contributions. They demand evidence-based criteria for critical drugs to ensure measures do not disproportionately increase costs. Additionally, they call for mandatory shortage reporting and penalties for non-compliance.
This prevents the diversion of insurance funds and maintains the system's financial stability.
Drug manufacturers would face higher administrative burdens and significant fines for supply failures.

Healthcare distributors urge EU funding for medicine supply resilience

European Healthcare Distribution Association, 27 Feb 2025

The association requests financial incentives and funding to support wholesalers as critical infrastructure. They also propose harmonized stockpiling and rules to ensure equitable distribution through wholesale channels.
Subsidies and service fees would compensate wholesalers for the costs of distributing low-margin medicines.
Manufacturers could face restrictions on direct-to-pharmacy sales and new costs for mandatory stockpiling.

Consultation response

Pharmaceutical Group of the European Union, 27 Jun 2025

Medicine shortages have become a persistent threat to public health across Europe. Despite community pharmacists continued efforts to find solutions, we continue to see a negative impact on patients health and a concerning erosion of patients trust in the medicines supply chain. In 2024,…

Consultation response

Pharmaceutical Group of the European Union, 26 Feb 2025

The Pharmaceutical Group of the European Union (PGEU) welcomes the European Commissions initiative for a Critical Medicines Act as a necessary step to improve the availability of medicines for European patients. PGEU represents over 400,000 community pharmacists across Europe, who are on the…

Consultation response

Cooperativas Agro-alimentarias de España, 29 Apr 2025

Reforzar la disponibilidad y la seguridad del suministro de medicamentos críticos, así como la disponibilidad y accesibilidad de los medicamentos de interés común es esencial para asegurar la salud a nivel europeo. Sin embargo, consideramos que la propuesta presentada es insuficiente ya que no…

DSM-Firmenich Urges EU Support for Vulnerable Drug Ingredient Makers

DSM-Firmenich, 27 Feb 2025

DSM-Firmenich recommends targeted funding and tax incentives to bolster domestic drug ingredient manufacturing. They propose assessing supply chain vulnerabilities and reforming pricing models to ensure long-term producer profitability.
These subsidies would offset high compliance costs and improve the firm's global competitiveness.
Public health budgets may face higher costs if procurement prioritizes resilience over cheap imports.

Consultation response

European Social Insurance Platform AISBL, 3 Jul 2025

The European Social Insurance Platform (ESIP) shares the growing concern over shortages of critical medicines across the EU and welcomes the objective of the proposal for a Critical Medicines Act to address vulnerabilities in the pharmaceutical supply chain. Any intervention to strengthen supply…

Pharma Deutschland urges long-term incentives for European medicine production

Pharma Deutschland e.V, 27 Feb 2025

Pharma Deutschland requests a review of environmental laws to protect supply security. They seek streamlined reporting and digital-only information to ease cross-border distribution.
This would lower compliance costs and improve profitability for mid-sized pharmaceutical manufacturers.
Environmental groups lose if wastewater standards are lowered to reduce industry financial pressure.

ESIP urges financial transparency in Critical Medicines Act

European Social Insurance Platform AISBL, 26 Feb 2025

The organization calls for strict conditions on public funding, requiring manufacturers to maintain stocks and prioritize European supply. They demand a full impact assessment to ensure new measures do not increase medicine prices. Furthermore, they advocate for public transparency regarding research and production incentives to aid price negotiations.
This would help social insurers maintain affordable patient access and healthcare system sustainability.
Pharmaceutical manufacturers would face new reporting burdens and financial penalties for supply failures.

Consultation response

European Respiratory Society, 6 Jul 2025

European Respiratory Society and European Lung Foundation feedback on European Commissions proposal for a Regulation - 2025/102 (COD) The European Respiratory Society (ERS) and the European Lung Foundation (ELF) support the European Commissions proposal for a Critical Medicines Act. Strengthening…

CSL Behring Urges EU to Bolster Plasma Supply Chains

CSL Behring, 26 Feb 2025

The organization calls for increased plasma collection within Europe and a network of trusted partner countries. They propose mandatory tender criteria to reward supply reliability and urge a reconsideration of pricing policies. They also advocate for flexible, interconnected stockpiles instead of uncoordinated national requirements.
Reforming pricing and tender rules would improve the company's profitability and market stability.
National health budgets may face higher costs if price containment policies are relaxed.

Consultation response

European Society for Paediatric Oncology, 4 Jul 2025

The European Society for Paediatric Oncology (SIOPE) welcomes the EUs ongoing efforts of complementing the measures present in the EU Pharmaceutical legislation with the Critical Medicines Act (CMA) to address critical medicine shortages impacting childhood cancer patients. Each year in Europe,…

Paediatric oncology group urges EU to protect essential medicines

European Society for Paediatric Oncology, 27 Feb 2025

The organization requests the inclusion of essential paediatric oncology treatments in the Critical Medicines List. They also want paediatric cancer experts consulted during legislative updates.
This would safeguard the availability of off-patent medicines and reduce clinical risks.
Children and adolescents currently face health risks due to persistent medicine shortages.

Transgender Europe urges recognition of hormones as essential medicines

Transgender Europe, 21 Feb 2025

Hormones must be officially recognized as essential medications to ensure consistent supply. They recommend relaxing rules for alternative prescriptions and importing unlicensed drugs during shortages.
Categorizing hormones as essential would protect trans people from health risks and unregulated markets.
Pharmaceutical companies could face reduced profit margins from joint procurement and pricing transparency.

Consultation response

Bundesverband der Pharmazeutischen Industrie e.V., 4 Jul 2025

The German Pharmaceutical Industry Association (BPI) welcomes the European Commissions initiative to reinforce Europes role as a pharmaceutical production hub. We support measures such as promoting strategic projects, streamlining administrative processes, and revising procurement criteria to…

German pharma group BPI urges investment in medicine production

Bundesverband der Pharmazeutischen Industrie e.V., 27 Feb 2025

The association recommends limiting the rules to the Union List of Critical Medicines. They advocate for state aid and tax credits to support European manufacturing. They also call for drug procurement to prioritize supply security over price.
The industry would benefit from increased subsidies and reduced competition from low-cost imports.
Public health budgets may face higher costs if purchasing focuses on factors beyond price.

Consultation response

European Society for Medical Oncology (ESMO), 11 Jun 2025

The European Society for Medical Oncology (ESMO) - a professional society representing over 40,000 members from 179 countries and territories - welcomes the European Commissions (EC) proposal for a Critical Medicines Act (CMA) and strongly supports its objective to enhance the resilience and…

Takeda advocates for tailored rules on critical medicine supply

Takeda Pharmaceuticals International AG, 27 Feb 2025

The organization requests a risk-based approach that avoids duplicating existing regulations. They oppose national stockpiling for plasma-derived products and urge focus on increasing plasma collection.
Tailored regulatory measures would prevent disruptions to complex manufacturing and lower inventory costs.
Patients in some regions lose access if national stockpiling causes medicine shortages elsewhere.

Consultation response

Federation of Veterinarians of Europe, 5 Jul 2025

The Federation of Veterinarians of Europe (FVE), representing over 330,000 veterinarians across Europe, welcomes the European Commissions initiative to strengthen the resilience of the supply chain for critical medicinal products through the proposed Critical Medicines Act and appreciates the…

Consultation response

The European Association of Hospital Pharmacists, 4 Jul 2025

Medicine shortages remain a serious threat to patient safety and quality of care across Europe. The European Association of Hospital Pharmacists (EAHP), representing over 29,000 hospital pharmacists in 37 countries, was the first healthcare professional organisation to raise the alarm on medicine…

Consultation response

Cancer Patients Europe, 4 Jul 2025

Cancer Patients Europe (CPE) welcomes the European Commissions proposal for a Critical Medicines Act (CMA) as a vital step toward preventing medicine shortages, especially for patients facing life-threatening conditions such as cancer. A resilient medicine supply chain must be anchored in public…

European veterinarians urge inclusion of animal health in Medicines Act

Federation of Veterinarians of Europe, 27 Feb 2025

The federation requests that veterinary medicines be included in the Act to reflect shared manufacturing processes. They call for an ambitious mitigation plan to strengthen the resilience of animal health supplies. This includes investing in European production to reduce reliance on external suppliers.
A more resilient supply chain would prevent medicine shortages for diverse animal species.
Food safety and security are threatened if animal medicine shortages remain unaddressed.

Consultation response

The European Association of Hospital Pharmacists, 27 Feb 2025

The European Association of Hospital Pharmacists (EAHP) has been at the forefront for addressing medicines shortages and ensure patients access to medicines for over a decade. The Critical Medicines Act has the potential to constitute a major step forward in ensuring access to medicines.…

Cancer Patients Europe demands central role in medicine supply law

Cancer Patients Europe, 26 Feb 2025

CPE calls for patient organisations to be meaningfully involved in policy design and implementation. They also advocate for public manufacturing and repurposing off-patent drugs to resolve shortages.
Patients would secure more reliable access to life-saving treatments regardless of their location.
Private drug suppliers may face competition from new public and not-for-profit manufacturing initiatives.

Consultation response

F. Hoffmann-La Roche Ltd, 4 Jul 2025

F. Hoffmann-La Roche Ltd (Roche) shares the objectives of the EC to bolster supply chain resilience and improve patient access across Europe. Roche's comments below are complementary to EFPIA's consultation response, which we endorse. To ensure that the goals to reinforce supply chain resilience…

Consultation response

Bundesärztekammer, 24 Apr 2025

(Please find our full statement attached) The German Medical Association (GMA) welcomes the objective of the proposed Regulation and supports its approach to encourage Member States (MS) to prioritise production in Europe, apply differentiated tendering criteria, and expand voluntary joint…

Bundesärztekammer calls for mandatory reporting to end medicine shortages

Bundesärztekammer, 27 Feb 2025

The association demands a medicine reserve, incentives for EU-based production, and mandatory reporting of shortages. They argue that pharmaceutical companies should face criminal penalties for failing to disclose supply disruptions.
Doctors would benefit from fewer disruptions to daily clinical operations and improved patient safety.
Pharmaceutical companies would face higher compliance costs and legal risks from mandatory reporting requirements.

Roche Urges EU to Treat Swiss Production as Reliable

F. Hoffmann-La Roche Ltd, 25 Feb 2025

Roche requests that the Critical Medicines Act focuses strictly on the Union List of Critical Medicines. They want Swiss production recognized as a reliable partner to avoid supply risk labels. They also call for streamlined administration using existing data to avoid duplication.
This ensures Roche's Swiss production remains competitive and minimizes regulatory compliance costs.
Manufacturers in non-G7 regions may lose market share if procurement shifts away from lowest-price criteria.

Consultation response

Hospodářská komora České republiky, 4 Jul 2025

You will find the comments of the Czech Chamber of Commerce in the attachement.

Czech Chamber of Commerce urges market-based solutions for medicine shortages

Hospodářská komora České republiky, 27 Feb 2025

The focus should shift to generic medicines and utilizing existing market mechanisms like parallel distribution. They oppose creating new IT monitoring systems, preferring to use data already available in current verification databases.
Using existing data and market channels would reduce administrative burdens and lower costs.
Societies suffer from reduced competition and higher costs driven by fragmented national incentives.

Consultation response

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 4 Jul 2025

Plasma Protein Therapeutics Association (PPTA), representing leading manufacturers of life-saving plasma-derived medicinal products (PDMPs) and companies collecting plasma for fractionation, welcomes the Commission's efforts to address supply chain vulnerabilities to strengthen the availability of…

Plasma industry warns against one-size-fits-all EU medicine rules

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 26 Feb 2025

The PPTA requests a tailored regulatory approach that recognizes the unique, non-synthetic nature of plasma-derived medicines. They oppose mandatory national stockpiling, arguing it disrupts regional supply and worsens shortages for patients in other countries. They also call for streamlined reporting systems and expanded private sector plasma collection across the EU.
Tailored rules would lower production costs and prevent logistical disruptions from mandatory stockpiling.
Patients in smaller member states lose access if large nations monopolize limited plasma stocks.

Consultation response

European Association of E-Pharmacies, 26 Feb 2025

As the organisation representing the voice of the online pharmacy sector in Europe, the European Association of E-Pharmacies (EAEP) is particularly concerned with the growing issue of medicine shortages in Europe. This phenomenon stems from manufacturing issues, supply chain disruptions, and market…

Consultation response

European Blood Alliance, 25 Feb 2025

There are 17 plasma-derived medicinal products in the Union list of critical medicines (version 2). The starting material for these medicines is human plasma, some of which is imported from the US. In the attached response to the consultation, public and non-profit blood establishments, as the…

Consultation response

Deutsche Krankenhausgesellschaft e.V., 17 Apr 2025

Die deutschen Krankenhäuser begrüßen die Intention des vorgelegten Verordnungsentwurfes ausdrücklich. Der Umgang mit Arzneimittellieferengpässen ist bereits seit einigen Jahren eine fordernde Aufgabe für Politik und für alle an der Lieferkette und Gesundheitsversorgung beteiligten Akteure.…

Consultation response

Deutsche Krankenhausgesellschaft e.V., 24 Feb 2025

Als Dachorganisation der 1.874 deutschen Krankenhäuser in öffentlicher, freigemeinnütziger und privater Trägerschaft beteiligt sich die Deutsche Krankenhausgesellschaft (DKG) bereits seit vielen Jahren konstruktiv an den gesundheitspolitischen Debatten auf EU-Ebene. Insbesondere bei den…

Consultation response

BGP Products Operations GmbH – a Viatris Company, 3 Jul 2025

Viatris as one of the major suppliers of critical medicines to the European market welcomes the European Commissions proposal for a Regulation on the Critical Medicines Act as a vital step toward ensuring availability and security of supply of critical medicinal products. To further strengthen…

Consultation response

BGP Products Operations GmbH – a Viatris Company, 27 Feb 2025

Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a robust supply chain designed to reach 1billion patients globally. We are one of the main providers of critical medicines in European markets, supplying approximately half…

Consultation response

Corbion, 10 Jun 2025

Corbion welcomes the European Commissions initiative to strengthen the resilience and sustainability of the pharmaceutical supply chain through the Critical Medicines Act. As a European-based manufacturer of high-quality fermentation-derived ingredients, including lactic acid and its derivatives,…

Consultation response

CCI Europe, 4 Jul 2025

Childhood Cancer International - Europe (CCI-E) welcomes the European Commissions proposal for a Critical Medicines Act (CMA) and fully supports its objective to strengthen the EUs supply resilience for essential medicines. Representing Children, Adolescent, and Young Adult (CAYA) cancer patients,…

Consultation response

CCI Europe, 27 Feb 2025

Childhood Cancer International - Europe (CCI-E, or CCI Europe) is the biggest pan-European childhood cancer parents and survivors organisation. It represents childhood cancer parent and survivor groups as well as other childhood cancer organisations in Europe: 64 organisations in more than 30…

Consultation response

France Assos Santé, 2 Jul 2025

France Assos Santé (FAS), qui regroupe une centaine dassociations de patients et dusagers, contribue depuis de nombreuses années à la lutte contre les pénuries de médicaments en France et au niveau de lUE. A ce titre, nous accueillons favorablement la proposition de règlement visant à renforcer la…

Consultation response

Associazione delle Imprese del farmaco, 27 Feb 2025

Per l'industria farmaceutica è prioritario garantire l'accesso dei pazienti ai farmaci e filiere di fornitura sostenibili e resilienti. Farmindustria, in linea con EFPIA, sostiene gli obiettivi della Commissione UE di stimolare l'innovazione in Europa e di rafforzare le filiere di fornitura.…

Consultation response

Association Mieux Prescrire, 2 Jul 2025

The attached document outlines the position of Prescrire on the proposal for a Critical Medicines Act.

Consultation response

Roquette, 27 Feb 2025

Roquette, excipients and APIs producer, appreciates the opportunity to contribute to this important consultation, as APIs and excipients are integral to the formulation of safe and effective medicines, contributing to public health and the EU's strategic autonomy in pharmaceuticals. We welcome the…

Consultation response

Association Mieux Prescrire, 19 Feb 2025

Prescrires response to the Call for evidence on a Proposal for a Critical Medicines Act (19 February 2025) Shortages of medicines are a long-standing problem in Europe and beyond. In our view the Critical Medicines Act should focus more on a better visibility on vulnerabilities of the supply chain…

Consultation response

Becton Dickinson, 5 Feb 2025

The visibility of the supply chain, stocks and demand, in the down stream is critical to anticipate and improve management of medication shortages. This visibility of the supply chain in conjunction with Data analytics and AI systems, have multiple benefits: 1. Improved Forecasting and Inventory…

Consultation response

European Hospital and Healthcare Federation, 30 Jun 2025

Overall, HOPE welcomes the ambition to strengthen the resilience of the pharmaceutical supply and is positive about the direction of the proposal Critical Medicines Act submitted to consultation. HOPE considers however that: - The proposed regulation needs a strong impact assessment. - The proposed…

Consultation response

Access VetMed, 4 Jul 2025

Access VetMed, representing the industry of generic and added-value veterinary medicines in Europe, welcomes the European Commissions initiative to establish a Critical Medicines Act and appreciates the opportunity to contribute to this important consultation. We strongly support the efforts to…

Consultation response

The Employers' Union of Innovative Pharmaceutical Companies, 3 Jul 2025

The Employers' Union of Innovative Pharmaceutical Companies INFARMA (Poland) supports the goals of the Critical Medicines Act (CMA), particularly in strengthening medicine supply chains and improving patient access across the EU. However, the Act's success depends on a careful, risk-based approach…

Consultation response

Verband Forschender Arzneimittelhersteller e.V., 6 Jun 2025

The German association of research-based pharmaceutical companies (vfa) welcomes the political goal of increasing the resilience of pharmaceutical supply chains, reducing unilateral dependencies, and ensuring long-term security of supply in Europe. The vfa notes that different product categories,…

Consultation response

The Employers' Union of Innovative Pharmaceutical Companies, 27 Feb 2025

The Employers' Union of Innovative Pharmaceutical Companies INFARMA (Poland) supports the European Commission's goal of fostering innovation in Europe and ensuring a sustainable, resilient supply chain. The goal of a Critical Medicines Act should prioritize innovation and actively support the…

Consultation response

International Patient Organisation for Primary Immunodeficiencies, 27 Feb 2025

Medicine shortages are a real challenge for patients requiring therapies for life, such as those living with primary immunodeficiencies (PIDs) and associated conditions. IPOPI, the International Patient Organisation for Primary Immunodeficiencies, welcomes the prioritisation of tackling medicines…

Consultation response

Nuclear Medicine Europe, 26 Feb 2025

Nuclear Medicine, Europe (NMEU) represents the majority of the pharmaceutical & imaging equipment companies in the field of Nuclear Medicine and follows European initiatives pertaining to medical applications of ionising radiation. Every year, more than 10 million patients in Europe benefit from…

Consultation response

Zentiva Group a.s., 4 Jul 2025

Zentiva is a major European manufacturer of affordable, high-quality medicines, with EU production sites in Prague and Bucharest. We produce around 600 million packs annually and serve 100 million patients across Europe. As a company integrated into EU supply chains, we are directly affected by the…

Consultation response

Hollandbio, 30 Jun 2025

Hollandbio heeft zowel zelfstandig als in samenwerking met Empowered by Us een standpunt geschreven over de Critical Medicines Act. Beiden hebben we in de bijlage bijgevoegd.

Consultation response

Zentiva Group a.s., 27 Feb 2025

The European Commissions efforts to reinforce pharmaceutical manufacturing in the EU and strengthen supply chains are a welcome step. However, achieving true resilience requires a well-coordinated approach among EU and national authorities. A lack of alignment between policies, fragmented…

Consultation response

K+S Aktiengesellschaft, 27 Feb 2025

Support and strengthening of domestic production is the easiest way to achieve goals of Critical Medicines Act for potassium and magnesium salts The EU Commission announced a proposal for a Critical Medicines Act on 30th January 2025. The overall goal is to support the security of supply and the…

Consultation response

Cerus Europe B.V., 27 Feb 2025

Cerus Corporation welcomes the European Commission's initiative to establish a Critical Medicines Act. We urge the Commission to acknowledge the critical role of blood, blood components, and enabling medical devices in ensuring a resilient healthcare system. The attached document provides detailed…

Consultation response

Forum of International Research and Development Pharmaceutical Companies, EIG, 3 Jul 2025

Forum of International Research and Development Pharmaceutical Companies (EIG), the Slovenian innovative pharmaceutical industry association, supports the European Commissions objective to strengthen the resilience of pharmaceutical supply chains and improve access to critical medicines across the…

Consultation response

EUROPEAN CHEMICAL REGIONS NETWORK, 2 Jul 2025

The European Chemical Regions Network (ECRN) strongly supports the objectives of the Critical Medicines Act, recognizing the strategic importance of securing the supply and accessibility of essential medicines across Europe. As an alliance representing diverse chemical regions, we underline the…

Consultation response

Medicines for Poland, 5 May 2025

Dear Please find attached the position paper of Medicines for Poland. Yours sincerely

Consultation response

INSUD PHARMA, 26 Feb 2025

Please, find attach our feed-back provided.

Consultation response

ASOCIACIÓN NACIONAL EMPRESARIAL DE LA INDUSTRIA FARMACÉUTICA, 24 Feb 2025

Farmaindustria, como representante de la industria farmacéutica innovadora en España, está comprometida con garantizar el acceso de los pacientes a los medicamentos que necesitan. Un ejemplo fue la respuesta del sector a la COVID-19, con el rápido desarrollo de vacunas y la adaptación de las…

Consultation response

Medicines for Poland, 24 Feb 2025

Europe's growing dependence on the supply of raw materials necessary for pharmaceutical production from sources outside our continent has been the subject of debate at EU level for several years. The Critical Medicines Act, which has been announced for years and explicitly mentioned in the 'EU…

Consultation response

Forum of International Research and Development Pharmaceutical Companies, EIG, 21 Feb 2025

Please see attached the feedback from the Slovenian Inovative Pharma Industry Association

Consultation response

UNESSA, 4 Jul 2025

As an union of Belgian federations (UNESSA, Zorgnet-Icuro, GIBBIS and Santhea), we feel that a European approach to the supply of critical medicines is both relevant and necessary, and any regulation in this area must be grounded in a thorough impact assessment that considers the entire medicinal…

Consultation response

ASOCIACION ESPAÑOLA DE BIOEMPRESAS, 4 Jul 2025

AseBio, the Spanish Association of Biocompanies, represents the Spanish biotechnology sector, brings together a diverse ecosystem of over 300 entities, including innovative small and medium-sized enterprises (SMEs), large corporations, and other vital players. AseBio actively collaborates with…

Consultation response

VÖWG, 4 Jul 2025

Aus Sicht des Verbands der öffentlichen Wirtschaft und Gemeinwirtschaft (VÖWG) ist es zu begrüßen, dass die EU im Bereich der Versorgungssicherheit von Arzneimitteln aktiv wird. Gleichzeitig enthält der Rechtsvorschlag einige regulatorische Mängel: 1. Finanzielle und beihilferechtliche Hürden für…

Consultation response

European Research Infrastructure for Translational Medicine, 16 Jun 2025

The draft regulation contains many commendable elements and serves as a strong foundation for a resilient pharmaceutical supply system. However, to fully realise its objectives, we recommend the inclusion of provisions supporting advanced personalised manufacturing, formulation innovation for…

Consultation response

Blood Transfusion Association, 27 Feb 2025

The Blood Transfusion Association (BTA) welcomes the European Commissions initiative to strengthen the resilience of Critical Medicines supply chains in the EU. However, while ensuring pharmaceutical production and distribution is essential, the availability of medical devices required for the…

Consultation response

UNESSA, 27 Feb 2025

UNESSA (Belgium), the Federation of Care, Support, Assistance, and Personal Care, wishes to highlight several key elements regarding the future Critical Medicines Act. It emphasizes the relevance and necessity of a European approach to ensuring the supply of critical medicines. A coordinated…

Consultation response

European Platform for the Responsible use of medicines in animals, 27 Feb 2025

EPRUMA is a multi-stakeholder platform operating since 2005, linking best practice with animal health, public health and environmental health. The platform has European organisations as members and national organisations as associate members, representing supply chains from animal breeding, to feed…

Consultation response

European Association of Nuclear Medicine, 27 Feb 2025

The European Association of Nuclear Medicine (EANM) welcomes the opportunity to provide input on this Call for Evidence on the EU Critical Medicines Act. Please find the EANM feedback attached.

Consultation response

Polish Confederation Lewiatan, 27 Feb 2025

We fully support the work on the Critical Medicines Act. Our organization's position is attached.

Consultation response

European Research Infrastructure for Translational Medicine, 27 Feb 2025

Ensuring the availability of critical medicines is essential for patient care, public health, and healthcare system resilience. Medicine shortages pose serious risks, particularly for essential and off-patent medicines with few or no alternatives. Shortages disproportionately affect underserved…

Italian consumer group urges EU to boost medicine production

U.Di.Con. APS Unione per la Difesa dei Consumatori, 26 Feb 2025

U.Di.Con. requests economic incentives for EU-based manufacturers to increase domestic production of critical drugs. They also propose regulating exports to third countries and launching campaigns to prevent medicine misuse.
Consumers would benefit from more stable supplies and reduced risks of medicine shortages.
Pharmaceutical exporters would lose revenue from potential restrictions on selling to non-EU markets.

Consultation response

Pro Generika e.V., 26 Feb 2025

Pro Generika, the German Association of generic and Biosimilar medicines, welcomes that the Critical Medicines Act acknowledges the importance of this sector as the backbone of medicinal supply. However, the legislation should not be drafted without the thorough involvement of the industry and its…

Consultation response

Movimento Difesa del Cittadino, 19 Feb 2025

Il Movimento Difesa del Cittadino valuta positivamente la proposta della Commissione Europea per latto legislativo sui medicinali critici. Con il documento allegato siamo lieti di proporre il nostro contributo ai lavori della DG Sante. Dal 2018 al 2024 il numero di farmaci a rischio carenza in…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 4 Jul 2025

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA welcomes a proposal for a Critical Medicines Act as a clear effort to mitigate critical…

Consultation response

Empowered By Us, 1 Jul 2025

Empowered By Us welcomes the opportunity to contribute to the implementation of the Critical Medicines Act. This submission focuses on the specific vulnerabilities faced by rare disease patients and low-volume therapies within European medicine supply systems. It highlights structural equity gaps…

Consultation response

Allgemeine Ortskrankenkasse-Bundesverband, 30 Jun 2025

As statutory health insurance funds, the AOKs insure around 27.5 million people in Germany and provided services worth 115 billion euros in 2024. The draft Regulation aims to strengthen the security of supply and availability of critical medicines. Specific measures envisaged are: Expanding…

Consultation response

Österreichischer Generikaverband, 26 Jun 2025

Stellungnahme der pharmazeutischen Industrie in Österreich zum Verordnungsvorschlag COM(2025) 102 final ("Critical Medicines Act"). Erstellt vom Fachverband der chemischen Industrie (FCIO), dem Österreichische Generikaverband (OeGV) und PHARMIG Verband der pharmazeutischen Industrie Österreichs.…

Consultation response

Egualia, 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…

Consultation response

syndicat de l’industrie chimique organique de synthèse et de la biochimie, 19 May 2025

Le Sicos se réjouit de la mise à lagenda européen de la nécessité de renforcer les chaînes de valeur de médicaments critiques en soutenant et valorisant une base industrielle durable et performante en Europe. Ce sujet est porté depuis de nombreuses années par le SICOS qui alerte sur les…

Consultation response

Medac Gesellschaft für klinische Spezialpräparate m.b.H., 27 Feb 2025

medac ist ein in Deutschland ansässiges Pharmaunternehmen mit Produktion in Deutschland und Tschechien, produziert und vertreibt derzeit 15 pharmazeutische Medikamente auf der Unionsliste kritischer Arzneimittel v.2 und der Schwerpunkt unserer Absatzmärkte liegt in Europa. Daher begrüßt medac die…

Consultation response

Egualia, 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…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 27 Feb 2025

EFA welcomes a proposal for a Critical Medicines Act, as EU-level action is fundamental to address the global issue of access to medicines. EU legislation can help tackle cross-border shortages of medicinal products and increase EU-wide security of supply, contributing to access to medicines for…

Consultation response

Consorci de Salut i d'Atenció Social de Catalunya, 27 Feb 2025

The Consorci de Salut i Social de Catalunya (CSC) welcomes the opportunity to provide input to the Call for Evidence on the proposed Critical Medicines Act. As a central purchasing body for hospitals and other non-profit entities in our region, the CSC plays a key role in ensuring the continuous…

Consultation response

Allgemeine Ortskrankenkasse-Bundesverband, 27 Feb 2025

AOK statutory health insurance funds insure about 27.5 million people in Germany providing benefits worth 107 billion Euros in 2023. The AOK welcomes recent efforts to tackle shortages of medicinal products and secure patient care in the EU following a coordinated approach. We express concerns…

Consultation response

Ινστιτούτο Φαρμακευτικής Έρευνας & Τεχνολογίας ΜΑΕ, 27 Feb 2025

Please find attached the contribution of Institute of Pharmaceutical Research & Technology (IFET SA) - Supply chain challenges. EU-Level Coordination: Enhancing coordination at the EU level to effectively tackle supply chain challenges. This includes harmonizing regulations and fostering…

Consultation response

European Industrial Pharmacists Group, 26 Feb 2025

EIPG members fully support the objectives and ongoing efforts to ensure sustainable and reliable access to critical medicines. The participation of a heterogeneous group of stakeholders to submit ideas and contributions to support the development of the draft law to integrate proposals from a wide…

Consultation response

Asociación Española de Fabricantes de Química para la Salud, 26 Feb 2025

We are AFAQUIM, the Spanish Association of APIs Manufacturers and proud members of MfE, EFCG and the Critical Medicines Alliance. We are pleased to have been part of the collaborative efforts between authorities and stakeholders, where all voices were heard in the process of drafting a law on…

Consultation response

SEQENS, 21 Feb 2025

As the Strategic Report of the Critical Medicines Alliance highlights, the European pharmaceutical supply chain is currently facing significant challenges due to its heavy reliance on non-EU countries for Active Pharmaceutical Ingredients (APIs), intermediates and starting materials. This…