Critical Medicines Act

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 lives globally.

In general, the Czech innovative pharmaceutical industry supports the European Commission’s ambition to strengthen the medicines supply chain in Europe through the Regulation. The security of the pharmaceutical market should be regarded as an integral part of the EU’s broader security framework.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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.

The Czech Association of Pharmaceutical Companies represents manufacturers and suppliers of off-patent medicines in the Czech Republic, including those producing and supplying critical medicines. We welcome the Commissions proposal and its overarching objectives.

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.

The Austrian Economic Chamber welcomes in principle the aim of the proposal to increase the security of supply and the availability of critical medicines. In this context, the highest priority should be to ensure that these measures are feasible and that the requirements do not result in additional red tape or financial burdens for businesses.

Filed in German · English published by the European Commission

The European Unions Critical Medicines Act (CMA) is a prospective regulatory framework designed to reinforce pharmaceutical resilience across the EU. The COVID-19 pandemic emphasized the immense value of recombinant vaccines, revealing vulnerabilities in their global supply chains.

CSL is a leading global biotechnology company specializing in the development and manufacturing of plasma-derived medicinal products (PDMPs) and other innovative therapies for the treatment of rare and serious diseases such as those in hematology and immunology.

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 opportunity to contribute to this consultation.

Statement on the European Commission proposal for a Critical Medicines Act Childhood Cancer Ireland (CCI) 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.

J&J supports the EUs ambition to address long-term industrial challenges in supplying vulnerable critical medicines. The Act should reflect the EUs goals for a competitive life sciences ecosystem, consider the cumulative impact of EU initiatives, and prioritize simplification and competitiveness.

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.

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.

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 shortages at the European level over 12 years ago.

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 health products. We welcome the opportunity of providing feedback on the commission proposal for a Critical Medicines Act.

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.

Pfizer welcomes the European Commission's ambition to strengthen Europe's pharmaceutical supply chains and prevent shortages of critical medicines through the Critical Medicines Act (CMA). As a leading global pharmaceutical company, Pfizer operates one of the most sophisticated supply chain systems in the industry and manufactures a number of products on the Union List of Critical Medicines.

The European Commission presented the much-anticipated Critical Medicines Act, a proposal aimed at strengthening the resilience and autonomy of the EUs pharmaceutical supply chain. The European Brain Council (EBC) welcomes this initiative as an important step toward a stronger, more innovative, and competitive Health Union, particularly in light of increased geopolitical challenges and international tensions, as…

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 improve the production and availability of critical medicines.

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 product chain, from production to consumption.

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 jobs.

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 critical medicines.

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 for coordinated action across sectors.

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.

Critical Medicines Act Position of the Czech Chamber of Commerce The Czech Chamber of Commerce welcomes the opportunity to comment on the call for the evidence regarding Critical Medicines Act. You can find the comments of our members below. The pharmaceutical industry supports the European Commission’s objective of strengthening the resilience and security of the medicines supply chain in Europe.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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 sustained efforts over decades.

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 scope of the CMA has been broadened to address access to medicines of common interest.

The German Environment Agency supports the prevention of adverse environmental impacts and maintenance of high environmental protection standards included in the current proposal, particularly as addressed in recital (19).

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, risk-based, and supportive of innovation.

AbbVie is a global, research-driven biopharmaceutical company committed to delivering life-changing solutions for patients. With 11 manufacturing sites, 4 R&D hubs and clinical studies active in 24 EU countries, the European Union (EU) plays an important role in our mission to discover and deliver innovative medicines.

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.

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 medicine shortages in the EU and continue completing the legislative framework of the EU Health Union.

General principles of Regulation: It is clear that the stated intent of the Regulation is to support and help secure a more reliable and resilient supply of medicines for EU citizens. Definitions such as critical medicine, and particularly medicines with common interest, must be precisely defined to deliver the objective of the Regulation.

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 health priorities.

In the view of the Association of the Public Economy and Public Economy (VÖWG), it is to be welcomed that the EU is taking action in the field of the security of supply of medicinal products. At the same time, the legislative proposal contains some regulatory shortcomings: 1.

Filed in German · English published by the European Commission

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 Critical Medicines Act (CMA) in both positive and challenging ways.

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.

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 enhance the availability and resilience of medicines supply in the European Union.

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 chain resilience must be evidence-based and accompanied by appropriate incentives and conditionalities.

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.

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 that avoids unnecessary regulatory burdens and promotes innovation.

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 EU.

France Assos Santé (FAS), which brings together around 100 patients ‘and dusagers’ associations, has been helping to tackle medicine shortages in France and at EU level for many years. In this connection, we welcome the proposal for a regulation to strengthen the availability and security of supply of critical medicines (CMA), which complements the provisions of the pharmaceutical package currently being adopted.

Filed in French · English published by the European Commission

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 necessity for cohesive, inclusive, and regionally balanced approaches to pharmaceutical and chemical sector resilience.

Feedback on Commission’s proposal of 11.03.2025 for a regulation “laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795” Prescrire’s response 2 July 2025 The assessment of vulnerabilities and dependencies on supply chains is a…

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

Opinion of the pharmaceutical industry on the proposal for a Regulation COM(2025) 102 final (‘Critical Medicines Act’) drawn up by the Fachverband der Chemie Industrie (FCIO), the Austrian Federation of generic medicines (OeGV) and the PHARMIG Association of the Pharmaceutical Industry of Austria.

Filed in German · English published by the European Commission

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.

Joint Statement on the Critical Medicines Act: Empowered By Us and hollandbio This joint statement reflects shared priorities between a patient-led access organisation (Empowered By Us) and a national biotech association (hollandbio). Although our perspectives begin from different places: one rooted in lived experience and access equity, the other in system design and innovation, we found strong common ground.

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.

1 Critical Medicines Act: extra horde of Europese oplossing?Ref. Ares(2025)5226253 - 30/06/2025 Inbreng hollandbio EC Critical Medicines Act, 24 juni 2025 Gebrekkige toegang tot geneesmiddelen houdt steeds meer mensen van de straat Geneesmiddelentekorten zijn als een veelkoppig monster, dat helaas niet met één oplossing te bestrijden is, schreef voormalig minister Agema eerder.

Filed in Dutch · English published by the European Commission

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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 regulation needs legal clarity. - The proposed regulation should stick to a manageable list of critical medicines.

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 these objectives.

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.

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.

Opinion of the pharmaceutical industry in Austria on the proposal for a Regulation COM(2025) 102 final (‘Critical Medicines Act’). Prepared by the Fachverband der Chemie Industrie (FCIO), the Austrian Association of generic medicines (OeGV) and PHARMIG Association of the Pharmaceutical Industry of Austria.

Filed in German · English published by the European Commission

The attached paper outlines the position of the International Association of Mutual Benefit Societies (AIM) on the Critical Medicines Act and its potential impact on healthcare access and affordability as well as the role of solidarity based, not-for-profit health insurers and mutuals thereon.

STATEMENT JUNE 2025 The Standing Committee of European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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.

Dear Sir / Madam, On behalf of the PHOENIX group, the largest European integrated healthcare provider with 224 sites in the business areas of pharmaceutical wholesale and pre-wholesale across 29 European countries and with more than 3,200 pharmacies in 17 European countries, please find attached our position on the Critical Medicines Act incl. proposals for the text change.

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 vulnerable populations, and systematic drug repurposing pathways.

The preparatory work for the Critical Medicines Act proposed by the European Union (EU) Commission is closely followed by Türkiye, as well. As you are well aware, Türkiye and the EU have a deep-rooted history and bilateral relations have reached an important level with the entry into force of the Customs Union (CU) on January 1, 1996.

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 security of supply for critical medicinal products in the EU.

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, Corbion supplies essential components used in pharmaceutical manufacturing across a diverse global customer base.

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, i.e.

With this letter, we, the Bundesverband Selbsthilfe Österreich (BVSHOE), submit our comments on the Regulation of the European Parliament and of the Council establishing a framework for strengthening the availability and security of supply of critical medicinal products and the availability and accessibility of medicinal products of common interest and amending Regulation (EU) 2024/795.

Filed in German · English published by the European Commission

SICOS welcomes the need to strengthen the value chains of critical medicines by supporting and valuing a sustainable and efficient industrial base in Europe on the European agenda. This topic has been raised for many years by SICOS, which warns about the impact of the deterioration of our industrial fabric and the race for the lowest price on the availability of critical medicines…

Filed in French · English published by the European Commission

______________________________________________________________ Medicines for Poland Position of Medicines for Poland National Pharmaceutical Manufacturers on the proposal of the Critical Medicines Act Position Paper of Medicines for Poland - National Pharmaceutical Manufacturers on the Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and…

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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 forward-looking, coherent and resilient health initiatives.

Strengthening the availability and security of supply of critical medicines as well as the availability and accessibility of medicinal products of common interest is essential to ensure health at European level. However, we consider that the proposal submitted is insufficient as it does not cover animal health. The One Health strategy followed by the European Union is known.

Filed in Spanish · English published by the European Commission

(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 procurement. However, several passages should be clarified to achieve the Regulations's objective.

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.

I commend the European Commission for recognizing the urgent need to safeguard the supply of critical medicines through this proposed Act. The COVID-19 pandemic and recent geopolitical events have painfully revealed how fragile pharmaceutical supply chains are and how these disruptions directly harm patients.

Health is as much a critical infrastructure as food, energy, and security because all are necessary to protect human life. Thus, we at DUDE CHEM welcome the European Commissions initiative to address supply chain vulnerabilities and secure the availability of critical medicines.

Urenco is one of a small number of western suppliers of enriched and depleted isotopes for industrial, medical and research purposes. With our centrifuge technology, we produce isotopes for final use in diagnostics and brachytherapy. Each year, our stable isotopes support the treatment of over two million patients worldwide.

MEDAC is a German-based pharmaceutical company with production in Germany and Czechia, currently producing and distributing 15 pharmaceutical medicines on the Union list of critical medicines v.2 and our markets are concentrated in Europe.

Filed in German · English published by the European Commission

The General Pharmaceutical Council of Spain welcomes the opportunity to provide comments on the proposal for a Critical Medicines Act. As representatives of pharmacists in Spain, we are very concerned about the impact shortages have on patients and health professionals.

Takeda is a patient-focused, values-based, R&D-driven biopharmaceutical company committed to delivering highly innovative medicines and transformative care to improve lives worldwide. We welcome the Commissions ambition to strengthen the security and resilience of critical medicine supply chains in Europe.

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.

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 responsibilities, and insufficient cooperation pose significant risks to the success of these initiatives.

J&J is committed to having resilient and agile global supply chains to ensure all patients have access to medical goods. We support the EUs intention to address the long-term industrial challenges related to the supply of vulnerable critical medicines. However, policy measures must be fit for purpose, targeting product-specific root causes in line with the EU objectives for simplification & competitiveness.

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 produced in Europe.

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 of the 216 molecules listed on the EU Critical Medicines List.

CAFF welcomes the Commissions initiative to halt the relocation of pharmaceutical manufacturing outside the EU, strengthen supply chains, and enhance self-sufficiency to prevent medicine shortages. However, achieving these goals requires coordinated action across multiple EU and national authorities. Fragmented competences and insufficient collaboration pose a major risk to success. Key Considerations 1.

Ensuring patient access to sustainable and resilient medicines and supply chains is a priority for the pharmaceutical industry. Farmindustria, in line with EFPIA, supports the EU Commission’s objectives of stimulating innovation in Europe and strengthening supply chains.

Filed in Italian · English published by the European Commission

MedTech Europe is providing the following feedback on behalf of its members, representing the medical technology sector, which includes diagnostics, medical devices and digital health solutions. Both the pharmaceutical and the medical technology sectors operate in the healthcare space, providing critical medical solutions to healthcare systems and patients across the EU.

BEUC welcomes the opportunity to provide comments on the upcoming proposal for a Critical Medicines Act. As representatives of national consumer organisations, we are highly concerned about the increasing problem of medicine shortages. Consumer surveys show that between January 2023 and January 2024, almost 40% of households faced a shortage.

The Critical Medicines Alliance laid the foundations for a common understanding of the current levers of the supply of pharmaceutical products in general and critical medicines in particular. It did a remarkable job in determining a methodology for the assessment of vulnerabilities and the root causes for challenges. diagnosis made by the Alliance especially on the root causes of the shortages.

Pfizer supports the goal of strengthening the security of supply of critical medicines for patients in Europe. We participated in the previous Structured Dialogue on the security of medicines supply and are an active member of the Critical Medicines Alliance.

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 collection, processing, and administration of these medicines must also be safeguarded.

A key step to ensuring access to critical medicines is to protect their essential building blocks: Active Pharmaceutical Ingredients (APIs). The API manufacturing sector is facing increasing pressure from rising manufacturing and regulatory compliance costs, as well as unsustainable pricing mechanisms. These factors have eroded the ability of European API producers to withstand global competition.

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 strategy at the European level is essential to guarantee the availability of these medicines and prevent shortages.

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 allergy, food allergy, atopic eczema, asthma and COPD patients across Europe.

Over the past decades, we've witnessed an increasing reliance on a limited number of suppliers for APIs and intermediates, driven by a variety of factors. A primary factor is the intense pressure on pricing, with cost now being the dominant criterion for selecting suppliers, often taking precedence over other important considerations such as quality and regulatory compliance.

The German Pharmaceutical Industry Association (BPI) welcomes the European Commissions efforts to strengthen access to medicines and enhance the resilience of Europes pharmaceutical industry. The Critical Medicines Act (CMA) must be based on a comprehensive impact assessment to ensure a balanced approach.

The European Society for Paediatric Oncology (SIOPE) is the only pan-European organisation representing all professionals working in the field of childhood cancers. With more than 2,700 members across 36 European countries, SIOPE is dedicated to ensuring the best possible care and outcomes for all children and adolescents with cancer.

The Critical Medicines Act presents an opportunity to strengthen EU pharmaceutical supply chains while contributing to global health security, equitable medicine access, and sustainability. To ensure its effectiveness, the Act must integrate global health R&D, gender-sensitive policies, and ethical procurement models. Our recommendations highlight five key areas: 1.

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.

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 and animal health, farming, as well as pets.

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.

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 health products.

Critical Medicines Act – Call for Evidence European Association of Nuclear Medicine feedback February 2025 The European Association of Nuclear Medicine welcomes the opportunity to provide feedback on the Critical Medicines Act. We believe that it has the potential to constitute a major step forward in ensuring access to medicines.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

Security of supply is a major concern for the Federal Republic of Germany especially with regard to critical medicinal products. Our aim is to reduce dependencies on third countries, strengthen EU production and diversify the supply chains for critical medicinal products. The key industrial challenges for critical medicinal products as outlined in the Call for Evidence document are in line with our local analysis.

Critical Medicines Act - feedback from the Czech Chamber of Commerce The Czech Chamber of Commerce welcomes the opportunity to comment on the call for evidence regarding Critical Medicines Act. Below you will find comments from our members.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

EPODIN, the European Patient Organisation for Dysimmune and Inflammatory Neuropathies welcomes the opportunity to provide input for this Call for Evidence as to EUs Critical Medicines Act (the Act). EPODIN commends this step toward strengthening the resilience of the EUs pharmaceutical supply chains and ensuring equitable access of EPODIN patients to critical medicines, such as plasma-derived immunoglobulins on EUs…

LIF is the trade association representing the research pharmaceutical companies in Sweden. LIF and our members are actively working to ensure that patients have access to the medicines they need. This was highlighted during the COVID-19 pandemic with a record pace of vaccine development and rapid global adaptation of production and necessary supply chains.

Filed in Swedish · English published by the European Commission

The International Association of Mutual Benefit Societies (AIM) welcomes the potential implementation of a Critical Medicines Act as a crucial step toward ensuring equitable access to medicines across Member States. While innovation is important, the Act should primarily focus on addressing shortages, which mainly affect off-patent medicines.

Pharma Deutschland welcomes a Critical Medicines Act as it aims to facilitate pharmaceutical production in Europe and reduce reliance on non-EU suppliers. To achieve these objectives, a well-considered and holistic regulatory and financial framework is essential - first, to maintain existing pharmaceutical production in Europe and, potentially, to create opportunities for new active pharmaceutical ingredient (API)…

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 supply of medicines to healthcare institutions.

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 European countries are members of CCI-E.

When it comes to critical medical needs, Latvia should be encouraged to focus on a cohort such as citizens and enlist the help of private entrepreneurs who have the know-how. Now there are only three steps instead of the necessary four - reserves for disasters - emergency medicine, ensuring the reserve operation of hospitals and medicines for the needs of the army, but the provision of the population has been…

Aschimfarma, the association of Italian producers of active pharmaceutical ingredients (API) and intermediates, considers the dependence from far-east manufacturersof API the main cause of the shortages of critical medicines in the EU territory, since APIs are essential components for the production as well as for the efficacy of drugs.

The Federal Medical Association would like to thank for the opportunity to comment on a possible proposal for a Critical Medicines Act of the European Commission. This opinion was drawn up in close technical consultation with the German Medical Medicines Commission (AkdÄ). Shortages of medicinal products are also part of everyday clinical life in the Federal Republic of Germany.

Filed in German · English published by the European Commission

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.

As industriAll European Trade Union, representing 7 million workers across industrial sectors, we emphasise that workers rights, social dialogue, health and safety, training and upskilling must be at the core of each European legislative initiative and revision. We welcome the European Commissions intention to secure the medicines supply chain.

The Federation of Veterinarians of Europe (FVE) represents around 330,000 veterinarians across Europe. We welcome this consultation on the Critical Medicines Act and wish to highlight the importance of considering medicine availability for both human and animal healthcare within the One Health approach. For further details, see attachment

POLPHARMA GROUP HOLDING BV POSITIONON CRITICAL MEDICINES ACT Polpharma Group welcomes the European Commissions initiative for a Critical Medicines Act as a necessary step to prevent shortages of critical medicines via several measures aiming at the sustainability of European manufacturing of critical API and Finished dosage forms of critical medicines.

The Center for Reproductive Rights welcomes the proposal for EU legislation on critical medicines and other medicinal products of common interests, which aims to ensure equal access to essential medicines and address shortages of supply.

Public consultation to proposal for a Critical Medicines Act Contribution of Ministry of Social Affairs of Estonia We support the Commission’s intention to present a legislative proposal (the Critical Medicinal Act), which will aim to address supply chain vulnerabilities and to reduce the EU’s dependencies in order to strengthen the supply of critical medicines.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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.

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 initiative to tackle medicines shortages, with particular focus on critical medicines, defined as those where supply shortages cause serious harm, is welcomed. EUCOPE members support the need to develop a robust framework which promotes patient access to medicines.

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 advancement of critical new technologies in Europe.

Given the increasing frequency of medicinal product shortages in recent years and the heightened geopolitical vulnerabilities, we welcome and commend this initiative of the European Commission. We believe that the Critical Medicines Act (CMA) offers an opportunity to strengthen the EU's pharmaceutical security, improve the resilience of the supply chain and promote equitable access to essential medicinal products.

Warszawa, 26 lutego 2025 r. KL/84/27/KO/2025 Stanowisko Konfederacji Lewiatan w ramach konsultacji Komisji Europejskiej dot. Critical Medicines Act Rosnące uzależnienie Europy od dostaw surowców niezbędnych do produkcji farmaceutycznej spoza naszego kontynentu od kilku lat stanowi przedmiot debaty na poziomie UE.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

GIRP, the European Healthcare Distribution Association, welcomes the upcoming publication of a Critical Medicines Act and its announced scope to support the security of supply and the availability of critical medicinal products, and to support the availability and accessibility of other medicinal products of common interest. GIRP is the umbrella organisation for pharmaceutical full-line wholesalers in Europe.

The Latvian Pharmaceutical Industry Association (LPIA) strongly supports the Critical Medicines Act (CMA) and the Strategic Report of the Critical Medicines Alliance, welcoming the European Commissions commitment to sustainable medicine production, supply resilience, and equitable access to critical medicines.

More than 2.000 companies operate in the self-care sector in Europe. There are more than 200 Active Pharmaceutical Ingredients (APIs), available without prescription in Europe, and over 4.000 different products containing those APIs. - There is healthy and effective competition among NPM manufacturers, with a high number of medicines containing the same active pharmaceutical ingredients.

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.

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.

As a company deeply rooted in Europe with a legacy of over 160 years, Bayer welcomes the European Commissions initiative to address medicine shortages, particularly concerning vulnerable critical medicines where shortages can lead to substantial harm. As a member of the Critical Medicines Alliance, we remain committed to working constructively to address medicine shortages.

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 collaboration among Member States to ensure a unified approach to critical medicine supply.

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 shortages in the EU and the intention of the new Commission to approach the topic in an expedite manner.

As a regional pharmaceutical manufacturer of both Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs), we fully support the Critical Medicines Act (CMA) as a key step in strengthening Europes pharmaceutical security. However, to ensure a sustainable supply of critical medicines, targeted financial support and policy adjustments are necessary. Key Points: 1.

27 February 2025 Contribution by EDQM of Council of Europe to the Call for Evidence on Critical Medicines Act 1. Background information on EDQM The European Directorate for the Quality of Medicines and HealthCare (EDQM) within the Council of Europe contributes to ensuring the availability of and access to good quality medicines and health products.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The European Patients Forum (EPF) and its members welcome the opportunity to provide input in the context of the development of the future Critical Medicines Act. We are deeply concerned about the growing problem of shortages in the EU in recent years, undermining patients' fundamental right to equitable access to safe, quality healthcare. A common effort at EU level to address the issue is therefore needed.

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 range of perspectives and expertise is surely the most appropriate approach.

The French authorities welcome the initiative to establish a Critical Medicines Act and wish to emphasize the need of securing supply of critical medicines in the midst of increasing shortages. Against this backdrop, the Critical Medicines Alliance produced ambitious and evidence-based recommendations to strengthen EU production capacities of critical medicines.

The innovative pharmaceutical industry supports the European Commissions objective to stimulate innovation in Europe and a sustainable and resilient supply chain. However, policy solutions need to be fit for purpose, targeting the specific root causes of shortages. Taking into account the recommendations attached to this submission, a Critical Medicines Act should: 1.

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.

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 frontline of patient care and experience daily the impact of medicines shortages.

The European Social Insurance Platform (ESIP) emphasizes the urgent need to ensure the continued availability of critical medicines within the EU. ESIP members play a pivotal role in procuring critical medicines, a core component of the upcoming Critical Medicines Act (CMA).

Plasma Protein Therapeutics Association (PPTA) welcomes EU efforts to address key challenges across all medicines on the Critical Medicines List and recommends avoiding a one-size-fits-all approach. Unlike API-based medicines, plasma-derived medicines (PDMPs) require human plasma for fractionation, which cannot be synthetically produced.

Cancer Patients Europe (CPE) welcomes the European Commission's Proposal for a Critical Medicines Act as a key step in preventing medicine shortages and ensuring equitable access to essential treatments. The CMA must prioritise patient needs, maintaining access to high-quality, safe, and effective medicines while addressing disparities in availability across Europe.

LSMA welcomes the opportunity to provide feedback on the Critical Medicines Act. The pandemic highlighted the life sciences industry's vital role in healthcare access and the need for robust supply chains. Key Messages: The pandemic showed the importance of strong supply chains. Disruptions, even from well-intended regulations, can cause shortages, risking patient care.

Critical Medicines Act: time for urgent action As a reminder, since 2016, 80% of the top 10 best-selling, all generics, have experienced supply challenges and more than 300 molecules were concerned by supply challenges in recent years, mainly due to issues from China[1]. Recent shortage events reinforce the urgent necessity to secure a sustainable European production.

As Bioton we are writing to convey our unequivocal support for the European Commission's initiative to propose a Critical Medicines Act (CMA). As delineated in the call for evidence document, this initiative represents a pivotal step towards mitigating the persistent and escalating issue of medicine shortages within the European Union, which poses substantial risks to public health and patient care.

The supply of generics has become highly efficient to ensure health payers can make considerable savings and widen accessibility of medicines to more patients. The pressure on manufacturers to deliver at sustained low prices has in general led to longer and leaner supply chains, which can be more susceptible when problems do occur.

The association shares the EU’s concerns about the shortage of medicines and proposes several measures: Incentivise domestic production of critical medicines. Firstly, it is essential to provide incentives, both economic and not only, for pharmaceutical companies having their registered office in the Member States to develop and produce critical medicinal products.

Filed in Italian · English published by the European Commission

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to provide feedback on the future Critical Medicines Act (CMA). Strengthening the security of supply and availability of critical medicinal products in the EU is essential to ensure resilience and autonomy.

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 dynamics, putting increasing pressure on healthcare systems.

The Belgian Federal Public Health Authorities welcome the initiative to establish a Critical Medicines Act and emphasise the importance of a robust and fit-for-purpose European framework to secure the supply of critical medicines.

AmCham EU thanks the European Commission for providing the opportunity to share our views on the upcoming Critical Medicines Act. Please see attached our feedback and position paper on how regulators can bolster resilience of European life sciences supply chains.

Danish Agriculture and Food Council acknowledge that the growing scarcity of critical medicines across the EU primarily affects human medicine. Concerning the veterinary sector, we wish to draw attention to the fact that the supply of penicillin for the treatment of production animals may be limited, as these products are produced in very few locations.

General comments: The Swedish Association of Local Authorities and Regions (SALAR) shares the concern about the growing shortages of critical medicines in the EU, which create significant risks to patient health and healthcare systems. It is urgent to address these problems and the future legislative initiatives need to aim for solutions focusing on the existing supply chain vulnerabilities and their root causes.

The future Critical Medicines Act should strive to enhance EUs open strategic autonomy and supply resilience by ensuring an industrial ecosystem that can deliver on the existence of resilient and diversified supply chains, based on a robust and well-performing industrial base.

The Austrian Chamber of Commerce welcomes the proposal’s objective of increasing security of supply and the availability of critical medicines. In this context, it should be a top priority that these measures are workable and that the requirements do not lead to further additional bureaucracy or financial burdens for businesses.

Filed in German · English published by the European Commission

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 critical medicines that encompasses the entire value chain of the healthcare sector.

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.

CIF: B83628248 VAT: ESB83628248 Inscrita en el Registro Mercantil de Madrid / Tomo 18.722 / Folio 180 / Sección 8ª / Hoja M-326.179 / Inscripción 1ª Domicilio social: Manuel Pombo Angulo, 28 3ª planta 28050 Madrid - España The Critical Medicines Act must lead to a resilient, competitive, and sustainable off-patent pharmaceutical industry.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The European Haemophilia Consortium (EHC) welcomes the opportunity to provide input to the EU Critical Medicines Act. The EHC commends this essential step toward strengthening the resilience of Europes pharmaceutical supply chains and ensuring equitable access to essential medicines, particularly for patients with rare diseases such as bleeding disorders.

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 expertise in this extremely complex market, so as not to unintentionally trigger effects that are contrary to those…

Input of the Czech Republic to the European Commission’s public consultation as part of the preparation of the Critical Medicines Act The scope of the future legislative act: The Czech Republic considers that the act should cover not only critical medicinal products included in the EU list, but also critical medicinal products in general, as well as medicinal products of common interest expressed at Member State…

Filed in Czech · English published by the European Commission

FEFAC representing the EU compound feed and premixtures sector would like to take the opportunity of this consultation on a critical medicines act to remind that in the context of the One-Health policy, the question of availability of medicines should be considered simultaneously both for human and animal care.

There are 17 Plasma-derived medicinal products (PDMPs) in the Union list of critical medicines (version 2). The Critical Medicines Act represents the ideal opportunity to ensure that the PDMP-patient population needs are met by providing legislative guarantees to underpin the sufficient public control over the plasma-PDMP-patient chain which must accompany national commitments to collect sufficient volumes of…

F. Hoffmann-La Roche ltd (Roche) shares the objectives of the European Commission (EC) to address critical medicines shortages by tackling challenges identified along the entire innovative pharmaceutical value chain.

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 larger collectors of plasma in Europe, identify the main supply chain vulnerabilities and propose concrete ways to address…

To whom this may concern, As a full member of the Critical Medicines Alliance, PHOENIX group is happy to share its contribution to the Commission's call for evidence on the Critical Medicines Act (please see attached the document). PHOENIX group stands ready to support Commission and Member States in providing critical medicines to patients and countries in need.

1 _ Evidence-based and transparent measures DSV welcomes the CMA’s objective of reducing dependence on few manufacturers and non-European production sites. However, supply shortages have multiple causes. A stronger sourcing of products from Europe alone does not guarantee security of supply. It is essential to monitor market and supply situations and analyse the causes of shortages.

Filed in German · English published by the European Commission

Ecolab is committed to enhancing the resilience and optimization of pharmaceutical and biopharmaceutical manufacturing processes. Our goal is to support the EUs policy objectives by ensuring a secure supply chain through innovative solutions such as advanced resins, digital tools, and comprehensive response plans. Ecolab is dedicated to supporting HERAs mission.

Farmaindustria, as representative of the innovative pharmaceutical industry in Spain, is committed to ensuring patients’ access to the medicines they need. An example was the sector’s response to COVID-19, with the rapid development of vaccines and the adaptation of global supply chains to an unstable geopolitical environment.

Filed in Spanish · English published by the European Commission

- Strategic importance of a stable supply of medicines - Due to its innovative strength, above-average labor productivity as well as export and employment strength, the industrial healthcare industry and in particular the pharmaceutical industry has been a key industry and an economic and social anchor of stability for Europe for many years.

As the umbrella organisation of the 1874 German hospitals in the public, non-profit and private sector, the German Hospital Society (DKG) has been constructively involved in health policy debates at EU level for many years. In particular, sustainability and digitalisation, but also current challenges such as tackling shortages of medicines and security of supply of medical devices.

Filed in German · English published by the European Commission

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 Competitiveness Compass' published at the end of January, aims to increase their production in Europe and reduce reliance on…

Orano would like to thank the European Commission for organizing this public consultation and welcomes the announcement of the upcoming publication of the Critical Medicines Act (CMA). This future legislative act should help strengthen the EU's security of supply in the healthcare sector. Siège social : 125, Avenue de Paris 92320 Châtillon Tél.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

FarmaForum comments to the proposed Critical Medicines Act (CMA) FarmaForum, the Slovenian innovative pharmaceutical industry association, endorses the European Commission’s objectives to enhance the resilience and accessibility of critical medicines.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

Input to the Call for Evidence for an Initiative: Proposal for a Critical Medicines Act Prepared by TGEU and ILGA-Europe February 2025 Introduction This submission addresses the shortages of hormones and HIV-related medication in the EU, and more broadly in Europe, and its impact on LGBTI people.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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 patients and healthcare systems, helps alleviate shortages, and increases access to medicines by supplying markets facing…

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.

The Movement for the Protection of Citizens welcomes the European Commission’s proposal for a legislative act on critical medicines. With the attached document, we are pleased to propose our contribution to the work of DG Sante. From 2018 to 2024, the number of medicines at risk of shortages in Italy doubled from around 1.600 to more than 3.700.

Filed in Italian · English published by the European Commission

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 including dependencies on non-European countries manufacturing and supply chain capacities.

STATEMENT The Standing Committee of European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The initiative to tackle medicines shortages, with particular focus on critical medicines, defined as those where supply shortages cause serious harm, is welcomed. EUCOPE members support the need to develop a robust framework which promotes patient access to medicines.

As RareGen Youth Network, we are submitting this comprehensive analysis of the EU Critical Medicines Act and its impact on rare disease patients. Our response draws from our direct experience advocating for youth with rare diseases while incorporating key research on orphan drug development and access challenges.

Curriculum Vitae Negar Riahi 19740727-1043 www.twitter.com/NegarRiahi, www.facebook.com/2014NAFAS , www.negarpaintings.blogspot.se * Dentsply Friadent 13:th World Symposium, Berlin 18-19 April 2008 * Student på Göteborgs Universitet VT 2008, Faculty of Odontology, Dental Biomaterials [email removed] *Nobel Rondo Nobel Biocare, Göteborg 2008.02.27 *Ankylos protetik i detaljer!

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

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.

TBD Pharmatech welcomes the European Commissions initiative to introduce the Critical Medicines Act as a crucial step toward ensuring a stable and resilient pharmaceutical supply chain within the EU. As a company deeply committed to pharmaceutical innovation and custom synthesis, we recognize the growing challenges posed by medicine shortages and the need for a coordinated, sustainable approach to securing critical…

We can continue spending our lifetime talking about the best way to apply a EU directive, but the reality will scratch us. We are a Spanish API manufacturer who has to fight unfair competition from China and India every day because we have to follow several laws to sell our products in Europe, but our competitors are not following them. How can we survive in these hard conditions?

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Opening of the attached position paper · the full paper is on the Commission’s record (source link above)