435 submissions from 317 organizations told the European Commission what they think about this file. Here is what each of them said, in their own words.
The Commission received 539 submissions on this file. Shown here: the 435 from organizations. Not shown: 72 from private individuals. Their submissions are personal data; the Commission publishes them under its own legal basis, and republishing them by name here would need one we do not have. Organizations act in a public capacity, so their positions are public record. Also not shown: 32 organizational submissions with no quotable text (a comment under 250 characters and no readable paper). About this data →
CommitteeSANTRapporteurPernille Weiss-ehler (EPP)
Approval of the provisional agreement with the Council by the EP committee responsible · 18 Mar 2026
Committee Approved the Provisional Agreement · 18 Mar 2026
Endorsement of the provisional agreement by Coreper · 6 Mar 2026
Deliberations in Coreper · 19 Dec 2025
INTERINSTITUTIONAL_NEGOTIATION · 10 Dec 2025
Who showed up
227 submissions from industry — companies and their trade associations — against 125 from civil society: NGOs, consumer organizations, environmental groups and trade unions. That is 1.8 industry submissions for every one from civil society.
Industry 227Civil society 125Public authorities, academia, other 83
Groupings use the respondent type each organization selected when filing. Counting submissions, not organizations — a body that filed twice is counted twice.
What the room declares
154 of 317
in the EU Register
550
full-time lobbying staff
€80.0M+
declared costs a year
371
EP accreditations declared
Self-declared to the EU Transparency Register (snapshot 2 Sept 2026). The cost figure sums band floors, so the true total is higher.
The file, right now
The consultation closed on 8 Nov 2023 — it ran from 26 Apr 2023.
One block of text on this file was submitted, identically, by three or more organizations. Shared text is a fact about the filings; what it means is for the reader.
12 organizations: Arztpraxis, DTZ Berlin, Georg-August-University Göttingen, Heart and Diabetes Center - University Hospital Bochum - Radiopharmacy, Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Nuklearmedizin Neumann MVZ, Nuklearmedizinische Praxis, PET e.V., Schwarzwald-Baar-Klinikum, University hospital, University Hospital Münster, Zuhayra, Maaz, Prof. Dr., Radiopharmacist, Nucleare Medicine UKSH, Campus Kiel
“The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.”
Showing 25 of 185 submissions on this page · page 2 of 2 · 435 across the file. Search the whole file
The EU General Pharmaceutical Legislation (GPL) will fundamentally change the life sciences ecosystem in Europe. As proposed, the legislation is a step back from Europe's historically strong support for IP protections. That policy shift compromises the EUs ambition to build a competitive and knowledge-based economy.
EUCOPE acknowledges the objectives of the review. While numerous regulatory provisions will streamline the functioning of the market, changes to the incentive framework outweigh these, weakening EU global competitiveness.
EUCOPE acknowledges the objectives of the Pharmaceutical Package, and welcomes maintaining a separate Directive and Regulation for decentralized and central approval processes. While we appreciate streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will undermine R&D, innovation, EU competitiveness, and be particularly detrimental for patients and small and…
The European Association of E-Pharmacies (EAEP), which represents online pharmacies and their patients on the European continent, welcomes the publication of the revision of the EU general pharmaceuticals legislation, and appreciates the opportunity to provide its feedback.
Amgen welcomes proposals in the Regulation shortening CHMP opinion timelines to 180 days, allowing reliance for inspections, streamlining of PRIME, and establishing regulatory sandbox. Moreover, Amgen welcomes the supply chains provisions currently included in the Regulation as they will ensure an EU wide approach to address supply chain challenges. We offer the following recommendations: Art.
Amgen welcomes this opportunity for commenting and offers the following recommendations: Art. 4(26): Clarify that in vitro diagnostics are not included within the definition of a combination of a medicinal product with a product other than a medical device. The definition should be revised to: 26) ...
The Swedish Society for Nature Conservations (SSNCs) comments on the EU general pharmaceuticals legislation: Regulation COM(2023) 193 (see separate feedback for Directive COM(2023) 192). Please find attached the pdf file containing a detailed response. GENERAL VIEWS: The SSNC supports the Commission's overall intentions regarding greater consideration for the environment in pharmaceuticals legislation.
The Swedish Society for Nature Conservations (SSNCs) comments on the EU general pharmaceuticals legislation: Directive COM(2023) 192 (see separate feedback for Regulation COM(2023) 193). SUMMARY: 1) SSNC proposes that environmental risks should be included in the benefit-risk assessment of a pharmaceutical.
United European Gastroenterology (UEG) is the leading non-profit organisation for excellence in digestive health in Europe and beyond. We promote science, research, education, quality of care and advocate to prevent and reduce health inequalities across Europe to achieve optimal patient care. We unite 17 Specialist Member Societies and 49 National Member Societies.
PASMI Statement on the Revision of EU Pharmaceutical Legislation PASMI Polish Association of Self Medication Industry welcomes the European Commissions proposal for a revision of the EU pharmaceutical legislation.
Statement of the BAG SELBSTHILFE, Federal association of self-help for people with chronic disease and their relatives e.V. (BAG SELBSTHILFE) to the Legislative Proposal for the Revision of the EU Medi-cines Law of the European Commission As umbrella organization of 123 federal associations of the self-help of chronical-ly ill and handicapped humans and their members as well as of 12 regional work-ing groups the BAG…
The Japan Pharmaceutical Manufacturers Association (JPMA) is a voluntary association comprising 72 research-oriented pharmaceutical companies (as of May 1, 2023). Established in 1968 with the mission of realizing patient-oriented healthcare, JPMA has been contributing to global healthcare advocacy through the development of innovative ethical drugs.
The International Patient Organisation for Primary Immunodeficiencies (IPOPI) is the global patient organisation representing patients living with primary immunodeficiencies (PIDs). PIDs are genetic chronic and rare disorders (RD) in which the immune system does not work properly or at all.
The Multi-Regional Clinical Trials Center, an academic research/policy center that addresses the conduct and oversight of clinical trials, convened a multi-stakeholder workgroup to address barriers to transnational pediatric trials and regulatory cooperation.
France Assos Santé, which brings together around 100 patient and dusager associations, has been supporting the process of updating the EU’s body of pharmaceutical legislation from the outset in order to improve patients’ access to safe, effective, effectively available medicines at affordable prices.
Filed in French · English published by the European Commission
The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) is a multi-professional organisation whose mission is to reduce the burden of digestive and nutritional diseases and to promote digestive and nutritional health in paediatric age groups.
AESGP expresses support for the Commission Proposal to revise the EU general pharmaceutical legislation. We believe this long-awaited revision will consolidate and streamline legislation which underwent multiple updates over the past 20 years. While AESGP members acknowledge the legislation's goals, we raise concerns on unintended consequences for non-prescription medicines (NPMs).
Hollandbio’s response to the main lines of the review of the EU’s general pharmaceutical legislation can be found on our website: https://www.hollandbio.nl/nieuws/grijp-die-kans-geneesmiddelen-sneller-beter-slimmer-goedkoper-en-groener-beschikbaar-dankzij-herziening-eu-geneesmiddelenwetgeving/ in addition to this, in the excel attached, we set out our more detailed position with regard to the different measures.
Filed in Dutch · English published by the European Commission
As a global leader in medical technology innovations for structural heart disease, critical care, and surgical monitoring, Edwards Lifesciences is committed to addressing unmet healthcare needs and improving patient outcomes.
The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit organization accelerating the development of and access to lifesaving treatments for drug-resistant infections that pose the greatest threat to health. GARDP has the following feedback: 1.
Dear ladies and gentlemen, you may find the opinion of Pohl-Boskamp concerning the proposals for the DIRECTIVE 2023/0132 (COD) and for the REGULATION 2023/0131 (COD) as an attached file (English version followed by German version). The opinion contains a brief summary on the first two pages followed by a full statement with detailed references to concerned articles of the proposed DIRECTIVE and REGULATION.
Dear ladies and gentlemen, you may find the opinion of Pohl-Boskamp concerning the proposals for the DIRECTIVE 2023/0132 (COD) and for the REGULATION 2023/0131 (COD) as an attached file (English version followed by German version). The opinion contains a brief summary on the first two pages followed by a full statement with detailed references to concerned articles of the proposed DIRECTIVE and REGULATION.
The European Alliance for Transformative Therapies (TRANSFORM) is a multi-stakeholder coalition comprised of patient organisations, clinicians, researchers, and industry. It fosters dialogue around Advanced Therapy Medicinal Products (ATMPs) and provides evidence-based, consensus policy recommendations to enable safe and timely patient access to innovative therapies.
Lyme disease (including Borreliosis), which is transmitted to humans by infected ticks, is the most common zoonotic disease in Europe. It is often treated with antimicrobials, which work well if taken properly. However, if left unattended, the disease can have a huge impact on the body.
The development of new and innovative pharmaceutical products has become much more research intensive. Most products available are the result of academia delivering new knowledge based on biomedical and chemical research and pharmaceutical companies further developing those novel insights into safe and effective products.
The League of European Research Universities (LERU) is an association of 23 leading research-intensive universities in Europe. Our members play a key role in the research and development of new pharmaceutical products, and, through their university hospitals, in the supply and GMP-compliant manufacturing of treatments and their supply to patients, especially when it comes to ATMPs through the Hospital Exemption.
The European River Memorandum Coalition (ERM Coalition) of associations of waterworks in the river basins of Rhine, Danube, Elbe, Meuse and Scheldt, with a total of 188 million inhabitants, is committed to ensuring safe tap water in the future.
PTC therapeutics agrees with the overall objectives of the proposed Pharmaceutical Package (proposed Regulation and Directive): As a company we are striving to develop therapies for people living with a rare disease and as such we want to contribute to creating an innovative and competitive EU healthcare ecosystem with standards that can compete at a global level.
PTC therapeutics agrees with the overall objectives of the proposed Pharmaceutical Package (proposed Regulation and Directive): As a company we are striving to develop therapies for people living with a rare disease and as such we want to contribute to creating an innovative and competitive EU healthcare ecosystem with standards that can compete at a global level.
This response focuses on one specific aspect of the proposed revised Regulation. The revised Pharmaceuticals Strategy explicitly excludes addressing issues and revising provisions for homeopathy and other CAM but their current approval frameworks in the Regulation differ very significantly from those appertaining to evidence-based medicinal products.
Progeny’s opinion on the revision of EU pharmaceutical legislation (situation as at 7 June 2023) welcomes the fact that, on the basis of the translations of the draft laws that are not yet available, we can comment on EU legislation on a provisional basis.
Filed in German · English published by the European Commission
The EORTC believes the revision of the general pharmaceutical legislation provides with an opportunity to introduce the concept of treatment optimisation into the legislation. What is treatment optimisation? Many drugs enter the market without evidence of their true clinical benefit for patients.
The U.S. Chamber of Commerce (Chamber) is the world’s largest business federation, representing the interests of more than three million enterprises of all sizes and sectors and a longtime advocate for strong commercial ties between the U.S. and EU.
PhRMA supports the goal of ensuring that the pharmaceutical legislation in the EU is fit-for-purpose and that EU patients with unmet medical needs have timely access to medicines. Initial industry perspectives on the broad issues raised in the Impact Assessment follow: Incentivizing Innovation in Areas of Unmet Need: Industry is committed to addressing unmet needs and supports preserving and enhancing incentives to…
Relevant paediatric specificities should be considered when defining objectives and policy options of the whole Pharmaceutical Policy, according to the following considerations: 1- Shortage of medicines in Europe has increased the risk of undercured patients affected by COVID-19 and its complications and should be strongly reduced.
While we welcome the reforms and actions put forward by the Commission in this strategy, there is also a lack of ambition when it comes to expanding the use of the tools already available in the toolbox. This includes creating a better framework for the parallel import/distribution sector in order to deliver better affordability and access.
ERS appreciates the opportunity to contribute to this roadmap on the revision of the General Pharmaceutical legislation (namely Directive 2001/83/EC1 and Regulation (EC) No 726/20042). Join the dots: Legislation must foster medical advancement not hamper it.
The steps towards more flexibility in the regulatory framework are welcomed and much needed as for any economic agent the ability to act in general determines the ability to adapt to evolving circumstances, such as by pursuing permanent technological development or responding to a random crisis.
As independent scientists and researchers, we applaud the opportunity to provide the European Commission with feedback on the EU Pharmaceutical legislation. We have one comment pertaining to regulatory standards, and three comments pertaining to improved transparency. Regulatory standards 1.
The BEAM Alliance welcomes the European Commission’s intention to modify the EU Pharmaceutical legislation. As far as the antimicrobial resistance (AMR) field is concerned, the revision should lay down the foundation for a more attractive market that allows SMEs, the main innovation engine in the AMR field, to operate in comparable way to other therapeutic fields.
1/. In parallel with the revision of the EU general pharmaceutical legislation there is a revision of the EU legislation on Blood, Tissues and Cells (BTC). These two initiatives need to be harmonized. There are two major concerns with the proposed changes in the BTC legislation which both could have a major negative impact on the future safety and efficacy of advanced medicinal products based on genes, tissues or…
SICOS contribution to the public consultation on the revision of the EU general pharmaceutical legal framework SICOS is the French industrial sector group representing the manufacturers of Active Pharmaceutical Ingredients (API), excipients and intermediates located in France.
IDFE, a pan-European organisation representing people living with diabetes (PwD) and healthcare professionals (HCPs) in 70 member associations across 44 countries in Europe, welcomes the opportunity to respond to the evaluation and revision of the general pharmaceutical legislation.
Our mission is to reimagine medicine to improve and extend people’s lives, developing and delivering transformative medicines for patients in Europe and around the world. Novartis is a leader in Europe in innovative, generic and biosimilar medicines. Novartis appreciates the Commission (EC)’s recognition of the urgent need to modernize the regulatory framework.
The review of the General Pharmaceutical Legislation is an important opportunity to improve the effectiveness and efficiency of the regulatory system in Europe. Maximising patient benefit should always be the guiding principle–and the competitiveness of the system contributes to this. Enhancing competitiveness includes the flexibility to embrace new scientific and manufacturing developments, and new sources of data.
EURORDIS-Rare Diseases Europe welcomes the opportunity to comment on the combined evaluation roadmap / inception impact assessment of the general pharmaceutical legislation and commits to contribute to best of its ability to the outline process. Each of the over 6000 identified rare diseases affects a very small population, but altogether they affect nearly 30 million people in the EU.
The Avicenna Alliance supports the Commission’s ambition to revise the EU’s general pharmaceuticals legislation as it represents an ideal opportunity to update the regulatory framework to reflect the uptake of new technologies, including in silico technologies such as Computer Modelling and Simulation (CM&S), for medicinal products including combination products and Advanced therapy medicinal products (ATMPs). 1.
Changing the pharmaceutical market in the EU and in the Schengen Area requires the implementation of an IT system that will enable control and management of this market. Such a system must constantly have up-to-date data on stocks, trade transactions and future plans. We are more than willing to help you prepare project of such a system by sharing knowledge from implementation of similar systems in Poland.
AIM welcomes the release of the European Commission’s inception impact assessment on the revision of the basic pharmaceutical legislation. AIM, the International Association of Mutual Benefit Societies, is providing its preliminary feedback on the roadmap. AIM calls for the following actions: To improve medicines’ affordability o Create an expert group on medicines cost transparency.
The European Idiopathic Pulmonary Fibrosis & Related Disorders Federation (EU-IPFF) welcomes this opportunity provided by the European Commission to provide feedback on the revision of the EU general pharmaceuticals legislation.
General remark: As far as the issue of unequal access to affordable medicines for patients across the EU is concerned, we would like to highlight the possibility of developing the principles of equal access to centrally registered medicines and equal access to vaccines in countries with lower vaccine demand.
The FCIO advocates an adaptive legal framework that not only provides strong incentives to promote progress in science, technological development and innovation in medicine, but also ensures the supply of medicines, including generic ones. This evaluation is an opportunity to implement the lessons learned from the Covid-19 crisis and to create one of the world’s most advanced legal frameworks for Europe.
Filed in German · English published by the European Commission
To achieve the goal of safe and affordable medicines and to support the European pharmaceutical industry to innovate, the Commission must put humane and human-relevant preclinical assessment at the heart of this strategy. Currently 90% of drugs fail in clinical trials on humans despite having passed pre-clinical studies, including extensive tests in animals.
The European Cancer Organisation welcomes the forthcoming revision of the general pharmaceutical legislation. It is a chance to address a wide range of stakeholder concerns, and realise new opportunities in respect to patients’ access to outcome changing treatment.
ANF, on behalf of the Portuguese Community Pharmacies, welcomes the opportunity to provide input in the context of the European Commission roadmap/inception impact assessment on the Evaluation and revision of the general pharmaceutical legislation.
EFCG, the European Fine Chemicals Group, represents European manufacturers of APIs, excipients and fine chemicals. As producers of the essential building blocks used to make medicines, we welcome the Commission’s initiative to ensure a future-proof and crisis-resistant medicines regulatory system that will allow all EU citizens full and equal access to safe, state-of-the-art therapies.
Czech Association of Pharmaceutical Companies (ČAFF) is an association which represents companies that produce or commercialize generic and biosimilar medicines on the Czech market. Covid19 crisis has threatened all health systems and their sustainability as well as the social stability of a country during an emergency, but it has especially affected non-covid19 patients worldwide, challenging their right to health…
The BPI e.V. (BPI) representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Startups. These companies ensure a timely and safe supply of medicinal products for all patients across the EU and globally.
Vaccines Europe (VE) believes that this evaluation is an opportunity to implement learnings from COVID-19 to ensure a future-proof and resilient healthcare system. The pandemic shows the importance of: EU crisis preparedness, a flexible regulatory environment, maintaining and enhancing innovative research and development, and an industrial capability and capacity in the EU.
The evaluation and revision of the general pharmaceutical legislation is the opportunity to create a future-proof, patient-oriented and leading life sciences and biotechnology sector in the EU. New biotechnology-derived vaccines and treatments have helped to tackle numerous life-threatening illnesses. Targeted cell and gene therapies and new mRNA platforms are paving the way for future treatments.
The EU’s general pharmaceutical legislation has provided strong foundations for pharmaceutical innovation and medicines development, helping to tackle some of the leading causes of disease and life-threatening illnesses.
A FIT PHARMACEUTICAL LEGISLATION TO BENEFIT E.U. CITIZENS AND HEALTH SYSTEMS AESGP supports a pragmatic and risk-based regulatory framework that fosters a stronger role for self-care and prevention. The current structure is overall fit for purpose although some issues may arise from divergent interpretation, disharmonised application and addition of gold plating or administrative elements.
The Association of Innovative Pharmaceutical Industry (AIFP) shares the EFPIA’s view expressed in its input into this Inception Impact Assessment. Further to this, we would like to stress some of our main concerns and observations. The European citizens expect to have equal access to safe, state-of-the-art and affordable innovative and established therapies.
Europe is home to a rich innovation eco-system and the COVID-19 pandemic has highlighted the importance of a vibrant research-based pharmaceutical sector for the EU. To address future health threats and remain a global biopharmaceutical leader, the EU needs to implement pro-innovation policies that support companies’ investments to translate scientific excellence into medicines and vaccines that help citizens stay…
BEUC supports the European Commission’s initiative to evaluate and revise the general pharmaceutical legislation to improve access to medicines. We agree with the main gaps identified in the roadmap and corrective measures, but have additional recommendations. These are the most pressing issues and necessary changes for consumers: Unmet medical needs: Antimicrobial resistance is a global public health-threat.
IPEC Europe fully supports the proposed revision of the general pharmaceutical legislation and is pleased to be able to offer feedback as it pertains to pharmaceutical excipients. IPEC Europe represents the producers, the distributors of pharmaceuticals excipients as well as the pharmaceutical companies using excipients.
Europharm is the European Association representing Medium Sized Pharmaceuticals companies in the EU. Europharm fully supports the Commission’s ‘targeted approach’ in this revision as it serves the purpose to enhance regulatory simplification and efficiency. This approach could be most efficiently pursued on the basis of the existing legal acts, i.e.
FR supported the general objectives and the different options for the evolution of the scheme. The revision of the EU texts will make it possible to adapt and speed up MA procedures in line with scientific and technical developments.
Filed in French · English published by the European Commission
The German Environment Agency (UBA) welcomes the opportunity given by the European Commission to comment on the inception impact assessment regarding the evaluation and revision of the general pharmaceutical legislation as part of the realisation of the Pharmaceutical Strategy.
Rare Cancers Europe (RCE), a 40-partner strong multi-stakeholder partnership, welcomes the consultation and would like to emphasise the following: 1. Ensure access: • HTA: RCE encourages the harmonisation of HTA processes and to ensure the concept of joint clinical assessments, to avoid the duplication of clinical assessments at national level, as foreseen by the draft HTA regulation.
The Association of Innovative Pharmaceutical Employers INFARMA represents 25 pharmaceutical, R & D and innovative medicines companies. The mission of INFARMA member companies is to ensure accessible treatments for all Polish patients and to improve their treatment standards.
Filed in Polish · English published by the European Commission
BIOSIM represents 14 manufacturers of biosimilar medicines supplying close to 90% of dispensed prescription medicines in Spain. Spanish biosimilar market accounted for almost €700 million in 2020. According to García-Goñi et al. (2021) the utilization of biosimilar medicines in the Spanish NHS have generated savings of about €2.3 billion in the period 2009-2019.
EANM highly appreciates the initiative to revise the legislative framework for medicinal products in Europe and takes the chance to highlight aspects of significant importance for the application of Nuclear Medicine technology.
Phare is in favour of an agile regulatory framework and an attractive incentive system to support and promote progress in science, technology and medicine. Adequate conditions need to be put in place to support a sustainable market for pharmaceuticals (AM) in order to strengthen the supply and production of this AM in the EU.
Filed in German · English published by the European Commission
Representing more than 25,000 oncology professionals from over 160 countries, ESMO welcomes this important consultation. In light of this, we recommend the following: 1. Ensure access: • HTA: ESMO believes that unifying HTA across Europe through joint clinical assessments will contribute to improving access to high quality medicines.
The European Alliance for Transformative Therapies (TRANSFORM) is a multi-stakeholder coalition that fosters effective dialogue around cell and gene therapies and provides evidence-based policy recommendations to enable patient access to innovative therapies.
SIOPE welcome evaluation and revision of General Pharmaceutical Legislation hoping that it can deliver urgently needed improvements for over 6000 youngest citizens dying of cancer each year in Europe by addressing: 1.Revise Legislation to Unlock Innovation Concluded by Paediatric and Orphan Regulations (OPR) evaluation “neither regulation has proven effective in boosting development of innovative medicines for…
Hematology is at the forefront of medical and technological advances which have brought truly patient-centered, personalized medicine within reach. Clinicians, researchers, policymakers and regulators at the EU and national level, research funders and the pharmaceutical industry have a shared responsibility to ensure that innovative treatments are affordable and available for all patients in Europe.
GIRP welcomes the opportunity to comment on the evaluation and revision of the general pharmaceutical legislation by the European Commission (EC). GIRP identifies 4 key areas to improve access to medicines: 1. Ensure through a regulated and enforced framework (with appropriate incentives) the safe, efficient, and fair distribution of medicinal products, and medical devices, to all patients in crisis and non-crisis…
Boehringer Ingelheim welcomes the opportunity to input into this consultation. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective and stands for continuous investment in medical innovation to improve the health of humans and animals. As a research-driven biopharmaceutical company, our patient-centric research focus lies on areas of high unmet medical need.
Grifols, an EU-headquartered leader in plasma collection and fractionation of plasma derived medicinal products (PDMPs), welcomes the opportunity to provide input on the pharmaceutical strategy. As the roadmap noted, the EU is not as competitive as it could be: the current framework lacks dynamism and is not well suited to promote innovation.
The proposed impact assessment will form a good foundation for revision of the general pharmaceutical legislation. We would however emphasise the importance of devoting sufficient attention to the proper functioning of the legislation regarding off-patent medicinal products. There are substantial differences in access, affordability, sustainability and security of supply for off patented and patented medicines.
Médecins Sans Frontières (MSF) welcomes the European Commission’s ambition to ensure access to affordable medical tools. Beyond evaluating and revising the pharmaceuticals legislation, the Commission should take a comprehensive approach to revising the EU’s intellectual property (IP) and research and development (R&D) legislation and policies to meet this ambition.
Learning from Covid19, Farmindustria supports a process to update the EU regulatory framework and a more robust and flexible system to enhance pharmaceutical innovation (breakthrough & incremental) and help bring therapies quickly to as many patients as possible, implement efficient value-based assessments and strengthen EU role towards regulatory convergence.
GEMME is an association which represents companies that produce or commercialize generic and biosimilar medicines on the French market. The association works in favor of more competitiveness for the French pharmaceutical industry as well as a more sustainable healthcare system. Shortages and tensions in the supply chain constitute a major health concern at both national and European levels.
The revision of the EU general pharmaceuticals legislation should aim to address the problems of availability, accessibility and affordability of medicines as well as to incentivise meaningful, public health needs-driven biomedical innovation. Put simply, it should serve the goal of having better and affordable medicines for those who need them.
ARPIM, the Romanian EFPIA affiliate, supports all strategic initiatives that aim to bring innovation faster to Romanian and EU patients. In order to (re)build resilient healthcare systems and to have a sound pharmaceutical strategy, the EU must strengthen its role in world-class research, by providing a smart, flexible and predictable regulatory environment, taking into account therapeutical innovation, AI role…
ECL welcomes the opportunity to contribute to the revision of the general pharmaceutical legislation. Across the legislative changes in the health space, it is essential to remember that health is a public good and should not be discussed as a marketing item. ECL’s keywords: conditionalities, transparency, and cross-border collaborations.
REIF CONTRIBUTION TO THE EVALUATION ROADMAP AND INCEPTION IMPACT ASSESSMENT ON THE REVISION OF THE EU PHARMACEUTICAL LEGISLATION REIF, the Representation of French social security institutions to the EU, welcomes the Commission’s intention to revise the EU pharmaceutical legislation.
The European Heart Network (EHN) welcomes the patient-centred approach of the Pharmaceutical Strategy for Europe, with a view to foster patient access to innovative, safe, available and affordable medicines. EHN represents heart foundations and cardiovascular patient associations dedicated to improving cardiovascular health in Europe.
The American Chamber of Commerce to the EU (AmCham EU) is committed to the development of a regulatory environment which furthers the capabilities of European healthcare, improving accessibility and ensuring a crisis-resistant medicines regulatory system.
As a research-driven biopharmaceutical company, AbbVie supports the Commission objectives to create a patient-centered and globally competitive European pharmaceutical policy environment that enhances the availability of medicines across the EU and incentivizes development of treatments for unmet health needs in both diseases where no treatments exist as well as those where the existing treatments do not…
Sanofi welcomes the European Commission’s (EC) assessment that the general pharmaceutical legislation should be fully adapted to cover new scientific and technological developments. We have identified six areas where procedures could be simplified and/or streamlined to reduce timelines, regulatory burden, and improve patient access. 1.
CCI-Europe is thankful for the opportunity to give feedback on the revision of the EU General Pharmaceutical Legislation. CCI-Europe is the biggest pan- European childhood cancer parents’, survivors’ and patient representatives’ organisation (66 organisations in 33 European countries) that advocates patient-centred treatments and research via inclusion, collaboration and transparency.
Swedwatch continues to call on the European Commission to ensure that the new revision of the general pharmaceutical legislation to protect and respect fundamental human rights to a safe, clean, and sustainable environment.
A vital innovation ecosystem accompanied by an agile regulatory framework are prerequisites for a modern pharmaceutical system. Therefore, the German Association of Research-Based Pharmaceutical Companies (vfa), representing 47 of the world’s leading research-based pharmaceutical companies, welcomes the initiative by the Eu-ropean Commission to review the long-standing general pharmaceuti-cal legislation.
The LEEM calls for a robust and agile regulatory framework and incentive system, which encourages advances in science, technology and medicines, draws lessons from COVID-19, and promotes the global competitiveness of industry. Businesses make easier access to medicines for as many patients a real commitment. However, amending legislation is not the only way to address access and affordability issues in Europe.
Filed in French · English published by the European Commission
The BAH supports the objective of strengthening the European Health Union and the Pharmaceutical Strategy to make the pharmaceutical system more patient-centred, future-proof and crisis-proof. Unmet Medical Need • Unmet medical need definition: It makes sense to define unmet needs or gaps in health care. The well-known definition under Article 4 (2) of Regulation (EC) No 507/2006 is very broad.
Filed in German · English published by the European Commission
EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.
Orano would like to thank the European Commission for giving the opportunity to express its views on the revision of the general pharmaceutical legislation. More precisely, Orano shares the European Commission’s concerns about the “inefficiency and administrative burden of regulatory procedures” as pointed out in its Impact Assessment. Such shortcomings are indeed experienced for innovative nuclear medicine.
AAA, a Novartis company, is a pioneer and leader in radioligand therapy (RLT). We welcome the EC's roadmap as a key step to build a flexible pharmaceutical legislation and we agree on the need to adapt the current framework to developments in medicine. There are several regulatory challenges in the field of therapeutic radiopharmaceuticals that may limit the uptake of this new pillar in cancer care.
The European Patients' Forum (EPF) believes that embedding meaningful patient involvement in everything that affects the patients’ own access to medicines and care is key for tackling medicines shortages, evaluating new medicines, and making the medicines’ supply chain more efficient. It is critical to reduce inequity in access to medicines.
The European Association of E-Pharmacies (EAEP) would like to submit initial remarks on the evaluation and revision of the general pharmaceutical legislation. As outlined in the combined evaluation roadmap and Inception Impact Assessment, the revision of the general pharmaceutical legal framework aims to ensure access to affordable medicines in the EU.
The EU should be ambitious and strive for being the world leader in medical innovation as this benefits European patients and people. Global competition for life science investments is heavy. Europe should invest in the fact that Europe is an attractive and competitive operating environment for pharmaceutical research and development.
PGEU welcomes the opportunity to provide input in the context of the European Commission roadmap/inception impact assessment on the Evaluation and revision of the general pharmaceutical legislation. Our contribution addresses the issues that have a direct impact on community pharmacy, namely security of supply of medicines including shortages, medicines accessibility, and environmental sustainability.
Teva is a strategic partner of EU healthcare systems, producing 93% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries (53% of our APIs are manufactured in house, 40% of which is in Europe), and saving healthcare systems more than €7.5B across 12 countries in which we support more than 112,600 jobs.
Roche expects fast-paced developments in medicines, devices, data and digitalisation to converge into more personalised healthcare solutions, with increased benefit to society at a significantly reduced cost. While this evolution has started and will continue over the next decades, details are hard to predict.
Farmaindustria considers it crucial to preserve the stability and predictability of the current European framework of incentives to attract investment and enable the pharmaceutical industry to continue to innovate in Europe, achieving better health outcomes.
Filed in Spanish · English published by the European Commission
Creating an ambitious healthcare research ecosystem with pro-innovation policies and a fit for purpose research infrastructure is of utmost importance for Europe to remain competitive on the world stage and deliver breakthrough treatments for patients.
Amgen supports an agile regulatory framework for EU to become more competitive and attractive for innovation globally. We are concerned that some proposals would not help achieve the roadmap goals and suggest approaches below (indent letters refer to EC roadmap section B) b) We propose: -Reduce regulatory approval times and costs: develop a more efficient marketing authorisation; shorten time to CHMP opinion by…
VIATRIS is a new healthcare company, formed in 2020 through the combination of Mylan and Upjohn. We are committed to providing access to medicines, advancing sustainable operations and developing innovative solutions to improve patient outcomes.
Digestive Cancers Europe (DiCE), the European umbrella organisation representing patients with digestive cancer, welcomes the opportunity to provide feedback to the evaluation roadmap to the EU general pharmaceuticals legislation. We welcome the EC’s intentions to improve access to affordable medicines and enhance the existing provisions on access to biosimilar medicines.
As a manufacturer working in innovative areas of medicines development and manufacturing, we support the Commission’s efforts to future-proof the EU’s general legislation and adapt to scientific and technological developments. The Commission’s IIA highlights the need to introduce elements of flexibility to this end.
Baxter is a global healthcare company with a leading portfolio of critical care, nutrition, renal, hospital and surgical products and we are driven by our mission to save and sustain lives. We stand ready to partner with EU policy-makers during the on-going process to modernise the EU’s regulatory environment for pharmaceuticals.
Galapagos is a pioneering European biotech dedicated to improving patients' lives. We focus our R&D on areas of high unmet need. We believe Europe can be a hub for innovation. The COVID-19 pandemic has once more shown how vital the European biotechnology sector is for Europe and the world.
Health systems in the EU face the challenge of ensuring a high quality of affordable supply of medicines in the face of high prices. The German Social Insurance Agency therefore welcomes the EU’s intention to revise European pharmaceutical legislation.
Filed in German · English published by the European Commission
ESIP, representing statutory social health insurers in the EU, UK and Switzerland, welcomes the Commission’s intention to revise the pharmaceutical legislation. Increasingly high prices of medicines, sometimes coupled with low levels of evidence at time of market authorisation, create pressure on healthcare budgets, consequently hindering access to innovative medicines for patients.
To whom it may concern, The Medtech & Pharma Platform Association (MPP) is writing to you to share its views on the European Commission’s combined roadmap/inception impact assessment on the evaluation and revision of the general pharmaceutical legislation. MPP is fully supportive of the points laid out in the evaluation roadmap.
The document describes accurately the context where this initiative takes place. Indeed, the problems addressed by the document are the most impacting ones that the industry and stakeholders have to deal with. However, we would like to take this opportunity to point out some concerns: 1.
Since patients’ access to pharmaceuticals is increasingly jeopardised by a steady rise in pharmaceutical spending and pricing of medicinal products within the EU, the Austrian Social Insurance welcomes the evaluation and revision of the general pharmaceutical legislation.
Pfizer acknowledges that access, affordability and availability of medicines are key priorities of the EU Pharma Strategy. We remain committed to partner with EU policy-makers to address these challenges. However, the root causes of obstacles to the availability of innovative medicines are multi-factorial and fall mostly beyond EU competences.
The Panhellenic Union of Pharmaceutical Industry, represents the collective domestic pharmaceutical manufacturers of generic medicines in Greece. As National member of Medicines for Europe, the European association that represents manufacturers of off-patent medicines in Europe, we would like to reiterate the below important issues in light of the revision of the general pharmaceutical legislation.
EUCOPE is the voice of small to midsize innovative companies active in the field of pharmaceuticals and medical technologies at the European level. The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness.
IVAA welcomes the patient-centered approach of the Revision, as well as the environmental perspective, in order to ensure the supply of safe and affordable medicines to meet patients’ needs in the EU. Like other complementary medicinal products, anthroposophic medicinal products (AMPs) have a long tradition of medical use.
Lif supports an agile, pragmatic and risk-based regulatory framework and a strong incentives’ system that encourage advances in science, technology and medicines. However, EU legislation itself cannot solve issues around access and affordability, which are in close connection to national competences.
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. The Covid-19 crisis has shown that Europe needs to reflect on how to deliver resilient health systems whilst remaining a competitive actor on the global stage.
GSK supports a modernisation of the EU general pharmaceutical legislation which ensures a robust, agile and predictable regulatory framework, and which embraces and clearly recognises innovation in addition to facilitating access to new innovative medicines and vaccines for the benefit of patients and society.
As a biotechnology firm developing innovative, potentially safer and greener medicines, Mithra believes that the main obstacles to green innovation in the industry are financial and regulatory obstacles. Green innovation should therefore be supported through effective measures such as : • New funding opportunities to help companies innovate not only medically but also environmentally; • Prioritized EMA review for…
Together with EFPIA, pharma.be supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology and medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.
ACCELERATE, the international multi-stakeholder platform which aims to accelerate innovation in drug development for children and adolescent with cancer, welcomes the revision of the general pharmaceutical legislative framework in the scope of the pharmaceutical Strategy for Europe.
Finland would like to thank for the possibility to comment and in general, we are in favour of the revision of the pharmaceutical legislation. The regulatory system should be sound and flexible, the legislative framework must not be too detailed, and the administrative burden must not be increased. It is important to make processes as streamlined and cost-effective as possible and to avoid inefficiency.
The Vereniging Innovatieve Geneesmiddelen (VIG) considers the evaluation of the pharmaceutical legislation an opportunity to draw lessons from the COVID-19 pandemic and prepare for the future. To remain attractive for innovation and R&D while effectively responding to future challenges and threats.
The G-BA appreciates the objectives and the identified key areas where changes in the pharmaceutical legislation are needed. As the decision-making/HTA body, we would like to highlight some of the issues addressed by the initiative: Regulatory standards: The G-BA generally welcomes the initiative to simplify administrative elements of the legislation, to explore ways to adapt marketing authorisations more easily…
The Women’s Brain Project (WBP) is an international non-profit organisation studying sex and gender determinants of brain and mental health to achieve precision medicine.(1) On 25 November 2020, the European Commission published a Communication on a Pharmaceutical Strategy for Europe.(2) In the Strategy, the WBP is delighted to see that the European Commission acknowledges that treatments for neurodegenerative…
The Association of Clinical Research Organizations (ACRO) is pleased to provide five comments. 1—SIMPLIFYING THE LEGISLATION: Harmonising the interplay with other regulatory frameworks will be particularly important, especially for combined products. Harmonisation will provide predictability, fostering innovation in Europe. Please consider the lessons from COVID-19.
CSL Behring is strongly committed to bringing valuable, innovative products to market that address unmet medical needs so patients can lead healthy and productive lives. Our strong R&D pipeline utilizes its expertise in plasma fractionation, recombinant technology, and cell and gene therapy.
The future EU frameworks for regulatory approval, access and incentives to innovation must be articulated around strong industrial policies, attractiveness and predictability, as key enablers to innovation and speeding up access to patients. The legislative review should support European developers and manufacturers in leading science progress and remaining competitive globally.
The Plasma Protein Therapeutics Association (PPTA) promotes the availability of, and access to, safe and effective plasma-derived medicinal products (PDMPs) which treat a variety of rare, chronic, and potentially life-threatening conditions. 300,000 European patients rely on these essential medicines, without which they might not survive or would have a substantially diminished quality of life.
HAI welcomes the opportunity to provide feedback to the evaluation and revision of the general pharmaceutical legislation and appreciates the importance of the initiative taken by the European commission to update and adapt a keystone of the European Health Union.
The European Society of Cardiology (ESC) welcomes the evaluation and revision of the EU pharmaceutical legislation. As leading professional organisation in cardiovascular healthcare, we are dedicated to providing effective, safe and innovative cardiovascular therapy to our patients. We share the impression that the COVID-19 pandemic has revealed both strengths and weaknesses of the EU pharmaceutical legislation.
Access to Medicines Ireland (AMI) welcomes the opportunity to contribute to the revision of the general pharmaceutical legislation. We have comments, and recommendations in the following areas: Unmet Need 1. Towards a definition of ‘unmet need’, we recommend developing a fair, equitable and transparent decision-making process for what is an ‘unmet need’. 2.
The Danish Association of the Pharmaceutical Industry (Lif) supports an agile regulatory framework a strong and stable incentives’ system that embrace and encourage advances and development in innovative medicines.
Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines.
As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care.
BUND / FoE Germany welcomes the intention of the Commission to strengthen the pharmaceutical legislation. We regret that the roadmap is apparently limited to human medicines (HMP) and does not include plans to further improve legislative measures for veterinary medicinal products.
For APIFARMA, equity should be the baseline in the future healthcare policy. Europe has the opportunity to foster investment in research and innovation paving the way for a new generation of highly innovative treatments and of highest added value. Only by developing treatments for the unmet needs, reducing delays, and ensuring equal access to therapies can we truly leave no citizen suffering a disease behind.
ARM welcomes the review of the general Pharma legislation and the Commission’s objectives of enabling innovation, reducing the regulatory burden, whilst ensuring high quality and safety standards for pharmaceuticals.
The review of pharmaceutical legislation with the aim of guaranteeing access to affordable medicines and health products in the EU, must include both existing legislation on medicine and on medical devices. Considering both legislative fields, the following aspects should be considered: • Support for research and innovation of medicines and health products.
UCB has a fundamental commitment to enabling people living with severe diseases, their caregivers & families to live their best lives. We continuously innovate to bring differentiated solutions with unique outcomes, which help specific patients achieve their life goals. To deliver on that commitment now and into the future, sustainability is a strategic imperative for us.
The European Alliance for Access to Safe Medicines (EAASM) welcomes the revision of the EU general pharmaceuticals legislation and with a view to protect patient safety and enhance scientific and technological developments in Europe, it is firmly resolved to significantly reduce medication errors and promote, at European and national levels, the implementation of comprehensive electronic traceability systems in…
HollandBIO, the Dutch biotech industry association, appreciates the opportunity to provide feedback on the roadmap towards the evaluation and revision of the general pharmaceutical legislation to further improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. An ambition very close to our heart.
Access to medicines and shortages have today more than ever raised questions. Regulatory approaches as well as the regulation of supply and demand condition a fluctuating market, ranging from the promotion of generics and the multiplication of patents to high-cost technological innovations .
I note with interest that your Combined Evaluation Roadmap refers to the need to "enable innovation for the development of high quality, safe, effective medicines". In the view of my organisation, HealthWatch, the UK charity that campaigns for ethical, evidence-based health care, this is also an opportunity to remove any form of official support for, or recognition of, homeopathy.
Bristol Myers Squibb (BMS) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. New medical technologies, from innovative oncology and immunotherapies to mRNA and CRISPR gene editing offer unprecedented opportunities to improve the lives of Europeans.
The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry. The legislation should ban patent linkage – a major cause of generic/biosimilar entry delays, which the EC considers anti-competitive and “unlawful”.
The Alliance for Safe Online Pharmacy (ASOP EU - https://buysaferx.pharmacy/eu/) welcomes the revision of the EU general pharmaceuticals legislation calling for patient safety and campaigning for tough action against illegal online pharmacies. ASOP EU aims to make real and positive change to improve online safety and Europe can play a vital role in securing practical solutions to combat falsified medicines.
We welcome the European Commission call to improve current access to innovative medicines across the European Union. Following the EFPIA report on the root causes of unavailability and delays of innovative medicines we acknowledge causes are multifactorial and as a pharmaceutical company, we play a role in this.
It its Water Vision, Water Europe (WE) has set out a blueprint for a society in which the true value of water is recognized and realized, and all available water sources are managed in such a way that water scarcity and pollution of water are avoided, water and resource loops are largely closed to foster a circular economy and optimal resource efficiency, while the water system is resilient against the impact of…
The European Commission states its intention for its Pharmaceutical Strategy for Europe to be ‘patient-centred’. However, it is crucial that the concept of ‘patient value’ is integrated in the pharmaceutical legislation.
ECHAMP, the European Coalition on Homeopathic & Anthroposophic Medicinal Products, represents the majority of the companies active in the production and distribution of those products in the EU. We endorse the rights of more than 110 million patients and consumers in the EU to have easy and comprehensive access to reliable homeopathic and anthroposophic medicinal products which meet the highest standards of quality…
FOR HOMEOPATHIE: We request that homeopathic products be removed from the Medicines Directive. Indeed, to date, there is no professional recommendation from health agencies, Academy of Sciences, Medicine or Pharmacia to recommend the use of homeopathy regardless of the pathology or symptoms. Rather, there is a consensus to indicate the lack of efficacy of homeopathy, which adds nothing to the placebo effect.
Filed in French · English published by the European Commission
Biogen is one of the world’s leading biotechnology companies, with a focus on discovering, developing, and delivering worldwide innovative therapies for people living with serious neurological diseases. The planned initiative to evaluate the general pharmaceutical legislation is an opportunity to incorporate learnings into a future medicine regulatory framework that supports innovation and can accommodate rapid…
We welcome the European Commission’s initiative to launch a process of evaluating a general review of pharmaceutical legislation, in particular with regard to improving administrative and regulatory procedures, strengthening the supply structure for medicinal products, quality, environmental challenges and sustainability.
Filed in Italian · English published by the European Commission
Good afternoon. I am Fernando Cervera Rodríguez, molecular biologist, representative and member of the Board of Directors of the Association for Protecting Pseudo-Scientific Therapias (www.apetp.com). Please find enclosed in this comment as coordinator of the First Worldwide manifesto against pseudosciences in health, the document setting out the request of 2750 scientists and health workers from 44 countries…
Filed in Spanish · English published by the European Commission
1. The roadmap needs to consider, or at least explore with stakeholders, the benefits, particularly for small organisations, of a standardised mandatory model contractual agreement forconduct of clinical studies between Sponsor and site/healthcare facility conducting the study.
EIGA supports this public consultation and like to provide following feedback for consideration on two aspects: Inefficiency and administrative burden of regulatory procedures Our medical gases industry have, during the COVID19 proposed regulatory flexibilities (see attached BN25 and on www.eiga.eu). Most EU Member States have adopted them in full.
Eli Lilly & Company (Lilly) wishes to offer this solution-oriented reply for improving the EU medicines ecosystem, making life better for patients, and facilitating the EU’s leadership in life sciences. Future-proofed system Policies that enable adaptability and adequate resourcing will ensure that the EU regulatory system is efficient, effective, and competitive.
The unprecedented health crisis that is particularly affecting Europe has highlighted our continent's shortcomings in terms of health sovereignty. As the cradle of pharmaceutical synthesis, Europe has gradually lost its capacity to develop new production processes.
About section B. Objectives and Policy options Ensure access to affordable medicines for patients, and address unmet medical needs; d) Consider the creation of specific incentives to promote the development of new classes of antimicrobials in combination with rules aiming to promote their prudent use and measures aligning use to patient needs, such as reduction of package sizes; Time for Lyme ASBL welcomes the…
THE EUROPEAN MEDICAL ASSOCIATION POSITION PAPER ON EUROPEAN HEALTH EMERGENCY PREPAREDNESS AND RESPONSE AUTHORITY (HERA) The European Medical Association is a not-for-profit more than 30 years old Organization, with expertise in drafting analysis and policy briefs, joining professionally and scientifically qualified members. Their shared background is clinical, i.e.
APOGEN represents manufacturers of off-patent medicines supplying 63% in retail market and 76% in hospitals of dispensed prescription medicines in Portugal. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch…
Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines.
The European Alliance for Access to Safe Medicines (EAASM) welcomes the revision of the EU general pharmaceuticals legislation and with a view to foster innovation and protect patient safety across Europe, including in areas of unmet medical need, the EAASM stresses the importance of establishing a fit for purpose regulatory framework for nanomedicines at the EU level.
The European Fair Pricing Network (EFPN) welcomes the Commission’s initiative to revise the EU general pharmaceutical legislation. The EFPN urges the Commission to prioritize the following problems: First, unequal access to affordable medicines for patients EU wide is a great problem that threatens the health and lives of many Europeans.
Forum, as a Slovenian R&D pharmaceutical industry association, hereby expresses its support of the European Commission's effort to build a regulatory framework which will ensure availability of innovative, effective and safe medicines throughout the whole European union and that all needs of European patients will be adequately addressed.
McKesson Europe fully supports the European Commission’s (EC) evaluation of the General Pharmaceutical Legislation. We strongly believe that the EU’s General Pharmaceutical Legislation is overdue a comprehensive review. The EC needs to utilize this opportunity and make General Pharmaceutical Legislation more effective for European patients.
This feedback relates to the impact of pharmaceuticals substances on the environment. It is based on the results of the Bellecombe site –Sipibel–. SIPIBEL (www.sipibel.org) is a research and observation site created in 2011 in order to study the characterisation, treatability and impacts of hospital effluents and pharmaceuticals residues in a urban sewage treatment plant.
The issue of access to medicines for as many people as possible is a major issue of society and it can only be positive to address it. However, from an environmental point of view, I would like to note that the use of any pharmaceutical substance, in particular for the oral route, leads to the excretion of part of it.
Filed in French · English published by the European Commission
DVGW welcomes the European Commission intention to evaluate and revise the pharmaceuticals legislative framework, as anticipated in the Pharmaceuticals Strategy, and in particular the resolve to address environmental issues and AMR. Pharmaceutical residues represent one of the many examples of contaminants of emerging concern that can directly or indirectly enter the water cycle through many pathways.
The General Directorate for Common NHS Services Portfolio and Pharmacy at the Ministry of Health in Spain welcomes the EC - initiative for the Roadmap and the establishment of a Pharmaceutical Strategy seeking to ensure availability and access to and affordability of pharmaceutical innovations in Europe. This department appreciates to be given the opportunity to comment and give feedback.
EurEau welcomes the European Commission intention to evaluate and revise the pharmaceuticals legislative framework, as anticipated in the Pharmaceuticals Strategy, and in particular the resolve to address environmental issues and AMR. Pharmaceutical residues represent one of the many examples of contaminants of emerging concern that can directly or indirectly enter the water cycle through many pathways.
Health Care Without Harm (HCWH) Europe welcomes the opportunity to comment on the European Commission’s inception impact assessment on the evaluation and revision of the general pharmaceutical legislation that aims to ensure access to affordable medicines, foster innovation, and enhance security of supply in the framework of a stronger European Health Union.
Vienna, April 2021 The Austrian Institute for Health Technology Assessment (AIHTA) welcomes the EC - initiative for the Roadmap and the establishment of a Pharmaceutical Strategy seeking to ensure availability and access to and affordability of pharmaceutical innovations in Europe.
EORTC would like to stress several aspects that would deserve specific actions: Access to medicines is definitively a key aspect. The affordability of medicines has implications for both public and household finances. EORTC fully endorses the Commission statement that minimising waste and optimising the value of spending on medicines are also critical to achieving efficient and sustainable health systems.
Enhance Security of supply Medication shortages are not just a pharmacy problem; addressing shortages requires action on multiple fronts. But in the meantime healthcare provider organizations must have the right protocols , technology and systems in place to manage drug shortages. Many healthcare provider´s supply chains are not supporting good management of medicines shortages.
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