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Evaluation and revision of the general pharmaceutical legislation

Public health

The revision of the general pharmaceutical legal framework, aims to ensure access to affordable medicines in the EU. It aims to foster innovation including in areas of unmet medical need (such as in antimicrobials) and to enhance security of supply while adapting to new scientific and technological developments and reducing regulatory burden where possible. Drawing lessons from the COVID-19 pandemic, it will support a future-proof and crisis-resistant pharmaceuticals system.

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Public consultation

ID: 12963

Lobbying Activity

273 responses

BEUC demands transparency and faster access to generic medicines

Bureau Européen des Unions de Consommateurs, 8 Nov 2023

BEUC demands mandatory comparative clinical trials and transparency regarding public funding. They propose a six-month filing deadline to ensure faster availability of new medicines. The group also insists on keeping paper leaflets to protect consumer rights.
These changes would lower costs for consumers and improve overall pharmaceutical transparency.
Large pharmaceutical companies would lose market exclusivity to generic competitors more quickly.

Consultation response

Bureau Européen des Unions de Consommateurs, 27 Apr 2021

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…

AmCham EU Urges Stronger Research Incentives for Pharmaceutical Innovation

American Chamber of Commerce to the European Union, 6 Nov 2023

They demand a globally competitive and predictable framework for Regulatory Data Protection. The group advises avoiding conditionality on incentives while expanding expedited regulatory pathways. They also request a broader, patient-centred definition of unmet medical need.
This would improve investment attractiveness and reduce unnecessary administrative costs for companies.
Environmental regulators lose the power to deny drug authorizations based on ecological risks.

AmCham EU urges competitive R&D incentives for pharmaceutical innovation

American Chamber of Commerce to the European Union, 6 Nov 2023

The group seeks faster drug approval processes and stronger protection for new inventions. They recommend broadening the definition of medical needs and making supply chain rules more proportionate. They also oppose blocking medicine sales solely because of environmental concerns.
These changes would lower compliance costs and improve the profitability of drug development.
Environmental standards might be weakened if sustainability criteria do not prevent medicine approvals.

Consultation response

American Chamber of Commerce to the European Union, 27 Apr 2021

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. The following outlines our key viewpoints…

Chemical industry urges EU manufacturing reliance to reduce drug dependence on Asia

European Chemical Industry Council, 27 Apr 2021

The organization requests policies to support existing European API manufacturers and reduce dependency on Asian imports. They call for public procurement rules favoring EU suppliers meeting strict environmental and safety standards. They propose a long-term industrial policy accelerating sustainable manufacturing technologies within EU territory.
This would increase demand for their European manufacturing facilities and ensure long-term profitability.
Asian API manufacturers lose market share as EU procurement prioritizes European suppliers.

Consultation response

European Federation of Pharmaceutical Industries and Associations, 27 Apr 2021

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…

Eurogroup for Animals Urges Shift Toward Animal-Free Drug Innovation

Eurogroup for Animals, 8 Nov 2023

The organization calls for a transition away from animal testing toward human-relevant approaches. They recommend including language that accommodates innovative technologies like AI and organoids.
This approach would reduce research costs and improve the success rate of drug development.
Patients currently suffer when effective treatments are discarded because of misleading animal test results.

Consultation response

Bayer AG, 7 Nov 2023

Bayer is grateful for the opportunity to engage in the dialogue concerning the pharmaceutical legislation reform. Alongside our primary recommendations below, additional details can be found in the annex. Bayer has a 160-year legacy of European innovation and proudly maintains 11 Pharma R&D and…

Consultation response

Bayer AG, 7 Nov 2023

Bayer is grateful for the opportunity to engage in the dialogue concerning the pharmaceutical legislation reform. Alongside our primary recommendations below, additional details can be found in the annex. Bayer has a 160-year legacy of European innovation and proudly maintains 11 Pharma R&D and…

Bayer calls for agile EU regulation to boost pharmaceutical innovation

Bayer AG, 27 Apr 2021

Bayer proposes institutionalizing pandemic-era agility by streamlining EMA committees and granting them direct approval powers. They also advocate for expanding centralized procedures to clinical trials and harmonizing data protection rules.
This would speed up market entry and foster an environment where genetic research can flourish.
National regulators may lose funding if fees are distributed solely based on quality and resource needs.

Consultation response

MEDICINES FOR EUROPE, 29 Sept 2023

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic…

Consultation response

MEDICINES FOR EUROPE, 29 Sept 2023

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas,…

Consultation response

MEDICINES FOR EUROPE, 22 Apr 2021

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…

Consultation response

Friends of the Earth Europe, 26 Apr 2021

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. Focusing on…

IndustriAll Europe demands social conditions for pharmaceutical sector support

industriAll European Trade Union, 25 Oct 2023

They demand linking market exclusivity to social criteria like collective agreements and quality employment. The union also urges reshoring production through domestic production requirements in public tenders.
Trade unions would secure quality jobs and stronger collective bargaining rights within Europe.
Pharmaceutical companies lose commercial autonomy regarding which national markets they choose to supply.

WKÖ warns EU pharma reform threatens international competitiveness

Wirtschaftskammer Österreich, 8 Nov 2023

The chamber calls for less bureaucracy and stronger protection of intellectual property to maintain competitiveness. They demand prioritizing patient access over environmental assessments and removing unrealistic market entry requirements.
Reducing reporting duties would lower administrative burdens and maintain high investment levels.
Environmental health and patients in smaller member states face higher risks and delays.

Consultation response

MedTech Europe, 26 Apr 2021

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. MedTech…

Novartis urges faster EU drug approvals through regulatory modernization

Novartis International AG, 27 Apr 2021

Novartis requests quicker regulatory approvals through more flexible regulations that embrace scientific advances like real-world data and artificial intelligence. They want simplified processes based on COVID-19 lessons and warn against lengthy legislative changes that could delay innovation.
This would maintain Europe's attractiveness for their R&D investments and speed market access.
Patient safety advocates lose stricter approval processes that ensure thorough medicine evaluation.

Novo Nordisk calls for faster EU drug approvals and IP protection

Novo Nordisk A/S, 27 Apr 2021

The company requests faster approval timelines, integration of real-world evidence, predictable intellectual property protections, and holistic assessment of chronic disease treatments. They argue current approval times lag behind the US and Japan, delaying patient access to innovation.
This would protect their development investments and allow faster market access for their products.
Generic and biosimilar manufacturers face stricter requirements limiting competition and affordable alternatives.

EuropaBio warns pharmaceutical revision threatens European biotech innovation

EuropaBio, 9 Oct 2023

EuropaBio requests stable regulatory incentives and rejects conditioning data protection on market launches. They want a faster, more flexible regulatory framework to accommodate future medical innovation.
Retaining strong data protection ensures biotech firms remain attractive to global investors.
Small biotech firms lose because they cannot afford simultaneous launches across all markets.

Consultation response

EuropaBio, 27 Apr 2021

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…

Eli Lilly opposes EU plan to reduce drug patent protections

Eli Lilly and Company, 7 Nov 2023

Lilly requests greater regulatory data protection instead of reductions and opposes linking intellectual property to EU-wide market access. They advocate against expanding exemptions to pricing and reimbursement activities during patent terms. They support streamlined approval timelines and risk-based shortage prevention focused on critical medicines only.
This would maintain patent protections supporting high-risk research investments in difficult diseases like Alzheimers.
Generic manufacturers lose earlier opportunities to prepare market entry and price negotiations.

Eli Lilly opposes cuts to drug data protection periods

Eli Lilly and Company, 7 Nov 2023

Lilly requests maintaining strong Regulatory Data Protection without conditions linking IP to access in all EU27. They argue the proposed RDP reduction and conditionality system is unpredictable and undermines European competitiveness. They advocate for greater RDP to drive innovation into difficult diseases like Alzheimer's.
This would preserve IP incentives needed to justify high-risk investment in slow-progressing diseases.
Generic and biosimilar manufacturers face continued delays in bringing affordable alternatives to market.

Austrian industry warns pharma reforms threaten European research innovation

Vereinigung der österreichischen Industrie - Industriellenvereinigung, 7 Nov 2023

The organization opposes shortening data protection periods from eight to six years, as it discourages investment. They request predictable frameworks that protect intellectual property to keep the pharmaceutical sector competitive.
Retaining longer protections would safeguard the investment stability and revenues of drug manufacturers.
Public health systems and patients may face delayed access to affordable medicines.

Consultation response

Eli Lilly and Company, 26 Apr 2021

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…

Sanofi warns EU pharmaceutical reforms threaten European life sciences competitiveness

SANOFI, 8 Nov 2023

Sanofi requests longer orphan market exclusivity with a 15-year cap instead of 13 years, removal of the high unmet medical need definition, and rejection of six-month advance notification for supply disruptions. They support risk-based shortage prevention plans and streamlined regulatory approval processes.
This would extend patent protection for their rare disease drugs and reduce administrative burdens.
Patients lose faster access to affordable medicines through extended monopoly periods for treatments.

Sanofi warns pharmaceutical reforms threaten European innovation and competitiveness

SANOFI, 8 Nov 2023

Sanofi opposes reducing regulatory data protection from 8 to 6 years and linking it to supply obligations. They seek stronger incentives including extending baseline protection to compete globally. They advocate a broader definition of unmet medical need focused on patient outcomes rather than just mortality reduction.
This would maintain their competitive position against US markets offering 12-year protection for biologics.
Patients lose faster access as companies delay launches in smaller markets without supply obligations.

German chemical association warns against pharmaceutical data protection cuts

Verband der Chemischen Industrie e.V., 7 Nov 2023

VCI urges the EU to maintain current data exclusivity periods to protect innovation. They also oppose using environmental assessments as the sole reason to reject medicines. Finally, reporting requirements for shortages should only apply to critical medications.
Retaining current protection periods ensures longer market exclusivity and higher returns on investment.
Environmental health suffers if medicines are approved despite failing rigorous ecological impact assessments.

VCI warns EU pharma reform threatens investment and innovation

Verband der Chemischen Industrie e.V., 7 Nov 2023

VCI opposes reducing data exclusivity periods to protect research and development achievements. They reject using environmental risk assessments as the sole reason for denying medicine approvals. The association requests limiting shortage prevention plans strictly to previously identified critical medicines.
Avoiding the reduction in data exclusivity periods maintains investment security for manufacturers.
Environmental safety and public health might suffer if environmental risk assessments are weakened.

Sanofi urges streamlined drug approvals and digital product information

SANOFI, 27 Apr 2021

Sanofi requests replacing paper leaflets with electronic product information, adopting common EU packaging for essential medicines, and implementing risk-based vaccine batch testing instead of systematic retesting. They also seek full integration of ICH Q12 guidelines and streamlined GMO assessment processes.
This would reduce regulatory burden, speed up product availability, and cut wastage costs.

Consultation response

Johnson Johnson, 27 Apr 2021

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. We welcome the opportunity to discuss improvements to ensure the framework is…

Consultation response

Merck Sharp Dohme Europe Belgium SRL, 27 Apr 2021

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…

Consultation response

Médecins Sans Frontières International, 27 Apr 2021

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…

European Patients' Forum calls for patient-centred pharmaceutical regulation

European Patients' Forum (EPF), 6 Nov 2023

The organization requests an EU-wide definition of added therapeutic value developed with patients, modulated incentives balancing R&D and access, and embedded patient participation throughout regulatory processes. They call for comprehensive unmet medical need criteria including quality of life impacts.
This would ensure medicines development targets patient priorities and improve their access to treatments.
Pharmaceutical companies lose extended market exclusivity periods that delay generic competition and maintain higher prices.

European Patients' Forum seeks patient-led reform of drug laws

European Patients' Forum (EPF), 27 Apr 2021

The group advocates for mandatory patient involvement in drug development and clearer definitions for medical needs. They call for medicine incentives to be tied to affordability and availability across Europe.
Patients would secure more influence over drug approvals and access to cheaper treatments.
Pharmaceutical companies could face reduced profits due to mandatory price and research transparency.

Vaccines Europe Warns New Rules Threaten Vaccine Innovation

Vaccines Europe, 4 Oct 2023

The group opposes linking market protection to product launches in all member states. They want medical needs to include disease prevention and community protection. They also advocate for digital leaflets and shared European packaging.
This prevents loss of market protection caused by unpredictable national approval delays.
Citizens in smaller countries might face persistent delays in vaccine availability.

Consultation response

Vaccines Europe, 27 Apr 2021

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…

AbbVie warns EU pharmaceutical reforms risk undermining innovation

AbbVie, 27 Apr 2021

AbbVie supports efficient regulatory frameworks and faster assessments but opposes linking intellectual property incentives to market placement requirements or R&D cost disclosure. They argue regulatory incentives should not address availability issues caused by member state policies.
This would preserve their intellectual property protections and avoid cost-based pricing pressures.
Patients in smaller EU markets lose if companies avoid launches there.

European Cancer Organisation demands broader definitions of medical need

European Cancer Organisation, 8 Nov 2023

The organization urges a broader definition of unmet medical need including quality of life. They request support for drug repurposing and protecting hospital-based medicine production.
Non-commercial researchers and hospitals would secure regulatory support and maintain their production roles.
Commercial drug developers may face more competition from non-commercial entities and hospital-produced therapies.

Consultation response

European Cancer Organisation, 27 Apr 2021

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. In responding to this Roadmap…

Consultation response

Affordable Medicines Europe, 27 Apr 2021

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…

GSK warns EU pharma reforms threaten innovation and investment

GSK, 7 Nov 2023

GSK requests maintaining current regulatory data protection periods and removing access conditionalities from innovation incentives. They argue the proposed reductions would harm Europe's competitiveness and patient access to new treatments.
This would preserve their intellectual property protection periods and avoid penalties for access delays beyond their control.
Patients and healthcare systems lose faster access to affordable generic and biosimilar medicines.

GSK warns EU pharmaceutical reform could harm innovation and access

GSK, 7 Nov 2023

GSK requests maintaining current regulatory data protection levels and removing access-based conditions on innovation incentives. They argue linking incentives to access conditions outside manufacturer control is impracticable and could harm European competitiveness.
This would protect their investment returns and maintain Europe's attractiveness for life sciences investment.

GSK Urges EU to Protect Innovation Incentives in Pharma Reform

GSK, 27 Apr 2021

GSK requests a world-class regulatory framework adapted to innovations like AI and advanced therapies, with expedited approval pathways. They want incentives stabilized and not reduced or linked to new obligations, warning this would undermine innovation.
This would protect their return on high-risk drug development investments and reduce regulatory burden.
Patients in countries with access inequalities may wait longer for affordable medicines.

Rare disease advocates call for EU-wide cooperation on innovation and access

EUROPEAN ORGANISATION FOR RARE DISEASES, 27 Apr 2021

The organization requests multi-stakeholder early dialogue on unmet medical needs, including patient representatives, and stronger EU cooperation on pricing negotiations. They emphasize the need for definitions of unmet needs that include disease severity and patient-reported metrics.
This would give rare disease patients earlier influence over drug development and more coordinated access across EU countries.

EPHA urges tougher drug data standards and shortage controls

European Public Health Alliance, 27 Apr 2021

EPHA demands "comparative randomised double-blind clinical trials" to ensure higher quality data. They also want "mandatory constitution of safety stocks" and "dissuasive sanctions" for shortages.
These reforms would directly help the alliance achieve its core health advocacy goals.
Pharmaceutical manufacturers would lose flexibility and face monetary fines for failing supply obligations.

Consultation response

Water Europe, 26 Apr 2021

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…

Pfizer warns EU pharmaceutical reforms risk undermining innovation leadership

Pfizer Inc., 31 Oct 2023

Pfizer supports streamlined regulatory processes and antimicrobial incentives but opposes making regulatory data protection contingent on launching across all 27 Member States. They argue this ignores fragmented market access dynamics and places entire burden on companies rather than addressing root causes in national reimbursement processes. On supply security, they want definitions to reference medical demand and oppose mandatory shortage prevention plans for all medicines as disproportionate and resource-intensive.
This would preserve their regulatory data protection without requiring launch commitments across fragmented markets.
Patients in smaller EU markets lose leverage for faster medicine launches.

Consultation response

Pfizer Inc., 27 Apr 2021

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…

DSW Urges Global Health Focus in EU Pharma Overhaul

DSW (Deutsche Stiftung Weltbevoelkerung), 8 Nov 2023

DSW calls for aligning pharmaceutical legislation with the EU Global Health Strategy. They recommend including neglected infectious diseases within the scope of the laws. The organization supports introducing priority review vouchers to incentivize international health research.
This would secure more regulatory support and funding for DSW's global development objectives.
Vulnerable European populations risk exposure to drug-resistant diseases that lack adequate treatment options.

Merck warns pharma reform threatens European innovation and investment

Merck, 9 Oct 2023

Merck opposes reducing data protection periods and narrowing definitions of medical needs. They argue these changes create unpredictability and risk for research investments.
Longer exclusivity periods protect Merck’s profit margins and future market position.
Generic manufacturers and public health budgets lose from delayed market competition.

Merck warns EU pharma reforms will discourage medical innovation

Merck, 9 Oct 2023

Merck urges the EU to maintain stable and predictable regulatory data protection to support research investments. They caution against narrowing the definition of unmet medical needs, which could discourage incremental innovation.
Maintaining current protection periods ensures the company can finance future drug development and stay competitive.
Patients may suffer from fewer innovative medicines being available if research investments move outside Europe.

Consultation response

Merck, 26 Apr 2021

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…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 5 Sept 2023

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 concept of modulating orphan market exclusivity…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 5 Sept 2023

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…

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 27 Apr 2021

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…

Consultation response

Orano, 27 Apr 2021

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”…

US Chamber warns EU against weakening drug patent protections

Chamber of Commerce of the United States of America, 27 Apr 2021

The Chamber asks the EU to maintain strong intellectual property rights and avoid cutting investment incentives. They also oppose rules forcing companies to launch products in all member states and suggest faster reimbursement.
Maintaining current incentives protects the global competitiveness and investment returns of US biotech firms.
European healthcare systems and consumers could face higher costs if supply chains are forced local.

Consultation response

Association of the European Self-Care Industry, 19 Jul 2023

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…

Consultation response

Association of the European Self-Care Industry, 27 Apr 2021

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…

Humane World for Animals Europe urges shift to non-animal testing

Humane World for Animals Europe, 8 Nov 2023

The EU should prioritize human-relevant technologies and treat animal testing as a last resort. The proposal must be amended to integrate computational tools and prevent any duplication of animal trials.
These reforms would lower drug development costs and improve clinical success rates.
Animal testing facilities face reduced demand as the sector shifts to modern alternatives.

Humane World for Animals Europe urges prioritising non-animal drug testing

Humane World for Animals Europe, 8 Nov 2023

The group urges prioritizing human-relevant technologies like laboratory and computer-based models. Animal testing should be a last resort and duplication must always be avoided. These updates would better address patient needs by modernizing the pharmaceutical sector.
This would reduce drug failure rates and lower costs for the pharmaceutical sector.

European Doctors Demand Mandatory Drug Stocks and Stricter Shortage Rules

Standing Committee of European Doctors, 3 Nov 2023

The group demands mandatory safety stocks and an obligation for manufacturers to seek pricing approval across all Member States. They also seek to replace antimicrobial vouchers with alternative funding models to avoid market distortions.
Stricter evidence requirements and better shortage communication would help doctors prescribe safer and more reliable treatments.
Drug manufacturers would face higher expenses through mandatory stockpiling, increased transparency requirements, and financial penalties.

Consultation response

Standing Committee of European Doctors, 26 Apr 2021

Attached please find the feedback of the Standing Committee of European Doctors (CPME) on the "Revision of the EU general pharmaceuticals legislation".

Consultation response

Boehringer Ingelheim, 27 Apr 2021

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…

Teva seeks predictable incentives and streamlined drug shortage reporting

Teva Pharmaceuticals Europe BV, 8 Nov 2023

Teva requests predictable incentives and opposes the 6-month advance notice for supply disruptions. They want shortage prevention plans limited to critical medicines to reduce administrative work.
Teva would face fewer regulatory hurdles and lower costs for manufacturing generic medicines.
Regulatory agencies might have less time to address and resolve medicine shortages.

Teva Pharmaceuticals Urges Predictable Incentives and Faster Generic Entry

Teva Pharmaceuticals Europe BV, 8 Nov 2023

Teva calls for a predictable incentive system that ensures the day-one launch of generic medicines. They advocate for a more inclusive definition of medical needs and digital patient leaflets. They also oppose revoking drug authorizations based on environmental risk assessments.
This would reduce Teva's regulatory compliance costs and speed up market entry for generics.
Environmental protections could be undermined if market access is prioritized over ecological risk assessments.

Consultation response

Teva Pharmaceuticals Europe BV, 27 Apr 2021

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…

Rights group urges EU to end contraceptive medicine exemptions

Center for Reproductive Rights, Inc., 8 Nov 2023

The organization wants to remove a specific legal exception that lets countries restrict access to contraceptives and abortion medication. They argue these products should be treated exactly like other essential medicines under EU law.
Deleting this exemption would strengthen legal arguments for cross-border access to reproductive healthcare services.
Conservative governments lose their legal ability to block specific pharmaceutical products based on national ideology.

Consultation response

Polish Confederation Lewiatan, 7 Nov 2023

Polish Confederation Lewiatan is the biggest trade association in Poland. We represent over 4,000 companies brought together in 34 industry and 20 regional associations. Over 20 companies are direct members of Lewiatan. Our members employ over a million employees. 1) We are of the opinion that in…

Consultation response

Bristol-Myers Squibb Company, 26 Apr 2021

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…

Health mutuals demand transparency to reduce high medicine costs

Association Internationale de la Mutualité, 27 Apr 2021

AIM proposes creating an expert group to calculate fair price ranges for key medicines. They demand disclosure of public funding amounts and stricter rules for revoking market exclusivity.
Publicly sharing pricing elements would strengthen the negotiation power of health insurance funds.
Pharmaceutical companies would lose high-profit margins and intellectual property protections for certain medicines.

Consultation response

International Diabetes Federation European Region, 27 Apr 2021

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. We strongly…

Consultation response

European Federation of National Associations of Water Services, 21 Apr 2021

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…

Haleon urges EU to protect access to non-prescription medicines

Haleon, 6 Nov 2023

Haleon requests increasing data protection for switches to three years. They also support maintaining current marketing authorization pathways. They oppose mandatory prescriptions for common antifungal treatments.
This would lower development costs and extend market exclusivity for non-prescription medicines.
Environmental protection goals may be compromised if product restrictions are significantly delayed.

GIRP Urges Mandatory Drug Supply to Wholesalers to Curb Shortages

European Healthcare Distribution Association, 8 Nov 2023

GIRP requests mandatory manufacturer supply to wholesalers to prevent distribution bypasses. They advocate for harmonized terminology and oppose using the European Medicines Verification System.
This ensures wholesalers maintain product access and prevents exclusion from pharmaceutical distribution channels.
Pharmaceutical manufacturers lose the flexibility to select specific distributors or bypass wholesalers entirely.

Consultation response

European Healthcare Distribution Association, 27 Apr 2021

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…

Pharmacists back shortage tools but defend paper leaflets

Pharmaceutical Group of the European Union, 7 Nov 2023

PGEU supports tools to address shortages but wants electronic information to complement rather than replace paper leaflets. They request that the Directive maintain its scope to avoid including medicines compounded by pharmacists. They also seek alternatives to proposed antimicrobial vouchers.
This would allow pharmacists to continue compounding medicines to bypass supply shortages.
Patients without digital access lose vital safety instructions if paper leaflets are removed.

Consultation response

Pharmaceutical Group of the European Union, 27 Apr 2021

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…

Social insurers demand tougher drug trials and lower prices

European Social Insurance Platform AISBL, 8 Nov 2023

The group requests stronger clinical evidence at approval and shorter data protection to boost competition. They also reject using vouchers to incentivize new antibiotics for resistance.
Earlier competition from generics would lower costs and improve healthcare system sustainability.
Pharmaceutical companies would see reduced revenues from shorter market exclusivity and stricter regulations.

Pharma Deutschland slams bureaucratic EU pharmaceutical reform plans.

Pharma Deutschland e.V, 3 Nov 2023

The group requests limiting shortage prevention plans only to critical medicines. They advocate for clear incentives for pediatric drug research to prevent off-label use. They demand that authorization holders be consulted before updating product information using health data.
Limiting regulatory requirements reduces compliance costs and preserves competitiveness for medical manufacturers.
Medium-sized companies face reduced market competitiveness due to more difficult access to approval procedures.

Pharma Deutschland Warns EU Drug Reform Threatens Industry Competitiveness

Pharma Deutschland e.V, 3 Nov 2023

The association opposes mandatory prescriptions for antivirals and requests longer data protection for over-the-counter medicines. They also request removing new bureaucratic burdens like stricter environmental assessments and shortage obligations.
These changes would preserve market access and reduce compliance costs for mid-sized pharmaceutical manufacturers.
Patients and health systems face higher costs and delayed care if common medicines require prescriptions.

Pharma Deutschland Urges Strong Patent Protection and Simpler Regulation

Pharma Deutschland e.V, 27 Apr 2021

The organization insists that intellectual property protection must not be restricted. They propose extending data exclusivity for non-prescription switches to three years. They also suggest making pandemic-era regulatory flexibilities, such as remote assessments, permanent.
Extended exclusivity periods would safeguard their research investments from generic competition.
Generic drug manufacturers would face significant delays entering the European market.

Consultation response

European Social Insurance Platform AISBL, 27 Apr 2021

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…

CSL Behring warns new pharma rules threaten European innovation

CSL Behring, 4 Nov 2023

CSL Behring opposes linking market exclusivity incentives to mandatory product launches in all member states. They advocate for a broader definition of medical needs and urgent policies to increase plasma collection.
Maintaining current data protection periods would protect their market position and profits.
Patients in smaller markets may face delays if launch requirements are scrapped.

Consultation response

League of European Research Universities, 26 Apr 2021

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…

Paediatric cancer doctors seek 12-year exclusivity for child-specific medicines

European Society for Paediatric Oncology, 8 Nov 2023

They seek 12-year market exclusivity for orphan drugs addressing high unmet needs in children. They request that reducing toxicity be recognized as meeting an unmet medical need. They want professional organizations systematically included in regulatory consultation processes.
This would secure their formal role in regulation and incentivize development of safer childhood treatments.
National health budgets may face higher costs due to extended market exclusivity periods for medicines.

Cancer Leagues demand drug cost transparency to lower medicine prices

Association of European Cancer Leagues, 18 Sept 2023

The organization calls for mandatory disclosure of research costs and tax breaks. They urge for harmonized hospital exemptions to improve access to advanced therapies. They also oppose data exclusivity vouchers for antimicrobials to prevent treatment barriers.
Lower medicine prices would help member cancer societies improve patient access to treatment.
Pharmaceutical firms would lose lucrative exclusivity vouchers and face intense price scrutiny.

Consultation response

BEAM Alliance, 27 Apr 2021

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…

Consultation response

European Society for Paediatric Oncology, 27 Apr 2021

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…

Consultation response

Association of European Cancer Leagues, 27 Apr 2021

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,…

German pharmaceutical association BPI urges EU to protect drug data

Bundesverband der Pharmazeutischen Industrie e.V., 1 Nov 2023

The organization calls for the current eight-year data protection period to be maintained and for five-year protection for repurposed medicines. They advocate for a flexible definition of medical needs and the rapid adoption of electronic product information.
Maintaining long-term data protection avoids the reduction of profitability and encourages future investment decisions.
Generic producers and public health budgets lose from delayed entry of cheaper medicines.

Consultation response

Bundesverband der Pharmazeutischen Industrie e.V., 27 Apr 2021

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…

Consultation response

Novavax, 8 Nov 2023

Novavax is a global company that promotes improved health by discovering, developing, and commercializing innovative vaccines to help protect against serious infectious diseases. Our COVID-19 vaccine was the first protein-based option available in Europe during the pandemic. Novavax employs over…

Edwards Lifesciences demands priority review for medical devices

Edwards Lifesciences, 17 Jul 2023

The organization requests extending priority review and enhanced scientific support to medical devices addressing unmet needs. They propose a 150-day conformity assessment timeline to match accelerated pharmaceutical procedures.
Faster approvals would help the company bring innovative heart technologies to market more quickly.
Patients requiring innovative devices face unfair delays compared to those treated with pharmaceuticals.

Consultation response

European Heart Network, 27 Apr 2021

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…

ESMO Urges Tailored EU Rules for Rare Cancer Medicines

European Society for Medical Oncology (ESMO), 8 Nov 2023

ESMO calls for mandatory consultations with expert disease communities. They request defining rare cancers by annual incidence rather than prevalence.
These reforms would strengthen the group's regulatory influence and speed up drug designations.
Lowering statistical evidence requirements might increase uncertainty regarding the effectiveness of new treatments.

Consultation response

European Society for Medical Oncology (ESMO), 27 Apr 2021

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…

Takeda Urges EU to Protect Predictable Pharmaceutical Innovation Incentives

Takeda Pharmaceuticals International AG, 24 Oct 2023

Takeda argues against using a strict legal definition of medical need to determine incentives. They reject requirements to launch products in every member state within a fixed timeline.
This would allow the company to maintain its current, predictable market protection periods.
Environmental protection efforts suffer if risks cannot block medicine approvals by regulators.

Takeda urges predictable drug incentives and flexible market rules

Takeda Pharmaceuticals International AG, 24 Oct 2023

Takeda seeks a predictable incentive system and opposes binding definitions of medical needs. They reject making rewards dependent on launching products across all member states.
A predictable framework allows the company to secure long-term investments in innovative treatments.
Environmental advocates lose if ecological risks are excluded from drug marketing authorization decisions.

Consultation response

Lääketeollisuus ry, 27 Apr 2021

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…

Takeda urges EU to modernize pharma rules through data innovation

Takeda Pharmaceuticals International AG, 27 Apr 2021

Takeda advocates for a regulatory system that integrates real-world data and artificial intelligence. They also support a consensus-based definition for unmet medical needs.
Reducing administrative burdens and simplifying clinical trials would significantly lower compliance costs.

Consultation response

Moderna, Inc., 8 Nov 2023

Moderna, with its mission to deliver the greatest possible impact to people through mRNA medicines, welcomes the overall objectives of the revision of the General Pharma Legislation (GPL) as proposed by the Commission to create an innovative and competitive EU healthcare ecosystem, to invest in…

Consultation response

Moderna, Inc., 8 Nov 2023

Moderna, with its mission to deliver the greatest possible impact to people through mRNA medicines, welcomes the overall objectives of the revision of the General Pharma Legislation (GPL) as proposed by the Commission to create an innovative and competitive EU healthcare ecosystem, to invest in…

Hospital pharmacists urge stronger safety rules and shortage controls

The European Association of Hospital Pharmacists, 4 Sept 2023

The association requests barcodes on primary packaging to reduce errors and warns against removing paper leaflets for out-patients. They also advocate for hospital pharmacists to produce essential medicines during supply shortages.
This would expand the clinical role of pharmacists and improve safety for healthcare staff.
Drug manufacturers would face new burdens regarding mandatory safety plans and shortage reporting.

Consultation response

The European Association of Hospital Pharmacists, 27 Apr 2021

Please find attached the feedback of the European Association of Hospital Pharmacists (EAHP) on the combined evaluation roadmap/inception impact assessment for the evaluation and revision of the general pharmaceutical legislation.

PHARMIG warns EU pharma reform threatens medical innovation

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 8 Nov 2023

PHARMIG demands maintaining long data protection periods and decoupling incentives from mandatory market launches. They call for a broader definition of medical needs to foster research.
Preserving existing protection periods would safeguard investments and reduce risks for pharmaceutical companies.
Generic manufacturers lose predictability and face delayed opportunities to offer more affordable alternatives.

Austrian Drug Industry Opposes Cuts to Research Data Protections

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 8 Nov 2023

PHARMIG requests maintaining current data protections and removing requirements to launch in all member states. They advocate for an inclusive definition of medical needs to support research.
This protects high profit margins by delaying competition from cheaper, non-branded generic medicine manufacturers.
Environmental organizations lose if ecological risks cannot be used as grounds for refusing medicine approvals.

Roche Warns EU Pharma Revision Threatens Innovation and Patient Access

F. Hoffmann-La Roche Ltd, 8 Nov 2023

Roche disagrees with linking data protection incentives to launching products in all Member States. They request the baseline duration for protection remain at eight years. They also require consultation for product label changes.
Maintaining current incentives protects Roche's revenue streams from earlier competition by generic manufacturers.
National health budgets and patients could lose savings derived from faster generic market entry.

Roche warns EU pharma rules will stifle medical innovation

F. Hoffmann-La Roche Ltd, 20 Oct 2023

Roche opposes linking data protection incentives to a mandatory two-year launch across all member states. They call for broad definitions of medical needs and caution against using environmental risks to deny drug approvals.
Longer exclusivity periods would protect the company's profit margins and investment predictability for new treatments.
Future patients may lose access to breakthroughs if reduced incentives drive pharmaceutical investment away from Europe.

Amgen warns EU pharma rules could stifle orphan drug research

Amgen Inc, 29 Aug 2023

Amgen calls for predictable criteria for unmet medical needs and stronger market exclusivity for orphan drugs. They propose limiting pediatric trial requirements to avoid placing a disproportionate burden on developers.
Higher incentives and fewer mandatory studies would protect Amgen’s revenue and reduce research costs.
Patients with rare conditions may face fewer treatment options if companies prioritize single-use drugs.

Amgen warns pharmaceutical reforms will undermine European research investment

Amgen Inc, 29 Aug 2023

Amgen opposes reporting public research funding and wants the term 'bio-hybrid' removed. They reject tying data protections to launching products in every Member State.
These changes would reduce administrative overhead and preserve existing market exclusivity periods.
Regulators and taxpayers lose transparency regarding public funds used for medical research.

PHARMIG warns against linking research incentives to market access

PHARMIG - Verband der pharmazeutischen Industrie Österreichs, 27 Apr 2021

PHARMIG calls for an agile, centralized framework for approvals and faster innovation pathways. They oppose linking research incentives to market access because access depends on national policies.
Reduced administrative requirements and digital labeling would lower company compliance costs.
Patients risk continued delays if national governments do not remove market access barriers.

Amgen urges EU to shorten drug approvals and digitize leaflets

Amgen Inc, 27 Apr 2021

Amgen proposes to shorten assessment processes and include rolling review features. They recommend replacing paper patient information leaflets with electronic versions. They also oppose linking incentives to the transparency of R&D costs.
This would lower administrative burdens and protect the company's financial returns.
Smaller countries may face delays if incentives aren't tied to market launches.

Consultation response

F. Hoffmann-La Roche Ltd, 27 Apr 2021

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…

Czech Chamber of Commerce Defends Pharmaceutical Data Protection Periods

Hospodářská komora České republiky, 8 Nov 2023

They strongly oppose reducing the data protection period from eight to six years. They also reject making additional protection conditional on supplying all twenty-seven EU markets. Finally, they argue that rewards should not depend on meeting unpredictable medical needs.
Maintaining current protection levels ensures that expensive research and development costs remain recoverable.
European patients face decreased access to new treatments if innovators shift focus elsewhere.

Czech Chamber of Commerce Urges Stronger Drug Data Protection

Hospodářská komora České republiky, 8 Nov 2023

The organization rejects reducing data protection from eight to six years. They oppose mandatory supply to all twenty-seven member states for incentives. They call for predictable intellectual property protections to attract investment.
Longer exclusivity periods protect their profit margins and reduce competition from generic drugs.
Patients and national health budgets lose earlier access to more affordable generic medicines.

Consultation response

European Organisation for Research and Treatment of Cancer, 30 Oct 2023

The European Organisation for Research and Treatment of Cancer (EORTC), with a mission to design, coordinate, and conduct multidisciplinary clinical and translational trials to improve the standard of cancer treatment for patients, welcomes the proposal to review the EU general pharmaceutical…

Consultation response

European Organisation for Research and Treatment of Cancer, 25 May 2023

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.…

Consultation response

European Organisation for Research and Treatment of Cancer, 14 Apr 2021

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…

Plasma industry urges tailored rules to protect medicine supplies

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 29 Oct 2023

The group requests maintaining a shorter two-month notification period for medicine shortages. They advocate for streamlining regulatory processes and aligning with international standards.
Reducing administrative red tape would lower operational costs and accelerate supply chains.
Patients in some EU countries could lose access if stockpiling requirements divert supplies.

Plasma industry group urges regulatory reform for essential medicines

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 29 Oct 2023

The group requests a clear definition of plasma for fractionation to facilitate global regulatory alignment. They also advocate for risk-based manufacturing inspections and the removal of redundant administrative steps.
Streamlined regulations would lower operational costs and improve the industry's global competitiveness.
Patients in some regions may lose access if mandatory stockpiling diverts supplies.

Consultation response

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 26 Apr 2021

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…

Regenerative medicine alliance seeks tailored rules for advanced therapies

Alliance for Regenerative Medicine, 7 Nov 2023

The group requests harmonized hospital exemptions and a dedicated expert working party at the EMA. They also want advanced therapies exempted from mandatory market launch timelines.
These changes would protect market exclusivity and reduce regulatory hurdles for gene therapy developers.
Hospital-based developers would face stricter limits on producing alternative treatments without a central marketing authorization.

Medicines for Europe calls for scrapping antimicrobial exclusivity vouchers

Związek Przedsiębiorców i Pracodawców, 7 Nov 2023

The group calls for rejecting transferable exclusivity vouchers for new antibiotics and suggests a digital shortage reporting system. They also want manufacturers to choose between different marketing authorization procedures to improve efficiency.
This would enable faster market entry and reduce administrative reporting costs.
Brand-name pharmaceutical companies would lose extended monopoly protections on their most profitable drugs.

European E-Pharmacy association demands EU-wide online prescription sales

European Association of E-Pharmacies, 1 Sept 2023

The association urges the EU to permit online sales of prescription medicines across member states. They also request removing marketing restrictions and clarifying rules for electronic patient leaflets.
These changes would remove barriers to market expansion and reduce administrative marketing burdens.
Traditional pharmacies may lose market share and face stricter enforcement regarding delivery regulations.

Consultation response

European Association of E-Pharmacies, 27 Apr 2021

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…

Consultation response

Stichting Health Action International, 26 Apr 2021

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. While the European…

Consultation response

Angelini Pharma, 3 Nov 2023

ANGELINI PHARMA POSITION PAPER ON THE GENERAL PHARMACEUTICAL LEGISLATION REVISION (October 2023)

Consultation response

European Blood Alliance, 17 Oct 2023

The European Blood Alliance, representing public/not-for-profit blood establishments, welcomes the European Commissions publication of its proposal for a reform of the EU pharmaceutical legislation. The review aims to reach a number of important goals, such as improving access to innovative…

Consultation response

Grifols, S.A., 27 Apr 2021

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…

Consultation response

Astellas Pharma Europe Limited, 26 Apr 2021

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…

Consultation response

Deutsche Krankenhausgesellschaft e.V., 2 Nov 2023

Als Dachorganisation der 1.887 deutschen Krankenhäuser in öffentlicher, freigemeinnütziger und privater Trägerschaft beteiligt sich die Deutsche Krankenhausgesellschaft (DKG) bereits seit vielen Jahren konstruktiv an den gesundheitspolitischen Debatten auf EU-Ebene. Insbesondere bei den…

Consultation response

United European Gastroenterology, 28 Aug 2023

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…

Consultation response

European Industrial Gases Association AISBL, 26 Apr 2021

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…

BioMed Alliance seeks flexible definition for unmet medical needs

Biomedical Alliance in Europe, 8 Nov 2023

The alliance requests a flexible definition of unmet medical needs developed with professionals. They argue for retaining the Paediatric Committee and incentivizing drug repurposing.
Support for registries and expert bodies secures the alliance's professional influence.
Public health systems may face higher costs from new antibiotic development incentives.

Consultation response

Platform for Better Oral Health in Europe, 8 Nov 2023

As the umbrella organisation bringing together oral health organisations active in Europe, the Platform for Better Oral Health in Europe welcomes the European Commissions ambition to review the EUs pharmaceutical framework and address areas of unmet medical need, particularly in the area of…

Consultation response

BGP Products Operations GmbH – a Viatris Company, 8 Nov 2023

Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a European portfolio comprising more than 1,400 approved molecules across all major therapeutic areas. Annually, Viatris supplies 36.8 billion doses of medicine in Europe,…

Consultation response

BGP Products Operations GmbH – a Viatris Company, 8 Nov 2023

Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a European portfolio comprising more than 1,400 approved molecules across all major therapeutic areas. Annually, Viatris supplies 36.8 billion doses of medicine in Europe,…

Consultation response

Swedwatch, 27 Apr 2021

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. Promotion of affordable medicine without an adequate framework to control…

Consultation response

BGP Products Operations GmbH – a Viatris Company, 27 Apr 2021

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. Our portfolio comprises more than 1,400 molecules…

Consultation response

Dachverband der österreichischen Sozialversicherung, 27 Apr 2021

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. In recent years, the…

Consultation response

Health Care Without Harm Europe, 20 Apr 2021

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…

Consultation response

CCI Europe, 6 Nov 2023

Childhood Cancer International Europe (CCI-E), the largest European patients organisation in paediatric cancer, has been involved in the review of the EU Paediatric and Orphan Regulations since 2012. We welcome the proposal by the Commission for revision of the EU Pharmaceutical legislation as it…

Consultation response

PTC Therapeutics, 26 Jun 2023

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…

Consultation response

PTC Therapeutics, 26 Jun 2023

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…

Consultation response

CCI Europe, 27 Apr 2021

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…

Consultation response

Ipsen Pharma, 6 Nov 2023

Ipsen, a global biopharmaceutical company committed to improving patients' lives through breakthrough innovations, focuses on unmet medical needs, particularly in oncology, rare diseases and neuroscience. We support the objectives of the reform but urge more ambition to foster innovation for people…

Consultation response

Associazione delle Imprese del farmaco, 2 Nov 2023

Con 49mld di produzione nel 2022 di cui 47,6 di export, 3,3 mld dinvestimenti, lindustria farmaceutica in Italia rappresenta un asset strategico per leconomia nazionale ed UE. Farmindustria sostiene gli obiettivi della Commissione UE di migliorare la disponibilità e accessibilità dei farmaci,…

Consultation response

Associazione delle Imprese del farmaco, 2 Nov 2023

Con 49mld di produzione nel 2022 di cui 47,6 di export, 3,3 mld dinvestimenti, lindustria farmaceutica in Italia rappresenta un asset strategico per leconomia nazionale ed UE. Farmindustria sostiene gli obiettivi della Commissione UE di migliorare la disponibilità e accessibilità dei farmaci,…

Consultation response

France Assos Santé, 27 Jul 2023

France Assos Santé, qui regroupe une centaine dassociations de patients et dusagers, soutient depuis le début le processus visant à mettre à jour le corpus législatif pharmaceutique de lUE afin daméliorer laccès des patients à des médicaments sûrs, efficaces, effectivement disponibles, à des prix…

Consultation response

Associazione delle Imprese del farmaco, 27 Apr 2021

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…

Consultation response

Baxter Healthcare SA, 27 Apr 2021

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…

Consultation response

Association Mieux Prescrire, 8 Nov 2023

Réponse de Prescrire à la consultation sur la révision de la législation générale de l'Union relative aux produits pharmaceutiques Les propositions législatives de la Commission européenne sont présentées comme tentant de répondre à plusieurs défis en matière de politique pharmaceutique, notamment…

Consultation response

Hellenic Association of Pharmaceutical Companies, 8 Nov 2023

The reform of the EUs pharmaceutical sector is a milestone of the European Health Union and a crucial step in our collective effort to pave the way towards a healthier, more resilient, and more equal Europe.SFEE fully supports the objectives of enhancing the availability and accessibility of…

Consultation response

Vereniging Innovatieve Geneesmiddelen, 7 Nov 2023

Namens de Vereniging Innovatieve Geneesmiddelen (VIG), de Nederlandse branchevereniging van 44 innovatieve geneesmiddelenfabrikanten, onze reactie op de voorgestelde herziening van de EU-geneesmiddelenwetgeving. De leden van de VIG zijn actief binnen het biofarmaceutische ecosysteem van Nederland,…

Consultation response

Vereniging Innovatieve Geneesmiddelen, 7 Nov 2023

Namens de Vereniging Innovatieve Geneesmiddelen (VIG), de Nederlandse branchevereniging van 44 innovatieve geneesmiddelenfabrikanten, onze reactie op de voorgestelde herziening van de EU-geneesmiddelenwetgeving. De leden van de VIG zijn actief binnen het biofarmaceutische ecosysteem van Nederland,…

Consultation response

European Carton Makers Association, 6 Nov 2023

MLPS Feedback for Directive on Medicinal Products for Human Use: MLPS (Medical Leaflets = Patient Safety), a subgroup of the European Carton Makers Association, expresses its concerns regarding the European Commission's proposed Directive on medicinal products for human use, related to the use of…

Consultation response

ALAN asbl-Maladies Rares Luxembourg, 20 Oct 2023

ALAN asbl Maladies Rares Luxembourg, the rare disease alliance of Luxembourg supports the objectives of the legislation. However, we see three areas of improvement namely: patient engagement, the concept of unmet needs and pediatric medicine. Patient engagement Although we welcome the initiatives…

Consultation response

Etablissement français du sang, 19 Sept 2023

LEtablissement Français du Sang (EFS) remercie la Commission européenne pour sa proposition, qui répond à certaines attentes des parties prenantes, mais qui crée des incertitudes quant aux produits frontières. Nous tenons à saluer en particulier les points suivants : La réaffirmation du principe du…

Consultation response

Association Mieux Prescrire, 27 Apr 2021

Prescrire's feedback to the roadmap and Inception Impact Assessment on the revision of the general pharmaceutical legislation is outlined in the attached document.

Consultation response

The Alliance for Safe Online Pharmacy in the EU, 26 Apr 2021

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…

Consultation response

DVGW Deutscher Verein des Gas- und Wasserfaches e.V. - Technisch wissenschaftlicher Verein, 21 Apr 2021

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…

Consultation response

Becton Dickinson, 5 Apr 2021

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…

Consultation response

European Health Management Association asbl, 8 Nov 2023

The European Health Managements Association (EHMA), EPACT Alliance urges the European Commission and the European Parliament to seize the opportunity to strengthen hospitals pharmaceutical management pathways for 1. The welling being of patients and staff. 2. The availability, accessibility, and…

Consultation response

Fresenius Kabi Deutschland GmbH, 8 Nov 2023

As part of the globally active Fresenius Group, headquartered in Bad Homburg, Germany. Fresenius Kabi corporate philosophy is caring for life. Our generics and biosimilars play a crucial role in ensuring access to medicines with 15,000 employees in Europe alone and our production facilities in…

Consultation response

Digestive Cancers Europe, 27 Apr 2021

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…

Consultation response

Nuclear Medicine Europe, 8 Nov 2023

The New EU Pharmaceuticals law is a very important legislation for the future of healthcare in the European Union and Nuclear Medicine Europe (NMEU) would like to draw your attention to some specific aspects that touch on the field of Nuclear Medicine. NMEU represents the majority of the…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 8 Nov 2023

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. We bring together 45 national associations from 26 countries. EFA is a full member of the…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 8 Nov 2023

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. We bring together 45 national associations from 26 countries. EFA is a full member of the…

Consultation response

The Employers' Union of Innovative Pharmaceutical Companies, 7 Nov 2023

Przegląd unijnego prawodawstwa farmaceutycznego ma kluczowe znaczenie dla kształtowania warunków rynkowych dla przemysłu farmaceutycznego oraz przede wszystkim dla poprawy dostępu pacjentów do leków innowacyjnych. Od ostatecznej formy tych przepisów zależeć będzie konkurencyjność oraz…

Consultation response

PETA Science Consortium International e.V., 3 Nov 2023

PETA Science Consortium International e.V. response to the European Commissions call for views on the revision of the EU general pharmaceuticals legislation

Consultation response

International Patient Organisation for Primary Immunodeficiencies, 1 Aug 2023

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. PID…

Consultation response

Verband Forschender Arzneimittelhersteller e.V., 27 Apr 2021

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,…

Consultation response

Anticancer Fund, 26 Apr 2021

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. It is not sufficient that the EU pharmaceutical system simply ensures quality…

Consultation response

The Global Alliance for TB Drug Development, 8 Nov 2023

TB Alliance welcomes the European Commissions proposed pharmaceutical package, especially with regards to: 1) addressing unmet medical needs, 2) proposing incentives to tackle antimicrobial resistance, 3) regulatory support, and 4) reporting on publicly funded financial support. TB Alliance is a…

Consultation response

International Federation of Anthroposophic Medical Associations, 7 Nov 2023

As with other integrative medical systems, Anthroposophic Medicine is based on a holistic approach; it merges conventional and complementary medicine and it includes all dimensions of the patient: physical, emotional, mental and spiritual, as well as the impact of a person's environment and social…

Consultation response

European Society of Oncology Pharmacy, 3 Nov 2023

ESOP Global: response to the new EU pharmaceutical legislation proposal The members of ESOP Global, who represent health care professionals from 67 countries worldwide including all countries inside the European Union, applaud the presented proposals for the new legislative pharmaceutical…

Consultation response

Hollandbio, 17 Jul 2023

Hollandbio's reactie op hoofdlijnen op de herziening van de algemene geneesmiddelenwetgeving van de EU is te vinden op onze website: https://www.hollandbio.nl/nieuws/grijp-die-kans-geneesmiddelen-sneller-beter-slimmer-goedkoper-en-groener-beschikbaar-dankzij-herziening-eu-geneesmiddelenwetgeving/…

Consultation response

International Federation of Anthroposophic Medical Associations, 27 Apr 2021

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…

Consultation response

Fundacja SMA, 8 Nov 2023

Fundacja SMA welcomes the reform of the EU pharmaceutical legislation, seeing many of the proposed changes as an ambitious tool that will improve the development of, and access to, treatments for rare disorders. That said, wed like to share a few comments (see attached document).

Consultation response

Fondazione Telethon ETS, 8 Nov 2023

Fondazione Telethon (Italy) is an Italian non-profit organization that has been supporting bio-medical research on rare and genetic diseases for more than 30 years. Since 2023 it has become the first not-for profit marketing authorization holder of an ATMP for a ultra-rare disease in the EU.…

Consultation response

European Federation of Pharmacy chains, 8 Nov 2023

European Federation of Pharmacy Chains (EFPC) welcomes the opportunity to contribute to the revision of the EUs general pharmaceutical legislation. We believe that our comments, together with harnessing the potential of pharmacies, can contribute to the development of regulation that ensures high…

Consultation response

Algemene vereniging van de Geneesmiddelenindustrie, 8 Nov 2023

pharma.be supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory…

Consultation response

Intergraf European Federation for Print and Digital Communication, 7 Nov 2023

Intergraf represents the European printing industry. Intergraf contribution addresses the provision on package leaflets (article 63.3). The proposal presents a revolutionary approach in granting the flexibility to Member States to remove paper leaflets from the packaging to rely only on the…

Consultation response

Avicenna Alliance, 6 Nov 2023

The Avicenna Alliance represents a collaborative effort among stakeholders committed to advancing in silico medicine. This initiative harnesses the power of computer modelling and simulation to revolutionize the development and delivery of innovative medical treatments. By using virtual patient…

Consultation response

Avicenna Alliance, 6 Nov 2023

The Avicenna Alliance represents a collaborative effort among stakeholders committed to advancing in silico medicine. This initiative harnesses the power of computer modelling and simulation to revolutionize the development and delivery of innovative medical treatments. By using virtual patient…

Consultation response

ASOCIACIÓN NACIONAL EMPRESARIAL DE LA INDUSTRIA FARMACÉUTICA, 6 Nov 2023

Farmaindustria (FI) apoya el objetivo último de la Propuesta de la CE de mejorar la disponibilidad y acceso a medicamentos fomentando a su vez un entorno innovador y competitivo en la UE. Acogemos positivamente el propósito de preparar un marco regulatorio para el futuro, maximizando el uso de…

Consultation response

Medicines for Poland, 31 Oct 2023

Medicines for Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic…

Consultation response

Medicines for Poland, 31 Oct 2023

Medicines for Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas,…

Consultation response

European Coalition on Homeopathic and Anthroposophic Medicinal Products, 23 Oct 2023

ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, represents an EU-based industry that has been serving the European market for decades. EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States; the EU being the…

Consultation response

European Coalition on Homeopathic and Anthroposophic Medicinal Products, 23 Oct 2023

ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, represents an EU-based industry that has been serving the European market for decades. EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States; the EU being the…

Consultation response

European Society for Paediatric Gastroenterology, Hepatology and Nutrition, 25 Jul 2023

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. The Societal goals are…

Consultation response

Netherlands Federation of University Medical Centres, 30 Jun 2023

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…

Consultation response

Panhellenic Union of Pharmaceutical Industry, 27 Apr 2021

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…

Consultation response

Algemene vereniging van de Geneesmiddelenindustrie, 27 Apr 2021

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…

Consultation response

Women's Brain Project, 26 Apr 2021

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…

Consultation response

UCB, 26 Apr 2021

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…

Consultation response

European Coalition on Homeopathic and Anthroposophic Medicinal Products, 26 Apr 2021

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…

Consultation response

Medicines for Poland, 26 Apr 2021

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”. While incentives have generated some…

Consultation response

KWF Kankerbestrijding, 22 Apr 2021

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…

Consultation response

Fachverband der Chemischen Industrie Österreichs, 8 Nov 2023

Der Fachverband hat die Ziele der Europäischen Kommission im Rahmen der Arzneimittelstrategie als Chance für die Stärkung des Pharmastandortes in Österreich und Europa begriffen und unterstützt diese nach wie vor. Der vorliegende Vorschlag zur Umsetzung dieser Strategie wird diesen Zielen nicht…

Consultation response

European Alliance For Vision Research and Ophthalmology, 8 Nov 2023

Access to affordable treatments for rare diseases remain a challenge in eye diseases.We applaud the European Commission's support to the retention & strengthening of Hospital Exemption (HE) as it contributes in reducing the current misalignment between public health priorities & industry outputs…

Consultation response

European Patient Organisation for Dysimmune and Inflammatory Neuropathies, 8 Nov 2023

EPODIN represents an important patient community in Europe suffering of life-threatening neurological conditions, and which rely on adequate access to lifesaving plasma-derived medicinal products (PDMPs). 1.EPODIN welcomes the proposed EU Pharma Regulation with its focus on tackling and preventing…

Consultation response

European Patient Organisation for Dysimmune and Inflammatory Neuropathies, 8 Nov 2023

EPODIN represents an important patient community in Europe suffering of severely life-threatening neurological medical conditions. EPODIN welcomes the Commission proposal for a separate EU Pharma Directive and strongly supports the overall objective to harmonise the rules governing pharmaceuticals…

Consultation response

Consejo General de Colegios Farmacéuticos, 8 Nov 2023

Acogemos la propuesta de la Comisión Europea para la reforma de la legislación farmacéutica de la UE. Los farmacéuticos españoles consideramos que la propuesta incluye disposiciones importantes para mejorar el suministro de medicamentos con el fin de satisfacer las necesidades de los pacientes. En…

Consultation response

Council of European Dentists, 8 Nov 2023

The Council of European Dentists (CED) is a European not-for-profit association representing over 340,000 dentists across Europe. Established in 1961, CED comprises 33 national dental associations from 31 European countries, all of which share a collective commitment to upholding the highest…

Consultation response

European Association of Nuclear Medicine, 8 Nov 2023

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. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous…

Consultation response

Intellectual Property Owners Association, 7 Nov 2023

Please see the attached comments by the Intellectual Property Owners Association. Thank you for the opportunity to provide this feedback.

Consultation response

ΑΣΤΙΚΗ ΜΗ ΚΕΡΔΟΣΚΟΠΙΚΗ ΕΤΑΙΡΕΙΑ ΚΑΡΚΙΝΑΚΙ ΕΝΗΜΕΡΩΣΗ ΓΙΑ ΤΟΝ ΚΑΡΚΙΝΟ ΣΤΗΝ ΠΑΙΔΙΚΗ ΚΑΙ ΕΦΗΒΙΚΗ ΗΛΙΚΙΑ, 7 Nov 2023

Η χρήση της έννοιας του μοριακού στόχου είναι ευθυγραμμισμένη με τον νόμο RACE for Children των ΗΠΑ και ανταποκρίνεται στις προσδοκίες μας για εναρμόνιση του παγκόσμιου ρυθμιστικού περιβάλλοντος. Θεωρούμε την παροχή ειδικής πρόσθετης προστασίας δεδομένων (24 μήνες) για την εισαγωγή ενός νέου…

Consultation response

Pro Generika e.V., 25 Oct 2023

Pro Generika ist der Verband der Generika- und Biosimilarunternehmen in Deutschland. Unsere Mitgliedsunternehmen sind der Garant dafür, dass das Versprechen des deutschen Gesundheitssystems, wonach jeder Patient Zugang zu modernen und bezahlbaren Arzneimitteltherapien hat, eingelöst werden kann.…

Consultation response

Medtech & Pharma Platform Association, 13 Oct 2023

The Medtech & Pharma Platform Association (MPP) welcomes the proposals objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness. We would like to propose amendments on points which are of importance for products combining…

Consultation response

Medtech & Pharma Platform Association, 13 Oct 2023

The Medtech & Pharma Platform Association (MPP) welcomes the proposals objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness. We would like to propose amendments on points which are of importance for products combining…

Consultation response

ASOCIACIÓN ESPAÑOLA DE MEDICAMENTOS BIOSIMILARES, 4 Oct 2023

La Asociación Española de Medicamentos Biosimilares participa de este acto público remitiendo los comentarios recogidos en el archivo adjunto, tanto de carácter general como específicos a la Directiva y al Reglamento.

Consultation response

Conseil national de l'Ordre des pharmaciens, 13 Sept 2023

L'Ordre national des pharmaciens salue les propositions du « paquet pharmaceutique » présentées au printemps 2023 dans leur ensemble. Nous nous réjouissons particulièrement du modèle ambitieux proposé pour la surveillance et la gestion des pénuries, ainsi que de l'attention portée à la résistance…

Consultation response

Pro Generika e.V., 13 Jun 2023

Stellungnahme von Pro Generika zur Revision des EU-Arzneimittelrechts (Stand vom 07.06.2023) Pro Generika begrüßt, dass wir aufgrund der noch nicht vorliegenden Übersetzungen der Gesetzesentwürfe auf vorläufiger Basis - zur EU-Gesetzgebung Stellung nehmen können. Wir hoffen, dass die Positionen der…

Consultation response

Avicenna Alliance -, 27 Apr 2021

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…

Consultation response

Fachverband der Chemischen Industrie Österreichs, 27 Apr 2021

Der FCIO tritt für einen anpassungsfähigen Rechtsrahmen ein, mit dem nicht nur starke Anreize zur Förderung des Fortschritts in der Wissenschaft, der technologischen Entwicklung und Innovation in der Medizin gesetzt werden, sondern auch die Versorgung mit Arzneimitteln, auch der generischen,…

Consultation response

Protection sociale française, 27 Apr 2021

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. Opening this…

Consultation response

European Association of Nuclear Medicine, 27 Apr 2021

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. We propose modifications well suited to contribute to the overall aims…

Consultation response

Medtech & Pharma Platform Association, 27 Apr 2021

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…

Consultation response

European Alliance for Access to Safe Medicines, 26 Apr 2021

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…

Consultation response

Association Nationale des Etudiants en Pharmacie de France, 26 Apr 2021

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…

Consultation response

Biogen Inc., 26 Apr 2021

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…

Consultation response

European Alliance For Vision Research and Ophthalmology, 26 Apr 2021

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. Potential benefits…

Consultation response

Seqens, 26 Apr 2021

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. Today, more than 80% of Europe's…

Consultation response

Asociación para Proteger al Enfermo de Terapias Pseudocientíficas, 8 Nov 2023

Nuestra asociación busca proteger al enfermo de las muchas falsas terapias que pueden perjudicar su salud activamente, causar retraso o abandono de un tratamiento avalado científicamente, y/o pagar sustancialmente por ellos. Consideramos que las medidas propuestas en el borrador supondrán…

Consultation response

European Industrial Pharmacists Group, 8 Nov 2023

Since it was not possible to preview the attached file I also include the feedback from EIPG here: EIPG POSITION PAPER ON THE REVISED EUROPEAN PHARMACEUTICAL LEGISLATION The European Industrial Pharmacists Group (EIPG) is a European association representing the national, and professional…

Consultation response

Associação Portuguesa da Indústria Farmacêutica, 8 Nov 2023

Commissions proposal is the start of the discussion for a balanced package. It is an opportunity to enhance Europe's attractiveness for research, development, and production of medicines. APIFARMA would like to contribute to this public consultation based on some of its specific points of view. The…

Consultation response

Lymphoma Coalition, 8 Nov 2023

Lymphoma Coalition response on the Pharmaceutical Legislation Consultation Lymphoma Coalition (LC) is a global network of patient organisations focused on providing support to those affected by lymphoma, including chronic lymphocytic leukaemia (CLL) for over two decades. It was clear there was a…

Consultation response

NF Patients United - Global Network of Neurofibromatosis Patient Organisations, 8 Nov 2023

Neurofibromatosis Patients United (NFPU) serves as the preeminent umbrella association for patient organizations that work for neurofibromatosis patients within the European region. Neurofibromatosis patients throughout Europe confront remarkably uniform challenges, including constrained access to…

Consultation response

NF Patients United - Global Network of Neurofibromatosis Patient Organisations, 8 Nov 2023

Neurofibromatosis Patients United (NFPU) serves as the preeminent umbrella association for patient organizations that work for neurofibromatosis patients within the European region. Neurofibromatosis patients throughout Europe confront remarkably uniform challenges, including constrained access to…

Consultation response

Romanian Association of International Medicines Manufacturers, 8 Nov 2023

ARPIM supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory…

Consultation response

Romanian Association of International Medicines Manufacturers, 8 Nov 2023

ARPIM supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory…

Consultation response

Fédération nationale des centres de lutte contre le cancer, 8 Nov 2023

Unicancer, the French hospital federation of comprehensive cancer centers, expresses its gratitude to the European Commission for the opportunity to provide feedback in the public consultation on the legislative proposal for revising the EUs legislation on pharmaceuticals. While we welcome the…

Consultation response

European Hematology Association, 8 Nov 2023

The European Hematology Association (EHA) is the leading representative of hematology and hematology professionals in Europe. A not-for-profit, public-benefit organization with nearly 7,000 members, EHA supports career development and research, develops and harmonizes hematology education, and…

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European Hematology Association, 8 Nov 2023

The European Hematology Association (EHA) is the leading representative of hematology and hematology professionals in Europe. A not-for-profit, public-benefit organization with nearly 7,000 members, EHA supports career development and research, develops and harmonizes hematology education, and…

Consultation response

Rare Diseases Ireland, 8 Nov 2023

Rare Diseases Ireland is the national alliance for rare disease patient organisations in Ireland. As such we are concerned about innovation and the development and approval of medicines across all rare diseases, and timely access for people living with rare disease to those medicines. We are happy…

Consultation response

NVC Netherlands Packaging Centre, 8 Nov 2023

NVC proposal for further improvements/modifications on the new EU Pharma Directive relating to medicinal products for human use with particular emphasis on: The appropriate definitions of the terminology used: packaging (verb/noun), packing, pack, filling, leaflet, patient information, labeling,…

Consultation response

European Cancer Patient Coalition, 7 Nov 2023

Regulatory Aspects ECPC welcomes the proposal to involve patients in the regulatory cycle of medicines, such as in the Committee for Medicinal Products for Human Use within the EMA. However, we recommend that the new EMA governance structure considers patient involvement throughout the whole…

Consultation response

European Forum for Good Clinical Practice, 7 Nov 2023

Feedback is given in the attachment by the EFGCP Childrens' Medicines Working Party (CMWP), a multi-stakeholder not-for-profit group of experts in paediatric medicines development.

Consultation response

Asociación Española de laboratorios Huérfanos y Ultrahuérfanos, 6 Nov 2023

AELMHU, Asociación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuérfanos, a non-profit organization that brings together 25 biotechnology and pharmaceutical companies committed to the discovery, research, development and commercialization of innovative therapies capable of improving…

Consultation response

Federazione Italiana Associazioni Genitori e Guariti Oncologia Pediatrica, 6 Nov 2023

FIAGOP (fiagop.it) - Federazione Italiana Associazioni Genitori e Guariti Oncoematologia Pediatrica è stata fondata nel 1995 con lobiettivo di creare sinergie tra le Associazioni presenti sul territorio nazionale e assicurare una rappresentanza istituzionale sia a livello nazionale che…

Austrian public health group opposes extending drug patent periods

Verband der öffentlichen Wirtschaft und Gemeinwirtschaft Österreichs, 6 Nov 2023

VÖWG argues against extending drug exclusivity and suggests shortening it instead. They want to block transferable vouchers to prevent skyrocketing healthcare costs. The group also demands stricter definitions for rare diseases to stop industry tactics.
This would reduce the financial pressure on public health systems and hospitals.
Pharmaceutical firms would lose profits from extended monopolies and niche market statuses.

Consultation response

PHARMABIOTIC RESEARCH INSTITUTE, 6 Nov 2023

The PRI welcomes the proposal for a pharma Regulation which will forge further EU harmonization in terms of the quality, safety, and efficacy assessment of "SoHO-derived medicinal products other than ATMPs (hereinafter abbreviated SoHO-DMP). Integration of provisions addressing Orphan and Pediatric…

Consultation response

PHARMABIOTIC RESEARCH INSTITUTE, 6 Nov 2023

The PRI welcomes the proposal for a new Directive as it is a step towards recognizing microbiome-based medicinal products by defining SoHO-derived medicinal product other than ATMPs (hereinafter abbreviated SoHO-DMP) (which will include microbiome-based medicinal products produced from human…

Consultation response

Acreditar - Associação de Pais e Amigos de Crianças com Cancro, 6 Nov 2023

A ACREDITAR - Associação de pais e amigos de crianças com cancro, congratula-se com a revisão a legislação geral da UE em matéria de produtos farmacêuticos. Como membros da comunidade alargada de oncologia pediátrica, a Childhood Cancer International (CCI) temos tornado pública a necessidade da…

Consultation response

Institut National du Cancer, 6 Nov 2023

The INC has the pleasure of submitting its feedback prepared in consultation with the interinstitutional WG on oncopediatrics of the 2nd National Cancer Plan of Luxembourg. -Science-based paediatric drug development: We value the introduction of paediatric medicine development based on the…

Consultation response

PHOENIX Pharma SE, 3 Nov 2023

To whom this may concern, Please find attached PHOENIX group contribution to the European Commissions public consultation on the Revision of the EU general pharmaceuticals legislation. PHOENIX group applauds the European Commission for reviewing and updating the outdated European pharmaceutical…

Consultation response

International Society for Pharmaceutical Engineering, 3 Nov 2023

2 November 2023 European Commission, Directorate-General for Health and Food Safety Reference: CELEX number: 52023PC0193 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and…

Consultation response

Asociatia Daruieste Aripi, 3 Nov 2023

Science Based Paediatric Medicine Development: We welcome the introduction of paediatric medicine development based on the molecular target of a new medicine in the Commissions proposal. Improved access to essential anticancer medicines: We support the introduction of a dedicated chapter on the…

Consultation response

International Society for Pharmaceutical Engineering, 2 Nov 2023

2 November 2023 European Commission, Directorate-General for Health and Food Safety Reference: CELEX number: 52023PC0192 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and…

Consultation response

Associação Portuguesa de Medicamentos Genéricos e Biossimilares, 2 Oct 2023

APOGEN, Portuguese Generic and Biosimilar Medicines Association represents the companies of generic and biosimilar medicines in Portugal, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across…

Consultation response

Associação Portuguesa de Medicamentos Genéricos e Biossimilares, 2 Oct 2023

APOGEN, Portuguese Generic and Biosimilar Medicines Association represents the companies of generic and biosimilar medicines in Portugal, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering…

Consultation response

Life Science Acceleration Alliance e.V, 5 Sept 2023

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…

Consultation response

EuroLyme, 1 Jul 2023

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…

Consultation response

ECA Foundation, 25 Jun 2023

Please find the comments of the ECA Foundation & European QP Association in the attached file.

Consultation response

The Swedish Childhood Cancer Fund, 27 Apr 2021

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…

Consultation response

European Pulmonary Fibrosis Federation, 27 Apr 2021

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. We are a Belgium registered International not-for-profit organisation…

Consultation response

Le Conseil International des Excipients Pharmaceutiques - Europe, 27 Apr 2021

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…

Consultation response

Associação Nacional das Farmácias, 27 Apr 2021

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. Many of the issues raised by the European…

Consultation response

Europharm Small and Medium Size Companies, 27 Apr 2021

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…

Consultation response

European Hematology Association, 27 Apr 2021

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…

Consultation response

Vifor Pharma Management, 27 Apr 2021

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…

Consultation response

Galapagos NV, 27 Apr 2021

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. To…

Consultation response

ACCELERATE Paediatric Oncology Multi-stakeholder Platform, 27 Apr 2021

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. ACCELERATE…

Consultation response

Association of Clinical Research Organizations, 26 Apr 2021

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,…

Consultation response

Associação Portuguesa da Indústria Farmacêutica, 26 Apr 2021

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,…

Consultation response

Asociación para Proteger al Enfermo de Terapias Pseudocientíficas, 26 Apr 2021

Buenas tardes. Soy Fernando Cervera Rodríguez, biólogo molecular, representante y miembro de la Junta Directiva de la Asociación para Proteger al Enfermo de Terapias Pseudocientíficas (www.apetp.com). Adjunto en este comentario como coordinador del First worldwide manifesto against pseudosciences…

Consultation response

Time for Lyme ASBL, 25 Apr 2021

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…

Consultation response

Syndicat des Eaux et de l'Assainissement Alsace-Moselle, 22 Apr 2021

La question de l'accès aux médicaments au plus grand nombre est une question de société majeure et il ne peut être que positif de s'y intéresser. Nous souhaitons toutefois noter, d'un point de vue environnemental, que l'usage de toute substance pharmaceutique, quelle qu'elle soit, et ce en…

Consultation response

HTA Austria Austrian Institute für Health Technology Assessment, 19 Apr 2021

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. There is…