EFPIA

EFPIA and its members support the EUs ambition to advance a circular economy for packaging while safeguarding public health and resilient global supply chains. EFPIA welcomes the timely adoption of the Implementing Act (IA) on national registers of producers under the Packaging and Packaging Waste Regulation (PPWR), but calls for realistic, coherent and sector-specific implementation, particularly regarding Article…

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the research-based pharmaceutical industry operating in Europe and is committed to advancing patient care through responsible innovation.

The European Federation of Pharmaceutical Industries Associations (EFPIA) welcomes the Commissions efforts to simplify and streamline Europes digital rulebook. For the pharmaceutical sector, clarity in the digital acquis is essential to ensure regulatory frameworks enable, rather than inhibit, research and innovation.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its members support the EUs ambition to advance a circular economy and share the objective of fostering sustainability while safeguarding public health and the resilience of global supply chains. We are committed to innovation, sustainable manufacturing, and responsible resource use.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the innovative pharmaceutical industry in Europe, creating a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe and support sustainable development.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to submit feedback on the effectiveness of the EU public procurement directives. Recourse to the public procurement of medicines has increased in recent years as payers across the EU struggle to balance constrained healthcare budgets and increasing demand.

EFPIA fully supports the aim of the targeted revision for the MDR/IVDR to simplify and streamline the current regulatory framework. However, the proposal misses the opportunity to enhance the current system even further. On the governance process, EFPIA supports a greater coordination role taken by the EMA as well as expansion of expert panels remits.

EFPIA welcomes the European Commissions call for evidence gathering input to address the identified problems highlighted in the MDR-IVDR targeted evaluation of March 2025 and is providing input related to drug-device/diagnostic used together (combined products) during clinical development and life cycle.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. EFPIA welcomes the opportunity to share our feedback on the Proposal by the Commission on the Packaging and Packaging Waste Regulation (COM(2022) 677 final) (PPWR). The Commission proposal includes some derogations for packaging used in pharmaceuticals.

The European Commissions initiative to propose an EU Inc. corporate legal framework is a strong structural reform to support competitiveness and innovation in Europe. This proposal to reduce legal and administrative fragmentation is welcome by EFPIA and especially its SME members which experience the difficulty to scale up their business in Europe.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for feedback on the review of the EU Taxonomy Environmental Delegated Act.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence in for the review of Climate Delegated Act. EFPIA represents the biopharmaceutical industry operating in Europe, bringing together 36 national associations, 40 leading pharmaceutical companies and a growing number of small and medium-sized enterprises.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence in for the review of Environmental Delegated Act. EFPIA represents the biopharmaceutical industry operating in Europe, bringing together 36 national associations, 40 leading pharmaceutical companies and a growing number of small and medium-sized enterprises.

To turn life science competitiveness goals into reality, Europe needs an MFF that includes ambitious funding for health and life sciences that aligns with the competitiveness compass objectives. The MFF proposal offers some positive signals.

EFPIA 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 decision-making processes, and reducing unnecessary administrative burdens.

EFPIA 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 decision-making processes, and reducing unnecessary administrative burdens.

EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for feedback on the Revised European sustainability reporting standards.

EFPIA applauds the Commission for launching the first ever legal framework on AI that elaborates on a European approach for AI with an aim to promote Europe’s innovation and industry capacity in AI that could bring benefits to entire healthcare system. We welcome a risk-based approach to AI with an oversight proportionate to the intended use and led by defined risk categories.

EFPIA, the research-based pharmaceutical industry is supportive of the European Commission initiative to increase product sustainability as indicated in the roadmap for the Sustainable Products Initiative. We would like to contribute to the policy debate with recommendations that aim at safeguarding the future access to care for patients and at improving human health.

EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.

EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.

EFPIA strongly support the ambition to foster a world-class innovation environment for biotechnologies.To make the EU more attractive for researching, developing and manufacturing new technologies,we urge coordinated and urgent action across several areas.

EFPIA, the European Federation of Pharmaceutical Industries and Associations, represents the innovative biopharmaceutical industry operating in Europe. We would like to reiterate our strong support for the overarching objectives of the CSS (Chemical Strategy for Sustainability) and welcome the opportunity to provide feedback on the open public consultation on the Revision of the Regulation on Classification…

EFPIA, the research-based pharmaceutical industry is supportive of the European Commission initiatives related implementation of the Green Deal, specifically the chemicals strategy for sustainability, which sets out a number of actions that require a targeted revision of the Regulation on the classification, labelling and packaging of chemical substances and mixtures.

EFPIA & VE welcome the ECs initiative to develop the Biotech Act II and supports the objective of strengthening Europes industrial biotechnology and biomanufacturing ecosystem. The Biotech Act II should primarily focus on improving framework conditions that enable advanced biomanufacturing and manufacturing innovation in Europe, helping to translate scientific excellence into commercial success.

Europes innovation ecosystem faces lack of capital, fragmentation, insufficient coordination, and regulatory complexity. For life sciences, these elements limit competitiveness and discourage investment. At the same time, Europe is losing global market share in R&D, clinical trials, and biomanufacturing, while talent continues to move abroad.

Commission Feedback Data Act & amended rules on the legal protection of databases EFPIA welcomes the opportunity to provide feedback to the proposed Data Act and amended rules on the legal protection of databases, published on 23 February 2022. There are many aspects of the Commission’s proposal which EFPIA fully supports, including the overall goal of facilitating the re-use of data.

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

EFPIA Comments on Inception Impact Assessment for Data Act (including the review of the Directive 96/9/EC on the legal protection of databases) EFPIA welcomes the chance to comment on the Inception Assessment for the Data Act. We note the objectives of the Act to: - Promote fair reliable and transparent B2G data sharing.

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

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and…

EFPIA (the European Federation of Pharmaceutical Industries and Associations), representing research-based pharmaceutical manufacturers in Europe, welcomes the recently launched proposal for a new Digital Services Act package, which aims to modernise the current legal framework for digital services.

The legislative proposal on a European Health Data Space (EHDS) and respective horizontal proposals provide an unprecedented opportunity to shape the future health data and digital ecosystem. Digital transformation has the potential to increase the innovation and productivity of the EU economy and ensure that Europe remains an innovator and world leader in the development and manufacture of medicines, supporting…

EFPIA welcomes the proposal to create sectoral and horizontal legislative frameworks to unlock the value of data, support the use, re-use and exchange of health data at the EU level and ensure coherence between the operation of the different legislations contributing to the functioning of the Data Space.

EFPIA • Welcomes the Data Governance Act as an important milestone in the delivery of the EU’s Data Strategy • Hopes the act will address fragmentation in the implementation and interpretation of GDPR and underpin the agreed flexibilities of GDPR in relation to scientific research • Believes that the new data intermediation entities have the potential to improve data access for researchers but must operate…

EFPIA • Welcomes the Data Governance Act as an important milestone in the delivery of the EU’s Data Strategy • Hopes the act will address fragmentation in the implementation and interpretation of GDPR and underpin the agreed flexibilities of GDPR in relation to scientific research • Believes that the new data intermediation entities have the potential to improve data access for researchers but must operate…

EFPIA reply to the consultation for the impact assessment on the legislative framework for the governance of common European data spaces EFPIA welcomes the proposal to create a horizontal legislative framework aiming to unlock the value of data, support the use of data, lower the cost of data use and transaction cost and support the development of sectoral data spaces.

EFPIA, the research-based pharmaceutical industry, supports the Commission’s objective to revise, improve and simplify the REACH regulation. We welcome the opportunity to be recognised as a key stakeholder to develop and implement better chemical regulations.

EFPIA welcomes the inclusion of EU-level targets in the Safe Hearts Plan and believes that the Council Recommendation (CR) should translate into even greater ambition at national level. CR should include a clear commitment that every person receives a comprehensive cardiometabolic risk assessment by age 35 (Know Your Numbers by 35), with regular reassessment thereafter.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to comment on the revision of the Customs Union Code. EFPIA represents the biopharmaceutical industry in Europe. Please find an explanation of our position attached. EFPIA supports the objectives of the revision and wishes to highlight a few elements that require further explanation.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. EFPIA appreciates the opportunity to provide comments on the Proposal for an Extension of the Transitional Provisions for Certain Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), issued on 6 January 2023.

EFPIA, representing the innovative, research-based pharmaceutical industry in Europe, welcomes the European Commissions work to establish sustainability criteria for plastic recycling technologies under the PPWR.

EFPIA, representing the innovative, research-based pharmaceutical industry in Europe, welcomes the European Commission's efforts to establish a clear and harmonised methodology for the calculation and verification of post-consumer recycled content in plastic packaging under the Packaging and Packaging Waste Regulation (PPWR).

The proposed Substances of Human Origin(SoHO) Regulation intends to harmonize measures for Member States and organizations involved in activities related to SoHOs for human application, facilitating cross-border exchange and continuity of supply in the EU. EFPIA supports these aims but is concerned about areas of the SoHO Regulation that appear incoherent with medicinal product regulation.

Revision of the Blood, Tissues & Cells (BTC) Legislation offers an important opportunity to ensure regulatory standards safeguarding patient safety and public health keep pace with technical and scientific advances, legal certainty and risk-based flexibility to facilitate innovation, and sustainability of supplies across EU for both therapeutic need and producing products derived from BTC.

EFPIA, representing the innovative pharmaceutical industry, is aware that medicinal products have been detected in European Surface Waters. We are supportive of the Urban Wastewater Treatment Directive Proposals objective to protect the environment and human health from the adverse effects of urban wastewater discharges and are committed to play our part in achieving this objective in a fair and equitable way.

EFPIA, representing the innovative, research-based pharmaceutical industry in Europe, welcomes the European Commissions efforts to establish a clear and harmonised methodology for assessing, verifying and certifying the equivalence of recycled materials collected or recycled in third countries under the Packaging and Packaging Waste Regulation (PPWR).

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. EFPIA welcomes the opportunity to provide our views on the One Substance-One Assessment (OS-OA) legislative package.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical research based industry operating in Europe. It is essential for EFPIA that any actions on implementation of the One Substance One Assessment (OSOA) concept as part of the EU chemicals strategy for sustainability do not have a negative impact on ensuring the access of safe, efficient medicines and vaccines…

EFPIA members are committed to ensuring that unmet needs are addressed and that available treatments reach all European patients. Children and rare disease (RD) patients have greatly benefited from the progress achieved through the Paediatric and Orphan Regulations. The Paediatric Regulation is meeting best-case expectations from its impact assessment (IA) conducted in 2004.

EFPIA response to the Commission Call for Evidence on Chemicals – making best use of EU agencies to streamline scientific assessments The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. It is essential for EFPIA that any actions as part of the EU Chemicals Strategy for Sustainability (CSS), do not have a negative impact on ensuring the access of safe, efficient medicines and vaccines to citizens in Europe.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 37 national associations, 38 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIAs mission is to create a collaborative environment that enables our members to innovate, discover, develop and…

In its Compulsory Licensing (CL) proposal, the European Commission (EC) posits a new EU-wide CL for crisis response. This harms IP rights and is a dramatic expansion of the ECs role into Member State (MS) remit, where viable CL provisions already exist. CLs are a last resort, all attempts at voluntary licensing having failed.

The substantial investment in R&D by multiple actors over many years into novel technologies, vaccine, therapeutic and other products now available to address Covid-19 would not have occurred without the robust IP system in the EU and elsewhere. IP protections, particularly patents, has provided the legal framework and incentive for the high risk, high-cost investment underpinning the response to the pandemic.

EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection.

EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection.

Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) along with the Association of the European Self-Care Industry (AESGP) and Medicines for Europe (MfE) note positive aspects in the revision of the Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and the…

EFPIA welcomes the opportunity to comment on the draft Commission Implementing Act laying down the minimum metadata elements and their characteristics for dataset descriptions under the European Health Data Space (EHDS).

EFPIA welcomes the opportunity to comment on the draft Commission Implementing Act laying down the measures for the establishment and operation of the European Health Data Space (EHDS) Board. We support the Commissions efforts to develop a robust governance structure for the EHDS and recognise the importance of the Board in ensuring consistent implementation across Member States.

EFPIA, representing the biopharmaceutical industry operating in Europe, welcomes the opportunity to contribute to the European Commission's open consultation on the EU Access and Benefit-Sharing (ABS) Regulation (EU No 511/2014).

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, reinforcing the mandate of the ECDC. It is critically important that as part of its extended missions and tasks (art. 3), the ECDC can get full and immediate access to all epidemiological data from Member States.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 37 national associations, 38 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIAs mission is to create a collaborative environment that enables our members to innovate, discover, develop and…

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, extending the mandate of the EMA. The current crisis has shown the importance of close dialogue between EU authorities and the industry, to address medicines’ shortages.

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity. We welcome the proposed Regulation strengthening Europe’s preparedness against serious cross-border health threats, and believe that it can be improved further to ensure it delivers on its objectives.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to submit feedback on the Foreign Subsidies Guidelines. The FSR aims to subject subsidies granted by non-EU countries to the same sort of scrutiny as applies to EU Member State subsidies under EU State aid rules.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence on past implementation of the Regulation concerning customs enforcement of intellectual property rights (Regulation (EU) No 608/2013) .

EFPIA welcomes the opportunity to comment on the EU Commissions EMA fees proposal. EFPIAs comments reflect those of its members in the innovative industry which extensively remit EMA fees. Exacerbated by the COVID crisis and the impact of Brexit, the EU regulatory system is experiencing significant resourcing challenges that hinder its ability to achieve optimal efficiency and sustainability.

EFPIA welcomes the opportunity to contribute to the Call for Evidence regarding the Good Laboratory Practice (GLP) framework. From our perspective, the current GLP directive and the existing framework are functioning well and continue to support high-quality non-clinical studies across the EU. EFPIA finds that the GLP principles as defined by the OECD are both relevant and value-adding.

EFPIA supports the Commissions objective of preventing designer precursors from being used for the illicit manufacture of drugs and acknowledges the need for effective and proactive controls. At the same time, the proposed scheduling of 148 substances as Category 1 precursors should be implemented in a way that avoids unintended barriers to legitimate pharmaceutical research and development.