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EuropaBio

EuropaBio is Europe's largest biotech industry group, representing healthcare and industrial biotech sectors in EU policy.

Lobbying Activity

Meeting with Maria Pilar Aguar Fernandez (Director Research and Innovation) and

15 Jan 2026 · Exchange of views with private members of the Innovative Health Initiative Joint Undertaking (IHI-JU).

EuropaBio urges biotech inclusion in EU Advanced Materials Act

12 Jan 2026
Topic — The consultation seeks views on strengthening European production and innovation capacities for advanced materials.
Message — The group wants the EU to fully integrate biotechnology as a design and production pathway. They recommend expanding biomanufacturing capacity and creating predictable regulatory pathways for scaling up.12
Why — This would ensure biotech companies receive specialized funding and benefit from faster regulatory pathways.34
Impact — Conventional chemical manufacturers may face reduced market share due to government-favored bio-based substitutes.5
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Meeting with Bruno Tobback (Member of the European Parliament)

17 Dec 2025 · Making the Biotech Act Work for Europe: Aligning Innovation with Regulation

EuropaBio urges inclusive biomass rules in EU Taxonomy

4 Dec 2025
Topic — The European Commission is reviewing environmental criteria for its sustainable finance taxonomy framework.
Message — The organization requests a more inclusive view of biological materials for sustainable financing mechanisms. They also call for distinguishing between biotech and conventional processes to recognize sustainable biomanufacturing.123
Why — Removing feedstock restrictions would increase funding access and reduce investment uncertainty for biotechnology companies.45
Impact — Conventional chemical manufacturers may face reduced investment as biotechnology is classified as more energy efficient.67
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EuropaBio urges EU to remove biotech barriers in Circular Economy Act

5 Nov 2025
Topic — EU regulation to enhance economic security and promote sustainable circular economy business models.
Message — EuropaBio requests flexibility to use primary biomass as feedstock, alignment of legislation with circularity principles, and simplified permitting for biorefineries. They argue current regulations create barriers that slow innovation and generate waste.1234
Why — This would allow biotech firms to use cheaper primary materials and reduce regulatory compliance costs.56
Impact — Environmental groups lose stronger waste reduction requirements and recycling prioritization over virgin materials.7
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EuropaBio urges EU to streamline biotech food approvals

13 Oct 2025
Topic — Simplifying EU regulations on plant protection, feed additives, and food safety.
Message — The organization requests clarification of fermentation product legal status, inclusion of scientific advice in pre-submission, removal of mandatory 10-year feed additive renewals, and streamlined data requirements. They argue current frameworks are outdated with unclear timelines that deter market applications.123
Why — This would reduce costly product recalls and accelerate their market access for biotech innovations.45
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EuropaBio urges streamlined rules for combined drug-device clinical trials

6 Oct 2025
Topic — The consultation evaluates and revises EU rules for medical devices and diagnostics.
Message — EuropaBio calls for a harmonised procedure for combined drug-device trials to replace repetitive applications. They advocate for parallel assessments, standardized timelines, and specific exemptions for rare disease diagnostics.12
Why — Streamlined procedures would reduce the regulatory burden and accelerate biotech innovation timelines.3
Impact — Patients face delayed access to innovative treatments due to inefficient regulatory procedures.4
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EuropaBio urges EU to close biotech funding gap and streamline innovation policies

2 Oct 2025
Topic — Framework for strengthening Europe's innovation ecosystem to support competitive innovative companies.
Message — The organization requests innovation stress-tests for legislation, regulatory sandboxes, harmonized funding coordination, practical IPR-backed financing, competitive stock option rules, strategic public procurement for biotech, and stronger technology transfer frameworks. They argue current fragmentation prevents biotech companies from scaling and reaching market.12345
Why — This would reduce regulatory burdens, improve access to late-stage capital, and help retain talent.678
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Meeting with Kristin Schreiber (Director Internal Market, Industry, Entrepreneurship and SMEs) and

3 Sept 2025 · Attitudes towards food biotechnology

Meeting with Klaus Berend (Director Health and Food Safety), Rainer Becker (Director Health and Food Safety) and

17 Jul 2025 · EU Biotech Act

Meeting with Marco Marsella (Director Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations and

10 Jul 2025 · EHDS and IHI calls

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur)

8 Jul 2025 · Critical Medicines Act

Meeting with Eero Heinäluoma (Member of the European Parliament)

7 Jul 2025 · Discussion on Bioindustries

EuropaBio calls for biotech inclusion in EU industrial decarbonisation law

4 Jul 2025
Topic — The initiative aims to accelerate industrial decarbonisation and boost European competitiveness.
Message — The organization urges including biotechnology in the new legislation. They request streamlined permitting and tax incentives to support market access.12
Why — This would grant biotech firms faster market entry and valuable tax advantages.34
Impact — Traditional petrochemical producers may lose market dominance to bio-based competitors.5
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Response to Critical Medicines Act

4 Jul 2025

EuropaBio supports the goal of the Critical Medicines Act (CMA) to strengthen the security of supply for medicines in the EU. Medicine shortages have various causes and require tailored solutions. Addressing long-standing external dependencies and rebuilding manufacturing capacity will require sustained efforts over decades. Delivering the critical medicines of tomorrow demands urgent action today through reinforced global value chains and stronger EU leadership and competitiveness in biotech and life sciences innovation. EuropaBio actively contributed to the work of the Critical Medicines Alliance to ensure a pragmatic, fit-for-purpose proposal. The CMA lacks concrete measures to ensure sustainable access to raw materials and feedstock and to build strategic partnerships, two vital elements for long-term resilience. The absence of a comprehensive impact assessment raises serious concerns. Attached EuropaBio's full contribution.
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EuropaBio urges EU to prioritize bioeconomy as industrial policy pillar

23 Jun 2025
Topic — The EU is updating its strategy for a circular and competitive bioeconomy.
Message — The group calls for a reliable policy framework to attract capital and investment. They recommend creating a dedicated EU Biotech Office to ensure strategic policy coherence.12
Why — Improved access to finance and streamlined regulations would accelerate product commercialization.34
Impact — The fossil fuel industry may lose market share as bio-based products receive priority.56
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Meeting with Olivér Várhelyi (Commissioner) and

17 Jun 2025 · EU biotech policy

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

12 Jun 2025 · Biotechnology Act and wider global impacts for EU biotechnology

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

12 Jun 2025 · to follow

EuropaBio demands Biotech Act to drive European industrial leadership

10 Jun 2025
Topic — This initiative seeks to improve the regulatory environment for biotechnology and biomanufacturing across Europe
Message — EuropaBio requests a dedicated Biotech Omnibus Package to resolve barriers and streamline market access. They advocate for an EU biotech NASDAQ to help companies raise capital locally.12
Why — Faster permitting and better financing would prevent innovative companies from moving to non-EU markets.3
Impact — Fossil-based product manufacturers would face increased competition from bio-based alternatives through new sustainability accounting.4
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Meeting with Marc Lemaitre (Director-General Research and Innovation) and European Federation of Pharmaceutical Industries and Associations and

4 Jun 2025 · 2nd dialogue with representatives from across the life sciences to review the progress of the IHI, to discuss opportunities to optimise the current partnership and to exchange views on the future of EU research and innovation programmes.

EuropaBio Urges EU to Boost AI Integration in Biotechnology

3 Jun 2025
Topic — The initiative aims to accelerate industrial AI adoption and foster innovation breakthroughs.
Message — EuropaBio calls for AI integration in biotech via predictable regulatory oversight. They demand clear AI Act R&D exemptions and coordination with medicines regulators. The group supports alignment with the new EU Biotech Act and skills development.1234
Why — This would accelerate scientific discovery while reducing costs from redundant regulatory requirements.56
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Meeting with Ekaterina Zaharieva (Commissioner) and

3 Jun 2025 · Life sciences

Meeting with Pernille Weiss-Ehler (Cabinet of Commissioner Jessika Roswall)

26 May 2025 · The Water Resilience Strategy and the upcoming, updated Bioeconomy Strategy

Meeting with Olivér Várhelyi (Commissioner) and

20 May 2025 · EU biotech policy

Meeting with Olivier Chastel (Member of the European Parliament, Shadow rapporteur)

15 May 2025 · Biotech - Politique de santé de l'UE

Meeting with Rainer Becker (Director Health and Food Safety)

13 May 2025 · Patient BioForum (event hosted by MEP Andras Tivadar Kulja)

Meeting with Stine Bosse (Member of the European Parliament)

8 May 2025 · Biotech policy

EuropaBio urges streamlined EU rules to boost biotech competitiveness

16 Apr 2025
Topic — This consultation seeks views on a strategy to boost European life sciences competitiveness.
Message — EuropaBio calls for a streamlined and predictable legislative environment for all biotech innovators. They urge the EU to accelerate product deployment through favorable market conditions. They also request a dedicated EU Biotech Office to improve policy coordination.123
Why — Regulatory simplification and new financial mechanisms would unlock investment for biotech companies.45
Impact — Fossil-based sectors may lose market share due to targets favoring renewable products.6
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Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs) and

10 Apr 2025 · Impact of US tariffs

Meeting with Stéphane Séjourné (Executive Vice-President) and

10 Apr 2025 · Impact of US tariffs

Meeting with Eero Heinäluoma (Member of the European Parliament, Shadow rapporteur) and Fresenius SE & Co.KGaA

27 Mar 2025 · Biotech and Biomanufacturing

Meeting with Morten Løkkegaard (Member of the European Parliament, Shadow rapporteur)

25 Mar 2025 · Biotechnology

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of the Regulation on Medical Devices (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR). EuropaBio emphasises the need to improve the interplay between the Clinical Trials Regulation (CTR) and the MDR/IVDR, in particular in trials involving both medicinal products and medical devices (MDs) or in-vitro diagnostics (IVDs), so-called combined trials. Such devices play important roles in clinical trials involving a medicinal product, such as drug administration, monitoring parameters, collecting data, or diagnostic use. When a clinical trial investigates both a medicinal product and a medical device or in-vitro diagnostics simultaneously, sponsors face over-regulation. Attached EuropaBio full response.
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Response to EU Start-up and Scale-up Strategy

14 Mar 2025

EuropaBio, representing European biotechnology companies, welcomes the opportunity to contribute to the EU Startup and Scaleup Strategy call for evidence. Through its national associations and SME Platform, EuropaBio represents over 4500 biotech small and medium-sized companies, including startups and scaleups. Startups and scaleups are a core part of the biotech ecosystem as a source of innovation in delivering new products to the market. These companies are key contributors to the European economy, industrial transition and society. Through their contribution, the gross value added from biotechnology activities hit 38,1 billion in 2022, almost doubled since 2008. Whilst healthcare biotechnology remains the dominant sector, reflecting the maturity of the sector, industrial biotechnology is the fastest growing GVA rate, at 5.3% - over double that of the EU total economy. Biotechnology startups and scaleups face the hurdles identified in the call for evidence (Question 1) and as detailed within this response. EuropaBio is committed to providing solutions to resolve these challenges. This response builds on our startup and scaleup members' insights and showcases proposals to overcome each challenge (Question 3). Please see the attached document. EuropaBio and its members remain available to provide further feedback and case studies or to connect the European Commission with biotechnology startups and scaleups.
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Meeting with Stine Bosse (Member of the European Parliament) and Confederation of Danish Industry

14 Mar 2025 · European health policy

EuropaBio Urges Biotech-Focused Reforms to EU Procurement Rules

7 Mar 2025
Topic — The EU is evaluating directives governing public contracts to ensure effectiveness and relevance.
Message — EuropaBio requests procurement rules be adapted to stimulate the uptake of innovative biotechnology products. They suggest using value-based criteria instead of just price to recognize biotech innovation. Furthermore, they seek reduced administrative burdens to help smaller firms compete for public contracts.123
Why — These reforms would accelerate market expansion and drive investment into European biotechnology firms.45
Impact — Fossil-based manufacturers would face increased competition from prioritized bio-based alternatives.6
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Meeting with Rainer Becker (Director Health and Food Safety)

6 Mar 2025 · Exchange of views on the Biotech Act

Meeting with Stine Bosse (Member of the European Parliament)

6 Mar 2025 · Life sciences and biotech policy

Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

4 Mar 2025 · Bioeconomy, Biotech

Meeting with Stine Bosse (Member of the European Parliament)

27 Feb 2025 · European health policy

Meeting with Hildegard Bentele (Member of the European Parliament, Rapporteur) and Verband der Chemischen Industrie e.V. and

27 Feb 2025 · Biotech

EuropaBio advocates for targeted rules in Critical Medicines Act

26 Feb 2025
Topic — The consultation addresses supply chain vulnerabilities to ensure the availability of critical medicines.
Message — EuropaBio recommends focusing new requirements on companies with a history of medicine shortages. They suggest excluding rare disease medicines and prioritizing strategic partnerships over new legislation.123
Why — This would minimize administrative expenses and prevent unnecessary regulatory pressure on biotech manufacturers.4
Impact — Organizations that have failed to prevent medicine shortages would be subject to stricter oversight.5
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Meeting with Ilaria Flores Martin (Cabinet of Commissioner Jessika Roswall), Jan Ceyssens (Cabinet of Commissioner Jessika Roswall), Paulina Dejmek Hack (Cabinet of Commissioner Jessika Roswall)

24 Feb 2025 · linkages between Commissioner’s portfolio area and the bioindustry

Meeting with Elisa Roller (Director Secretariat-General)

21 Feb 2025 · Exchange of views on initiatives that will have an impact on the biotechnology sector like the Competitiveness Compass, Clean Industrial Deal, the Pharmaceutical Package, the Critical Medicines Act, the New Genomic Techniques proposal or the Biotechn

Response to List of net-zero technology final products and their main specific components

20 Feb 2025

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to comment on the Implementing Act on the list of net-zero technology final products and main specific components. We fully support the inclusion of microorganisms and enzymes in both final products and as main specific components under Biotech Climate and Energy Solutions. Industrial biotechnology and biomanufacturing are substantial contributors to net-zero, for example, by replacing a non-renewable resource by a bio-based resource and/or by using techniques such as fermentation which are generally less energy-intensive than conventional processes. An example is the production of vitamin B2, which reduces the use of fossil raw materials by 70% and wastewater by 65%, while reducing production costs by 40%. Other examples include the use of enzymes to replace chlorine in paper bleaching which reduces energy needs by 40% or in detergents to allow the use of lower temperatures during laundry and consequently a reduction of electricity use by 30%. An important consideration for Biotech climate and energy solutions is the feedstock used in the process. Biomanufacturing processes using microorganisms and enzymes (in scope of the NZIA) can use biogenic carbon as well as recycled carbon and carbon capture and use (CCU, also falling in scope of the NZIA). The list of final products and main specific components currently only captures biogenic feedstock for biotech climate and energy solutions. This should be expanded to reflect additional sources of carbon that support the overall defossilisation of EU industry. We would therefore like to submit some specific comments to further clarify and strengthen the criteria for final products and main specific components under Biotech climate and energy solutions. Please see below and attached in Annex. methanogens should be replaced by Archaea, to be consistent with the other broad classifications of microorganisms. microbial strains is a descriptor of specific lineages of microorganisms. It would be more accurate to either delete this, or move outside of the parenthesis i.e. Microorganisms and microbial strains (such as bacteria, yeasts, ) Biopolymers and recycled carbon fuels, recycled carbon chemicals, and renewable fuels produced by fermentation using recycled or non-organic carbon sources should be added alongside biofuels, bio-based chemicals, bio-based materials and bio-based products: convert feedstock into biofuels, recycled carbon fuels and renewable fuels, bio-based and recycled carbon chemicals, biopolymers, bio-based materials, and bio-based products. Specific examples are outlined for enzymes (amylase and cellulase). We understand that this is to provide examples without introducing limitations through a prescriptive list, which would not be future proof. We suggest amending the text accordingly to read Enzymes (including but not limited to amylase and cellulase).
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Meeting with Eero Heinäluoma (Member of the European Parliament, Shadow rapporteur)

11 Feb 2025 · Biotech

Meeting with Stine Bosse (Member of the European Parliament)

11 Feb 2025 · Life sciences and biotech policy

EuropaBio calls for EU Biotech Act to harmonise regulations

30 Jan 2025
Topic — The consultation focuses on developing a single market strategy for cross-border growth.
Message — EuropaBio requests a simplified, harmonized regulatory framework and an ambitious EU Biotech Act to address fragmentation. They call for strengthened intellectual property rights and tailored financial support for small innovators.123
Why — Centralized rules would accelerate product approvals and reduce the costs of market entry.45
Impact — Member States lose the authority to enforce national bans on innovative food products.6
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Meeting with Biljana Borzan (Member of the European Parliament)

28 Jan 2025 · Biotechnology across the 2025-2029

Meeting with Eszter Lakos (Member of the European Parliament)

24 Jan 2025 · Biotechnology policy

Meeting with András Tivadar Kulja (Member of the European Parliament)

24 Jan 2025 · Patient-centric and future proof regulatory framework in healthcare

Meeting with Anna Strolenberg (Member of the European Parliament)

4 Dec 2024 · Biotechnology in food and agriculture

Meeting with Stefan Köhler (Member of the European Parliament) and Zentralverband des Deutschen Handwerks e.V.

5 Nov 2024 · Politischer Austausch

Meeting with András Tivadar Kulja (Member of the European Parliament)

31 Oct 2024 · Biotechnology industry challanges

Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

28 Oct 2024

EuropaBio welcomes the publication of the draft implementing act (IA) on procedures for joint scientific consultations (JSC) under the framework of Regulation (EU) 2021/2282 (HTA Regulation), which is timely considering the Regulation will apply from 2025. The HTA Regulation is an important tool to provide transparent and inclusive framework for HTA across Europe, reducing duplication and improving predictability for all stakeholders. Overall, EuropaBio remains concerned about the effectiveness and resourcing of the EU HTA framework and its ability to provide the necessary predictability and simplification to health technology developers (HTD). JSCs are essential elements to the effectiveness and attractiveness of the EU HTA Regulation. EuropaBio believes the recommendations and success of the EUnetHTA Joint Actions should serve as blueprint for the IA. In this context, EuropaBio calls on the European Commission and Coordination Group to consider the following improvements in the attached document.
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Meeting with Bruno Tobback (Member of the European Parliament)

26 Sept 2024 · Nieuw Genomische Technieken (NGTs) en wasmiddelen

Meeting with Eszter Lakos (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations

25 Sept 2024 · Public health

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

30 Apr 2024 · Presentatiion of EuropaBio study ‘Impact of the EU's General Pharmaceutical Legislation on Europe’s innovation ecosystem and biotechnology companies’ and to request a meeting

EuropaBio Urges Early Developer Involvement in Clinical Assessments

29 Mar 2024
Topic — The consultation concerns implementing rules for joint clinical assessments of medicinal products.
Message — Developers seek involvement in the scoping phase to provide quality evidence. They also request harmonized timelines to prepare submissions and correct factual inaccuracies.12
Why — This would improve predictability and minimize the burden of duplicating clinical data.3
Impact — Regulators may struggle with assessment scopes that exceed their time and resources.4
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Response to Revision of the variation framework for medicines

29 Feb 2024

EuropaBio welcomes the initiative from the European Commission to revise the variation framework last updated by the Commission Regulation (EU) No 712/2012. In the light of the Pharmaceutical Strategy for Europe, the need to revise the variation framework in a stepwise approach is particularly relevant considering the wide range of instruments currently discussed with the aim of future-proofing Europes regulatory framework. The new variation framework must be able to enable innovation, embrace technical and scientific progress and render the granting of variations more efficient. Simplifying and streamlining the variation system is key as currently a disproportionate amount of resources are required to handle and maintain a marketing authorisation (MA), both at Competent Authority and Marketing Authorisation Holder levels. Building on more than a decade of experience with the current framework, EuropaBio supports the goal of streamlining and simplifying post marketing lifecycle management and invites the Commission to ensure the proposed initiative is fit for purpose and does not increase burden on MA holders, including small and mid-size developers. EuropaBio welcomes the draft Delegated Regulation on the examination of variations to the terms of marketing authorisations for medicinal products for human use, and in particular changes introduced to: Introduce the new concept of super grouping across multiple marketing authorizations to also include purely national authorizations In the light of a public health emergency, increase regulatory flexibility regarding variations to a relevant human vaccine Harmonise and streamline the principle of change categorisation, both science-based and risk-based; update the list of variations in Annex II, for example removing the default classification to Type II for manufacturing changes for biologics. Introduce an annual update the classification guidelines to take into account scientific and technical progress and making use of the mechanism of recommendations on unforeseen variations according to Article 5 Introduce the option of ranges in alignment with the relevant authority for certain changes (new Article 6a) Allow annual reporting of minor changes, whilst retaining the option of submission flexibility based on readily achievable acceptance of justifications EuropaBio asks Considering the limited scope of the revision as part of an intermediate step before more significant changes to the variation framework planned after the entry into force of the revised general pharmaceutical legislation, EuropaBio would like to invite the European Commission to consider additional amendments to the draft Delegated Regulation to enable the full implementation of ICH Q12 guidelines before the revised pharmaceutical legislation becomes applicable. Furthermore, in the spirit of streamlining, reporting obligations already in place for medical devices and IVDs under the MDR and IVDR should not be required to be duplicated, as well as increasing scope and flexibility in grouping as an example possibility to include grouping of type IA and IB that are not consequential in the context of a type II CMC variation. Importantly, the revision of the variations framework will only be able to achieve its objectives through a comprehensive and sensible revision of the classification guidelines that will be undertaken as a subsequent step of the revision of the EU rules on changes to marketing authorisation. EuropaBio is looking forward to contributing and providing input to the revision of the classification guidelines when made available for public consultation. Conclusion EuropaBio remains fully committed to work and partner with the relevant stakeholders and European institutions in order to help shaping a regulatory framework that delivers innovative therapies to patients across the EU.
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and MEDICINES FOR EUROPE and Novo Nordisk A/S

22 Jan 2024 · Directive on Medicinal products for human use

Meeting with Martin Hojsík (Member of the European Parliament, Shadow rapporteur)

8 Nov 2023 · Detergents regulation, biotechnology

Meeting with Juozas Olekas (Member of the European Parliament, Shadow rapporteur for opinion)

7 Nov 2023 · New plant breeding techniques

EuropaBio urges EU to expand genomic rules to microorganisms

31 Oct 2023
Topic — The European Commission is proposing new rules for plants developed using advanced genomic techniques.
Message — The industry group requests that the EU commit to a 2024 proposal for genetically modified microorganisms. They also call for a faster update of all GMO laws to match scientific progress.12
Why — Modernized rules would provide regulatory certainty and help biotech firms launch innovative products.34
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Meeting with Tom Berendsen (Member of the European Parliament)

24 Oct 2023 · Speaker at plenary opening of European Forum for Industrial Biotechnology and the Bioeconomy (EFIB)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Merck

11 Oct 2023 · Directive on Medicinal products for human use

EuropaBio warns pharmaceutical revision threatens European biotech innovation

9 Oct 2023
Topic — Revision of EU pharmaceutical laws to ensure affordable and accessible medicines.
Message — 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.123
Why — Retaining strong data protection ensures biotech firms remain attractive to global investors.45
Impact — Small biotech firms lose because they cannot afford simultaneous launches across all markets.67
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EuropaBio Urges Simpler Rules for Biotech Medicine Approval Updates

26 Sept 2023
Topic — The initiative reviews procedures for making post-authorisation changes to human medicine authorisations.
Message — EuropaBio requests harmonising change categorisation and reconsidering the default complex review status for biologics. They suggest using non-legislative changes, such as IT updates, to reduce current administrative burdens.123
Why — This would reduce the heavy resource burden required to maintain marketing authorisations.4
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Meeting with Jan Huitema (Member of the European Parliament, Shadow rapporteur) and Deutscher Bauernverband

26 Sept 2023 · New Genomic Techniques

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur) and European Patients' Forum (EPF)

20 Sept 2023 · Pharmaceutical legislation

Meeting with José Manuel Fernandes (Member of the European Parliament, Rapporteur)

7 Sept 2023 · STEP

Response to Compulsory licensing of patents

28 Jul 2023

The COVID-19 pandemic has shown the importance for Europe to have the right tools to respond to major health crises. The EU has already adopted several laws to improve its ability to respond to health emergencies and the coordination between the Member States. National and international instruments on compulsory licensing (CL) already exist, questioning the actual need to propose a new framework at EU level that is inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and EU law. Intellectual property (IP) is a fundamental pillar to drive innovation and investment in the biotech sector, allowing companies to recoup R&D costs, stimulate further discoveries, and deliver valuable solutions to society. The proposed Regulation, combined with Article 80(4) of the proposed revision of Directive 2001/83/EC, runs the risk of further eroding intellectual property protection and setting a dangerous precedent about the stability and value of IP in Europe. Importantly, while the CL rules are intended to apply to the EU only, they will have a ripple effect and could weaken the value of innovation globally as any company with a patent registered in the EU will be impacted. The experience of the COVID-19 pandemic has shown that IP is not a barrier to access. In fact, thanks to collaboration between all actors of the innovation ecosystem and Member States, sufficient and continuous supply of vaccines and therapeutics to and from Europe were delivered without the need for CL. In strengthening its resilience, the EU must not create an unattractive environment that would lead to medical countermeasures (MCMs) being developed and manufactured outside Europe. It would therefore be more appropriate to build on the lessons learnt from the pandemic to strengthen collaborative networks that can deliver fast responses to emerging health crises as well as reinforce Europes biomanufacturing capacity to quickly produce and deploy the necessary MCM. The proposed Regulation will also significantly impact small and mid-size companies. Although the impact assessment accompanying the proposal is correct that those companies hold a relatively low number of patents, it fails to properly recognise that few or even just one patent is often the key value to the existence of those companies, without which they would not be able to get investments. In addition, large companies regularly in-license from smaller companies as this is where innovation in this sector comes from to a large degree. This means SMEs would be licensors and impacted by the CL. CL must remain a last resort option, triggered appropriately within the right legal framework, and subject to continuous, independent, and fair judicial oversight through all phases of the CL process, which is lacking in the current draft proposal. The attached paper highlights EuropaBios key concerns as regards the compulsory licensing of medicines. We remain committed to working with policymakers and stakeholders to ensure the proposal does not negatively impact Europes innovative biotech industries.
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Response to Revision of Regulation (EC) 648/2004 on Detergents

26 Jul 2023

EuropaBio welcomes the Revision of the Detergents Regulation and in particular the possibility to market microbial detergents by establishing requirements for their placing on the market. EuropaBio and its members support the setting of high industry standards, taking into account the safety, efficacy, and sustainability profile of products. In this regard, EuropaBio advocates for pragmatic and proportional regulatory frameworks that strike a balance between the legitimate interests of protection and the need for innovation. Please find our comments attached.
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

4 Jul 2023 · Directive on Medicinal products for human use

EuropaBio urges EU to include biotechnology in Net Zero Act

27 Jun 2023
Topic — A legislative framework for strengthening Europe’s net-zero technology products manufacturing ecosystem.
Message — The organization requests the inclusion of biotechnology in the legislative text. They advocate for a new initiative prioritizing industrial biotechnology and biomanufacturing scale-up.1
Why — Prioritizing these sectors ensures Europe maintains competitiveness against global economic rivals.2
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament)

12 May 2023 · Resolution on EU action to combat antimicrobial resistance

EuropaBio Urges Inclusive Feedstock Rules in EU Green Taxonomy

3 May 2023
Topic — The Commission is establishing technical criteria for sustainable investments contributing to the circular economy.
Message — EuropaBio requests the inclusion of primary biomass alongside bio-waste as eligible feedstock for sustainable plastic packaging. They also advocate for derogations allowing the use of enzymes classified as respiratory sensitisers.12
Why — Broader eligibility for green investment would accelerate biotech innovation and reduce fossil-fuel dependence.3
Impact — Safety advocates lose protections against respiratory sensitisers through the requested hazard-based exemptions.4
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Meeting with Jörgen Warborn (Member of the European Parliament)

12 Apr 2023 · Läkemedelsstrategin - SMEs

Meeting with Pierre-Arnaud Proux (Cabinet of Executive Vice-President Margrethe Vestager), Stina Soewarta (Cabinet of Executive Vice-President Margrethe Vestager)

22 Mar 2023 · Pharmaceutical package, biopharma

Meeting with Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis) and Novartis International AG and Eli Lilly and Company

6 Mar 2023 · Pharma package

Meeting with Simeona Manova (Cabinet of Commissioner Elisa Ferreira)

16 Feb 2023 · Presentation of a cross-sector Biomanufacturing Platform

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

25 Oct 2022 · Exchange of views on the upcoming reform of the pharmaceutical legislation

Meeting with Susana Solís Pérez (Member of the European Parliament, Shadow rapporteur)

7 Oct 2022 · EHDS

Response to Revision of the Union legislation on blood, tissues and cells

7 Sept 2022

EuropaBio welcomes the adoption of the proposal for a Regulation on SoHO revising the EU’s Blood, Tissues, and Cells (BTC) legislation. The EU needs a predictable, future-proof, and robust SoHO framework to ensure the uptake of transformative advanced therapies which hold great potential for both the health and wellbeing of patients and the sustainability of healthcare systems. The revision of the BTC legislation is important for the ATMP sector as requirements for donation, procurement and testing apply to SoHO used in the production of ATMPs. EuropaBio considers the proposal to be an opportunity for convergence of requirements across Member States and ensure that regulatory standards protecting patient safety and public health keep pace with technical and scientific advances. EuropaBio welcomes the proposal’s definitions and interplay with the ATMP Regulation and considers that they should be maintained in the adopted Regulation. EuropaBio is concerned about instances where the SoHO Regulation would interfere with the EU rules on medicinal products. Classification decisions from SoHO Coordination Board could contradict the decisions of the EMA’s Committee for Advanced Therapies (CAT) which currently participates in providing scientific recommendations on the classification of ATMPs. Such situations would add unnecessary uncertainty and burden for developers of ATMPs. EuropaBio is likewise concerned as regards the reference to genetically modified organisms (GMOs) in the proposal’s recital and considers that ATMPs that consist of or contain GMOs should continue to be regulated by the ATMP Regulation. EuropaBio believes that the governance of the new SoHO framework could be further strengthened to avoid divergence between Member States over time. The governance should also enable collaborative dialogue with industry stakeholders and the EMA’s CAT to facilitate the resolution of classification issues for borderline products. This collaborative dialogue will be particularly important for technical expert bodies like EDQM and ECDC as they develop or update technical guidelines to help adapt the legislation to scientific progress. Additional clarifications are also necessary to avoid legal uncertainty with respect to the equivalence assessment referred to in Article 23, the recognition of the SoHO establishment authorisation in another Member State in Article 25, and the content of the EU SoHO Platform in Article 41. The revision is also important to improve the sustainability of supply of SoHO across the EU for both direct administration and the manufacture of products derived from SoHO. However, certain provisions of the proposal, specifically Articles 42-44, could interfere with the pharmaceutical legislation as regards the distribution of SoHOs used in medicinal products manufacturing. EuropaBio believes the proposal insufficiently guarantees access to SoHO for the pharmaceutical companies and manufacturers of SoHO-derived products and encourages the co-legislators to introduce the principles of equal treatment and non-discrimination to access to SoHO to the Regulation. It is important that the legislation supports Member States in ensuring reliable supply of essential SoHO, including plasma for fractionation to manufacture plasma-derived therapies to address Europe’s reliance on the US for this essential starting material. As such, while we welcome the differentiation between plasma for fractionation and blood components for transfusion, we are concerned to see plasma donation defined as a “procedure of significant risk” without scientific justification as this may discourage plasma donations. As the European Association of innovative biopharmaceutical and biotechnology companies representing developers of cell-based and plasma-derived medicines, EuropaBio is committed to supporting patient access to essential and innovative therapies and to becoming a global leader in ATMP innovation.
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Response to A New European Innovation Agenda

10 May 2022

In 2018, the European biotechnology sector accounted for €34.5 bn, with an annual growth of 4.1%, more than twice as fast as the overall economy, making it one of the fastest growing innovative industries in Europe. The EU should use its scientific and industrial excellence to drive growth in the biotechnology industry, from SMEs to large companies. This can be done by addressing regulatory hurdles, increasing investments, and simplifying access to finance to facilitate scale-up in Europe. By harnessing the biotechnology industry’s potential, the EU will continue to deliver significant benefits for people and planet. A future-proof regulatory framework which removes barriers to innovation will allow cutting edge technology products to be developed and launched in Europe. Establishing regulatory sandboxes may be a relevant first step in some policy areas, enabling more efficient regulatory pathways. The current GMO legislation puts European patients at a relative disadvantage, creating hurdles which result in extended timeframes, from initiation of clinical trials through to marketing authorisation. For industrial biotechnology, inefficient regulatory procedures have detrimental effects on the development and market access of innovative and sustainable bio-based products and solutions. Notably, the process-based approach of GM legislation results in unequal regulatory treatment for similar products with equivalent risk profiles. A science-based, proportionate, and predictable policy and regulatory approach would help leverage the full potential of biotechnology, to benefit citizens, the economy, and the environment. The EU should continue efforts to invest in its scientific and industrial excellence and bridge the innovation gap between Member States. Initiatives aimed at reinforcing international cooperation in research and innovation, for example within Horizon Europe, or in collaboration with specific industrial sectors, such as the Innovative Health Initiative or Circular Bio-Based Industries Joint Undertaking, are a key component of the EU innovation ecosystem. On innovation performance, there is an urgent need to ensure fit for purpose regulation coupled with the right incentives for the life sciences industry. Rewarding innovation is critical to achieve the objectives of the EU Green Deal and the Pharmaceutical Strategy. It will enable development and faster market access of bioindustrial products, as well as faster delivery of life-changing innovative medicines to European patients. Innovation-friendly legislation will empower the twin green and digital transitions and overall EU sustainability goals, which require a range of solutions, including those coming from innovative biotechnologies. The EU needs to harness innovation created by the biotechnology sector to unleash its economic potential, creating, and maintaining jobs and value for citizens. Appropriate structures to build digital literacy skills are vital to maximise the impact of the digital transformation. It is essential that we invest collectively to build societal understanding of how data can contribute to better healthcare outcomes. The 2018 updated EU Bioeconomy Strategy set out measures to promote education, training, and skills development which should continue to be implemented to foster European industrial competitiveness and innovation in key enabling technologies such as industrial biotechnology. Biotechnology will help achieve a healthier, more sustainable, and autonomous Europe that attracts innovation and delivers for its citizens. This will ultimately be achieved by ensuring innovation-friendly regulation; increased financing for cutting-edge innovation of SMEs and maintaining strong intellectual property rights protections; developing the digital and science-based skillset across society and sectors; and improving R&D incentives to foster advanced manufacturing for sustainable bio-based production, and novel treatment options for patients.
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Response to Soil Health Law – protecting, sustainably managing and restoring EU soils

15 Mar 2022

The EU Soil Strategy for 2030, published in November 2021, noted that soils can contribute to key challenges linked to climate change, circular economy, human and environmental health, and water resources. Their capacity to do so, however, is jeopardized by soil desertification, degradation, and pollution. To address this, the Strategy outlined a number of aspects that should be considered in the impact assessment for soil health. We would particularly like to highlight measures that can contribute to reducing nutrient losses by at least 50% without deterioration in soil fertility (resulting in the reduction of fertiliser use by at least 20%). Industrial biotechnology (IB) supports sustainable crop cultivation and soil health while providing an alternative to fossil-fuel derived products. For example, agricultural biostimulants include diverse formulations of substances and microorganisms that complement mineral fertilisers and are applied to plants or soils to improve crop vigour, yields, stress tolerance, and quality. They do so by enhancing plant nutrition and soil health. Industrial biotechnology derived microbials and microbial products also work as biological crop protection products, or biocontrols, and can help farmers to protect plants from pests and diseases, including weeds. Thus, they can be used to complement, or even replace pesticides. Bioherbicides (bio-based chemical molecules used in herbicides, for example pelargonic acid) represent a valuable alternative to conventional herbicides for improving the sustainability of herbicides in agriculture. Industrial biotechnology solutions, including microorganisms and products developed using microorganisms, should be considered as part of the toolbox for improving soil health and fertility. Good soil health and nutrition is also a key part of the circular bioeconomy, in which bio-based solutions, derived from renewable feedstock and developed using industrial biotechnology, also play a role. For example, biodegradable and compostable plastics, whether bio-based or conventional, can also contribute to high-value bio-waste. Biodegradable and compostable plastics are designed for specific applications and follow specific end-of-life management processes, where they are collected separately and organically recycled with bio-waste. Bio-waste can in turn be used to produce high-quality compost and organic fertiliser that helps restore soil organic carbon, increase soil fertility, and tackle desertification. Land degradation is a recognised problem in Europe, with large territories at risk. In this regard, the maintenance and improvement of soil health, with its many associated co-benefits, such as climate resilient agriculture, enhanced biodiversity, and carbon farming, should be prioritised. In this context methodologies and agricultural practices that increase soil organic matter content (e.g., incorporation of cover crops, expansion of crop rotations and conservation tillage or no till soil preparation techniques) should be implemented and encouraged. At the same time, it is important to foster, promote and fund the development of new innovations (e.g., new genomic techniques). Enabling regulatory frameworks for innovative solutions will support the delivery of EU green ambitions, promote innovation and foster growth. Policy initiatives linked to soil health should consider the role that bio-based solutions developed by industrial biotechnology can play in improving soil health and increasing soil carbon sequestration.
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Response to Amendment of Annex II of Regulation (EC) No 1107/2009 to specify approval criteria for microbial active substances

23 Nov 2021

EuropaBio supports the ambition for increased sustainability of the EU food system and welcomes the Commission’s aim to facilitating the placing on the market of biological active substances such as microorganisms in order to reduce dependency on chemical pesticides. Microbials can work as biological crop production products, or biocontrols, and can help farmers to protect plants from pests and diseases, including weeds. Thus, they can be used to complement, or even replace pesticides. There is therefore significant potential for biocontrol to contribute towards Farm to Fork goals on reducing pesticide use, although we note some concerns regarding regulatory barriers for biocontrol. Timelines for biocontrol approvals are extensive (currently ranging from 6-12 years), resulting in a delay for new innovative solutions reaching the market. The updated regulations should be further supported by efforts dealing with the approval timelines across Member States. More specifically, it is important that the EU further builds up the microbial competences and have dedicated resources at Member State level for handling microbial dossiers. In addition, the revised regulations need to be supported by a targeted action to address the insufficient number of microbial experts in the Member States responsible for handling dossiers. Finally, we consider that sustainability in food systems should focus on the entire sustainability footprint of a product and needs to be supported by the best available solutions. While there are no silver bullets, all technologies including both established and cutting-edge techniques like new genomic techniques should be considered as part of the toolbox available to food chain actors. In this regard we welcome the Commission’s intention to pursue a legislative initiative for plants developed using new genomic techniques but at the same time we encourage the Commission to broaden the scope of its actions to also include microorganisms.
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Response to Policy framework on biobased, biodegradable and compostable plastics

27 Oct 2021

EuropaBio appreciates the opportunity to comment on the roadmap on a policy framework on biobased, biodegradable, and compostable plastics. Biobased plastics (BBP) and biodegradable and compostable plastics (BDCP) can contribute to replacing fossil carbon-based products as well as improved management of plastic already on the market whilst creating jobs, growth and competitiveness and creating value along an increasing number of biobased value chains within a circular bioeconomy. Policy under the EU Green Deal should be developed in such a way that it enables further innovation in the bioeconomy sectors. If designed and implemented appropriately, a policy framework for BBP and BDCP could help contribute to driving innovation and sustainable development of the bioplastics industry whilst also promoting a broader range of new biomaterials which equally can replace plastics – all whilst supporting the transition to a circular bioeconomy as part of EU Green Deal ambitions. We consider it important that such a policy framework acknowledges these sectors for the important source of growth in the development of innovative products that they represent, and that it does not create biases against their introduction. Consistency and coherence with other policy instruments touching upon these sectors is also key (EU Taxonomy, the RED III, Sustainable Products Initiative, Product environment Footprint). More specifically, increased use of BBP would also contribute solutions towards the growing need to decrease dependence on, and extraction of, fossil carbon resources while bringing additional benefits such as reduced CO2 emissions from plastics production and sequestering atmospheric carbon. We regret that the roadmap states that the benefits of BBP should “go beyond reducing fossil carbon use” when the same is not required of other renewable sectors e.g., wind, solar, tidal, etc. The potential for BBP to contribute towards climate neutrality should not be unfairly valued. BBP can be mechanically and chemically recycled in an efficient way. BDCP are designed for specific applications and follow specific end-of-life management where they are collected separately and organically recycled with biowaste. Mechanical, organic, and chemical recycling are all necessary, are interdependent, and should be equally promoted. It is important to note that while certain applications of BDCP are uniquely well suited to help with the recovery and organic recycling of biowaste, we consider that policy should not be prescriptive on applications for BBP and BDCP. Such legislation would likely hamper and limit future research and innovation in beneficial resource-efficient products (including in EU-funded projects). Standards can help remove uncertainties and provide a sound basis for new products to be introduced into the market, thereby accelerating market entries and uptake as well as overcoming barriers caused by unclear or incompatible specifications. Standards and labelling are important for the functioning of the internal market and can provide the basis for certification and labels which, in turn, can stimulate consumer awareness, uptake and public procurement. In light of the forthcoming policy initiative, the range of standards for BBP and BDCP already available should be duly noted and taken into consideration. Among other actions, CEN’s Technical Committee 411 has, based on a Commission mandate under its Lead Markets initiative for biobased products, developed a set of standards for biobased products, covering horizontal aspects which are relevant to consider when developing policy frameworks linked to biobased products (1). BBP, BDCP and more broadly biomaterials can provide crucial innovative solutions for the development of a circular bioeconomy and an expanded policy framework for these should contribute to driving innovation and sustainable development of the industry. (1) See e.g. https://www.nen.nl/media/PDF/IG_Biobased_product.pdf
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Response to Sustainable food system – setting up an EU framework

26 Oct 2021

EuropaBio supports the ambition for a sustainable EU and global food system, as enhanced sustainability in the food chain can benefit both people and planet. This initiative, as with all new EU initiatives addressing sustainability, should consider the three pillars of sustainability: economic, environmental, and social. Rather than commenting in detail on the policy options that will be part of the impact assessment at this stage, we would like to comment on some more specific items included within the roadmap: In terms of the sustainability assessment of products to be placed on the market, we consider that all products should be assessed equally. Assessment of products to be placed on the market should remain science- and risk-based, with any new sustainability requirements ideally falling into existing informational requirements for approval and assessment to avoid increasing the administrative burden on food chain actors. The roadmap also outlines the possibility of developing sustainability labelling for consumer information and to support market pull for sustainable products. We note that any labelling developed for the purpose of informing consumers regarding sustainability criteria should be informative and standardized, similar to current labelling norms around allergen presence and nutritional information. This would also enhance transparency for the consumer by preventing (or reducing) the use of sustainability terms used as subjective marketing terms. Labelling should be meaningful and truthful. The bioeconomy sectors have important roles to play in contributing towards sustainable food systems, improving industrial efficiencies and reducing food waste. As part of this, we consider that sustainability in food systems should focus on the entire sustainability footprint of a product and needs to be supported by the best available solutions, and not on the process used to make them. While there are no silver bullets, all technologies including both established and cutting-edge techniques like new genomic techniques should be considered as part of the toolbox available to food chain actors. In this regard we welcome the Commission’s intention to pursue a legislative initiative for plants developed using new genomic techniques but at the same time we encourage the Commission to broaden the scope of its actions to also include microorganisms Finally, we would like to emphasize that biorefineries are key as they valorise every component of renewable feedstock to produce a wide range of products and ingredients for food and feed, amongst other sectors. They significantly contribute to the principles of a circular bioeconomy and move towards a ‘zero waste’ society.
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Response to Restoring sustainable carbon cycles

4 Oct 2021

EuropaBio appreciates the opportunity to comment on the roadmap on restoring sustainable carbon cycles. Europe’s goal to become the first climate-neutral continent will rely on reducing overall EU greenhouse gas emissions and further transition from fossil carbon to renewable carbon. We appreciate the focus on sustainable carbon cycles, rather than decarbonization: as the roadmap notes, carbon feedstock will still be needed in 2050 and beyond to produce sustainable fuels, plastics, chemicals, materials, and food. We note that the roadmap places equal emphasis on technological and nature-based solutions and welcome the inclusion of recycling carbon from biomass and waste to replace fossil carbon. A vibrant EU bioeconomy will be a key component contributing towards sustainable carbon cycles. By storing and utilizing carbon dioxide and replacing carbon intensive fossil-based resources, sustainably sourced renewable materials offer a key opportunity to contribute towards achieving Europe’s climate ambitions. The bioeconomy optimizes land use and food security through a sustainable, resource-efficient, and largely waste-free utilisation of Europe’s renewable raw materials, thereby contributing significantly to a circular economy with reduced dependence on fossil resources. In this context, it is also worth noting that when biomass is used for making longer life-span products, the carbon dioxide absorbed from the atmosphere is stored in those products for the long-term. We consider that this forthcoming Communication should reflect the critical importance of integrating bioeconomy considerations throughout relevant EU policies within the EU Green Deal, such as the Circular Economy Action Plan and the Farm to Fork strategy. In addition, the 2018 Bioeconomy Strategy should also be fully implemented to support the goals of this initiative as relevant and applicable (we note the public consultation on the stock take and future development of the Bioeconomy Strategy held earlier this year). As global challenges become increasingly pressing, so does the need to prioritise and invest in innovative solutions from the bioeconomy sectors. This includes cutting-edge technologies like industrial biotechnology and tools such as genome editing and new genomic techniques. Enabling efficient use of renewable feedstocks would support climate mitigation and contribute towards achieving the ambitions of the EU Green Deal.
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Response to European Bioeconomy Policy: Stocktaking and future developments

26 Aug 2021

EuropaBio supports an ambitious implementation of the updated 2018 EU Bioeconomy Strategy and welcomes the activity to assess the progress of the Strategy and the 14 actions outlined therein. In the bioeconomy, land use and food security are optimised through a sustainable, resource-efficient, and largely waste-free utilisation of Europe’s renewable raw materials, thereby contributing significantly to a circular economy with reduced dependence on fossil resources. It also plays an important role in boosting Europe’s competitiveness by revitalising rural areas, thus providing jobs and growth over the coming decades. Progress in the development of a bio-based economy has been supported by increases in EU R&I funds through e.g., the Bio-based Industries Joint Undertaking (BBI JU), which attracted investments, spurred innovation, and created new value chains. The importance of research and innovation in the bioeconomy was reemphasized in the 2018 Bioeconomy Strategy and is now demonstrated through the continuation of a dedicated institutional partnership, the Circular Bio-Based Europe Joint Undertaking, as well as through the Horizon Europe Cluster 6 on Food, Bioeconomy, Natural Resources, Agriculture and Environment. There is also clear potential to further stimulate market uptake of bio-based products. Visibility and awareness of bio-based products and their benefits should be promoted to drive demand. The EU could also integrate references to bio-based content in green and public procurement actions. The EU policy landscape has changed since the publication of the Bioeconomy Strategy in 2018, most notably through the European Green Deal and its many associated strategies. There are synergies between the Bioeconomy Strategy and various Green Deal initiatives including the Circular Economy Action Plan, the Farm to Fork strategy, the Biodiversity Strategy, and the Industrial Strategy. It is critical to integrate the bioeconomy throughout relevant EU policies and to reinforce the interplay between key EU strategies to achieve the goals set out in the Bioeconomy Strategy as well as the overall European Green Deal ambitions. All facets of the bioeconomy, also including the blue bioeconomy, should be considered and built upon. An innovation-driven bioeconomy, with increased sustainability as its end goal, can provide renewability, circularity and multifunctionality, whilst helping to deliver solutions to the UN SDGs and European Green Deal ambitions. Within the bioeconomy, industrial biotechnology plays a central role as an enabling technology, harnessing the power of microbes for industrial and manufacturing applications to develop a wide variety of bio-based chemicals, materials, pharmaceuticals, food, feed, and fuels. This helps reduce CO2 emissions, provide sustainable alternatives to fossil-based products, improve resource efficiency of industrial processes, and deliver solutions to help improve health and nutrition. Industrial biotechnology is also recognized as a central pillar of innovation in Europe and is established as one of Europe’s Key Enabling Technologies (KETs), including in the recent Staff Working Document on strategic dependencies and capacities published as part of the update to the 2020 EU Industrial Strategy. As global challenges become increasingly pressing, so does the need to prioritise and invest in innovative, enabling solutions from the bioeconomy sectors and cutting-edge technologies like industrial biotechnology. Also, to engage decision makers and stakeholders from the fields of agriculture, regional policy, environment, industry, climate, trade, energy and research and innovation, amongst other sectors, to speed up the implementation of the bioeconomy, which in turn contributes to equipping the EU to deliver concrete results on Green Deal ambitions.
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Response to Evaluation and revision of the general pharmaceutical legislation

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 illnesses. Targeted cell and gene therapies and new mRNA platforms are paving the way for future treatments. COVID-19 has shown that only science-based and high-risk research embedded in a strong life science industry ecosystem can bring the lasting solutions to health challenges. The first aim of the Commission initiative should be to regain EU’s global leadership as a home for R&D and a cutting-edge industry to secure high-quality and affordable care for citizens. Improved access to accelerated innovation, long-term vision for the healthcare ecosystem and better coordination among Member States will enable us to respond effectively to future health threats. We caution against the current temptation to use the regulatory tools designed for medicines authorization to address availability issues that are clearly within the remit of Member States. Ensure access to affordable medicines While equal access across the EU is a shared goal, we believe that measures which link incentives with placing medicines on markets will not deliver this goal but may yield unintended consequences. Updating guidance, utilising soft law policy instruments instead of legislative change should be considered to enhance access of medicines and ensure security of supply. Through simplifying processes across Member States access and availability of medicines can be improved. No patient should be left behind or prioritised over another. We caution against defining unmet need too narrowly. Conditions with no treatment and those with insufficient treatments where quality of life can be improved should be both prioritised. Enable innovation for quality, safe, effective medicines The EU biotech sector, mostly made up of SMEs, relies on robust IP and targeted incentives that enable companies to raise risk capital, with the prospect of remaining unprofitable for years. It is due to these set of incentives that the EU has retained its capability to produce breakthrough innovation. To keep pace with the rest of the world, future incentives should reflect the economic challenges of developing health innovation. The uptake of digital tools not only improves R&D, but also optimises diagnostics and treatments, while increasing cost-effectiveness of healthcare systems. An appropriate legislative framework is needed to ensure common EU standards for the collection, interoperability, access and use of data. Enhance the security of medicine supply EuropaBio supports this objective. Working with manufacturers to ensure supply mechanisms are robust and secure is an effective and expedient option. Reduce regulatory burden There is need for EU regulatory processes which are easy to navigate, swifter and up to date with science and technology to truly support innovation. Expedited regulatory pathways proved effective in accelerating COVID-19 products. These should be refined based on COVID-19 learnings for application in critical areas of unmet needs. Simplification and acceleration of the GMO assessment process through an exemption scheme by law for clinical trials with ATMPs will increase Europe’s attractiveness. A flexible PRIME scheme with earlier access, capacity to provide rapid scientific advice and regulatory input would accelerate innovation. Fit-for-purpose RWE for regulatory benefit-risk assessment should be accepted to drive clinical development. Decentralised and single-arm clinical trials offer a patient-centric approach and could speed up access to novel technologies. This result of this review is critical to the growth of the EU biotech industry and the health of European patients. EuropaBio is eager to work with the Commission to achieve an innovation supportive outcome.
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Response to Conditions for derogation from mandatory accreditation of official laboratories

16 Apr 2021

EuropaBio appreciates the opportunity to comment on the delegated regulation. It is important for us to highlight the importance and responsibility of the European Union reference laboratories in sampling and analysis for the official control of feed/food as regards presence of genetically modified material. According to recital 72 of Regulation (EU) 2017/625, the European Union reference laboratory for genetically modified food and feed and the European Union reference laboratory for feed additives are responsible to fulfill the purposes of Regulation (EC) No 1829/2003 and of Regulation (EC) No 1831/2003. Moreover, in Article 93, point 5 of Regulation (EU) 2017/625 is written: ”By way of derogation from paragraphs 1 and 2 of this Article, the laboratories referred to in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of the Article 21 of Regulation (EC) No 1831/2003 shall be the European Union reference laboratories having the responsibilities and performing the tasks referred to in Article 94 of this Regulation in the areas respectively of: (a) GMOs and genetically modified food and feed; and (b) feed additives.” Our understanding is that the PCR analysis on recombinant DNA in conjunction with Regulations (EC) No 1829/2003 and 1831/2003 is the responsibility and the task of the European Union reference laboratories and that the transfer to other laboratories should not be allowed and not covered by this delegated regulation.
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Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

4 Mar 2021 · New Europa Bio Director-General Dr. Claire Skentelbery, and new Chair of the Board Andrew Topen, wish to introduce themselves to Director-General Kerstin Jorna and hear DG GROW’s priorities, to see where EuropaBio could potentially assist.

Response to European Health Emergency Response Authority

24 Feb 2021

1. Introduction: Hera has a critical role to play in public health and better crisis preparedness to address cross-border health threats and improving crisis management capacity. It should learn lessons from ongoing initiatives world-wide, including BARDA and collaborate where suitable with wider international partners. It should be autonomous in decision-making, risk-taking, be allowed to fail given the nature of its investments and well-funded to address the long-term challenges. Its scope of responsibilities should start with pandemics and AMR to allow it to grow robustly and effectively. An appropriate governance structure should allow for transparency of decisions, flexibility of operation, speed of implementation and sustainability of operation. 2. Enabling an agile ecosystem: Policy, framework and society: Health challenges will be tackled by working together across borders with increased coordination at EU level. Within Covid the strength of European science was evident, with the biotechnology industry joining forces to deliver vaccines in unprecedented speed. Implementation will depend on clear division of competences between the EU and the Member States, good governance, and clarification of the future role of the Health Security Committee and the European agencies. A policy environment that understands the high attrition rate of biotechnology R&D is critical, with policy makers and funding providers within an enabling framework. This extends to IP rights, where short term restrictions may impact long term investment and prevent technology maturation. 3. Mapping resources and risks: Harmonised mapping of European landscape is needed, as many assets are already identified but often fragmented. Europe has the tools to respond in the short term e.g. production of hand gel to long term production and completion of vaccines. Public and private capabilities should be mapped that could respond to coordinated European actions. HERA should take on a catalysing and coordinating role monitoring health threats and addressing them by connecting the dots of the current ecosystem and stimulating set-up of additional needs in R&D and production in collaboration with public and private partners. Hera should remediate structural gaps in the EU’s health preparedness and response capacities. 4. Stimulating research, discovery and development: Hera initiatives should include further stimulation of bioscientific research, rapid patient access and uptake of innovative treatments in Europe in the future. Creating the right incentives and rewarding innovation is critical to recovering European leadership position in life sciences. There is a need to invest in technology platforms that aim at providing broad responses to emerging pathogens. The example from Moderna and BioNTech shows that only a long-term effort can pay off. EuropaBio encourages a holistic approach in its preparatory work for HERA by engaging with all stakeholders from science, academia, clinical research networks, industry and citizens. 5. Funding: The ability to respond quickly and at scale requires sufficient funding appropriated in advance, in both public and private spaces. HERA needs to be structured to maintain long-term effort and investment decisions, regardless of threat level from health risks. If Europe is to have local innovative companies with R&D and manufacturing capabilities that provide the ability to respond to health emergencies, we need to have the ability to fund them in Europe. 6. Supporting scale up and production: Public financing has been critical in supporting companies to run in parallel R&D and ramping up production capabilities allowing them to be ready to distribute vaccines much faster than what would normally be expected. EuropaBio is looking forward to actively participating in the discussions around the role and extended mandates of the HERA proposal in 2021.
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Response to A European Health Data Space

3 Feb 2021

EuropaBio welcomes the EC's plan to begin a discussion with stakeholders to develop the EHDS. Science is evolving fast and digital tools are accelerating our ability to conduct research. For the biotechnology industry, it is imperative quality data sets are collected and analysed, while protecting privacy and maintaining trust in how the data are used. This initiative is an opportunity to accelerate innovations that will optimise diagnostic and treatments, while increasing cost-effectiveness of healthcare systems. The EC should work with the MSs to develop/harmonise the infrastructures required to make this feasible. While the EHDS would enable sharing data among research organizations within the EU, this should not distract from also developing ways to effectively share such data with research organizations internationally. The success of the EHDS should be measured on its capacity to increase the competitiveness in the EU health sector and to create health innovations to the benefit of researchers, healthcare professionals and citizens. Objective 1: Ensuring access, sharing and use of health data for healthcare delivery purposes Access/exchange of health data for research, including secondary use health data, is today too limited in the EU. EuropaBio supports the intention to reduce fragmentation of legislation through introducing a governance framework to clarify the rules across the EU with regards to collecting, accessing, and analysing health data. As a research-based industry with a history of handling patient data, access to such quality data would accelerate the sector’s ability to develop innovations in diagnostics and therapeutics. Interoperable data infrastructures should be developed. The value of such a network lies in the participation of all MSs and their ability to create such infrastructures. It will be equally important that all MSs, supported by the EC, maintain these to a common standard, including through appropriate funding mechanisms and sharing of relevant expertise. It will also be important to ensure local HCPs, as a key part of the system, are also trained on the harmonised system for entering and reading the data. Furthermore, patient trust in sharing their data is key to the success of any initiative to harness data for healthcare purposes and research. Citizens must be assured their data is protected and only used for purposes within the principle of data altruism. Patients should remain owners of their data, and research entities should remain the owners of the data resulting from their research. Objective 2: Fostering a genuine single market in digital health covering digital health services Digital health services are an essential part of the Digital Single Market. Improved access to digital health services and products, including tele-health and mHealth, have the potential to greatly improve access to healthcare and patient ability to manage their own health. Other key initiatives, such as cross-border healthcare, are enabled by such digital infrastructures. Objective 3: Enhancing the development, deployment, and application of trustworthy digital health products and services, including those incorporating AI in the field of health The adoption of digital technologies in health, in particular AI, will play a critical role on how healthcare is delivered in the future. it will support process efficiencies, and help overcome staff shortages. Telemedicine can provide health expertise to remote areas of the EU, which may be distant from specialised HCPs or centres of excellence but can also serve in situations of emergency and, in general, simplify patients’ lives by avoiding unnecessary movements, speed up time to diagnoses and make available expertise. In conclusion, EuropaBio is ready to serve as a constructive partner in exploring all options and co-designing a framework to ensure we can harness the data revolution in the interest of citizens, society, and the economy.
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Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

Developing medicines for children and rare diseases is a lengthy and complex undertaking. Much less is known about these illnesses when compared to more common conditions, meaning extensive research is required before scientists and researchers can seek to transform their ideas into potential treatments. Funding to conduct such research is vital for biotech companies, especially SMEs, to bring their investigational therapies to life. These companies need to make a very strong case to convince potential investors to incur the high economic risk of early-stage research and lengthy therapeutic development timelines, particularly when the number of patients is limited, and the condition is difficult to characterise. The study to support the evaluation of the EU Orphan Regulation reveals that 86% of turnover levels for orphan medicines are below €100m in Europe with an average annual turnover (2008-2016) of €56m, showing that financial barriers to development still exist. Since 2000, the number of medicines in development for rare conditions has increased consistently with over 2000 medicines for rare diseases in development by the end of 2020. Regarding the development of paediatric medicines, the EC’s 10-year report found that between 2007–2016, over 260 new medicines for use by children were authorised. For these reasons, EuropaBio believes that any evaluation of the EU legislation on medicines for children and rare diseases should have, at its heart, the goal to build on the current success of the existing legislation and to encourage further investment in rare diseases in order to increase and accelerate innovation. Unmet medical need should not exclude areas where treatment is available but encompass areas where patients still need better outcomes. For paediatric indications, it is unrealistic to assume that only rewarding research in unmet need would attract more R&D effort. On the contrary, the evaluation as proposed could lead to more obligations for limited rewards. Lowering prevalence criteria, eroding market exclusivity, limiting access to the Orphan Designation, or reducing the possibility to develop medicines in multiple indications, will complicate biotech companies’ efforts to attract long term investments. It will only increase the attractivity of other regions in the world for R&D. Similarly, linking rewards to market launch requirements will be counterproductive. Instead, the EC should fully focus on potentially viable incentives for encouraging further research and making the EU a future leading region in the development of medicines for children and rare conditions. Extending the EMA’s PRIME scheme to orphans, increasing the access and dialogue to EMA early advices in particular for SMEs, introducing additional regulatory flexibility or developing public-private partnerships targeting areas of specific relevance could be explored. In general, the orphan market is small, it is only innovation, and not biosimilars/generics, that will create the treatments needed in the future. EuropaBio understands there are concerns regarding the differences in availability of certain medicines among the EU Member States. These concerns are often the result of fragmented data requirements, reimbursement processes, and bureaucratic timelines, which fall mostly within the national competence. These concerns can, and must, be addressed without jeopardising EU legislation that successfully encourages research into these conditions of unmet need. Trying to address these access issues through a weakening of a carefully crafted European incentives system could ultimately have the opposite effect to the objective sought for. In conclusion, EuropaBio encourages a discussion with all stakeholders, comprised of public officials, patients, regulators, payers, and industry, to address the fragmented access pathways for innovative therapies among the EU Member States and discuss how processes could be streamlined or accelerated
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Response to Climate change mitigation and adaptation taxonomy

17 Dec 2020

EuropaBio supports the Commission’s intent in developing sustainable financing as part of the Green Deal. However, we believe that the publication of the first draft delegated act and its annexes poses a serious threat to the bioeconomy and its ability to contribute towards climate change mitigation and adaptation, specifically by excluding food and feed crops from the manufacture of bio-based products and ingredients. Food and feed must primarily serve food security but should also be available for other bio-based products. The bioeconomy can play a significant role in contributing to Green Deal objectives. Use of bio-based products can help accelerate the shift towards a greener economy, creating jobs and growth, and reducing dependence on fossil-based carbon and CO2 emissions. Excluding food and feed crops from sustainable finance schemes would fail to acknowledge such benefits and threaten to hinder the development of parts of the bioeconomy. Food and feed crops are the most established agricultural commodity chains globally, presenting the highest cost competitiveness as well as year-round availability and reliable sourcing. Developing the bioeconomy requires building on these global commodity streams. 1. Sustainable sourcing of biomass EuropaBio fully supports the sustainable sourcing of biomass, taking food security, land use and biodiversity loss into account. Biomass is a valuable resource, and many parameters need to be considered when assessing its use. In many cases, there is complementarity between food and non-food uses of biomass. Restricting the use of feedstocks usable in the bioeconomy would drastically limit the availability of biologically accessible materials, preventing the synthesis of value-added products. This indicates that the exclusion of food & feed crops does not necessarily enhance the sustainability of the bioeconomy. Focus should rather be on setting and enforcing criteria for the sustainable sourcing of biomass. For instance, Annex I of the draft delegated act provides recommendations to protect non-agricultural land with high carbon stock from land use change. Similar provisions could be considered for the recommendations on food or feed crops. 2. Considering all three pillars of sustainability In addition to the environmental pillar, the social and economic pillars of sustainability should also be considered. The use of food and feed crops for biomass contributes to the sustainability of farms by ensuring farmers' income and the continued production of food crops. All outlets of the bioeconomy are instrumental in preserving the competitiveness of its industries and their suppliers. Restricting the use of renewable raw materials puts the value chain at stake. 3. Cohesive policymaking The draft delegated act is intended to supplement Regulation 2020/852, which provides several requirements for technical screening criteria (Article 19). The criteria outlined in the draft delegated act are not fully in line with requirements around conclusive scientific evidence and assessment of the potential market impacts of the transition to a more sustainable economy. Also, we note inconsistencies between the consequences of the draft delegated act as it currently reads and EU statements/policies, e.g. the Commission’s long-term strategy for decarbonisation; the new CEAP and the Bioeconomy Strategy. Bio-based solutions are based on currently available technologies and feedstocks. Limiting these will also limit the opportunity to deliver sustainable solutions to the EU green transformation. On this basis, EuropaBio would support a more inclusive view of feedstocks eligible for sustainable financing mechanisms, by for instance taking into consideration sustainable sourcing rather than simply limiting feedstocks (see Annex 1 attached). This approach would promote the future innovation and investment in the bioeconomy and in doing so assist in the gradual further transition towards alternative feedstocks.
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Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides)

24 Sept 2020 · Exchange of views on the upcoming pharmaceutical strategy

Response to Intellectual Property Action Plan

12 Aug 2020

Life sciences and biotechnology drive strategic innovations in key industrial ecosystems – e.g. health, low-carbon and agri-food. These innovations would not be without a robust IP framework to encourage investments in high-risk research and diversified product development. Maintaining the criticality of IP for innovation requires policy coherence. In health, the ongoing “Incentives Review” must recognise IP as the main driver for innovation and not misidentify IP as a barrier to patient access. Enable unitary patents The EU biotechnology ecosystem is confronted with high costs of patenting, while competing with other high-tech regions (US, Japan, China). Enabling the unitary patent system to mitigate the patent cost hurdle will bring to market more innovative products. The Unitary Patent necessitates a timely, stable and uniform application, and all Member States using it. SPCs A Unitary SPC would reduce internal time and resources for SPC filings in each Member State. It would facilitate a consistent interpretation of the SPC Regulation and provide harmonisation in granting procedures by one authority and in appeal decisions in one court. It would ensure consistent and predictable decision-making if relying on examination guidelines, which should build on the recent case law. Despite the implementation challenges, a virtual granting authority of experts from NPOs and a virtual work-sharing platform with its decisions challengeable at the UPC is a way forward. We support a Single Grant Mechanism if certain essential elements are ensured - identifying a suitable, appeal structure; and propose a Single Application Portal to work seamlessly alongside national SPC grants. Better IP uptake for SMEs A survey of 190 venture capital-seeking biotech companies showed that having at least one patent application filed reduced the time period to the first VC investment by 76% (Discussion Paper No. 09-003, To Be Financed or Not: The Role of Patents for Venture Capital Financing). Biotechnology SMEs are particularly likely to struggle with high patent costs in the fragmented EU and post-COVID19. The risks include bankruptcy or filings elsewhere, missing out on the benefits for society. SMEs need special incentives for the creation, registration, and use of IP assets, e.g. fast-track registration procedures, reduced filing fees, centralised advice, and technical assistance. IP & data sharing There are various examples of successful data sharing obligations and voluntary initiatives, e.g. IMI 'Big Data for Better Outcomes' program or the ClinicalStudyDataRequest.com. Biopharmaceutical companies have been operating satisfactorily with contractual and technical measures. Looking forward, the adequacy of the existing legal framework for a data-agile economy, incl. a Health Data Space, should be evaluated. In particular, the development of robust voluntary data sharing competition exemptions and appropriate incentives should be explored with stakeholders, incl. EuropaBio. IP availability in crisis In response to COVID-19, our industry has been collaborating broadly to develop quicker than ever more than 1000 potential treatments and vaccines. Products, knowledge and research capacity developed over many years relying on robust IP were the foundation for this unprecedented response. IP will continue to play a crucial role long after this pandemic to ensure preparedness with innovative solutions for pressing healthcare needs. Global fair play Our industry often finds itself the target of discriminatory localisation measures, which have serious consequences for its ability to operate in key markets, esp. for SMEs. Robust IP protection and enforcement is critical to incentivising investments in innovative industries and should be at the core of an ambitious EU trade policy. Digitalisation is a key opportunity for the EU to become a trusted global leader. The EU needs to coordinate with relevant organisations (WIPO) to develop specific rules on AI.
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Response to Communication on the future of research and innovation and the European Research Area

31 Jul 2020

EuropaBio commends the Commission's initiative to revitalise the European Research Area (ERA). European R&I ecosystems are currently at the fore of the political agenda and now is the time to build upon the advances already initiated by the ERA. Over the past 25 years, the ERA has positively contributed to the development of the European biotechnology ecosystem. EuropaBio believes breakthrough R&I in biotechnology will help achieve the goals of the Green Deal and related strategies, delivering a healthier and more sustainable European society; biotechnology is a core industry and can provide innovative solutions to the ecological, social, and economic transitions facing Europe. Here we draw on three policy recommendations from EuropaBio's vision document, "Unleashing the full potential of life sciences and biotechnology in Europe", relevant to R&D and Innovation: Communicating R&D Innovation: We believe the ERA needs to place the public at the centre of communications policy. To contribute to building public trust in science, all institutions and authorities should actively reject misinformation around GMOs, chemicals, vaccines, and other innovations scientifically proven to be safe and effective. Coupled with this, ERA strategies that champion researchers and scientists should be promoted, offering them a true voice on the complexities of R&I. Addressing Regulatory Barriers to R&D and Innovation: EuropaBio believes the Innovation Principle, which centralises the need for legislation to support innovation, should be mainstreamed as part of the better regulation process. Integral to the future ERA vision, the Innovation Principle should guarantee sustainable development, R&I investment, and the growth of start-ups in the EU single market. Responsible Research and Innovation should be promoted, bringing stakeholders together ensuring the legitimacy of breakthrough innovation at the societal level. Skills and Labour: EuropaBio recommends the creation of EU-wide indicators to identify best practices for integrating and promoting STEM subjects in national and regional early-year education curricula. Collaboration between industry and academic research should be enhanced. Member States should offer tailored educational programmes to equip tomorrow's workforce with the necessary skills for a thriving European life sciences and biotechnology sector. Furthermore, we call for a wider implementation of Action 2.4 of the 2018 Bioeconomy Strategy, which seeks to promote education, training and skills across the bioeconomy, and for it to apply to health and agriculture. To support the development of a new transformative vision for the ERA, we invite you to read our attached vision document in full. We identify policy recommendations across eight key areas we believe will help achieve a healthier and more sustainable Europe, that swiftly recovers from the COVID-19 pandemic and delivers for its citizens, its regions, and its economy. These areas are capital and financing, skills and labour, R&D and innovation, intellectual property and incentives, manufacturing, digitalisation, regional development and global competitiveness. The ERA should be empowered to guarantee proper utilisation of European R&I for the betterment of citizens. A strong ERA can impact on the creation of highly skilled jobs and support quality education which are necessary to ensure Europe regains its footing as a globally competitive world-class R&I environment. We firmly believe that unleashing the full potential of biotechnology is fundamental to finding new solutions to the global challenges facing Europe in health and ageing, climate change, food supply, digital, and industrial transformations, sustainable economic, environmental, and societal development.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

EuropaBio sees the Pharmaceutical Strategy as a crucial chance to strengthen the EU life sciences & biotechnology ecosystem; protecting citizens’ health and enhancing EU’s competitiveness vs US and China. COVID-19 has revealed the critical role of innovation in dealing with health emergencies. Of utmost importance is nurturing the bio-science sector and stimulating innovation to meet patient needs. The research-based biotechnology industry is a core EU industrial sector. EuropaBio calls on the Commission to align its Pharma Strategy with the Industrial Strategy. Within the existing regulatory framework, all objectives of the Roadmap can be achieved. Increased collaboration of EU, Member States, public and private stakeholders will create solutions for value-based innovations. Access & availability -Improved access to new treatments (ATMPs, OMPs) should be prioritised. A series of challenges relating to HTA and reimbursement must be overcome. -R&D of novel biotherapeutics requires streamlined regulatory processes: rapid centralised scientific advice procedures, continuous dialogue and re-evaluation for additional requirements, e.g. GMO. Flexible regulatory pathways used for COVID-19 medicines should be applicable to better address unmet medical needs: faster approval, rolling reviews, labelling flexibility, increased interactions with regulators. -The OMP legislation increased investors’ interest in biotechnology but more supportive measures are vitally important to drive future medicine development for rare diseases. Its framework should be preserved as only 5% of existing rare diseases have a treatment available. -The definition of unmet need should better incorporate the needs of patients. Affordability & health systems sustainability -Affordability measures should be balanced against the need for both sustainable health systems and a viable, competitive biotechnology ecosystem. -Cost-effectiveness or therapeutic value should be considered through systematic patient feedback to fill evidence generation gaps (ATMPs). -Early interaction between health authorities, HTA bodies and payers along with evidence generation in consultation with these stakeholders can lead to better access. -Financial schemes or performance-based agreements should be considered. -Procurement through the Most Economically Advantageous Tender (MEAT) can be useful in exceptional cases of cross-border threats. It remains undesirable if used only for cost containment. Innovation for unmet needs via digital & emerging technologies -IP & incentives are critical to encourage long-term investments in high-risk, complex research & diversified product development (ATMPs, OMPs). Access to capital remains a challenge when compared to the US and China. Caveating incentives or building in conditionalities will not increase patient access and will jeopardise European research competitiveness. -The EU needs a strong collaborative network involving EMA and national agencies with sufficient resources and the right expertise to anticipate increasing complexities linked with breakthrough innovation. -Consideration should be given for continued use of non-legislative approaches to emerging technology which have proven effective in responding to COVID-19. -Timely access to standardised data sets and streamlined GDPR implementation will enhance data use for cross-border scientific collaboration. -High-quality RWD & AI must be harnessed as part of the planned EU Health Data Space. RWE should be supported by EU-wide measures. EU competitiveness & less dependence on non-EU manufacturing -Flexibility and funding must be improved for innovative biotechnology SMEs. -Supply chains of innovative treatments are global by necessity. A strategic approach to support innovative manufacturing in the EU will ensure reliable supply and create high-skilled jobs for the future. Long-term investment is key to create a competitive and innovative EU life sciences & biotechnology ecosystem.
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Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

23 Jun 2020 · EuropaBio raises their concerns on the industrial strategy should inform the recovery; how industrial biotechnology and life science contribute to the Green Deal, competitiveness of industrial value chains and global level playing field

Response to Chemicals strategy for sustainability

19 Jun 2020

EuropaBio welcomes the commitment to adopt a Chemicals Strategy for Sustainability to protect citizens and the environment better against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives. Industrial biotechnology is a central pillar of innovation in Europe and a Key Enabling Technology (KET). Biotechnology enables a variety of products and applications like: • Production of bio-based chemicals by using renewable sources instead of fossil sources; • Efficient processes that save fossil resources, by reducing input of those, helping overall to reduce GHG emissions; • Microorganisms improved to enable the production of chemical building blocks which can be applied in several industries, such as textiles, paint or plastics; • Biochemical building blocks transformed into a wide range of products which are either similar or offer additional functionality compared to fossil-based products; and • Use of biomass having a very versatile chemical composition, which the chemical industry can benefit from. In view of the new Chemicals Strategy, it is important to emphasise the role that bio-based chemicals and biotechnology can play for a more circular and sustainable chemicals industry and we ask the Commission to encourage the use of bio-based and low carbon alternatives in the chemicals sector. We support the EU on its way to achieve climate neutrality by 2050 to protect the future of our planet, while creating a sustainable competitive advantage for the European industry. The EU Green Deal represents both an opportunity and a challenge: achieving climate neutrality requires the contribution of all sectors of the European economy, including the chemical sector. We welcome the strategy’s intention to promote research and development for the sustainable transformation of the chemical industry and the creation of green and sustainable manufacturing capacity in Europe. Compared to conventional chemical processes, industrial biotechnology based processes are at a less mature stage of development, thus further R&I can help further drive scalability. As a KET, industrial biotechnology is an important sector for the development of new innovative products, industrial competitiveness, jobs and growth. We take note of the Commission’s intention to simplify and strengthen the legal framework and that the regulatory framework will need to rapidly reflect scientific evidence on the risk posed by combination effects of different chemicals. It is important to ensure a science-based, but also proportionate, non-discriminatory and predictable regulatory approach with appropriate and realistic policy and regulatory requirements. It is indeed conceivable that two or more chemicals may exert synergistic effects when acting together, and that these effects would be missed if each chemical were assessed on its own. But given the huge number of chemical/natural substances, it is also not possible to test for potential effects of all possible combinations of (bio-) chemical substances.
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Response to Farm to Fork Strategy

15 Mar 2020

EuropaBio welcomes the European Commission’s intentions to accelerate the transition towards a more sustainable food system that has a neutral or positive environmental impact, is capable of adapting to and mitigating climate change and ensures food security. Biotechnology is a central pillar of innovation in Europe that can contribute to a more resource efficient, climate neutral and innovation driven knowledge-based economy that improves the health and well-being of people and planet. As a foundational matter, EuropaBio underlines the importance of using meaningful and objective indicators to set sustainability objectives and measure progress. Such indicators include greenhouse gas emissions, (efficient) land use, soil conservation, and water and energy use, as well as acidification and eutrophication potential, regardless of the farming model. With respect to the Commission’s intention to make food production more sustainable, EuropaBio considers it important to encourage the use of bio-based alternatives for sustainable crop cultivation, as well as innovation in plant breeding. Biotechnology supports sustainable crop cultivation through biostimulants and biocontrols that provide an alternative to fossil-fuel derived products. It can also provide the tools to create more sustainable food processing and more sustainable, safe, healthy and nutritional end products. The EU should adopt concrete and pragmatic measures to support the uptake and use of such bio-based products, as well as innovative feed additives that can improve animal welfare and health, air and water quality, and reduce GHG emissions. Innovation in plant breeding has the potential to bring several thousand new plant varieties to the market each year. Many of them are stronger and less dependent on inputs than older varieties and can increase yields, thereby ensuring efficient land use and carbon capture in soils. Likewise, climate change is starting to bring new pests and more extreme weather conditions, and new genomic techniques can provide much of the needed acceleration of plant breeding innovation for disease- and insect-resistant varieties. Finally, genome edited plants can bring important health and nutritional benefits such as soya for healthier food oils, coeliac friendly wheat and potatoes producing far less acrylamide when fried. These and more examples already coming on the market outside the EU can be found on the EuropaBio website here: https://www.europabio.org/cross-sector/publications/genome-editing-%E2%80%94-what-if-we-embraced-its-potential . With these many benefits in mind, EuropaBio welcomes the Commission’s ongoing initiative to assess the role of new genomic techniques and their status under Union law. A science-based, proportionate and predictable regulatory approach to current and future biotech innovation, is urgently needed if the EU wants to have these and many more solutions on its market. The Commission should also ensure that the CAP post 2020 is fit for purpose to incentivize the smart and sustainable use of biomass and encourage Member States to include concrete bioeconomy related measures in their future Strategic Plans. In addition, EuropaBio calls upon the Commission to confirm an appropriate level of funding for cutting edge clean technologies such as industrial biotech under Horizon Europe, contributing to a sustainable circular bioeconomy and delivering solutions that advance the UN SDGs. The Farm to Fork strategy can increase the contribution of innovative bio-based solutions in fostering sustainable agriculture and the bioeconomy, and empower the EU to further increase innovation, the role of new genomic techniques, sustainability and competitiveness.
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Meeting with Irena Joveva (Member of the European Parliament)

12 Feb 2020 · Bio production in Europe

Meeting with Dara Murphy (Cabinet of Commissioner Mariya Gabriel)

27 Jan 2020 · Future of European Bio Industries

Meeting with Tom Tynan (Cabinet of Commissioner Phil Hogan)

22 Jan 2020 · Business discussion

Response to A new Circular Economy Action Plan

20 Jan 2020

EuropaBio welcomes the foreseen new Circular Economy Action Plan and publish it with the Industrial Strategy. Industrial biotechnology is a central pillar of innovation in Europe and one of Europe’s KETs. It enables development of smarter, more sustainable products and processes, based on renewable raw materials, which make better use of natural resources, adding value in the process and helping to reduce GHG emissions. Europe needs strong policy signals, measures and incentives, consolidated through its circular economy strategy, in order to engage industry in the creation of smarter products, processes and partnerships. It is important to ensure the development of a coherent, holistic, supportive policy for the circular economy and for bio-based industries along the value-chain and integrate bioeconomy and circular economy throughout EU policies. Biorefineries, where industrial biotechnology helps convert renewable feedstocks (which can include municipal solid waste, agricultural and forestry waste) into everyday products, are at the centre of the circular economy. The biorefinery model has an important role to play in contributing to ‘zero waste’ objectives. It will also be important to further explore the efficient use of novel biomass and future potential wastes and residues as important resources for developing the bioeconomy. With industrial biotechnology also other materials can be recovered from organic wastes (lg. carbon or phosphates) and from sludges in biorefineries. With a view to the commercialisation of innovative bio-based products produced in biorefineries, it will be important to have ‘end of waste’ certification and standards in place. We believe that the bioeconomy should be included in the future EU Circular Economy Action Plan, since the combination of both could boost the achievement of EU ambitions in fields such as climate, resource efficiency and waste. Bio-based plastics, produced from biomass, help to decrease our dependence on fossil carbon resources and can offer significant CO2 emissions savings. Biodegradable and compostable plastics are designed for specific applications where recycling is not an option when for example items are soiled, and can also offer a key advantage when it comes to the logistics of bio-waste recycling from households. According to the revised Waste Framework Directive, separate collection of bio-waste will be mandatory by end 2023, and thus it is expected that there will be more waste to be efficiently processed or recycled organically, thanks to home or industrial composting systems. However, we are concerned the generic definition of "biodegradable" can be confusing. Currently, Directive 94/62/EC established the principle of ‘organic recycling’, which makes use of biodegradability of packaging. However, in points 3c and 3d of Annex II with the definitions of essential requirements a differentiation is made between recoverable packaging in the form of compost (3c) and biodegradable packaging (3d), which can generate the erroneous idea that ‘biodegradable packaging’ is different from ‘compostable packaging’. The corresponding harmonised standard EN 13432 requires conformity to the essential requirements for packaging with regard to biodegradable packaging recoverable in the form of compost in accordance with the European Directive. Therefore, clear definitions in the legislation are important. In relation to forthcoming initiatives on packaging and waste, we believe that the benefits of using renewable resources for the manufacturing of packaging should also be reflected and equally promoted compared to recycled content. EuropaBio welcomes the intention to address enabling conditions, such as innovation and investment opportunities for circular business models and enabling technologies. Furthermore, EuropaBio supports the continuation of an ambitious public-private partnership on circular bio-based industries, building on the BBI JU’s successes.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

9 Sept 2019 · discussion around bio pharmaceutical development and how to maintain the strength of this sector

Meeting with Vytenis Andriukaitis (Commissioner) and

4 Sept 2019 · Science based decision making. New biotechnologies

Meeting with Timo Pesonen (Acting Director-General Internal Market, Industry, Entrepreneurship and SMEs)

10 Jul 2019 · Courtesy meeting to introduce themselves and present their priorities

Meeting with Jean-Eric Paquet (Director-General Research and Innovation)

23 Apr 2019 · R&I in Biotechnology

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis) and Syngenta Crop Protection AG and DuPont de Nemours International SARL

12 Mar 2019 · GMO import approvals and new breeding techniques

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

12 Oct 2018 · Introductory meeting with the new SG

Response to Transparency and sustainability of the EU risk assessment model in the food chain

22 Jun 2018

We fully support the Commission’s objective to increase trust and confidence in the EU’s procedure for risk assessment in the food chain, by making it more transparent and sustainable. The EU’s risk assessment system is robust, but looking ahead, we agree that it should become more efficient, consistent, and transparent to help ensure consumer confidence and the system’s viability in the long term. Much can be learned from other risk assessment systems in the EU and around the world. Comprehensive transparency should not be limited to regulatory studies, but include more transparency in EFSA’s processes and a step change in communication. Let the science speak loud and clear! The focus of this initiative should be on informing the wider public about real versus perceived health threats, and on tackling disinformation and misperceptions, so that consumers can rest assured that their food is safe. Europe’s citizens deserve to know the truth: modern food and agriculture have brought unprecedented levels of food safety to Europe, and food security to the world. Certain elements of the Commission proposal such as improved risk communication can help to achieve the stated objectives of increasing transparency and sustainability. We also strongly support the idea of making certain procedural aspects of EFSA more like in the European Medicines Agency (EMA), including the introduction of pre-submission activities. On the other hand, the proposed processes for publishing regulatory studies and conducting verification studies require clarification to ensure that they meet the aim of enhancing trust without having a counter-productive impact on the decision-making process and on competitiveness. Given that the risk assessment system is critical for food safety, innovation and all regulated industries, it is regrettable that the Commission has decided not to produce an impact assessment.
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Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

Meeting with Michael Hager (Cabinet of Vice-President Günther Oettinger)

18 May 2018 · SPC manufacturing waiver

Meeting with Tom Tynan (Cabinet of Commissioner Phil Hogan)

25 Apr 2018 · Business discussion

Meeting with Leila Fernandez-Stembridge (Cabinet of Commissioner Pierre Moscovici)

10 Apr 2018 · IP regime generic manufacturers in the pharmaceutical industry

Response to Update of the 2012 Bioeconomy Strategy

19 Mar 2018

EuropaBio welcomes the Commission’s initiative to update the EU Bioeconomy Strategy. The EU’s leadership in this field has boosted activity, impact and interest in developing sustainable bioeconomies throughout the member states (ms) and regions. Industrial biotech (IB) enables a more competitive and sustainable bioeconomy, delivering solutions to the UN SDGs. We now call for the incorporation of the following concrete actions: 1. Introduce a long-term, stable and transparent policy and incentive framework: • Increase efforts to engage and connect EU decision makers and stakeholders from agriculture, regional policy, environment, industry, climate, trade, energy and research and innovation in clear, long term initiatives, to speed up the evolution of the bioeconomy • Develop and implement an EU SDGs Strategy linked to the Bioeconomy Strategy • Develop and fund communications strategies to share best practice, knowledge, expertise and information on EU-led initiatives to develop regional bioeconomies 2. Expand opportunities for feedstock production and use: • Ensure that the modernised and simplified CAP is fit for purpose to incentivise the smart and sustainable use of biomass to meet societal challenges • Include EU recommendations on ms and regional support for awareness raising, ensuring a fair price for feedstocks and developing an infrastructure for collection, storage and transport of biomass • Foster a balanced dialogue, with all relevant stakeholders, around the smart and sustainable future use of land and biomass • Develop a clearer picture of future potential for developing the bioeconomy from wastes and residues • Ensure that bio/circular economy strategies are developed in synergy to maximise the contribution of bio-based materials, including the separate collection and treatment of bio-waste 3. Develop a highly-skilled workforce: • Encourage measures to develop a bioeconomy workforce to maintain competitiveness and improve sustainability in rural, coastal, de-industrialised and urban areas • Develop skills to optimise separation technologies, bioconversion and downstream processing of industrial biotechnology products. Enhance microbial strains to produce new products, making them resistant to contaminants within lignocellulosic and waste feedstocks • Adopt novel teaching methods in parallel with identifying skills gaps • Boost the potential of clusters through mapping and support measures. Foster creation of new clusters where gaps exist (especially in newer ms) 4. Increase funding and improve coherence of financing mechanisms: • Link delivery of SDGs through bioeconomy development to FP9 funding priorities • Ensure a BBI JU 2.0 as part of this commitment • Establish a European Bioeconomy Strategic Investment Fund (EBESIF) to combine resources from different financing mechanisms • Keep financing industrial biotechnology under the KETs as a key enabler of the bioeconomy • Identify opportunities within bioeconomy to deliver financial incentives and/or tax reductions as part of the EU’s commitment to reducing its dependency on fossil-carbon 5. Boost market uptake of bio-based products: • Encourage and fund ms and regional schemes to increase consumer awareness of the Bioeconomy in strategic sectors which deliver on the UN SDGs • Create and fund a dedicated EU ‘Bioeconomy Week’, enabling citizens to discover regionally sourced bio-based products and initiatives • Roll out public procurement initiatives to build on the work of the Bio-based Products Expert Group and projects such as InnProBio • Fund measures to communicate bio-based standards, labels and bio-based products availability through EU sustainability schemes (PEFs/Ecolabel/Ecodesign/GPP etc) • Tax fossil carbon in virgin products to finance recycling of the virgin carbon, where overall reductions in plastic use are not possible, to promote recycling and also the use of renewable carbon in products
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Meeting with Robert Schröder (Cabinet of Commissioner Carlos Moedas)

23 Jan 2018 · Update of the Bioeconomy strategy

Response to Transparency and sustainability of the EU risk assessment model in the food chain

17 Jan 2018

EuropaBio welcomes the opportunity to provide our views on the roadmap and trusts that any forthcoming legislative proposal will be accompanied by an impact assessment. More transparency of the EU risk assessment: EU legislation already provides for public consultations and opportunities for public access to the non-confidential parts of product applications. The publication of even more information in itself is unlikely to improve the public understanding of science and the trust in the risk assessment process. Instead, the European Commission, EFSA and other relevant authorities including at the national level, should provide easy to understand information about food safety and product authorization processes. We acknowledge the public demand for more transparency in the risk assessment process. However, any new initiative aimed to further increase the transparency should avoid the unfair commercial use of regulatory data owned by competing market actors with a view to maintain the incentives of businesses to invest and create jobs and innovation in the EU. Independence of industry generated studies/data: We agree with the Commission’s analysis in communication C(2017)8414 that public money should not be used to commission studies that eventually help industry put a product on the market, especially since individual studies cost between several thousand to several million euro each. The robustness and quality of the applicants’ studies are verified by independent risk assessment experts from Member States and EFSA, who thoroughly evaluate each study and, if deemed necessary, request any additional information from the applicant. Changing the basic principle underlying this system will create a precedent which needs to be carefully thought through in the context of other regulated products outside the food and feed sector which are assessed by other EU regulatory agencies (chemicals, medicines, etc.). Risk communication: We applaud the communication initiatives of EFSA and the Commission to explain the product authorisation systems in videos and infographics. We are convinced that a step change in risk communication initiatives led by the EU bodies will be of utmost importance. Quality, comprehensibility, lucidity and relevance of information are more important than quantity. For instance, most citizens are unlikely to be interested in reading a regulatory study assessing the allergenicity of a particular substance. Instead, information tailored to the consumers explaining and putting into perspective food-related health risks would be more relevant. Such essential information should be easy for citizens to find on the social media pages and websites of the Commission and EFSA. Relevant public administrations, risk management and risk assessment authorities could do much more to explain the basics of food safety, and clearly distinguish between proven and perceived food related threats. If misinformation is allowed to flourish and expand, science-based risk assessment and the credibility of EFSA and national risk assessment authorities will continue to be undermined. EFSA's scientific expertise: The current rules on the establishment of Scientific Panels in EFSA limit the accessibility of many EU experts qualified to conduct risk assessment in specific areas to EFSA. In particular, the rules for conflict of interest prevent a number of experts from research institutions and universities from participating in the risk assessment process conducted by EFSA due to collaborations they might have had with the business community in the past, such as participation in public-private partnerships (which are paradoxically being promoted by the Commission in a variety of scientific fields). In addition, a three-year term of office does not ensure the continuity of the risk assessment and causes delays of the risk assessment as the new Panel members often need to get acquainted with complex and lengthy dossiers.
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Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

11 Jan 2018 · Discussion on future EuropaBio events

Response to Definition of the concept "similar medicinal product"

27 Nov 2017

General comments Regulation 141/2000 (Orphan Regulation) and the accompanying Commission Regulation EC 847/2000 have successfully stimulated research and development of orphan medicinal products. The EFPIA-EuropaBio Joint Task Force would like to emphasise the vital importance of maintaining a favourable regulatory environment to continue to see progress in treating rare diseases. In order to have a consistent and transparent process, further elaboration on the definition, methodology and level of information required would provide clarity for all stakeholders. While we understand assessment of similarity will always be done on a case by case basis it would be useful to have specific examples demonstrating the interpretation of the text in each category. These aspects could be addressed in a complimentary Q&A document or guideline as this would allow for easy revision with the evolution of new science. Examples of areas which could be covered in this document are: 1) Article 1 (c) – “biological and functional characteristics”, examples of characteristics that would be considered together with how these are evaluated to determine similarity. 2) The term “significant impact” and the level of evidence expected – it is important that this concept is not confused with “significant benefit”, which must be demonstrated when satisfactory methods are available within the community. 3) The term “minor changes” and “not major”, which are contained throughout the document. 4) Clarification on how non-similarity will be established on the basis of manufacturing differences is also needed. Manufacturing details are highly confidential and it may be difficult for applicants to make meaningful comparisons with other products. Ideally, the complementary Q&A or guideline should be released at the same time as the final regulation to avoid a period of uncertainty in implementing the revised definition. However, this should not delay the release of the final guidance. We appreciate the addition of the section on advanced therapy medicinal products and support the general principle of reliance on differences biological and functional characteristics when similarity cannot be established on the basis of principle structural molecular features. Specific comments MONOCLONAL ANTIBODIES The draft Regulation defines similar monoclonal antibodies (mAB) based on their “mechanism of action” as it refers to “binding” to epitopes, whereas the remaining definitions throughout the Regulation are based on the “principal molecular structural features”. The definition for mAB should also be based on the concept of the “principal molecular structural features” to provide better clarity and certainty to developers of mABs and also to be harmonized with the remaining definitions in the Regulation. In particular, the similarity assessment for monoclonal antibodies should be based on the Complementary Determining Region (CDR) sequences or the additional structural elements relevant for function of the mAB, which are both elements of the molecular structural features of monoclonal antibodies. Article 1 (2.1) last paragraph should be amended as follows: “Two monoclonal antibodies, monoclonal antibody conjugates or fusion proteins could be determined to be non-similar if different Complementary Determining Region (CDR) sequences of the antibody or the additional structural element of the conjugated or fused monoclonal antibody, or other functionally relevant sequences significantly affects the binding epitope and/or the biological and functional characteristics of the substance” VACCINES - please refer to file in attachment for specific considerations Contacts for EFPIA-EuropaBio Joint Task Force: Davide Marchi (d.marchi@europabio.org); François Lamérant (francois.lamerant@efpia.eu). European Biopharmaceutical Enterprises (EBE) and Vaccines Europe were consulted and contributed to this response as specialised groups within EFPIA.
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Meeting with Dermot Ryan (Cabinet of Commissioner Phil Hogan), Dermot Ryan (Cabinet of Commissioner Phil Hogan), Dermot Ryan (Cabinet of Commissioner Phil Hogan)

29 Aug 2017 · GMO import authorization process including several dossiers pending Commission authorization (following recent appeal committee votes), EC proposal to change comitology rules , Debate around the legal status of New Plant Breeding Techniques including genome editing

Meeting with Giulia Del Brenna (Cabinet of Commissioner Carlos Moedas)

24 Aug 2017 · Introduction of the New Secretary General

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

13 Jul 2017 · Introductory meeting of EuropaBio's new Secretary General

Response to Draft Commission Directive updating the environmental risk assessment of GMOs

29 Nov 2016

Preamble (5) refers to case-by-case risk assessment. Similar to Commission Impl Reg 503/2013, we recommend the inclusion of a new Article in the draft Directive which provides for notifying GMOs which do not satisfy all requirements provided that particular information is not scientifically necessary or technically possible to supply. Annex II General and specific considerations: Useful to add a sentence clarifying that e.r.a must consider scope of the notification, the genetic modification & the crop. C.1. Para 1 Unintended effects: Rephrase to “Unintended effects due to the genetic modification”. Not all differences identified between GMO and comparator are due to genetic modification, but also to natural variation. C.1 Para 3 Different levels of information would be required depending on the scope of the notification (field trials/import/cultivation). C.1 Sub-para 2 para 3 None or few toxicological studies are included for notifications only submitted under Directive 2001/18, better to include data standards in a general paragraph which applies to all studies. C.1 Para 3 (c) Add third bullet point indicating that where (i) or (ii) cannot be met, justification must be provided. C.1 Sub-para 1 para 4 Both for part B and part C notifications, should be possible to allow for flexibility and a case-by-case & proportionate risk assessment of staked GMO. C2 Para 1 Keep wording from Directive 2001/18. “into which the GMO will be released and into which the transgene may spread” is not needed as taken into account under problem formulation. C3 Para 1 Add a step describing potential exposure routes and then a description of the pathways to harm. Applicants should not set magnitude of tolerable effects. “Potential adverse effects shall not be discounted on the basis that they are unlikely to occur” is not in line with the stage of problem formulation. Delete list of Potential adverse effects of GMOs, not fully in line with EFSA ERA GD. C3 Para 3 Use of different risk assessment methodologies should be allowed. Delete “A qualitative assessment shall be further defined using an appropriate scale, which may notably consist in a numerical scale from 0 to1. Align with EFSA ERA GD: “Depending upon the intended uses of a GM plant, such as import, processing, food, feed and/or cultivation, the pathways and levels of exposure of the GM plant to the environment will vary.” Annex III to state that different levels of information are required depending on the scope of the notification (e.g. field trials, import, or cultivation). Point (ii) For field trials, this information might be limited. Point (i) A checklist seems contradictory to the problem formulation and case-by-case approach. The problem formulation step should provide the rationale followed in the e.r.a, including a rationale for which studies were conducted why. Annex III B Section I For field trials, during the research phase, there may not be as much information available as it is required here. Agricultural biotechnology research is important in the EU and thus should not be blocked. I.B.2.(b)(ii) sequence Field trials under Part B notifications enable the selection of the elite event. Full sequence characterisation might not be conducted at that stage. Maintain current requirement in Directive 2001/18/EC (i.e. size and structure of the insert) to also allow academia and SMEs to carry out field trials. II.B.4.(c)(ii): Resistance development is not an environmental risk. Applicant and risk manager should work together independently of the risk assessment. II.B.4.(d)(i): This suggests that all listed classes of NTOs would need to be assessed also for import notifications. Advisable it is stated that data requirements will depend on the scope of the application and for the NTO part, not to list functional groups of NTOs.
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Meeting with Vytenis Andriukaitis (Commissioner) and

17 Nov 2016 · Roundtable on the future of the General Food Law Regulation

Response to REACH Regulation - Annex XIV

12 Oct 2016

EuropaBio represents 77 corporate and associate members and bio regions, and 18 national biotechnology associations in turn representing over 1800 biotech SMEs. We address our comments specifically to 4-tert-Octylphenol ethoxylates (herein referenced as Triton X-100). Patient Safety: Triton X-100 is a substance which allows the biopharmaceutical industry to remove viruses from medicines without affecting the efficiency of the active pharmaceutical ingredients. It is used to ensure that biological medicinal products from mammalian cell lines, as well as plasma, are virus free. Triton X-100 is considered the most widely used/validated and robust pathogen inactivation technology known today, and also one of the most efficient to inactivate new and evolving viruses. The overall impact of a time limited authorisation to public health could therefore be significant. Socio-economic impact: The Commission’s proposal states that the socio-economic benefits arising from the use and analysis of alternatives to the substance have been taken into account. The Commission’s Better Regulation guidelines state that “stakeholders must be able to provide feedback on the basis of an inception Impact assessment” and a 12-week internet based public consultation covering all the main elements of the Impact Assessment (IA). We therefore ask that the Commission release this IA for public consultation. Moreover, EuropaBio believes that a time-limited authorisation of Triton X-100 will lead to important disruptions to the European market and price changes for manufacturers that can source their medicine outside the EU, placing severe pressure on the supply chain of critical medicines. It will have critical ramifications for SMEs, the livelihood of many of which depend on very few to one product in the pipeline. SMEs can in no way afford to stall their development processes to seek alternatives. In the long run, the uncertainty and short-term of the review period compared to the industry investment cycle will lead to reduced long-term investment in EU manufacturing facilities preferring other global locations, particularly for pipeline medicines that use those substances. This puts the competitiveness of the EU biopharma industry at risk. Review periods: The Commission’s proposal notes that in instances where there is no suitable alternative, appropriate and effective risk management measures and high benefits from the use, “as could be the case for uses in the production of medicinal products”, review periods should be long with no further specification. This leaves a very high level of uncertainty that puts Europe at a competitive disadvantage as compared to other global regions in terms of investments and capacity to deliver timely treatments to patients. According to a CRA Report the potential impact to the biopharmaceutical sector of a decision on Triton X-100 could be c. 3.5€ billion. We therefore urge the Commission to conduct Socio-economic and Patient Safety Impact Assessments ahead of any REACH Committee consideration to place Triton X-100 on Annex XIV. REACH does not foresee a maximum length of review period. As REACH is currently undergoing review, we would also ask the Commission to formally consider this specific issue within the REACH review and assess the opportunity to review the guidelines on setting the review periods on an application for authorisation. 12.10.2016
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Meeting with Vytenis Andriukaitis (Commissioner) and

27 Jun 2016 · New breeding techniques, innovation in seeds

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

7 Dec 2015 · Health and food aspect of biotech

Meeting with Lowri Evans (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

21 Oct 2015 · current challenges for the biotech industry

Meeting with Kaius Kristian Hedberg (Cabinet of Commissioner Elżbieta Bieńkowska)

16 Jul 2015 · Biotechnology Industry

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology) and JOŽE TRONTELJ INSTITUTE FOR ETHICS AND VALUES

8 Jul 2015 · Digital Publishing

Meeting with Vytenis Andriukaitis (Commissioner) and

23 Jun 2015 · Participation of Commissioner at event

Meeting with Vytenis Andriukaitis (Commissioner) and

2 Mar 2015 · Healthcare (personalised medicine which will be a priority of the LU Presidency, Biosimilars, Advanced Therapy Medicinal Products (ATMPs), Health Technology Assessment (HTA) and GMO'S

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology)

17 Feb 2015 · Health and JCJ Goals

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology) and BASF SE and

12 Feb 2015 · Digital Single Market, Innovation

Meeting with Jyrki Katainen (Vice-President) and

3 Feb 2015 · Bioeconomy

Meeting with Carlos Moedas (Commissioner) and European farmers and

2 Feb 2015 · Meeting with the European Bioeconomy Alliance on the Bioeconomy Strategy

Meeting with Ladislav Miko (acting Director-General Health and Food Safety)

21 Jan 2015 · GMO

Meeting with Heidi Jern (Cabinet of Vice-President Jyrki Katainen)

14 Jan 2015 · Bioindustries and biotechnology

Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

14 Jan 2015 · Meeting with Introductory meeting w. Europabio to discuss the biotechnology industry in Europe (healthcare, agri-food and bioeconomy/industrial biotechnology field)

Meeting with Shane Sutherland (Cabinet of Commissioner Phil Hogan)

10 Dec 2014 · Biotechnology

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

9 Dec 2014 · Preparation of Commissioner's participation to future Europabio event, personalised medicines; GMOs.

Meeting with Ladislav Miko (acting Director-General Health and Food Safety)

5 Dec 2014 · New transparency rules and pending GM authorisations