BIO Deutschland
Ziele von BIO Deutschland sind: * Sprachrohr der deutschen Biotech-Branche innerhalb von Gesellschaft und Politik * Breite Image-Positionierung der deutschen Biotechnologie-Industrie auf nationaler und internationaler Ebene als ein entscheidender Erfolgsfaktor für die Wettbewerbsfähigkeit Deutschlands * Unterstützung und Katalysator für die Etablierung eines innovativen und finanziell starken Industriezweiges innerhalb der deutschen Wirtschaft auf der Basis moderner Biowissenschaften * Politische Interessenvertretung der deutschen Biotechnologie-Branche gegenüber der nationalen und europäischen Legislative * Aktive Zusammenarbeit mit den BioRegionen und deren Unterstützung Aufgaben von BIO Deutschland sind: * Diskussion und Austausch mit Vertretern aus Wirtschaft und Politik * Positionierung der deutschen Biotechnologie auf nationalen und internationalen Veranstaltungen * Förderung der Forschung und des Technologietransfers * Ausrichtung von Branchenevents
ID: 66742324074-50
Lobbying Activity
Meeting with Hildegard Bentele (Member of the European Parliament)
13 Nov 2025 · Biotech
Response to Revision of the Rescue and Restructuring Guidelines
7 Oct 2025
While the exemption is intended to prevent the automatic classification of young companies as undertakings in difficulty under Article 2(18) of the General Block Exemption Regulation (GBER), it does not address the full complexity of early-stage business realitiesparticularly in capital-intensive and research-driven sectors such as biotechnology, clean technology, and deep tech. In practice, many start-ups, especially those with high upfront R&D expenditures, experience negative equity or accumulated losses well before reaching the three-year threshold. Although these losses are often a natural and expected part of the business model, such companies may still be excluded from aid programs that reference Article 2(18), especially where national funding authorities interpret the regulation strictly. This issue is further compounded by modern financing structures such as convertible loans or venture capital instruments, which may not be reflected as equity in conventional accounting terms, leading to a misleading appearance of financial distress. Moreover, the rigid three-year time frame does not account for the typical development cycles in highly innovative sectors, where regulatory approvals, product development, and market entry may take considerably longer. As a result, even start-ups with strong investor backing and long-term viability may be prematurely disqualified from crucial funding instruments. In summary, while the exemption offers some initial relief, it does not go far enough to accommodate the financial characteristics and developmental timelines of innovative start-ups. In some cases, extending the exemption period from 3 to 10 years is not sufficient a more sector-specific, criteria-based approach would be more appropriateparticularly in industries with long development times, high upfront costs, and delayed or unpredictable revenues, such as biotechnology (in areas like gene therapy or vaccine development).Instead of a fixed exemption period (e.g. 10 years), the regulation could be amended to include buffer criteria for these industries that allow companiesregardless of ageto avoid being classed as undertakings in difficulty if they meet certain demonstrable conditions. For example: A biotech company which can show that a major portion of its losses are due to research & development activities which are a normal part of its business plan, not due to mismanagement or operational failure. A company that has secured firm financing commitments (venture capital / grants / public R&D contracts) that cover its projected cash burn for at least the next 1824 months. A company whose product(s) are in advanced stages of regulatory approval (e.g. Phase II or III trials) or where there are delays outside of its control (e.g. regulatory, supply chain), but with documented progress or milestones. Optionally, criteria about capital structure: e.g. convertible debt / venture financing should not automatically count as losses of equity if convertible and backed by credible investors. These criteria would allow older biotech firms (with histories >10 years) to avoid being punished simply by virtue of age plus capital intensive development cycles.
Read full responseResponse to Biotech Act
6 Jun 2025
BIO Deutschland welcomes an EU Biotech Act. In order to leverage the power of biotechnology, the EU Biotech Act must strengthen Europes global position in the development of this strategic technology through an ambitious, cross-sectoral approach. In doing so, the EU Biotech Act should further bolster the effectiveness and impact of EU initiatives such as the Life Sciences and Biotechnology Strategy, the Bioeconomy Strategy, and the Clean Industrial Deal. Our further comments on the content of an EU Biotech Act can be found in the attached document.
Read full responseMeeting with Oliver Schenk (Member of the European Parliament)
20 May 2025 · Biotech in Europa
Meeting with Stefan Köhler (Member of the European Parliament)
20 May 2025 · Politischer Austausch
Meeting with Axel Voss (Member of the European Parliament)
4 Apr 2025 · EU Biotec Act
Meeting with Andrea Wechsler (Member of the European Parliament) and Forward Global
3 Apr 2025 · EU energy and industry policy
Meeting with Christine Singer (Member of the European Parliament)
27 Mar 2025 · EU Biotech Act
Meeting with Andreas Glück (Member of the European Parliament)
13 Mar 2025 · Biotech
Response to EU Start-up and Scale-up Strategy
12 Mar 2025
Als Branchenverband und Sprachrohr der deutschen Biotechnologieindustrie teilen wir die Ansicht, dass Start-ups und/oder Scale-ups mit den genannten Hürden konfrontiert sind. Um die Wettbewerbs- und Innovationsfähigkeit der Europäischen Union aufrechtzuerhalten, sollten die Hürden abgebaut werden. Unsere Vorschläge dazu finden sich in dem angehängten Dokument wieder.
Read full responseMeeting with Stefan Köhler (Member of the European Parliament, Shadow rapporteur for opinion) and Carlsberg Breweries A/S and Albert Schweitzer Stiftung für unsere Mitwelt
6 Nov 2024 · Politischer Austausch
Meeting with Andrea Wechsler (Member of the European Parliament) and Energy and Climate Policy and Innovation Council e.V.
6 Nov 2024 · EU Energy and Industry Policy
Meeting with Andrea Wechsler (Member of the European Parliament) and The Sherwin-Williams Company
8 Oct 2024 · EU Energy and Industry Policy
Meeting with Michael Kauch (Member of the European Parliament)
21 Feb 2024 · General exchange
Response to Legislation for plants produced by certain new genomic techniques
2 Nov 2023
Der deutsche Biotechnologie-Branchenverband BIO Deutschland e. V. begrüßt den Vorschlag der Kommission, das EU-Gentechnikrecht bzw. die Regulierung von mit bestimmten neuen genomischen Techniken gewonnenen Pflanzen an den Stand der Wissenschaft anzupassen. Es ist ein wichtiger Schritt in die richtige Richtung, um es Europa bzw. seinen Bürgerinnen und Bürgern zu ermöglichen, von diesen innovativen neuen Technologien zu profitieren. Mit Hilfe der Genom-Editierung lassen sich gezielt und präzise erwünschte Änderungen in Genome einführen, die so auch auf natürlichem Weg hätten entstehen können. In dem Vorschlag der Kommission werden Pflanzen, die durch solche Änderungen gewonnen werden als Kategorie 1 eingeordnet. Es ist richtig, dass gentechnische Veränderungen, die in diese Kategorie fallen, aus der GVO-Regulierung ausgenommen werden. Die vorgeschlagene Regel mit einer maximalen Anzahl genetischer Veränderungen für die Kategorie 1 ist zwar wissenschaftlich nicht ganz nachvollziehbar, aber dennoch ein guter Startpunkt. Die Entscheidung für den Kommissions-Vorschlag sollte wissens- und faktenbasiert erfolgen und nicht politischen oder weltanschaulich motiviert sein. Die neuen genomischen Techniken erweitern den Werkzeugkasten der Biotechnologie ganz erheblich und eröffnen damit noch mehr Möglichkeiten die vielen Herausforderungen unserer Gesellschaft zu bewältigen, wie z. B. gesunde nachhaltige Ernährung, eine resiliente Landwirtschaft und Klimaschutz. Es ist deshalb auch wichtig zu betonen, dass eine Novellierung des EU-Gentechnikrechts für den Anwendungsbereich der Mikroorganismen und Nutztiere perspektivisch ebenso dringend notwendig ist, um auch hier das riesige Potenzial der Genom-Editierung heben zu können.
Read full responseResponse to Compulsory licensing of patents
21 Jul 2023
Please see attached on behalf of BIO Deutschland e.V.
Read full responseResponse to Circular economy monitoring framework - Revision
3 Jun 2022
BIO Deutschland als der Branchenverband der Biotechnologieindustrie in Deutschland bedankt sich für die Möglichkeit, die Überarbeitung des Überwachungsrahmens für Kreislaufwirtschaft zu kommentieren.
In diesem Zusammenhang möchten wir darauf hinweisen, dass bei der Kreislaufwirtschaft auch die industrielle Bioökonomie mitgedacht werden sollte. Während sich Kreislaufwirtschaft und Kaskadennutzung darauf konzentrieren, den Wert von Produkten, Stoffen und Ressourcen innerhalb der Wirtschaft so lange wie möglich zu erhalten und die Umwelteffizienz der Prozesse zu verbessern, umfasst die Bioökonomie die nachhaltige Produktion erneuerbarer biologischer Ressourcen und die Umwandlung dieser Ressourcen und Abfallströme in Produkte mit einem Mehrwert, wie Lebensmittel, Futtermittel, biobasierte Produkte und Bioenergie. Durch den Einsatz innovativer Technologien ist es möglich, biobasierte Produkte in allen Bereichen der Wirtschaft herzustellen. Die wissensbasierte Bioökonomie zur Unterstützung einer Kreislaufwirtschaft ist nur mit Biotechnologie möglich. Die Industrielle Biotechnologie ist somit eine der tragenden Säulen des Transformationsprozesses in eine bio-basierte und nachhaltige Wirtschaft, eine Bioökonomie.
Read full responseResponse to Compulsory licensing of patents
29 Apr 2022
BIO Deutschland ist der Deutsche Verband der Biotechnologie-Industrie und mit 360 Mitgliedsunternehmen die Stimme des innovativen Mittelstandes dieser Branche. Als wichtigstes Ziel in der COVID-19-Pandemie begreift BIO Deutschland, dass der Zugang zu Impfstoffen für jedermann ermöglicht wird. Um möglichst schnell die Bevölkerung mit Impfstoffen gegen das Coronavirus SARS-CoV-2 zu versorgen, sind jedoch Beschränkungen geistiger Eigentumsrechte durch die Erteilung von Zwangslizenzen oder Benutzungsanordnungen für Patente weder geeignet noch erforderlich, um eine effiziente Krisenbewältigung zu gewährleisten.
Diese Diskussion ist auch im Rahmen des sogenannten Patent-Waivers im Rahmen des TRIPs-Abkommens zu sehen mit der die seit über 25 Jahren geltenden und von 164 Staaten akzeptierten WTO-Regeln außer Kraft gesetzt würden.
Zugleich würden legislative Maßnahmen für einheitliche erleichterte Zwangslizenzerteilungen in Bezug auf patentierte Erfindungen auf EU-Ebene das Schutzsystem geistiger Eigentumsrechte zumindest schwächen und damit künftige Investitionen in biotechnologische Innovationen behindern und sich nachhaltig negativ auf die zukünftige Versorgung der Bevölkerung mit innovativen Arzneimitteln auswirken. Die Produktion neuartiger Impfstoffe setzt ein erhebliches Know-how und entsprechende Produktionsanlagen voraus und lässt sich daher nicht ohne Weiteres und schon gar nicht innerhalb kurzer Zeit auf dritte Unternehmen übertragen oder in andere Länder ausweiten. Die Übertragung einer GMP gerechten und zulassungsfähigen Produktion eines sicheren biologischen (z.B. RNA basierten) Impfstoffs oder Therapeutikums in hoher Qualität zur sicheren Versorgung der Patienten dauert in der Regel mehrere Jahre, auch wenn das ursprüngliche Unternehmen erhebliche Ressourcen freisetzt, um notwendiges Know-how zu übertragen.
BIO Deutschland spricht sich daher gegen Änderungen der geltenden Rechtsvorschriften aus. Insbesondere die Einführung einer „Zwangslizenz auf EU-Ebene“ für die Nutzung in einer Krise (vgl. Option c)) wäre nicht gerechtfertigt. Es gibt kein einheitliches Gesundheitssystem in der EU und die kritische Infrastruktur in den Mitgliedsstaaten ist heterogen aufgestellt. Die COVID-19-Pandemie hat weiterhin die sehr unterschiedlichen Ansätze der Mitgliedsstaaten bei der Bekämpfung gezeigt und daher sollte folglich auch auf die bestehenden und bewährten nationalen Systeme zur Zwangslizensierung vertraut werden.
Vorzugswürdig erscheint demgegenüber die Förderung von freiwilligen Maßnahmen der EU-weiten und globalen Zusammenarbeit von Unternehmen untereinander und mit öffentlichen Stellen, um im Krisenfall die Bereitstellung von kritischen Produkten schnell, effizient und umfassend zu gewährleisten.
Eine ausführliche Einschätzung zu diesem Thema finden Sie bitte im Anhang.
Read full responseResponse to Sustainable and Smart Mobility Strategy
10 Aug 2020
As the sector association of the biotechnology industry, BIO Deutschland has set itself the objective of supporting and promoting the development of an innovative economic sector based on modern biosciences. The Berlin-based association currently has over 330 members.
BIO Deutschland welcomes the initiative of the European Commission to adopt a comprehensive strategy to meet the Green Deal targets to reduce transport-related GHG emissions and to ensure that the EU transport sector is fit for a clean, digital and modern economy.
Transport plays a key role in reducing GHG emissions. Therefore, all reasonable options for avoiding CO2 emissions must be used. There is no doubt that electrification of road transport is part of the mix of solutions. However, a full transition of all car segments (let alone all other transport segments) will take a long time. Therefore, it is critical to complement the electrification of the car fleet with the use of existing environmentally friendly solutions such as biofuels.
When burning energy from biomass, as much CO2 is released as it was fixed from the air during the growth phase. Since only emissions arise that were and are bound by biomass in a timely manner, biomass offers a considerable advantage over fossil fuels because only minor additional emissions are caused. It should also be taken into account that the world's strictest sustainability criteria for biofuels apply in Europe.
Biotechnology enables the production of sustainable and climate-neutral liquid fuels with a high energy density from biomass. This includes 2nd and 3rd generation biofuels. In modern 2nd generation biofuels, either the lignocellulosic material (e.g. from agricultural residues) or the entire dedicated energy crop is used. 3rd generation biofuels are produced using algae and carry out photosynthesis with their entire biomass.
Such modern biofuels can use the existing infrastructure and can be used immediately in the vehicle fleet. This means that biofuels can be used without wasting time and without high investment costs. 3rd generation biofuels are also highly variable, since the growth of the producing organisms can be accelerated by artificially increasing the CO2 concentration.
The increased use of modern biofuels can significantly reduce GHG emissions in traffic. Modern biofuels are indispensable for more sustainability and climate protection in heavy goods and air traffic.
In private transport, modern biofuels represent a crucial bridge technology for moving away from petroleum-based fuels.
BIO Deutschland calls for:
The EU Commission must support all available and sustainable options for GHG reduction and create the necessary regulatory framework. Renewable fuels that have already been introduced must be used. New fuel solutions and drive technologies must be implemented in Europe so that they can make their contribution to reducing GHG emissions.
Stable and long-term political framework conditions are essential, which enable economic operators to build up production capacities, establish new value chains and make targeted investments in research and development.
Clever climate policy must support the technological leadership of the companies based here and thus strengthen Europe as an industrial and research location in the long term. Especially in the field of biotechnology, Europe must be careful not to miss the international connection. This also includes the necessary funding for biofuels.
Read full responseResponse to Communication on the future of research and innovation and the European Research Area
3 Aug 2020
The sector association of the biotechnology industry, BIO Deutschland, welcomes the initiative to strengthen research and innovation.
Biotechnology is about developing new therapies and drugs, breeding improved crop plants and producing industrial raw materials. And the biotechnology industry is mainly driven by small and medium-sized businesses. In addition, start-ups are decisive for the development of the biotechnology sector. Biotech start-ups are essential for translating scientific research results into real innovations. For the overall industry, a certain renewal rate is crucial for further growth and competitiveness.
Nevertheless, other regions have far better conditions for innovation financing. Unlike in Anglo-American countries, Europe lacks for the most part an innovation financing ecosystem due to there being little equity capital available for development and growth financing. The paradigm-shifting business models of companies such as Google, Facebook, Amazon and Tesla, and in the biotechnology sector Genentech, Kite, Bluebird, Amgen, Gilead, Biogen, and others, are inconceivable in the absence of large sums of private venture capital for development financing. Such companies are financed through private equity (also known as venture capital, VC) provided by investors; the investors become partners or co-founders of the company. The only possible way to level the playing field is by creating a more favourable environment for venture capital and/or for initial public offerings (IPOs) in early stages of company development.
There are several options to provide biotechnology companies with the venture capital needed during the growth stage.
Pension systems in Europe are usually financed on a pay-as-you-go basis, which means a key source of capital accumulation is lacking. This very source of capital accumulation provides the foundation for a very productive venture capital financing ecosystem, especially in the United States. Such an ecosystem involves traditional venture capital in the early stage and institutional investors that invest in innovative development through listed companies. These forms of financing open up the possibility for active VC investors to recoup their investment and make a profit through early-stage IPOs, and enable growth companies to be financed through the stock market up to market readiness or market penetration.
There is a huge amount of capital and assets in Germany and Europe looking for investment possibilities. Insurers, pension funds and private individuals could contribute to innovative capacity by providing extensive inflows of capital.
Read full responseResponse to Legislative framework for the governance of common European data spaces
31 Jul 2020
As the sector association of the biotechnology industry, BIO Deutschland has set itself the objective of supporting and promoting the development of an innovative economic sector based on modern biosciences. The Berlin-based association currently has over 330 members.
Biotechnology is an innovation driver for the healthcare industry. The success of biotechnological research provides important impulses for new, innovative products in the healthcare industry. For future health research and care data is an important resource.
BIO Deutschland welcomes that this initiative addresses low availability of data for research and innovative uses. Considering the recent judgment of the ECJ in the Schrems II case (judgment of 16 July 2020, C-311/18) and the obligations it imposes on data controllers and processors as regards international transfers of, in particular, sensitive personal data, it seems ever more important to strengthen the efforts for the exchange of such data within the EU/EEA member states.
In order to trigger a further innovation boost in the research and development of new therapies and medical technologies, health data must also be able to be used for secondary purposes. Private research and the industrial healthcare industry, as a central pillar of medical research, must also have access to health data for research and development, with corresponding regulations in accordance with the General Data Protection Regulation (GDPR). However, though the GDPR has facilitated the processing of personal data within the EU/EEA member states in many fields, varying national legislation, that has been maintained or passed in accordance with Art. 9 para. 4 of the GDPR, must be considered a significant hindrance for the exchange and use of personal data in the biotechnology industry. Thus, upholding different legal provisions adversely affect the societal benefit that could be derived from an intensified collaboration within the EU/EEA.
The common ground for a broad data exchange and usability are interoperability, standardization and data quality. The FAIR principles should apply for all accessible data sets. To ensure interoperability between different data rooms, an aligned, EU-wide data policy catalogue is required to define standards and protocols. Particular attention should be paid to integrating existing national health data infrastructures (e.g. existing electronic patient files) to the EHDS. It is also of central importance to ensure interoperability with existing pilot projects (e.g. EHDEN or MIDAS) and research networks (e.g. European Institute for Biomedical Imaging Research, EIBIR). The virtual layer should not be an independent data store, but rather enable standardized exchange and analysis of the data for various purposes. Modern architectures and access logic need to be applied to simplify queries of decentralized data pools and enable distributed computing to form a suitable network for the larger Healthcare and Life Sciences ecosystem. Data access rights, tracking of data origin and use plus EU-wide harmonized governmental guidance regarding anonymization and data sharing rights / duties should be considered. Transparency is essential for identification of the source and validation and certification of the data sets. This should be one of the core tasks of the new health data agency to be created. Powerful semantic search engines should be implemented to enable data search and analysis.
In order to improve acceptance for health data transfers (e.g. from health tracker apps or electronic patient files) and to enable an educated approach of indivuals regarding the use of their data, the increase of competencies in digital literacy of the population is necessary.
The resulting network should also allow individuals to actively participate by informing them on the purpose of their collected data and the use of this data to advance medicine and to serve society purposes.
Read full response