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ASOCIACION ESPAÑOLA DE BIOEMPRESAS

ASEBIO

ASEBIO brings together companies, associations, foundations, universities, research and technology centers that carry out activities directly or indirectly related to biotechnology in Spain.

Lobbying Activity

Meeting with Roman Arjona (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs)

19 Jan 2026 · Exchange of views on the evolution of EU competitiveness and the situation of the biotechnology sector.

Response to EU’s next long-term budget (MFF) – performance of the EU budget

12 Nov 2025

AseBio, the Spanish Bioindustry Association, represents the Spanish biotechnology sector, brings together a diverse ecosystem of over 300 entities, including innovative small and medium-sized enterprises (SMEs), large corporations, and other vital players. AseBio warmly welcomes the post-2027 Multiannual Financial Framework (MFF) and for the next generation of financial programme. From AseBios perspective, biotechnology is a critical technology and a strategic sector for Europes competitiveness, economic security, and open strategic autonomy. Its development drives innovation, productivity, and industrial leadership, acting as a cross-cutting enabler in health, sustainability, food systems, and the bioeconomy AseBio's contribution to this consultation directly addresses the identified challenges and opportunities for the biotechnology sector within the next MFF 2028-2034, aiming to reinforce Europes commitment to biotechnology as a strategic sector, ensuring sufficient resources to maintain European leadership in innovation and competitiveness and strategic autonomy. Our recommendations are structured around three key pillars, aligned with the broader European industry consensus, to build a resilient, competitive, and globally attractive biotech ecosystem, under a coherent financial and regulatory architecture:1) Simplification, agility access and budget adjustments for the next European Framework Programme for Research and Innovation financing, 2) Regulatory simplification and agility to accelerate innovation; and 3) Clear and standardized procedures to facilitate investment.
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Response to Revision of the Rescue and Restructuring Guidelines

13 Oct 2025

The current legal framework needs to be modified to avoid its pernicious effects on the ability of companies that develop innovative technologies, start-ups and scale-ups, to gain access to national public financing in Europe. Furthermore, the last targeted reviews of the GBER did not address some of the main concerns identified by the Staff Working Document in 2020 regarding the rescue and restructuring guidelines and the definition of Undertaking in Difficulty. Consequently, the current definition hinders Member States from promoting the development of their innovative businesses, damaging Europes ability to foster the competitiveness of European economy. At a time when the European Union has decided to boost its Open Strategic Autonomy, support biotechnology as a strategic technology for its economic security and is about to launch a specific biotech act to boost biotech innovation in Europe, the need to tackle the limitations imposed by the current definition of undertakings in difficulty in the GBER is more pressing than ever. AseBio believes that the current legal framework should be changed to overcome the identified limitations. Consequently, we urge the Commission to review the GBER and its provisions according to the following principles: 1. Companies that are R&D-intensive because of their business models show losses repeatedly, and the undertaking in difficulty criterion does not reflect their solvency, meaning that the aid conferred on the R&D projects conducted by these companies does not conflict with the bailout and restructuring framework of undertakings in difficulty. Likewise, no factors that could distort competition would arise by granting aid to R&D projects in R&D-intensive companies in that this definition does not match their technical or economic solvency. Accordingly, R&D-intensive companies should be exempted from the exclusion stipulated by the GBER. 2. The definition of the undertaking in difficulty criterion could be changed to make it less harmful to R&D-intensive companies with long maturation processes. In this sense, several alternatives could be considered, and some of them could even be implemented simultaneously: a. Equity loans and similar instruments should be considered as net assets and therefore as a balancing element that could offset the accumulated losses for the purposes of defining undertaking in difficulty. b. Similar to what occurs in the cases of dissolution or bankruptcy, the base of calculation should be share capital, thus excluding the share premium. In Spanish law, the share premium is fully available and is not part of the companys share capital. Therefore, the accumulated losses will be charged to reserves and the share premium (as the fully available reserve that it is), and once they have been fully burned down, the consumption of social capital would be calculated by the remaining accumulated losses, and this remaining social capital would have to be more than 50% of subscribed share capital not to be considered an undertaking in difficulty. c. In order to ensure that the definition includes companies with long maturation periods, the exception for companies less than 3 years old could be changed to define longer periods, as in the framework of aid for risk financing, of 7 years starting from the first commercial sale. This way, the definition would not be applied to companies whose business model consists in developing a product over long periods of time until they begin to generate income from sales.
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Response to European Innovation Act

3 Oct 2025

The European Union must urgently overcome its innovation gap. While Europe boasts a world-class scientific base and a wealth of talent, its potential is consistently hampered by systemic barriers: regulatory fragmentation, obstacles to long-term financing, and a systemic talent shortage. These issues affect all innovative sectors, creating a significant competitive disadvantage compared to other global powers. From the perspective of AseBio, we firmly believe that the biotechnology sector can serve as a model for resolving these challenges. As a high-intensity R&D industry, our needs and pain points are a microcosm of Europe's broader systemic issues. The solutions proposed for biotechnology are not merely for our sector alone; they are a blueprint for a modern, pro-innovation framework that can have a multiplying effect across the entire economy. ASEBIOs contribution to this consultation directly tackles the challenges and opportunities within the European innovation landscape, with a particular focus on the biotech sector, aiming to strengthen Europes innovation capacity. Our recommendations are organized around three key pillars, aligned with the broader consensus of the European industry, to foster a resilient, competitive, and innovation-driven Europe: 1) regulatory simplification and agility to accelerate innovation; 2) faster and more accessible financing to power Innovation; 3) fostering a pan-European talent and knowledge ecosystem.
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Response to General revision of the General Block Exemption Regulation

3 Oct 2025

At AseBio, we believe that the current legal framework of the European Union must be modified, as it prevents innovative companiesespecially start-ups and scale-upsfrom accessing national public funding. The current framework and the definition of undertaking in difficulty limit the ability of Member States to promote innovation and European competitiveness at a time when the EU aims to strengthen its strategic autonomy and foster biotechnology as a key sector for economic security. Therefore, we propose reviewing the GBER in order to adapt the definition of undertaking in difficulty to the reality of R&D-intensive companies. These companies, although they may show recurring losses, should not be considered insolvent, since their viability is not measured by the same criteria as other industries. In addition, we propose recognizing equity loans as net assets, modifying the calculation base of share capital by excluding the share premium, and extending the exemption period for young companies from three to seven years from the first commercial sale. These measures would make it possible to support R&D projects without distorting competition and to strengthen the development of European biotechnology.
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Response to 28th regime – a single harmonized set of rules for innovative companies throughout the EU

30 Sept 2025

ASEBIO's contribution to this consultation directly addresses the identified challenges and opportunities within the biotech sector. Our recommendations are structured around three key pillars, aligned with the broader European industry consensus, to build a resilient, competitive, and globally attractive biotech ecosystem, based on a single regulatory framework: 1) regulatory simplification and agility to accelerate innovation; 2) clear and standardized procedures to facilitate investment; 3) fostering a pan-European talent and knowledge ecosystem.
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Response to Critical Medicines Act

4 Jul 2025

AseBio, the Spanish Association of Biocompanies, represents the Spanish biotechnology sector, brings together a diverse ecosystem of over 300 entities, including innovative small and medium-sized enterprises (SMEs), large corporations, and other vital players. AseBio actively collaborates with European associations such as EuropaBio and public-private platforms that advance biotechnology-driven health solutions across the EU. Spains biotech sector plays an increasingly strategic role in Europes pharmaceutical landscape, particularly through its growing biomanufacturing capabilities, innovation in biologics, and development of critical active pharmaceutical ingredients. As the primary voice promoting biotechnology in Spain, AseBio is well-positioned to offer insights derived from the national experience to provide valuable insights on the future Critical Medicines Act. AseBios response to this crucial consultation follows the structure and priorities outlined by the European Commission in its proposal for a Critical Medicines Act. It aims to directly address the key challenges and opportunities identified across the EU pharmaceutical and biotechnology landscape. Building on the experience of our members, our input is organized to provide concrete insights and proposals on areas such as risk-based measures for supply resilience, the reinforcement of global value chains and EU leadership in biomanufacturing, strategic support for innovation and sustainability, the role of SMEs within the regulatory framework, and the alignment of governance and procurement mechanisms. In doing so, we seek to contribute to a balanced and effective regulatory framework that ensures long-term access to critical medicines, strengthens Europes industrial base, and preserves a competitive and innovative life sciences sector. At AseBio, we strongly support the objectives of the Critical Medicines Act (CMA) and believe its success hinges on a clear, targeted, and innovation-driven approach. We advocate for focusing regulatory action on medicines with demonstrated supply vulnerabilities, ensuring definitions and scopes are precise to avoid regulatory overreach and unintended disruptions to functional supply chainsparticularly for complex products like biologics. We call for stronger EU-level coordination on contingency stock requirements and procurement practices that go beyond price, rewarding supply resilience, sustainability, and innovation. To truly enhance Europe's pharmaceutical resilience, the CMA must actively support investment in advanced manufacturing technologies and strategic biomanufacturing projects, while ensuring SMEskey drivers of innovationreceive dedicated support through simplified regulation and improved funding access. We also stress the need to reinforce global value chains through well-structured transnational partnerships and a flexible, EU-coordinated response to upstream supply vulnerabilities.
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Response to State aid rules for Research, Development and Innovation

22 Dec 2020

Las aportaciones de AseBio se circunscriben al Reglamento General de Exención por Categorías (RGEC) y el Criterio de Empresa en Crisis. AseBio aboga por modificar la definición de empresa en crisis para evitar que las empresas biotecnológicas sean excluidas de las ayudas de los estados miembro dirigidas a apoyar a la I+D o alternativamente, a eximir a las ayudas a la I+D de la exclusión del criterio de empresa en crisis. A partir de las definiciones del RGEC y las directrices de salvamento y restructuración se ha consolidado una interpretación según la cual aquellas empresas que consumen la mitad de su capital social más prima de emisión serán consideradas “empresas en crisis”. Además, dicha interpretación se ha ido aplicando cada vez de forma más inflexible, sin tener en cuenta información adicional que pudiera presentar el interesado para argumentar la desaparición de la causa (ampliaciones de capital y operaciones societarias) u otros argumentos que pudieran presentar las empresas para justificar la continuidad de las operaciones (operaciones mercantiles), reduciendo el espíritu de la definición conceptual a una mera aplicación de ratios. La aplicación de la definición de empresa en crisis como criterio excluyente en las convocatorias ha afectado principalmente a empresas de alta intensidad de inversión en I+D+I que requieren largos periodos de maduración hasta llegar al mercado. Como consecuencia de su modelo de negocio basado en la I+D y en el desarrollo de productos y servicios innovadores con largos plazos de maduración, y por tanto, la ausencia de ventas significativas durante este plazo, es habitual que las empresas biotecnológicas acumulen pérdidas de forma reiterada durante varios años y que dichas pérdidas lleguen a consumir la mitad de su capital social + prima de emisión, pasando a ser consideradas empresas en crisis. Sin embargo, se trata de empresas plenamente viables, solventes tanto técnicamente como económicamente, y con proyectos ambiciosos y de impacto. Asimismo, la definición obvia que la prima de emisión es una partida de libre disposición según la normativa mercantil española, a diferencia del capital. Desde la entrada en vigor del reglamento, y su despliegue en España en la normativa nacional y por parte de las diferentes agencias financiadoras, el sector biotecnológico ha sufrido diferencias en la aplicación de este criterio que se ha ido homogeneizando y endureciendo progresivamente. Como consecuencia de ello, cada vez más empresas biotecnológicas son excluidas de los programas de apoyo a la I+D. Un ejemplo reciente, sería la resolución de exclusión de las ayudas del Centro para el Desarrollo Tecnológico Industrial (CDTI) Misiones Ciencia e Innovación. De las 33 denegaciones en 23 de ellas el motivo de exclusión fue que la agrupación no pudo acceder a la condición de beneficiario por incurrir alguno de sus miembros en la definición de Empresa en crisis, correspondiendo al 70% de las denegaciones. El informe de conclusiones del fitness check efectuado al Marco de Ayudas de Estado de 2012 apunta respecto a las directrices de reestructuración y salvamiento (páginas 74 a 77) que el criterio relativo a la desaparición de capital es excesivamente conservador como criterio de aplicación único, ya que podría excluir a empresas que no se pretendían excluir cuando el marco fue promulgado. Asimismo, hace referencia a que la definición no es adecuada para empresas start-up, scale-up, así como para empresas que desarrollan tecnologías innovadoras, particularmente las financiadas con capital riesgo. Por otro lado, en el apartado relativo a la eficiencia del Marco de Ayudas de Estado para proporcionar un acceso rápido a las ayudas, se hace referencia (pag 97) a la preocupación de las autoridades nacionales respecto a la definición de las empresas en crisis y el criterio del consumo del capital social suscrito
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