The European Union Pharmaceutical Legislation proposal jeopardizes biotechnological innovation
- This is evident in the study conducted by EuropaBio, titled "Impact of the General Pharmaceutical Legislation of the European Union on the Innovation Ecosystem and Biotechnological Companies in Europe."
- The study highlights that the European Commission's proposal sends a concerning message to investors and innovative companies: the European Union has sidelined innovation in the field of health.
- The only way for the European Union to meet the current needs of patients, the economy, and its long-term resilience is to prioritize high levels of innovation in biotechnology.

EuropaBio, an association representing the biotechnological industry in Europe, of which AseBio is a part, has today released the results of its study titled "Impact of the General Pharmaceutical Legislation of the European Union on the Innovation Ecosystem and Biotechnological Companies in Europe."
The research raises concerns about the negative impact of the European Commission's General Pharmaceutical Legislation (GPL) project on innovation in the biotechnological sector, particularly for small companies. This can have a significant effect on countries like Spain, where 96% of biotechnological companies are SMEs and micro-enterprises, causing substantial harm at a critical time when we are engaged in a global race to improve patient safety in healthcare and maintain a competitive position.
Biotechnology emerges as a cornerstone of innovation in healthcare, as evidenced by advancements in addressing complex diseases through precision medicine and the progress made in recent years with advanced therapies.
The biotechnological sector operates in highly complex and regulated markets. In this regard, the current landscape reveals high risks and long development timelines until disruptive ideas translate into tangible benefits for patients. This scenario emphasizes the role of small companies as the primary drivers of innovation in an environment where collaboration between companies of all sizes is crucial.
The study denounces that the GPL sends a concerning message to investors and innovators: the European Union has relegated innovation in the field of health. In this regard, it criticizes that the reduction of foundational incentives serves as a barrier for early-stage biotechnology programs in all companies, regardless of their size. This situation significantly impacts small innovative companies, endangering the robust research base currently present in Europe.
According to the study's conclusions, the path outlined by the GPL makes it less likely to achieve objectives related to, for example, rare diseases, as restrictions and reductions in incentives also affect clinical trials and therapeutic options available to European patients.
The proposed reductions in incentives are part of the foundations of collaboration, essential for drug development. The study suggests that this reduction in incentives will decrease demand from more mature companies for technologies in early stages, thus negatively impacting collaborations between these companies and more innovative ones, significantly harming smaller companies.
The GPL should promote biotechnological innovation in the European Union
The study emphasizes that the positive changes introduced by the GPL do not offset the negative impact of the rest of the proposals or deems them ineffective, especially from the perspective of smaller companies. In this regard, the research argues that Europe progresses and succeeds when there is a commitment to fostering innovation. Increasing foundational incentives in the biotechnological sector will help more companies secure the necessary investment to tackle novel projects in early stages.
In a challenging market and investment landscape in Europe, innovative companies must be provided with a clear vision at all stages, as is done in other regions of the world. The study emphasizes that the GPL should allow biotechnological companies to take risks and thrive by attracting unrestricted investments. Therefore, its authors insist that the GPL should empower small biotech companies that innovate in the old continent rather than restrict them.
"The GPL should be a central pillar for the European Union's strategy for healthcare resilience through global competitiveness in biotechnology. It should empower European innovators, especially small and growing biotechnological companies, and re-prioritize the crucial role of our sector," argues Claire Skentelbery, the Director-General of EuropaBio.
"Instead of reducing, we should increase foundational incentives, eliminate the seven-year limit for Orphan Designation, extend market exclusivity for orphan drugs, and avoid definitions that restrict progress against rare diseases in Europe. This will allow Europe to grow as a global center of excellence in research and be a breeding ground for innovative drugs, benefiting patients, economies, and healthcare systems," concludes Skentelbery.
"We believe that the Commission's proposal has not taken into account the negative effects that changing the rules of the game will have on the most innovative and disruptive biotechnological companies, particularly small and medium-sized biotechs. Reducing incentives for innovation and overly complicating them jeopardizes the foundations upon which the biotechnological innovation ecosystem works, which, let's not forget, is the origin of 2/3 of biomedical innovations," concludes Ion Arocena, CEO of AseBio.
Ángel Luis Jiménez
Head of Communication and Content
662 172 126
ajimenez@asebio.com
AseBio brings together 300 entities and represents the entire Spanish biotechnology sector. Its mission is to lead the transformation of the country by positioning science, innovation, and especially biotechnology as drivers of economic growth and social well-being. Among its members are companies, associations, foundations, universities, technology centers, and research institutions that directly or indirectly engage in biotechnology-related activities in Spain.