Scalable Life Sciences
Scalable
Scalable Life Sciences is a strategic communications consultancy specializing in life sciences.
ID: 996467721056-18
Lobbying Activity
Response to Union prevention, preparedness, and response plan for health crises
20 Oct 2025
We applaud the European Commission with its plan to promote an effective and coordinated response to serious cross-border health threats at the EU and Member State levels. Such an EU-wide approach is urgently needed for adequate prevention, preparedness and response to the growing threats from natural and man-made origins, resulting from developments like climate change but also scenarios such as state sponsored terrorism and large-scale combat operations. This plan will also be crucial for the broad societal resilience the Union needs against these threats by assuring the timely availability of relevant medical countermeasures (MCMs). The Union plan will justifiably complement national prevention, preparedness and response plans. As serious health emergencies and threats may not limit themselves to one Member State, cross-border preparedness can only be effective if an adequate preparation at EU-level is matched by the necessary measures and investments within the Member States. Regarding the available budgets we feel the need to stress that the current budgets of the European Commission and the Member States are insufficient for adequate preparedness. Considerably higher investments are necessary. A strongly stimulating and coordinating role will be needed from the European Commission. Only with a shared EU-wide agreement on the priorities and the needs, adequate preparedness can be reached, especially because of the limited budgets available. We support the priority list of the Health Emergency Preparedness and Response Authority (HERA): (1) Pathogens with high pandemic potential, (2) Chemical, biological, radiological and nuclear threats (CBRN) and (3) Antimicrobial resistance (AMR). The plan should include a comprehensive approach for MCMs. Stockpiles of MCMs are crucial for medical countermeasures that are needed immediately or needed more quickly than they can be produced or imported in case of a relevant threat or outbreak. Reserve manufacturing capacity will be necessary for mid-term and future needs while the development of new medical countermeasures is needed for currently unknown health threats and relevant threats without effective countermeasures. To achieve the objectives set by the plan, it is vital to promote close coordination between public sector, industry, civil society, academia, and further relevant stakeholders, at both EU and national levels. Close coordination may help, for instance, to address potential bottlenecks concerning MCMs (e.g. in production or supply chains). Bilateral and regular exchanges with companies developing and supplying MCMs are also crucial to enhance the understanding of different needs and objectives from both public and private perspectives. It is important to ensure full alignment with already adopted initiatives to maximize effectiveness of the policies. In this context we would like to refer to the important role of HERA and initiatives like the EU Preparedness Union Strategy, the EU Medical Countermeasures Strategy and the Stockpiling Strategy.
Read full responseResponse to Biotech Act
11 Jun 2025
Strengthening Resilience, Strategic Independence, and Safety Through Biotech We would like to stress the importance of linking the future EU Biotech Act strongly to the need for strengthening broad societal resilience, strategic independence and safety of the European Union, especially in the health area. We applaud the European Commission on the initiative to strengthen biotech in Europe. Biotechnology contributes already to making the EU stronger against threats that we face now and in future in very different areas like climate change, health threats, state-level threats and terrorism. Especially as the technology is the foundation for many innovations that are and will be indispensable for broad societal resilience, effective responses against the different kinds of threats and EU strategic independence. A robust and internationally competitive biotech sector will be crucial to reach the objectives defined in the Niinistö Report on Preparedness and Readiness of the EU. In our opinion the three main tasks are making the EU attractive for biotech manufacturing, assuring the fast development within the EU of innovations against priority threats and most importantly a clear focus on the effective use of these biotech solutions on the EU and Member State levels. To accomplish this, the EU must also ensure that its internal market becomes competitive from a worldwide perspective and strongly supports the use of biotech innovations. The Act will have to address regulatory fragmentation, reach EU-wide agreement on priorities, harmonize procedures across Member States, and create a coherent framework that supports the deployment of biotechnology for safeguarding public health, security and safety. Furthermore, biotechnology has significant implications for security, safety and defense. The EU Biotech Act will not only have to help making (medical) countermeasures available but also incorporate measures to mitigate risks associated with dual-use technologies, biosecurity, state-level threats and terrorism. In essence, the EU Biotech Act should be a bold step toward securing Europe's future. By leveraging biotechnology for health resilience, strategic independence, and defense, the EU is reinforcing its position as a global leader in innovation, safety and security.
Read full responseResponse to EU Strategy on medical countermeasures
4 May 2025
The availability of medical countermeasures against priority health threats is crucial for preparedness and resilience within the European Union. An EU-wide coordinated approach with shared priorities and substantial additional investments at EU and national level are necessary to reach adequate preparedness. The European Commission rightly focuses in its plans on short- and long-term preparedness for the growing threat of health emergencies of both natural and man-made origin by state and non-state actors. We applaud HERAs priority list of top 3 health threats in the context of medical countermeasures that require coordination, action and substantial investments, namely: (1) Pathogens with high pandemic potential, (2) Chemical, biological, radiological and nuclear threats (CBRN) and (3) Antimicrobial resistance (AMR) with the related sub-topics of climate change and emerging technologies. We would like to stress the need for substantial investments in the development, timely availability, manufacturing and stockpiling of specialised biomedical countermeasures and vaccines for priority threats. Innovation remains critical to be prepared for known and yet unknown diseases, mutations of known diseases and those diseases that jump from animals to humans. Developments such as the fast growth of worldwide travel and climate change make this innovation even more important for our future preparedness. However, certain countermeasures will only be needed in numbers that are too small to recoup the development and / or manufacturing costs. Other products that we may need, will hopefully never be used at all. Therefore, the development of these types of products is not feasible for companies if only 50 percent of the R&D costs can be financed by the EU as currently is the case. In these situations, tailor-made financial support, a clear market-outlook / guarantee, regulatory collaboration, and regulatory flexibility may be needed to ensure that the industry can develop and manufacture these priority biomedical countermeasures. European financial incentives will have to be matched by national initiatives and a range of other policy options. In our view, the availability of additional manufacturing capacity remains important for the timely manufacturing of newly developed medical countermeasures or in case of unexpected high demand of current products. In this context, we would like to stress the need to ensure diversity between large players and small and mid-sized innovative companies. Stockpiling is crucial for improving the resilience of the EU, especially for critical medical countermeasures against priority cross-border health threats with a potentially large health and societal impact. In our view, stockpiling of medical countermeasures is important particularly for products against known health threats that are needed more quickly than they can be produced or imported during an outbreak or incident. An EU-wide coordinated approach and substantial additional investments at EU and national level are necessary to reach adequate preparedness.
Read full responseResponse to Communication on the EU Stockpiling Strategy
4 May 2025
Stockpiling is crucial for improving the preparedness and resilience of the EU, especially for critical medical countermeasures against priority cross-border health threats with a potentially large health and societal impact. In our view, stockpiling of medical countermeasures is important particularly for products against known health threats that are needed more quickly than they can be produced or imported during an outbreak or incident. An EU-wide coordinated approach and substantial additional investments at EU and national level are necessary to reach adequate preparedness. As serious health emergencies and threats may not limit themselves to one Member State, cross-border preparedness can only be effective if an adequate preparation at EU-level is matched by the necessary measures within the Member States. Highly pathogenic diseases pose a significant risk to people in Member States and across borders. Especially for dangerous infectious diseases or highly disruptive threats that spread easily, it is important to contain an outbreak or incident as quickly as possible. For these types of diseases, minimum local and regional stockpiles are needed not only to treat people, but also to prevent a disease from spreading further. The European Commission rightly focuses in its plans on short- and long-term preparedness for the growing threat of health emergencies of both natural and man-made origin by state and non-state actors. We applaud HERAs priority list of top 3 health threats in the context of medical countermeasures that require coordination, action and substantial investments, namely: (1) Pathogens with high pandemic potential, (2) Chemical, biological, radiological and nuclear threats (CBRN) and (3) Antimicrobial resistance (AMR) with the related sub-topics of climate change and emerging technologies. We would like to refer to the EUCOPE stockpiling white paper for more information (https://www.eucope.org/eucope-releases-a-white-paper-on-eu-wide-stockpiling/).
Read full response