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Läkemedelsindustriföreningen

Lif

Lif är branschorganisationen för de forskande läkemedelsföretagen i Sverige.

Lobbying Activity

Response to Union prevention, preparedness, and response plan for health crises

29 Oct 2025

Lif the Swedish Association of the Research-Based Pharmaceutical Industry, representing nearly 100 innovative pharmaceutical companies in Sweden wishes to contribute to the Unions health crisis prevention, preparedness, and response plan. Lif wishes to emphasise that, irrespective of the actions proposed in the plan, the capacity to respond effectively during times of crisis will be severely undermined unless there are competitive market conditions, a skilled and readily available workforce, and the ability to allocate capital effectively during periods of normality. The COVID-19 pandemic underscored the need for a robust, agile, and competitive European capacity to develop, manufacture, and deploy medical countermeasures. To achieve this,it is of outmost importance that the EU must establish a policy and regulatory environment that enables innovation, investment, and resilient production capacity and mechanisms that connect the research, regulation, manufacturing, and deployment throughout the crisis cycle. Cooperation among EU institutions, industry, academia and international partners is therefore essential. Appropriate measures to include in this plan are streamlined regulatory pathways that enable fast-track and proportionate routes for medical countermeasures addressing high-priority threats,a seamless framework for adaptive, multicountry trials with harmonised ethics procedures, interoperable data governance, and mutual recognition of authorisations, and reinforcement of EU-wide research networks and data systems to ensure interoperability between research sites, clinical trials hubs, and real-time surveillance platforms to prevent fragmentation and accelerate activation. These measures would enhance the EUs capacity to prevent and prepare for future crises. Multicountry clinical trials and fast-tracking high-priority treatments will help ensure a stronger, more resilient EU. It is vital that the accelerated assessment and emergency fast-track mechanisms in the new EU pharmaceutical legislation are maintained throughout the legislative process and implemented. Another action to increase the ability to handle future crises is to create a system that facilitates rapid and coordinated deployment of medical countermeasures. During crises, fragmented national actions undermine equitable supply. Lif are thus pleased to see that the plan intends to focus on multisectoral collaboration and cross-border solutions. The pharmaceutical industry is dependent on a well-functioning collaboration between member states and multiple other actors, both public and private, to produce and develop new innovative treatments. It is therefore essential that the private sector is involved in the formation of this type of a plan. Producing new medical countermeasures is accompanied by high risk and high costs. It is thus of outmost importance that the EU facilitates a coherent, long-term investment and coordination framework. Sustained public-private collaboration should serve as the backbone of preparedness with connecting research, innovation, manufacturing, regulation, and logistics. A skilled and mobile workforce underpins the above mentioned and thus the EU should promote mutual recognition of qualification, flexible mobility for critical health and manufacturing personnel, and investment in scientific, digital, and regulatory skills to ensure expertise can be deployed swiftly across borders. To enhance cross-border collaboration, the Erasmus+ program should also be expanded to include researchers, fostering mobility and knowledge exchange across Europe. This would increase the ability to attracted and keep skilled researchers within the union. Lif welcomes the initiative and are happy to give further feedback on the composition and focus of this plan.
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Response to European Innovation Act

3 Oct 2025

Lif the research-based pharmaceuticals industry in Sweden is grateful for the opportunity to give our remarks on the proposed regulation. The pharmaceutical industry in Sweden is of great strategic importance. Employing over 16,000 people, its total exports of pharmaceuticals from Sweden amount to SEK 151 billion. Swedish and European companies in this sector invest heavily in research and development. In Sweden the pharmaceutical industry contributes with SEK 11.9 billion in research investments and employs 2 800 researchers. Its importance was highlighted during the pandemic, when rapid vaccine development and the supply of critical diagnostics were vital. Lif appreciates the opportunity to comment on the call for evidence for an impact assessment. The areas of intervention that are considered to address the innovation gap between EU and its global competitors are the following: (i) Simplifying and making the existing regulatory framework more innovation friendly; (ii) Facilitating access to finance; (iii) Supporting access of innovative companies to EU and national funds; (iv) Supporting innovative companies in developing and testing their innovations; (v) Facilitating the deployment and diffusion of innovations in the market; (vi) Enabling innovative companies to better attract and retain talent; (vii) Improving the commercialisation and lastly; (viii) Establishing a framework facilitating coordination of innovation policies. The objective of the act to closing the innovation gap is much welcomed but in this legislative process and especially in regard to the areas of intervention that are being considered Lif would like to highlight the need for critical thinking and reflection by the Commission. Many of the areas mentioned above adress challenges that are adressed in other legislative initiatives. Examples of this are the multiple Omnibus packages, the Savings and Investments Union, revision of the Horizon Europe and Competitiveness Fund, European Research Area Act and the Biotech Act. In the following impact assessment, Lif would like the Commission to carefully scrutinize related legislative initiatives. With the Commission´s objective of simplification, the areas of intervention mentioned above risk create overlapping legislations and thus hindering the ability to simplify. The pharmaceutical industry is currently facing significant geopolitical shifts, which present substantial challenges to its operations. Pharmaceutical companies are now confronted with pricing policies with the Most Favoured Nation (MFN) principle, as well as increased tariffs, both presented by the US administration. These developments necessitate decisive and robust action within the European Union. It is imperative that the EU acts swiftly and strategically to prevent a further erosion of its market share in the global pharmaceutical market. In the spirit of simplification and the great need for it, Lif support the overall objectives of the European Innovation Act but questions if another act is the right way to handle the mentioned challenges. Lif thus advocates for a revision of the different legislations that today affect innovative sectors and their ability to operate and be competitive. The revision of legislation affecting the pharmaceutical industry through a Pharmaceuticals Omnibus is of great need for and importance of in times where the global market is witnessing a great shift. A shift that, if the EU does not take the necessary actions, risk the availability of innovative medicines to European patients. EU must make its own market more attractive for innovative companies an Omnibus focused on the sector with the largest export to the US is a necessary first step to safeguard EU competitiveness now and in the future the EU must act to create the right market conditions for the pharmaceutical sector and thus safeguarding the accessibility of innovative medicines to EU citizens.
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Response to Omnibus Regulation Aligning product legislation with the digital age

1 Sept 2025

Lif the research-based pharmaceuticals industry in Sweden is grateful for the opportunity to give our remarks on the proposed regulation and directive with the goal of aligning product legislation with the digital age. The life sciences sectorcovering pharmaceuticals, medical devices, in vitro diagnostics, medical software, and biotechnologyis a strategic industry for Sweden. Employing over 52,000 people, it accounts for 10% of the countrys total goods exports. Swedish and European companies in this sector invest heavily in research and development, fueling advances in biotechnology, AI, and digital health. Its importance was highlighted during the pandemic, when rapid vaccine development and the supply of critical diagnostics were vital. Lif appreciates the opportunity to comment on the proposed regulation and directive, with a focus on the provision for common specifications as an alternative to harmonised standards. Digital first From Lifs standpoint, we strongly support the overall move towards a more digitalized EU regulatory environment. We believe that electronic communication with authorities should become the standard approach, reflecting the needs of an innovative and future-oriented life science sector that already experience heavy administrative burden. Simplification and a digital first principle present clear advantagesstreamlined processes, faster responses, and improved accessibility for companies and regulators alike. Lif advocates for the possibility to conduct interactions with authorities in a smooth, secure, and user-friendly manner through digital channels and reliable electronic services. In our view, prioritizing digital communication is not only a logical step given technological advances but is also essential for maintaining the competitiveness and agility of the Swedish and European life sciences industries. Standards and specifications The pharmaceutical sector is highly regulated, and the use of standards and specifications plays a central role. For our companies, it is crucial that globally accepted standards are applied and that the standards required by different authorities are consistent. We would like to stress that both standards and specifications are needed. While standards provide an essential foundation, they alone are not sufficiently specific to enable true digital advancement. Specifications must therefore complement them. However, it is vital that EU standards and specifications do not become arbitrary or diverge from internationally recognized norms. There must be assurance for companies that any specifications created within the EU will be respected and recognized on the global market. If this is not ensured, there is a clear risk to the EUs competitiveness and growth potential, as increased divergence would weaken the connection between European and global markets. Sharing data between authorities One important dimension Lif believes should be addressed is enabling authorities within the EU to share data seamlessly among themselves. Implementing such measures would greatly alleviate the reporting demands placed upon companies, fostering a regulatory environment that is both more efficient and less cumbersome. At a time when the EU Commission is actively seeking to simplify regulations and enhance competitiveness, facilitating data exchange between authorities would create considerable relief for businessesespecially for small and medium-sized enterprises. This approach would reduce the redundancy of submitting identical information to multiple authorities, allowing companies to direct their resources toward innovation and growth. Data sharing should be enabled while recognising the nature of the information exchanged between authorities. It is essential to protect companies trade secrets, ensuring ongoing dialogue between companies and relevant authorities.
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Response to Omnibus Directive Aligning product legislation with the digital age

1 Sept 2025

Lif the research-based pharmaceuticals industry in Sweden is grateful for the opportunity to give our remarks on the proposed regulation and directive with the goal of aligning product legislation with the digital age. The life sciences sectorcovering pharmaceuticals, medical devices, in vitro diagnostics, medical software, and biotechnologyis a strategic industry for Sweden. Employing over 52,000 people, it accounts for 10% of the countrys total goods exports. Swedish and European companies in this sector invest heavily in research and development, fueling advances in biotechnology, AI, and digital health. Its importance was highlighted during the pandemic, when rapid vaccine development and the supply of critical diagnostics were vital. Lif appreciates the opportunity to comment on the proposed regulation and directive, with a focus on the provision for common specifications as an alternative to harmonised standards. Digital first From Lifs standpoint, we strongly support the overall move towards a more digitalized EU regulatory environment. We believe that electronic communication with authorities should become the standard approach, reflecting the needs of an innovative and future-oriented life science sector that already experience heavy administrative burden. Simplification and a digital first principle present clear advantagesstreamlined processes, faster responses, and improved accessibility for companies and regulators alike. Lif advocates for the possibility to conduct interactions with authorities in a smooth, secure, and user-friendly manner through digital channels and reliable electronic services. In our view, prioritizing digital communication is not only a logical step given technological advances but is also essential for maintaining the competitiveness and agility of the Swedish and European life sciences industries. Standards and specifications The pharmaceutical sector is highly regulated, and the use of standards and specifications plays a central role. For our companies, it is crucial that globally accepted standards are applied and that the standards required by different authorities are consistent. We would like to stress that both standards and specifications are needed. While standards provide an essential foundation, they alone are not sufficiently specific to enable true digital advancement. Specifications must therefore complement them. However, it is vital that EU standards and specifications do not become arbitrary or diverge from internationally recognized norms. There must be assurance for companies that any specifications created within the EU will be respected and recognized on the global market. If this is not ensured, there is a clear risk to the EUs competitiveness and growth potential, as increased divergence would weaken the connection between European and global markets. Sharing data between authorities One important dimension Lif believes should be addressed is enabling authorities within the EU to share data seamlessly among themselves. Implementing such measures would greatly alleviate the reporting demands placed upon companies, fostering a regulatory environment that is both more efficient and less cumbersome. At a time when the EU Commission is actively seeking to simplify regulations and enhance competitiveness, facilitating data exchange between authorities would create considerable relief for businessesespecially for small and medium-sized enterprises. This approach would reduce the redundancy of submitting identical information to multiple authorities, allowing companies to direct their resources toward innovation and growth. Data sharing should be enabled while recognising the nature of the information exchanged between authorities. It is essential to protect companies trade secrets, ensuring ongoing dialogue between companies and relevant authorities.
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Response to Biotech Act

11 Jun 2025

Lif and SwedenBIO welcomes the opportunity to be a part of the creation of the Biotech Act and strongly support the intent to foster an innovation-conducive framework to improve the competitiveness of the EU biopharmaceutical sector. At the light of the geopolitical reality the EU now faces, ongoing and future regulation must ensure innovation and competitiveness without imposing additional regulatory burdens. Lif and SwedenBIO emphasize that the Biotech Act should not exacerbate the already complex regulatory environment within EU. A well-structured impact assessment is critical to fully address the biotechnology sector's needs while avoiding unnecessary hindrances to businesses, regardless of their size. It is vital that the Biotech Act supports both SMEs, start-ups and spin-offs and large corporations, recognizing their interdependence within the pharmaceutical sector and ensuring that its provisions enhance, rather than obstruct, growth and efficiency. In light of the falling share of clinical trials conducted in the EU, the Biotech Act should focus on conducting a pragmatic implementation of the Clinical Trials Regulation, avoiding requirements beyond its scope. Changing this trend is an important step in increasing the competitiveness of the EU market. The Biotech Act must align with existing legislation and ongoing initiatives, such as the General Pharmaceutical Legislation, Critical Medicines Act, AI in Science and Apply AI strategy, Urban Wastewater Treatment Directive, HTAR, and other relevant strategies and regulations. The EU must seize this opportunity to streamline legislation and foster a business and market environment that encourages innovation and competitiveness, allowing biotechnology companies to thrive. The market's success hinges on the actual use of biotechnology products, supported by efficient access systems and healthcare demand within the EU. A well-functioning home market is imperative for a company to expand and succeed at the international level. By combining targeted incentives, infrastructure investment, regulatory modernization, establishing a centre of excellence for manufacturing innovation underpinned by resources, confidentiality and sandbox principles, and strategic support for innovation ecosystems, the EU can ensure that biotech companies not only thrive but lead globally from within Europe. The Biotech Act might establish a center specifically designed for promoting the manufacturing of innovation. It should be supported by adequate resources and confidentiality and sandbox testing environments. The Biotech Act also provides an important opportunity for strengthening the life science industries in EU via strengthening the IP framework. If EU established a bestin-class IP environment it would underpin and support critical R&D and encourage investment, resulting in new innovative therapies. Reforming the next EU framework program to better align with industry requirements and societal objectives is essential. We urge policymakers to consider reforms to pension fund regulations that would unlock private investment by increasing liquidity for venture capital and SME financing. Targeted strategic research and innovation initiatives to increase collaboration between academia, healthcare, and companies are necessary to enhance the ability to address the societal challenges faced by the biotech sector and, at the same time, connect scientists to the industry ecosystem. To maximize health data's value for AI, interoperability between systems and AI-ready data formats are essential. It is essential that the proposed Biotech Act is designed in a manner that anticipates future developments and aligns seamlessly with existing AIand Data-related regulations and strategies, such as the AI in Science Strategy, the Apply AI Strategy, and the EHDS.
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Response to A European Strategy for AI in science – paving the way for a European AI research council

4 Jun 2025

Lif the Swedish Association of the Research-Based Pharmaceutical Industry, representing nearly 100 innovative pharmaceutical companies in Sweden welcomes the opportunity to contribute to the AI in Science and Applied AI strategies. The AI in Science Strategy and the Applied AI strategy is vital for the pharmaceutical industry, where Artificial Intelligence (AI) could significantly boost European competitiveness and AI holds transformative potential across the pharmaceutical value chain, from drug discovery and clinical trial optimization to manufacturing and personalised medicine. AI is rapidly transforming healthcare and life sciences by enhancing research efficiency, accelerating treatment development, and improving patient care. From drug discovery and precision medicine to predictive diagnostics and healthcare management, AI offers unprecedented opportunities to make treatments more effective, accessible, and sustainable. However, to fully unlock this potential, it is essential to address regulatory challenges, improve data accessibility, and ensure coordinated policy efforts across the EU, while fostering ethical and responsible AI practices to promote widespread and sustainable adoption. Key applications of AI in pharmaceuticals Drug discovery and development: AI accelerates target identification, drug formulation, and patient selection in clinical trials, significantly reducing time and costs. Manufacturing and quality control: AI-driven automation boosts efficiency, minimizes variability, and enhances quality control, ensuring consistent output. Pharmacovigilance and post-market surveillance: AI continuously monitors realworld data to detect safety signals early, improving patient safety and ensuring regulatory compliance. Precision medicine: By integrating omics data, registry data, and clinical information, AI enable enhanced development of targeted treatment plans that enhance therapeutic effectiveness while minimizing side effects. Research efficiency: AI supports data-driven research by automating repetitive tasks, analyzing large datasets, and identifying patterns that would be challenging for traditional methods, accelerating innovation and discovery. Given these transformative applications, to ensure that Europe remains competitive in AI, a research-friendly ecosystem is needed that promotes the rapid translation of scientific breakthroughs into practical applications. Lif welcomes EU-level rules and guidelines that address the risks associated with AI while establishing a robust policy framework for responsible AI, such as the AI Act. These measures are essential to fostering public trust in new technologies. However, it is equally crucial that these rules remain proportionate and balanced, avoiding excessive details that could stifle innovation or impose unnecessary administrative burdens on companies and thereby reducing their competitiveness and the EUs ability to attract international investments. Equally important is policy coherence between different AI-related regulations to ensure consistency and predictability for businesses. A coordinated, innovation-friendly approach will help maintain regulatory clarity while supporting the responsible development and deployment of AI solutions.
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Response to Apply AI Strategy

4 Jun 2025

Lif the Swedish Association of the Research-Based Pharmaceutical Industry, representing nearly 100 innovative pharmaceutical companies in Sweden welcomes the opportunity to contribute to the AI in Science and Applied AI strategies. The AI in Science Strategy and the Applied AI strategy is vital for the pharmaceutical industry, where Artificial Intelligence (AI) could significantly boost European competitiveness and AI holds transformative potential across the pharmaceutical value chain, from drug discovery and clinical trial optimization to manufacturing and personalised medicine. AI is rapidly transforming healthcare and life sciences by enhancing research efficiency, accelerating treatment development, and improving patient care. From drug discovery and precision medicine to predictive diagnostics and healthcare management, AI offers unprecedented opportunities to make treatments more effective, accessible, and sustainable. However, to fully unlock this potential, it is essential to address regulatory challenges, improve data accessibility, and ensure coordinated policy efforts across the EU, while fostering ethical and responsible AI practices to promote widespread and sustainable adoption. Key applications of AI in pharmaceuticals Drug discovery and development: AI accelerates target identification, drug formulation, and patient selection in clinical trials, significantly reducing time and costs. Manufacturing and quality control: AI-driven automation boosts efficiency, minimizes variability, and enhances quality control, ensuring consistent output. Pharmacovigilance and post-market surveillance: AI continuously monitors realworld data to detect safety signals early, improving patient safety and ensuring regulatory compliance. Precision medicine: By integrating omics data, registry data, and clinical information, AI enable enhanced development of targeted treatment plans that enhance therapeutic effectiveness while minimizing side effects. Research efficiency: AI supports data-driven research by automating repetitive tasks, analyzing large datasets, and identifying patterns that would be challenging for traditional methods, accelerating innovation and discovery. Given these transformative applications, to ensure that Europe remains competitive in AI, a research-friendly ecosystem is needed that promotes the rapid translation of scientific breakthroughs into practical applications. Lif welcomes EU-level rules and guidelines that address the risks associated with AI while establishing a robust policy framework for responsible AI, such as the AI Act. These measures are essential to fostering public trust in new technologies. However, it is equally crucial that these rules remain proportionate and balanced, avoiding excessive details that could stifle innovation or impose unnecessary administrative burdens on companies and thereby reducing their competitiveness and the EUs ability to attract international investments. Equally important is policy coherence between different AI-related regulations to ensure consistency and predictability for businesses. A coordinated, innovation-friendly approach will help maintain regulatory clarity while supporting the responsible development and deployment of AI solutions.
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Response to European strategy on research and technology infrastructures

22 May 2025

Lif representing nearly 100 innovative pharmaceutical companies in Sweden welcomes the European Commissions initiative to develop a coherent and future-proof EU strategy on research and technology infrastructures. The paper emphasizes the critical role of these infrastructures in supporting scientific excellence, industrial innovation, and European competitiveness, particularly in the face of growing global competition. Lif underscores the need for a strategy that balances academic excellence with industry relevance. The pharmaceutical sector, being one of the most innovative in the EU, must be better integrated into the EUs research ecosystem to translate scientific advancements into societal and economic value. The organization supports a stronger business-oriented perspective within EU research policy, including access to shared research infrastructures, scale-up environments, and cross-sector collaboration platforms. Key priorities highlighted include: A focus on competitiveness: Addressing the EU's declining global share in R&D and clinical trials by facilitating greater industry access to infrastructure and ensuring predictable, efficient processes. Development of shared innovation platforms: Investing in jointly funded, collaborative environments that support the full innovation chain, from research to commercialization. Reduction of administrative barriers: Streamlining contracting and access procedures to foster more strategic partnerships between academia and industry. Sustainable and aligned funding: Reforming EU framework programs to be more accessible, strategically focused, and conducive to private sector engagement, while improving coordination of public R&D funding. Improved transparency and access to resources: Establishing an EU-wide platform to centralize information on funding and infrastructure opportunities for life sciences. Lif urges the Commission to maintain a strong dialogue with industry stakeholders and ensure that the final strategy is equipped to drive meaningful innovation, create jobs, and enhance the EUs position as a global leader in life sciences and pharmaceutical research. Lif shares the EUs ambitions of strengthening the functioning of the research and technology infrastructure in the EU and the need to increase our efforts to tackle the challenges brought by and increasingly competitive international environment. Research infrastructures constitute an important pillar of the European research and innovation system and are a key component for achieving the Commission's ambitious objectives. Creating good organisational and structural conditions for these facilities, as well as the strategic prioritisation of facilities that offer the greatest value for enhancing the EUs competitiveness, is therefore of utmost importance together with the need that the functioning and operation of research infrastructures are considered from a broader perspective and based on the needs of more actors beyond purely academic research. The challenges the EU currently faces are well documented, and coordinated and effective measures are necessary. Lif, who represents the pharmaceutical industry, concur on the challenges described by the Draghi report, with the EU are falling behind our competitors in several areas, and thus emphasizes the importance of a strategy focused on both scientific and societal objectives where the governance models must balance academic excellence with user relevance, including industry need. In this context, Lif welcomes the Commissions initiative and contributes the following perspectives.
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Response to Communication on the EU Stockpiling Strategy

9 May 2025

Lif welcomes the EUs initiative to develop a coordinated stockpiling strategy as part of broader efforts to strengthen crisis preparedness. While the strategy spans multiple sectors, Lifs input focuses on pharmaceuticals. Stockpiling can be useful in well-justified cases such as for low-volume, critical, or semi-finished medicines but should not be seen as a stand-alone solution. It must form part of a proportionate, efficient, and targeted approach that safeguards market functioning, competition, and patient access. A future-proof strategy should promote smarter coordination between Member States, enhance transparency, and be guided by clear principles on when, what, and how to stockpile. With the right frameworks in place, stockpiling can in specific cases support resilience if it complements rather than disrupts existing pharmaceutical ecosystems. Lif the Swedish Association of the Research-Based Pharmaceutical Industry, representing nearly 100 innovative pharmaceutical companies in Sweden welcomes the opportunity to contribute to a future-proof EU Stockpiling Strategy. We share the EUs goal of strengthening supply security and ensuring patient access in times of crisis. Lif supports a balanced and evidence-based approach that improves resilience without undermining innovation, competition, or the Single Market. Lif does not see a clear need for legally mandated stockpiling obligations involving large-scale pharmaceutical reserves. The current supply system has proven robust, including during the COVID-19 pandemic, when major disruptions were largely avoided despite global pressure. Lif believes long-term resilience is better achieved by addressing the root causes of shortages through stronger, more diversified value chains, increased European production capacity, and regulatory frameworks that support both reliable supply and the EU pharmaceutical sectors global competitiveness. At the same time, we acknowledge that stockpiling may have a role in specific, well-justified cases. Increased safety stocks can provide a short-term buffer during unexpected disruptions, particularly for critical or low-volume medicines. However, stockpiling should remain one of several complementary tools not a stand-alone or broadly applied solution.
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Response to EU Life sciences strategy

15 Apr 2025

Important Factors for the EU Life Sciences Strategy The life sciences sectorencompassing pharmaceuticals, medical devices, in vitro diagnostics, medical software, and biotechnologyis one of Swedens most strategic industries. With over 52,000 employees, it is a key driver of job creation and accounts for 10% of Swedens total goods exports. The Swedish and European life sciences sectors invest a significant share of their revenue in research and development, driving progress in groundbreaking technologies such as biotechnology, AI, and digital health. The sector also holds substantial geostrategic importance, as demonstrated during the pandemic, when the rapid development and production of vaccines proved essential as well as the supply of medical devices and in vitro diagnostics to diagnose and treat patients. These strengths present the EU with a unique opportunity to consolidate and strengthen its global position. However, realizing this potential requires decisive and targeted measures to enhance competitiveness and resilience. The EU thus needs to ensure a more efficient, sustainable and resilient health-care infrastructure throughout the future multi-annual financial framework. The European life sciences sector faces fierce competition from the United States and China, both of which are making substantial investments to strengthen their positions. The Draghi report highlights that Europe has lost 25% of its global Research & Development investment share over the past two decades, while its share of clinical trials has declined from 25.6% to 19.3%. Simultaneously, escalating geopolitical tensions underscore the need to reinforce Europes production capacity to ensure greater resilience in times of crisis. These developments emphasize the urgency of a renewed European strategyone that not only addresses these challenges but also enhances the EUs attractiveness as a destination for Research & Development investment, manufacturing, and clinical trials. The announcement of a new European life sciences strategy is a highly welcomed initiative. A coordinated strategy is essential to create the right conditions for restoring EUs leadership in the sector. Since 2019, Sweden has successfully implemented a national life sciences strategy, with several initiatives that could be scaled up to benefit the entire EU. The new EU strategy should incorporate the following key elements to enhance the sectors global competitiveness: Effective governance through a dedicated Life Sciences Office Facilitating access to groundbreaking innovations Strengthening conditions for research and innovation Improving framework conditions for production in the EU Promoting free and fair trade By integrating these elements, the EU can reinforce its position as a global leader in life sciences while driving innovation, economic growth, and resilience across the sector.
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Meeting with Jessika Roswall (Commissioner) and

15 Mar 2025 · Impact of EU environmental policies on the life science sector

Meeting with Rainer Becker (Director Health and Food Safety)

11 Feb 2025 · Exchange of views on EU policies in the areas of life science and biotechnology

Meeting with Giulia Del Brenna (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs)

11 Feb 2025 · The current state of the EU pharmaceutical sector, ways to strengthen EU competitiveness, the forthcoming Life Sciences Strategy and Biotech Act

Meeting with Karin Karlsbro (Member of the European Parliament) and AstraZeneca PLC

29 Jan 2025 · Läkemedelsindustri

Meeting with Sara Skyttedal (Member of the European Parliament)

17 May 2022 · EU Pharmaceutical Strategy

Meeting with Fabrice Comptour (Cabinet of Commissioner Elżbieta Bieńkowska), Kaius Kristian Hedberg (Cabinet of Commissioner Elżbieta Bieńkowska) and

15 Feb 2018 · pharmaceutical IP incentives