What role can the EU play in driving sustainable growth, resilience, and global biotechnology leadership?
Gilles Marrache: Geopolitical shifts are reshaping the playing field for the strategically important life sciences industry. Despite a rich legacy in life sciences, Europe’s biotechnology sector is increasingly constrained by a fragmented, complex environment resulting in limited access to innovative medicines for patients.
To remain competitive in line with the Draghi report’s ambitions and ensure better outcomes for patients and economic opportunities, the EU must attract global investment by modernising regulatory systems, strengthening intellectual property protections, and increasing investment in innovative medicines.
The upcoming European Biotech Act offers a crucial opportunity to address long-standing structural barriers and re-establish the EU as a world-class destination for biotech investment and innovation.
Tomislav Sokol: The EU has a key role to play in biotechnology by boosting R&I, creating a more innovation-friendly regulatory framework, and investing in biomanufacturing capacity to strengthen resilience and strategic autonomy. This is particularly true for the pharmaceutical sector, which is both a strategic industry and essential for public health.
Translating its strong scientific base into sustainable growth, greater resilience, and global leadership in biotechnology requires scaling up support for cutting-edge science, fostering cross-border collaboration, and ensuring faster, harmonized approval pathways.
We have already begun working on the Critical Medicines Act, which will strongly boost the EU pharmaceutical sector competitiveness with strategic projects to help scale up the industry in Europe and by ensuring that public procurement prioritises medicinal products produced in the EU rather than relying solely on price criteria.
Increasing funding for health in the next MFF will be essential, as is preserving EU4Health as a separate and self-standing program to drive global leadership in biotechnology. This must go along with easing private investments — crucial to unlock the full potential of innovation in both pharmaceutical and biotechnology sectors. When effectively combined with strategic public funding, this approach accelerates the development and availability of advanced therapies, ultimately improving health outcomes for patients across the European Union.
Increasing funding for health in the next MFF will be essential, as is preserving EU4Health as a separate and self-standing program to drive global leadership in biotechnology
How could the Biotech Act benefit European patients?
GM: Today, many innovative medicines rely on complex manufacturing processes that demand advanced regulatory expertise. Yet, Europe’s framework hasn’t kept pace with scientific progress.
By creating faster and more predictable pathways for therapies to reach the market, the Biotech Act can ensure that people living with cancer, rare diseases, and other serious conditions can access life-changing innovations.
Clinical trial streamlining can also bring research opportunities closer to patients across Europe, which is especially important given Europe’s share of commercial trials fell from 22% (2013) to 12% (2023) even as global trials rose 38% — implying ~60,000 fewer patient places in EEA trials. Meanwhile, supply chain modernisation can improve resiliency and reduce delays in access to medicines.
TS: It has the potential to deliver major benefits for European patients by accelerating access to innovative treatments, encouraging investment in advanced therapies, and reinforcing Europe’s position in global biotech innovation, which can ensure that patients gain earlier access to new medicines and more options for rare diseases.
This would help keep Europe at the forefront of medical progress while improving health outcomes. To maximise these benefits, the EU also needs to modernise its clinical trial framework.
Simplifying and harmonising trial rules would make Europe more attractive for research, increase the number of trials conducted, and allow patients to access cutting-edge therapies sooner, while strengthening Europe’s contribution to global medical research.
How should the Biotech Act enhance Europe’s industrial competitiveness and resolve the regulatory hurdles that slow biotech innovation?
GM: Over the last 20 years pharmaceutical investment in the EU has not kept pace with global markets, particularly the U.S. and China. For instance, the U.S.-Europe private pharma R&D gap widened from ~€2 billion (2002) to ~€25 billion (2020).
The Biotech Act is an opportunity to modernise approval processes to reflect the current realities of biotechnology by streamlining clinical trial procedures across Member States, accelerating regulatory pathways, and eliminating duplicative requirements such as redundant import testing.
Furthermore, our intellectual property system needs to be more consistent and predictable in the review and enforcement of IP rights in order to attract biotech investment.
TS: It should do so by creating a more predictable and innovation-friendly regulatory environment: clearer rules and faster procedures would incentivise companies to invest and scale in the EU, ensuring Europe can keep pace with the US and China, which are currently leading in biotech innovation.
Strengthening Europe’s industrial base would support jobs, secure supply chains, and position the EU as a global player in advanced therapies. At the same time, the Act must tackle the regulatory hurdles that slow biotech progress, such as fragmented approval processes, inconsistent implementation across Member States, and lengthy timelines.
Simplifying, harmonising, and speeding up regulatory pathways would reduce uncertainty for innovators, accelerate translation of research into marketable products, and improve patient access to breakthrough treatments.
By creating faster and more predictable pathways for therapies to reach the market, the Biotech Act can ensure that people living with cancer, rare diseases, and other serious conditions can access life-changing innovations
How can we ensure the Biotech Act complements rather than duplicates existing EU legislation, while providing the tools to deliver faster access to patients?
GM: Within Europe, there is a need for an overarching piece of legislation that ensures upcoming and ongoing policy initiatives work efficiently together in the context of biotechnology.
The Biotech Act should complement, not duplicate, existing frameworks such as the Clinical Trial Regulation and the In Vitro Diagnostic Device Regulation by creating a centralised and coordinated clinical trial process under EMA supervision, standardising ethics reviews across Member States, and establishing regulatory sandboxes that allow new technologies to be tested in a controlled way.
At the same time, it must provide flexibility in addressing today’s fast-moving knowledge and technical landscape, including digitalisation and the use of artificial intelligence. Ultimately, these changes will result in a stronger, modernised biotech ecosystem that leads to healthier societies, with sustainable healthcare systems and patients able to benefit from the latest scientific breakthroughs without leaving Europe behind.
TS: The Biotech Act should work as a framework that fills gaps and makes the existing system faster and more coherent. To avoid duplication, it must clearly define its scope and align closely with existing EU laws.
At the same time, it could address areas that are not fully covered today, such as scaling up manufacturing capacity for advanced therapies or creating a more supportive environment for cross-border clinical trials.
By streamlining processes and reducing red tape, it can complement the existing framework and ensure that patients across Europe gain quicker access to biotech innovation.
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