The Biotech Act can help Europe compete again in life sciences but on its own cannot deliver the change that Europe urgently requires

Europe has enormous strengths in science, manufacturing and its industrial base, but struggles to translate this into investment, clinical trials and new medicines. Faced with rising global competition, a more ambitious approach is needed.

The rationale for strengthening Europe’s position in the global life sciences ecosystem is clear. If Europe can match or exceed the pace and scale of other regions, it will mean stronger growth, more high-value jobs, and better health for our populations.

There is much to be proud of: our industrial base; Europe’s world-leading scientific excellence, reflected in the EU’s continued leadership in producing highly cited medical sciences publications; and the fact that without the pharmaceutical industry, the EU’s goods trade balance would shift from a €133 billion surplus to a €93 billion deficit.

In other areas, the picture is less encouraging. In 2025, out of a total of 104 new molecules, 46 originated from Chinese headquartered companies, whilst 28 and 16 originated from US and European headquartered companies respectively. Europe lost its position as the world leader in discovering new molecules in 2000. By 2025, it ranked third globally, behind China and the United States.

Over the last decade, European pharmaceutical R&D investment has grown steadily, but at a pace that has not kept up with global trends. EU growth rates are lower than the US and less than half China’s rate of growth.

Despite some progress, EU approval timelines remain longer than that of China and the US. China’s approval times stand at 390 days, and the US is approving medicines within a year (356 days), compared with 430 days in Europe.

Even for products that navigate European’s regulatory system, there is no guarantee of reaching patients. The median time to access new treatments in Europe is 532 days, ranging from 56 days in Germany to 1,201 days in Romania. Only half of approved innovative medicines are available to European patients.

Access issues have persisted for more than a decade and with today’s geopolitical pressures, they risk getting worse. Data shows a downward trend of FDA approved medicines being approved in Europe, with a particularly steeply drop since October 2025.

Should this trend continue, China will overtake Europe for the first time in approving and launching new medicines.

An opportunity to improve the clinical trials landscape in Europe

The Biotech Act can provide a timely boost for research, clinical development and advanced manufacturing, ultimately accelerating access to new therapies for patients.

The Act has the potential to tackle one of the most enduring and concerning trends in the life sciences: Europe’s relative decline in clinical trials.

Trials attract investment and talent, while helping to bring the latest treatments to patients. Over the past decade, despite the total number of global clinical trials increasing by 38%, Europe has lost 60,000 trial places.

At the same time, the United States and China have invested heavily in becoming more attractive for research and innovation. That has clear implications for Europe’s global competitiveness and should ring alarm bells not only in the life sciences sector, but for policymakers and society.

There are several reasons for this worrying trend. Fragmentation in the administration of clinical trials in the EU has presented a long-standing challenge for pharmaceutical companies. Faster, more predictable, harmonised approvals processes are sorely needed. This means accelerating timelines for trial start-up and assessment, while ensuring that multi-country trials can operate through a single, streamlined process without additional national requirements.

The Biotech Act’s ambition to reduce clinical trial approval timelines to 75 days would make Europe more attractive for innovative or time-critical trials. These timelines would also be among the fastest globally, particularly as they include ethics committee approval, unlike in some other jurisdictions where this is handled separately.

At the same time, Europe must invest in the future of clinical research by strengthening infrastructure, supporting trial sites, developing expert talent, and advancing digital tools. Underpinning all of this is the need to ensure that the EU Clinical Trials Information System (CTIS) is simple, reliable, flexible, and genuinely user-friendly.

SPC extension: an effective incentive for R&D investment

Clinical trials are an important piece of the puzzle – intellectual property (IP) is another. Recent research shows that compared with global peers, the EU currently falls behind the US, UK and Switzerland for its intellectual property offering. Strengthening IP protection, through a targeted extension of the Supplementary Protection Certificate (SPC) regime, will be an important lever to enhance Europe’s attractiveness for pharmaceutical R&D.

SPCs were introduced to address a structural imbalance: medicines typically take 12 to 15 years to develop, yet the 20-year patent term begins at the time of filing. By the time a product reaches the market, a substantial portion of this limited patent protection period has already elapsed. SPCs restore some of this lost time.

In its current form, the Commission’s proposal is unlikely to move the needle in terms of company investment decision. A new report by Copenhagen Economics shows that Europe faces a strategic choice. If the objective is to strengthen competitiveness, attract R&D investment and support the development of innovative medicines, the SPC extension must be designed as a meaningful innovation incentive, with a sufficiently broad scope and flexible, workable and non-cumulative eligibility criteria.

Strategic enablers for a competitive European biotech ecosystem

A robust Strategic Projects framework can accelerate innovation, support scale-up, reduce fragmentation, and foster high-density innovation clusters that attract investment and talent. At the same time, enhanced and more accessible funding instruments are essential to provide biotechnology companies with the long-term capital needed to develop and commercialise innovations in Europe, preventing the relocation of promising projects outside the EU. Finally, a coherent and innovation-friendly approach to AI governance and data access, aligned with existing regulatory frameworks and supported by secure, interoperable data infrastructures, will enable the responsible integration of AI across the biotechnology value chain.

The choices made today will shape Europe’s long-term strength

Europe has a choice to make. The global life science landscape is shifting, demanding a rapid, bold response.

The Biotech Act is an important signal of the kind of innovation ecosystem Europe wants to create, but it is not a standalone solution. When access to innovative medicines is slow and unpredictable, innovation goes elsewhere.

It is unrealistic to expect greater investment and faster access to new treatments for Europeans if Member States also demand the lowest possible prices and highest government clawback rates. Reversing Europe’s decline in research and development investment would require sustained structural reform, stronger action at the Member-State level, and a rethink of how healthcare systems invest in innovation.

Europe has the science. It has the talent. Now it must create the right conditions for companies to choose Europe as a place to research, develop and deliver new medicines to patients. If we get it right, the reward is higher growth, greater resilience, and better health. The choice is ours.