EU Biotechnology Law Aims to Boost Innovation and Cut Trial Delays

The European Commissioner for Health, Olivér Várhelyi , has presented a proposal for a European Union Biotechnology Law to the European Parliament’s Committees on Public Health (SANT) and Industry (ITRE). This technical initiative aims to prevent legislative fragmentation and ensure that biotechnology investment and production remain within the continent.

According to data provided by the Commissioner, the European share of biotechnology trials has fallen from 18 to 9 percent in the last decade, while China has risen to occupy 30 percent of the global market.

The proposal places clinical trials at the heart of competitiveness. Várhelyi pointed out that the authorization time in Europe is much longer than in competitors such as the United Kingdom or the United States.

To reverse this trend, the European Commission’s proposal introduces a drastic simplification of timelines, streamlining rules and eliminating red tape. The main objective is to reduce the timeframe for trials conducted in multiple countries from the current 106 days to a maximum of 65 days. For trials carried out in a single Member State, the authorization period will be reduced from 75 to 47 days.

This reduction in timeframes, which “will not compromise safety or scientific quality,” will rely on greater coordination among member states. Várhelyi explained that the system must evolve toward a model based on “trusting member state reports and ethical reviews.” With this measure, Brussels seeks to eliminate the legislative fragmentation that currently hinders the sector.

During his address to the European Parliament’s Health and Industry committees, Várhelyi stressed that the legislation will not be a mere regulatory exercise, but a tool to “generate real economic value” that will allow European biotechnology companies to attract global investors and retain innovation on the continent.

One of the most significant announcements has been the commitment to Artificial Intelligence (AI) to optimize research design. According to the commissioner, applying this technology in phase 2 of clinical trials—specifically in the chemical phase, considered the most expensive and time-consuming—would reduce the average execution time from the current five or six years to less than two.

This acceleration would be accompanied by a drastic reduction in operating costs, which Várhelyi has estimated at up to 2 percent of total expenditure, a figure with a significant impact given the volume of investment required for these processes.

Market value incentives

To strengthen the startup and scale-up ecosystem, the Commission proposes extending the Supplementary Protection Certificate as a “fundamental economic incentive.” This mechanism, which grants additional market value to intellectual property, will be conditional on developments presenting a novel biotechnological mechanism or a novel active substance.

Várhelyi has argued that these incentives are “absolutely necessary” for European science, which often ends up being commercially exploited in the United States, to generate wealth within the European Union.

The commissioner also addressed the issue of multi-country trials, acknowledging that Europe “is losing the global race.” The new strategy aims to eliminate bottlenecks in the design of these studies to prevent excessive regulation by member states from acting as a barrier. In this regard, Brussels has opted for a regulation to ensure uniform application of the rules and prevent countries from creating additional conditions that hinder competitiveness.

Orphan and critical drugs

Regarding drugs for rare diseases, the Commission’s approach will shift towards market creation. Várhelyi explained that, with orphan drugs, the main challenge is not the length of development, but the size of the market.

Therefore, the Biotechnology Act will be linked to the future Critical Medicines Act to promote a commercial environment that incentivizes the entry and continued availability of these products in the European healthcare system. “We are doing everything possible to put Europe back on the map for clinical trials.”

Strategic investment and advanced therapies

Funding is another key pillar of the reform. The Commissioner noted that the United States invests nine times more in biotechnology startups than the European Union. To address this capital gap, the Commission and the European Investment Bank (EIB) plan to mobilize € 10 billion this year and next through the Biotech EU program.

This funding will bridge the gap to the next Multiannual Financial Framework (MFF) funding period. Furthermore, the law establishes a new framework for designating strategic biotechnology projects, which will receive specific incentives and protection through intellectual property certificates.

Reactions to the new Biotechnology Law from parliamentary groups

During the debate, the speakers and parliamentary spokespeople expressed their support for the robustness of the proposal, although they pointed out remaining challenges. W. Beke, spokesperson for the European People’s Party ( EPP ) Group in ITRE, emphasized that the legislation has great potential to make Europe a hub for innovation, but noted that none of the ten best-selling products belong to a European company.

In this regard, he stated that “investment in clinical trials is increasingly leaving Europe” and that a “Made in Europe” approach is essential to guarantee patients’ rapid access to effective treatments.

On behalf of the Progressive Alliance of Socialists and Democrats ( S&D ), Dario Nardella welcomed the reduction in timeframes for multinational clinical trials. However, he stressed the importance of maintaining ethical standards and supporting small businesses.

Nardella questioned whether the regulatory simplification would be accompanied by easier access to funding, noting that “intellectual property must have effective protection because, without it, there is no investment.” He also called for guarantees that SMEs can navigate complex regulatory processes without losing competitiveness.

Fragmentation and strategic autonomy

Concern about the brain drain and the loss of capital was a recurring theme in the debate. Margarita de la Pisa Carrión , representing the Health and Industry parliamentary groups, welcomed the focus on improving the connection between research and the market.

The MEP inquired about specific instruments to strengthen innovative capacity and how it would be ensured that “applicable environmental legislation does not become an obstacle to innovation and competitiveness in the biotechnology sector.” She also emphasized the need to strengthen manufacturing capacity within Member States in the context of critical medicines.

Speaking on behalf of Renew Europe , rapporteur Christophe Grudler warned that the European Union cannot afford any more mistakes after witnessing how successful businesses are leaving the EU for the United States. Grudler emphasized that biotechnology is not an abstract concept, but a tool that offers hope to patients with diseases that until recently were considered incurable. The MEP urged a shift from a fragmented response to a coherent strategy that links research with the goals of global leadership.

Finally, Commissioner Várhelyi reiterated that the implementation of the European Health Data Area will be crucial for improving the success rates of clinical trials. The Commission hopes that the Biotechnology Act will pave the way for ideas to be translated into real cures at an accelerated pace. “If we want innovation to stay in Europe, we must act now to create the most appropriate conditions,” the Commission representative concluded.

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(Featured image by ALEXANDRE LALLEMAND via Unsplash)

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