OECD Paper Compares Regulatory Environments for Biotechnology and Biosolutions between the EU and United States

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February 09, 2026

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by Lynn L. Bergeson and Carla N. Hutton (Bergeson & Campbell) The Organisation for Economic Co-operation and Development (OECD) posted a working paper on January 30, 2026, entitled A comparison of the innovation and regulatory environments for biotechnology and biosolutions across the European Union and the United States. According to the authors, the working paper “strengthens the evidence base for biotechnology policymaking by examining two critical dimensions: innovation-enabling conditions and regulatory practices.”

Focusing on the European Union (EU) and the United States, the working paper provides a comparative assessment of the innovation potential of biotechnologies and of the respective regulatory landscapes. The authors note that both jurisdictions have achieved advanced biotechnology research and innovation ecosystems, industries, and regulatory regimes while following diverging approaches.

Section 1 of the working paper assesses enabling conditions for biotechnology in both jurisdictions, looking at quantitative and qualitative evidence in the areas of intellectual property, entrepreneurship, finance, manufacturing capacity, and skilled workforce access.

Section 2 examines the regulatory landscape, providing a general background on the respective regimes, illustrating the regulatory pathways that a series of biotechnology products undergo in each jurisdiction, and summarizing the cross-cutting challenges they face.

The working paper identifies challenges and opportunities spanning both approaches, including:

Regulatory overlaps: There co-exist both biotechnology and sectoral (e.g., food, agriculture) regulations across European Commission (EC) and EU member states. In the United States, there is jurisdictional overlap between regulatory agencies for genetically modified (GM) products in agriculture, environment, and food.

Regulatory complexity: In the EU, the process-based approach can be intensive and lack clarity with respect to where new technologies fit into the regulatory regime, whereas the United States is comparatively streamlined and rapid as GM products are often determined to be of “substantial equivalence” to conventional counterparts.

Flexibility: The EU system features strict data requirements from regulators with modest possibility for derogations. In the United States, there are more streamlined processes of voluntary applications and limited reviews since liability rests on the producer, although some are concerned about gaps in reviews.

Pre-submission consultation: In the EU, discussions between innovators and regulators are limited, which can lead to inefficient review processes and time-consuming requests for additional data. According to the working paper, the United States system offers more interaction that allows innovators to clarify and negotiate data requirements and discuss petitions of non-regulated status.

Approval times and cost. Length and complexity of regulatory approval process is greater in the EU. The United States features shorter timeframes and costs due to clearer testing requirements and faster approval/notification processes.

The OECD published policy recommendations stemming from the working paper in its policy paper entitled “Boosting biotechnology innovation through agile regulation and finance instruments” in November 2025. The working paper provides the evidence base to support those policy recommendations. More information on the policy paper is available in our December 3, 2025, blog item. READ MORE

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OECD Policy Brief Explores Biotechnology Investment and Regulatory Policy Landscapes in the EU and United States (Bergeson & Campbell)

Excerpt from Bergeson & Campbell: The policy brief lists the following key messages:

The United States attracts substantially more venture capital funding than the EU across the different fields of biotechnology. Investment in biosolutions in the EU also lags behind the United States, but the gap is smaller.

Regulatory hurdles to biotechnology innovations are particularly acute in the EU. OECD notes that innovators “cite regulatory complexity, lengthy approvals and fragmented oversight as major barriers to bringing innovations into the market.”

Predictable and transparent regulations can strengthen investor confidence. Evidence points to a correlation between how well governance systems are perceived to function and the level of financing that the two regions attract.

Agile regulation and collaboration across jurisdictions are needed. According to OECD, governments could reduce bottlenecks by promoting early engagement between innovators and regulators, well before formal approval reviews, and by experimenting with tools such as regulatory sandboxes and innovation test beds.

Smarter financing can de-risk innovation and boost demand. OECD states that driving biotechnology innovation will require a mix of financial instruments to de-risk investment and to stimulate demand. A coherent strategy could combine targeted de-risking tools, blended finance, and market-shaping policies — all anchored in predictable and transparent regulation. READ MORE