Biotech industry groups, Biotechnology Innovation Organization (US) and EuropaBio (Europe), weigh in on evolving US trade policy and how to strengthen the life-sciences industry’s competitiveness.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Weighing in on tariffs
How tariffs will evolve in the US is very much a situation in flux, but two industry associations representing the biotechnology industry, the Biotechnology Innovation Organization (BIO) in the US and EuropaBio in Europe, have both issued statements over the negative impact that tariffs could have. As it stands now (as reported on April 24, 2025), the US government has imposed a baseline tariff of 10% on all US imports and two additional sets of tariffs are under consideration: (1) reciprocal taxes, which are imposed on a country-by-country basis and (2) specific pharmaceutical industry tariffs.

The Trump Administration first laid out a plan for imposing reciprocal tariffs in February (February 2025) as a means to counter non-reciprocal trading arrangements with its trading partners and as a way to improve US competitiveness, including in manufacturing. Those reciprocal taxes were scheduled to go into effect on April 9, 2025, but the Administration placed a 90-day pause (until July 9, 2025) on their implementation to enable countries to negotiate these tariffs with the US government. One exception was China, which had issued trade countermeasures in response to the pending reciprocal tariffs imposed on it. It is now subject to a 125% import tariff announced by the White House on April 9, 2025, plus an additional 20% fentanyl-related tariff already imposed in February and March (2025), effectively creating a 145% tariff rate on imports to the US from China.

Another set of tariffs, separate and specific to the pharmaceutical industry, are also under evaluation. Earlier this month (April 2025), the US Department of Commerce initiated an investigation to determine the effects on US national security of imports of pharmaceuticals and pharmaceutical ingredients. The investigation was initiated under Section 232 of the Trade Expansion Act of 1962, as amended, which allows the President to impose import restrictions based on an investigation and affirmative determination by the US Department of Commerce that certain imports threaten to impair US national security. In general, a Section 232 investigation considers the following (1) existing domestic production of the product; (2) future capacity needs; (3) manpower, raw materials, production equipment, facilities, and other supplies needed to meet projected national defense requirements; (4) growth requirements, including the investment, exploration, and development to meet them; and (5) any other relevant factors. For pharmaceuticals, the US Commerce Department provided public notice in the Federal Register of its Section 232 investigation into pharmaceuticals and is requesting public comment by May 7, 2025.

Throughout this process, the biotechnology industry, via BIO and EuropaBio, which represent both large and small biotechnology and bio/pharmaceutical companies, have commented on the potential harmful impact that tariffs would have on the industry. In late March (March 26, 2025), BIO released the results of a survey of its members taken in February (February 2025) that underscored the global nature of the bio/pharmaceutical supply chain and the negative impact that tariffs would have, particularly on imports from the European Union (EU). Globally, according to the study, nearly 90% of US biotech companies rely on imported components for at least half of their FDA-approved products. With respect to the EU specifically, the study found that 94% of biotech firms anticipate higher manufacturing costs if tariffs are placed on imports from the EU and that proposed tariffs on the EU would oblige 50% of companies to potentially find new research and manufacturing partners. In addition, overall, half of those companies surveyed say they would have to rework or potentially delay regulatory filings, and 80% of biotech companies said they would need at least 12 months to find alternative suppliers, and 44% said it would require more than two years.

“This survey demonstrates the far reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” said BIO President and CEO John F. Crowley, in a March 26, 2025, statement. “We fully support strong policies and programs that incentivize the manufacture of medicines here in America. Re-onshoring key parts of the biotechnology supply chain to the US and our allies and strengthening the American manufacturing base should be a high priority for both national and economic security. It will take years, though, for this shift, and we need to be mindful of the negative consequences of these proposed tariffs.”

EuropaBio, which represents biotech and bio/pharmaceutical companies in Europe, weighed in on the tariff situation earlier this month (April 8, 2024) prior to the 90-day pause on reciprocal taxes and the later action of the US government to initiate an evaluation of specific tariffs on the pharmaceutical industry. It called for an exemption of tariffs on bio/pharmaceuticals and a continuation by EU policymakers to advance the competitiveness of the EU biotechnology industry through several strategic policy and legislative proposals.

“In this critical moment, EuropaBio actively supports the European Commission, our company members and national biotech associations to enhance EU ambition, competitiveness and attractiveness for biotech innovators of all sizes,” said EuropaBio, in an April 8, 2025, statement. “Specifically, EuropaBio calls for an exemption for biopharmaceuticals and their manufacturing inputs, plus strengthening biotech value chains, to preserve and grow global resilience and positioning. We have called on the [European] Commission to accelerate the positive work already underway for biotech through the Biotech Communication of 2024, with regulatory streamlining, and the EU Biotech Act. This ambition should also be translated into related initiatives, including the Life Sciences Strategy, Pharma Package, and Bioeconomy Strategy, to secure EU leadership across value chains and industrial ecosystems.”

EU’s Life Sciences Strategy
The European Commission is preparing a new Strategy for European Life Sciences, to be adopted in 2025, as a means to strengthen life-sciences research and innovation in the EU and invited public comment on the strategy, which ended last week (April 17, 2025). Both EuropaBio and the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents innovator drug companies and national pharmaceutical association in Europe, issued recommendations for the European Life Sciences Strategy to be considered by EU policymakers.

EuropaBio’s recommendations
A key point made by EuropaBio is that EU policy needs to better support product innovation and the translation of research into commercial products through greater public spending in R&D, incentives for financial and capital markets as well as regulatory reforms.  

With respect to financial and capital markets, EuropaBio is recommending several actions as outlined below.

Biotech and Life Science Index. Establish a Biotech and Life Science Index allowing biotech companies to raise capital, including in later stages, where significant gaps exist, from EU investors in high liquidity markets.

Biotech for Europe Initiative. Establish a Biotech for Europe Initiative to support the acceleration of R&D and development of biotech and biomanufacturing through direct financing (loans and grants) for development and/or scale-up programs in the EU.

Improve EU financial and capital markets for innovation. Take forward the measures announced in the European Commission’s Communication on a Savings and Investment Union (an initiative to improve the way the EU financial system channels savings to productive investments) to improve the competitiveness of EU financial and capital markets for innovation-driven industries.

Patent reform. Accelerate the roll-out of the Unified Patent System, including creating a one-stop shop for patent protection and enforcement across the EU and encourage all EU member states to ratify and implement the agreement.

EU R&D funding support. Support life sciences innovation by preserving “Framework Program 10” funding levels (the EU’s funding plan to support, research, science and innovation) and continue to support public-private partnerships.

University funding support. Accelerate academic discovery into industry by earmarking additional EU funding for universities with high-tech transfers/spin-offs and establish metrics to measure impact of discovery of translational research and incentivize higher technology readiness levels.

On the regulatory front, EuropaBio is recommending the following actions.

AI and digital transformation. Accelerate the digital transformation, including the use of AI, in priority areas such as green processes, product approval processes, and administrative requirements.

Support for SMEs. Introduce “Competitiveness” and “Fit for SME [Small to Medium-Sized Enterprises]” criterion within the Better Regulation guidelines (principles that the European Commission follows when preparing new initiatives and proposals) and revise the “coherence” criteria” (criteria to include that EU policies function clearly and do not contradict each other) to include impact across legislations beyond the immediate policy area, such as horizontal legislation (e.g., chemicals, environmental, sustainability).

Biotech product approval process. Modernize biotech product approval pathways to accelerate time to market and be innovation-proof for all biotech products, including from genetic modifications, as well as use of innovative tools such as regulatory sandboxes.

Clinical trial reforms. Review the Clinical Trials Regulation to create an EU environment capable of supporting large-scale and multi-country clinical trials, including by improving the coordination between committees and streamlining approval timelines for clinical trials to reduce burden on authorities and sponsors.

Regulatory approval process. Modernize the European Medicines Agency’s centralized procedure approval pathway to introduce greater flexibility that can accommodate the growing number of biotech therapies in the pipeline, including fit-for-purpose requirements, quality controls, standards, and acceptance of real-world evidence.

Improved and coordinated government and EU member state administration. EuropaBio is also calling for moves to improve coordination among EU member states and related EU government bodies. One suggested measure is to create an EU Biotech & Life Science Office, headed by a Chief Biotech Officer, within the European Commission Secretariat General responsible for improving coordination and collaboration across all Commission directorates to ensure coherence and to designate national Biotech Offices to foster policy coherence and the creation and scale-up of biotech innovators across the EU.

EFPIA’s recommendations
Like EuropaBio’s recommendations, EFPIA’s recommendations are centered on ways to cultivate product innovation while strengthening manufacturing. Its comments are centered in four main areas: (1) translating research into innovative products; (2) restoring EU’s leadership in clinical trials; (3) strengthening the EU’s manufacturing base; and (4) ensuring timely and equitable access to innovation.

With respect to manufacturing, EFPIA is calling on EU policymakers to focus on two key areas: (1) align environmental, chemical and animal welfare policy with open strategic autonomy ensuring essential substances (e.g., polyfluoroalkyl substances and titanium dioxide) are not unduly restricted as to risk medicine supply and (2) fund next-generation manufacturing and workforce reskilling for sustainable production.

On the clinical trial front, EFPIA says that Europe has lost 60,000 clinical trial places to other regions, thereby weakening its global role in drug development. To address that, it is recommending that the EU should streamline approvals for multi-country clinical trials to reduce delays and maintain Europe’s attractiveness to conduct clinical trials. EFPIA is also calling for effective implementation of the European Health Data Space regulation, which regulates the use and exchange of electronic health data in the EU, and regulation on artificial intelligence to enable data-driven innovation, guard citizens’ privacy and, protect and promote industrial innovation.