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Joint Swedish response to the EU’s new life science strategy
Ahead of the EU Commission’s presentation of a new strategy for life sciences, four industry organizations in Sweden, Lif – the research-based pharmaceutical companies, SwedenBIO, IKEM, and Swedish Medtech, have submitted a joint statement.
April 16, 2025
Competition from other regions is intensifying and the EU has over time lost ground to the US and China, which are investing heavily in research, production and data-driven health innovation. There is now an urgent need for action to strengthen Europe’s competitiveness, states the organizations.
The new strategy must focus on concrete reforms.
“The EU has a choice to make. Either we act and secure Europe’s position as a leading region for research and innovation, or we watch as others take the lead. The new strategy must focus on concrete reforms. Better incentives for innovation, regulatory simplification and a more coordinated view of production, trade and sustainability,” says Sofia Wallström, CEO of Lif.
A life science office in Brussels
The main recommendation raised by the four actors is the establishment of a life science office in Brussels to coordinate work across all EU authorities and entities working on issues that directly or indirectly affect the life science industry.
The Swedish government’s life science office is highlighted as a successful example.
Regulatory simplification
The stakeholders highlight regulatory simplification as another high-priority recommendation and call on the EU to ensure that all proposals are accompanied by impact assessments to ensure that policies promote innovation rather than hinder it.
“Revisions to the Medical Devices Regulation and the In Vitro Diagnostics Regulation are needed. This requires regular consultations with the industry to be formalized,” says Anna Lefevre Skjöldebrand, CEO, Swedish Medtech.
A more balanced legislation, which combines innovation, competitiveness, safety, and sustainability, is crucial for Europe’s innovation capacity and for a strong ecosystem in life sciences.
For legislation to truly contribute to a competitive and innovative Europe, the organizations emphasize the importance of a new approach.
“We need a new approach where legislation weighs industrial and societal benefits against risks. A more balanced legislation, which combines innovation, competitiveness, safety, and sustainability, is crucial for Europe’s innovation capacity and for a strong ecosystem in life sciences,” says Jonas Hagelqvist, CEO, IKEM.
A binding EU body responsible for approving multinational clinical trials
Another proposal concerns clinical trials. Although the EU has taken steps in the right direction, challenges remain for those wishing to conduct multinational clinical trials. To simplify the process, the four actors propose the establishment of a binding EU body responsible for approving multinational clinical trials.
New clinical trial map launched in the EU
A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS).
“The strategy should promote effective coordination between national ethical review boards and regulatory authorities, as well as establish an EU body with a binding mandate to approve multinational clinical trials – this will significantly simplify and accelerate the start of trials throughout Europe,” says Jessica Martinsson, CEO, SwedenBIO.
US market tariffs: Impact on the life science industry
At a White House press event on Wednesday April 2, President Trump advanced the next stage of his economic plan by unveiling baseline tariffs of 10% on the vast majority of goods imported to the US. After several years of increasing export figures, Sweden’s pharmaceutical exports now risk being severely affected by the Trump administration’s tariffs, warns the industry association SwedenBIO.
The report covers many issues affecting the life science industry with concrete solutions that the European Commission is urged to include in its upcoming strategy. The joint input paper has been submitted to the EU Commission, Swedish decision-makers and other relevant actors within the EU institutions.
Published: April 16, 2025
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