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THE CHANGING WORLD // EUROPE PHOTO IDA WANG “We n
eed to make Europe even more enticing so that people choose to come and live and work here. We also need to create international centers of excellence combining world-class academia with an inspiring start-up community, entrepreneurial spirit, and access to lab facilities and top-notch hospitals.” NIELS ABEL BONDE Regulatory simplification The European Commission will soon release a new Strategy for European Life Sciences, to be adopted in 2025. It has been 22 years since the last one was developed. Stakeholders had until April 17, 2025 to provide the Commission their views and help design the strategy. In April four industry organizations in Sweden, Lif – the researchbased pharmaceutical companies, SwedenBIO, IKEM – the industry and employer organization for Sweden's innovation and chemical companies, and Swedish Medtech – the Association for Medical Technology in Sweden, submitted a joint statement emphasizing the need for a focus on concrete reforms. They stressed that for legislation to truly contribute to a competitive and innovative Europe, the EU needs a new approach where legislation weighs industrial and societal benefits against risks. A recommendation raised by the organizations was the Niels Abel Bonde, Chairman, Medicon Valley Alliance The main recommendation raised by the four organizations was 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. EFPIA has also recommended that the Commission ensure leadership through a dedicated Office for Life Sciences in the Commission and dialogue with the sector via a new European Life Sciences Council. The EFPIA also suggests putting resources into reforming the regulatory system to make it more agile for faster approvals of new medicines, as well as investment in modern manufacturing. Multinational clinical trials Another proposal to the EU from the four Swedish life science organizations is related to clinical trials. Although the EU has taken steps in the right direction, challenges remain for those who wish to conduct multinational clinical trials. “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,” stated Jessica Martinsson, CEO of SwedenBIO. US market tariffs While pharmaceutical companies have not yet been subject to reciprocal tariffs, the Trump administration is considering launching a so-called 232 investigation into pharmaceuticals, which could lead to import duties under the Trade Expansion Act. Speaking at an event at the National Republican Congressional Committee in April, Trump said the tariff will incentivize drug companies to move their operations to the US, reported Reuters. SwedenBIO stated that this temporary relief is welcome, as time is of the essence, but the problem remains and must 36 | NORDICLIFESCIENCE.ORG