ARM works with the EU institutions in Brussels and national decision-makers to advance policies that promote innovation and access to advanced therapies.
As the EU develops its biotech vision amid fierce global competition, ARM advocates for decisive measures to build a competitive ecosystem that nurtures innovation, attracts investment, and ensures patients across Europe benefit from advanced therapies.
While Europe has world-class science capabilities, fragmented policy frameworks threaten its ability to lead in the development of advanced therapies. ARM is spearheading actions to harmonize the use of the hospital exemption, simplify GMO rules, and ensure future-proof regulatory frameworks.
Health technology assessments (HTAs) evaluate products to inform reimbursement decisions. The EU’s JCA seeks to improve patient access by centralizing clinical assessments. ARM is driving efforts for the JCA to consider all available evidence when assessing advanced therapies.
ARM welcomes the publication of the European Commission’s EU Biotech Act as a potential turning point for Europe’s advanced therapies agenda. The act takes important steps toward advancing Europe’s advanced therapy (ATMP) landscape.
ARM regularly comments on EU legislative proposals, initiatives, and other policies shaping the future of cell and gene therapy.
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