AmCham EU responds to impact assessment on medicines for children and rare diseases
AmCham EU responded to the recent inception impact assessment on the revision of the EU legislation on medicines for children and rare diseases. In the response we encouraged the European Commission to protect frameworks that stimulate R&D, to build on the EU’s strengths and to incorporate learning from other regions. Read the full response here.
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Healthcare, competitiveness, innovation and simplification
Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation.
The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment.
The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains.
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Strengthening EU competitiveness through an adaptive MDR/IVDR framework
A global approach to strengthening Europe’s biotechnology ecosystem
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