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Rare Cancers Europe (RCE), a 40-partner strong multi-stakeholder partnership, welcomes the consultation and would like to emphasise the following: 1. Ensure access: • HTA: RCE encourages the harmonisation of HTA processes and to ensure the concept of joint clinical assessments, to avoid the duplication of clinical assessments at national level, as foreseen by the draft HTA regulation.

The American Chamber of Commerce to the EU (AmCham EU) is committed to the development of a regulatory environment which furthers the capabilities of European healthcare, improving accessibility and ensuring a crisis-resistant medicines regulatory system.

Introduction To be truly future proof and innovation friendly, the EU's proposed pharmaceutical package must address the blocs declining attractiveness for investment. We therefore urge EU co-legislators to secure globally competitive incentives for research and development (R&D) and avoid additional unnecessary administrative burdens on companies.

Introduction To be truly future proof and innovation friendly, the EU's proposed pharmaceutical package must address the blocs declining attractiveness for investment. We therefore urge EU co-legislators to secure globally competitive incentives for research and development (R&D) and avoid additional unnecessary administrative burdens on companies.

Rare Cancers Europe (RCE), a 40-partner strong multi-stakeholder partnership, welcomes the EU efforts towards the creation of a European Health Data Space (EHDS). Rare cancers are a neglected area deserving dedicated attention as 24% of all new cancer diagnoses, including all paediatric cancers, are rare.

The American Chamber of Commerce to the European Union (AmCham EU) shares the European Commission’s view that EU-level action is required to address the fragmented environment of European health data, the lack of data available for (re-)use in scientific research and the need for increased uniformity in Member States’ applications of data regulations.

AmCham EU speaks for American companies committed to Europe on trade, investment and competitiveness issues. It aims to ensure a growth-orientated business and investment climate in Europe. AmCham EU facilitates the resolution of transatlantic issues that impact business and plays a role in creating better understanding of EU and US positions on business matters.

EuropaBio welcomes the European Commission’s bold ambition to make Europe the most competitive data economy globally. The power of data in the healthcare sphere is evident and realising the potential of healthcare data is a crucial step to ensure the EU is a leader in the development of next generational medicines.

Rare Cancers Europe (RCE), a 39 partner strong multi-stakeholder partnership, welcomes the EU efforts to assessing solutions to improve the legislative environment on medicines for rare diseases, including rare cancers. With more than 20% of all new cancer cases being rare, including all paediatric cancers, rare cancers belong to both cancers and rare diseases.

Representing American companies operating in the EU, AmCham EU is well aware of the differences and respective strengths of innovation ecosystems on both sides of the Atlantic. The options laid out in the inception impact assessment (IIA) risk undermining an EU framework that has proven largely successful, rather than preserving the EU’s strengths and incorporating learnings from other regions.