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The proposed impact assessment will form a good foundation for revision of the general pharmaceutical legislation. We would however emphasise the importance of devoting sufficient attention to the proper functioning of the legislation regarding off-patent medicinal products. There are substantial differences in access, affordability, sustainability and security of supply for off patented and patented medicines.

EUCOPE is the voice of small to midsize innovative companies active in the field of pharmaceuticals and medical technologies at the European level. The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness.

EUCOPE acknowledges the objectives of the review. While numerous regulatory provisions will streamline the functioning of the market, changes to the incentive framework outweigh these, weakening EU global competitiveness.

EUCOPE acknowledges the objectives of the Pharmaceutical Package, and welcomes maintaining a separate Directive and Regulation for decentralized and central approval processes. While we appreciate streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will undermine R&D, innovation, EU competitiveness, and be particularly detrimental for patients and small and…

Comments from the Norwegian Medicines Agency on the Inception Impact Assessment for the revision of the Union legislation on blood, tissues and cells The Norwegian Medicines Agency (NOMA) welcomes the possibility to comment on the Commission’s Inception Impact Assessment for the revision of the blood, cell and tissue (BTC) legislation. NOMA acknowledges the need for revision of the BTC legislation.

EUCOPE, the voice of small to mid-sized innovative companies active in the field of pharmaceuticals, bio- and medical technologies at the European level, shares the Commission’s views that the Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC (the BTC legislation) does not provide adequate measures for self-sufficient supplies of blood, tissues and cells and that divergent approaches at…

EUCOPE welcomes the proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. We welcome the transition of the BTC Directives into one Regulation which will increase regulatory predictability and harmonization. We welcome the continued regulatory delineation between BTCs and pharmaceutical products to increase regulatory predictability.