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Grifols, an EU-headquartered leader in plasma collection and fractionation of plasma derived medicinal products (PDMPs), welcomes the opportunity to provide input on the pharmaceutical strategy. As the roadmap noted, the EU is not as competitive as it could be: the current framework lacks dynamism and is not well suited to promote innovation.

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…

Grifols welcomes the opportunity to provide input to the Inception Impact Assessment for the revision of the BTC legislation. This legislation has helped standardize quality and safety requirements for blood, tissues and cells but it has not adapted to an evolving reality for blood establishments and patients who rely on blood products.

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.

Grifols welcomes the adoption of the proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO). The proposal is an important step to modernise the SoHO regulatory framework and has the potential to increase the supply of essential medicines for patients reliant on plasma therapies for rare, chronic and life-threatening conditions.

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the proposal for a regulation 2020/0322 within the framework of better cross-border crisis preparedness and management.

Grifols welcomes the opportunity to provide input on the Regulation on serious cross-border health threats. During recent public health crises, including COVID-19 and Ebola, Grifols has contributed our expertise in the development of plasma-derived therapeutics and diagnostics to aid in the response to these health emergencies. We look forward to working with the Commission to improve resilience.