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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.

EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.

EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.

EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.

Revision of the Blood, Tissues & Cells (BTC) Legislation offers an important opportunity to ensure regulatory standards safeguarding patient safety and public health keep pace with technical and scientific advances, legal certainty and risk-based flexibility to facilitate innovation, and sustainability of supplies across EU for both therapeutic need and producing products derived from BTC.

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.

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.

The proposed Substances of Human Origin(SoHO) Regulation intends to harmonize measures for Member States and organizations involved in activities related to SoHOs for human application, facilitating cross-border exchange and continuity of supply in the EU. EFPIA supports these aims but is concerned about areas of the SoHO Regulation that appear incoherent with medicinal product regulation.

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.

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity. We welcome the proposed Regulation strengthening Europe’s preparedness against serious cross-border health threats, and believe that it can be improved further to ensure it delivers on its objectives.