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As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care.

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.

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.

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial consultation regarding the revision of the Union legislation on blood, tissues and cells.

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.

MedTech Europe welcomes the Proposal for a Regulation on substances of human origin adopted by the European Commission in July 2022. We agree that the sector needs updated legislation, and the proposed text reinforces the rules for safety and quality. We are looking forward patients to having smooth access to products, the availability of which is uninterrupted on the European market.

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.

MedTech Europe welcomes the objective of the European Commission’s proposed ‘Health Union’ package of 11 November 2020. Better coordination and pooling of efforts are needed across the Union to strengthen Europe’s preparedness to tackle future public health emergencies, and the proposed Regulation on serious cross-border threats to health constitutes an important step in this direction.