Side by side
Consultation participation and their own register declarations, side by side. Counts, not judgments — participation is not influence.
Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
NGO · Belgium
Declared costs: not declared · in the register since 2014
Industry association · Belgium
Declared costs: €6M+ a year · in the register since 2009
Standards of quality and safety for substances of human origin intended for human application · Revision of the EU legislation on medicines for children and rare diseases
Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.
Their opening passages on the files they share, verbatim and in filing order. We do not summarize, compare, or characterize positions — read them at source.
EFPIA · filed 11 Dec 2020 · source
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.
European Haemophilia Consortium (EHC) · filed 14 Dec 2020 · source
The EHC is pleased to see that the revision of the legislation maintains its original objectives, i.e. to ensure safety and quality of blood components as well as to safeguard the health of patients and donors. This is paramount to the rare bleeding disorders community, which in the past has experienced first-hand devastating effects of the lack of provisions ensuring safety and quality of plasma-derived therapies…
European Haemophilia Consortium (EHC) · filed 8 Sept 2022 · source
The European Haemophilia Consortium (EHC) welcomes the European Commission’s proposal for a regulation on quality and safety standards for substances of human origin. The EHC represents European people with rare congenital bleeding disorders, including haemophilia and von Willebrand Disease. For some of these conditions, plasma-derived medicinal products (PDMP) remain the primary source of treatment.
EFPIA · filed 8 Sept 2022 · source
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.
European Haemophilia Consortium (EHC) · filed 6 Jan 2021 · source
The European Haemophilia Consortium (EHC) welcomes the revision of paediatric and orphan medicinal products' regulations. In haemophilia, the OMPR has brought much innovation in the past decade; however, we are disappointed to see that the uptake from the Member States has been variable.
EFPIA · filed 6 Jan 2021 · source
EFPIA members are committed to ensuring that unmet needs are addressed and that available treatments reach all European patients. Children and rare disease (RD) patients have greatly benefited from the progress achieved through the Paediatric and Orphan Regulations. The Paediatric Regulation is meeting best-case expectations from its impact assessment (IA) conducted in 2004.
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