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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.

BIO
Biotechnology Innovation Organization

Industry association · United States

2
files engaged
of 583 tracked
2
positions filed
in those 583 files
declared FTE
self-declared
EP accreditations
as declared to the register
16
files engaged
of 583 tracked
24
positions filed
in those 583 files
4.4
declared FTE
self-declared
10
EP accreditations
as declared to the register

Declared costs: €800K+ a year · in the register since 2009

Files both filed on (2)

Medicinal products for human use · Compulsory licensing of patents in crisis situations

Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.

What each said, in their own words

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.

Medicinal products for human use

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) · filed 27 Apr 2021 · source

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.

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) · filed 5 Sept 2023 · source

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…

Biotechnology Innovation Organization · filed 8 Nov 2023 · source

BIO supports the EUs objectives of increasing access to medicines and fostering innovation. We welcome the EUs efforts to enhance the regulatory environment, including the use of expedited pathways, streamlining regulatory decision-making processes, and reducing administrative burdens.

Compulsory licensing of patents in crisis situations

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) · filed 28 Apr 2022 · source

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the European trade association for small to mid-sized innovative companies active in the field of pharmaceuticals and medical technologies at the European level.

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) · filed 28 Jul 2023 · source

The development of new medicines requires extensive research and considerable time and resources, the path from basic research to a new authorised medicine is long and involves many uncertainties. To deal with uncertainties, and the long timelines for development and marketing authorisation, IP rights are fundamental.

Biotechnology Innovation Organization · filed 30 Jul 2023 · source

BIO is deeply concerned with the Commissions initiative to revise its compulsory licensing (CL) legislation. The proposal of a revised CL regime suggests that the envisioned new framework remedies a dysfunctional system despite no objective evidence that the existing regime is inadequate.

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