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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
ME
Medicines for Europe

Industry association · Belgium

15
files engaged
of 583 tracked
22
positions filed
in those 583 files
7.9
declared FTE
self-declared
10
EP accreditations
as declared to the register

Declared costs: €500K+ 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

Medicines for Europe · filed 22 Apr 2021 · source

Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines.

Medicines for Europe · filed 29 Sept 2023 · source

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…

Medicines for Europe · filed 29 Sept 2023 · source

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective 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

Medicines for Europe · filed 27 Apr 2022 · source

Medicines for Europe welcomes the chance to provide feedback on the proposal to review the compulsory licensing system in Europe. Medicines for Europe is strongly convinced that voluntary licensing agreements are the right way forward to tackle health crises.

Medicines for Europe · filed 28 Jul 2023 · source

Medicines for Europe welcomes the opportunity to provide valuable feedback on the EC proposal to review the compulsory licensing system in Europe. At Medicines for Europe, we firmly maintain that voluntary licensing agreements present the most effective approach to tackle health crises.

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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