BioMed Alliance believes that certain aspects of the Omnibus proposals might reduce some of the barriers to data driven health research, and quality assurance of AI-based software tools implemented in clinical practice, while others may open the door for potential misuse and reidentification of patients based on sensitive health data.
BA
BioMed Alliance
Other · Belgium · EU Transparency Register 876034021209-88
12
positions filed
in the 665 files tracked
9
legislative files
of 665 tracked
12
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,800 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
Who they are
Among the 410 trade unions and professional associations on this site, they rank #61 by legislative files engaged, a count of participation, not a measure of influence.
3
declared lobbying FTE
self-declared
€100K+
declared costs / yr (floor)
2
EP accreditations
as declared to the register
2016
in the register since
Declares membership of
- http://www.biomedeurope.org/about/members.html
- https://www.biomedeurope.org/about/cooperation.html
Self-declared to the EU Transparency Register (snapshot 15 Oct 2026).
- Register category
- Trade unions and professional associations
- Registered as
- Biomedical Alliance in Europe (the BioMed Alliance)
- Head office
- Brussels, Belgium
Self-declared to the EU Transparency Register (snapshot 15 Oct 2026); cost bands are floors, not audited totals. Reused under Commission Decision 2011/833/EU.
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Their record over time
BioMed Alliance filed 12 positions between 3 Feb 2021 and 5 Aug 2026, across 9 of the 665 legislative files tracked here, attaching a full position paper 12 times.
2021 · 1 filed2022 · 2 filed2023 · 1 filed2025 · 4 filed2026 · 4 filed
What they argued
BioMed Alliance welcomes the European Commissions intention to simplify digital rules including through the Digital Omnibus Package but urges policy makers to take into account the specific circumstances in different sectors.
The 34 European Medical Societies that the BioMed Alliance represents believe that reform of the regulatory system is necessary, as some of the unintended consequences of the MDR and IVDR implementation led to high costs and reduced availability of essential devices and diagnostics .
--Please find our response to the call for evidence attached-- SUMMARY: The BioMed Alliance supports the objectives of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to safeguard patient safety and ensure innovation. However, implementation has revealed significant challenges that must be addressed to protect patients access to safe, effective, and innovative technologies.
BioMed Alliance (35 medical & research societies) calls on policy makers to ensure that the next multiannual EU budget will be fit-for-purpose to address current and future health threats. We ask the Commission, the Council and the Parliament to ensure strong, ringfenced health funding in a dedicated cluster or window, and to ensure that patient needs will be met.
The BioMed Alliance (representing 36 medical societies) welcomes the objectives that the European Commission set for the revision of the EU pharmaceutical legislation. We recognise that there are persisting issues including problems with the access, the affordability, and the availability of medicines.
The BioMed Alliance welcomes the European Commissions initiative to develop a European Biotech Act as an important opportunity to strengthen Europes biotechnology ecosystem, enhance its global competitiveness and accelerate the translation of scientific innovation into solutions that benefit society.
BioMed Alliance vision on the EHDS: The European Health Data Space could have a transformative effect on the healthcare and research sectors by facilitating health data sharing and use for primary and secondary purposes.
The BioMed Alliance welcomes the European Health Data Space (EHDS). We believe it can play an important role in facilitating health data sharing to improve the health of European citizens. The 35 members of the BioMed Alliance contribute to this mission in multiple ways; they conduct health research, provide information and education to healthcare professionals and strive to improve European healthcare in general.
The BioMed Alliance welcomes the European Commissions intention to improve research in Europe through the development of a new European Research Area Act. We hope that the Act will play a role in supporting the fifth freedom, the free movement of researchers, scientific knowledge, and technology in the EU single market, but it needs to be fit for purpose and not add unnecessary regulatory complexity.
We welcome the European Commissions intention to review the complementarity, efficiency and effectiveness of the EU digital rulebook. The EU digital sector, and particularly the digital health sector, are burdened by a large number of overlapping regulatory frameworks that enhance regulatory complexity and put a burden on different actors in the system.
The Biomedical Alliance in Europe (BioMed Alliance) welcomes the efforts of the European Commission to ensure a full single market freedoms for associations, simplifying their cross-EU activities and promoting their fundamental rights.
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Quotes are verbatim from submissions published by the European Commission, trimmed to their opening passage and never summarized by a model. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.