# An antitrust safe harbour for cross-company combination trials and data pooling

Source: https://onco.cc/ideas/idea-fund-antitrust-safe-harbour/  
OnCo record `idea-fund-antitrust-safe-harbour` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Companies say competition law stops them coordinating on combination trials and sharing failure data. A clear legal safe harbour for defined pro-patient collaborations would remove that excuse.

## Summary

Competition authorities issue guidance or a block exemption, as the EU has for research and development agreements and as the US did for certain healthcare collaborations, that explicitly protects defined oncology collaborations: joint combination trials, sharing of safety and negative-efficacy data, pooled control arms, pre-competitive target validation and standard combination agreements, subject to transparency conditions (registration of the collaboration, publication of results). Companies frequently cite antitrust uncertainty as a reason not to share data or coordinate trials; whether that is a real barrier or a convenient one, a safe harbour removes it and lets other collaboration proposals proceed.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: After the safe harbour, the number of registered multi-company oncology collaborations involving data sharing or joint trials rises by at least half within two years, and companies stop citing antitrust risk in surveys of collaboration barriers.
- Rationale: The EU R&D block exemption and US National Cooperative Research and Production Act show that legal clarity increases pre-competitive collaboration; regulators including the FDA have encouraged industry data pooling (for example on immune-related adverse events) but companies report legal caution.
- Proposed test: Survey collaboration barriers before and after issuing guidance in one jurisdiction; count registered collaborations meeting the safe-harbour criteria over two years.
- Maturity: speculative
- Actor: policy

## Sources

- Bottleneck evidence (Secrecy and intellectual property block collaboration): Danchev et al., Evaluation of data sharing after implementation of the ICMJE data sharing statement requirement (JAMA Netw Open 2021): https://doi.org/10.1001/jamanetworkopen.2020.33972

## Connected records

- ideas: [A legal right to obtain marketed cancer drugs at cost for combination trials](https://onco.cc/ideas/idea-fund-compulsory-combination-access/), [A single oncology trial data trust with mandatory deposit within eighteen months](https://onco.cc/ideas/idea-fund-trial-data-trust/), [An oncology patent pool for combination trials across companies](https://onco.cc/ideas/idea-fund-combination-patent-pool/)
- bottlenecks: [Secrecy and intellectual property block collaboration](https://onco.cc/bottlenecks/b-ip-collaboration/)
- key papers: [Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement](https://onco.cc/key-papers/paper-danchev-jama-netw-open/)

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