{"entity":{"id":"idea-fund-antitrust-safe-harbour","kind":"idea","name":"An antitrust safe harbour for cross-company combination trials and data pooling","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"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)","url":"https://doi.org/10.1001/jamanetworkopen.2020.33972"}],"tags":[],"related":["idea-fund-compulsory-combination-access","idea-fund-trial-data-trust","idea-fund-combination-patent-pool"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-ip-collaboration"],"keyPapers":["paper-danchev-jama-netw-open"],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"small","horizonYears":2},"route":"/ideas/idea-fund-antitrust-safe-harbour/","neighbours":{"idea":[{"id":"idea-fund-compulsory-combination-access","kind":"idea","name":"A legal right to obtain marketed cancer drugs at cost for combination trials","route":"/ideas/idea-fund-compulsory-combination-access/"},{"id":"idea-fund-trial-data-trust","kind":"idea","name":"A single oncology trial data trust with mandatory deposit within eighteen months","route":"/ideas/idea-fund-trial-data-trust/"},{"id":"idea-fund-combination-patent-pool","kind":"idea","name":"An oncology patent pool for combination trials across companies","route":"/ideas/idea-fund-combination-patent-pool/"}],"bottleneck":[{"id":"b-ip-collaboration","kind":"bottleneck","name":"Secrecy and intellectual property block collaboration","route":"/bottlenecks/b-ip-collaboration/"}],"paper":[{"id":"paper-danchev-jama-netw-open","kind":"paper","name":"Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement","route":"/key-papers/paper-danchev-jama-netw-open/"}]}}