Confidentiality in clinical trials: Arbitration as the preferred route for dispute resolution

In the life sciences sector, clinical trials are the engine of innovation but also a source of risk. Disputes over trial outcomes, safety protocols, or licensing terms can derail product pipelines and irreversibly damage reputations. 

Arbitration offers a private, flexible, and procedurally dynamic forum to resolve these conflicts without exposing sensitive data or commercial strategies.

The legal framework: Arbitral confidentiality under English law

Unlike English court proceedings, which are underpinned by principals of open justice and therefore generally open to the public, English law arbitration is a private process. The default rule under English law is that arbitral proceedings in England are subject to an implied duty of confidentiality. 

This has been taken to mean, amongst other things, that documents produced or disclosed in the course of an arbitration may not be used by the parties outside the arbitration and that third parties are excluded from the hearing and conduct of the arbitration. This confidentiality is an important advantage of arbitration for parties who wish to keep their commercially sensitive information out of the public eye. 

The exact scope of arbitral confidentiality is not defined and is the subject of hot debate. A recent English High Court case, A Corporation v Firm B & Anor [2025] EWHC 1092 (Comm), has clarified elements of the scope of arbitral confidentiality under English law. The judgment confirms that confidentiality extends to: 

• the hearing(s) in the arbitration, including transcripts or notes;
• documents and evidence disclosed in arbitration to another party, in the hands of that other party;
• documents “generated for” or “prepared for” and then used or produced in the arbitration (this would include pleadings, witness statements, expert reports written submissions and correspondence between the parties and representatives);
• information derived from these documents; and
• the arbitral award (decision) itself . 

However, the existence of the dispute itself is not necessarily confidential.

This distinction between court and arbitral proceedings is crucial for life sciences companies, which routinely seek to protect proprietary trial data, unpublished results and internal communications. The case reinforces the value of the arbitration process in shielding sensitive material from public disclosure in the event of a dispute, while allowing for the disclosure of the existence of the dispute itself, for example under public listing rules or in the preparation of annual reports by external auditors. 

Case studies

Coronavirus vaccine supply dispute

A confidential ICC arbitration involving the supply of coronavirus vaccines illustrates these principles in practice. A major pharmaceutical company initiated proceedings against a biotech partner over delays and discrepancies in Phase III trial data. The dispute centred on proprietary trial protocols and sensitive efficacy metrics. This information, if publicly disclosed, could have undermined regulatory approvals and market confidence. Arbitration allowed the parties to resolve the matter privately, preserving both the confidentiality of highly sensitive data and commercial reputation whilst allowing for the dispute to be resolved in a legally enforceable forum.

Manufacturing of high-tech equipment

Another case involved a dispute arising out of the manufacturing of add-on hardware for high-value cancer-treatment equipment across the globe. In that case, the parties disagreed as to whether and how the equipment worked as intended and whether or not it met the pre-agreed specifications under the suite of contracts. The supplier argued that the equipment did work and to the extent that it did not, it was the fault of the Original Equipment Manufacturer (OEM) for failing to make certain parameters available to the supplier during testing. 

The OEM on the other hand argued that the supplier had vastly overpromised on the safety value of the equipment was in any event unable to deliver even basic functionality, either in budget or on time. This highly complex “blame game” is a recurring theme not only in disputes in the life sciences sector but in the technology sector more widely. It is often the very crux of the dispute and it is the duty of the arbitrators to disentangle the various components, both legal and technical. 

In the circumstances, the arbitration proceedings involved intricate expert evidence on international procurement laws, competition laws, marketing principles and conflict of laws. Given the strict emphasis on safety in the relevant industry as well as a very high standard of technological competence offered by the OEM in all of its devices, it was of utmost importance that even the basic details of the dispute remained highly confidential.

By contrast, the existence of the dispute itself was publicly known, including as a result of disclosure obligations in annual reports. As such, this particular dispute demonstrates how arbitration is able to safeguard confidentiality of the parties to the dispute, while allowing the disclosure of key information such as the existence of the dispute and, in a very granular manner, the outcome of the dispute.

The growing trend: Life sciences arbitration

These cases reflect a broader trend. Life sciences disputes are amongst the fastest-growing categories in international arbitration. The reasons are clear: clinical trials involve high-value intellectual property, sensitive data, and multi-jurisdictional regulatory frameworks, some of which inevitably collide. Traditional litigation exposes parties to public disclosure of the results of proprietary research, regulatory scrutiny as a result of court filings and media coverage, reputational risk and jurisdictional complexity (in cases were multiple courts may be seized of the same dispute).

By contrast, arbitration creates a safe, predictable and streamlined space for the parties to a dispute and the decision-makers to analyse and assess the contemporaneous and expert evidence, commercial parameters and fact witnesses without the risk of this information reaching the public domain. 

AI, digital health and confidentiality

As artificial intelligence and digital health technologies become embedded in clinical trials, the confidentiality stakes are rising. Algorithms used in patient stratification, trial design, and endpoint analysis are often proprietary and poorly understood even by their creators. Disputes over algorithmic bias, data handling, or outcome validity will require not just expert evidence but a forum that can handle technical ambiguity and commercial sensitivity without public spectacle.

The integration of real-world evidence, wearable devices, and decentralised trial models adds further layers of complexity. Each innovation generates new categories of proprietary data and new potential flashpoints for dispute. Arbitration's flexibility allows it to evolve alongside these technologies, providing bespoke procedural solutions that courts, which are bound by rigid rules of evidence and disclosure, cannot match.

Conclusion: Arbitration should be a serious consideration

For life sciences companies navigating the complex terrain of clinical research and life-changing client facing technology, arbitration offers a way to resolve disputes with minimal disruption and maximum control. In an industry where a single data breach or premature disclosure can cost billions and delay life-saving treatments, the confidentiality protections afforded by arbitration are invaluable.

For that reason, life sciences companies that are negotiating commercial agreements under which critical confidential information will be shared should seriously consider whether: 

• the agreement should include well-crafted arbitration clauses – to enable arbitral (rather than court) proceedings, including where parties are based in different and multiple jurisdictions;
• it would benefit from including additional clauses that clearly define confidential information (over and above implied arbitral confidentiality) – to avoid uncertainty about whether confidentiality applies to certain information; and,
• it should include an agreed remedy for breach (such as an indemnity or liquidated damages) – to act as a deterrent to breach.

Companies that have entered into such agreements should be vigilant for any indication that confidential information might be disclosed in breach of the agreement. A timely injunction preventing disclosure is often the most desirable remedy in such cases as it preserves confidentiality and removes the need for any protracted claim to prove the cause and extent of the damage.