Regulatory Data Protection (RDP) is a type of intellectual property that safeguards the confidential data biopharmaceutical innovators submit to government regulators to prove a medicine’s safety and effectiveness. It prevents disclosure and, for a limited period, bars third parties from relying on confidential data to obtain marketing approval. RDP works alongside patents to incentivize and protect investment in new treatments while improving access: countries with RDP have access to three times more innovative medicines than those without it. And yet, too many countries fall short on this critical protection.

Global trade rules require countries to implement RDP. Despite these international obligations, some countries lack enforceable RDP systems, allow third-party reliance on confidential data during protection periods, or are considering weakening their RDP regimes. For example:

• Argentina helped write the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) provision requiring RDP. However, Argentinian law explicitly allows third parties to use confidential data submitted by innovators to obtain approval for follow-on products.
• China committed to providing RDP under its accession to the World Trade Organization. However, China does not have a mechanism to grant RDP, and follow-on manufacturers appear to improperly rely on originator confidential data to secure approvals for their products.
• The European Union is seeking to erode RDP protections by conditioning them on market access and other stipulations, introducing uncertainty that could dampen innovation and patient access.
• Mexico does not provide RDP for all medicines, contrary to its commitments under the United States-Mexico-Canada Agreement (USMCA).

Without strong, enforceable RDP, the risks and costs of developing new medicines increase. Weak or inconsistent RDP allows competitors to shortcut the development process, relying on data they didn’t produce— and disincentivizing investment by innovators. Weak RDP protections undermine both scientific progress and patient access. 

Upholding international commitments to provide adequate and effective RDP is essential to encourage the next generation of treatments and cures, and to ensure that patients around the world can benefit from them. The time to act is now.