IGBA releases first global Intellectual Property and Competition Report

The International Generic and Biosimilar Medicines Association (IGBA) has released a report titled “Gaming the System – An Overview of Originator Companies’ Evergreening Strategies Used to Hinder Access to Generic and Biosimilar Products.” The report outlines market practices that delay the entry of generic and biosimilar medicines, affecting affordability and competition in global healthcare.

IGBA Chair, Shinichiro Hirose, emphasised the need for regulatory balance, stating, “The report’s findings highlight the urgent need to reinforce the balance in intellectual property and regulatory systems to address market abuses. Healthy competition requires clear guardrails, which is why we are taking a lead to raise awareness and invite conversation and action to rebalance innovation and access for the future.”

The report compiles global examples of strategies used to extend patent monopolies beyond their intended terms. It highlights the impact of patent system abuses, where patents designed to limit competition negatively affect patients and healthcare budgets. Other market practices, such as influencing pricing, volume, and access, contribute to restricted availability of generic and biosimilar medicines. These practices create barriers to competition, limiting affordable treatment options and affecting the long-term sustainability of healthcare systems.

Archana Jatkar, Chair of the IGBA International Trade and IP Committee, pointed to the widespread nature of the issue, stating, “This report shows that no region is immune to practices delaying the launch of safe, effective, cost-effective, and quality-assured medicines. Practices previously seen in the U.S. and Europe are increasingly being observed in emerging markets. This leads to lost savings and jeopardises future investments in medicine development.”

The report includes recommendations to address these challenges. Sergio Napolitano, Vice-Chair of the IGBA International Trade and IP Committee, outlined the key proposals, stating, “Key recommendations include recognition by stakeholders that the problem needs to be addressed; enhanced collaboration among competition authorities, patent offices, and health authorities to share information on practices leading to delayed access; and the need for robust patent offices granting quality patents.”

The findings aim to inform patent offices, health authorities, and competition agencies in preventing the granting of low-quality patents. The report calls for coordinated efforts among stakeholders to ensure access to medicines, emphasising the importance of a balanced approach to innovation and competition within the pharma sector.