The International Generic and Biosimilar Medicines Association (IGBA) in line with its goals of promoting the widest possible access to safe, effective, and quality-assured medicines; and of promoting intellectual property regimes which foster innovation and allow the timely entry of generic and biosimilar medicines, has released its report called “GAMING THE SYSTEM- An overview of originator companies’ evergreening strategies used to hinder access to generic and biosimilar products”.
“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”, said IGBA Chair, Shinichiro Hirose.
This is the first global reference report collecting a compendium of strategies employed worldwide to extend monopolies of patent-protected pharmaceutical products beyond their intended terms including through abuses of the patent system. While genuine, quality patents that protect innovation are key to society across the globe, patents designed to hinder competition are detrimental for patients and healthcare budgets alike and are an abuse of intellectual property regimes. Other market distorting practices such as meddling pricing, volume, and access have the same undesirable consequences for patients and healthcare budgets. Such disruptions in the system preclude generic and biosimilar medicines competition, which negatively affect affordable access to treatment for patients, sustainability of healthcare systems as well as competition more generally, disincentivizing further innovation.
“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 jeopardizes future investments in medicine development.”, indicated Archana Jatkar, Chair of the IGBA International Trade and IP Committee.
“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”, said Sergio Napolitano, Vice-Chair of the IGBA International Trade and IP Committee.
The report provides cases to inform patent offices, health authorities and competition agencies in the prevention of low-quality patent granting. Enabling access to medicines for people around the world requires many stakeholders to work together with a shared understanding and respect for the unique and complementary roles of all actors in the medicine ecosystem.
The full report is available on the IGBA webpage: https://www.igbamedicines.org/doc/IGBA_IP&Comp_Report-v20250123.pdf
Info: info@igbamedicines.org
Geneva, 19 February 2025