Impact of Orphan Drug Act on rare disease investment in the US FIGURE 5 Source: Rana, P . and Chawla, S.99Orphan product appr oval Orphan pr oduct designationNumber of orphan products Year0 19831238 6 9 910 11 11 112618 20 20 20 201526 263249 4839 2416 17 15 14 13 13613 13 153949 335771778981 556558 57 57536778 78 6495132 123142 119165 164195203 190260293354 333 701984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 201650100150200250300350400Number of orphan product approvals and designations by FDA (1983-2016) Complexity of climate-health data integration The complexity of climate-health data integration, which involves integrating climate information into routine decision-making in the health sector, is another significant roadblock. One complication is the diversity of regulations governing data privacy and security. Rules such as Europe’s General Data Protection Regulation (GDPR),104 the US’s Health Insurance Portability and Accountability Act105 and China’s Personal Information Protection Law106 impose varying privacy standards. Although these regulations are an important step in data security and digital privacy, they make cross- border data sharing and integration challenging. Building and investing in advanced climate-health data platforms107 that integrate diverse data sets would enable better forecasting108 of climate-driven diseases, improving response times and leading to more targeted interventions.109 Investment in AI-driven platforms that link environmental, biodiversity and health data can help identify disease patterns influenced by climate change, enabling pharmaceutical companies to proactively develop solutions. For instance, the Global Virome Project,110 which unites climate and health experts to predict zoonotic disease outbreaks, serves as a model that could be adapted for climate-sensitive diseases. With better predictive tools, companies can design more effective solutions that address both emerging health risks and longer-term public health impacts. In 2023, private and public sector thought leaders, including WHO, the World Meteorological Organization, the Wellcome Trust and the Rockefeller Foundation, agreed on a three-year action agenda111 to integrate climate and health data and surveillance systems. This includes identifying high-priority gaps and initial requirements for the integration of climate and weather information into health information systems. Healthcare in a Changing Climate: Investing in Resilient Solutions 26

Healthcare in a Changing Climate 2025